[Senate Hearing 117-400]
[From the U.S. Government Publishing Office]
S. Hrg. 117-400
AN UPDATE ON THE ONGOING
FEDERAL RESPONSE TO COVID 19:
CURRENT STATUS AND FUTURE PLANNING
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING AN UPDATE ON THE ONGOING FEDERAL RESPONSE TO COVID-19,
FOCUSING ON CURRENT STATUS AND FUTURE PLANNING
__________
JUNE 16, 2022
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
48-911 PDF WASHINGTON : 2023
-----------------------------------------------------------------------------------
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
PATTY MURRAY, Washington, Chair
BERNIE SANDERS (I), Vermont RICHARD BURR, North Carolina,
ROBERT P. CASEY, JR., Pennsylvania Ranking Member
TAMMY BALDWIN, Wisconsin RAND PAUL, M.D., Kentucky
CHRISTOPHER S. MURPHY, Connecticut SUSAN M. COLLINS, Maine
TIM KAINE, Virginia BILL CASSIDY, M.D., Louisiana
MAGGIE HASSAN, New Hampshire LISA MURKOWSKI, Alaska
TINA SMITH, Minnesota MIKE BRAUN, Indiana
JACKY ROSEN, Nevada ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico TIM SCOTT, South Carolina
JOHN HICKENLOOPER, Colorado MITT ROMNEY, Utah
TOMMY TUBERVILLE, Alabama
JERRY MORAN, Kansas
Evan T. Schatz, Staff Director
David P. Cleary, Republican Staff Director
John Righter, Deputy Staff Director
C O N T E N T S
----------
STATEMENTS
THURSDAY, JUNE 16, 2022
Page
Committee Members
Murray, Hon. Patty, Chair, Committee on Health, Education, Labor,
and Pensions, Opening statement................................ 1
Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State
of North Carolina, Opening statement........................... 5
Witnesses
Walensky, Rochelle, M.D., M.P.H., Director, United States Centers
for Disease Control and Prevention, Atlanta, GA................ 8
Prepared statement........................................... 10
Fauci, Anthony, M.D., Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, Bethesda,
MD............................................................. 13
Prepared statement........................................... 14
Califf, Robert, M.D., Commissioner, United States Food and Drug
Administration, Silver Spring, MD.............................. 18
Prepared statement........................................... 20
O'Connell, Dawn, Assistant Secretary for Preparedness and
Response, United States Department of Health and Human
Services, Washington, DC....................................... 39
Prepared statement........................................... 40
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
Romney, Hon. Mitt:
``Fact Sheet: Consequences of Lack of Funding for Efforts to
Combat COVID-19 if Congress Does Not Act'', Submitted for
the Record................................................. 81
Letter from various organizations in response to the VALID
Act........................................................ 83
QUESTIONS AND ANSWERS
Response by Rochelle Walensky to questions of:
Sen. Burr.................................................... 87
Sen. Murkowski............................................... 88
Sen. Scott................................................... 93
Response by Anthony Fauci to questions of:
Sen. Burr.................................................... 94
Sen. Murkowski............................................... 95
Response by Robert Califf to questions of:
Sen. Burr.................................................... 97
Sen. Cassidy................................................. 98
Sen. Murkowski............................................... 99
Response by Dawn O'Connell to questions of:
Sen. Kaine................................................... 100
Sen. Burr.................................................... 100
Sen. Murkowski............................................... 102
Sen. Tuberville.............................................. 103
AN UPDATE ON THE ONGOING
FEDERAL RESPONSE TO COVID-19:
CURRENT STATUS AND FUTURE PLANNING
----------
Thursday, June 16, 2022
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 9:32 a.m., in
room 106, Dirksen Senate Office Building, Hon. Patty Murray,
Chair of the Committee, presiding.
Present: Senators Murray [presiding], Sanders, Casey,
Baldwin, Kaine, Hassan, Rosen, Lujan, Hickenlooper [presiding],
Smith, Burr, Paul, Collins, Cassidy, Braun, Marshall, and
Romney.
OPENING STATEMENT OF SENATOR MURRAY
The Chair. Good morning. The Senate Health, Education,
Labor, and Pensions Committee will please come to order. Today
we are having a hearing on the ongoing Federal response to the
COVID-19 pandemic. I will have an opening statement followed by
Ranking Member Burr, and then we will introduce our witnesses.
After they give their testimony, Senators will each have 5
minutes for a round of questions. Today, we will be having one
of our witnesses, Dr. Fauci, testify remotely by video
following a positive COVID test.
I appreciate the work of our Committee staff to make it
possible for us to accommodate this so that we can hear from
Dr. Fauci while he isolates and recovers. While we are unable
to have the hearing fully open to the public or media for in-
person attendance, live video is available on our Committee
website at help.senate.gov.
If anyone needs accommodations including closed captioning,
please reach out to the Committee or the Office of
Congressional Accessibility Services. Before we do get started
on this hearing, there is another issue we are all extremely
focused on, the formula crisis. Dr. Califf, I understand
flooding from the storms has forced Abbott's infant formula
manufacturing facility in Sturgis offline once again.
Ranking Member Burr and I agreed, and I would like to give
you a moment before we begin to update the Committee on the
latest with the plant. I hope you can speak directly to the
families in Washington State and across the country about what
happened, and how you are taking action to get them formula and
making sure this doesn't worsen the crisis or delay our work to
get formula back on the shelves as soon as possible.
Dr. Califf, I want to return to you for that before we
begin the rest of the hearing.
Dr. Califf. There we go. Thanks, Senator Murray and Senator
Burr for giving me a minute to speak about this. You know, we
have twice daily intensive calls about all the work streams
working on the infant formula issue.
At the end of the call yesterday, I commented it was one of
the first days that we hadn't had any surprises, 20 minutes
later the email came across about the flood in Sturgis, which
has forced the facility to temporarily shut down. This is an
unfortunate setback and a reminder that natural weather events
can cause unforeseen disruptions in supply chains. I had a call
with the CEO last night.
He is sharing our desire to get the facility up and running
again as quickly as possible. Abbott is working to assess
damage today and we will be talking daily, and we have our
people in the facility to help get it up as quickly as we
possibly can.
To your main question, which I know is of utmost importance
and we are all, certainly all of us are very concerned about
parents trying to get a formula for their infants, I do want to
reassure parents and caregivers that the all the Government
work to increase supply means will have more than enough
product to meet current demand and FDA is committed to working
closely with Abbott so that Sturgis can restart producing safe
and quality formula products quickly.
Thanks to the collaboration of all of the players in the
market, we now for the first time are getting production
numbers from them about how much formula each company is
producing, including Abbott, which has ramped up its other
plants and is currently meeting the supply production quotas
that they were using before the shutdown.
All the other manufacturers have increased their production
and of course we have flying formula in full swing now. I have
good numbers to indicate there will be adequate supply. We had
hoped to have a super supply so that we get the shelves
completely restocked.
The estimate is perhaps 2 weeks, but it is too early to
give an exact estimate of what the delay will be in the Sturgis
plant.
The Chair. Well, thank you, Dr. Califf. I assure you that
this Committee and all Americans will be following this very
closely. We want to be kept updated and apprized as closely as
possible as you learn the facts and make sure that parents
across this country are getting what they need.
Dr. Califf. I understand. Thank you.
The Chair. Thank you. With that, we will turn to the
hearing at hand. And let me just begin by saying that we have
made a lot of progress in the fight against this pandemic. It
is much easier to get tests. Schools have safely return to in-
person learning. Businesses have reopened.
There are new life saving treatments for people with COVID,
and multiple safe, effective vaccines. And there is encouraging
news to suggest vaccines for kids under age five will be
available soon. Something I know that parents across my state
and the country are eagerly awaiting.
Across the country, we have gotten over half a billion
shots in arms. Three in four people have gotten their first
COVID vaccination. Two-thirds of people are fully vaccinated.
This is really remarkable progress,. But we have to remember
the hardships of this pandemic, especially the early days and
the hard work it took us to get to where we are today. COVID-19
has killed over 1 million people in our Country.
That is an unthinkable loss. It closed businesses, shifted
schools online, and as we all know a lot more. We cannot afford
to get caught off guard by this virus again. We cannot afford
to go back. That is why I am shocked I still have to remind my
colleagues the progress we have made so far was not guaranteed.
It was accomplished through congressional action and through
robust investments.
What happens next is not a given either. It is up to us to
stay the course in our support and investments if we are going
to protect our families and communities from whatever this
pandemic throws at us next. That is why passing emergency
funding to continue our response has to be a top priority for
every single one of us.
Because make no mistake, it is not a matter of if this
pandemic will throw us another curveball, it is a matter of
when. That is why emergency COVID funding is not something that
would be nice to have.
It is something that we desperately need. Because if we
wait until there is already a new dangerous variant, or until
we are in the middle of a fall or winter surge, which some
experts are predicting will happen, we will have missed the
boat. We need to be doing everything we can now to get ready.
That is what people back in Washington State and across the
country are depending on Congress to do.
It is why I want to hear more about--that is what I want to
hear more about from all of our witnesses today, what do we
need to do right now so we are not caught off guard later?
Because one thing we already know is when it comes to
pandemics, when it comes to public health, an ounce of
prevention is worth a pound of cure.
We need to be investing in prevention now. We need to be
ordering the treatments we need for a fall surge now,
especially when it can take 6 months, by the way, to
manufacture paxlovid. We need to be ordering the vaccines we
will need now. We need to be combating misinformation that is
already far too prevalent and damaging now.
We need to be getting the testing, PPE we will need lined
up, especially for our schools and health care facilities, now.
And let's be clear, we can't just keep buying the same tests,
treatments, and vaccines, especially when this virus is getting
more effective at evading them.
As important as they continue to be to our progress, we
cannot continue acting as though the vaccines and therapeutics
we have now are the end all, be all. We have got to support the
next generation, keep several irons in the fire, and avoid
getting caught in a situation where our tools or options are
limited to just a few companies.
After all, we know this virus will not play favorites. That
is why it is critical we invest in the research and development
of the next generation tests, vaccines, and treatments that are
more effective or easier to store or transport or administer.
Because once there is a variant that cannot be detected by
our current tests, that does not respond to current treatments,
that is not stopped by our current vaccines, we have got to be
ready. And the research and development of these critical tools
can take time. And let's be clear, none of that would be
unprecedented, in fact, it is to be expected.
When it happens, time is of the essence to save lives, and
families are counting on us right now to act like it. The
reality is we are already running out of resources to prepare
for the fall, and we are running out of time to fix that.
Democrats have been hammering this home for months. We have
been yelling from the rooftops, warning what is at risk if we
do not get this done. I am at a loss as to how I can possibly
make the urgency of this moment more clear to all of our
Republican colleagues. The fact that the Administration has had
to resort to allocating resources from our long term needs to
keep our short term response afloat, that is not a solution.
That is a stopgap, and it should be a clear sign of how
urgent it is that Congress take action. We need to continue to
support a full, robust response. This is simply too important
to scramble again on short notice or shortchange our
communities.
In addition to more resources, we need to make sure we are
getting our communities the guidance and technical assistance
they need to get ready as well. This is especially critical for
our schools.
School officials and educators want to do everything they
can to keep our students safely in the classroom. In fact,
everyone wants that. But we can't leave them waiting until back
to school season if we are going to make it happen. Schools
back in my state want to know what they can be doing right now
to get ready for the next school year.
How can they best position themselves to make sure if we
have a fall surge, they have the resources and a plan in place
that protects students and educators and keeps them safely in
the classroom. I want to hear more from our witnesses about how
they are working with the Department of Education to get
schools the support they need.
Of course, in addition to making sure we prepare for what
is next in the course of this pandemic, we need to make sure we
are ready for whatever public health threat we face next,
period. That means making sustained annual investments in our
public health system like I have proposed, so we can end the
cycle of crisis and complacency.
It means making bold investments in pandemic preparedness.
It means strengthening our Federal policies and processes like
Senator Burr and I are working to do in our bipartisan Prevent
Pandemics Act. I know I have said it already, but I will say it
again and again until we get this done.
It means passing the emergency COVID funding. We need to
make sure our communities are able to continue getting back to
normal, not back to the darkest days of this pandemic, when we
couldn't get tests, when we didn't have effective treatments,
when we didn't have vaccines.
After everything we have been through, it should be clear
this is not the time to settle for doing too little or acting
too late. I can tell you that it is clear to me, and it is
certainly clear to the families I am hearing from back in
Washington State. I am going to keep pressing for us to get
emergency funding passed as soon as possible and get our
communities everything they need to keep people safe.
I am asking my Republican colleagues to please consider the
cost of inaction. Consider what it means for our doctors, for
our nurses, our small business owners, our high risk families
and friends, including seniors and immunocompromised people,
our educators, our students, if we let COVID get the better of
us because we failed to make a modest investment right now.
I hope we can work together and find a path forward here.
Senator Burr, I will turn it over to you.
OPENING STATEMENT OF SENATOR BURR
Senator Burr. Thank you, Madam Chairman. I welcome our
guest. Tony, I hope you are having a mild case. To our
witnesses, thank you for coming back to the HELP Committee.
When we were last together in January, the country was in the
throes of the original Omicron surge.
At that time, I asked you one basic question, what is the
plan? I hope in your opening statements or maybe when I ask
this question in the question around somebody or give me an
answer. The Chair just did a fabulous job of painting
Republicans into the obstacle for there not being enough
emergency funding.
I remind my colleagues, we spent $1.9 billion just on COVID
a year ago. Where is that money gone? How is it being spent?
Where is it obligated? No plan has been presented, but on
multiple occasions, the Chair has been in the room when I have
said, here is a condition, present us a plan.
Now in early May, this plan went out. It just tells me what
you would buy if you got $10 million and what you would buy if
you got $17.5 billion. And it says confidential. This isn't a
plan. When is somebody going to share with the American people
the destination we are trying to get to and how we are going to
get to that destination?
We are still in crisis management, and we are two and a
half years into this. I am really sympathetic of Dr. Fauci's
position, because Tony, more than anybody understands, we are
dealing with a virus that continues to evolve and change. But
since the time we last got together, we have seen Omicron
subvariants take hold.
Right now, cases of BA.4 and BA.5 are creeping up around
the country. In January, I asked yet again how this
Administration was looking to other countries that have already
experienced new surges so that we can prepare for the impacts
of new variants in the U.S. and inform our response.
BA.4 and BA.5, for example, caused a new wave of infections
in countries where they are dominant, like South Africa and
Portugal. 22 percent of the cases in the United States are
currently BA.4 or BA.5, a number that continues to increase
daily. We are learning from other countries and regions that
are ahead of us, like Israel and Europe.
What do we need to be doing today to ensure that we are
prepared for what we face in the weeks and the months to come?
I have asked you repeatedly about studies out of Israel and
other countries. I have been frustrated by the lack of detail
about what you are learning from other countries and how it
informs our COVID response.
Quite frankly, I sent my staff to Israel over the Memorial
Day recess. It is my understanding that we meet regularly,
either by phone or in person, with our Israeli counterparts.
During these meetings, they share the latest COVID trends in
Israel and any updated data on the vaccine clinical trials and
studies. If you are getting the information regularly, why is
it taking so long for us to act on it?
In January, Israel became the first country to offer a
fourth vaccine dose to individuals over 6,0 and health care
workers that were at least 4 months past their first dose--
their third dose. Israeli health ministers announced new data
at the end of January, demonstrating additional protections
from a fourth vaccine dose for those 60 and over.
It took CDC 3 months to take similar steps. I will say it
again, 3 months. Israel has also taken steps to appropriately
target the use of limited COVID-19 countermeasures. Israel
targeted its supply of oral antivirals to treat those with the
greatest risk of severe illness to keep them out of the
hospital and to keep them alive.
Meanwhile, the Biden administration developed a new plan,
Test and Treat, a strategy to provide therapeutics to anybody
who presented infected and came up positive. The terms of the
emergency use authorization are that Pfizer drugs should be
given to high risk patients, not everyone who tests positive.
There is the Israeli data influence.
But the way we have applied the EUA instructions from FDA
is hand it out to anybody who walks in and tests positive.
Tests positive, get an antiviral. The terms of the emergency
use authorization, I said, but I will quote this, people can--
this was the President, ``people can get tested at a pharmacy
and if they are positive, receive anti-viral pills on the spot
at no cost.''
Either the President was confused about his own
announcement, or you are deliberately giving these pills to too
many patients, violating the terms of the EUA, putting people
at risk, and wasting treatments and taxpayer dollars. I am
puzzled by the wide gap in our approaches when so much data is
regularly being shared between health leaders in both
countries.
Before you say our countries are of different sizes, I will
remind you that we can approve drugs and devices based on
samples of just a few thousand patients. The virus is the same
in Israel and in the United States. And we have seen Israel get
hit by new variants every--between six and 8 weeks before the
United States.
Israel's quick and decisive actions in early December
delayed the onset of the Omicron wave by 5 weeks. They had a
clear path and clear leadership. Meanwhile, we have discarded
over 82 million COVID vaccine doses in the United States, and
this Administration assumes that at least 50 percent of booster
doses we purchase this fall will go to waste.
My God, folks, let's figure out a different plan for
inoculating these people. Why don't we keep falling further
behind? Why aren't we trying to do better? Why aren't we
learning from our mistakes? It doesn't seem like we are
striving for anything other than mediocrity. Have we given up?
Let me highlight just a few of the more glaring
inconsistencies.
In April, CDC released data indicating that nearly 60
percent of the Americans and about 75 percent of American
people and 75 percent of children had at least one COVID-19
infection by the end of February. Though more recent data has
not been released, I imagine the infection rate is even higher
today given the recent spikes in cases.
We know the majority of Americans aged five and over are
vaccinated. So the majority of Americans have some degree of
protection against the virus, yet we only removed our pre-
departure testing requirements for travelers entering the
United States legally this past Sunday. Many EU countries
lifted their pre-entry testing requirements for fully
vaccinated travelers in February and March.
Canada followed suit in April. This is not an isolated
example of where we lag behind because we either don't believe
the data that they are providing, or it doesn't fit with the
narrative that we are trying to carry out. In response to a
letter I wrote about my concerns with CDC termination of Title
42 order, you wrote, ``the COVID-19 risk for U.S. communities
is greatly reduced for most people compared to earlier in the
pandemic.''
Why are we still in an urgent state of emergency and taking
months to remove restrictions that other countries have been
removing since February? American people are fed up with
confusing messaging and inconsistent response.
Let me ask again, what is the plan? More than 2 years ago--
two years into this pandemic, the American people are going
back to work in person, attending weddings, events, traveling
for work and leisure, and Government still allows its employees
even at the FDA, CDC, and within HHS platform to work remotely.
Individuals who are at higher risk of severe illness or
those who live in communities with higher levels of circulating
virus know the precautions they need to take to keep themselves
and their family safe. And if they get sick, we have tests and
treatments to help them recover. We know more now than we did 2
years ago.
We have more tools today to save more lives. Do we know
everything? No. It is past time to think about the future. I
have asked you in over and over and over again for a plan. The
plan for gaining back the trust of the American people and
moving our Country forward. Six months later, I still haven't
received an adequate response to what plan--the plan actually
is.
Since I am having trouble getting a response to my initial
question, let me end with asking each of you a slightly
different one. Every good plan is crafted around an intended
outcome. I hope all of you can answer this. What is your
endgame? Maybe I will respond differently to the Chair about
the attacks that we are standing, Republicans in the way of
funding emergency money.
But CDC says it is not an emergency anymore. That is why
they are ending Title 42. I can go through a litany of things
that suggest this has transformed to somewhere. We are in a
period that there needs to be an accountability for how we
spent the $1.9 trillion devoted to COVID. I think any country
in the world laughs at the way we are spending our money
relative to this crisis and this virus.
I will continue to ask you for a plan until we get one, and
I will continue to be a roadblock for those who believe that we
can blindly just appropriate emergency money, borrow it from
the Chinese, and spend it on something that none of us have a
clue as to what the plan is. I thank the Chair. I yield back.
The Chair. Thank you, Senator Burr. I will now introduce
today's witnesses. Dr. Rochelle Walensky is the Director of the
Centers for Disease Control and Prevention and the
Administrator of the Agency for Toxic Substances and Disease
Registry.
Dr. Anthony Fauci is the Director of the National Institute
of Allergy and Infectious Diseases and the Chief Medical
Adviser in President Biden's COVID-19 response team. Dr. Fauci,
we do appreciate you joining us virtually following your
positive COVID test. And of course, we all do wish you a very
speedy recovery.
Dr. Robert Califf is the Commissioner of the Food and Drug
Administration. Dawn O'Connell is the Assistant Secretary for
Preparedness and Response. Director Walensky, Director Fauci,
Commissioner Califf, Assistant Secretary O'Connell, thank you
all so much for joining us today. We look forward to your
testimony. We will begin with Dr. Walensky.
STATEMENT OF ROCHELLE WALENSKY, M.D., M.P.H., DIRECTOR, UNITED
STATES CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA
Dr. Walensky. Chair Murray, Ranking Member Burr, Members of
the Senate HELP Committee, I appreciate the opportunity to join
you once again to provide an update on the COVID-19 pandemic
and the work CDC continues to do to help Americans live safer,
healthier lives. It was just over a month ago that we surpassed
1 million COVID deaths in the United States.
To many, that numbers seemed unthinkable when the pandemic
began, but it is a sobering reality that so many of us have
experienced great loss over the past 2 years. We recently
experienced another increase in COVID cases, which was
accompanied by an increase in hospitalizations and deaths.
Through this, we continue to see that immunity through
vaccination and infection has resulted in fewer
hospitalizations and deaths from COVID surges prior to Omicron.
At this time, 67 percent of our population live in counties at
medium or high COVID community levels, twice as many as people
1 month ago.
CDC's COVID community levels have been an important tool to
empower localities and jurisdictions to decide where and when
to use proven prevention strategies to limit the impact of
COVID-19. Our ability to manage this virus today is in large
part due to the tools we have, vaccines, tests, treatments, and
masks.
We continue to work hard to increase access to these
important tools every day so that Americans can better protect
themselves. For example, we have recently expanded the
eligibility of COVID vaccine boosters for children ages 5 to
11. And just this week, we are coordinating with our colleagues
at FDA to consider recommendations for those 6 months to 4
years to receive their first COVID shots.
Since the start of this pandemic, nearly 8 million
children, 11 and younger, have been diagnosed with COVID. Over
50,000 have been hospitalized and over 600 have died. I know
that many parents are anxiously waiting to vaccinate their
children under five, and we are committed to carefully
reviewing the data so that these vaccines are recommended only
if they have both safe and effective profiles.
As I look toward the future of CDC's COVID response, thanks
to congressional support, CDC will be awarding $3 billion to
your states to recruit, hire, and train public health workers
to face current and emerging public health threats.
While this is an exciting opportunity to help address a
long standing gap, I am deeply concerned that a lack of
additional funding for other response activities will end or
substantially scale back critical COVID response work. Congress
and the American people expect that CDC will continue
nationwide studies to evaluate immunity, to conduct long term
surveillance on COVID, including on post COVID conditions, and
to support future vaccination efforts both globally and
domestically.
We need additional funding to do this work. As we continue
to support our COVID-19 response effort, we must not forget
that this will not be our last public health challenge and we
continue to face future public health threats. Just this past
month, we have seen outbreaks of monkeypox in non-endemic
countries, including here in the United States.
CDC's swift action has supported testing and case
identification. However, as threats like monkeypox emerge, we
run the risk of again being constrained by incomplete data from
our fragmented public health data reporting system. We need to
work together to support new authority for CDC to receive
timely, standardized, and uniform data.
This pandemic has highlighted the need for disease agnostic
investments to address the long standing vulnerabilities in our
public health system. The Fiscal Year 2023 budget request
proposes $28 billion for CDC over 5 years to enhance early
warning and situational awareness capabilities, to support
workforce programs, to bolster public health infrastructure, to
invest in data modernization, and to prioritize global health
security initiatives.
The budget also proposes a vaccine for adults program
modeled on the successful vaccine for children's program. This
program highlights my and the Administration's commitment to
health equity by creating a mandatory funding stream through
which uninsured adults would have increased access to
vaccinations, sustaining the infrastructure built during the
COVID pandemic. Congressional support for these initiatives,
accompanied by additional authorities to collect and coordinate
public health data, will strengthen our Nation's ability to
prepare for and respond to emerging public health and
biosecurity threats.
I am committed to working with each and every one of you to
find common ground, to support public health and make
meaningful strides toward achieving health security for all
Americans, both now and into the future. Thank you, and I look
forward to your questions.
[The prepared statement of Dr. Walensky follows:]
prepared statement of rochelle p. walensky
Chair Murray, Ranking Member Burr, and distinguished Members of the
Committee, it is an honor to appear before you today to discuss the
Centers for Disease Control and Prevention's (CDC) ongoing response to
the COVID-19 pandemic. It is my privilege to represent CDC, America's
health protection agency. Since launching an agency-wide response to
the COVID-19 pandemic over 2 years ago, CDC has learned more every day
about this novel pathogen, how it spreads, and how it affects people
and communities. We are committed to continuing our work to provide
science-based guidance about how we can best protect ourselves and our
communities as the virus and the pandemic evolve.
State of the Pandemic
Last month, we reached a tragic milestone: 1 million reported
deaths from COVID-19 in the United States, a heartbreaking reminder
that COVID-19 is still with us. While we mourn the overwhelming loss
that these numbers represent, and we honor each of the individuals who
have passed, there are many reasons for hope. We have learned an
incredible amount about this virus in a short period of time. We have
increased access to the tools we need to protect ourselves and those
around us.
Over the past 2 months we have seen increases in cases and
hospitalizations on the national level. Cases are beginning to level
off on the national level, although we continue to see increases in
some regions of the country. And, while the 7-day average of daily
deaths continues to decrease, there are still tragically too many
deaths each day from this disease. Although COVID-19 continues to
circulate, we now have vaccines, tests, and treatments that work to
prevent severe disease and death. Most Americans have some immunity due
to receipt of vaccines, past infection, or both. In February, CDC
transitioned to using COVID-19 Community Levels, leveraging community
level data to offer guidance to local jurisdictions and to empower them
to decide when and where to implement prevention measures. CDC looks at
the combination of three metrics--new COVID-19 admissions per 100,000
population in the past 7 days, the percent of staffed inpatient beds
occupied by COVID-19 patients, and total new COVID-19 cases per 100,000
population in the past 7 days--to determine the COVID-19 community
level. New COVID-19 admissions and the percent of staffed inpatient
beds occupied represent the current potential for strain on the health
system. Data on new cases acts as an early warning indicator of
potential increases in health system strain in the event of a COVID-19
surge. Jurisdictions can use these data to prioritize efforts to
minimize the impact COVID-19 has on our health, our healthcare systems,
and our society, while focusing efforts on protecting those who are
most at risk of severe illness. As of June 9, 2022, nearly 78 percent
of the U.S. population is in a location with low or medium COVID-19
Community Level.
The pandemic is not over, and we must continue to do all we can to
decrease severe disease and death. Despite widespread availability of
vaccines, including booster doses, we know that some parts of the
country continue to see their healthcare systems stretched thin by the
pandemic. In addition, there are many Americans who have a compromised
immune system, one or more disabilities, other serious medical
conditions, or who continue to be at elevated risk because of their age
or other factors. We must continue to use the prevention tools in our
toolbox to limit the impact COVID-19 has on those who are most
vulnerable and our communities.
Genomic Sequencing and Surveillance
CDC continuously monitors and analyzes the evolution of SARS-CoV-2
and the emergence of variants domestically and internationally, and our
national genomic surveillance system can reliably detect variants,
including those circulating at low levels. CDC's National Genomic
Surveillance System employs critically important and comprehensive
strategies to detect and track variants.
Building on years of investments, CDC has intensified efforts to
vastly expand genomic sequencing capacity at both the Federal and state
levels over the past year. In addition to direct support to public
health laboratories, CDC provides support to academic institutions to
conduct genomic surveillance research in collaboration with public
health agencies. CDC also augments sequencing capacity through
contracts with commercial diagnostic laboratories to support the
national genomic surveillance system and the sequencing of thousands of
specimens per week.
The rapid detection of emerging variants, including Omicron and its
subvariants, in the U.S. reflects the work that CDC and partners have
done over the course of the pandemic to build local capacity, enhance
communication and information exchange, and advance new technologies.
CDC continues to accelerate this work, as it is essential to the
Nation's ability to rapidly detect and respond to emerging threats. In
addition, CDC and other Federal agencies continue to work with
international partners to learn more about variants circulating
globally; CDC will continue to monitor all data sources closely to
identify cases of COVID-19 from emerging variants across the world.
As the pandemic and the virus evolve, we at CDC are working quickly
to adapt with it, including identifying new strategies to understand
what is happening in real time to better inform our decisionmaking and
guidance. For example, in early February 2022, CDC unveiled new
National Wastewater Surveillance data. We are tracking more than 995
testing sites nationwide, covering over 110 million Americans. Of
these, 773 sites are currently represented on COVID Data Tracker. This
empowers local and state officials to detect increases in SARS-CoV-2
infection 4-6 days before traditional sentinel signals like test
positivity, case counts, and hospitalizations.
Vaccination Efforts
Since December 2020, more than 591 million doses of COVID-19
vaccine have been administered in the U.S. Overall, as of June 13,
2022, over 221 million people in the U.S. have received their primary
vaccine series and over 104 million people have received at least one
booster dose. Approximately 71 percent of the U.S. population 5 years
of age and above have completed a primary vaccination series and 48.8
percent of the population 12 years of age and above have received their
booster dose. While progress is being made, these numbers indicate
there is still more work to be done. Vaccination remains the best
public health measure to protect from severe disease. CDC recommends
that everyone who is eligible protect themselves from COVID-19 by
getting vaccinated and staying up to date on their vaccinations. This
includes CDC's recommendation for boosters for anyone 5 years and older
and a second booster of an mRNA vaccine for adults ages 50 years and
older and for people aged 12 and older who are moderately or severely
immunocompromised.
Strong confidence in COVID-19 vaccines within communities leads to
more adults, adolescents, and children getting vaccinated, which in
turn can lead to fewer SARS-CoV-2 related hospitalizations and deaths.
CDC is employing a variety of approaches to improve vaccine uptake,
including developing training materials for healthcare providers,
funding a number of on-the-ground social mobilization efforts, offering
communication materials to the public, and distributing the COVID-19
State of Vaccine Confidence Insights Reports, which identify the
public's questions, concerns, frustrations, and misinformation they are
encountering while providing readers ways they can act on the findings.
Furthermore, the Federal Retail Pharmacy Program continues to be an
important component in our commitment to address the disproportionate
and severe impact of COVID-19 on communities of color and other
underserved populations. CDC partnered with 21 national pharmacy
organizations and independent pharmacy networks that represent over
41,000 locations nationwide--to ensure that the public has access to
COVID-19 vaccines in a familiar setting. Almost 90 percent of Americans
live within five miles of a retail pharmacy. As of June 8, 2022, more
than 254 million doses have been administered and reported by retail
pharmacies across programs in the U.S., which includes approximately 8
million doses administered onsite in long-term care facilities in the
early days of the vaccination program. As of June 8, 2022, 42 percent
of the cumulative doses administered through these pharmacy programs
have gone to a person from a racial or ethnic minority group. CDC
continues to identify and engage in opportunities that align with the
guiding principles of the CDC COVID-19 Response Health Equity Strategy,
and CDC works to accelerate and strengthen efforts to reduce the
disproportionate burden of the pandemic on communities of color and
other populations of focus.
Global Efforts
CDC global health experts have worked tirelessly with partners and
public health officials globally to respond to the COVID-19 pandemic,
leveraging and adapting our global health investments, systems, and
programs for the global COVID-19 response. CDC has worked hand-in-hand
with Ministries of Health in dozens of countries to provide critical
support during the COVID-19 pandemic. CDC's ability to leverage core
public health capacities overseas for the global COVID-19 response is
built on longstanding investments in surveillance, laboratory networks,
emergency management, and workforce development. For example, CDC has
supported the development and strengthening of over 30 national
Emergency Operations Centers worldwide, and CDC's PEPFAR-supported
investments in laboratory networks and systems have been critical to
COVID-19 diagnosis and surveillance, with 73 percent of PEPFAR-
supported centralized labs implementing SARS-CoV-2 testing.
Just as in all our work at CDC, advancing health equity is a core
tenet of CDC's global health work. CDC supports over 70 countries to
receive and administer COVID-19 vaccines.
Around the world, CDC is committed to widespread and equitable
access to safe and effective COVID-19 vaccines, while continuing to
build capacity for essential immunization systems. CDC's approach to
global health prioritizes host country ownership, investment in local
partnerships, development of sustainable capabilities, and sharing of
technical expertise. CDC works to identify, partner with, and reach
underserved populations around the globe.
Looking Ahead
When looking ahead, the fiscal year 2023 Budget Request for CDC and
ATSDR, provides an important framework to establish future investments
in public health. This includes $10.7 billion in program funding for
ongoing and expanded efforts to support our mission--protecting America
from health, safety, and security threats, at home and abroad. The
fiscal year 2023 Budget also outlines transformative mandatory
proposals, building upon the lessons learned through our experience
with COVID-19 and emphasizing recovery and revitalization of the
Nation's public health system. The proposed new Vaccines for Adults
program highlights my and the Administration's commitment to health
equity by creating a structure and mandatory funding stream through
which uninsured adults would have access to all vaccines that have been
recommended by CDC's Advisory Committee on Immunization Practices and
CDC. In addition, that program will help sustain the adult vaccine
infrastructure built with investments during the COVID-19 pandemic, and
it will be a critical step toward being prepared for the next pandemic.
The Budget also proposes $81.7 billion for pandemic preparedness at the
Department of Health and Human Services, of which $28 billion would be
allocated to CDC. This will provide early warning and situational
awareness, strengthen core capabilities, and strengthen public health
systems including workforce and global health security.
Congressional support for these initiatives, accompanied by
additional authorities to collect public health data, will make the
Nation better prepared for future pandemics, but there are still
additional COVID-19 problems to solve here at home and abroad. To
continue essential COVID-19 response activities, as delineated in the
Administration's $22.5 billion supplemental request to Congress on
March 2, 2022, CDC needs additional funds to support infrastructure for
surveillance and laboratory capacity, as well as to support ongoing
global response needs, including to accelerate vaccine uptake through
the U.S. Initiative for Global Vaccine Access, to limit the spread of
variants and protect lives here and globally.
In April 2022, CDC announced the launch of the new Center for
Forecasting and Outbreak Analytics (CFA). CFA seeks to enhance the
Nation's ability to use data, models, and analytics to enable timely,
effective decisionmaking in response to public health threats for CDC
and its public health partners. CFA's work will focus on three main
goals: to predict, inform, and innovate. CFA has begun to build a
world-class outbreak analytics team with experts across several
disciplines to develop faster, richer evidence to predict trends and
guide decisionmaking during emergencies. CFA will also continue to
advance the state of the science of outbreak data, models and analytics
to improve the Nation's ability to respond to health emergencies.
Conclusion
While we have come a long way since the beginning of the pandemic,
there is still much work to be done, and we all have a role to play. I
continue to encourage everyone who is eligible to get vaccinated and
boosted to protect both themselves and their fellow community members
from COVID-19. We must bolster our public health infrastructure by
supporting new authorities to enable us to be better prepared, and
resources like those in the fiscal year 2023 President's Budget to
support pandemic preparedness, data modernization, public health
laboratories, domestic and global disease surveillance, and state,
territorial, and local public health partners. We must also continue to
make investments now to make sure we address the long-standing
vulnerabilities in our public health system. I am committed to working
with Congress to find common ground to equitably support our public
health system and make meaningful strides toward achieving health
security for all Americans now and into the future.
Thank you, and I look forward to your questions.
______
The Chair. Thank you.
Dr. Fauci.
STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE
OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF
HEALTH, BETHESDA, MD
Dr. Fauci. Madam Chair, Ranking Member Burr, Members of the
Committee, thank you for giving me the opportunity to discuss
with you the role of the National Institute of Allergy and
Infectious Diseases in conducting and supporting research
addressing our Nation's response to COVID-19.
In a prior hearing before this Committee on January the
11th, I discussed the research efforts by NIH to address the
Omicron variant. This variant has evolved with multiple
mutations that are associated with an increased efficiency of
transmission and immune evasion.
Fortunately, our current vaccines have maintained their
effectiveness in preventing severe COVID-19. However,
individuals who have received only their primary vaccine
regimen have a greater likelihood of getting infected with the
Omicron variant than with previous variants.
Importantly, booster shots have been shown to significantly
reconstitute and enhance the level of antibodies that
neutralize the Omicron variant and its sub-lineages. Since I
last appeared before this Committee, NIAID launched the COVAIL
trial to learn whether various fourth dose booster regimens can
further increase the breadth and the durability of immune
responses in adults who have received a primary COVID-19
vaccination plus a single boost.
We remain concerned that most children eligible to receive
a COVID-19 vaccine have not been vaccinated. NIAID and BARDA
have collaborated with Moderna on the KidCOVE study to evaluate
the safety and efficacy of Moderna's mRNA vaccine in children,
including those under 5 years of age.
Initial results from the KidCOVE study have helped inform
the FDA's VRBPAC Advisory Committee and their recommendations
to the FDA concerning potential emergency use authorization for
their vaccine in this population, and also ultimately to inform
the CDC in their recommendations.
Looking ahead to the anticipated emergence of new variants,
the importance of developing the next generation of coronavirus
vaccines is paramount. I referred to a vaccine that would be
effective against all SARS-CoV-2 variants and ultimately run
effective against all coronaviruses.
NIAID has issued new awards to fund research focused on
designing and developing such pan-coronavirus vaccines. NIAID
and other involved entities also have made significant progress
in the development of COVID-19 therapeutics. We now have the
toolkit, the therapeutics that remain effective against the
Omicron variant, and its currently circulating sub-lineage
variants.
These therapeutics include the oral antiviral drugs
paxlovid and molnupiravir, as well as remdesivir and the
monoclonal antibody bebtelovimab, all of which have NIAID
fingerprints on their development.
In addition, NIAID is funding nine antiviral drug discovery
centers for pathogens of pandemic concern that will develop
oral antivirals for use in outpatient settings that target
SARS-CoV-2 and other viruses with high potential to cause a
pandemic.
We know that even after people recover from an infection
with SARS-CoV-2, some will experience ongoing symptoms or other
negative health effects after the acute infection has resolved.
The NIH Recovery Initiative complements ongoing NIAID studies
to better understand the various post-acute manifestations of
COVID-19.
The recovered team is building a diverse national study
cohort and supporting large scale studies on the long term
effects of COVID-19. NIAID also is participating in caring for
children with COVID, a trans NIH effort to better understand
the rare but extremely serious multisystem inflammatory
syndrome or MIS-C that has been associated with SARS-CoV-2
infection in children and adolescents.
NIAID will play an important role in the all of Government
plan for pandemic preparedness that aims to develop and
implement a range of countermeasures against important
prototype pathogen families of viruses that threaten the health
and safety not only of our Nation, but the entire world.
Thank you for your attention. I would be happy to answer
your questions following the presentations of my colleagues.
[The prepared statement of Dr. Fauci follows:]
prepared statement of anthony s. fauci
Madam Chair, Ranking Member Burr, and Members of the Committee:
Thank you for the opportunity to discuss the role of the National
Institute of Allergy and Infectious Diseases (NIAID) in the research
response to coronavirus disease 2019 (COVID-19) and its etiologic
agent, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Within the Department of Health and Human Services (HHS) and the
National Institutes of Health (NIH), NIAID is responsible for
conducting and supporting basic and clinical research on emerging and
re-emerging infectious diseases, including COVID-19. As the Director of
NIAID and the Chief Medical Advisor to the President, I am pleased to
discuss NIAID research addressing this once-in-a-lifetime infectious
disease pandemic.
The public health response to COVID-19 has required an
unprecedented global public-private research effort. NIAID has played a
central role in this response by capitalizing on decades of basic,
clinical, and applied research to facilitate the rapid development of
COVID-19 vaccines, which continue to be important tools to reduce the
threat of COVID-19 in the United States and worldwide. NIAID also
initiated clinical trials with creative and adaptive designs to
evaluate multiple new and existing therapeutics for the treatment of
COVID-19.
Responding to Emerging Variants of SARS-CoV-2
The emergence of SARS-CoV-2 variants--some of which demonstrate
increased transmissibility and an ability to partially evade the immune
response from previous infection and/or vaccination--makes it critical
that all eligible individuals remain up to date on their COVID-19
vaccines, including recommended booster doses, to ensure the highest
possible level of protection. NIAID has launched collaborative research
to rapidly assess the effectiveness of vaccines, monoclonal antibodies,
and antiviral drugs against SARS-CoV-2 variants. NIAID also is
exploring ways to enhance protection afforded by COVID-19 vaccines and
supports and conducts research to understand the impact of SARS-CoV-2
variants on infection-and vaccine-induced immunity. NIH, including
NIAID, participates in the HHS-established SARS-CoV-2 Interagency Group
(SIG) along with the Centers for Disease Control and Prevention (CDC),
U.S. Food and Drug Administration (FDA), Biomedical Advanced Research
and Development Authority (BARDA), Department of Defense (DOD), and
U.S. Department of Agriculture. The SIG tracks variants in real time to
address the potential impact of emerging variants on critical SARS-CoV-
2 countermeasures.
NIAID also facilitates the use of cutting-edge tools such as
disease modeling and structural biology to understand how SARS-CoV-2
variants may potentially evade the immune system and/or COVID-19
therapeutics. In addition, NIAID supports the development of next-
generation COVID-19 vaccines that could provide protection against
disease caused by emerging SARS-CoV-2 variants. Strategies for next-
generation COVID-19 vaccines include targeting viral antigens that are
highly conserved among SARS-CoV-2 strains and utilizing alternative
routes of inoculation, such as intranasal vaccine approaches. NIAID
also is conducting research on pan-coronavirus vaccines designed to
provide broad protective immunity against emerging SARS-CoV-2 variants
and other coronaviruses with pandemic potential. In 2021, NIAID
announced awards to four academic institutions to conduct research to
develop pan-coronavirus vaccines.
Developing Vaccines to Prevent COVID-19
Sustained research investments by NIAID over decades prior to the
emergence of SARS-CoV-2 allowed the unprecedented pace of COVID-19
vaccine development. Longstanding NIAID support enabled the development
of versatile vaccine platforms and the use of structural biology tools
including cryo-electron microscopy to design specific proteins--called
immunogens--that powerfully stimulate the immune system. Prior to the
COVID-19 pandemic, scientists at the NIAID Vaccine Research Center
(VRC) and their collaborators made the critical scientific discovery of
how to mutationally stabilize--in a highly immunogenic form--viral
proteins that SARS-CoV-2 uses to infect human cells. This strategy
facilitated the design of vaccine candidates that generate robust
protective immune responses. As soon as the sequence of SARS-CoV-2 was
made available in early January 2020, NIAID VRC researchers rapidly
generated a stabilized SARS-CoV-2 spike protein for use in COVID-19
vaccine development. This crucial breakthrough in structure-based
vaccine design led to the development of safe and effective COVID-19
vaccine candidates, several of which are now authorized or approved by
the FDA, built upon across a range of vaccine platforms including the
highly successful mRNA platform.
Through sustained support for fundamental research underlying the
vaccine concepts and the establishment and utilization of an extensive
clinical trials network, NIAID helped advance the development of six
candidate COVID-19 vaccines. NIAID supported the Phase 3 clinical
trials for two vaccines that are currently available for use in the
United States: the mRNA-1273 vaccine, developed through a collaboration
between the NIAID VRC and Moderna, Inc., and the Ad26.COV2.S vaccine
candidate from Johnson & Johnson/Janssen. NIAID also is supporting
Phase 3 clinical trials of investigational COVID-19 vaccine candidates
from AstraZeneca (AZD1222), Novavax (NVX-CoV2373), and Sanofi/GSK
(SARS-CoV-2 adjuvanted recombinant protein vaccine).
In addition, NIAID supports research on COVID-19 vaccines in
special populations, such as children and individuals who are pregnant
or lactating. NIAID and BARDA are collaborating with Moderna on the
Phase 2/3 KidCOVE study to evaluate the safety and efficacy of mRNA-
1273 in children ages 6 months to less than 12 years. KidCOVE
investigators recently reported positive initial results, and Moderna
has submitted to FDA a request for an Emergency Use Authorization of
the vaccine in this population. NIAID will continue to explore
opportunities to support additional trials to test vaccine candidates
in children, adolescents, and other special populations.
Ensuring Protection by the use of COVID-19 Vaccine Boosters
FDA-authorized and FDA-approved COVID-19 vaccines have maintained
their effectiveness in preventing severe COVID-19. However, we have
seen with both the Delta and Omicron variants that protection against
mild and moderate disease begins to decrease over time following the
primary vaccine series. NIAID quickly established that boosting with
the same vaccine that was used for the primary vaccine series could
significantly increase levels of antibodies against all current
variants, compared to levels in individuals who received the primary
regimen alone. This ``homologous'' boosting has translated into
increased protection against severe disease as well as mild infection.
In addition, an NIAID-led study showed that boosting with a COVID-19
vaccine different than the one used for the primary vaccine series
(``mix and match'') was safe and prompted a robust immune response.
Data from this study were evaluated by FDA in their decisionmaking to
authorize the use of a ``mix and match'' approach to boosters for FDA-
authorized or approved COVID-19 vaccines.
As SARS-CoV-2 variants have emerged, NIAID moved rapidly to
investigate the potential of targeted boosters to enhance immune
responses to emerging variants. Shortly after the Omicron variant was
first described, the NIAID VRC began conducting preclinical testing of
an Omicron-specific booster candidate. NIAID scientists showed in
animals that boosting with either the existing mRNA-1273 vaccine or an
Omicron-specific vaccine enhanced antibodies against Omicron and
increased protection following challenge with the Omicron variant.
NIAID now will examine whether people who received boosters--either
mRNA-1273 or variant-specific COVID-19 boosters--generate antibodies
that can bind to and neutralize the Omicron variant and its
sublineages.
NIAID also is supporting additional preclinical and clinical
research to assess the durability of immunity induced by COVID-19
vaccines, as well as the effect of COVID-19 vaccine boosters. In 2021,
NIAID launched multiple trials assessing the response to COVID-19
vaccination in people with immune systems weakened due to a variety of
diseases or organ transplantation. Additionally, NIAID recently
launched the Phase 2 COVID-19 Variant Immunologic Landscape (COVAIL)
trial to learn whether different vaccine booster regimens can broaden
and increase the durability of immune responses in adults who already
have received a primary vaccination series and a first booster shot.
Identifying Therapeutics to Treat COVID-19
Additional safe and effective therapeutics are urgently needed to
treat patients with COVID-19. NIAID has worked quickly from the
earliest days of the pandemic to evaluate promising therapeutics for
COVID-19 in rigorous, randomized, controlled clinical trials.
Early in the outbreak, NIAID launched a multicenter, randomized,
placebo-controlled clinical trial--the Adaptive COVID-19 Treatment
Trial (ACTT)--to evaluate the safety and efficacy of multiple
investigational therapeutics for COVID-19. Data from ACTT were critical
for FDA approval of the antiviral drug remdesivir and the anti-
inflammatory drug baricitinib for treatment of COVID-19. NIAID, in
collaboration with other NIH Institutes, also launched the Accelerating
COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private
partnership, which is focused on late-stage clinical trials
investigating candidate drugs for outpatient and inpatient settings.
ACTIV uses flexible master protocols for clinical trials, allowing the
inclusion of additional investigational therapeutics as the trials
continue.
The widespread availability of highly effective oral antivirals
that can be taken at home early in the course of infection could help
prevent SARS-CoV-2 transmission, mitigate overwhelming surges in
hospitalizations, and save lives. In collaboration with the DOD Defense
Threat Reduction Agency, NIAID supported basic research and product
development for the oral antiviral drug molnupiravir (Lagevrio), which
the FDA authorized for the treatment of mild-to-moderate COVID-19 in
certain populations and situations. NIAID also provided expert advice
for clinical trials of Pfizer's oral antiviral Paxlovid, which the FDA
authorized for the treatment of mild-to-moderate COVID-19 in certain
populations. Paxlovid is now the leading antiviral drug for the
treatment of COVID-19, with an almost 90 percent efficacy in preventing
severe disease resulting in hospitalization if administered early in
the course of infection.
NIH has prioritized and accelerated the development of oral
antivirals against potential pandemic pathogens by collaborating with
BARDA to launch the Antiviral Program for Pandemics (APP). APP aims to
develop safe and effective oral antivirals for broad use in outpatient
settings to treat and prevent infection with RNA viruses of pandemic
potential. The program will build sustainable approaches for targeted
antiviral discovery and development. As part of APP, NIAID recently
established nine multidisciplinary Antiviral Drug Discovery (AViDD)
Centers for Pathogens of Pandemic Concern with the goal of creating
platforms that will target RNA viruses with pandemic potential, helping
to better prepare the Nation for future viral threats.
NIAID also conducts and supports research to determine the impact
of SARS-CoV-2 variants on the effectiveness of monoclonal antibodies
and other therapeutics. For example, research suggests that although
effectiveness of certain monoclonal antibodies against Omicron is
markedly diminished, the monoclonal antibody bebtelovimab, discovered
by AbCellera in collaboration with the NIAID VRC, is active in vitro
against all circulating Omicron subvariants. In addition, NIAID is
working to develop new drugs, including therapeutics that inhibit
essential processes in the virus replication cycle or that address the
host response to COVID-19, with an eye toward agents that maintain
their effectiveness against emerging variants.
NIH also established the COVID-19 Treatment Guidelines Panel to
provide recommendations to health care providers regarding specific
COVID-19 treatments based on the best available science. Each Treatment
Guidelines section consists of recommendations developed by a working
group of Panel members with expertise in the area addressed in the
specific section; these members conduct systematic, comprehensive
reviews of relevant information and scientific literature. The Panel
meets regularly to evaluate possible treatment options for COVID-19 and
update the Treatment Guidelines as new clinical evidence emerges.
Understanding COVID-19 Immunity and Pathogenesis
Data on immunity induced by infection with SARS-CoV-2, including
studies by NIAID scientists and NIAID-supported researchers, clearly
demonstrate that following infection most people generate a protective
immune response. NIAID continues to support research to understand
immune responses to SARS-CoV-2 infection and COVID-19 vaccination,
including projects investigating the durability of immune responses;
whether immunity differs in certain populations; and how SARS-CoV-2
variants may evade immunity. These studies include research across the
range of immune components, including the role of memory T and B cell
responses in preventing progression of disease during SARS-CoV-2
infection.
In addition, NIAID is engaged in efforts to understand the rare,
but extremely serious, multisystem inflammatory syndrome in children
(MIS-C) that has been associated with SARS-CoV-2 infection in children
and adolescents. NIAID is supporting multiple studies to evaluate acute
and long-term clinical and immunological aspects of MIS-C and SARS-CoV-
2 infection in children. NIAID also is participating in a trans-NIH
effort to coordinate MIS-C research, the Collaboration to Assess Risk
and Identify Long-term Outcomes for Children with COVID (CARING for
Children with COVID). This effort supports data sharing across studies
funded by multiple NIH Institutes to determine the spectrum of illness
and predict long-term consequences of infection in children.
Addressing the Long-term Effects of COVID-19
While most people recover quickly and fully from infection with
SARS-CoV-2, some experience ongoing or new symptoms or other health
effects after the acute infection has resolved; this syndrome is
referred to as post-acute sequelae of SARS-CoV-2 infection (PASC). NIH
supports research to inform estimates of PASC prevalence as well as to
understand the pathogenic mechanisms underlying the wide range of
observed symptoms and the risk factors for developing PASC. NIH also
launched the Researching COVID to Enhance Recovery (RECOVER)
Initiative, a trans-NIH effort that includes targeted funding for
research in this critical area. The NIH RECOVER Initiative complements
ongoing NIAID studies to better understand the various post-acute
manifestations of COVID-19 and will engage more than 100 researchers at
more than 30 institutions to build a diverse national study population
and support large-scale studies on the long-term effects of COVID-19.
Conclusion
NIAID continues to expand efforts to elucidate the biology,
pathogenesis, and clinical manifestations of SARS-CoV-2 infection,
including with variants of concern such as Delta and Omicron, and to
apply this knowledge to develop safe and effective interventions to
diagnose, treat, and prevent SARS-CoV-2 infection and/or COVID-19.
NIAID also supports early stage research on candidate vaccines that
could protect against multiple strains of coronaviruses. These efforts
will improve our response to the current pandemic and bolster our
preparedness for the next inevitable emerging infectious disease
outbreak.
______
The Chair. Thank you, Dr. Fauci.
Dr. Califf.
STATEMENT OF ROBERT CALIFF, M.D., COMMISSIONER, UNITED STATES
FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD
Dr. Califf. Chair Murray, Ranking Member Burr, and Members
of the Committee, thanks for the opportunity to provide an
update on FDA's ongoing work related to the COVID-19 pandemic.
FDA's thousands of employees remain steadfast in their
commitment to fighting the pandemic, and we will continue to
use every tool in our toolbox to arm ourselves with the best
available diagnostics, lifesaving therapeutics, and vaccines to
fight the virus.
Since our last update to this Committee, FDA has approved a
second vaccine, the Moderna vaccine, for individuals 18 and
older, authorized a second booster dose of Pfizer-BioNTech and
Moderna vaccines for older people and certain immunocompromised
individuals, and expanded eligibility for the Pfizer-BioNTech
vaccine booster dose to children 5 to 11 years.
We have also held advisory committee meetings this month
related to the emergency use requests for the Novavax vaccine
to prevent COVID-19 in individuals 18 years of age and older,
for the Moderna vaccine for 6 years to 17 years of age, and
just yesterday, for both the Moderna vaccine for 6 months
through 5 years of age and the Pfizer-BioNTech vaccine for 6
months through 4 years of age.
In each case, without a dissenting vote, the committee
agreed that the benefits outweigh the risks in the intended
population. The agency is working diligently to complete our
evaluation of the data for these submissions, including taking
into account the advisory committee's recommendations and we
will make a determination as quickly as we can. Authorizing a
vaccine with adequate evidence for safety and efficacy for
young children in particular remains a top agency priority.
In addition, on June 28, the Advisory Committee will meet
to discuss whether the strain composition of COVID-19 vaccines
should be modified, and which strains should be selected for
the fall. We also continue to employ our Iowa authorities to
facilitate availability of tests, including at home diagnostic
tests, molecular antigen and serology tests.
For treatments, as of May 31st, 2022, there are more than
700 drug development programs in the planning stages, and we
have reviewed more than 460 trials for potential COVID-19
therapies. These include antivirals, immunomodulators,
neutralizing antibodies, and combinations of these products, as
well as cell and gene therapies.
Regarding treatments for COVID-19, in February, FDA issued
an EUA for bebtelovimab for the treatment of mild to moderate
COVID-19 in certain adults and pediatric patients. And in May
approved olumiant, baricitinib for treatment of COVID-19 in
certain hospitalized adults. I am a cardiologist.
I am accustomed to dealing directly with life and death.
The best way to avoid dying or getting critically ill requiring
hospitalization from COVID is to be up to date on your
vaccinations. And if you then get infected and you are high
risk, these new therapies offer additional protection against
being dead or in the hospital.
Just like heart attack patients who die without proper
treatment to open the blocked artery, a person who dies of
COVID without appropriate vaccination and treatment is an
unnecessary loss of life. I have evaluated therapies for four
decades now, and this is among the most robust data for saving
lives that I have ever seen. It is not too late to get
vaccinated or boosted so that you are up to date with your
vaccinations.
More than 2 years into this pandemic, we continue to work
around the clock while not compromising our scientific
standards. We also continue to monitor changes in the pandemic.
Using our finite resources, we are supporting the expansion of
the country's arsenal of safe and effective vaccines and
treatments and accurate and reliable tests that will protect
the American people as the virus continues to evolve.
We continue to face challenges, particularly in the area of
access to the data we need to make the best decisions. It is
imperative that we have access to complete data in order to
prevent shortages, track adverse events, and evaluate the
safety and effectiveness of medical products that are critical
to our response efforts, particularly since the virus continues
to change, leading to ongoing questions about the pertinence of
initial data that leads to the EUA.
We are constantly working to get the data we need together
with our partners in a very collaborative ecosystem. But the
fragmentation of our health system makes it difficult for us to
access the complete data needed to monitor key parameters, so
we can do better.
I hope we can continue to work together to address issues
like these and learn from the COVID-19 response efforts. Thank
you, and I look forward to your questions.
[The prepared statement of Dr. Califf follows:]
prepared statement of robert m. califf
Introduction
Chair Murray, Ranking Member Burr, distinguished Members of the
Committee, thank you for the opportunity to testify before you today to
describe the Food and Drug Administration's (FDA's or the Agency's)
coronavirus disease 2019 (COVID-19) response efforts. All of our
efforts are in close coordination and collaboration with our partners,
both within the Department of Health and Human Services (HHS) and
across the Federal Government, to help ensure the development,
authorization, licensure, approval, and availability of critical, safe,
and effective medical products to address the COVID-19 public health
emergency.
I want to note that this testimony is just a snapshot of some of
our extensive work and is in the context of efforts across the Agency
to address this pandemic. There are thousands of FDA employees who have
been working on COVID-19 response efforts non-stop since the start of
the pandemic. I want to commend and recognize their efforts and thank
them for their dedication and service. I also want to thank all FDA
employees who have continued to work on the myriad issues the Agency is
responsible for that do not directly involve COVID-19.
From the beginning of this public health emergency, FDA has taken
an active leadership role in the all-of-government response to the
COVID-19 pandemic, inspired by the resiliency of the American people
and our great innovators. FDA stood up an intra-agency group that
continues to ensure we are doing everything possible to protect the
American public, help ensure the safety, efficacy, and quality of FDA-
regulated medical products, and provide the industries we regulate with
the guidance and tools to do the same. We continue to focus on
facilitating the development and availability of medical
countermeasures to diagnose, treat, and prevent COVID-19, surveilling
the medical product and food supply chains for potential shortages or
disruptions, and helping to mitigate such impacts, as necessary to
protect the public health.
This includes working to quickly address any potential impacts of
new variants. FDA continues to evaluate the potential impact of new
variants on the currently available diagnostics, therapeutics and
vaccines. We are closely monitoring changes to the virus and are
committed to communicating with the public as we learn more. In
response to the omicron variant, we updated the SARS-CoV-2 Viral
Mutations: Impact on COVID-19 Tests web page \1\ to share new
information on the variants and their impact on antigen diagnostic
tests. FDA is committed to continuing to use every tool in our toolbox
to fight this pandemic, including pivoting as the virus adapts, to arm
ourselves with the best available diagnostics, life-saving therapeutics
and vaccines to fight this virus.
---------------------------------------------------------------------------
\1\ https://www.fda.gov/medical-devices/coronavirus-covid--19-and-
medical-devices/sars-cov-2-viral-mutations-impact-covid--19-tests
---------------------------------------------------------------------------
At this time, the current vaccines remain highly effective at
preventing serious clinical outcomes associated with a COVID-19
infection, including hospitalization and death. Additionally, currently
available data from our international partners and vaccine
manufacturers that has been evaluated by the Agency, suggests that an
additional booster shot following the completion of a primary
vaccination provides further protection. Data also suggest a second
booster dose of either the Pfizer-BioNTech Vaccine or Moderna COVID-19
Vaccine could help increase protection levels for certain higher-risk
individuals.
Getting vaccinated or receiving a booster with one of the currently
available vaccines is the best thing Americans can do right now, in
addition to standard precautions like wearing a mask, to help protect
themselves and their families.
Biologics, Including Vaccines
FDA's Center for Biologics Evaluation and Research (CBER) continues
to use every tool available to help facilitate the development and
availability of vaccines and other biological products to combat the
COVID-19 pandemic expeditiously and safely.
CBER is working on multiple fronts to address the COVID-19
pandemic, including:
Helping to facilitate expedited clinical trials for
vaccines and certain therapeutic biological products that hold
promise to prevent or treat COVID-19 by providing timely
interactions, scientific advice, and recommendations for
individual sponsors and through issuance of guidance documents;
Supporting product development and facilitating the
scaling up of manufacturing capacity for high priority products
to treat COVID-19 and conducting timely reviews;
Expediting the review of Emergency Use Authorization
(EUA) requests and Biologics License Applications (BLAs) for
vaccines and other critical medical products to address COVID-
19, including the evaluation of booster doses of COVID-19
vaccines and the use of COVID-19 vaccines in certain pediatric
populations;
Helping to ensure an adequate and safe blood supply;
and
Providing information to healthcare providers and
researchers to help them submit expanded access investigational
new drug application (IND) requests to permit the use of CBER-
regulated investigational products for patients with COVID-19.
CBER's work on COVID-19 vaccines, as discussed below, has made a
tremendous difference in addressing the pandemic by facilitating the
availability of COVID-19 vaccines that meet the Agency's rigorous
standards as expeditiously as possible. Through our transparent
scientific evaluation process, FDA has issued EUAs for three COVID-19
vaccines: the Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5
years of age and older; the Moderna COVID-19 Vaccine for use in
individuals 18 years of age and older; and the Janssen COVID-19 Vaccine
for use in certain individuals 18 years of age and older.
FDA has also approved Comirnaty (known as Pfizer-BioNTech COVID-19
Vaccine under the EUA) for use in individuals 16 years of age and older
and Spikevax (known as the Moderna COVID-19 Vaccine under the EUA) for
use in individuals 18 years of age and older. In doing so, we have
relied upon the Agency's rigorous standards for safety, effectiveness,
and manufacturing quality. These COVID-19 vaccines were developed
without cutting corners or compromising our regulatory and scientific
standards.
Intensive interactions between FDA and manufacturers minimized the
time between different studies in the clinical development process;
allowed seamless movement throughout the different phases of clinical
trials; and simultaneously facilitated manufacturers proceeding with
manufacturing scale-up before it was clear whether the safety and
effectiveness data for a vaccine would support an EUA, allowing for
quicker access to products once FDA reviewed the data and found the
products met the Agency's rigorous standards for authorization or
approval.
For the approved vaccines, as well as those that have been
authorized for emergency use, our process included a thorough
evaluation of the data by the Agency's career staff. We also solicited
input from independent scientific and public health experts through our
public advisory committee meetings for the COVID-19 vaccines that we
have authorized. Throughout our scientific and regulatory process, FDA
took additional steps to facilitate transparency, such as posting
sponsor and FDA briefing documents and key decisional memoranda.
The COVID-19 vaccines that are available in the United States have
shown clear and compelling efficacy in large, well-designed phase 3
trials. These vaccines are helping the country in the fight against
this pandemic and have met FDA's rigorous standards for safety and
effectiveness to support either EUA or approval. The vaccines are
approved or authorized to prevent COVID-19, and have been shown to
significantly reduce the associated serious outcomes, including
hospitalization and death.
As part of our continued efforts to be transparent and educate the
public, we have a wealth of information on our website about the COVID-
19 vaccines available for use in the United States. The information
includes fact sheets for healthcare providers (vaccination providers)
and fact sheets for vaccine recipients and caregivers in multiple
languages, with important information such as dosing instructions;
information about the benefits and risks of each vaccine; and topical
Questions and Answers developed by FDA for the approved vaccines and
each authorized vaccine. \2\
---------------------------------------------------------------------------
\2\ https://www.fda.gov/emergency-preparedness-and-response/
coronavirus-disease--2019-covid--19--covid--19-frequently asked-
questions
---------------------------------------------------------------------------
It is also important to highlight that, as part of each EUA or
approval, manufacturers and vaccination providers are required to
report serious adverse events, cases of Multisystem Inflammatory
Syndrome (MIS), and cases of COVID-19 that result in hospitalization or
death to the Vaccine Adverse Event Reporting System (VAERS), a national
vaccine safety surveillance program jointly run by FDA and the Centers
for Disease Control and Prevention (CDC).
COVID-19 vaccine safety is a top priority for the Federal
Government, and we take all reports of health problems following COVID-
19 vaccination very seriously. FDA and CDC have implemented a
coordinated and overlapping approach for continuous safety monitoring
of all COVID-19 vaccines using state-of-the-art technologies.
Specifically, the Agency's monitoring following authorization of the
COVID-19 vaccines uses a multi-pronged approach including:
(1) passive surveillance using VAERS consisting of
safety reports submitted by healthcare providers, \3\ patients,
parents and other members of the public; combined with
---------------------------------------------------------------------------
\3\ Providers in the CDC COVID-19 Vaccination Program are required
to report certain adverse events following COVID-19 vaccination to
VAERS
---------------------------------------------------------------------------
(2) active surveillance, using large population-based
healthcare datasets.
These latter healthcare data systems offer a higher likelihood of
detecting rare adverse events because they capture medical data on
millions of Americans, cover diverse subpopulations (i.e., pregnant
women, elderly, and patients with comorbidities), and can provide a
longer duration of follow-up when compared to the prelicensure clinical
studies.
In addition, COVID-19 vaccine recipients are encouraged to enroll
in CDC's v-safe After Vaccination Health Checker smartphone-based tool
that uses text messaging and web surveys to check-in with vaccine
recipients over time after they receive a COVID-19 vaccine. Through v-
safe, they can quickly tell CDC if they have any side effects after
getting a COVID-19 vaccine. Together, the passive and active safety
surveillance provide a coordinated and overlapping approach to vaccine
safety monitoring for COVID-19 vaccines.
On August 23, 2021, FDA announced the first approval of a COVID-19
vaccine. The vaccine previously known as the Pfizer-BioNTech COVID-19
Vaccine was approved and marketed as Comirnaty for the prevention of
COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech
COVID-19 Vaccine has continued to be available under an EUA and is
currently authorized as a:
Two-dose primary series for individuals 5 years of
age and older; third primary series dose for individuals 5
years of age and older with certain immunocompromising
conditions;
homologous first booster dose (matching the primary
vaccination) administered at least 5 months after completion of
primary vaccination to individuals 5 years of age and older;
heterologous first booster dose (not matching the
primary vaccination) administered after completion of primary
vaccination to individuals 18 years of age and older (the
dosing interval is the same as that authorized for a booster
dose of the vaccine used for primary vaccination);
homologous second booster dose administered at least
4 months after a first booster dose to individuals 50 years of
age and older and individuals 12 years of age and older with
certain immunocompromising conditions; and
heterologous second booster dose administered at
least 4 months after a first booster dose to individuals 50
years of age and older and individuals 18 years of age and
older with certain immunocompromising conditions.
On January 31, 2022, FDA approved a second COVID-19 vaccine. The
vaccine has been known as the Moderna COVID-19 Vaccine; the approved
vaccine is marketed as Spikevax for the prevention of COVID-19 in
individuals 18 years of age and older. The Moderna COVID-19 Vaccine has
continued to be available under an EUA and is currently authorized as
a:
Two-dose primary series for individuals 18 years of
age and older;
third primary series dose for individuals 18 years of
age and older with certain immunocompromising conditions;
homologous or heterologous first booster dose
administered after completion of primary vaccination to
individuals 18 years of age and older (the authorized dosing
interval for a homologous booster is at least 5 months after
completion of a primary series, and the authorized interval for
a heterologous booster is the same as that authorized for a
booster dose of the vaccine used for primary vaccination); and
a homologous or heterologous second booster dose
administered at least 4 months after the first booster dose to
individuals 50 years of age and older and individuals 18 years
of age and older with certain immunocompromising conditions.
The Janssen COVID-19 Vaccine was originally authorized on February
27, 2021. On May 5, 2022, FDA limited the authorized use of the Janssen
COVID-19 Vaccine to individuals 18 years of age and older for whom
other authorized or approved COVID-19 vaccines are not accessible or
clinically appropriate, and to individuals 18 years of age and older
who elect to receive the Janssen COVID-19 Vaccine because they would
otherwise not receive a COVID-19 vaccine.
At this time FDA is closely monitoring the emergence of new
variants in order to determine what, if anything, needs to be changed
in the composition of COVID-19 vaccines moving forward to best protect
the population. The Agency has already issued COVID-19 vaccine-specific
guidance to address the emergence and potential future emergence of
variants of SARS-CoV-2, the virus that causes COVID-19. \4\
---------------------------------------------------------------------------
\4\ Emergency Use Authorization for Vaccines to Prevent COVID-19,
updated March 31, 2022: https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/emergency-use-authorization-vaccines-
prevent-covid--19
FDA recently held the following virtual meetings of its Vaccines
and Related Biological Products Advisory Committee (VRBPAC) related to
emergency use requests that have been publicly announced by COVID-19
---------------------------------------------------------------------------
vaccine manufacturers.
On June 7, FDA convened VRBPAC to discuss an EUA
request for a COVID-19 vaccine manufactured by Novavax to
prevent COVID-19 in individuals 18 years of age and older.
On June 14, FDA and its advisory committee of
external experts met to discuss Moderna's EUA request for 6
years through 17 years of age.
On June 15, FDA and its advisory committee of
external experts met to discuss the Moderna EUA request for 6
months through 5 years of age and the Pfizer-BioNTech EUA
request for 6 months through 4 years of age.
On June 28, FDA plans to convene the VRBPAC to discuss whether the
SARS-CoV-2 strain composition of COVID-19 vaccines should be modified,
and if so, which strain(s) should be selected for Fall 2022. This
meeting is a follow-up to the April 6 VRBPAC meeting that discussed
general considerations for future COVID-19 vaccine booster doses and
the strain composition of COVID-19 vaccines to further meet public
health needs.
Figure 1
This pandemic is dynamic and evolving, with new data continuously
emerging about vaccine safety and effectiveness. As we obtain more data
about the safety and effectiveness of COVID-19 vaccines, including the
use of booster doses, we will continue to evaluate the rapidly changing
science and keep the public informed.
At this time, it is clear that the approved or authorized vaccines
reduce the risk of severe illness; however, data are not yet available
to make a determination about how long they will provide protection.
Additionally, although we do not yet know the full range of SARS-CoV-2
variants that each of the vaccines will protect against, there is
evidence that the available vaccines protect against severe disease
caused by variants circulating in the United States.
To date, having three authorized vaccines and two approved vaccines
that meet FDA's expectations for safety and effectiveness at this point
of the COVID-19 pandemic is a tremendous achievement and a testament to
the dedication of vaccine developers and FDA's career scientists and
physicians. We are highly engaged in ensuring that all COVID-19
vaccines meet the high quality that the American public expects and
deserves. The Agency is very proud of these efforts, and we believe
that the vaccines will help bring this pandemic to an end.
In addition to its work on COVID-19 vaccines, CBER also has been
actively involved in reviewing data related to COVID-19 convalescent
plasma and on December 28, 2021, FDA updated the EUA for COVID-19
convalescent plasma. The update limits the authorization to the use of
COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2
antibodies for the treatment of COVID-19 in patients with
immunosuppressive disease or who are receiving immunosuppressive
treatment. These patients may be treated in outpatient or inpatient
settings.
Additionally, to help assure the manufacture of high titer COVID-19
convalescent plasma, the update to the EUA revises acceptable tests and
increases qualifying result cutoffs to be used for manufacturing COVID-
19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies.
Drug Products
Since the beginning of the COVID-19 pandemic, FDA's Center for Drug
Evaluation and Research (CDER) has been working tirelessly to
facilitate the development and availability of therapeutics for use by
patients, physicians, and health systems as expeditiously and safely as
possible. FDA accelerated the development and publication of guidance
and other information for industry and researchers on developing COVID-
19-related treatments.
Further, FDA created an emergency review and development program
for possible therapies for COVID-19, the Coronavirus Treatment
Acceleration Program, or ``CTAP.'' Under CTAP, FDA is using every
available authority and regulatory flexibility to facilitate the
development of safe and effective products to treat patients with
COVID-19. As of May 31, 2022, there are more than 700 drug development
programs in the planning stages and the Agency has reviewed more than
460 trials of potential therapies for COVID-19. These therapies include
antivirals, immunomodulators, neutralizing antibodies, and combinations
of these products, as well as cell and gene therapies regulated by
CBER. The diversity of therapeutic approaches being investigated is
important because it rapidly expands our understanding of the effect of
different categories of potential treatments.
Figure 2
As of May 31, 2022, FDA has approved two drugs to treat COVID-19
and currently there are 13 authorized therapeutics for emergency use.
On December 8, 2021, FDA issued an EUA for AstraZeneca's Evusheld
(tixagevimab co-packaged with cilgavimab and administered together) for
the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults
and pediatric individuals (12 years of age and older weighing at least
40 kilograms [about 88 pounds]).
On December 22, 2021, FDA issued an EUA for the first oral
antiviral, Paxlovid, manufactured by Pfizer. Paxlovid (nirmatrelvir
tablets and ritonavir tablets, co-packaged for oral use) is authorized
for the treatment of mild-to-moderate coronavirus disease (COVID-19) in
adults and pediatric patients (12 years of age and older weighing at
least 40 kilograms or about 88 pounds) with positive results of direct
SARS-CoV-2 testing, and who are at high risk for progression to severe
COVID-19, including hospitalization or death. In the large clinical
trial that was conducted among high-risk patients, Paxlovid reduced the
risk of hospitalization or death by nearly 90 percent compared to
placebo.
On December 23, 2021, FDA issued an EUA for another oral antiviral,
molnupiravir, manufactured by Merck. Molnupiravir is authorized for the
treatment of mild-to-moderate coronavirus disease (COVID-19) in adults
with positive results of direct SARS-CoV-2 viral testing, and who are
at high risk for progression to severe COVID-19, including
hospitalization or death, and for whom alternative COVID-19 treatment
options authorized by FDA are not accessible or clinically appropriate.
On February 11, 2022, FDA issued an EUA for bebtelovimab,
manufactured by Eli Lilly and Company. Bebtelovimab is authorized for
the treatment of mild-to-moderate coronavirus disease (COVID-19) in
adults and pediatric patients (12 years of age and older weighing at
least 40 kg or about 88 pounds) with positive results of direct SARS-
CoV-2 viral testing, and who are at high risk for progression to severe
COVID-19, including hospitalization or death, and for whom alternative
COVID-19 treatment options authorized by the FDA are not accessible or
clinically appropriate.
In considering EUA requests for therapeutics, we promptly and
carefully evaluate the totality of the scientific evidence to determine
whether the statutory criteria for issuance under section 564 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3)
are met. Among other criteria, this evaluation considers whether the
product may be effective for its proposed authorized uses, and whether
the product's known and potential benefits when used as proposed
outweigh the known and potential risks of such product.
Our goal is to be as transparent as possible about the scientific
basis for recommending that a drug or biological product be authorized
for emergency use under section 564 of the FD&C Act or for recommending
that an EUA be revised or revoked. \6\
---------------------------------------------------------------------------
\6\ https://www.fda.gov/news-events/press-announcements/covid-19-
update-fdas-ongoing-commitment-transparency-covid-19-euas
---------------------------------------------------------------------------
FDA continues to work closely with manufacturers to mitigate and
prevent shortages as the COVID-19 pandemic evolves. For example, the
Agency has issued four EUAs to authorize the emergency use of certain
therapeutic products intended to treat serious or life-threatening
diseases or conditions (e.g., Acute Kidney Injury, Acute Respiratory
Distress Syndrome) caused by COVID-19 after determining that sufficient
FDA-approved alternatives to these products were not available to fully
meet the emergency need. This has helped to alleviate shortages of some
therapies that are essential for the care of critically ill COVID-19
patients.
FDA is working with manufacturers to increase supplies to meet
current demand by expediting review of applications. In addition, the
Agency has prioritized the review of generic drug applications for
potential treatments and supportive therapies for patients with COVID-
19, such as sedatives used in ventilated patients, anticoagulants, and
pulmonary medications. In June 2021, FDA reached a milestone of
approving 1,000 original and supplemental generic drug applications
since the start of the pandemic to help in the treatment of patients
with COVID-19. This supports FDA's everyday mission of improving access
to safe, effective, high-quality treatment options, especially during
the COVID-19 pandemic.
Medical Devices
FDA's work to support access to devices for the COVID-19 response
began in January 2020--before the public health emergency was declared
in the U.S. and 2 months before the pandemic was declared worldwide--
due to the immediate need for COVID-19 tests and testing supplies,
collection kits, personal protective equipment (PPE), ventilators, and
other devices. The need for medical devices to respond to the COVID-19
pandemic has far exceeded what we experienced in any prior public
health emergency. The first EUAs issued for the COVID-19 public health
emergency were for medical devices, and the volume of EUA requests
quickly surpassed (by two orders of magnitude) that of any prior public
health emergency or other situation. To help combat the COVID-19
pandemic, FDA and the staff of the Center for Devices and Radiological
Health (CDRH) have continued to go well beyond normal operating
procedures to help ensure the availability of appropriately safe and
effective COVID-19-related devices as quickly as possible.
From early in the pandemic, CDRH has actively reached out to and
engaged other government agencies, medical device developers and
international regulatory agencies, among other stakeholders. CDRH
continues to hold weekly virtual town halls with industry to address
COVID-19 test development and validation, as well as additional
webinars and town halls addressing other policies and questions
including PPE, 3D-printed swabs and manufacturing disruptions during
the public health emergency.
CDRH staff have also interacted frequently with test developers and
manufacturers through the Pre-Emergency Use Authorization (pre-EUA)
process, including rolling reviews of information that helped to
further expedite EUA of critical medical devices for patients and
health care professionals on the front lines. Since January 2020, FDA
has received more than 8,000 EUA requests and Pre-EUA submissions for
devices (including more than 1,000 so far in fiscal year 2022).
The emergency use requests included submissions for devices that
CDRH had never received EUA requests for during prior public health
emergencies. This included ventilators and novel devices such as
extracorporeal blood purification devices, as well as novel indications
for devices such as continuous renal replacement therapy devices. CDRH
continues to receive nearly 120 EUA requests and pre-EUA submissions
each month, the majority for in vitro diagnostic (IVD) tests, and has
begun receiving conventional submissions from firms intending to
transition their products beyond emergency use.
Since the start of the pandemic, FDA has issued EUAs or granted
marketing authorization to nearly 2,300 medical devices for COVID-19-
related uses. In addition, FDA rigorously monitors safety signals and
medical device reports, using the information to publish 23 letters to
healthcare providers and 14 safety communications. FDA completed other
pivotal work activities such as addressing supply chain shortages and
counterfeit products related to COVID-19.
Diagnostic tests are the first line of defense in an outbreak, and
FDA plays an important role to ensure these tests work through the EUA
review. The EUA process expedites access to appropriately accurate
diagnostic tests during emergencies, when, without such access,
information gaps and false results could adversely affect individual
patient care and public health decisionmaking. Through this process,
molecular diagnostic tests are able to be developed, validated,
authorized, and deployed within weeks rather than several months to
over a year, as is typical for test development and traditional
premarket submissions. The Agency employed its EUA authorities to
facilitate availability of tests in six previous emergencies. Careful
review of tests is critical because false test results can adversely
impact the Nation's response. In public health emergencies, FDA is
generally open to receiving and reviewing EUA requests for tests from
any developer, including commercial kit manufacturers and laboratories,
for tests that address the public health need.
FDA sought to facilitate COVID-19 test evaluation and authorization
through the development and availability of templates for EUA requests.
The templates provide recommendations for test validation and a fill-
in-the-blank form to streamline the paperwork and make it easier for
developers to provide information in support of a request for an EUA.
Since providing the first template in January 2020, FDA has been in
daily contact with test developers to answer questions and help them
through the EUA process. This has proved to be a helpful tool for many.
FDA had as many as ten posted templates and continues to update, add,
combine, and remove templates as the science evolves and as necessary
to support developers of COVID-19 tests. As of April 13, 2022, these
templates have received over 618,543 hits from those visiting FDA's
website. FDA also supported test developers through establishment of a
dedicated mailbox, 24-7 toll-free hotline that ran until July 2020, the
posting of over 100 frequently asked questions on our website, and by
hosting 86 virtual town halls for test developers.
FDA has prioritized review of EUA requests for at-home tests since
Spring 2020--almost a year before other countries pursued expansive use
of home tests--and has consistently actively engaged with test
developers to support their development. To date, FDA has authorized 19
distinct over-the-counter (OTC) COVID-19 tests, 11 of which were
authorized in 4 weeks or less, with five authorized within a week.
The Agency first discussed this prioritization in the Spring of
2020, during one of its weekly virtual Town Halls on COVID-19 tests,
due to their potential impact on test accessibility and public health.
To further encourage such test development, on July 29, 2020, FDA
posted a template for at-home diagnostic tests. This template includes
recommendations for validating OTC tests for screening asymptomatic
individuals with general performance expectations that are lower than
for lab-based tests. The Agency recognizes the benefits of increased
availability of OTC tests, and these recommendations have helped to
increase OTC screening test availability, particularly rapid antigen
tests.
Throughout the pandemic, FDA has also monitored evolving
circumstances and growing scientific knowledge and made adjustments
when appropriate to help streamline and expedite the path to market for
these and other tests as much as possible while assuring they are
supported by sound science. In March 2021, FDA obtained results from a
National Institutes of Health (NIH)-sponsored study that supported
further streamlining of FDA's at-home test recommendations. Based on
these data, on March 16, 2021, FDA issued an EUA that provides a
streamlined path to authorize tests with at least 80 percent
sensitivity in symptomatic individuals, with sensitivity falling in a
range as low as 70 percent in certain circumstances, for developers to
offer their test for OTC serial screening without additional data
collection. Multiple tests were authorized under this approach within
weeks.
FDA authorized the first at-home test on November 17, 2020. At-home
tests, also referred to as self-tests, are those that can be performed
by a lay user at home, or in other settings, with a self-collected
sample. As of June 1, 2022, the 19 authorized OTC at-home tests have a
combined manufacturing capacity of hundreds of millions of tests per
month based on data provided to FDA by the manufacturers, and we
understand many have scaled beyond their initial estimated capacity
with additional government support.
FDA further streamlined the process for manufacturers developing
over-the-counter at-home tests on October 25, 2021, by facilitating at-
home single-use testing for symptomatic individuals for tests currently
authorized only for serial testing. Developers of certain tests may
request authorization to add single-use testing for symptomatic
individuals without submitting additional data. This change would allow
tests authorized for single use to be sold in singles, meaning more
individual tests for sale potentially at a lower price.
On November 15, 2021, FDA published an update to its Policy for
Coronavirus Disease-2019 Tests During the Public Health Emergency that
describes our review priorities based on the current needs of the
pandemic. In that update, FDA stated that going forward, the Agency
generally intends to focus its review on EUA requests for the following
types of tests:
At-home and point-of-care (POC) diagnostic tests that
can be manufactured in high volumes;
Certain high-volume, lab-based molecular diagnostic
tests (and home collection kits for use with such tests) that
expand testing capacity or accessibility such as through
pooling of specimens to increase throughput, testing specimens
collected at home and shipped to the lab, screening
asymptomatic individuals or detecting multiple different
respiratory viruses at once;
Certain lab-based and POC high volume antibody tests
that can measure the amount of antibodies (fully quantitative
antibody tests) or the amount of neutralizing antibodies; and
Tests for which the request is from, or supported by,
a U.S. Government stakeholder, such as the Biomedical Advanced
Research and Development Authority or NIH's Rapid Acceleration
of Diagnostics (RADx) initiative.
These priorities help developers focus their prospective efforts
where they are most needed and reduce inefficient use of developer and
FDA time on tests with less public health impact. Ultimately, we
anticipate we will receive EUA requests only for those tests identified
in the guidance for which the public health need is greatest, and we
will be able to focus our attention on the review of such tests.
FDA also partnered with the NIH to establish the Independent Test
Assessment Program (ITAP), \7\ which streamlines validation and
authorization of at-home antigen tests with potential for large-scale
manufacturing. This program is an extension of the NIH RADx program
which has already supported development of several authorized tests,
including the first OTC COVID-19 test. ITAP also supports studies on
OTC tests and works with companies to provide complete, high-quality
submissions for FDA review. The first two successful candidates to come
through this process were authorized by FDA in the last week of 2021,
which was weeks, if not months, ahead of schedule. FDA has authorized
five OTC, at-home COVID-19 tests that participated in this program
through this accelerated pathway--one manufactured by SD Biosensor and
distributed by Roche, one manufactured by Siemens, a third manufactured
by Maxim Biomedical, a fourth manufactured by Osang, LLC, and a fifth
manufactured by Xiamen Boson Biotech Co., Ltd. \8\ We are already
seeing shorter review times for such EUA requests due to our
partnership with ITAP in establishing the evaluation program that
provides high quality data. The average FDA review time for a test
evaluated under ITAP is just over a week, and can be as short as 1 day,
after receipt of a complete data package.
---------------------------------------------------------------------------
\7\ https://www.hhs.gov/about/news/2021/10/25/new-hhs-actions-add-
biden-administration-efforts-increase-access-easy-use-over-counter-
covid--19-tests.html
\8\ https://www.nibib.nih.gov/covid--19/radx-tech-program/ITAP
---------------------------------------------------------------------------
Going forward, FDA continues to take steps to increase access to
reliable, accurate rapid antigen tests. This includes continuing to
prioritize review of EUA requests for at-home antigen tests and
increasing staffing on the antigen test review team as resources
permit. FDA is actively working to increase the pipeline of at-home
tests by engaging with companies to obtain data that can be used to
support their EUA, working with developers with authorized POC tests to
expand their authorization for at-home use, continuing support of ITAP
and engagement with RADx and international regulators, and conducting
targeted outreach to manufacturers of home tests in non-U.S. markets.
To date, FDA has engaged with over 1,000 developers and authorized
more than 475 tests and sample collection devices that provide a wide
array of test options. In addition to at-home diagnostic tests, these
include other types of molecular and antigen tests, as well as serology
tests; POC tests, home collection tests, multi-analyte tests that can
detect both COVID-19 and flu; tests using various sample types,
including saliva tests; and tests for pooling, screening, and serial
testing. \9\ Most recently, FDA issued an EUA for the first COVID-19
diagnostic test that detects chemical compounds in breath samples
associated with a SARS-CoV-2 infection. \10\
---------------------------------------------------------------------------
\9\ https://www.fda.gov/medical-devices/coronavirus-disease-2019-
covid--19-emergency-use-authorizations-medical-devices/in-vitro-
diagnostics-euas
\10\ https://www.fda.gov/news-events/press-announcements/
coronavirus-covid--19-update-fda-authorizes-first-covid--19-diagnostic-
test-using-breath-samples
---------------------------------------------------------------------------
As noted in Figure 3 below, as part of this effort, FDA has
authorized 302 molecular tests and sample collection devices, 84
antibody and other immune response tests, and 49 antigen tests. We have
also authorized 34 tests for serial screening programs (27 antigen and
seven molecular).
The volume and variety of authorized tests is a testament to FDA's
support of innovative test design and our commitment to public health.
FDA will continue to adapt to address public health needs and increase
access to tests for consumers, including at-home diagnostic tests,
adopting an approach that is grounded in sound science.
Figure 3
In addition to these efforts, FDA has been actively monitoring for
the possible emergence of SARS-CoV-2 variants since early in the
pandemic and has worked with test developers when a new variant (or
mutation) emerges that could impact test performance. FDA also works
with test developers, who are required to monitor their authorized test
for the impact of viral mutations. As FDA's or the developer's analysis
identifies tests whose performance could be impacted by SARS-CoV-2
viral mutations, these tests are added to FDA's SARS-CoV-2 Viral
Mutations: Impact on COVID-19 Tests webpage. \11\ This includes posting
the latest information on the omicron variant and testing implications
as they become available. FDA also works with other agencies and
divisions in HHS, such as NIH, as we monitor tests for potential
effects of genetic variation on test performance on an ongoing basis.
---------------------------------------------------------------------------
\11\ https://www.fda.gov/medical-devices/coronavirus-covid-19-and-
medical-devices/sars-cov--2-viral-mutations-impact-covid--19-tests
---------------------------------------------------------------------------
FDA has authorized a wide variety of other medical devices for use
in combating the pandemic, including a wide range of PPE, ventilators,
and other therapeutic devices. As of May 31, 2022, FDA authorized 274
PPE devices, including 56 surgical masks, 205 filtering facepiece
respirators (FFRs), and issued 13 EUAs for face shields and other
barriers intended to protect the user from bodily fluids, liquid
splashes, or potentially infectious materials. See Figure 4. In
addition to issuing EUAs, CDRH has reviewed 510(k)'s for and cleared
over 1,400 devices that can be used for COVID-19 and certain similar
diseases, including in future pandemics, with over 500 devices in
fiscal year 2022 to date.
Figure 4
Since early 2020, FDA has adopted agile, interactive, and
innovative approaches to review EUA requests for all types of devices.
For example, FDA developed the umbrella EUA approach to efficiently
authorize multiple devices of the same type falling within the scope of
authorization and meeting the statutory criteria for issuance. The
Agency has also issued 28 guidance documents outlining policies to help
expand the availability of medical devices needed in response to COVID-
19.
For example, to help quickly increase availability of tests in the
early stages of the pandemic, FDA outlined a policy for developers of
certain tests who offered their tests, upon validation and notification
to FDA, while Agency review of the EUA request was pending.
Additionally, FDA outlined flexible approaches for manufacturers of
certain cleared and approved devices (e.g., remote monitoring systems,
ventilators, infusion pumps) regarding certain limited modifications
made to devices without submitting a premarket submission.
Further, FDA made several improvements to our EUA review processes
to make the most efficient use of our resources, including a front-end
triage process to identify devices that would have the greatest impact
on the public health. These improvements incorporate the latest
information on device availability and shortages, prioritizing novel or
critical devices not yet available on the market or those that would
address significant device shortages.
For medical devices, review times have increased over time as the
number of EUA requests and Pre-EUA submissions for medical devices have
increased to unprecedented levels. This is demonstrated in the tables
we have provided with review times for IVD EUA requests over time, and
submission volume for IVD EUA requests over time (see Figures 5 & 6
below).
At the beginning of the pandemic, FDA was authorizing tests and
other devices in as little as 1 or 2 days upon receipt of complete data
packages. Congress has provided critical, one-time funding that FDA has
used to leverage contractors from outside organizations, to provide
technical expertise to supplement our review staff in the review of EUA
requests and other marketing submissions.
These personnel are authorized to work alongside full-time
employees, integrated into our internal review teams to help with the
massive workload for tests, ventilators, PPE, and other devices, but
the workload has continued to greatly exceed capacity even with the
additional support.
Figure 5
Figure 6
FDA has significantly improved IVD EUA review times. The average
total time to decision (TTD) for Original IVD EUAs received in CY 2021
is 54 days, with 91 percent of the 2021 submissions closed.
Given the magnitude of the COVID-19 public health emergency, FDA
recognizes that continued flexibility, while still providing necessary
oversight, will be appropriate to facilitate an orderly and transparent
transition back to the eventual resumption of normal operations. In
December 2021, FDA issued draft guidance for public comment to help
manufacturers begin to plan a return to normal operations, including a
proposed phased-in transition period and recommendations relating to
submitting marketing submissions.
As proposed, FDA would announce the Advance Notice of Termination
(ANT) in the Federal Register, which would give manufacturers 180 days
to come into compliance with regulatory requirements and submit a
conventional marketing submission (e.g., 510(k) or PMA). Provided that
the submission is accepted by FDA by this time (180 days after the
ANT), FDA does not intend to object to these devices to continue to be
distributed and used while the submission is pending review.
FDA is working to address stakeholder feedback and timely finalize
this guidance and a companion guidance for devices that fall within
COVID-19-related enforcement policies. The transition plan for device
EUAs and other actions FDA is undertaking are intended to provide
transparency to our stakeholders and to avoid market disruptions and
shortages as the Agency and broader device ecosystem transition back to
normal operations.
FDA recognizes that medical devices, particularly tests, will
continue to play an important role in the next phase of the pandemic
response. The Agency is continuing to monitor its policies, the
marketplace, and national needs, and will continue to adapt as the
circumstances of the evolving pandemic warrant.
Human and Animal Food (Center for Food Safety and Applied Nutrition,
Center for Veterinary Medicine, and the Office of Food Policy and
Response)
Throughout the pandemic, FDA has worked with Federal, state, and
local partners, as well as industry, to help ensure a safe and adequate
food supply for both humans and animals.
While there is no evidence to show that SARS-CoV-2 is likely to be
transmitted by food, some components of the food system are
experiencing challenges and supply chain imbalances. We saw this at the
outset of the pandemic with the dramatic shift in where people were
eating, and most recently, we are seeing that the broad supply chain
issues impacting so many commodities are also impacting food. Overall,
food production and manufacturing in the U.S. has been remarkably
resilient, but we continue to monitor the food supply and apply
mitigation strategies for products for which availability has been
impacted in part by pandemic-related issues.
In response to the pandemic, FDA's Foods Program developed 21
Forward, a food supply chain data management tool, to help identify
where risks for interruptions in the continuity of the food supply may
be greatest. As part of 21 Forward, FDA conducted targeted outreach to
the food industry to offer additional resources and technical
assistance in addressing challenges.
As highlighted in the U.S. Department of Agriculture's (USDA's)
Agri-Food Supply Chain Assessment report, developed in response to
Executive Order 14017 on America's Supply Chains with input from FDA, a
dynamic, interconnected, supply chain monitoring platform and robust
data sets are necessary to be most effective in monitoring food supply
chains, managing risks, and identifying and quickly addressing supply
chain disruptions to reduce impacts on consumers.
FDA also recognizes that food supply chain stability and workers'
safety are two sides of the same coin. Thus, a stable and robust food
supply depends on the safety and health of the Nation's food and
agricultural workforce. Along with our Federal, state, and local
partners, we have provided best practices for food and agricultural
workers, industry, and consumers on how to stay safe, and help ensure
the continuity of operations in the food and agriculture critical
infrastructure sector during the pandemic.
In collaboration with HHS, CDC, Health Resources and Services
Administration (HRSA) and U.S. Department of Agriculture (USDA), data
from 21 Forward on the estimated numbers and distribution of food and
agricultural workers have been made available to assist states with
their vaccine distribution efforts to workers in the food and
agriculture sectors, including migratory and seasonal agricultural
workers. In addition, FDA has worked with its Federal partners to
provide both COVID-19 and flu vaccination encouragement messages for
the food industry.
FDA's Coordinated Outbreak Response and Evaluation team has been
working throughout the pandemic looking for signs of foodborne illness
outbreaks and initiating responses as needed. FDA's Center for
Veterinary Medicine (CVM) is monitoring the animal food supply and
initiating needed foodborne illness and natural disaster responses.
In terms of inspectional work, FDA's Office of Regulatory Affairs
(ORA) investigators continued to conduct mission-critical inspections
domestically and abroad, including inspections and investigations in
response to foodborne outbreaks, throughout the pandemic. FDA resumed
standard operations for domestic surveillance inspections in July 2021,
and since March 2022 has been conducting prioritized foreign
inspectional work, including surveillance and other inspections. FDA
continues to screen every line of every imported food shipment entering
the U.S. utilizing our Predictive Risk-Based Evaluation for Dynamic
Import Compliance Targeting (PREDICT) tool.
We continually adjust the algorithm in PREDICT to place increased
scrutiny on shipments from facilities where foreign surveillance
inspections have been postponed. FDA has made greater use of our
Foreign Supplier Verification Program (FSVP) regulation to review
importer records for information showing that foreign suppliers are
using processes and procedures consistent with FDA Food Safety
Modernization Act (FSMA) requirements. The shift to remote FSVP
inspections, along with other tools utilized by the foods program, was
critical to ensuring the safety of human and animal food from foreign
suppliers during the COVID-19 pandemic.
Since March 2020, FDA has conducted approximately 3,423 FSVP
inspections. Additionally, FDA continues to identify human and animal
foods that are unsafe, misbranded, or may cause a serious health
concern for the public at the border with over 15,324 lines being
refused admission since March 2020.
In July 2020, FDA announced the New Era of Smarter Food Safety
Blueprint outlining the Agency's plans over the next decade to create a
more digital, traceable, and safer food system. The Agency has learned
from its response to the pandemic that there is an accelerated need for
certain goals in this blueprint, especially those involving supply
chain continuity and resilience, modernized inspectional approaches,
strengthening food safety infrastructures with regulatory partners, and
the safety of foods ordered by consumers online.
The number of consumers ordering food online has been steadily
increasing over the years, but it has skyrocketed during the COVID-19
pandemic. Last year, FDA hosted a virtual Summit on E-Commerce, to help
the Agency improve its understanding of how human and animal foods are
sold through e-commerce models and to identify courses of action for
addressing potential food safety vulnerabilities, including those that
may arise in the ``last mile'' of delivery.
Imports, Inspections, Compliance and Protecting the Medical Supply
Chain
Similar to their work protecting the food supply, import
investigators have been onsite protecting the medical supply chain at
our ports of entry, courier facilities, and the international mail
facilities (IMFs) throughout the pandemic, with uninterrupted support
from ORA laboratories. Through continued vigilance, FDA has prevented
unsafe and unproven pharmaceuticals and other medical products from
entering the country. Since March 2020, with the cooperation of and in
coordination with the U.S. Customs and Border Protection (CBP), FDA has
refused and destroyed more than 119,000 products, totaling over
21,232,063 capsules, tablets, and other dosage forms of violative drugs
shipped via international mail.
Since March 2020, FDA has maintained the same level of screening
for products offered for import as pre-pandemic and refused
approximately 160,464 lines violative medical products offered for
import. FDA has focused examinations on COVID-19 relief supplies to
ensure that reviews of compliant products are expedited while
maintaining our commitment to refusing medical products that appear to
be unsafe, misbranded, unapproved, counterfeit, or may cause serious
illness or injury to the public. Import investigators have evaluated
donations of shipments destined for the Federal Emergency Management
Agency (FEMA) and have been instrumental in expediting the importation
of vaccines and related shipments and other COVID-19 necessities
starting with the first vaccines (Pfizer Belgium) shipped into the
United States in December 2020.
Despite generally pausing domestic and foreign surveillance
inspections in March 2020 to safeguard the health and well-being of our
staff, as well as employees at facilities we inspect, our investigators
continued to conduct mission critical inspections both domestically and
abroad and to do other prioritized domestic inspectional work when
possible, to ensure FDA-regulated industries were meeting applicable
FDA requirements. FDA developed a rating system to assist in
determining when and where it was safest to conduct prioritized
domestic inspections until we resumed standard inspectional operations
for domestic surveillance inspections in July 2021.
On May 5, 2021, FDA issued a report titled, ``Resiliency Roadmap
for FDA Inspectional Oversight,'' \12\ outlining the Agency's
inspectional activities during the COVID-19 pandemic and its detailed
plan to move toward a more consistent state of operations, including
FDA's priorities related to this work going forward. The report was
updated on November 22, 2021. \13\
---------------------------------------------------------------------------
\12\ https://www.fda.gov/media/148197/download
\13\ https://www.fda.gov/media/154293/download
---------------------------------------------------------------------------
The report described our oversight work during the pandemic and
outlined the inspectional activities that the Agency had postponed due
to travel restrictions or inability to ensure the safety of our
workforce or the workforces within the industries the Agency regulates.
The report also outlined the number of mission-critical inspections FDA
completed during that time, such as inspections of facilities for which
there was a drug shortage, inspections needed for the approval of novel
drugs or drugs related to the potential treatment of COVID-19, support
of pre-market and pre-license applications, and response to foodborne
disease outbreaks or other food safety risks such as food contaminated
with pathogens.
Additionally, the Resiliency Roadmap outlines FDA's continued,
successful use of alternative tools and approaches where inspections
are not feasible, including remote assessments (e.g. requests to
regulated establishments to remotely view records as well as remote
interactive evaluations that include remote livestreaming video of
operations), teleconferences, or screen sharing, and leveraging
information from trusted regulatory partners.
For example, ORA made over 2,100 requests to human and animal drug
and biological product manufacturers to remotely view records, to
support on-time regulatory decision actions. Our review of records
requested under section 704(a)(4) of the Federal Food, Drug, and
Cosmetic Act supported more than 350 approval recommendations for new
or abbreviated drug applications, as well as support for authorization
decisions for EUA requests, potentially allowing new products to come
to market and provide access to lower cost generic drugs to patients
more quickly than may have otherwise been possible.
Notably, FDA's bioresearch monitoring program staff have conducted
more than 200 remote assessments that were directly used in application
decisions. \14\ The new tool was incentivized for and supported by
industry and continues to provide the Agency with valuable information
to assist with risk-based targeting for inspections. FDA recognizes
that remote approaches do not replace inspections, and that there are
situations where only an inspection is appropriate, based on risk and
history of compliance with FDA regulations.
---------------------------------------------------------------------------
\14\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/remote-interactive-evaluations-drug-manufacturing-
and-bioresearch-monitoring-facilities-during-covid
---------------------------------------------------------------------------
The Resiliency Roadmap further outlined the ongoing steps the
Agency is taking to resume standard operational levels of inspection
activities, including how it intended to prioritize domestic and
foreign inspections that could not be performed during the pandemic.
FDA began to transition back to standard operations for domestic
surveillance inspections and other prioritized operational work on July
1, 2021, and exceeded the goals that were detailed in the May
Resiliency Roadmap. We also exceeded our performance goal related to
following up on previous inspections classified as official action
indicated (OAI).
Since October 1, 2021, FDA has been performing domestic inspections
at normal operational levels and recently began to conduct foreign
facility inspections, including surveillance and other inspectional
work, as well. As FDA works through the inventory of postponed
surveillance inspections, the Agency is prioritizing higher-risk
establishments. For example, a sterile manufacturing site that has not
been previously inspected and is making narrow therapeutic index drugs
would likely be deemed a higher risk than a site that had a well-known
inspectional and compliance history that is making solid oral dosage
form drugs. This means that postponed inspections will be prioritized
based on risk and conducted over a longer period of time, ultimately
increasing the amount of time between inspections of certain lower-risk
facilities in order to focus on products that present the greatest risk
to public health.
The Agency launched a multi-year modernization effort in July 2021
to further transform our data enterprise platforms and cross-program
interoperability infrastructure to better support innovation related to
its regulatory oversight role. This includes adopting technology to
support regulatory assessments to improve our remote receipt, review,
and analysis of industry data and records, and improve remote
interactions with industry entities to be easier, more efficient, more
consistent, and more secure.
This modernization effort includes a review of inspectional
approaches using next-generation assessment technologies and
improvements. FDA established an Agency-wide Inspectional Affairs
Council (FIAC) that provides coordination of inspection approaches and
assessment processes. The Agency intends to share more information on
these efforts as this work progresses. FDA will continue to leverage
and maximize every available tool and resource to meet its regulatory
oversight responsibilities, while achieving optimal public health
outcomes.
Compliance and Enforcement
FDA exercises its regulatory authority by, among other things,
issuing warning letters and pursuing civil and criminal enforcement
actions against firms and individuals who do not comply with regulatory
requirements, including those distributing unapproved products with
false or misleading claims that the products prevent, treat, mitigate,
diagnose, or cure COVID-19.
In March 2020, FDA launched Operation Quack Hack, which leverages
the Agency's expertise and advanced analytics to protect consumers from
fraudulent medical products, including unproven treatments,
illegitimate test kits, and substandard or counterfeit respirators. FDA
has sent hundreds of abuse complaints to domain name registrars and
internet marketplaces. The Agency also has sent 285 warning letters to
sellers of unproven products claiming to treat, prevent, or cure COVID-
19.
Working with the Department of Justice (DOJ), FDA has sought and
obtained preliminary and permanent injunctions that require defendants
to halt the sale of unproven products claiming to treat or prevent
COVID-19, including one product, ``Miracle Mineral Solution,'' that,
when used as directed, is equivalent to industrial bleach. In addition,
since the start of the COVID-19 pandemic, FDA has issued 22 warning
letters to owners and/or operators of illicit internet pharmacy
websites that offer unapproved and misbranded drugs purporting to treat
COVID-19 for sale to U.S. consumers.
In addition, ORA's Office of Criminal Investigations (OCI), working
with other Federal and local law enforcement agencies, has conducted
criminal investigations involving unproven COVID-19-related products.
In one such example, OCI investigated a physician who attempted to
profit from the pandemic by marketing and selling an unproven COVID-19
treatment. The physician marketed and sold treatment kits--which
included hydroxychloroquine--as a cure for COVID-19. In May 2022, the
physician was sentenced to 30 days' imprisonment and 1 year of home
confinement after pleading guilty to, among other things, trying to
smuggle hydroxychloroquine into the United States to sell in his COVID-
19 ``treatment kits.''
In another case, OCI investigated an individual who attempted to
import approximately 1,000 unlawful COVID-19 test kits from China,
which were intercepted at a FedEx facility in Memphis, Tennessee. As a
result of OCI's investigation, the individual was fined and sentenced
to 36 months of probation in October 2021 after pleading to a felony
smuggling charge. OCI also has conducted criminal investigations to
bring to justice those who tamper with COVID-19 vaccines.
For example, OCI investigated a hospital pharmacist who tampered
with COVID-19 vaccine doses at a Wisconsin hospital where he worked. On
two successive nights, the pharmacist purposefully removed a box of
COVID-19 vaccine vials from the hospital's refrigeration unit intending
to render the vaccines inert and no longer effective.
Before the full extent of his conduct was discovered, 57 people
received doses of the vaccine from these vials. In January 2021, the
pharmacist pleaded guilty to two counts of attempting to tamper with
consumer products with reckless disregard for the risk that another
person will be placed in danger of death or bodily injury. He has been
sentenced to 3 years imprisonment, followed by 3 years of supervised
release, and he must pay approximately $83,800 in restitution to the
hospital.
In addition, FDA investigators remain on the front lines at ports
of entry, quickly examining, reviewing, and sampling import entries,
and refusing admission of violative products where appropriate. We
protect the supply chain in two equally critical ways: first, we help
ensure safe products are coming in; and second, we help prevent
illegal, dangerous, and fraudulent products from getting into the
country. These efforts include partnering with U.S. Customs and Border
Protection (CBP) in establishing satellite laboratories at selected
International Mail Facilities (IMFs) with scientists using state-of-
the-art screening tools to rapidly identify unapproved, counterfeit and
illicit products.
In March 2020, OCI, with the help of domestic law enforcement
partners and foreign counterparts in the United Kingdom, led the
investigation of fraudulent COVID-19 ``treatment kits'' that were
falsely declared as ``water treatment.'' Import examination of these
shipments found misbranded ``kits'' intended to treat COVID-19. As a
result of this investigation, a British national was sentenced to 10
months of confinement after pleading guilty to shipping mislabeled and
unapproved products. In May 2020, FDA worked with CBP to intercept
several shipments of counterfeit facemasks, with the result that they
were refused and destroyed before entering U.S. commerce.
FDA also has taken steps to address hand sanitizer products that
pose safety concerns, such as products that do not meet the required
ethanol or isopropanol levels or that contain or may contain toxic
ingredients like methanol or 1-propanol.
FDA has tested several hundred products using field-based and
laboratory-based tools and found more than a hundred violative
products. FDA also has taken steps to help ensure that these dangerous
or subpotent products do not enter domestic commerce, including
coordinating with CBP to identify such products, and we have listed
products made by more than 70 manufacturers on import alert.
FDA also placed all alcohol-based hand sanitizers from Mexico on a
countrywide import alert to help stop products from entering the U.S.
that appear to be in violation until the Agency is able to review the
products. That action marked the first time the FDA has issued a
countrywide import alert for any category of drug product.
In addition to the use of compliance and enforcement tools, FDA
also used targeted communication to alert the public and address
misinformation about the efficacy of products purported to treat COVID.
Medical Product Supply Chain
FDA monitors and responds to worldwide demand and supply chain
disruptions for medical products caused by the COVID-19 pandemic. \15\
We work closely with manufacturers, within our current resources and
authorities, to help ensure they continue to notify the Agency of any
permanent discontinuance or interruption of drug (human and animal),
biological product, and device manufacturing in a timely manner, and we
are working to better position the Agency and our health care system to
assure a strong domestic supply chain in future emergencies.
---------------------------------------------------------------------------
\15\ https://www.whitehouse.gov/wp-content/uploads/2021/06/100-
day-supply chain-review-report.pdf
---------------------------------------------------------------------------
This is especially important as the COVID-19 pandemic has exposed
major vulnerabilities in the supply chain that FDA continues to face as
it works to help ensure access to the treatments and devices that
patients and healthcare providers need.
In addition to our usual communications with drug manufacturers, we
work closely with healthcare and pharmacy systems, hospitals,
providers, and others on the frontlines of COVID-19 patient care to
identify problems with access to critical care drugs used to treat
COVID-19.
FDA understands the significant impact shortages can have on
patient care, and we are using our authorities to help prevent and
alleviate disruptions. When we identify a shortage, we react swiftly to
help mitigate the impact to U.S. patients and health care
professionals, and quickly share that information with the public.
Restoring and increasing the supply of approved drugs has been the
Agency's priority. In addition, where necessary, FDA has issued
temporary policies during the COVID-19 emergency to respond to reports
from hospitals of increased demand and interruptions in supply, some of
which have not resulted in a drug shortage but caused concern about
continuing access to drugs to support hospitalized patients with COVID-
19.
We issued temporary policies for outsourcing facilities registered
with FDA and pharmacists in state-licensed pharmacies or Federal
facilities, regarding the compounding of certain drugs used for
hospitalized patients with COVID-19. The Agency has published guidances
to help applicants and manufacturers provide FDA with timely and
informative notifications about changes in the production of certain
human drugs, including biological products, and certain animal drugs.
We urged the timely submission of these notifications, which may
assist in our efforts to prevent or mitigate shortages of such
products. In addition, section 503B(a)(2)(A) of the FD&C Act permits
outsourcing facilities to use bulk drug substances to compound drug
products that appear on the drug shortage list in effect under section
506E of the FD&C Act at the time of compounding, distribution, and
dispensing, when all conditions of section 503B are met.
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act),
signed into law on March 27, 2020, included authorities intended to
enhance FDA's ability to identify, prevent, and mitigate possible drug
shortages by, among other things, enhancing FDA's visibility into drug
supply chains. The CARES Act expanded the requirement for manufacturers
of certain drugs to provide information on permanent discontinuances
and interruptions in manufacturing that may lead to a meaningful
disruption in supply to FDA, and required FDA to prioritize and
expedite, as appropriate, the review of certain applications and
inspections that could help mitigate or prevent a shortage of a drug
covered by section 506C(a) of the FD&C Act.
Our experience with COVID-19 only reemphasized that a strong
domestic supply chain depends on a resilient supply chain for medical
devices. Even before the pandemic hit the U.S., there were disruptions
in the medical device supply chain due to higher demand for devices in
other nations where COVID-19 was already prevalent and shutdowns in
locations from which supplies were sourced.
As a result, FDA began shortage mitigation activities for medical
devices in January 2020 before the public health emergency was declared
in the U.S., and 2 months before a pandemic was declared worldwide. At
that time, the Agency did not have any dedicated funding or explicit
authority regarding prevention or mitigation of medical device or
animal drug shortages.
The Agency lacked dedicated staff necessary to mitigate supply
chain disruptions and/or shortages. Nevertheless, the Agency took
several actions to rapidly respond to medical device supply chain
needs, including reassigning over 130 staff to perform shortages work
across CDRH and contacting over 1,000 manufacturing facilities in 12
countries in just a few weeks' time to get as much information as
possible about critical devices. However, because the Agency lacked any
explicit shortages authority at this time, only about one-third of
facilities that were contacted responded even in part to CDRH requests
because response was voluntary. This lack of explicit authority, staff
and supply chain information significantly hampered our efforts to
mitigate and prevent shortages at the outset of the pandemic.
The CARES Act gave FDA, for the first time, authority related to
device shortages (see section 506J of the FD&C Act). The enactment of
the CARES Act at the height of the initial pandemic response gave some
authority to help prevent or mitigate medical device shortages during
the public health emergency. \16\ Throughout COVID, FDA has dealt with
hundreds of thousands of device units that have been in shortage. FDA
used the information it received from its CARES Act authorities to
prevent or mitigate shortages including diagnostic testing supplies
such as swabs and viral transport media; blood collection tubes; PPE
(respirators, surgical masks, gowns, gloves); ventilators; pediatric
trach tubes; dialysis products; infusion pumps and accessories; saline
flush syringes, sharps containers, needles and syringes.
---------------------------------------------------------------------------
\16\ Specifically, section 506J of the FD&C Act requires
manufacturers to notify FDA of a permanent discontinuance in or
interruptions in the manufacture of certain devices that are likely to
lead to a meaningful disruption in supply of that device in the United
States during, or in advance of, a public health emergency. Section
506J also requires FDA to maintain a publicly available list of devices
the Agency has determined to be in shortage, as well as devices that
have been discontinued. The Agency is also directed to, as it deems
appropriate, prioritize and expedite inspections and review of
premarket submissions to help alleviate the supply chain constraint.
---------------------------------------------------------------------------
Specifically, FDA uses the information it receives from the CARES
Act to:
Expedite review of devices and changes to devices;
Allow/expedite importation;
Grant enforcement discretion, including outlining
flexible approaches for manufacturers of certain cleared and
approved devices (e.g., remote monitoring systems, ventilators,
infusion pumps) regarding certain limited modifications made to
devices without submitting a premarket submission;
Provide clinical impact assessments to the Assistant
Secretary for Preparedness and Response (ASPR) and the White
House supply chain coordinator to support informed
decisionmaking regarding shortages;
Authorize EUAs;
Communicate with healthcare providers about devices
in shortage;
Inform conservation strategies; and
Provide assessments that allow for informed
decisionmaking on medical device shortages across the U.S.
Government.
FDA is using this information to develop shortage assessments that
inform potential mitigations. This work has helped to protect patients
and health care providers around the Nation from critical shortages of
devices.
In addition to the implementation of the new device shortages
authorities, FDA has conducted horizon scanning to assess demand for
devices needed to respond to the pandemic, including PPE, ventilators,
diagnostic supplies, infusion pumps, and non-contact infrared
thermometers; and established a rapid response team, working with field
personnel to address fraudulent imports.
The Agency has likewise worked to prevent and mitigate shortages of
testing supplies and other critical medical devices. For example, FDA
collaborated with U.S. Cotton, one of the world's largest manufacturers
of cotton swabs, to develop and produce a polyester-based swab for
testing. FDA also collaborated with laboratories and clinical
investigators validating potential alternative sources of control
materials, transport media, and swabs.
As individual developers validated these alternative components,
FDA requested their permission to share their findings publicly so that
others could benefit, and we posted these alternatives on our website.
In this way, FDA has been serving as a clearinghouse for scientific
information that the entire community can leverage to mitigate
shortages and increase testing capacity. FDA continues to post this
information on a rolling basis on an FAQ website so that labs have
access to the latest information regarding alternative controls,
transport media, extraction, instruments, and swabs.
FDA has also worked across the medical device ecosystem to address
systemic challenges to our supply chain due to sterilization issues and
resin shortages. The impacts of supply chain disruptions caused by a
natural disaster (Texas Winter Storms) have significantly impacted our
most vulnerable populations. Most recently, devices used to compound
total parental nutrition for critically ill neonates were impacted by
the lack of availability of resins. FDA has worked with manufacturers
and suppliers to help mitigate this disruption.
FDA continues to work to implement and operationalize the new
device shortage authority, as well as utilize one time funding from
COVID supplementals and $5 million in the first annual appropriations
it received in fiscal year 2022 to stand up a new state-of-the-art
Resilient Supply chain Program (RSCP). Medical device shortages not
only put patients in harm's way but also jeopardize our health care
workers on the front lines, during public health emergencies like the
COVID-19 pandemic and every day in our health care system. Moreover,
device shortages disproportionately affect at-risk populations and
exacerbate health disparities.
For these reasons, FDA continues to do all it can within its
current authorities and resources to mitigate shortages and supply
chain interruptions for COVID-19 and within the U.S. health care system
generally, and why the Agency has requested additional authorities and
funding in fiscal year 2023 to improve our device supply chain
readiness going forward Congress has acknowledged the importance of
FDA's work on shortages in our health care system and we want to
continue working with this Committee and others to make sure FDA has
the resources and authorities needed to ensure U.S. patients and health
care providers have the medical products they need each day.
To ensure the U.S. is properly prepared now and in the future, we
must take action to secure our medical device supply chain, including
related materials, parts, and components. FDA recognizes that this will
take resources and expanded authority. The pandemic has demonstrated
that by the time a public health emergency is declared, it is often too
late to effectively prevent or mitigate device shortages.
Moreover, there are situations that occur frequently that do not
rise to the level of a public health emergency--such as cybersecurity
attacks, natural disasters, recalls and spot shortages that may impact
one region of the country or one particular hospital system, but for
which device shortages could significantly impact patient care. After
the COVID-19 emergency ends, these authorities remain tied to a public
health emergency--that is, during or in advance of a public health
emergency.
This limits FDA's ability to identify supply chain vulnerabilities
and work with the industry to respond to early signs of supply
constraints or a potential shortage situation. One need only look at
the ongoing resin supply chain issue, noted above, to see the wide-
spread impacts that have lasted for over a year and resulted in
shortages of multiple devices to include pediatric trach tubes, blood
collection tubes, diagnostic tests, and catheters.
Most recently, a critical device component was impacted by this
shortage which resulted in an inability to delivery total parental
nutrition for neonates \17\ Unfortunately, FDA will be very limited in
our ability to proactively identify and address device shortages after
the COVID-19 emergency ends while its device shortages authorities
remain tied to a public health emergency--that is, during or in advance
of a public health emergency.
---------------------------------------------------------------------------
\17\ https://www.childrenshospitals.org/content/public-policy/
letter/critical-shortages-fda-letter
---------------------------------------------------------------------------
Conclusion
FDA continues to advance its mission to protect and promote public
health by helping to ensure the safety of human and animal food, and
the safety and effectiveness of medical products. We take our public
health mandate very seriously and will continue to work each day to
help end this pandemic. We continue to communicate with the American
public and make regulatory decisions based on data and sound science. I
look forward to continuing to work with the Committee on these efforts
and thank you again for the opportunity to testify today.
______
The Chair. Thank you.
Assistant Secretary O'Connell.
STATEMENT OF DAWN O'CONNELL, ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, UNITED STATES DEPARTMENT OF HEALTH
AND HUMAN SERVICES, WASHINGTON, DC
Ms. O'Connell. Chair Murray, Ranking Member Burr, and
distinguished Members of the Committee, it is an honor to
testify before you today on efforts within ASPR to respond to
the COVID-19 pandemic.
The Administration continues to apply a whole of Government
approach to protecting Americans from COVID-19, and ASPR leads
the operational response with responsibilities for procuring
and distributing many of the tools needed to fight the virus,
including vaccines, therapeutics, and tests.
Thanks to the collaboration across HHS and with partners at
DOD and with private industry, ASPR has delivered more than 750
million doses of safe, effective, and free vaccine to 90,000
vaccinationsites around the country, contributing to 221
million people being fully vaccinated.
We continue to allocate vaccine and boosters to sites
nationwide. We are now preparing to support the distribution of
vaccine for kids under five, should FDA authorize, and CDC
recommend a vaccine for that population. We have made 10
million doses available to states, pharmacies, community health
centers, and Federal entities to order initially with more
doses becoming available soon after.
We are also preparing for the distribution of Novavax's
protein based vaccine should it receive authorization and
recommendation. This would provide those who are allergic to
mRNA vaccine or prefer a non-MRA vaccine, the option to get
vaccinated.
While vaccines remain the best way to prevent severe
illness caused by COVID-19, we continue to have therapeutics
available to prevent and treat infection. Today, ASPR allocates
four different products, two oral antivirals, one monoclonal
antibody for treatment, and one monoclonal antibody for pre-
exposure prophylaxis for immunocompromised people.
We remain focused on making sure that providers and
patients know these products are available, that they are free,
and they can be found at approximately 50,000 locations
nationwide. Testing continues to be an important part of our
COVID response.
We have made significant progress in increasing testing
supply availability and affordability over the past year. In
fact, we went from zero over-the-counter tests in January 2021
to approximately 300 million tests available this winter.
ASPR has secured more than 900 million at home tests for
distribution for free to American households through the U.S.
Postal Service. So far, we have delivered nearly 500 million
tests to more than 70 million American households via the
covidtest.gov program. And we have just opened our third round
of ordering.
Since May 2021, ASPR has also shipped over 149 rapid
antigen tests and 8.1 million point of care PCR tests to our
most vulnerable populations, including nursing homes, federally
qualified health centers, and long term care facilities. In
addition to the purchase and distribution of these tests, ASPR
continues to work with manufacturers, companies, and
laboratories to identify and proactively address any supply
issues.
ASPR continues to stock the Strategic National Stockpile,
or SNS inventory to at or above pre-covid-19 levels to ensure
that we are prepared for the next wave of cases. We are doing
so to the extent possible with domestically manufactured
supplies and equipment.
The SNS currently has 42 times the number of N95
respirators, 8.5 times the number of surgical and procedural
face masks, 12.5 times the number of gowns and coveralls, 272
times the number of gloves, and 10 times the number of
ventilators than we had prior to the start of the pandemic.
While COVID has been anything but predictable today, we are
in a much better position to respond than we were a year ago. A
big reason is because Congress, on a bipartisan basis, provided
the resources needed to make sure Americans had these free and
widely available tools to protect themselves.
Unfortunately, without additional funding, our ability to
prepare for whatever comes next is severely limited. Last week,
the Administration notified Congress that in the absence of new
funding, it was repurposing $10.2 billion in COVID supplemental
funding, taking it from critical programs in order to secure
more of our most important tools, lifesaving vaccines and
therapeutics.
The difficult decision was made to divert funds from our
testing program and the SNS at a time when both programs are
finally better positioned and better prepared than they have
been at any point in this response, and they require funding to
be maintained and strengthened in order to stay that way.
Without additional supplemental funds, we are at a point
where each spending decision comes with the difficult tradeoff,
tradeoffs that none of us want to make. I look forward to
working with you on these difficult funding decisions as we
continue to respond to COVID and prepare the country for
whatever this virus might bring next.
Thank you for your support and I look forward to answering
your questions.
[The prepared statement of Ms. O'Connell follows:]
prepared statement of dawn o'connell
Chair Murray, Ranking Member Burr, and distinguished Members of the
Committee, it is an honor to testify before you today on efforts within
the U.S. Department of Health and Human Services (HHS) Office of the
Assistant Secretary for Preparedness and Response (ASPR) to respond to
the current pandemic, restore and strengthen our capabilities, and
prepare for future health emergencies. I am grateful for this
opportunity to address this Committee and appreciate your continued
support.
Update on ASPR's COVID-19 Response Effort
As we enter the third year of the pandemic, we continue to apply a
whole of government approach to protect Americans from COVID-19. At the
direction of Secretary Becerra and in my role as ASPR, I am responsible
for leading HHS' COVID-19 response coordination. In this role, I work
closely with my fellow panelists on all facets of the Department's
response, however, for the purposes of this testimony, I will focus my
update on the work for which the ASPR organization is chiefly
responsible.
HHS Coordination Operations and Response Element (HCORE)
The vaccines and therapeutics available to us today are the result
of an unprecedented partnership between HHS and the Department of
Defense, through the Countermeasures Acceleration Group (CAG),
previously known as Operation Warp Speed. Together this team, has
helped develop and deliver over 751.4 million doses of vaccine and 11.3
million treatment courses to protect the American people from COVID-19.
On December 31, 2021, our Memorandum of Understanding with DOD
expired and on January 1, 2022, we successfully completed the planned
transition of this work to the recently established HHS Coordination
Operations and Response Element, or HCORE. HCORE institutionalizes the
efforts previously led by the CAG within ASPR. It will allow us to
build on the progress to date, retain expertise and skills, and
continue providing the necessary tools to the American people to
respond to the COVID-19 pandemic.
Since my last appearance before the Committee, HCORE continues to
lead, in partnership with CDC, the rollout and distribution of vaccines
and boosters. These vaccines are being administered widely at 90,000
locations around the country, and ample supply is available in the
field to meet the needs for both booster and primary series
vaccinations. Additionally, the introduction of vaccines for children
ages 5 through 11 has resulted in over 10.3 million first doses
delivered for this population. We are also preparing to support the
distribution of vaccine for kids under five, if and when FDA
authorizes, and CDC recommends, a vaccine for that population. We have
plenty of supply of both Pfizer and Moderna vaccines appropriate for
this population, and we are making 10 million doses available to
states, pharmacies, community health centers, and Federal entities to
order initially. Meanwhile, we are also preparing for the potential
emergency use authorization of Novavax's protein-based vaccine that, if
authorized, would provide those who are allergic to mRNA vaccine or
prefer non-mRNA an option to get vaccinated.
In addition to vaccines, HCORE continues to purchase and distribute
to states and jurisdictions a variety of treatments including
monoclonal antibodies and oral antivirals.
Today we allocate four different products--two oral antivirals,
Pfizer's Paxlovid and Merck's Lagevrio; the monoclonal antibody
treatment Bebtelovimab from Eli Lilly; and AstraZeneca's Evusheld for
pre-exposure prophylaxis for immunocompromised people. We are focused
on making sure that providers and patients know these products are
available, that they're free and that they are available at
approximately 50,000 locations nationwide.
In March, we launched the Test-to-Treat initiative that gives
individuals an opportunity to rapidly access free treatments at
approximately 2,600 pharmacy-based clinics, federally qualified health
centers, and community-based sites. Under this program, people are able
to get tested and if they are positive and treatments are recommended
for them, receive a prescription from a health care provider (either
onsite or via telehealth) and have their prescriptions filled all in
one location. In coordination with FEMA, we have also added a federally
supported Test to Treat initiative which allows us to partner with
states and territories to support additional Test to Treat sites around
the country. We currently have sites in Rhode Island and Minnesota and
are evaluating additional proposals from several states.
Biomedical Advanced Research and Development Authority
The Biomedical Advanced Research and Development Authority (BARDA)
continues to leverage the supplemental appropriations provided by
Congress to support the development of vaccines, therapeutics, and
diagnostics to end the COVID-19 pandemic. BARDA has awarded contracts
for 81 medical countermeasure projects to aid the COVID-19 response to
date. All of these contract awards are listed on
medicalcountermeasures.gov in detail and include 18 therapeutics, 56
diagnostics, and seven vaccine candidates. Notably, BARDA has placed
1.5 billion doses of vaccine under contract (including a combination of
adult primary, booster, and pediatric doses), distributed over 11.1
million treatment courses of monoclonal antibodies and antivirals, and
shipped more than 243 million diagnostic kits.
BARDA also supports research on expanding eligibility for the
current authorized and approved vaccines as well as the continued
development of vaccine candidates that have not yet been authorized or
approved. This ongoing work on vaccines is critical as we begin to look
for next generation vaccines that are easier to store, ship, administer
and may prove more durable than the current authorized and approved
vaccines.
BARDA's work on therapeutics is critical as we seek to balance the
ease of administration with the benefits of the treatment. For example,
monoclonal antibodies are administered by infusion, which must be done
in clinical settings, placing a high burden on patients and healthcare
staff. BARDA's collaboration with industry on developing oral
antivirals offers an important therapeutic option other than monoclonal
antibodies. As a result, there are now two oral antivirals available
under EUA for the prehospital treatment of patients at high risk for
progression to severe COVID-19. In fact, the administration of oral
antivirals has increased sixfold in recent weeks.
BARDA continues to play an important role in the development of
diagnostic tests that expand beyond central labs to point of care and
at home solutions. This includes contracts for three molecular and two
antigen tests for use in both point-of-care and home use settings and
for two molecular and five antigen tests for use specifically in point-
of-care settings. BARDA has also expanded its portfolio to include
development of respiratory panel tests that, at a minimum, can detect
SARS-CoV-2 (the virus that causes COVID-19) plus Influenza, but often
can detect for other respiratory viruses. BARDA is funding development
of an Omicron-specific molecular test for use in informing monoclonal
antibody therapy. Last, BARDA has funded six manufacturing capacity
expansion efforts to increase domestic testing capacity.
Strategic National Stockpile and Medical Supply Chain
The pandemic has severely strained our public health and medical
supply chains. As this Committee is well aware, the medical supply
chain ecosystem is complex, with different private sector players and
market dynamics across multiple domains of medical equipment and
supplies. Many vital products and their raw materials are primarily
made overseas, and practices like ``just in time'' inventory management
resulted in difficulty accelerating manufacturing when demand surged in
the spring of 2021. This created significant and devastating challenges
for states and healthcare systems that required access to these key
supplies.
Over the course of the COVID-19 response, the SNS has worked to
backstop states' medical supply needs at an accelerated pace. Since the
beginning of the pandemic, the SNS has deployed more than 610 million
items to aid the national response including Personal Protective
Equipment (PPE), ventilators, Federal Medical Stations, and
pharmaceuticals. In particular, the SNS deployed almost 3,000
ventilators to 17 jurisdictions between July and October 2021, to
respond to the Delta variant case surge. The SNS has deployed more than
300 ventilators and High Flow Nasal Cannula to six jurisdictions since
Omicron emerged.
I highlighted in my testimony in January that ASPR continues to
work to replenish SNS inventory to levels at or above pre-COVID-19
amounts to ensure that we are prepared for any subsequent wave of
additional cases and to do so--to the extent possible--with
domestically manufactured supplies and equipment. As of June 2, 2022,
the SNS has utilized approximately $12 billion from COVID-19
supplemental appropriations provided by Congress to have in its
inventory approximately: 541 million N95 respirators (42 times pre-
pandemic levels); 274 million surgical and procedure face masks (8.5
times pre-pandemic levels); 19.6 million face shields (two times pre-
pandemic levels); 59.6 million gowns and coveralls (12.5 times pre-
pandemic levels); 4.8 billion gloves (272 times pre-pandemic levels);
and 158,000 ventilators (10 times pre-pandemic levels). SNS has also
made investments to ensure that there is capacity to make these
critical supplies.
While replenishing the SNS is essential, it is also critical to
address the root cause of why supply chains were so strained in the
first place. ASPR is taking on this work as well since ensuring a safe
and consistent public health supply chain for medical materials,
ingredients, and supplies is critical for any national response to
public health emergencies.
In response to the COVID-19 pandemic, ASPR has leveraged the
authorities delegated to the Secretary under the Defense Production Act
(DPA) to issue 70 priority ratings. Priority ratings were issued on 54
U.S. Government (USG) contracts to support the development, production,
and/or procurement of critical COVID-19 countermeasures such as
vaccines, therapeutics, diagnostics, personal protective equipment,
ventilators, and ancillary medical supplies. Additionally, priority
ratings were issued on 10 USG contracts to support manufacturing
expansion for vaccines, diagnostics, N95s, and glass vials as well as
for vaccine distribution. In six circumstances, the HHS Secretary
authorized a private sector partner to apply priority ratings on select
purchase orders to ensure continued production of medical devices that
were essential in the COVID-19 response.
Also under the DPA, ASPR is strengthening the industrial base to
secure and develop domestic capacity, retool and expand industry
machinery, scale production facilities, train workforces, and
ultimately infuse the supply chain and marketplace with products the
U.S. needs to contain further pandemic waves. ASPR continues to invest
in critical funding in expanding domestic manufacturing including
investments in manufacturing PPE, testing consumables, vaccine raw
material, vaccine vials, at home and point of care tests, and testing
raw materials. Each of these domestic manufacturing initiatives meets
current, as well as future COVID-19 needs, and seeks to create or
sustain high-value domestic jobs.
All of these investments, and the industrial base overall, require
dedicated and persistent management and engagement. As such, my intent
is to institutionalize this mission in ASPR. I am working to integrate
and organize supply chain situational awareness and industrial
analysis, domestic industrial base expansion, and supply chain
logistics into a new office within ASPR. Bringing these pieces together
will strengthen our industry partnerships and support our work to
establish and maintain resilient supply chains. I ask for your support
as we work to address this effort and would be happy to provide future
briefings on this effort as needed.
Testing
In addition to the Industrial Base Expansion efforts I mentioned
previously, ASPR continues to support COVID-19 testing for the Nation.
We've made significant progress in increasing testing supply,
availability, and affordability over the past year. We went from zero
over-the-counter tests in January 2021 to approximately 300 million
tests available for use in December 2021. HHS has invested billions of
dollars in domestic testing manufacturers to accelerate production of
rapid tests and expand manufacturing capacity. At ASPR, we know
partnership with industry is critical to ensuring that success
continues, which is why I visited an Abbott BinaxNOW manufacturing
facility in Illinois to meet with company leadership, visit with the
employees on the production floor, and see the manufacturing process
up-close. The advances we have made in testing are reflective of a
broader effort within ASPR to bolster our industrial base expansion and
supply chain efforts.
In January, President Biden announced a plan to make 1 billion free
at-home tests available to the American people and mail them directly
to their homes via COVIDTests.gov. In partnership with the U.S. Postal
Service, we have delivered hundreds of millions of tests, and recently
opened up a third round of ordering. We are also creating a Federal
stockpile of COVID-19 tests to rapidly distribute in the event of a
surge.
Since May 2021, ASPR has also shipped over 149 million rapid
antigen tests and 8.1 million point-of-care PCR tests to our most
vulnerable populations, including nursing homes, federally qualified
health centers, and long-term care facilities. In addition to the
purchase and distribution of these tests, ASPR continues to work with
manufacturers, companies, and laboratories to identify and proactively
address any supply issues.
Conclusion
Thank you again for inviting me to testify before you on efforts
within ASPR to support the COVID-19 response. I look forward to
answering your questions and working with my team at ASPR and our
colleagues across HHS to end the COVID-19 pandemic.
______
The Chair. Thank you to all of our witnesses this morning.
We will now begin a round of 5 minute questions. I ask my
colleagues, please keep track of your clock and stay within the
5-minutes.
We are quickly running out of resources to prepare for
another COVID surge. I am talking about vaccines that can keep
us safe from the new COVID variants, more accurate tests, new
treatments that work against new variants to prevent serious
illness and death.
Developing those products is essential, but it takes
funding, and it takes time. If we don't provide more funding
now, the vaccines and treatments we need in the fall may not be
available. I don't want to be in a situation again where
schools and childcare centers are closed, or hospitals and
health care workers are overwhelmed. I want to make sure
everyone who wants a vaccine gets one in the fall.
I want to ask each one of you individually this morning,
why are additional investments in our COVID response needed
now, and how will our ability to prepare for and respond to
COVID change if we do not provide additional support? Dr.
Walensky, I will begin with you.
Dr. Walensky. Thank you, Chair Murray. We have numerous
ongoing studies that will not be able to continue, studies that
I believe the American people are interested in and need to
see, including two nationwide seroprevalence studies that need
to end in December 2022. These include the national burden and
incidence of infections, immunity and correlates of protection.
We are unable to continue our long term surveillance and
that includes comprehensive monitoring of post-COVID
conditions. We will be unable to continue our mother to baby
surveillance, and that includes mothers with COVID. We have
learned a lot about how the impact--they impact on their
babies, as well as the vaccine impact of pregnant women and on
their babies.
But we won't be able to do those studies for things like
paxlovid and other therapeutics, including monoclonal
antibodies. And then finally, CDC will not be able to continue
its global vaccine efforts and in the future, its domestic
vaccine efforts support as well. Thank you.
The Chair. Dr. Califf.
Dr. Califf. To me, the most important thing that will
happen is people will die or be hospitalized or experience long
COVID for days to months to maybe a lifetime unnecessarily if
they don't have access to the latest vaccines and antivirals.
Within the FDA, we have to keep track of all this and adapt to
this rapidly changing virus and the environment that it is in.
I want to add one more component we haven't talked about,
the supply chains of all of this. I have learned a lot about
the food supply chain in the last few months, and it is not
just infant formula. We have multiple areas of agricultural
supply that are tenuous if workers get sick and can't--and we
all remember the early days of the pandemic in that regard.
The Chair. Ms. O'Connell.
Ms. O'Connell. Thank you. Without additional funds, we have
already seen that we are going to be limited in our ability to
maintain domestic manufacturing of tests. We have been able to
support that over the last several months and keep it ramped up
to meet the demand the American people have had for over the
counter tests. We are now having to divert funds away from
that.
We are also not going to be able to expand our domestic
manufacturing of mRNA vaccines. This was one of the things that
we think is important for our current response and future
preparedness.
In addition, the Strategic National Stockpile is not going
to be able to purchase domestically manufactured surgical gowns
as we anticipated being able to do and will struggle to be able
to maintain the current PPA--PPE levels that I just walked
through. We also are unable to invest in the research and
advanced research and development for next generation vaccines
and therapeutics.
The Chair. Dr. Fauci.
Dr. Fauci. Yes, Madam Chair. As you know, the role of the
NIH is to do the basic clinical and translational research, to
develop the countermeasures that we have so successfully been
part of that process, to get us the vaccines, therapeutics, and
diagnostics.
As you mentioned in your opening statement, this virus is
changing, and we need to keep up with it. In order to do that,
we have got to do better with new vaccine platforms such as
nanoparticle vaccines. We cannot proceed with that unless we
get additional funding. Importantly, we need to both prevent
infection and transmission.
We know that we cannot do that unless we get a highly
effective, mucosal or intranasal vaccine. We have a number of
projects that will not be able to be funded unless we do get
new resources to continue this funding. These are challenges
that we have that I believe we will be letting the American
people down if we do not use our scientific capabilities to
meet the next challenge of this ever changing virus. Thank you.
The Chair. Thank you. You know, COVID-19 vaccines have done
incredible job keeping people from getting severely ill. COVID
treatments have, as we know, saved thousands of lives. However,
we only have a limited number of treatments and vaccines, and
they are produced by a small number of companies.
I think everyone in this room is worried we are over
reliant on current products and not doing enough to get ahead
with the next generation vaccines or treatments or tests. I am
worried we are not investing in that research and development
of products that we will need this winter.
In our conversations, Dr. Fauci and Ms. O'Connell, it is
clear that NIH and ASPR do not have sufficient resources to
invest in that necessary research and development work. Dr.
Fauci, you alluded to this a little bit, but talk about what
you are doing to ensure this next generation research is the
top priority for NIH.
What can NIH due to bring these products further along in
the process with its existing funding?
Dr. Fauci. Thank you, Madam Chair. Two examples of what we
are doing with regard to therapeutics is the antiviral program
for pandemics, where we are using both development and
discovery very similar to the paradigm that was used for the
highly successful development and discovery of drugs for HIV,
namely the antiviral drugs. We will absolutely need more
resources to get that done effectively.
In addition, we have just awarded nine centers that are
centers for it is called AViDD, the Antiviral Drug Discovery
Centers. We have very good investigators throughout this
country. We could fund many more and that would hasten the
capability that we have of developing new drugs.
How we can continue to further that is to do what we have
been doing all along, is to partner with our industrial
partners, to be able to do the fundamental, basic concept
development. And then together with BARDA, which we have been
very successful with in that partnership, to continue to
develop these new drugs as well as diagnostics.
The Chair. Thank you. Senator Burr.
Senator Burr. I will turn to each of you for a yes or no
answer. You have just described programs that you said would be
devastating if emergency funding was not made available. Did
the Administration request funding in their `23 budget for the
programs you just listed?
Dr. Walensky.
Dr. Walensky. I would have to get back with you and----
Senator Burr. Dr. Califf.
Dr. Califf. I am certain that parts of it were requested,
but not the full amount.
Senator Burr. Ms. O'Connell.
Ms. O'Connell. We are beginning the process of figuring out
how to absorb these costs into our annual budgets moving
forward.
Senator Burr. I asked, did they make a request? You came
with the very specific things that are not or are going to be
disastrous if emergency spending is not--now we are doing the
`23 budget, the budget request coming from the Administration.
Did they request these things?
Ms. O'Connell. It has been over a year since we have
received COVID specific funding. A lot has changed----
Senator Burr. In fact, Administration just took money from
the Strategic National Stockpile. They didn't ask for more.
They took it. They asked for less. Dr. Fauci, are all the
things that you just listed, are they in the `23 budget
Administration request of Congress to fund?
Dr. Fauci. Some of them are, Senator, but not all of them,
because at the time that we put in that request, the
opportunities to do some of the things we done were not
absolutely apparent to us. So the direct answer to your
question is not all of it is in the request.
Senator Burr. Are you beginning to see the pattern as to
why a plan is important? This has been a well-orchestrated
event up to this point. It has done you damage. It really has.
Dr. Califf, we have hit the point in public health response
where there is a commercial market for COVID vaccines,
treatments, and diagnostics, yet FDA is still limiting who can
purchase vaccines and treatment under the EUA.
Limit and nothing in the law requires that the purchaser of
an authorized or EUA vaccine or treatment must be Government.
Does FDA have a plan to allow states or health care providers,
including payers, to purchase vaccines and treatments to help
put purchasing decisions back in the hands of Americans rather
than Government?
Dr. Califf. Senator Burr, each of our major product areas,
drugs, devices, biologics is working with the industry to be
transitioning. A number of them already have transitioned to
full----
Senator Burr. You understood what I read in the statement
was, you actually write into the EUA, only Government can
purchase these.
Dr. Califf. That is correct.
Senator Burr. The law does not restrict anybody else from
purchasing under an EUA. It is the limitation you put in the
EUA, correct?
Dr. Califf. Yes, that is correct.
Senator Burr. All right. Let's talk about EUAs a little bit
further. The EUA on antivirals. Did I misstate anything that
the antiviral EUA states that it should only be prescribed to
individuals that are at risk?
Dr. Califf. Right. Pfizer did a robust clinical trial and
that included people at risk, at higher risk by certain
factors. We looked at the data. The data were compelling. That
was the basis for the EUA.
Senator Burr. The in the EUA says to be prescribed to
individuals at risk?
Dr. Califf. Those at high risk. Yes.
Senator Burr. So does Test and Treat violate the
restrictions in the EUA if individuals who show up are not at
risk, test positive, or are given an antiviral?
Dr. Califf. My interpretation of Test and Treat is it is
still prescribing paxlovid that is still within the EUA. And so
only those who meet the risk criteria would be prescribed it.
Senator Burr. Anybody that does not reach the risk criteria
would be in violation of the EUA?
Dr. Califf. I think prescribing, as you know, is a
complicated area of medical practice. So when you say in
violation, I am not sure what the legal meaning of that in the
context of medical practice. But people who are low risk, like
a 25 year old with COVID and no co-morbidities, would not be
expected to get benefited and so it wouldn't make sense to
prescribe it.
Senator Burr. Was the vice President high risk when she
took the antiviral?
Dr. Califf. I am not aware of the vice President's clinical
status, and as a physician, I wouldn't discuss a person's
medical history.
Senator Burr. Ms. O'Connell, just last week, HHS announced
that it had found $10 billion in the couch. Out of those funds
previously provided for COVID responses, I was surprised and
frustrated to hear that these funds were overwhelmingly
repurposed from within ASPR, including the stockpile.
It is my understanding that over $1 billion will be taken
from the Strategic National Stockpile. What are we giving up in
the stockpile so that that $1 billion can be spread across the
rest of the response?
Ms. O'Connell. Thank you, Senator. Without additional
funding, we have been forced to make very difficult decisions,
make tradeoffs that none of us want to make. And that included
finding an additional $1 billion from the Strategic National
Stockpile. That funding would have gone to securing the
purchase of domestically manufactured surgical gowns in order
to meet the requirement that the national stockpile has for
surgical gowns, so we are going to be short there. We also are
jeopardizing our ability to maintain the PPE at the levels that
we currently are. Every piece of equipment we have is
warehoused. The warehousing costs money.
Senator Burr. Ms. O'Connell, you are the ASPR, and by
statute, you are supposed to lead a pandemic. I am going to
turn to you. Tell me what the plan is.
Ms. O'Connell. Well, the Administration put forward a plan
on March 3rd with how it would spend the additional funds that
it was repurposing----
Senator Burr. I understand how you would spend it. Tell me
what the plan is to get to some endgame in COVID.
Ms. O'Connell. Our plan involves short term, providing,
making sure all Americans have access to the critical tools
needed to protect themselves. Medium term, making sure that we
have access to supplies moving forward. Investing in domestic
manufacturing so we are not caught short footed like we were in
March 2020.
Then long term, this research and development that we have
talked about to get us to the next generation of vaccines that
won't require multiple boosts, to get us to therapies that can
be prescribed for everybody. That is where we need to go.
Senator Burr. If you can take the outline you just
presented to me and get somebody from the Administration to
fill in in between the action steps that are going to be taken,
you might have a plan. Thank you, Madam Chair.
The Chair. Senator Paul.
Senator Paul. Dr. Fauci, the Government recommends
everybody take a booster over age five. Are you aware of any
studies that show a reduction in hospitalization or death for
children who take a booster?
Dr. Fauci. Right now, there is not enough data that has
been accumulated, Senator Paul, to indicate that that is the
case. The--I believe that the recommendation that was made was
based on the assumption that if you look at the morbidity and
mortality of children within each of the age groups, 0 to 5, 5
to 11----
Senator Paul. Right. So there are no studies, and Americans
should all know this, there are no studies on children showing
a reduction in hospitalization or death with taking a booster.
The only studies that were permitted, the only studies that
were presented were antibody studies.
They say if we give you a booster, you make antibodies.
Now, a lot of scientists would question whether or not that is
proof of efficacy of a vaccine. If I give you 10 or if I give a
patient 10 mRNA vaccines and they make protein each time or
they make antibody each time, is that proves that we should
give ten boosters, Dr. Fauci?
Dr. Fauci. No, I think that is somewhat of an absurd
exaggeration, Senator Paul.
Senator Paul. Well that is the proof that you use. Your
committees use that. That is the only proof you have to tell
children to take a booster so that they make antibodies. So it
is not an absurdity. You are already at like five boosters for
people. You have had two or three boosters. It is like, where
is the proof?
Now, I think there is probably some indication for older
folks that have some risk factors. For younger folks, there is
not. But here is the other thing. There are some risk factors
for the vaccine. So the risk of myocarditis with a second dose
for adolescent boys, 12 to 24, is about 80 and 1 million.
This is both from the CDC and from the Israeli study. It is
also in the VAERS study, remarkably similar, for boys, much
higher from boys than girls, and much higher than the
background. The background is about 2 per 1 million. So there
is risk and there are risk. And you are telling everybody in
America just blindly go out there because we made antibodies.
So it is not an absurd corollary to say if you have 10.
In fact, you probably make antibodies if you get a 100
boosters, all right. That is not science. That is conjecture.
And we should not be making public policy on it.
Dr. Fauci. So, Senator Paul, if I might respond to that, we
just heard in his opening statement, Ranking Member Burr talk
about his staff who went to Israel. And if you look at the data
from Israel, the boosts, both the third shot boost and the
fourth shot boost, was associated with a clear cut clinical
effect, mostly in elderly people, but also as they gathered
more data, even in people in the 40's and the 50's. So there is
clinical data----
Senator Paul. But not in children. Well, see, here is the
thing is, you are not willing to be honest with the American
people. So, for example, 75 percent of kids have had the
disease. Why is the CDC not including this in the data? You can
ask the question. You can do laboratory tests to find out who
has had it and who hasn't had the disease.
What is the incidence of hospitalization and death for
children who have been infected with COVID subsequently going
to the hospital and dying? What is the possibility if your kid
has had COVID, which is 75 percent of the country has had
COVID, what is the chance that my child is going to the
hospital or dying?
Dr. Fauci. If you look at the number of deaths in
pediatrics, Senator, you can see that there are more deaths----
Senator Paul. Of people who have had it--of people who have
had the disease.
Dr. Fauci. Senator, we also know from other studies that
the optimal degree of protection when you get infection is to
get vaccinated after infection. And in fact, showing
reinfection in the era of Omicron and the sub-lineages, that
vaccinated----
Senator Paul. But you can't answer the question I asked.
The question I asked is how many kids are dying and how many
kids are going to the hospital who have already had COVID? The
answer may be zero, but you are not even giving us the data
because you have so much wanted to protect everybody from all
the data because we are not smart enough to look at the data.
When you released data earlier, when the CDC released the
data, they left out the category of 18 to 49 on whether or not
there was a health benefit for adults 18 to 49. Why was it left
out? When critics finally complained, it was finally included
because there was no health benefit from taking a booster
between the 18 to 49 in the CDC study. Another question for
you.
The NIH continues to refuse to voluntarily divulge the
names of scientists who receive royalties and from which
companies. Over the period of time, from 2010 to 2016, 27,000
royalty payments were paid to 1,800 NIH employees. We know that
not because you told us, but because we forced you to tell us
through the Freedom of Information Act.
Over $193 million was given to these 1,800 employees. Can
you tell me that you have not received a royalty from any
entity that you ever oversaw the distribution of money in
research grants?
Dr. Fauci. Well, first of all, let's talk about royalties.
Senator Paul. That is the question. No, that is the
question. Have you ever overseen or received a royalty payment
from a company that you later oversaw money going to that
company?
Dr. Fauci. You know, I don't know as a fact, but I doubt
it.
Senator Paul. Well, here is the thing is, why don't you let
us know? Why don't you reveal how much you have gotten and from
what entities? The NIH refuses. We ask them. We ask them. The
NIH--we ask them whether or not who got it and how much. They
refused to tell us. They send it redacted. Here is what I want
to know. It is not just about you.
Everybody on the vaccine committee. Have any of them ever
received money from the people who make vaccines? Can you tell
me? Can you tell me if anybody on the vaccine approval
committees ever received any money--vaccines--?
Dr. Fauci. Are you going to let me answer the question?
Sound bite No. 1. Are you going to let me answer a question?
Okay. So let me give you some information. First of all,
according to the regulations, people who receive royalties are
not required to divulge them even on their financial statement,
according to the Bayh-Dole Act.
Let me give you some example. From 2015 to 2020, I--the
only royalties I have was my lab and I made a monoclonal
antibody for use in vitro reagent that had nothing to do with
patients. And during that period of time, my royalties ranged
from $21 a year to $17,700 a year, and the average per year was
$191.46.
Senator Paul. It is all redacted, and you can't get any
information on the NIH----
The Chair. Senator Paul, your time----
Senator Paul. We want to know whether or not people got
money from the people who made the manufacturing----
The Chair. Senator Paul, your time is long over expired. I
gave you an additional two and a half minutes. The witness has
responded. We are going to move on.
Senator Sanders.
Senator Sanders. Thank you all very much for being here.
One of the concerns that I have in terms of where we are now
and where we might be in the future, is that the American
people do not have ready access to the information they need as
to how they can receive the best treatment available of a
COVID.
An example of a 60 year old gentleman wakes up in the
morning, has bad symptoms, tests positive for COVID. I worry
that that person and millions of them may not even know that
there are therapeutics out there that can help them, that they
may have 5 days, only five--that they have to take it within
the first 5 days of symptoms.
Or can you tell us, Dr. Walensky, what we can do to make it
easier for people to get the therapeutics that they need?
Dr. Walensky. Thank you, Senator Sanders. This is key in
terms of our distributing and equitably distributing not only
our therapeutics, but in fact, even before therapeutics,
communities and at risk people need to understand to do a test
because that is the gateway into getting these therapeutics.
We need to have testing available, accessible. A lot of
what the ASPR has done in distributing home tests. We need to
have therapeutics available in at risk communities across the
country and then we need to do public health campaigns so that
people understand that a test should be done and that they have
access to these therapeutics.
Senator Sanders. But the concern is that in some of them,
at least, you should take the drug within five--the first 5
days. Are you confident that we have a system that if somebody
wakes up, they are going to have to get a prescription from a
doctor, do they have a doctor that they can get a prescription
from within the first few days? Do they know where to get the
drug, or--and do they have the money to pay for that drug?
Dr. Walensky. The drugs are free. The tests are free. But I
am not sure that everybody knows that. And we have expanded our
rollout and accessibility of paxlovid. But I will also say that
just like early in our vaccine work, we have seen inequities in
how that paxlovid has been used.
We will have more data forthcoming from the CDC soon on
that. But we have a lot of work to do in the equitable
distribution of paxlovid and to getting the education to the
communities, to community health centers, to physicians in
rural areas.
Senator Sanders. Should our goal be, it seems to me, to
make it nice and simple that if somebody is feeling ill, if
somebody has COVID, they can dial a 1-800 number and get the
drug as quickly as possible. Is that the goal that we striving
for?
Dr. Walensky. Yes, we need to do that under the EUA and
with the caveat that there are some things like renal
insufficiency or drug interactions that need to be assessed. We
need to make sure that those assessments are complete as well.
Senator Sanders. Okay. I want to change course a little bit
here and touch on a subject that I don't think we talk about
enough as a Nation, and that is that we have a significant
shortage of doctors, nurses, pharmacists, dentists, other
health care providers.
That shortage has only been exacerbated as a result of
burnout related to COVID. I know that is not necessarily within
your jurisdiction, but you can give us--can you give us some
thoughts about how serious that shortage of medical personnel
is and what we might want to do to address it?
Dr. Walensky. Yes, I think it is key. Not only medical
personnel, but public health personnel. The Beaumont Foundation
surveyed demonstrated that we are about 80,000 public health
workers in deficit right now and that we need to not only
retain the ones who have stepped up to the plate during the
COVID-19 pandemic, but we need to foster and invest in future
public health workers as well as health care workers.
That includes loan repayment and includes investing in the
time and making sure we are competitive from salary standpoint
so that we can retain the best of the best in these fields.
Senator Sanders. Okay. Let me ask Dr. Califf a question.
Senator Paul raised the issue about money and so forth. I look
at it, his questions are valid, but I look at it a slightly
different way. I am concerned, and you correct me if I am wrong
here, Moderna, who helped create one of the important vaccines
that is saving lives, received, as I recall, about $2.5
billion, I think, during the Trump administration.
My understanding, and you correct me if I am wrong, is that
the gentleman who is the head or was the head of Moderna
recently received a golden parachute of some $800 million, $2.5
billion of Federal funding to develop the drug, Moderna makes
huge amounts of money, this guy receives $800 million a golden
parachute. Am I right about that?
Dr. Califf. I am not aware of that. It is not something I
would keep up with, particularly in this job.
Senator Sanders. Not something you would keep up with. The
Head of the Food and Drug Administration, you would not be
concerned that a guy--when we are producing and trying to get
vaccines out to people, it was--I am corrected, it is $926
million golden parachute. If that is true, if the Federal
Government gives a company $2.5 billion and a short time later
the head of the company gets a $900 million golden parachute,
that is not a concern to you?
Dr. Califf. No, I didn't say it was not a concern. I said
it is not something I keep up with in daily life. What I am
very concerned about is the equitable distribution of vaccines
that save lives and antivirals that save lives. we are not
reaching the goals that we need.
Senator Sanders. Well, maybe, I think we need, I would hope
everybody agrees that we need the financial resources to make
sure that everybody has the vaccines. But if one guy ends up
with $900 million, rather than using that money to get out the
medicine we need, the vaccines we need, out to the people,
doesn't make a whole lot of sense to me. Thank you very much,
Madam Chair.
The Chair. Senator Romney.
Senator Romney. Thank you, Madam Chair. Senator Sanders, I
am one of those that doesn't understand why golden parachutes
are provided by boards ever. Doesn't make any sense to me to
pay someone to leave a ton of money. Not that you change the
law. I am just saying I can't figure out why a board would do
such a thing. Worth looking into.
I appreciate the work that each of you do and the effort
that you make to help the people of our Country have healthier
lives and have long lives. I realize that science is not all
knowing. And from time to time, there are mistakes. That is the
nature of humankind. But I appreciate very much the work that
you do and want to express my appreciation personally for that.
I do have an issue that is tangentially related to what you
do but related to the Administration of which you are you are
part of. And that is that back in March, I had a number of
other Members of this Committee sent a letter to the
Administration asking for an accounting of how the prior COVID
relief money had been spent, and then also how new money that
was being requested for emergency supplemental would be spent.
As part of that response to that letter, the Administration
released a statement regarding the lack of potential funding
for--going forward. I want to read a couple of excerpts from
that letter. One is, ``the Federal Government is unable to
purchase additional lifesaving monoclonal antibody treatments
and will run out of supply to send to states as soon as late
May.
The Federal Government cannot purchase sufficient
quantities of treatments for immunocompromised individuals, and
the Federal Government will be unable to sustain the testing
capacity we built over the last 14 months.'' And then
continuing, ``ending the purchase of monoclonal antibody
treatment, scaling back state and territorial allocations,
inability to purchase additional oral antiviral pills,
inability to purchase new antivirals, scaling back planned
purchases of preventative treatments.''
Again, what the Administration provided to us in Congress
in response to our letter was that the Administration would be
unable to purchase therapeutics and monoclonal antibodies,
unable to purchase. Madam Chair, I would ask unanimous consent
that this release from the Administration be entered into the
record.
The Chair. Without objection, so ordered.
[The following information can be found on page 81 in the
Additional Material:]
Senator Romney. Now, in good faith, I and a number of other
people worked over a number of months with Members of this
party and across the aisle to develop a supplemental bill
providing that $10 billion to address this inability to
purchase these things without the $10 billion.
But you can imagine my surprise when I find out that on
June 8th, the Federal Government did, in fact prioritize $5
billion for the purchase of additional vaccines, $4.9 billion
for therapeutics, and $300 million for additional monoclonal
antibodies. But it choose not to do so in February, March,
April, or May, again saying they had inability to do so. So the
Administration has recklessly and unilaterally spent taxpayers'
money. We have runaway inflation.
But instead of taking a real inventory of funds they had at
their disposal, they said, hey, we need more money. Now,
Washington operates on a relationship of trust between the
respective parties, the Administration, and Congress. For the
Administration to provide information to us that was patently
false is something which dramatically attacks that trust, which
I have, Members of my party have, Members of both parties have.
I hope that there is an appreciation that for the
Administration to say they could not purchase these things and
then after several months divert some funds and then purchase
them is unacceptable and makes our ability to work together and
have confidence in what we are being told very much shaken to
the core.
I would ask this question. If the Administration knew in
March that it was feasible to buy these things, do you know why
they waited to actually do so? Any one of you can respond. Dr.
Fauci, you are on the hot seat on the camera, so we will give
it to you. I hope you feel better, by the way.
Dr. Fauci. Yes. Thank you very much. Senator. I think that
question is probably best given to the Assistant Secretary Dawn
O'Connell.
Ms. O'Connell. Thank you, Dr. Fauci. Thank you, Senator
Romney. And thank you for your support in trying to get
additional funds freed for us to manage the COVID response.
Senator Romney. Yes, I didn't realize that they weren't
needed. I wouldn't have worked as hard with Leader Schumer and
with others over many weeks and intensive negotiations and gone
to my colleagues and told them these moneys were necessary had
I been told that, in fact, they weren't necessary.
It is--and I know money is--you are going to tell me that,
hey, we needed to spend money and other things, we had to
divert it, but that we could have been told. But we weren't
told that. We were told, we could not purchase therapeutics or
monoclonal antibodies. And now you have.
Ms. O'Connell. We had to do so with significant tradeoffs.
Tradeoffs that we--none of us wanted to make as----
Senator Romney. But we should have been--we are part of
Congress. When you are asking us for $10 billion, we should be
apprised of what those tradeoffs are and have that discussion
and help make that decision together. You shouldn't be able to
say, hey, we are looking at tradeoffs, we are not going to tell
you about them, just give us some more money. Isn't that not
unacceptable in a relationship between the Administration and
Congress?
Ms. O'Connell. We have worked hard to be transparent with
our funding needs. And again, I have appreciated the support
you have given us in trying to unlock additional funds. Making
the decision to spend this money, taking it away from critical
programs is absolutely difficult, and it is something we didn't
think was acceptable. We are now at a point, because Congress
has not given us additional funding, that we have had to do
these things that are unacceptable.
Senator Romney. Well we--my time is up. I will just say we
agreed on one word and that is, unacceptable. Thank you.
Madam Chair.
The Chair. Senator Lujan.
Senator Lujan. Thank you, Madam Chair. Now, as New Mexico
continues to battle the COVID-19 pandemic, we are now also
battling the largest wildfires the state has ever seen.
Wildfires that were started as a controlled burn by the Federal
Government and two fires that got out of control.
While I very much respect that people keep telling me 99.8
percent of control burns are always under control, I am more
interested in the 0.2 percent that destroyed our state. These
dual crises have stretched the resources of the state to the
breaking point.
As New Mexicans flee natural disaster, in many cases taking
only the belongings they can carry, they face increased
exposure to COVID-19 virus, which has run rampant in the
congregate settings being used to house evacuees. Assistant
Secretary O'Connell, how are you coordinating to support New
Mexico's COVID-19 response in light of the wildfires?
Ms. O'Connell. Thank you, Senator Lujan. And we continue to
keep the people of New Mexico who are currently experiencing
these two tragedies in our minds. The Secretary on May 9th,
realizing the extent of what was happening in New Mexico,
declared a public health emergency, and that public health
emergency freed up flexibilities for the health care system
there in order to respond in the emergent condition, including
providing telehealth for Medicare beneficiaries, freezing the
Medicaid rolls so no one would be--would lose insurance during
this time of tragedy.
At ASPR, we continue to support through our hospital
preparedness program, New Mexico's Coalition, a healthcare
coalition, which was responsible for evacuating many of the
hospitals and long term care facilities, nursing homes. And so
we continue to work closely with our colleagues there to make
sure that everybody is safe and accounted for. We also run the
Medical Reserve Corps, and the Medical Reserve Corps in New
Mexico has been activated in order to respond to the wildfires.
We continue to support our colleagues out there through
that effort. And we have been in close contact with FEMA. We
have offered virtual support to FEMA out in New Mexico. And
wherever we can be helpful, we are trying to be. And we have
not stopped our COVID response. We are continuing to make
vaccines and therapeutics and tests available to those in New
Mexico that need them.
Senator Lujan. Assistant Secretary O'Connell, this is a
follow-up to the solid answer with programs that have been made
available. The follow-up is, how is HHS ensuring that these
resources are being communicated to those impacted, especially
given the current lack of cellular and broadband service in
many regions of the state, which is nonexistent in these
communities?
Ms. O'Connell. Thank you, Senator. We continue to have
boots on the ground in New Mexico. We have got regional
emergency coordinators in the state that continue to
communicate with city and local leaders. We also have our CMS
representatives who are making sure that the Medicare and
Medicaid provisions are being well communicated to those
beneficiaries, and everything we can. We have got several
regional representatives leading this effort for us in New
Mexico and continue to rely on their ability to communicate on
the ground.
Senator Lujan. Now, I said earlier that many families were
forced to evacuate. They were living in congregate settings.
But they were not eligible for the fourth COVID-19 vaccine. Dr.
Walensky, will you commit to reconsidering CDC guidelines for
the fourth COVID-19 shot to account for the risks of people
fleeing from natural disasters who are forced into compact
living conditions?
Dr. Walensky. Thank you, Senator Lujan. And let me add my
support and strength to the people of New Mexico who are
experiencing these natural disasters. Maybe if I could just
back up and let you know some of the things that CDC has been
doing in including drafting recommendations and documents like
wildfire smoke and COVID-19, public health strategies to reduce
exposure to wildfire smoke during the COVID-19 pandemic.
Going to a public health--a public disaster shelter during
COVID-19. We have documents. We are providing technical
assistance on the ground, as well as public health
communication, exposure, assessment, and epidemiologic data in
order to support the efforts ongoing there. And we have been
working in our National Center for Environmental Health over
the last decade to support health Departments to prepare for,
respond to, and recover from wildfire disasters.
Specifically to your question about booster shots for this
population, CDC is committed to continuously reviewing the data
on the safety and efficacy and need for booster shots. We do so
all the time. We did--we strengthened our recommendation for
those--for fourths shots for those over the age of 50.
Should we see a need, safety and efficacy, we will continue
to expand, but we certainly want to follow the data as we do
so.
Senator Lujan. I appreciate that, Dr. Walensky. Madam
Chair, as my time expires, I have a couple of questions also
made into the record. But I am hoping that that is a long way
of saying yes definitively to making these changes. Not all of
us are over 50. There were a lot of--and I just turned 50 so I
can say--there are a lot of young families and children and
grandchildren who are in these settings above the age of five,
where we had them all in one place.
When we would get scares of spread or those that are tested
positive, it is a perfect place to help provide additional
support in a community where it is hard to get to and we don't
always have the availability.
This is an area that I will continue to push, and I am
hopeful we can find a positive remedy here because New Mexico
is not going to be the only state facing natural disasters.
We are in that season right now. I am hopeful that there
will be some positive direction in how we can take care of more
people. I thank you very much. Madam Chair, yield back.
The Chair. Senator Cassidy.
Senator Cassidy. Thank you all for being here. Thank you
for your efforts on part of our Country. And, of course, what
we are hearing is that there has to be more money appropriated
and dire consequences if not allocated. But that begs the
question of the stewardship of the current dollars being
allocated. Now, and so I personally think, and I think others
agree that physically showing up to work is important. So, Ms.
O'Connell, how many days in the last month were you physically
in your office?
Ms. O'Connell. The vast majority of those days.
Senator Cassidy. Can you give me a number? I mean, it is so
frustrating. I have never been able to get a straight answer
from one of you as to how many days you are in the office and
what is the return to work policy. So just give me--how many
days is past week? And if it is five, I am pleased. How many
days in the last week?
Ms. O'Connell. The HHS has continued its return to work
starting in April. We are bringing everybody back.
Senator Cassidy. No. How many days have you personally been
in your office this last week?
Ms. O'Connell. Multiple days, of course.
Senator Cassidy. Okay, this is not hard to remember. It is
only 5 days. And if you dissemble, it makes me think that you
have not been in the office, and you don't want to give me a
straight answer. I am speaking on behalf of the American people
who are paying taxes and a lot of salaries, and they think
people aren't showing up to work. How many days in the last
five were you physically in your office?
Ms. O'Connell. We continue to work----
Senator Cassidy. Okay, Dr. Califf. How many days in the
last five were you physically in your office?
Dr. Califf. I was down in North Carolina Monday and Tuesday
because the 18 year olds that you met at my confirmation are
graduating from high school----
Senator Cassidy [continuing]. give me 5 days. When there
wasn't a family issue, did you go the previous week?
Dr. Califf. I--five, every day. When I have been in
Washington and not on business travel, I go into the office at
White Oak.
Senator Cassidy. Okay, I get that. Every day you are in
Washington does not mean that when you are--that you are here.
So are you either doing business travel as part of FDA, and but
if not, you are physically in your office?
Dr. Califf. Yes. Except for family events like----
Senator Cassidy. Dr. Walensky, how many days in the last
five were you physically in your office?
Dr. Walensky. I am not in my office today, but I feel like
I am working on----
Senator Cassidy. No, no, not feel like, how many----
Dr. Walensky. I am working onsite. I have been in--I have
been traveling, so I have been in my office two, and I have
been traveling for two. One of them I was, in fact, in your----
Senator Cassidy. So, in the last month, do you typically
work out of Washington, or do you work out of your home in the
Northeast?
Dr. Walensky. We are an agency at CDC----
Senator Cassidy. Boy, it is really hard to get a straight
answer.
Dr. Walensky [continuing]. work--on the job work. And in
fact, some of our work is in your state when you ask us to
deploy.
Senator Cassidy. I get that. I get that. But let me read
something from Elon Musk, who is asking Tesla workers to go
back to 40 hours a week. ``The more senior you are, the more
visible you must be. That is why I have lived in the factory.
There are companies that don't require this. When was the last
time they shipped a great product? You don't ship great
products by phoning it in.''
There is a perception that your agencies are
underperforming. Now, if you are underperforming and you are
not showing up, that is not good stewardship. Now, let me ask,
because I understand that HHS has a policy which is allowing
people to come back every 2 weeks for 8 hours a day.
Now, do any of you have a policy in your agency which is
different than this pilot program of only requesting 8 hours in
the office every 2 weeks? Ms. O'Connell, yes, no.
Ms. O'Connell. We require more than that in the office.
Thank you.
Senator Cassidy. Dr. Califf.
Dr. Califf. Yes. I mean, we have talked a lot--we have a
pilot program, which adjusts every individual to the optimal
working situation for them to be productive.
Senator Cassidy. Yes, so that tells me that it is really up
to the individual to decide----
Dr. Califf. No. It is up to the individual, their
supervisor----
Senator Cassidy. In your laboratories, does every
laboratory worker show up every day physically? Because in a
laboratory you got to be there.
Dr. Califf. Well, Senator Cassidy, we are both doctors. You
know, everyone who has a job to do in the laboratory that
requires them to be there is there every day. But you also know
that when you analyze data----
Senator Cassidy. Analyze data. If you have got a lab tech,
the lab tech has to be there.
Dr. Califf. Absolutely.
Senator Cassidy. Is the lab tech there every day?
Dr. Califf. Yes.
Senator Cassidy. I am sorry to be insistent, but it is hard
to get an answer.
Dr. Walensky.
Dr. Walensky. Yes. Laboratory. The people who need to be in
our labs are working in our labs. But I will also say that----
Senator Cassidy. Are they are working full time, 40 hours a
week?
Dr. Walensky. When I have a data need at midnight on a
Saturday night, people are working. There are not necessarily
in the workplace, but they are working.
Senator Cassidy. I get that. But as a lab employee who is
only productive if they are in a lab, are they working 40 hours
a week?
Dr. Walensky. People who need to be onsite in the lab or
onsite in the lab, people who are deployed to the field,
deployed nationally, they are working outside the workplace.
Senator Cassidy. Yes, but I think there is a lot--I have
got 18,000 employees and I can't believe they are all deployed.
You know, I want to finish with this. You are asking for more
money. Ms. O'Connell, you suggested that there is tough
tradeoffs that have to be made.
That, by golly, if you don't give us the money, something
is going to be sacrificed. I suspect you haven't laid off a
single person. I also know that you have the ability to monitor
the at homework history as to whether or not they are actually
logging on. I would be interested in seeing that data.
But you have got maintenance people who haven't been
employed for two and a half years, and I suspect they have not
been laid off. But you are asking for more taxpayer dollars,
asking tough choices for that family at home trying to make
their balance work, and yet it seems as if there is not a tight
ship being run. I am over. I apologize. I yield.
The Chair. Senator Hassan.
Senator Hassan. Thank you, Madam Chair, and Ranking Member
Burr, for this hearing. And thank you to all of our witnesses
today for being here and for your service. Dr. Califf, I want
to start with a question to you about the infant formula
shortage. I want to follow-up on comments that you made at
start of today's hearing.
When you testified in front of this Committee 3 weeks ago,
you told me that within 2 months we should be, ``beyond normal
and with a plethora'' of infant formula. Then, as Chair Murray
noted, Abbott announced last night that its formula production
plant in Sturgis, Michigan, had flooded, which will, ``likely
delay production and distribution of new product for a few
weeks.''
But despite that setback, as I understood your answer to
Chair Murray earlier, you still hope to have a ``super-supply''
of baby formula on shelves in the next 2 to 3 weeks, which I
take to mean more formula available than was typical prior to
the Sturgis plant shutting down. So is that correct?
If so, how do you expect to achieve that goal with Abbott
saying that the Sturgis plant will remain shut down for another
few weeks?
Dr. Califf. Yes, that is correct, with two assumptions. One
is that the company stuck to the production data that they have
given us, which they have already demonstrated they can do. The
second is there is no other natural disaster like the
unexpected one last night.
But we have--one thing that has happened is we now get
production data from all the companies involved. It adds up to
a surplus relative to the needs that are demonstrated by the
number of babies using formula over the last several years. So
we should be over that number easily, and that doesn't count
the fly formula coming in.
Senator Hassan. What you are indicating to me is that other
producers have been increasing their production.
Dr. Califf. Absolutely. All of the manufacturers in the
U.S.--remember there were only four, which is another issue.
They have all stepped up and are running their plants 24 by 7
and the numbers show it.
Senator Hassan. Okay. During the last hearing, you
indicated that an interagency committee has developed a
comprehensive plan to get this super supply on the shelves.
Will you provide that written comprehensive plan to my office
after this hearing?
Dr. Califf. Well, we will provide our plan, yes.
Senator Hassan. Thank you. And will your--and once we have
looked at the plan, we may want to follow-up with you all for a
brief. That work for you.
Dr. Califf. I understand.
Senator Hassan. Okay. Second question is to Dr. Fauci and
Assistant Secretary O'Connell. Dr. Fauci, for nearly 2 years I
have been asking you when a COVID-19 vaccine for children under
age five would be ready and they are now nearly there.
While vaccines have been available for older individuals
for quite some time, the infant and toddler vaccine has been
much slower, leaving many families with young children in a
precarious position as they try to keep their kids safe.
Do you anticipate that children ages 6 months to 5 years
will be able to get their first dose by the end of this month?
Dr. Fauci. Well, again, Senator, thank you for that
question. But I do not want to get ahead of the advisory
committee. You heard from my opening statement and that of
Commissioner Califf that in fact, the VRBPAC, which is the
advisory committee to the FDA, made a recommendation, a
positive recommendation for an emergency use authorization.
The next step would be the CDC, in which Dr. Walensky's
advisory committee will likely--in fact, likely, I am sure they
will, look at the data and make a recommendation. And then at
the end of the day, it will be the Director of the CDC's
obligation and duty to make a recommendation. I hope it does.
But we never want to get ahead of the data. The data looked
very, very good, Senator. I mean, as you heard from
Commissioner Califf, the data looked really quite good. I
anticipate that that is going to happen, but it would not be
appropriate for me to get ahead of my CDC colleagues.
Senator Hassan. Got it. And just briefly, Dr. Walensky,
what does the timeline look like for that review?
Dr. Walensky. We are going to review tomorrow and working
on Saturday as well, because we understand the urgency of this
for American parents and recognize that even on a holiday
weekend, we need to be doing this to get it to American
parents.
Senator Hassan. Right. Thank you. Assistant Secretary
O'Connell, how will the Administration work to educate parents
on the safety of this vaccine and help as many families as
possible to get their youngest children vaccinated?
Ms. O'Connell. Absolutely. Assuming that the decisions come
through, as we may expect the approval and recommendation, we
have made available 10 million doses for states to order, and
the vast majority of them have placed those orders that will
allow us to ship out as soon as an EUA, should it come, comes
with the expectation that parents can begin getting their
children vaccinated next week. That is our intention.
Senator Hassan. Thank you very much. Thank you, Chair
Murray.
The Chair. Senator Collins.
Senator Collins. Thank you. Dr. Califf, we know that the
baby formula crisis was exacerbated by the fact that people
weren't working in the mailroom and that inspectors were not
working a normal schedule in the baby formula plants. In
response to a question from Dr. Cassidy, you referred to a
return to work pilot program.
How many FDA employees are part of that pilot program as
opposed to working full time right now in the office or in the
field?
Dr. Califf. Well, of course, as you allude to, they are all
working full time. I will have to get back to you on the exact
number. But it is a majority are in the pilot program in one
way or another. The goal is to adjust to the maximum
productivity and job satisfaction.
Senator Collins. But they can't do their work if they are
not present.
Dr. Califf. Well, if it is a job that they will do their
work best. If they are present, they will be--they are required
to be there.
Senator Collins. Well, I would really appreciate getting
the data on that.
Dr. Califf. I look forward to bringing the data to you. I
think it is going to be interesting. I will just say I was at
Google before this. As opposed to Elon Musk, I think Google is
doing pretty well with their hybrid program.
Senator Collins. Let me switch to another issue. I am very
alarmed by the response that I heard to Senator Sanders'
question, where he said you should be able to just dial 1-800
to get a prescription.
The Administration has pushed very hard on the Test and
Treat program so that you test positive, you get paxlovid right
off. And here is why I am concerned. The first is that paxlovid
interacts in a negative way with a lot of commonly taken
medications, including blood thinners, for example.
Second, just on Tuesday, Pfizer announced it was halting
enrollment in a trial for paxlovid in standard risk patients,
both vaccinated and unvaccinated, after its study revealed that
the treatment was not effective in reducing symptoms in that
group.
What we heard today and what the Administration seems to be
pushing is this notion that paxlovid is going to be the answer
if you have a positive COVID test. Do you really calling 1-800
is a good way to handle the prescription of a drug that has
been found to not be effective for standard risk patients and
has interactions with a lot of medications?
Dr. Califf. Thank you for asking that question. The place I
agree with Senator Sanders is that we have a vastly inequitable
distribution of lifesaving vaccines and antivirals. Now,
particularly, I know you are from a predominantly rural state.
Particularly rural people are suffering because they have lower
vaccination rates and less access.
I don't agree that an individual just calling a 1-800
number with no clinician involved is a good idea. First of all,
because the drug is not indicated except in people who are at
higher risk. It is not that it is totally ineffective in lower
risk. If you look at those data, I love to go over those with
you later, but it is not worth the prescription. In that case,
the benefits are minimal.
I think there does need to be an intermediary, either a
pharmacist or a physician, who can look at the risks and the
drug interactions and make a good judgment. But the concept is
right that having to find a physician, get an appointment, can
take over 5 days for many Americans. We have to have a system
that deals with that issue.
Senator Collins. Dr. Walensky, David Leonhart recently
wrote in The New York Times that while masks can work, the
evidence suggests that broad mask mandates have not much to
reduce COVID caseloads over the past 2 years. And in fact, he
says that daily average cases per capita during last winter's
surge were practically the same in counties and states that had
mask mandates and those that did not.
We have seen that Hong Kong, despite almost universal mask
wearing, recently endured one of the world's worst COVID
outbreaks. There are proven ways to lower hospitalizations and
deaths.
We know that vaccinations, therapeutics, but mask mandates
have contributed to a breakdown of trust in public health
officials given the scant evidence that they actually lower
caseloads. What specific data has the CDC examined that
demonstrate that broad based mask mandates lead to lowered
caseloads, because I can't find any.
Dr. Walensky. Thank you, Senator Collins. I actually
believe that that is a piece that has undergone substantial
criticism for moving forward.
But I will say that there are numerous studies that have
demonstrated--and we have to look at this over time, because
there are secular trends as to when these mask mandates have
occurred, there are population and aggregate anonymized data
that have demonstrated decreased rates of disease when mask
mandates have been put in place earlier in the pandemic.
We have to control for all of the things as to what has
been open, what interventions have been available. But there
have been other studies for certain to refute those data. Thank
you.
The Chair. Senator Smith.
Senator Smith. Thank you very much, Chair Murray, and
thanks to all of our panelists for being here today. I am going
to focus my questions on--questions of data and data sharing
and how that risks--how that reflects our ability to respond to
the pandemic. But I just want to, before I do that, I want to
reinforce the comments that Chair Murray made at the beginning
of this hearing, that we are making progress on the pandemic,
and we are in a much better position than we have been.
But it is essential that we have got sustained resources so
that we are ready as we look to whatever comes next with this
pandemic. I just want to associate myself with Chair Murray in
urging my colleagues to support the funding that we need so
that our COVID response can continue.
I appreciate very much my colleagues, Senator Cassidy and
Senator Collins and their work on accountability, but I just
want to ask you all a simple yes or no question. Has the work
of your agency been hampered in any way by people not being in
the office? Could you just say just yes or no?
Dr. Walensky. No.
Dr. Califf. No.
Ms. O'Connell. No.
Senator Smith. Dr. Fauci.
Dr. Fauci. No.
Senator Smith. Okay. Thank you very much. Dr. Walensky, I
want to bring up something that you and I have talked about.
This has to do with the resolving the issues around sharing
public health data with tribes. So this is a challenge that I
think we both are aware of and have been talking about.
For folks who aren't paying close attention to this, tribal
epidemiology centers were created by Congress as an essential
public health authority in Indian Country, and since the
beginning of the pandemic, they faced real challenges accessing
public health data through the CDC. I have introduced a bill to
resolve this issue. I am grateful for the work of my colleagues
as well on this, especially Senator Lujan.
Dr. Walensky, as you know, the GAO has issued a report
outlining recommendations to resolve the issues. I would just
appreciate knowing--and I know you appreciate the challenges of
this.
Can you commit to working with us to make sure that those
GAO recommendations for the CDC, the report back on that is
August 31st, 2022, could you please commit us to following
through on those recommendations?
Dr. Walensky. Thank you, Senator Smith. I have appreciated
the conversations I have had with you as well. We are working
with our tribal epidemiology consortium and meeting with--
Center Consortium, a meeting with them later this month, as
well as through the summer meeting with the tribes,
specifically about how best to work for data sharing.
We are aware of the GAO report and that we have two
specific items to address, and we are on a track to provide
timely response to those. But I do want to just comment that
this is not just a data issue with tribes, but a larger data
issue at hand. The CDC does not have the authority to request,
receive, share data in a way that gives us a comprehensive
overview, not only through CDC and a national forecast, but to
tribes, to localities, from one county to another.
We do not have the authority to do so. We have gotten some
of that through the public health emergency, through the CARES
Act, where we were able to receive lab data through CMS
authorities, where we have been able to receive hospital data.
But it has been really challenging during this pandemic that we
still have holes in the data that we are able to receive.
Now as we look to monkeypox and the outbreaks of monkeypox,
we are again revisiting the challenges that are--that we are
not able to see all of the data that would be necessary to
receive and to share so that we can have a coherent response.
Thank you.
Senator Smith. Well, Dr. Walensky, you have anticipated my
next question. I appreciate that. I want to get to that in a
minute. Just to close out on the tribal data sharing, I would
just ask that we stay in close touch on this as we approach
January 20--excuse me, August 31st, so that we can resolve
this, and those tribal epidemiology centers can have access to
the data that they are legally required to have.
Looking more broadly, I am aware that the CDC does have
challenges with data, and I just want to try to help to tease
this out a little bit in the few seconds that I have left. For
example, does the CDC have the authority to require hospitals
to report their COVID data? And if they do, is that authority
permanent or is it temporary?
Dr. Walensky. It is temporary through the public health
emergency, and it is not CDC's. It is through CMS.
Senator Smith. Have hospitals been reporting the data
that--I mean, do we have all the data that we need at this
moment?
Dr. Walensky. We do not. We receive the data that CMS has
the authority to request, but we don't receive all the data
that we would like to receive.
Senator Smith. I want to just acknowledge that Senator
Kaine has a bill which I co-sponsor, the Improving Data in
Public Health, which would make the crucial improvements that I
have come to understand we really need to make to strengthen
data sharing between public health authorities and the CDC and
the Federal Government more broadly.
Let's make sure that this data sharing isn't temporary but
that it is permanent so that we can continue to be responsive
at the Federal level and have the data so that we all can make
good decisions about how best to respond to the public health
challenges that we will continue to have.
Dr. Walensky. We are very grateful for your support and
Senator Kaine on that bill. Thank you very much.
Senator Smith. I look forward to working with my colleagues
and with Senator Kaine on that as well. Thank you very much.
The Chair. Senator Braun.
Senator Braun. Thank you, Madam Chair. Dr. Walensky, it was
about a month ago in an Appropriations hearing I asked Dr.
Fauci about lockdowns, and it was based upon the Johns Hopkins
study that said that tactic basically was neutral on mortality.
I don't think it got into maybe what mortality might have
been caused due to the fact that we were locked down in other
areas. But would you agree with Dr. Fauci on that, that we
probably won't ever need to use lockdowns again on COVID as we
currently know it?
Dr. Walensky. I certainly hope not, Senator Braun. I know
that that Hopkins study had some flaws and that there have been
other studies that have refuted that. We would be happy to get
you more details on that. But certainly we are doing everything
in our power to prevent that from happening. But COVID has sent
us numerous curveballs, so I will never say never.
Senator Braun. I might also add that in everything I
observed and keeping in touch with the business community who
took it pretty seriously, they did not think that transmission
was occurring at work. It was mostly elsewhere. And that
locking those businesses down, of course, I think we are
dealing with those consequences currently.
Another question, when it comes to vaccine mandates,
Supreme Court finally weighed in and said that did not make
sense when we were going to try to force businesses down to 100
employees to either have their employees get a vaccine or lose
their job. That seemed like the ultimate heavy hand of
Government.
Would you ever recommend doing that again? Because the
Administration seemed to err on the side of vaccine mandates
and lockdowns, which I talked about earlier.
Dr. Walensky. Mandates are generally, vaccine mandates are
generally a local decision. And what I will say is, we at CDC
are for promoting more people to get vaccinated because those
who are vaccinated and boosted have decreased risk of severe
disease and death. Generally, we would support getting more
people vaccinated.
Senator Braun. Well, I would like to cite the fact that the
Administration has forced it through all Federal employees, and
I believe that initiation of what would have been the biggest
mandate for getting vaccinated came from the Biden
administration, so through an Executive Order. I agree with you
that local prerogative should come into play. But this was not
that. Do you care to comment further on that?
Dr. Walensky. CDC stand is that the more people who are
vaccinated and boosted, the decreased risk of severe outcomes
and death.
Senator Braun. So, we have now gone a couple of years. We
have learned a lot. I think the data has shown that this has
ravaged, in a disproportionate way, in the elderly with co-
morbidities.
I would like your kind of assessment, going forward, with
the general dynamics of what we know about COVID, does it make
sense that we protect better where the data has shown that we
have had the most issues with? And also parallel this to the
flu. I know it is more transmissible.
But the flu generally has a broader fatality rate. In here,
as Senator Paul talked about it a little earlier, we know that
it has really hit one category very hard. And do you think we
are protecting them well enough, and you think it makes sense
to take the broad approaches for so much of the country that
was either asymptomatic or had mild symptoms?
Dr. Walensky. I think we need to do both. Certainly, our
elder community has been among those that have been the highest
risk, highest risk of severe disease and death. But I will also
say that COVID is one of the top leading killers of children
right now. Deaths among children during the COVID pandemic have
been higher than we generally see--from COVID have been higher
than we have seen for flu.
I actually think we need to protect young children as well
as protect everyone with the vaccine and especially protect
elders. I will say that we have recently endorsed and
recommended boosters for all those over the age of 50, a second
booster for all those over the age of 50, and we will have
forthcoming data later this week that will demonstrate,
compared to a third booster, that those over the age of 50 who
have gotten a fourth have a seven fold decreased risk of death.
We are actually doing both of those simultaneously, and
that is what I think we need to be doing.
Senator Braun. Thank you. And then finally for Dr. Fauci,
of course, we read this week after 675 years, we finally found
the origins of the Black Plague. Care to give us an update on
where we are at on tracking down the origins of COVID-19?
Dr. Fauci. Thank you for that question, Senator. There have
been a number of papers that have come out from highly
qualified virologists and viral file geneticists that indicate
that this is very, very likely a jumping species from an animal
host, perhaps through an intermediate host into a human
species, which then spread throughout the human population,
certainly, and almost certainly originating in China, in Wuhan.
We still open up and keep always an open mind as to whether
or not this had to do with a virus that was isolated out in the
environment and that came into a lab and then had what most
people refer to as a lab leak.
I believe that is less likely that that is the case. But I
also believe we need to keep an open mind and have all
possibilities be investigated. But the evidence from the
virology community point strongly toward a natural occurrence.
Senator Braun. Very quickly, do you think the Chinese will
cooperate with you to try to get to the thorough bottom of it?
Dr. Fauci. Senator, I certainly hope so, because we are not
going to get an answer that is a definitive answer--I mean,
even if they do cooperate, we may not do that. But certainly,
for example, if we want to continue surveillance among bat
populations and other wild animals that might serve as an
intermediary host, as well as understanding what was going on
in some of the laboratories, I believe it is essential to have
cooperation and collaboration with the Chinese.
The Chair. Thank you.
Senator Braun. Thank you.
The Chair. Senator Hickenlooper.
Senator Hickenlooper. Thank you, Madam Chair. I want to
just first thank all of you again. You have been here
repeatedly. I often wonder watching these, the back and forth
in these hearings, what message it sends to young people
deciding whether they want to get into public service.
It doesn't always look pleasant, but I appreciate your
maintenance of good spirits as you go through obviously
difficult, but I think important discussions. Dr. Califf, I am
going to start--I am going to try and look a little more
forward just because I am worried about the future equally as
much as trying to review the mistakes we made in the past.
You know, the unprecedented COVID-19 clinical trial
landscape has allowed for timely availability of vaccines and
therapies that have been essential to fighting this pandemic.
In this increasingly global world, we can, and I think really
have to work closely with our allied partners to advance
scientific and research efforts.
My question to you is, should we be thinking about multi
regional clinical trials as a way to expand volume and scope of
clinical trial data? And if so, how do we get there? And that
is, I know we have talked about it before, but I just keep
coming back to this as well.
Dr. Califf. Well, thanks for giving me a chance to talk
about my favorite thing. That is what I have done for a living
my entire career is multi-regional clinical trials in
cardiovascular disease, and that is what we need to do.
We are all very focused on diversity in clinical trials
within the United States, but we are only 4 percent of the
world's population. So if we really believe that we need to be
doing trials that are relevant to the populations all over the
world. I will point out, again, as Dr. Walensky pointed out, we
have a fragmented system in the U.S. So, yes, we depend on
Israel for data.
The fourth dose decision by the FDA was made based on
Israeli data. For, in many cases we depend on the UK for a
clinical trial results that are critical to us. With all the
technology and prowess we have in this country, we have got to
do better, and it is going to be a focus.
The CDC needs to have the authority to get the data it
needs so that we can be as good as the Israelis in producing
just in time data that is needed.
Senator Hickenlooper. Yes. When I was a kid, Marshall
McLuhan wrote a book and one of the key elements was
information is power. I think that is more true today than
ever. Dr. Fauci, many of us here, I have been beating the drum
loudly on pandemic preparedness and pandemic prevention. I
think it is imperative that we make investments today that will
help us better understand and prepare for viruses tomorrow.
You know this has been--we have watched some of the
discussion on this already. The President has put out a
pandemic preparedness plan and submitted a mandatory 5 year
funding request to Congress to truly stay ahead of the curve.
What progress do you think we have lost due to the
inability of Congress to significantly invest in the pandemic
preparedness and pandemic prevention?
Dr. Fauci. Yes. Well, thank you for that question, Senator.
Pandemic preparedness involves multiple buckets. Basic clinical
and translational science to develop the products such as the
vaccines and the antivirals that have helped us so dramatically
during the current outbreak, as well as a number of public
health issues involving, for example, the CDC, the FDA, BARDA,
ASPR, and others.
When you look at what has not been available from the
standpoint of resources, we have a pandemic preparedness plan
that is based on what we call the prototype pathogen approach,
which was to look at various families of viruses particularly,
and to develop commonalities among them, so that we will be
able, in the next challenged with an emerging microbe, mostly
likely a virus, that we will have enough back lot experience
that will be able to do it in the timeframe that we did with
coronavirus, which, as you know, was 65 days from the
recognition of the virus to a phase one trial.
Senator Hickenlooper. Right, so, let me interrupt you just
because I am going to run out of time here. The real question,
though, is how much do we lose by delaying the appropriate
investments to complete that preparedness work?
Dr. Fauci. Yes. You lose a significant amount. I mean,
every time you pull back on resources, the pace and the cadence
of the work slows down. Sometimes you can't even start a new
project. But the projects that are ongoing, if you don't get
the resources to fully implement them, you will delay the
development of interventions.
Senator Hickenlooper. Or have to take money from one other
pool that gets sidelined, and you interrupt something else.
Right. I follow that. Okay. I am out of time. I yield back to
the Chair. But I again want to thank each of you for your
public service. I realize science is not perfect, it is not
binary, and you have difficult, complicated jobs. I am
grateful.
The Chair. Thank you.
Senator Marshall.
Senator Marshall. Thank you, Madam Chair. Just yesterday we
learned that in the month of May, our Border Patrol encountered
an unprecedented 239,000 migrants at the Southern border, the
highest monthly total in DHS history. And now, thanks to our
inhumane open border policies, every state is now a border
state.
In my home State of Kansas, a person dies most every day
from fentanyl poisoning. Nationwide, over 200 people are dying
daily from fentanyl. The number is on the rise, and this is now
an epidemic. Just last week in Kansas City, authorities seized
15,000 counterfeit pills laced with fentanyl.
Chair Murray, in your State of Washington, five people are
dying per day from drug overdose. Ranking Member Burr in your
state, nine North Carolinians are dying every day from drug
overdose. I don't have to remind people on this Committee or
panel that fentanyl precursors are made in China.
Then the Chinese work with the cartels to process that into
a lethal fentanyl, often lacing other opioids, marijuana, meth,
Adderall, xanax, among others. And all across the Nation, a
counterfeit oxycodone pills like the ones behind me are now
actually laced with fentanyl.
Unfortunately, just one pill can kill. And in the case of
one young student in Shawnee, Kansas, it only took half of a
fake Percocet pill to take his life. Dr. Walensky, my
colleague, Senator Hagerty from the great State of Tennessee,
has introduced a bill that would expand Title 42 expedited
removal authority to combat the drug overdose epidemic
resulting from drug smuggling across our Southern border.
Dr. Walensky, I would like to ask you, yes or no, would you
commit to expanding the Title 42 authority to turn back
migrants to combat this prolific drug smuggling across the
U.S.-Mexico border in an effort to stop the flow and the
epidemic of fentanyl that is killing Americans every day?
Dr. Walensky. Thank you, Senator. I would like to just back
up and say that CDC is a public health agency, not an
immigration agency. And the question of Title 42 is a public
health policy. The question of Title 42 that was posed to me
is, is there a public health emergency that should bar people
from coming into the United States?
We now have, as of April 1st, when I commented on this, we
now have the tools, the tests, the vaccines, and the
therapeutics that are available. Our hospitals are not full.
Everyone and most people in this room are not wearing a mask.
There is no longer a public health emergency----
Senator Marshall. So, Dr. Walensky, I appreciate that. But
I hope you realize that fentanyl poisoning is killing more
individuals ages 18 to 45 than COVID-19. So for the same
reasons that you instituted Title 42 for COVID, why wouldn't
you consider instituting it for fentanyl poisoning, as well as
would you commit yes or no to tracking this similarly to the
way you did for COVID?
Dr. Walensky. To the larger immigration question, I turn
things back to you and Congress to address the larger
immigration question. As a public health emergency for COVID,
which is what Title 42 was put up to do, there was no longer
need----
Senator Marshall. Do you deny that there an epidemic of
fentanyl poisoning across this country?
Dr. Walensky. I do not.
Senator Marshall. Thank you. Secretary O'Connell, I have a
question I am going to submit for the record for the sake of
time. It has to do with, we are going to be giving some 300
million more doses of Moderna, more for Pfizer.
From by understanding of the marketplace, there is still a
substantial supply chain challenges for our medical products.
And to Ranking Member Burr's point, I hope that the
Administration can give us a plan to provide the ancillary
medical products to support the vaccine Administration, and we
would appreciate some type of a plan in writing. Thank you. My
last question for Dr. Fauci.
Dr. Fauci, the NIH is still funding research in China, at
least some $8 million since 2020. In the intelligence
community's 2022 annual threat assessment, the Chinese
Communist Party is presented as one of the top threats to the
United States, along with Russia, Iran, Syria, and North Korea.
To my knowledge, only China is receiving U.S. research
dollars. The CCP controls their scientists and controls the
release of research results they work on. However, NIH grants
policies requires a grantees to maintain supporting research
records, which they cannot do when those records are under
control of the Chinese Communist Party. When were you as
Director of NIAID stop funding research in China?
Dr. Fauci. Now, thank you for that question, Senator
Marshall. We have at the NIH and in other agencies in the
Federal Government, have very productive, peer reviewed, highly
regarded research projects with our Chinese colleagues that
have led to some major advances in biomedical research.
I don't think I would be able to tell you that we are going
to stop funding Chinese. We obviously need to be careful and
make sure that when we do fund them, we have the proper peer
review, and we go through all the established guidelines.
I might point out that grants that go to foreign countries,
including China, have State Department clearance. So any time
that we do fund anything in China or any other country, it has
to go through a clearance with the State Department.
Senator Marshall. But you would not deny that the research
done through EcoHealth, that the records, the studies from
there, that we still do not have access to them. Is that
correct?
Dr. Fauci. We have--no, Senator Marshall, we have access to
an extraordinary amount of information that has gone there.
There is a question that people raise with things going on
there that we didn't have access to.
But if you look at the grant, the $120,000 to $130,000 a
year grant that was given from EcoHealth as a sub award in
China to ask a very relevant, high priority question. We have
received from them published literature with data that shows
that they have done what they were given the grant for.
Now, obviously, none of us know everything that is going on
in China. But if the question at hand is that we have a small
grant, peer reviewed, high priority grant that was given from
Eco to China in a sub award, we have a lot of good information
that is in the public----
Senator Marshall. Do you have all the information that you
think that we should--?
The Chair. Senator Marshall, at this point, I am going to
move on. We have a number Senators. We have three votes that
have been called. I am going to move on to the next person. I
am going to turn this the Chair over to Senator Hickenlooper
while I go vote. This next Senator, I will call on as I do
that, is Senator Baldwin. Senator Hickenlooper, thank you for
coming up to Chair.
Senator Baldwin. Thank you, Madam Chair. I have been
encouraged by the work of this Committee and those of you on
the panel who have helped make more COVID-19 treatments
available. Unfortunately, local health Departments in Wisconsin
have experienced some obstacles when it comes to getting
paxlovid to those in need.
Dane County public health officials recently contacted my
office to raise their concerns about the lack of a clear policy
guidance and reimbursement for this critical treatment. So, Ms.
O'Connell, how is ASPR working with states to ensure that local
public health Departments have the information that they need
to make paxlovid available through the Administration's Test
and Treat initiative?
How can folks who are uninsured receive treatment, and what
additional resources might the Administration need to make
treatment available to everyone who needs it?
Ms. O'Connell. Thank you so much, Senator Baldwin. I will
take that in two parts. First of all, as far as communicating
with state public health Departments to make sure they know
that this treatment is available and how to access it, we do
weekly stakeholder calls and regular engagements with state
health officials. We also know it is on us to be--we need to
take responsibility for communicating very clearly the
importance of this therapy and its availability.
We have taken that on in numerous ways with various
outreach efforts. But, and we continue to work with states to
make sure that they are positioning these therapies in places
where folks are the most high risk. So that continues to be an
ongoing pursuit of ours, and we will continue to work at it.
Thank you for the feedback on Wisconsin.
We will reach out and make sure that we have closed that
loop and that they have the information they need. And then
part two of your question is about access for the uninsured.
So, one of the impacts of not getting additional supplemental
funding is we have had to shut down the uninsured fund.
The uninsured fund was one of the easiest ways for those
without insurance to get coverage during the COVID response, to
be able in this once in a lifetime pandemic get the care that
they need. We continue to make paxlovid even without the
uninsured fund. The paxlovid is available for free.
Pharmacies are not allowed to charge a dispensing fee, so
those that are uninsured should be able to access it. We
understand an important component of receiving paxlovid is also
having a health care assessment, and we know that that comes
with a fee.
We encourage those that are uninsured to go to the
federally qualified health centers, which provide these
services on a sliding scale and acknowledge whether you are
uninsured or not, or to seek care at their public health
Departments or now these new federally run test or treat sites.
But this is a challenge, and it is one that we are
continuing to overcome in light of the shutdown of the
uninsured fund.
Senator Baldwin. Thank you. I have heard also from state
health officials about declines in vaccination coverage for
routine immunization, such as the measles, mumps, and rubella,
that vaccine.
Dr. Walensky, how is the CDC working to ensure that any
forthcoming recommendation on the COVID-19 vaccine for kids
gives parents the information that they need to feel confident
about getting not just this vaccine, but as well as all other
routine immunizations? And is there an opportunity to up the
rate of vaccination for these other conditions at the same time
as you are vaccinating kids?
Dr. Walensky. Yes. Thank you so much, Senator Baldwin. So
we recently reported data that demonstrated a decrease of about
1 percent of all incoming kindergartners are completely
vaccinated for all of the recommended vaccines.
That is 35,000 children across this country who are no
longer up to date on all of their other vaccines, even before
COVID. We have a lot of make-up work to do there in addition to
what we need to do with COVID. As we roll out our pediatric
vaccines for children between the ages of 6 months to 5 years,
and in fact, as we continue to enforce the importance of
vaccination for our 5 to 18 year olds, we are seeing
differences in vaccine confidence and differences in rates and
vaccination.
We are doing a lot of work in terms of vaccine confidence,
putting these vaccines in pediatricians' offices and federally
qualified health care centers, in pharmacies, places where
parents trust, where they normally get this information. We are
also canvasing and understanding the vaccine confidence around
these areas so that we can focus our attention in areas where
confidence might be lacking.
We also, importantly, are starting to see really critical
data that show that much of this confidence is lacking in
areas--in rural areas. That we have about two times the
vaccination rate in urban areas compared to rural areas of our
children. So areas that we really need to focus, and we are
aware of that and are doing those activities as well.
Senator Baldwin. Thank you. I yield back, Mr. Chair.
Senator Hickenlooper. Thank you.
Senator Casey.
Senator Casey. Mr. Chairman, thank you very much. I want to
thank members of the panel for their public service and for
being here today. I just have, in the interest of time, I think
everybody--I just have got one question for Dr. Fauci. Doctor,
I want to wish you a speedy recovery, as well as congratulate
you on the naming of the science complex at Holy Cross College
in your honor.
I wanted to ask you a question, though, about our parents.
So many parents across the country right now are unsure about
whether to get their kids vaccinated. Uptake of the vaccine has
been relatively low for kids who are already eligible. I am
told that under something, like under 30 percent of children
ages 5 to 11 are fully vaccinated.
When the vaccine becomes available for children under five,
we will need to meet parents where they are and with the
information that they need to make informed decisions about
that vaccination.
Dr. Fauci, can you expand upon how the Administration is
working with trusted messengers in our society, whether they
are physicians or community leaders or others, to get accurate
information about the vaccinations to parents?
Dr. Fauci. Yes. Thank you for that very important question,
Senator Casey. Certainly, now that we have the data, which
looks very favorable, we really want to get these children
vaccinated because we know vaccinations prevent infection, but
to a greater extent prevent severe disease.
As you have heard from a number of us, including and
particularly Dr. Walensky, that there are more deaths and
serious consequences of COVID among children than there are in
influenza.
The Department, HHS, has a very comprehensive rollout plan,
which they have been literally preparing now for several weeks,
2 months in anticipation of if we do, and we did, get favorable
results on the clinical trials from Moderna and from Pfizer,
that we would be able to get children and get parents to
understand where these vaccines are available in pediatrician
offices and pharmacies and clinics.
This is something that the Department has taken very
seriously and hopefully we will do a very high uptake of
vaccines, because many parents, as we all know, have been
waiting some time now to get their children vaccinated. And
hopefully the program that HHS is rolling out will facilitate
that. Thank you.
Senator Casey. Doctor, thanks very much. Thank you, Mr.
Chairman.
Senator Hickenlooper. Great.
Senator Kaine.
Senator Kaine. Thank you, Senator Hickenlooper. And thanks
to our witnesses, I want to echo comments that I know Chair
Murray made earlier about the importance of more law--more
COVID funding in a variety of ways. We are--thankfully, we are
seeing hospitalizations come down dramatically in Virginia. It
was about 4,000 a day in January, about 500 a day now. That is
very, very positive.
I am looking at hospitalization and death data a lot more
intensely than the case data, because I think cases continue to
be high. But the--because transmissibility is high, but the
severity is dropping, which is what we would want. But I do
think we still need more funding to deal with COVID issues,
especially for low income people.
I would also say that U.S. vaccine diplomacy around the
world has been a real positive investment that has both helped
our own public health, helped the health of others around the
world, but built up goodwill. I am strongly for it. I do want
to just quibble with one thing.
Senator Smith asked you all the questions about whether you
are equally as effective, if you are working virtually or in
the office. And you said, yes, as effective. I am going to be
honest. There is one area, and it is in the FDA space, Dr.
Califf, where it is not as effective, and that is inspections.
The AP had a story that was out earlier this week that said
during the period largely from March 2020 till June 2021, you
were not at the FDA then, but during that period the FDA missed
15,000 inspections that would normally have done.
The FDA is racing to catch up, has cleared a backlog of
about 5,000 of those. But there is no substitute for an
inspection. There is just no substitute for it. And what
troubled me about that is, the folks working at plants that
need inspection like an infant formula plant, they are
essentially essential workers.
We can't stop producing formula, so they have to be there.
If they have to be there to do something that the public needs,
then the inspectors should be there, too. I recognize that
poses health challenges. But, and again, you were not at the
FDA during this period when the inspections were stopped.
But I frankly worry a little bit about, are there other
surprises around the corner for us in these spaces where we
weren't doing inspections? I am not even going to ask you about
it because I know you take it seriously and you are trying to
catch up on the backlog and----
Dr. Califf. Can I just comment that I agree? I was asked
about the office. So if you asked about--definitely, we had
inspections that were put on hold and there has been a price to
pay for that.
Senator Kaine. Yes. I would say an inspector is every bit
as essential a worker as the worker that we require to go to
the plant to produce medicine, to produce infant formula,
etcetera. I want to ask a question that I always ask of Dr.
Fauci. Dr. Fauci, I hope you are feeling well, and I am glad
you are able to join us virtually.
I started to share my own experiences with long COVID nerve
tingling symptoms about a year ago because, hey, I was having
them, and they are exactly the same as they were when I got
COVID in March 2020. But b, I was running into a lot of people
who were experiencing more serious symptoms and weren't being
believed. I felt like sharing from this podium that, yes, no, I
believe you because I am dealing with nerve tingling that I
would never felt in 62 years, might open up a discussion and
make people feel like they were being heard.
As I expected when I started to talk about this, my office
has become a real nerve center for people who want to share
their experiences with long COVID and ask for help. So what I
want to ask you to know, given that we have put in some
significant funding for long COVID research, what is the
current status of the NIH Recover Project?
Dr. Fauci. Yes. Thank you for that very important question,
Senator Kaine. Let me assure you that from the patients that we
have seen and the input we have seen from so many people, this
is a real syndrome. It is a real problem, and it is something
we really need to get to the bottom of. There are two tracks
that are going on.
One is a broad cohort track, which many people referred to
as the recovery program, where launch cohorts of individuals
are now being followed in long range to determine the
incidence, the prevalence, and hopefully learn about the
pathogenesis of this real syndrome. They are now accumulating
very large numbers of individuals.
One of the problems, Senator, is that there is no yet
identifiable pathogenic process. So people ask, why aren't you
treating it, what are you doing for it, is very, very difficult
to do that because this is a heterogeneous syndrome, as you
probably know from the people that now are essentially
addressing your own office because of your own personal
involvement.
But there are other things that are going on
simultaneously. For example, there's a pediatric research
immune network called PRISM, which is looking at this in
children, particularly children that might have the multisystem
inflammatory syndrome of children. There is the, what we call
immuno phenotyping to determine is there anything that relates
to a hyperactivity or an aberrant triggering of immune response
that is triggering some of the things that you might be
feeling, including the tingling in your nerves.
There is the broader cohort project and a number of
individual projects. I do hope, and I say that sincerely,
because there are so many people now, when you talk about the
tens and tens of millions of people who have COVID in this
country, that even a small percentage, and I am not so sure it
is that small, who wind up with varying degrees of long-covid--
we have to address this problem, find out the underlying
mechanism, and do something about it. Thank you.
Senator Kaine. Dr. Fauci, thank you so much. I yield back,
Senator Hickenlooper.
Senator Hickenlooper. Thank you.
Senator Rosen.
Senator Rosen. Well, thank you, Chair Hickenlooper. Dr.
Fauci, I know we all hope you are feeling all right. Thank you
for being here. And thank you to all of you for your continued
presence, your work, and your commitment to doing that good
work going forward. I want to talk about the vaccines and
booster shots just a little bit, because we know the COVID
virus, the COVID-19 virus, is going to continue to mutate.
It is critical that we use our best defense, we all know
this, it is vaccines, to keep our most vulnerable populations
safe. We are going to protect lives and livelihoods. I just
want to focus for 1 second on one of our highly vulnerable
populations, our seniors. Many of them may have unique
challenges because of their mobility or a variety of other
issues. So, Dr. Walensky, we know more than 90 percent of
seniors are fully vaccinated.
Nearly 70 percent have received their first booster dose.
But only a little over 30 percent of our seniors have received
their recommended second booster. So what are you doing to I
would say, just not just improve outreach, but what about those
access barriers that may--we may have with seniors in assisted
living, or nursing homes, memory care, and the like?
Dr. Walensky. Yes. Thank you, Senator Rosen. So several
weeks ago, we increased our recommendation--strengthen our
recommendation for a second booster shot. And that is in the
context of this increased number of infections for our elderly.
What I will tell you is we have data forthcoming later this
week that will demonstrate that that fourth dose compared to
the third dose has decreased the risk of death by seven fold.
We now have actually data from the United States that has
demonstrated the value of this booster dose, especially among
the elderly and the most frail. We are--we now have vaccine in
tens of thousands of sites. We have vaccines in pharmacies. We
have vaccines in providers, physicians' offices. We have
vaccine throughout the country and in our long term care
facilities.
We are continually looking at vaccine confidence and
canvasing our states to understand where we have challenges in
vaccine confidence. One of the areas, as I indicated earlier
for pediatrics. But also true for adults, is in our rural,
urban divide that we actually have challenges in reaching our
rural communities, both for vaccine confidence, but actually to
get folks boosted--for their first shot as well as their
second.
We are continuing outreach there through media, through
social media. I have done media with our collaborations through
the U.S. DEA and through Rural Public Health Association. So we
are continuing that outreach. Once we can understand where the
data are and where the challenges are, we focus on those areas
so that we can do more in those areas.
Senator Rosen. Well, maybe that is where our mobile health,
rural mobile health clinics can make a difference. But would
you follow-up on that really for our general population. You
said the updated guidance is going to come out in a few weeks
for access to the second booster dose for general population,
because we know it keeps people out of the hospital and from
suffering more severe disease.
Dr. Walensky. Yes. So we continue at CDC to follow the data
with regard to how our vaccines are performing. And so far, the
data on decreases of severe disease, hospitalizations, and
death have been limited--and the waning has been limited to the
elderly population. But we are continuing to follow the data
for the younger population to see if and when there is waning
in that population as well, and if and when we should bring
another booster dose to that population as well.
Senator Rosen. Thank you. I want to keep a little bit on
seniors, because we know that the pandemic has had real mental
health challenges for, of course, our children--for all of us
but I am going to focus on seniors today because ARP, as really
noted, that is critical to find a balance between patient
health and caregiving.
How the absence of caregivers or if the caregivers
themselves are vaccinated. It really makes a difference. I just
would like to know what lessons the CDC has learned from the
pandemic about caring for seniors and addressing the social
isolation that we felt prior to the vaccine. What can we do
there, do you think?
Dr. Walensky. We have learned really--hard learned lessons,
I would say, through the last two and a half years with regard
to mental health, not just in our seniors, but across the aged
demographic, in our in our students and in our seniors and
across the age demographic.
We at CDC are doing a lot of work across the country with
the VA, with NGO's, with community based organizations, within
our tribes to strengthen mental health resources, to decrease
suicide, to allow children to get back to school, to allow
parents and caregivers get the mental health resources that
they need so that they can combat the challenges of mental
health right now.
Senator Rosen. Thank you. I know my time is up. I
appreciate that going forward. For the K-through-12 population,
Senator Murkowski and I introduced bipartisan legislation to
bring mental health down. That was funding for health grants
that normally go to universities and colleges, but to bring it
down K through 12, because we have seen increased suicide,
increased mental health challenges.
Nevada, at one point, our Clark County School District was
the highest of youth suicide, I believe in the year 2020, a
list no one wants to top. I look forward to working with all of
you and trying to do what we can to promote good mental health
services and suicide prevention. Thank you.
Senator Hickenlooper. Thank you, Senator Rosen. I am going
to take just a moment of privilege. I want to ask one last
question to Dr. Walensky, just because I don't think the people
of America really understand how interconnected we are. I want
to just take a moment to--I mean, we have seen from the current
COVID pandemic that viral pathogens don't pay any attention to
national borders.
The reality is, I think it creates real danger for the
probability that new COVID variants or other pathogens like
monkeypox can emerge and spread quickly undetected in our
interconnected world. The number I have is 62 percent of the
global population is fully vaccinated against COVID, and
clearly there are significant disparities between countries.
Many countries just do not have the resources to get to a
significant part of their population. The more vaccines and
therapeutics we can distribute around the world, the less
chance we give variants to spread. I think that is the--we
don't really have a number on that yet in terms of what is
the--how are we increasing the probability of some new variant?
How serious is this danger by us allowing these large
populations in isolation to almost incubate new pathogens or
more importantly, new variants?
Dr. Walensky, how has the CDC tracking of viral threats
globally changed with the launch of the Center for Forecasting
and Outbreak Analytics? And what more do we need to do now to
address this global reality that we face in terms of public
health threats? And again, how do we--I will take
responsibility for how we spread that information to the
public, but it is something most people are not aware of.
Dr. Walensky. Thank you. Senator Hickenlooper. So we
launched the Center for Forecasting in Outbreak Analytics. This
is a Center that will be able, is currently able to scale up
and look at forecasting to inform local jurisdictions as well
as global jurisdictions to understand where the pathogens are
in their risk of coming to us, as well as to innovate and to
think about new ways that we might be able to forecast and
understand pathogens headed on our direction.
That Center has been really helpful in understanding the
importance of new variants, the Omicron variant. They have
stood up and in forecasting and understanding where we need to
put our resources at the local level. I do want to take one
moment to say, I think you are exactly right. We know through
this pandemic that no one is safe until everyone is safe. The
disparities that we have in vaccination coverage around this
world are likely to potentially lead to new variants.
If we don't control these new variants, they will likely
reach our shores again. I am concerned that with the lack of
supplemental funding that we at CDC will not be able to
continue our global vaccine efforts that we have in terms of
our technical assistance on the ground, our surveillance, our
genomic sequencing, and our ability to do vaccine surveillance
and vaccine safety surveillance within countries that we
support. So thank you very much for noting that.
Senator Hickenlooper. Thank you.
Senator Burr.
Senator Burr. Thanks, Senator Hickenlooper. I am going to
wrap up. I guess the Chair is not coming back. Couple of quick
questions. Dr. Walensky, public health emergency. It expires
July 15th. Do you intend to extend that?
Dr. Walensky. I am not the one who would extend it,
actually. Thank you, Senator Burr. That is for the Secretary.
Senator Burr. But you will make the recommendation, won't
you?
Dr. Walensky. I think it will be an all of HHS
recommendation.
Senator Burr. Okay, well, let me just say, we have removed
the mask requirement. We have eliminated the testing
requirements to reenter the country. Title 42 is a CDC
decision, and you said in your response to a letter to me that
you were lifting it because--and I will refer to how you, I
think, address Senator Marshall. You said, we have--you said we
have the tools, test and vaccinations, therefore, there is no
longer a public health emergency.
Dr. Walensky. Yes. I misspoke. We have the tools, tests,
and vaccinations, therefore, there is no longer a public health
reason to bar people from entering this country. Thank you. I
appreciate the opportunity to correct that.
Senator Burr. But there is a public health emergency still?
Dr. Walensky. I think the question of a public health
emergency is a different question for then, is there a public
health reason to bar people from entering into the country. I
would like to make that distinction.
Senator Burr. Well, it is already in the record, I think
what you wrote to me, which I think basically said we don't
have a public health concern. Let me ask you, what are you
looking forward to end the public health emergency?
Dr. Walensky. Maybe if I could defer that question to the
ASPR, that might--I think as part of HHS, that would be
helpful. Thank you.
Ms. O'Connell. Sure. Thank you, Dr. Walensky. And thank
you, Senator Burr. So the Secretary does have this authority,
and he did, the Secretary declared it in January 2020, previous
Secretary, and it has been extended multiple times.
One of the commitments we have made in this Administration
is that we are going to give states and local Governments 60
days' notice before we take it down in deciding whether to take
it down, we are in daily communication with our clinicians, our
scientists, the folks on the ground.
With the public health emergency unlocks, is health care
system flexibilities, that is something that CMS relies on
significantly. It extends Medicaid coverage for folks during
times of an emergency. It extends to health coverage to those
on Medicare. And it allows hospitals and nursing homes and
other health care facilities some flexibilities in responding
to the situation at hand.
We continue to be in touch to understand whether these are
still necessary. And as Dr. Walensky said, the Department will
come together and make that decision or recommendation to the
Secretary for him to decide. But we will give 60 days' notice
before it comes down.
Senator Burr. You have answered the question that I asked,
which was will it be extended? Yes, it will be extended because
60 days from now is past July 15th, right? So no notification
has been made to the state, so it will be extended past there.
I will write the Secretary and ask him what the criteria is to
end the state of emergency--the public health emergency, excuse
me.
I would only point out that the guidance that we currently
have going out does not suggest that there is a public health
emergency. We are beginning to dismantle everything. I am not
sure it is for any reason other than the fact that everybody
around the world is doing it, because we are 60 or 90 or 120
days behind them.
Now, all of you just told Senator Smith that remote work
hasn't hampered your agency's response efforts. Okay. FDA
failed to identify a crisis with baby formula. CDC, I think,
failed to lead as it relates to monkeypox. Secretary Becerra,
when I wrote him and asked him about HHS staffing and were they
actually at work when--were they actually working when not at
the office, wouldn't provide me anything.
Now, none of you seem to know how many people in your
complex--and Tony, I will leave NIH out of this because of the
unique nature of the work there. How many of you can tell me
how many people aren't at work? Pilot programs. Executive
declarations. That makes me wonder how you measure whether
people are actually working when at home. And then I come to
today.
I always like to bring things back to the present because I
have a tremendous amount of respect for all four of you. Some I
have dealt with longer than others. I supported where there was
public acknowledgment of it. Everybody--Tony outdates me. He
was here before I got here 28 years ago. Because I believed you
had the capacity, the intelligence, the education, and the
independence to serve in the role you are in. And for two of
you, I asked when you were confirmed.
Would you provide me with all the questions I ask as the
Minority Ranking Member? The answer was yes. Now we come to
today. This has been the most well-orchestrated event that I
have seen in the 28 years that I have been here. And for most
of you, you have been willing participants in it. This was
designed to pressure Republicans to open a checkbook, sign the
check, and let the Administration fill in the balance. With no
detail on how, when, for what that was being asked for.
I have never in 28 years seen an attempt to get an outcome
without answering questions. I leave today extremely
disappointed that maybe my judgment's been flawed. But I will
say this to each and every one of you. Nobody has worked harder
on this issue, I think, on the Hill than I have. Nobody has
gone to bat for emergency money with no strings attached than I
have.
But there is a point in time where my patience runs out,
where the requirement I have for my constituents in North
Carolina, my colleagues in the minority, which are 50, exactly
which are in the majority, requires a degree of detail. That
you and this Administration are not willing to share.
I personally believe that if the Federal Government doesn't
lead by forcing employees back to work--and Rob, Google is a
hell of a lot different than the FDA. Google can pull it off.
But the Federal Government has to set the example for the rest
of the country that it is time to leave your house.
I hate to see what the healthcare cost is going to be to
our Country for mental health now on the adult side. Husbands
and wives aren't used to spending all day together. Just like
kids need the interaction of school. Folks let's get back to
running your agencies. Let's bring the employees back into the
office.
Let's answer the questions that every Member of Congress
has for you and not just the ones the Administration wants to
do. You serve in a uniquely special capacity. And when you
address public health, it is not for some, it is for all. I
hope you will look at this dais in these Members and realize
there is no difference between one that sits on this side or
that side.
They are on this Committee because they are passionate
about the issues that we take up. I thank the Chair for his
indulgence. I thank the witnesses for their expertise and their
willingness to be here today. I yield back.
Senator Hickenlooper. Thank you, Senator Burr. I echo his
appreciation for all of your hard work. I realize that science
and especially medical sciences, is some of the most daunting--
present some of the most daunting challenges that we face.
I remember when I was a small business, the times that
caused me greatest anxiety and serious mental health challenges
was when I didn't have enough information to make important
decisions that were going to affect the lives of my employees
or sometimes even my customers.
That that challenge of having to deal with the facts we
have and not the facts that we would like, having to make
decisions that affect people's, well, their lives, is some of
the hardest decisions you can make when you don't have all--one
size doesn't give you all the answers or enough information to
know that you have got the answer. And yet you have all stood
up and continued your work and dealt with this evolving
situation.
I am very grateful. I would like to thank all my colleagues
on the Senate side of this, but also all of our witnesses, Dr.
Walensky, Dr. Fauci, Dr. Califf, Assistant Secretary O'Connell.
This is an important conversation. I hope after this discussion
it is clear, how critical it is that we pass emergency funding
and make sure that we can protect our communities from what
this pandemic throws next, which, again, we can't be certain
of.
For any Senators who wish to ask additional questions,
questions for the record will be due in ten business days, July
1st at 5.00 p.m.
This Committee stands adjourned.
------
ADDITIONAL MATERIAL
FACT SHEET: Consequences of Lack of Funding for Efforts to Combat
COVID-19 if Congress Does Not Act
The U.S. has made tremendous progress in our fight against COVID-
19. Over the past 14 months, the Biden Administration has made vital
investments--using resources Congress provided on a bipartisan basis--
to make sure the American people have free and widely available access
to lifesaving tools: vaccines, booster shots, treatments, tests, and
high-quality masks. As we enter a new moment in the pandemic, Congress
has not provided us with the f4nding we need to continue the COVID-19
response and minimize the pandemic's impact to tie Nation and our
economy. With cases rising abroad, scientific and medical experts have
been dear that in the next couple of months there could be increasing
cases of COVID-19 here in the U.S. as well. As the Administration has
warned, failure to fund these efforts now will have severe consequences
as we will not be equipped to deal with a future surge. Waiting to
provide finding once we're in a surge will be too late.
Without funding, the United States will not have enough additional
boosters or variant specific vaccines, if needed, for all Americans.
The Federal Government is unable to purchase additional life-saving
monoclonal antibody treatments and will run out of supply to send to
states as soon as late May. The Federal Government cannot purchase
sufficient quantities of treatments for immunocompromised individuals.
And, the Federal Government will be unable to sustain the testing
capacity we built over the last 14 months, as we head into the second
half of the year.
Earlier this month, President Biden laid out a comprehensive plan
to ensure that the country can continue to move forward safely and
remain prepared to fight new variants and future surges of the virus.
And the Administration has been clear that we need Congress to provide
additional resources, including $22.5 billion in immediate emergency
funding. Inaction will set us back in this fight, leave us less
prepared, and cost us more lives.
Consequences of lack of critical funding include:
Inability to Secure Sufficient Booster Doses and
Variant Specific Vaccines, If Needed:
The Federal Government does not have adequate resources to
purchase enough booster vaccine doses for all Americans, if
additional doses are needed. The shortages will be even more
acute if we need a variant-specific booster vaccine, since we
will not have any existing supply.
Providers No Longer Able to Submit Claims for
Testing, Treating, and Vaccinating the Uninsured:
The fund that reimburses doctors and other medical providers
for caring for uninsured individuals will start to be scaled
back this month and end completely in early April.
Specifically, 1 week from today--March 22--the Uninsured
Program will stop accepting new claims for testing and
treatment due to lack of sufficient funds. Providers will no
longer be able to submit claims for providing these services to
uninsured individuals, forcing providers to either absorb the
cost or turn away people who are uninsured, increasing the
disparity in access to critically needed health care and
putting additional burdens on safety net providers. Three weeks
from today-April 5-the Uninsured Program will also stop
accepting vaccination claims due to a lack of sufficient funds.
Ending the Purchase of Monoclonal Antibody
Treatments, Scaling Back State/Territory Allocations:
The Federal Government has no more funding for additional
monoclonals, including a planned order for March 25. To date,
the Federal Government has been able to provide these life-
saving treatments free of charge to Americans and work with
states to make sure they get to as many people as possible who
need them. In order to keep these treatments free and available
to the American people for as long as possible, the
Administration will now have to stretch our current supply and,
starting next week, will be forced to cut state allocations of
our limited existing supply of life-saving monoclonal antibody
treatments by more than 30 percent.
Halting Critical Testing, Vaccine, Treatment Efforts:
The President's National Preparedness Plan was clear that the
Federal Government must invest in next-generation vaccines and
treatments and maintain our testing capacity in order to fight
COVID-19 in the future. Now, without additional funding, we do
not have the ability to:
Y Purchase additional oral antiviral pills beyond the
20 million already secured.
Y Pre-purchase promising new antivirals. The reason
why the Administration has been able to secure more
oral antiviral pills than any other country is because
we committed to purchasing them early, even prior to an
Emergency Use Authorization (EUA). As even more
effective pills potentially become available, the
Federal Government is no longer able to make advance
purchase commitments to ensure America is one of the
first countries in line.
Y Accelerate the creation of a next-generation, pan-
COVID vaccine that would provide broad protection
against a range of variants. Vaccines are the most
effective tool to prevent COVID-19, and the
Administration does not have the funding for necessary
investments in research and to support the development
of promising new vaccine candidates. Such next-
generation vaccines hold potential to broaden
protection against known and future variants, reduce
dosing through single-dose primary regimens with
extended duration of protection (i.e., longer interval
between boosters or possible elimination of boosters
altogether), and reduce costs by increasing
manufacturing yields and extending shelf life.
Y Maintain our domestic testing capacity beyond June.
After spending the last year building up our testing
capacity, that progress will be squandered, the
Administration will be unable to help keep domestic
manufacturers online starting in June. That means,
heading into the second half of the year, there will be
significantly diminished domestic testing capacity and
we may be unprepared for surges.
Scaling Back Planned Purchases of Preventive
Treatments for Immunocompromised:
The Federal Government has been planning to move forward with a
purchase of preventative treatments for the immunocompromised
as soon as March 31 that would begin delivery in September,
once the treatments are manufactured. However, absent
additional funding the Federal Government will now be forced to
scale back that purchase of treatments for our most vulnerable.
Because these treatments take more than 6 months to
manufacture, the United States will likely not have enough of
these treatments by the end of the year. And being unable to
make additional purchase commitments now likely means that
fewer treatments will be available next year as well.
Reducing Ability to Rapidly Identify and Assess
Emerging Variants.
Robust surveillance and research are critical to identify,
understand and monitor emerging variants. With reduced
capability to perform adequate surveillance, the country will
be prone to being ``blindsided'' by future variants. In the
absence of funding to immediately assess lab-based efficacy and
real-world effectiveness of existing vaccines and treatments as
new variants emerge, health care professionals will be forced
to make insufficiently informed treatment decisions. The
Administration will need to wind down some COVID surveillance
investments, leaving us less able to detect the next variant.
Damage to Global Vaccination and COVID-19 Treatment
Efforts:
Without additional funding to support getting shots into arms,
USAID and interagency partners will have to cut short efforts
to turn vaccines into vaccinations across the globe. Leaving
large unvaccinated populations worldwide will increase the risk
of new deadly variants emerging that could evade our current
vaccines and treatments. Without additional funds, the
Administration would be unable to extend Global VAX surge
support to 20 plus additional under-vaccinated countries that
will need intensive support this year to get shots in arms.
This will devastate our ability to ensure those countries can
effectively deploy safe and effective vaccines. USAID will also
be unable to provide life-saving supplies, tests, therapeutics,
oxygen, and humanitarian aid to countries still struggling to
manage a continuing COVID disease burden.
In addition to the immediate need for funding, in order to
facilitate a smooth transition to insurance coverage of life-savings
COVID treatments the Administration is requesting that Congress
provides authority to ensure seamless access to Medicare and insurance
coverage for treatments under an Emergency Use Authorization (EUA).
______
Hon. Patty Murray, Chair,
Hon. Richard Burr, Ranking Member
U.S. Senate Committee on Health,
Education, Labor, and Pensions,
Washington, DC 20510.
Dear Chair Murray and Ranking Member Burr:
Thank you for the opportunity to provide this feedback on the
discussion draft of the Food and Drug Administration Safety and
Landmark Advancements (FDASLA) Act and in particular, Subtitle C of
Title VIII which includes the Verifying Accurate Leading-edge IVCT
Development (VALID) Act of 2022. The undersigned organizations
represent a diverse and broad community of healthcare professionals,
patient advocates, industry organizations, medical institutions, and
pathology departments who practice laboratory medicine, provide
clinical testing services, and deliver high quality care to patients
throughout the U.S..
We write to you today to express our significant concerns with the
VALID Act of 2022 and request that you provide additional and
sufficient time to resolve these concerns prior to advancing this
legislation. We recognize that the user fee reauthorization offers a
fast moving legislative vehicle; however, since this proposal
dramatically modifies the current regulatory framework for an entire
category of medical services, it's critical that this is done right to
protect patient access to innovative diagnostics. As such, we
respectfully request that you allow time for further refinement of the
VALID Act and do not rush this very flawed, problematic legislation
through the user fee reauthorization legislative process.
In 2019, bipartisan, bicameral sponsors of the VALID Act in concert
with staff from your Committee and the Energy and Commerce Committee
held a series of 2 hour roundtable discussions with stakeholders and
officials from the Food and Drug Administration (FDA) on draft
legislative language that was ultimately introduced as the VALID Act of
2020. Since then, stakeholders, including many on this letter, have
provided extensive written comments on each iteration of the
legislation, met with your offices and the bill's sponsors numerous
times, participated in staff briefings, and most recently, responded to
dozens of written questions from your staff circulated to stakeholders
this past winter. Given this immense and active engagement over the
past 4 years, we were very dismayed to see that the VALID Act of 2022
failed to incorporate most of our recommendations, even the most
significant.
To illustrate our concerns, the current discussion draft failed to
resolve these key areas:
1. Stifling Innovation and Constricting Patient Access to Care.
While each of our organizations hold specific positions, we are
unified in our view that the VALID Act of 2022 creates an onerous and
complex system that would radically alter the way that laboratory
testing is regulated to the detriment of patient care. The VALID
framework would be costly as laboratories would be subject to user fees
and need to finance the internal FDA compliance activities that would
be required. This would force many laboratories, especially community
laboratories, to consolidate their testing menu which would disrupt
localized patient care and minimize the innovative efforts at our most
prestigious institutions. While we appreciate that the laboratory
developed testing services offered today would be grandfathered, the
utility of these tests would diminish over time as the VALID Act puts
overly restrictive constraints on how they can be modified. Further,
testing consolidation away from academic and other laboratories would
result in a reduction in training opportunities for an already strained
laboratory workforce. Unfortunately, the laboratory workforce shortages
were a significant barrier for this country's ability to respond to the
COVID-19 pandemic and we are greatly concerned about the potential
impact the VALID Act would have on patient care in the decades to come.
2. Duplication With and Lack of Modernization of the Clinical
Laboratory Improvement Amendments (CLIA).
The VALID Act's provisions on quality systems, adverse event
reporting, and laboratory inspections duplicate requirements that
laboratories already comply with under the federally administered CLIA
program. The bill also references terms and aspects of the current
medical device regulations that are not translatable to laboratory
developed testing services. Simply directing the Secretary to avoid
duplication as is written in the VALID Act of 2022 is insufficient,
especially when other aspects of the legislation call for requirements
and activities that lead to duplicative and unnecessary regulatory
burden. Further, many stakeholders acknowledged the need to modernize
the CLIA program implemented more than thirty years ago. Any update to
the oversight of laboratory testing is incomplete and potentially
duplicative without considering updates to CLIA.
3. Preemption of State Requirements.
Many stakeholders actively participate in validity and quality
review programs such as those administered by the New York State
Department of Health (NYSDOH). The NYSDOH program in particular has
successfully incorporated the concept of reviewing certain testing
services into their assessment of the quality of a laboratory's
operations and its personnel which has resulted in a harmonious and
effective approach to regulating laboratory practice. As such,
stakeholders have encouraged the Committee to recognize the value of
such programs, prevent duplication with state efforts, and apply
lessons learned. The VALID Act of 2022 fails to incorporate any of
these recommendations and instead allows states with programs in place
prior to 2022 to continue their programs only if their requirements
match those of the FDA. Further, as developers will still need to
comply with both the FDA requirements and those state requirements,
this will create unavoidable duplication as drafted.
4. Lack of Clarity in the Risk Categorizations, Definitions,
Eligibility Criteria for Technical Certification, and Other Key Aspects
of the Legislation.
Lack of clarity in key aspects of the VALID Act of 2022 including
the definitions of high, moderate, and low risk, create ambiguities
that make it impossible to understand the implications of various
provisions on laboratory medicine and patient care. For instance, the
newly created definition of moderate risk appears to overlap with the
definition of high risk. Further, the criteria for the technical
certification program are unclear as to the types of tests eligible for
authorization under such an order. Even more concerning, terms
previously defined in an earlier version of the VALID Act such as
``well characterized'' and ``adverse event'' have been removed from
this version yet are still referenced in the legislation.
5. Unpredictable Regulatory Process Due to Significant Discretion Given
to the Secretary.
Throughout the legislation, the text grants discretion to the
Secretary creating an unpredictable regulatory process and ambiguities
in the significance of the policy. This is especially problematic as
stakeholders try to understand the implications for their laboratories
and practices. For example, in the section on an abbreviated premarket
review, the legislation says that developers will not need to provide
raw data as part of their submission unless requested by the FDA. The
requirement of providing raw data is a meaningful distinction between
full premarket review and abbreviated premarket review, and yet the
Secretary has the discretion in any instance to require that data.
Additionally, in the grandfathering provision, the Secretary has the
discretion to direct any grandfathered test for premarket review. This
further creates confusion as laboratories determine which of their
tests will be subject to review. There are dozens of instances in the
legislation similar to these examples. We strongly urge the Committee
to narrow the discretion so that stakeholders may better evaluate and
understand the implications of this legislation.
6. Subject Matter Experts, i.e. Test Developers, are Unable to Actively
Participate in the Accreditation Process.
The VALID Act of 2022 prohibits test developers from becoming
accredited third-party reviewers unless FDA waives this requirement,
which is in sharp contrast to how the medical and scientific community
usually act. These professionals are the subject matter experts most
qualified to assess the validity of a diagnostic test and as such,
their participation in these processes should not be left to the
discretion of the Secretary or agency. This country has a long history
of understanding the merits of and thus supporting scientific peer
review and without such a system, FDA will greatly lack access
expertise needed to regulate the tens of thousands laboratory developed
testing services that are used in clinical care.
7. FDA Lacks Adequate Resources to Meet These Obligations.
During the COVID-19 pandemic, the FDA was quickly overwhelmed by
the volume of applications submitted for the emergency use
authorization, so much so that they had to pause review of all other
non-EUA applications. This meant delays to the review and subsequent
access to potentially lifesaving tests such as for oncology
indications. Even with the funding infusion from user fees, based on
the experience during the pandemic, we are very much concerned that FDA
will be unable to handle implementing and administering the VALID Act.
In 2021, there were more than 160,000 individual genetic tests on the
market and FDA could not handle the influx of 2133 emergency use
authorization requests for COVID-19 from March 2020--April 2021.
8. The Emergency Use Authorization (EUA) Provision Will Create a
Similar Crisis Experienced in Winter and Spring 2020.
At the onset of the pandemic, a contaminant in the only EUA-
authorized test kit plus restrictions on clinical laboratories that
prevented them from offering laboratory developed testing services
without FDA review, led to a crisis in the United States in which we
had no testing for COVID-19 for over 1 month. Guidance published on
February 29, 2020 allowing the use of tests while laboratories awaited
an EUA decision was critical for the country's response. Recognizing
the importance of this guidance, the VALID Act of 2020 and the VALID
Act of 2021 included EUA language that allowed a similar approach. It's
unclear why this was removed in the VALID Act of 2022, and we encourage
the Committee to allow for similar approach in which laboratories can
quickly mobilize during a public health emergency.
These are just eight examples of instances in the VALID Act that
need major overhaul to address the concerns stakeholders have shared
countless times in writing and in meetings with the bill's sponsors and
with Committee staff. Before advancing this legislation, we implore you
to modify the legislation to reflect stakeholders' input and to do so
in a timeframe that ensures that policy fosters patient safety and
innovation instead of creating barriers and delays to access novel
diagnostics.
For these reasons, the undersigned organizations request that you
do not advance the VALID Act as part of the Food and Drug
Administration Safety and Landmark Advancements Act and instead work
with stakeholders to refine this legislation.
Sincerely,
20/20 GeneSystems, Inc.
Academy of Clinical Laboratory Physicians and Scientists
AdventHealth
Akron Children's Hospital
Alphadera Labs
American Association for Clinical Chemistry
American College of Medical Genetics and Genomics
American Society for Clinical Pathology
American Society for Histocompatibility and Immunogenetics
(ASHI)
American Society of Hematology
American Society of Transplantation
Amerimmune
ARUP Laboratories
Association for Molecular Pathology
Association for Pathology Informatics
Association of American Medical Colleges
Association of Organ Procurement Organizations
Association of Pathology Chairs
Atrium Health
Baylor Scott & White Health
Cancer Genomics Consortium (CGC)
Cedars-Sinai
Children's Hospital Los Angeles
Clinical Immunology Society (CIS)
Coalition for Innovative Laboratory Testing
Columbia University Irving Medical Center
Dartmouth Health
Department of Pathology & Laboratory Medicine, University
of California, Irvine
Department of Pathology & Laboratory Medicine, University
of Miami School of Medicine
Department of Pathology and Laboratory Medicine, Hartford
Hospital
Department of Pathology and Laboratory Medicine, Northwell
Health
Department of Pathology and Laboratory Medicine, Perelman
School of Medicine, University of Pennsylvania
Department of Pathology and Laboratory Medicine, University
of Florida--Jacksonville
Department of Pathology and Laboratory Medicine, University
of Louisville
Department of Pathology and Laboratory Medicine, University
of North Carolina School of Medicine
Department of Pathology, Duke University
Department of Pathology, East Carolina University Brody
School of Medicine
Department of Pathology, Texas Tech University Health
Sciences Center, El Paso, Texas
Department of Pathology, University of Arizona College of
Medicine Phoenix
Department of Pathology, University of Illinois at Chicago
Department of Pathology, University of Pittsburgh Medical
Center
Department of Pathology. University of Alabama at
Birmingham
Diaceutics, Inc.
Diamond Medical Laboratories
Emory Healthcare
Entvantage Diagnostics, Inc.
Everly Health
Gene By Gene
GeneMatters
Genome Medical, Inc.
Genomind
GenXys Health Care Systems Inc.
GoDx, Inc.
Gravity Diagnostics
Harbor-UCLA Medical Center
Helix Op Co, LLC
Invitae Corporation
IVD Logix, LLC
Johns Hopkins Health System
Kaiser Permanente
KRAS Kickers
Laboratory Access and Benefits Coalition
Lighthouse Lab Services
Mass Spectrometry & Advances in the Clinical Lab (MSACL)
Medical Group Management Association
My Gene Counsel
Nationwide Children's Hospital
Nebraska Medicine
NorthShore University HealthSystem
Northwest Pathology, P.S.
NYU Langone Health
Olive View-UCLA Medical Center
Oregon Health & Science University
Pan-American Society for Clinical Virology (PASCV)
PathGroup
Premier, Inc.
Progentec Diagnostics, Inc.
Pulmonary Pathology Society
Sapere Bio
Sema4 and GeneDx
TriCore Reference Laboratories
UC Davis Health
UC San Diego Health
UCI Health
UCLA Health
University of California Health
University of California San Francisco
University of Chicago Medical Center
University of Cincinnati Health
University of Nebraska Medical Center (UNMC)
University of New Mexico
University of Rochester
University of Vermont Health Network
UVA Health
UW Health
UW Medicine
Vanderbilt University Medical Center
Virginia Commonwealth University
Weill Cornell Medicine
West Virginia University Health System
______
QUESTIONS FOR THE RECORD
Response by Rochelle Walensky to Questions of Senator Burr, Senator
Murkowski, and Senator Scott
senator burr
Question 1. I want to talk about CDC's COVID-19 community levels
metrics. For those who are not familiar, CDC uses green, yellow, and
red to represent the impact of COVID-19 in each county, which you have
said is based on the health system's capacity to deal with the virus.
The color is determined by looking at the number of new cases in the
county, COVID hospital admissions, and the percent of inpatient beds
occupied by COVID patients.
I have heard that states are not using this tool at all, because it
does not accurately reflect the level of severe disease and ability to
surge. You can have one county in the green with COVID hospital
admissions well above another county that is in the yellow.
In North Carolina, for example, CDC identifies Rockingham County as
a green county, meaning low impact of COVID-19, Wake County as yellow,
and Durham County as red. Despite the color ratings, the number of
COVID hospital admissions is actually higher in Rockingham--a green
county--than it is in Wake--a yellow county--and the percent of
inpatient beds occupied by COVID patients in each of these three
counties hovers around 5 percent.
What outreach have you conducted to states and local public health
authorities to see if this tool is accurate and even helpful at all?
Answer 1. CDC Response: The Centers for Disease Control and
Prevention (CDC) has held calls with jurisdictions about the COVID-19
Community Levels (CCLs) and used the feedback shared as we continue to
evaluate and assess ways to improve the tool. Jurisdictions have
indicated they find the CCLs a useful informational tool. CDC has also
held over 20 meetings with public health partners regarding CCLs.
Topics included community levels data and technical assistance, CCL
report feedback and updates, and CCL Report Mockup/Pre-decisional
discussions. Attendees were jurisdictional and tribal partners
including State, Territorial, and Local Health Officials; state
epidemiologists; senior leadership from the Association of State and
Territorial Health Officials (ASTHO), the National Association of
County and City Health Officials (NACCHO), the Association of Public
Health Laboratories (APHL), the Big Cities Health Coalition (BCHC), and
the Council of State and Territorial Epidemiologists (CSTE); and the
CDC Foundation.
Question 2. CDC is encouraging doctors to test for monkeypox.
However, the only way to currently test for monkeypox in the United
States is through public health laboratories. Has CDC started working
with commercial and other private sector labs to develop tests for
monkeypox? If so, what is the timeline for their availability? If not,
why not? Why haven't you learned the lessons of CDC's failure at the
beginning of the COVID pandemic?
Answer 2. At this time, available testing capacity through public
health capacity is far greater than demand. 69 U.S. public health
laboratories are able to test for orthopoxvirus, producing a throughput
capacity between 6,000-8,000 specimen weekly. Orthopoxvirus testing is
utilizing approximately 2 percent of Laboratory Response Network
capacity as of June 16, 2022.
CDC is working with the Food and Drug Administration (FDA), the
Centers for Medicare & Medicaid Services (CMS), and other Federal
partners to explore options for expanding testing convenience and
options into the commercial space. CDC is working with commercial,
hospital, and academic laboratories to be prepared to expand testing
capacity. In particular, CDC began engaging with key commercial
laboratory partners about expanding orthopoxvirus testing capacity on
May 23, less than a week after the first detected U.S. case of
monkeypox was confirmed.
Unlike the currently circulating monkeypox virus, COVID-19 is a
novel pathogen that required development of an entirely new diagnostic
test. The United States is better positioned to respond to the
monkeypox outbreak, having a historic scientific basis of information
on the nature and effective medical counter measures for orthopox
viruses. Investments made in the Smallpox Research Agenda have
contributed to the availability of an FDA-cleared non-variola
orthopoxvirus test, therapeutic measures including the anti-viral
tecovirimat, and a deployable vaccine, JYNNEOS. Investments in the
Laboratory Response Network have helped build testing capacity, which
at this point have provided capacity far greater than current testing
demand.
senator murkowski
Question 1. Dr. Walensky, as you are aware by now the Alaskan
tourism economy took the largest hit from the COVID-19 pandemic in the
country, with a 33 percent loss in revenue to the state. We are hearing
that cruises this year are operating at around 70 percent capacity on
average. This past December, as we were looking ahead to the upcoming
cruise season in Alaska and safely rebuilding our economy, the Centers
for Disease Control elevated their Travel Risk Advisory for cruise
ships to a Level 3 Risk Advisory, which at the time was the same risk
as traveling to Ukraine.
The cruise industry was the only industry targeted by the travel
advisory during the COVID Pandemic, as all other risk advisories were
for geographic regions. At the time of this announcement, the U.S. was
seeing a surge in positive cases due to the Omicron variant; however,
vaccination rates onboard a cruise ship were typically upwards of 95
percent--significantly higher than the overall U.S. population which
was at about 60 percent.
Question 1(a). Why did CDC issue the Travel Advisory on cruise
ships when they had the highest level of safety precautions in place?
Answer 1. CDC has historically used Travel Health Notices (THNs) to
alert travelers and other audiences about current health issues that
impact travelers' health, like disease outbreaks, special events or
gatherings, and natural disasters, in destinations around the world.
These range from a watch level 1 to a warning level 3.
CDC issued a separate COVID-19 THN for cruise ships because the
risk of COVID-19 transmission on cruise ships is different from that of
shoreside travel and entertainment settings (such as U.S. resorts,
restaurants, bars, and theme parks). Specifically, cruise ships are
congregate residential settings with high risk of COVID-19 transmission
among travelers (passengers and crew). They have thousands of travelers
living for multiple days (or months for crew) on the same ship--eating,
sleeping, and participating in activities together in one location.
Data from the pandemic suggest COVID-19 spreads quickly in group
settings, including on cruise ships.
During the first 2 years of the pandemic, large outbreaks were
identified on many cruise ships during periods that coincided with
major pandemic waves. These outbreaks posed a health risk to travelers
on board by exposing them to the virus. In addition, on many affected
ships, COVID-19 cases overwhelmed onboard medical facilities, which led
to reduced access to healthcare services for travelers on board who
needed to seek medical care for COVID-19 or other health conditions.
Hence, CDC developed COVID-19 THN levels and criteria specific to
cruise ships to inform the public regarding COVID-19 conditions on
board. CDC used COVID-19 data reported by cruise ships and relevant
public health authorities to make determinations about the cruise ship
THN level. Additional information such as new variants of concern,
vaccination rates, severity of disease (such as hospitalizations,
medical evacuations, and deaths for crew or passengers) were considered
when determining the cruise ship THN level. Furthermore, CDC worked
with the cruise industry and public health authorities to gather
additional data as appropriate.
CDC removed the COVID-19 Cruise Ship Travel Health Notice on March
30, 2022. While cruising continues to pose some risk of COVID-19
transmission, travelers can make their own risk assessment when
choosing to cruise, much like they do in other travel settings, based
on factors such as their health and vaccination status, and personal
risk tolerance.
Question 1(b). Will CDC commit to ending COVID related travel
advisories that single out U.S. destinations?
Answer 1(b). CDC remains committed to leading with science and
protecting the American public during this pandemic. CDC issued a THN
for cruise ships to notify travelers and other audiences about a major
health issue that impacted cruise ship travelers (passengers and crew)
at the time. The cruise ship THN was not designed to single out any
U.S. or international destinations.
Question 1(c). When will CDC cease ending COVID related travel
advisories for the cruise industry?
Answer 1(c). CDC removed the COVID-19 Cruise Ship THN on March 30,
2022. While cruising continues to pose some risk of COVID-19
transmission, travelers can make their own risk assessment when
choosing to cruise, much like they do in other travel settings, based
on factors such as their health and vaccination status, and personal
risk tolerance.
Question 2. Dr. Walensky, I continue to be concerned about the
impacts of COVID-19 on the well-being of children and youth in Alaska.
We know that there have been devastating affects to our children and
youth's mental health, as we have seen a wave of emotional health
needs. Alaska continues to have the second highest rates of suicide in
the Nation, and suicide is the second leading cause of death for
individuals ages 25-44. And we have seen an alarming increase in mental
and behavioral health issues and suicide attempts by children.
Additionally, I am concerned about the well-being of our children
and youth due to the disrupted school years. There has been documented
learning loss due to the shift to virtual learning, and this is not
accounting for the social-emotional impacts. An analysis by McKinsey
suggests that students were (on average) 5 months behind mathematics
and 4 months behind in reading by the end of the 2021 school year.
In Alaska, I have heard from programs caring for young children,
that there have been significant increases in developmental delays
amongst babies' speech and language development--possibly attributed to
mask wearing.
Question 2(a). Has the CDC evaluated the negative impacts of the
COVID-19 pandemic, not just the mental health of children and youth,
but the effects on developmental delays and learning loss?
Answer 2(a). CDC remains committed to working with our state and
local partners to improve access to mental health resources as we
continue to address the long-term impacts of the pandemic. CDC is
analyzing data to understand the trends associated with students'
mental health during COVID. Data were collected as part of the
Monitoring School COVID-19 Mitigation Strategies Project, a project
funded by the CDC Foundation to inform CDC's Operational Strategy for
K-12 Schools through Phased Prevention COVID-19 recommendations. Data
were also collected as part of the Adolescent Behaviors and Experiences
Survey (ABES), a project funded through the CARES Act to assess the
impact of COVID-19 on behaviors and experiences of U.S. high school
students. ABES provides a nationally representative sample of high
school students experiences during the COVID-19 pandemic. According to
the new data, in 2021, more than a third (37 percent) of high school
students reported they experienced poor mental health during the COVID-
19 pandemic, and 44 percent reported they persistently felt sad or
hopeless during the past year.
CDC's Study to Explore Early Development (SEED) conducted a COVID-
19 Impact Assessment (January through June 2021) with over 1,000
parents of children 5-9 years of age who were already enrolled in SEED.
Study findings showed disruptions to regular health services were
common across all study groups (58 percent-65 percent) and disruption
to specialty services were more common for children with autism
spectrum disorder (76 percent) versus children with other developmental
disabilities (58 percent) and the general population (23 percent).
Between 70 percent-81 percent of children who received developmental
services through telehealth had a worse response compared to in person
visits. Ongoing analyses will address changes in daily living skills
and behavior problems, factors associated with childhood resiliency,
response to mitigation strategies and infection, and impact of pandemic
on parental mental health.
With COVID funding, CDC expanded its Act Early Ambassador program
to further support families with young children in high need
communities across the country by bolstering collaboration among early
childhood programs to identify and support children with developmental
delays and disabilities, and to promote resiliency skills among
families during the pandemic. Forty-three state and territorial
``COVID-19 Act Early Response Teams,'' including a team in Alaska,
completed a national needs assessment that described the impact of
COVID-19 on early identification of developmental disabilities across
early childhood system.
Question 3. I have had several conversations with Alaskan public
health officials, on lessons learned from the Federal response to the
COVID-19 pandemic. I am disappointed that CMS and IHS are not
testifying today, as we know they were pivotal in the response to
COVID-19. This pandemic was not only a public health crisis, but a
crisis affecting our health systems and the delivery of healthcare. I
believe that we must apply lessons learnt, to address new public health
epidemics, such as the drug overdose crisis that many of our
communities are experiencing. The Federal Government has to improve
transparency and integrate Federal services, to allow states to respond
to future public health crisis that arise. An example of this is the
drug overdose epidemic that many of our states are now experiencing.
The Federal Government has a responsibility to promote data-sharing
throughout all health systems. For example, we did not see a
significant improvement in the surveillance of COVID-19 until CMS
required hospitals to share data on bed capacity with ASPR. Sharing
data between hospital systems and state lines, is essential in
addressing future public health issues and most notably, the drug
overdose epidemic.
Question 3(a). How can HHS continue to work internally and with
other Federal agencies, such as the VA and DOD to integrate Federal
services and promote data-sharing throughout healthcare systems?
Answer 3(a). CDC participated in the VA/DOD hosted COVID-19 Data
Collaboratory during the week of May 16, 2022. The focus of the
Collaboratory was to discuss efforts at developing further coordination
across a host of areas, including common ways to collect, analyze, and
share data findings to track the burden of disease and the
effectiveness of prevention and treatment efforts. Engagement is
ongoing with the VA/DOD with a follow-up large group meeting schedule
in Fall 2022. Additionally, CDC is working with HHS leadership, such as
the Office of the National Coordinator for Health IT (ONC), as well as
other HHS OpDivs such as CMS, to better understand and coordinate the
way data is collected, shared, and analyzed. These efforts also support
ongoing work to update the HHS data strategy and ensure that data is
available, accessible, timely, equitable, meaningfully usable,
protected--and being actively used by HHS, our partners, and the public
to realize HHS' mission.
CDC currently lacks the authority to coordinate and require the
reporting of public health data from state and local health departments
and healthcare facilities. The result is a fragmented approach to
public health reporting that is hindered by a patchwork of policies
which vary from jurisdiction to jurisdiction and prohibits CDC from
developing the clear national picture of disease burden across the
country. The lack of a consistent, comprehensive reporting framework is
burdensome on healthcare providers, who must attempt to meet many and
varied requirements, and leaves large gaps in the Federal Government's
ability to prepare for and respond to disease outbreaks. This
discordance also reduces the quality of data that can be shared back
with jurisdictions and with interagency partners, such as the VA and
DOD.
Providing CDC with a modernized public health authority could
improve CDC's ability to share high quality data with our interagency
partners, like the VA and DOD, on a wide array of public health issues,
including the overdose epidemic. For example, the ability to require
emergency department data would help CDC and states to more rapidly
detect unusual spikes in visits related to overdoses, facilitating a
more rapid response.
Question 3(b). What can the CDC and ASPR do to continue to
streamline healthcare workforce efficiency and improve data
modernization?
Answer 3(b). The National Healthcare Safety Network (NHSN) is the
most comprehensive USG data collection and quality improvement system
for healthcare and is currently in use in more than 38,000 healthcare
facilities in the U.S., with more than 136,000 individual users
tracking and identifying emerging and enduring threats across
healthcare. At the outset of the COVID-19 pandemic, CDC rapidly
leveraged the reach that NHSN has into thousands of healthcare
facilities to collect urgently needed COVID-19 data from hospitals,
nursing homes, dialysis clinics, and other facilities. With support
from COVID supplemental funding, CDC now collects and analyzes COVID-19
data from every nursing home in the country (?15,400), including
vaccination coverage of their 1.2 million residents and 1.8 million
staff, as well as hospital staff COVID-19 vaccination from more than
7.6 million healthcare personnel.
CMS also relies on NHSN for regulatory functions, public reporting,
and incentive payment programs, including mandatory COVID-19 reporting
from all U.S. nursing homes and mandatory COVID-19 staff vaccination
reporting from all U.S. hospitals. CDC has consistently worked with CMS
to provide data from healthcare settings that is reported in NHSN and
other systems, including CMS public reporting of facility level COVID
data from NHSN. CDC has coordinated with VA and IHS to improve
reporting of COVID and other healthcare data by relevant facilities and
share data as appropriate to assist these agencies with their
prevention efforts. CDC has also worked with health departments
throughout the pandemic to provide access to NHSN reports and data to
inform their efforts.
CDC is working with other agencies, public health partners, and
industry to increase the automation of data reporting to NHSN and
modernize user interface and support. The goal is to accelerate the
integration of electronic healthcare records and other emerging data
standards to NHSN and provide a modern, flexible platform that can
serve as the hub of USG healthcare data for CDC, CMS, ASPR, and HHS to
identify and to respond to emerging and enduring health threats in
healthcare facilities. CDC is also exploring additional capabilities to
address future health emergencies as described in CMS's recently
proposed rule requiring ongoing reporting of COVID-19 data from
hospitals; reporting of pathogens of pandemic or epidemic potential
during future public health emergencies; as well as CMS' recently
finalized rule which extends nursing home COVID-19 reporting for
several years beyond the end of the current Public Health Emergency.
CDC will also work with health departments and other public health
partners to continue to expand and improve provision of analytic
reports and electronic data provided from NHSN to state and local
health departments, other Federal Government agencies--such as CMS and
ASPR--and public health partners to support infection control and
prevention activities and improve patient safety.
CDC, the Association of Public Health Laboratories (APHL), and the
Council of State and Territorial Epidemiologists (CSTE) are working
with healthcare organizations and their EHR vendors to automate the
reporting of conditions of significance to public health agencies that
is required of healthcare providers. Electronic case reporting (eCR)
modernizes the reporting by using data entered in electronic health
records as part of care delivery by healthcare providers. The
automation of this reporting reduces the burden on the providers to
submit reports in a manual process, typically by filling out a paper
form and faxing it to public health.
Question 4. We talk a lot about the importance of health equity,
and focusing on populations that have documented inequities. I have
been a vocal advocate for addressing health equity issues, particularly
the issues affecting Alaska Native and American Indian populations to
die at higher rates than other Americans in many categories, including
chronic liver disease and cirrhosis, diabetes mellitus, unintentional
injuries, assault/homicide, intentional self-harm/suicide, and chronic
lower respiratory diseases.
However, I want to discuss a different type of equity today, which
is an important part of the health equity discussion. When we are
evaluating our Federal response to COVID-19, we fail to discuss state
equity. States with larger populations, tend to have more purchasing
power for therapeutics, testing, and other medical supplies, leaving
many rural states (the majority Western states) behind. We saw this
during the COVID-19 pandemic, when Alaska was unable to compete with
New York City, California, or private investors in purchasing PPE,
therapeutics, and testing supplies.
Question 4(a). As we move to toward a new phase of COVID-19, how
are we going to ensure there is state equity when accessing these
supplies on the private market?
Answer 4(a). CDC defers to ASPR.
Question 4(b). What is HHS going to do to address these issue of
unequal purchasing power to ensure equal access?
Answer (b). Please see the answer from ASPR.
Question 4(c). What is HHS doing to continue to conduct
surveillance of COVID-19, to ensure states can plan appropriately for
different waves to come?
Answer 4(c). CDC has been sharing with Americans and the rest of
the world what we've learned about COVID-19. COVID Data Tracker
contains a wealth of numbers and tools to analyze COVID-19 cases,
deaths, and trends at the local, state, and national levels. Data
Tracker tool contains total cases; average number of daily cases during
the previous 7 days; total number of deaths; and total number of
vaccinations. The information, which is updated daily, is both big-
picture (with national data) and granular (down to the county level).
CDC is also working to detect and characterize new variants of the
virus that causes COVID-19. As CDC has learned new information about
the variants, the agency has been providing updates to the public and
our partners around the world. CDC's COVID-NET program collects data on
laboratory-confirmed, COVID-19-associated hospitalizations among
children and adults through a network of over 250 acute-care hospitals
in 14 states.
Question 5. The impacts of COVID-19 have exacerbated mental health
issues across the country and within the military. We've seen this
first hand in Alaska where 17 soldiers died in 2021 by suicide. Service
members and their families face difficult and unique circumstances
living in an austere and remote location, and COVID protocols increased
their isolation without providing enough access to resources such as
mental health providers. Just last week, Senator Sullivan and I
introduced the Don Young Arctic Warrior Act, which focuses increasing
the help and assistance they need and deserve.
Question 5(a). Is HHS working on any long-term solutions to address
the rise in military suicides, as exacerbated by the isolation brought
on by COVID?
Answer 5(a). CDC uses data to understand the contributors to
suicide, including its scope and magnitude, who is most impacted, and
to track trends over time to inform prevention and response efforts.
For almost 20 years, CDC has collected data on suicide deaths through
the National Violent Death Reporting System (NVDRS). CDC has ongoing
collaborations with the Departments of Defense (DoD) and the Department
of Veterans Affairs (VA) to strengthen suicide-related data to better
tailor prevention efforts for veterans and active-military. CDC and the
Department of Defense link and analyze data from the DoD's Suicide
Event Report (DoDSER) and NVDRS. DoD collects information on active-
duty service members while NVDRS collects data on people who have ever
served in the military, and civilian populations. Combining NVDRS and
DoDSER provides the opportunity to examine and better understand
suicides among, civilians, veterans, and active-duty military to inform
upstream prevention, tailor effective strategies, and identify hotspots
and gaps to target efforts. For example, this project creates detailed
mapping of suicide burden by county, as well as a thorough description
of the characteristics of veteran and active-duty suicides in areas
with the highest incidence. These maps are overlaid with military
installations, mental health clinics, and suicide prevention programs
to see which hotspots may lack infrastructure to address suicide burden
and to highlight areas in need of suicide prevention resources,
including upstream prevention. Additionally, CDC works with the VA to
link mortality data from CDC's National Death Index to VA data to
improve understanding of veteran suicide.
In addition, CDC is funding approaches to primary prevention of
suicide. CDC's Comprehensive Suicide Prevention (CSP) program funds
states and communities to implement multiple strategies and approaches
with attention to populations disproportionately affected by suicide,
including military and rural populations. These strategies are
discussed in further detail in the response below.
Question 5(b). Are there any lessons the military could learn from
the CDC or NIH on what strategies work in reducing suicides in highly
isolated populations?
Answer 5(b). While anyone can experience suicide risks, certain
groups have substantially higher rates of suicide than the general U.S.
population, and CDC recognizes that active-military and veterans bear a
disproportionate burden. Suicide is preventable, and the same scalable
prevention and protective strategies CDC has demonstrated effective for
individuals, families, and communities work for veterans and active
military too. CDC's Preventing Suicide: A Technical Package of
Policies, Programs, and Practices (https://www.cdc.gov/suicide/pdf/
suicideTechnicalPackage.pdf) highlights strategies based on the best
available evidence to prevent suicide including strategies that address
isolation such as. promoting connectedness, teaching coping and
problem-solving skills, and identifying and supporting people at risk.
A comprehensive approach to suicide prevention that includes
multiple strategies tailored to population needs (including military
and rural populations) can help reduce suicide and suicide risk. CDC's
Comprehensive Suicide Prevention (CSP) program funds states and
communities to implement multiple strategies and approaches from the
technical package with attention to populations disproportionately
affected by suicide, including military and rural populations. The
program seeks to reduce suicide and suicide attempts by 10 percent over
the course of the 5-year program. CDC also funds the Veteran Suicide
Prevention Evaluation Demonstration Project (VSPE) to improve the
evaluation capacity of veteran serving organizations (VSOs) to measure
the impact of their upstream suicide prevention programs (e.g. those
focused on improving connectedness). This project just completed its
fourth year. We know firsthand from working with VSOs participating in
this project that social connectedness is crucial in supporting
veterans in their communities and in reducing suicide risk.
To address isolation and reduce access barriers, some of our funded
partners are exploring the use of technology to reach and connect
veterans. For example, CDC funded Objective Zero Foundation (a VSO) to
develop a mobile app that helps veterans and community members 1)
independently access wellness tools, trainings, and resources; 2) seek
support through a crisis hotline or Ambassador; and 3) provide support
and resources to Ambassadors. The program is currently evaluating
outcomes, including social connectedness, awareness, and user intent to
access mental health and other resources and skills to help others.
Other CDC funded projects, such as Zero Suicide, are exploring
telehealth to reach at-risk populations to implement evidence-based
practices that engage and retain individuals at increased risk for
suicide in care services. Telehealth is a strategy that has been found
to be effective in reaching veterans and rural populations at risk of
suicide. Relaxed state laws allowing use of telehealth services enacted
during the COVID-19 pandemic helped reduce transportation barriers and
increase access through use of Medicaid funds to reimburse providers
for telehealth visits.
from senator scott
Question 1. Dr. Walensky--South Carolina had the 5th highest
prevalence of diabetes among adults in the U.S. in 2017 and it is the
7th leading cause of death in my state. I have a bill with Senator
Warner, the PREVENT DIABETES Act (S. 2173), which would align Medicare
coverage for diabetes prevention programs with the existing and highly
successful CDC recognition of these programs to simplify compliance and
expand patient access by allowing virtual suppliers of these services.
I was pleased to see that the National Clinical Care Commission, a
panel of national diabetes care experts recently made a similar
recommendation to HHS--recommending that the Medicare program better
align its coverage of these services with the CDC's national program by
allowing virtual access to diabetes prevention programs.
Can you discuss the public health and wellness opportunity that
would be created by expanding access to diabetes prevention programs
for seniors? Specifically, can you discuss the opportunity virtual
Diabetes Prevention Programs create to effectively help address the
increased rates of pre-diabetes--particularly rural areas without in-
person providers--as a result of the pandemic?
Answer 1. Approximately 26 million American adults 65 years and
older have prediabetes. Expanding Medicare beneficiaries' access to the
Medicare Diabetes Prevention Program (MDPP) can be critically important
to the health and well-being of this population. CMS offered greater
flexibility to provide virtual delivery of MDPP services during the
COVID-19 public health emergency (PHE) to ensure continuity of services
when in-person classes are not safe or feasible.
The MDPP expanded model was originally intended to provide
primarily in-person MDPP services and does not include a ``virtual
only'' option. CMS has not permitted virtual-only suppliers to furnish
MDPP services while the Public Health Emergency Policy is in effect.
This is because MDPP suppliers must remain prepared to resume delivery
of MDPP services in-person to start new cohorts and to serve
beneficiaries who wish to return to in-person services when the PHE has
concluded. At this time, CMS does not have a path for continuing
virtual delivery of MDPP post PHE except for the limited virtual
options that existed prior to the PHE.
A 2017 study in rural communities found that for the National
Diabetes Prevention Program (National DPP) lifestyle change program,
which the MDPP is modeled after, participants who participated through
telehealth videoconferencing had similar participation rates and
achieved similar weight loss outcomes as participants who attended in
person.1 More than 300,000 (. 60 percent) enrollees in the National DPP
lifestyle change program have participated in a virtual program, making
it the most popular delivery method. It seems virtual participation
could improve access while improving health care outcomes. The National
DPP lifestyle change program is cost effective and can contribute to
cost savings.
______
Response by Anthony Fauci to Questions of Senator Burr and Senator
Murkowski
senator burr
Question 1. Dr. Fauci, we have seen evidence that BA.4 and BA.5 are
more transmissible than other Omicron subvariants and are likely to
evade immunity from vaccines. A recent study from Israel indicates that
individuals who were vaccinated and recovered from Omicron may have
some more protection. What do we know about BA.4 and BA.5 so far and
what questions are we still asking-or what should we be asking?
Answer 1. Initial data indicate that the BA.4 and BA.5 variants of
SARS-CoV-2 are more transmissible than previous variants and may
partially evade the immune response from previous infection and/or
vaccination. The continued emergence of SARS-CoV-2 variants with such
attributes is a cause for concern. The National Institute of Allergy
and Infectious Diseases (NIAID) has launched collaborative research to
help answer key scientific questions related to BA.4, BA.5, and other
SARS-CoV-2 variants, namely the effectiveness of vaccines, monoclonal
antibodies, and antiviral drugs.
The National Institutes of Health (NIH), including NIAID,
participates in the Department of Health and Human Services-established
SARS-CoV-2 Interagency Group (SIG) along with the Centers for Disease
Control and Prevention (CDC), U.S. Food and Drug Administration (FDA),
Biomedical Advanced Research and Development Authority (BARDA),
Department of Defense (DOD), and U.S. Department of Agriculture. The
SIG tracks variants in real time to address the potential impact of
emerging variants on critical SARS-CoV-2 countermeasures. As part of
SIG, NIAID leads the SARS-CoV-2 Assessment of Viral Evolution (SAVE)
program to rapidly prioritize variants for studies to characterize
their properties, including whether immunity is maintained against
these variants. Through the SAVE program, NIAID-supported scientists
have generated in vitro neutralization data with post-vaccination sera
that show a reduction in neutralization titers for BA.5 compared to
earlier Omicron subvariants (BA.1). Studies are ongoing to assess how
sera from people who experienced a breakthrough BA.1 or BA.2 infection
are able to neutralize BA.4 or BA.5. NIH continues to assess this
phenomenon as other emerging variants may be able to further escape
immunity.
With both the Delta and Omicron variants, protection against mild
and moderate disease begins to decrease over time following the primary
vaccine series. As SARS-CoV-2 variants have emerged, NIAID moved
rapidly to investigate the potential of targeted boosters to enhance
immune responses to emerging variants. NIAID now will examine whether
people who received boosters--either mRNA-1273 or variant-specific
COVID-19 boosters--generate antibodies that can bind to and neutralize
the Omicron variant and its sublineages, including BA.4 and BA.5. NIAID
also is supporting additional preclinical and clinical research to
assess the durability of immunity induced by COVID-19 vaccines, as well
as the effect of COVID-19 vaccine boosters. NIAID recently launched the
Phase 2 COVID-19 Variant Immunologic Landscape (COVAIL) trial to learn
whether different vaccine booster regimens can broaden and increase the
durability of immune responses in adults who already have received a
primary vaccination series and a first booster shot.
NIAID also conducts and supports research to determine the impact
of SARS-CoV-2 variants on the effectiveness of monoclonal antibodies
and other therapeutics. For example, research suggests that although
the activity of certain monoclonal antibodies against Omicron is
markedly diminished, the monoclonal antibody bebtelovimab, discovered
by the NIAID VRC in collaboration with AbCellera, is active in vitro
against all circulating Omicron subvariants, including BA.4 and BA.5.
In addition, NIAID is working to develop new drugs, including
therapeutics that inhibit essential processes in the virus replication
cycle or that address the host response to COVID-19, with an eye toward
agents that maintain their effectiveness against emerging variants.
Additional SARS-CoV-2 variants can be expected to arise and NIAID
is supporting the development of next-generation COVID-19 vaccines that
could provide additional protection against disease caused by emerging
SARS-CoV-2 variants. Strategies for next-generation COVID-19 vaccines
include targeting viral antigens that are highly conserved among SARS-
CoV-2 strains, testing innovative antigen presentations, and utilizing
alternative routes of inoculation, such as intranasal vaccine
approaches to generate better mucosal immunity to potentially limit
infection and transmission. NIAID also is conducting research on pan-
coronavirus vaccines designed to provide broad protective immunity
against emerging SARS-CoV-2 variants, such as BA.4 and BA.5, and other
coronaviruses with pandemic potential.
senator murkowski
Question 1. I have had several conversations with Alaskan public
health officials, on lessons learnt from the Federal response to the
COVID-19 pandemic. I am disappointed that CMS and IHS are not
testifying today, as we know they were pivotal in the response to
COVID-19. This pandemic was not only a public health crisis, but a
crisis affecting our health systems and the delivery of healthcare. I
believe that we must apply lessons learnt, to address new public health
epidemics, such as the drug overdose crisis that many of our
communities are experiencing. The Federal Government has to improve
transparency and integrate Federal services, to allow states to respond
to future public health crisis that arise. An example of this is the
drug overdose epidemic that many of our states are now experiencing.
The Federal Government has a responsibility to promote data-sharing
throughout all health systems. For example, we did not see a
significant improvement in the surveillance of COVID-19 until CMS
required hospitals to share data on bed capacity with ASPR. Sharing
data between hospital systems and state lines, is essential in
addressing future public health issues and most notably, the drug
overdose epidemic. How can HHS continue to work internally and with
other Federal agencies, such as the VA and DOD to integrate Federal
services and promote data-sharing throughout healthcare systems?
Question 1(a). What can the CDC and ASPR do to continue to
streamline healthcare workforce efficiency and improve data
modernization?
Answer 1(a). NIAID defers to CDC and ASPR on the above questions.
Question 2. We talk a lot about the importance of health equity,
and focusing on populations that have documented inequities. I have
been a vocal advocate for addressing health equity issues, particularly
the issues affecting Alaska Native and American Indian populations to
die at higher rates than other Americans in many categories, including
chronic liver disease and cirrhosis, diabetes mellitus, unintentional
injuries, assault/homicide, intentional self-harm/suicide, and chronic
lower respiratory diseases.
However, I want to discuss a different type of equity today, which
is an important part of the health equity discussion. When we are
evaluating our Federal response to COVID-19, we fail to discuss state
equity. States with larger populations, tend to have more purchasing
power for therapeutics, testing, and other medical supplies, leaving
many rural states (the majority Western states) behind. We saw this
during the COVID-19 pandemic, when Alaska was unable to compete with
New York City, California, or private investors in purchasing PPE,
therapeutics, and testing supplies.
Question 2(a). As we move to toward a new phase of COVID-19, how
are we going to ensure there is state equity when accessing these
supplies on the private market?
Question 2(b). What is HHS going to do to address these issue of
unequal purchasing power to ensure equal access?
Question 2(c).What is HHS doing to continue to conduct surveillance
of COVID-19, to ensure states can plan appropriately for different
waves to come?
Answer 2. NIAID defers to CDC and ASPR on the above questions.
Question 3. The impacts of COVID-19 have exacerbated mental health
issues across the country and within the military. We've seen this
first hand in Alaska where 17 soldiers died in 2021 by suicide. Service
members and their families face difficult and unique circumstances
living in an austere and remote location, and COVID protocols increased
their isolation without providing enough access to resources such as
mental health providers. Just last week, Senator Sullivan and I
introduced the Don Young Arctic Warrior Act, which focuses increasing
the help and assistance they need and deserve.
Question 3(a). Is HHS working on any long-term solutions to address
the rise in military suicides, as exacerbated by the isolation brought
on by COVID?
Question 3(b). Are there any lessons the military could learn from
the CDC or NIH on what strategies work in reducing suicides in highly
isolated populations?
Answer 3. NIAID defers to CDC on the first question above.
The National Institute of Mental Health (NIMH) works with the
Department of Veterans Affairs (VA), the Department of Defense (DoD),
and clinicians and researchers to address the mental health needs of
active duty, National Guard, and Reserve service personnel, as well as
veterans and their families. NIMH-supported suicide prevention research
focuses on understanding risk factors, identifying effective prediction
and screening approaches, and developing effective, evidence-based
interventions. Additionally, the NIMH Office of Rural Mental Health
helps to ensure that such efforts positively impact highly isolated
populations, by supporting research to improve the delivery of services
for residents of rural areas.
NIMH funds research on coordinated services for individuals at
elevated risk of suicide across the health care system. This approach
is often referred to as the Zero Suicide framework, which emphasizes
the role of leadership, training, and continuous quality improvement to
optimize delivery of evidence-based strategies to identify, engage,
treat, and assist with transitions of care across clinical settings.
\1\ NIMH-funded research has shown that implementation of Zero Suicide
preventive practices is effective at decreasing suicide risk. 1A\2\ In
line with this approach, NIMH staff and grantees have published a
clinical pathway for suicide risk identification in adult primary care
settings, which emphasizes the importance of pairing screening with
evidence-based assessment and intervention strategies associated with
suicide risk reduction. 1A\3\ Provider training in suicide prevention
is important for ensuring that evidence-based clinical care is
delivered with high quality, and that care is appropriately tailored to
the level of risk. For example, for lower risk individuals, early
detection and intervention, with a focus on recovery and stress
management, can help reduce concerns about negative impact on
employment.
---------------------------------------------------------------------------
\1\ https://www.sprc.org/zero-suicide
\2\ Layman et al. (2021), https://doi.org/10.1176/
appi.ps.202000525
\3\ https://www.nimh.nih.gov/news/research-highlights/2022/a--
clinical-pathway-for-suicide-risk-screening-in-adult-primary-care
Other strategies that complement the Zero Suicide approach can also
help to create safer, healthier environments. For example, NIMH-
supported research has demonstrated that safe storage of lethal means
is an effective strategy for reducing suicide deaths. 1A\4\
Interventions to build cohesion, shared purpose, and the capacity to
manage career and personal stressors have also proven effective at
improving healthy behaviors and reducing psychiatric symptoms,
including suicide ideation. 1A\5\ Creating multi-level strategies for
suicide prevention is consistent with previous efforts by the military
that were associated with reduced suicide rates. 1A\6\
---------------------------------------------------------------------------
\4\ Shenassa et al. (2004), https://doi.org/10.1136/
jech.2003.017343
\5\ Wyman et al. (2022), https://doi.org/10.1016/
j.socscimed.2022.114737
\6\ Knox et al. (2010), https://doi.org/10.2105/ajph.2009.159871
Understanding risk associated with specific deployment contexts is
also important. As one example of ongoing research in this area, NIMH-
supported researchers aim to identify risk factors for suicide by
analyzing data from the Substance Use and Psychological Injury Combat
Study (SUPIC), a longitudinal data base of over 865,000 Army Active
Duty and National Guard/Reserve Soldiers returning from Operation
Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn
deployments, along with clinical and administrative data from the
Veterans Health Administration. 1A\7\ Findings from this study could
substantially improve suicide risk assessment and intervention
strategies.
---------------------------------------------------------------------------
\7\ reporter.nih.gov/project-details/10437762
Beyond the military context, implementation of evidence-based
approaches in isolated settings requires additional considerations.
Prior to the COVID-19 pandemic, telehealth had already been found to be
as effective as in-person treatments for mental illnesses, including
PTSD. 1A\8\ Expansion of telehealth services during the COVID-19
pandemic has provided further evidence that mental health care can
successfully be delivered to individuals in remote areas. The National
Action Alliance for Suicide Prevention issued guidance on screening for
suicide risk during telehealth visits. 1A\9\ Ensuring that individuals
maintain continuous access to their healthcare providers, regardless of
where they are physically located, remains a challenge for the mental
health field, with several notable efforts to solve this problem
underway. 1A\10\, 1A\11\ Finally, efforts to embed mental healthcare in
the primary care setting, known as behavioral health integration, can
help address shortages in the behavioral health workforce in rural
communities. One such approach, the Collaborative Care model, has been
shown to reduce the severity of suicidal ideation in a recent meta-
analysis. 1A\12\
---------------------------------------------------------------------------
\8\ Marchand et al. (2011), https://doi.org/10.1080--
percent2F10926771.2011.562479
\9\ https://theactionalliance.org/resource/covid-guidance-
screening-suicide-risk-during-telehealth-visits
\10\ https://psypact.site-ym.com/
\11\ https://www.imlcc.org/
\12\ Grigoroglou et al. (2021), https://doi.org/10.1016/
j.genhosppsych.2021.04.004
The NIMH Suicide Prevention website contains additional examples of
effective suicide prevention strategies, as well as resources for
people in suicidal crisis or emotional distress. \13\
---------------------------------------------------------------------------
\13\ www.nimh.nih.gov/health/topics/suicide-prevention
---------------------------------------------------------------------------
______
Response by Robert Califf to Questions of Senator Burr, Senator
Cassidy, and Senator Murkowski
senator burr
Question 1. We have heard concerns from some parents about the
delay between Moderna's EUA submission and the advisory committee
meeting. I've seen reporting that one of the reasons for the delay was
so that parents would not confuse the two different vaccines as each
has different doses and timelines. It's this kind of continued nanny
state approach that raises questions about what exactly FDA is doing,
as it seems FDA is evaluating other factors in addition to its role of
reviewing safety and efficacy.
Question 1(a). Can you provide any clarity regarding the reason for
the delay of authorizing one vaccine for children under 5?
Question 1(b). Did FDA consider waiting until the other vaccine was
submitted to make its decision about the first? If so, why?
Answer 1. On May 23, FDA revised the dates of the Vaccines and
Related Biological Products Advisory Committee (VRBPAC) meetings due to
new data from sponsors and expected submissions of emergency use
authorization (EUA) amendment requests. June 15 was the new meeting
date for the Moderna EUA amendment request for 6 months through 5 years
of age and Pfizer-BioNTech EUA amendment request for 6 months through 4
years of age, based on expected completion of an EUA submission to FDA.
FDA noted its plans to hold the VRBPAC meetings in anticipation of
complete submissions of EUA requests that had been publicly announced
by COVID-19 vaccine manufacturers. FDA also noted that the dates were
tentative as none of the submissions were complete.
FDA recognized that many parents and caregivers of children under
the age of 5 were eager to get their children vaccinated. The agency
proceeded with holding a 2-day VRBPAC meeting to present the safety and
effectiveness data for both vaccines to our committee of outside
experts. We believed that this was the best approach to solicit the
most informed advice from the VRBPAC because the committee had the
comprehensive analyses for both vaccines in the youngest pediatric
populations before them and did not have to wonder about results that
were mentioned only in a press release. Our top priority was ensuring
that the relevant data pertaining to the safety and effectiveness of
both vaccines were available for public consideration before we decided
whether to authorize these COVID-19 vaccines for pediatric populations.
senator cassidy
Question 1. When do you expect your respective workforces to return
to pre pandemic levels of in-office or field work on a full-time basis?
Answer 1. Throughout COVID-19, FDA staff have never stopped working
and continue to work extremely hard to successfully fulfill our public
health mission--regardless of whether work is performed from a FDA
office, or from an alternative work location. FDA initiated a Workplace
Flexibilities Pilot in April 2022 and will evaluate the best approach
for FDA's work environment moving forward, informed by how we can best
accomplish our mission and attract and retain highly qualified talent,
supported by our personnel policies.
FDA's reentry process is completely consistent with Government-wide
guidance. It is important to note that FDA must recruit highly skilled
and talented staff, often with specialized technical expertise, to keep
up with the innovative industries we regulate. To meet our mission, the
Agency must compete with industry for the most qualified staff and that
will require us to continue to leverage workplace flexibilities as
appropriate.
Question 2. What percent of your respective workforces, including
headquarters, agency, regional office, and field office employees are
currently working full or part time remotely?
Answer 2. As of June 2022, approximately 5,000 employees regularly
come into facilities or to work sites to perform non-portable work.
Other FDA employees are participating in the Workplace Flexibilities
Pilot, which provides remote-and telework-eligible options for
employees who receive supervisory approval for a period of 6 months.
Question 3. What agency-wide data have you collected regarding
remote work productivity levels that will help advise any agency plans
for increased telework in the future?
Answer 3. FDA initiated a Workplace Flexibilities Pilot in April
2022 for a limited time, after which time we will evaluate the best
approach for FDA's work environment moving forward, informed by how we
can best accomplish our mission and attract and retain highly qualified
talent, supported by our personnel policies.
Question 4. I hear that there are some companies that are trying to
bring new competitors on to the market relevant for COVID response but
are having difficulty getting samples of the products from the original
manufacturers, and thus don't have the supplies necessary to carry out
appropriate trials. They haven't been able to get good answers from the
Administration about what to do. I'm told that when a product is under
an EUA, the FDA cannot compel the that company to share samples. Dr.
Califf, is this something you've heard about and is this something that
the FDA could address through regulatory action?
Answer 4. As a general matter, if companies are blocking access to
product samples needed by competing product developers, there are
multiple pathways for addressing this. The law widely known as the
CREATES Act creates a pathway for eligible developers of generic,
505(b)(2) and biosimilar products to obtain needed samples of drug
products approved under sections 505(c) or (j) of the FD&C Act or
biological products licensed under sections 351(a) or (k) of the Public
Health Service Act. The CREATES Act establishes a private right of
action that allows eligible product developers to sue companies that
refuse to sell them samples of these products needed to support their
applications. If the product developer prevails, the court will order
the sale of samples, award attorneys' fees and litigation costs to the
product developer and may impose a monetary penalty on the company
withholding samples.
We note that, as a general matter, we also understand that the
Federal Trade Commission (FTC) takes enforcement action to address the
anticompetitive blocking of access to samples and other materials
needed for drug product development. While outside of FDA's purview, it
is our understanding that this action may result in, among other
things, issuance of an order requiring a company to make samples of
their product available to competing developers. While the CREATES
pathway is limited to obtaining samples of approved drug or biological
products, to the extent companies are engaging in the blocking of
access to other products or materials needed for product development,
we recommend that the matter be raised with the FTC so that they can
consider appropriate enforcement action.
In terms of issues that may be occurring in the COVID-19 vaccine
space, FDA intends to work with the Biomedical Advanced Research
Development Authority (BARDA) on making U.S. Government owned supply
available to developers.
Question 5. Dr. Califf, a Politico article published on May 19th
described the chaos and disarray of the foods program at FDA, which was
driven by lack of clear leadership over the program between CFSAN
Director Susan Mayne and Deputy Commissioner Yiannes. How do you think
that this lack of clear leadership contributed to the infant formula
crisis? May 19 article: https://www.politico.com/news/2022/05/19/
infant-formula-fallout-fda-woodcock--00033699
Answer 5. Deputy Commissioner Yiannas and Dr. Mayne are leaders
with tremendous experience in their respective fields. FDA's response
to the infant formula crisis required their vast array of skills. I am
committed to taking a close look at the foods program to determine what
investments, changes, and authorities may be needed to better position
the program for the future. I have asked Dr. Steve Solomon, Director of
the Center for Veterinary Medicine, to conduct a top-down review of the
events and activities that led up to the current situation involving
infant formula. Dr. Solomon has been with FDA for more than 30 years,
runs one of FDA's most efficient centers, and has familiarity with
Foods and Field-based issues, having previously worked in our Office of
Regulatory Affairs. I am confident that that review will provide even
more detail that will support our ability to implement the processes
and changes needed to prevent this situation from happening in the
future.
senator murkowski
Question 1. I have had several conversations with Alaskan public
health officials, on lessons learnt from the Federal response to the
COVID-19 pandemic. I am disappointed that CMS and IHS are not
testifying today, as we know they were pivotal in the response to
COVID-19. This pandemic was not only a public health crisis, but a
crisis affecting our health systems and the delivery of healthcare. I
believe that we must apply lessons learnt, to address new public health
epidemics, such as the drug overdose crisis that many of our
communities are experiencing. The Federal Government has to improve
transparency and integrate Federal services, to allow states to respond
to future public health crisis that arise. An example of this is the
drug overdose epidemic that many of our states are now experiencing.
The Federal Government has a responsibility to promote data-sharing
throughout all health systems. For example, we did not see a
significant improvement in the surveillance of COVID-19 until CMS
required hospitals to share data on bed capacity with ASPR. Sharing
data between hospital systems and state lines, is essential in
addressing future public health issues and most notably, the drug
overdose epidemic.
Question 1(a). How can HHS continue to work internally and with
other Federal agencies, such as the VA and DOD to integrate Federal
services and promote data-sharing throughout healthcare systems?
Question 1(b). What can the CDC and ASPR do to continue to
streamline healthcare workforce efficiency and improve data
modernization?
Answer 1. FDA defers to CDC and ASPR for a response to these
questions.
Question 2. We talk a lot about the importance of health equity,
and focusing on populations that have documented inequities. I have
been a vocal advocate for addressing health equity issues, particularly
the issues affecting Alaska Native and American Indian populations to
die at higher rates than other Americans in many categories, including
chronic liver disease and cirrhosis, diabetes mellitus, unintentional
injuries, assault/homicide, intentional self-harm/suicide, and chronic
lower respiratory diseases.
However, I want to discuss a different type of equity today, which
is an important part of the health equity discussion. When we are
evaluating our Federal response to COVID-19, we fail to discuss state
equity. States with larger populations, tend to have more purchasing
power for therapeutics, testing, and other medical supplies, leaving
many rural states (the majority Western states) behind. We saw this
during the COVID-19 pandemic, when Alaska was unable to compete with
New York City, California, or private investors in purchasing PPE,
therapeutics, and testing supplies.
Question 2(a). As we move to toward a new phase of COVID-19, how
are we going to ensure there is state equity when accessing these
supplies on the private market?
Question 2(b)1. What is HHS going to do to address these issue of
unequal purchasing power to ensure equal access?
Question 2(c)1. What is HHS doing to continue to conduct
surveillance of COVID-19, to ensure states can plan appropriately for
different waves to come?
FDA defers to CDC and ASPR for a response to these questions.
Question 3. The impacts of COVID-19 have exacerbated mental health
issues across the country and within the military. We've seen this
first hand in Alaska where 17 soldiers died in 2021 by suicide. Service
members and their families face difficult and unique circumstances
living in an austere and remote location, and COVID protocols increased
their isolation without providing enough access to resources such as
mental health providers. Just last week, Senator Sullivan and I
introduced the Don Young Arctic Warrior Act, which focuses increasing
the help and assistance they need and deserve.
Question 3(a)1. Is HHS working on any long-term solutions to
address the rise in military suicides, as exacerbated by the isolation
brought on by COVID?
Question 3(b)1. Are there any lessons the military could learn from
the CDC or NIH on what strategies work in reducing suicides in highly
isolated populations?
FDA defers to CDC and NIH for a response to these questions.
______
Response by Dawn O'Connell to Questions of Senator Kaine, Senator Burr,
Senator Murkowski, and Senator Tuberville
senator kaine
Assistant Secretary O'Connell, at a recent HELP hearing on the
ongoing Federal response to COVID-19, we discussed the importance of
next generation vaccines. I first want to acknowledge the success of
the important government and private sector partnerships that have
taken place over the last 2 years. BARDA, in coordination with other
government agencies, has led the way in working with researchers and
other entities on the development of several effective vaccines against
COVID-19. Yet COVID-19 has shown us that it can change. As new variants
emerge, we need vaccines that offer universal coverage against emerging
variants.
Question 1. Assistant Secretary O'Connell, what is the current
state of research on next generation vaccines and how has delayed
COVID-19 funding impacted BARDA's timeline?
Answer 1. Response: At this time, any investment in next generation
COVID-19 vaccines by the Biomedical Advanced Research and Development
Authority (BARDA) has been put on hold given the lack of supplemental
funding for such efforts. However, BARDA, in collaboration with
partners at the National Institutes of Health (NIH) as well as other
interagency partners, continues to assess the pipeline of vaccine
candidates and has put out Requests for Information to make sure that
the Federal Government is poised to act quickly, should funding be made
available. Since additional funding has not been provided, BARDA does
not have the resources to invest in next-generation vaccine candidates
that may offer key improvements in technical performance. Every day
that additional COVID-19 funding is delayed is a day lost in terms of
applying invaluable government resources, both financial and technical,
to such programs. With any current remaining funds, BARDA is exploring
whether it can--in partnership with NIH--establish a scientific
framework for consideration of next generation vaccines (assays, etc.)
so should next generation funding come available both teams can move
out quickly.
BARDA's TechWatch program remains open to all threat areas,
including COVID-19. Industry partners, including those developing
COVID-19 vaccines, are encouraged to request a TechWatch meeting. This
program continues to serve as a central location for industry to engage
interagency government partners with potential funding opportunities.
senator burr
Question 1. The recently released ASPR strategic plan is silent on
status or plan for National Disaster Medical System (NDMS). Can you
please provide your priorities, plans and intentions for NDMS?
Answer 1. ASPR has not released a new strategic plan. Rest assured,
ASPR continues to view the National Disaster Medical System (NDMS) as a
critical tool to aid and support response to public health emergencies
with communities are overwhelmed by disaster. As included in the fiscal
year 2023 President's Budget request, an additional $50 million was
requested for NDMS to support the recruitment, hiring, and training of
NDMS intermittent staff. If appropriated, funding would ensure that
NDMS is best positioned and resourced to aid communities in need. The
fiscal year 2023 request also includes an additional $13 million to
maintain NDMS caches and equipment that support the deployment of
personnel during response operations. It is critical that additional
funding be provided to support continued operation of NDMS. The system
remains a priority for me as the ASPR and is recognized as a national
tool that has been successful in bridging the gap when communities are
overwhelmed during a public health emergency or disaster.
Question 2. ASPR has created new models to predict potential
scenarios for the trajectory of COVID in our Country over the next few
months. While these models have been around for a few weeks and
supposedly have some important predictions for the next few months, the
American people have yet to get a read-out.
Question 2(a). What are these models predicting for the next 30,
60, and 90 days?
Answer 2. Response: ASPR's models support internal, operational
planning and are not intended or appropriate for public release. ASPR
defers to CDC's Center for Forecasting and Outbreak Analytics (CFA) on
the release of available public models.
Question 2(b). Should I expect to see different numbers and
predictions out of CDC's new forecasting center?
Answer 2(b). The CDC and ASPR models have different purposes. The
CDC forecasting ensemble CFA is focused on short-term projections over
the next 4 weeks. This is built on a `wisdom of the crowds' approach
that incorporates multiple academic and external models and are
validated during seasonal influenza before the pandemic.
ASPR Modeling is focused on actionable decision and planning
support that require longer-term timelines, providing scenarios that
capture key uncertainties and show how those might play out over the
next few months. The purpose of ASPR modeling is for planning of ASPR-
specific operational activities like procurement of Therapeutics, PPE,
tests etc. and is not targeted for general consumption or forecasting.
Despite these intentionally different purposes, the CDC forecasting
has projections for hospitalization and deaths 4 weeks out and the ASPR
models include scenarios consistent with these estimates.
Question 3. As new COVID variants emerge, they have learned to
evade some of our available treatments. We need to stay ahead of the
curve by maintaining a strong pipeline of new antivirals and
treatments. What is ASPR's plan to invest in the next generation of
COVID countermeasures for the long term, and your plan to balance this
important work with the other very real threats on your radar?
Answer 3. BARDA continues to closely monitor for the emergence of
new COVID-19 variants, evaluate potential impacts to the portfolio of
available products to determine which of the currently available
treatments would be most effective. The COVID-19 therapeutics team
continues to monitor the development of novel medical countermeasures
(MCMs) and next generation therapeutics for the treatment of COVID-19.
BARDA's TechWatch program affords companies an opportunity to present
their capabilities to BARDA and other interagency partners. Industry
partners are encouraged to request a TechWatch meeting to discuss their
products and explore the potential for future partnering opportunities.
There are no existing funds at this time to support the research
and advanced development of any new antivirals or treatments for COVID-
19. This spring, the Administration requested $22.5 billion to support
immediate needs to avoid disruption of ongoing response to COVID-19.
Funding would support additional investments in developing, procuring,
deploying and administering vaccines and therapeutics, including oral
antivirals, to aid this response and expand the COVID-19 therapeutics
portfolio and ensure we have effective MCMs available for use in the
future.
Question 4. Our current availability of vaccines and antivirals
that work against monkeypox is due to the successes of Project
BioShield and the efforts of the U.S. Government to prepare for
smallpox, but that means we have less smallpox vaccine to deploy from
the stockpile should we need it for its intended purpose--smallpox. I
hope that we will never have to use it for this purpose, but it is
still a threat, and on the material threat list. What modeling has ASPR
conducted on the depletion of our smallpox vaccine supply as a result
of the monkeypox outbreak? How quickly can we backfill our doses?
Answer 4. To ensure we are prepared for a potential smallpox
incident, the SNS currently holds a significant number of doses of
ACAM2000 and a much smaller stockpile of JYNNEOS vaccine. In the event
of a smallpox incident, JYNNEOS would be made available to special
populations who should not take ACAM2000 (immunocompromised, pregnant,
heart condition, etc.). Ultimately, all JYNNEOS and ACAM2000 that will
be deployed from the stockpile as part of the monkeypox response will
need to be replenished to ensure there is some product available in the
SNS to protect against a potential subsequent public health emergency
caused by smallpox or monkeypox. The cost to replace those doses is
more than replacing costs to fill/finish for the monkeypox outbreak--it
is replacing the previously purchased bulk vaccine that is being
utilized. As of the date of this hearing, ASPR estimated the cost to
replace vaccine used for the monkeypox outbreak will be $382M.
senator murkowski
Question 1. I have had several conversations with Alaskan public
health officials, on lessons learnt from the Federal response to the
COVID-19 pandemic. I am disappointed that CMS and IHS are not
testifying today, as we know they were pivotal in the response to
COVID-19. This pandemic was not only a public health crisis, but a
crisis affecting our health systems and the delivery of healthcare. I
believe that we must apply lessons learnt, to address new public health
epidemics, such as the drug overdose crisis that many of our
communities are experiencing. The Federal Government has to improve
transparency and integrate Federal services, to allow states to respond
to future public health crisis that arise. An example of this is the
drug overdose epidemic that many of our states are now experiencing.
The Federal Government has a responsibility to promote data-sharing
throughout all health systems. For example, we did not see a
significant improvement in the surveillance of COVID-19 until CMS
required hospitals to share data on bed capacity with ASPR. Sharing
data between hospital systems and state lines, is essential in
addressing future public health issues and most notably, the drug
overdose epidemic.
Question 1(a). How can HHS continue to work internally and with
other Federal agencies, such as the VA and DOD to integrate Federal
services and promote data-sharing throughout healthcare systems?
Answer 1. ASPR has supported internal development data governance
strategies, building out modernized IT systems for data sharing (HHS
Protect, Tiberius and ASPR Ready), and has coordinated closely with CDC
and the Office of the National Coordinator for Health Information
Technology (ONC). ASPR, CDC, CMS, and ONC are also closely coordinating
on all hazards healthcare information sharing together with government
and healthcare partners.
Question 1(b). What can the CDC and ASPR do to continue to
streamline healthcare workforce efficiency and improve data
modernization?
Answer 1(b). ASPR, CDC, CMS, and ONC are working together on all
hazards healthcare situational awareness, leveraging ongoing
initiatives and work to improve pathways for data collection. Access to
private sector data, capabilities, guidance and participation are
critical to successful government engagement on supply chain
challenges, to include deployment of stockpiled resources, strategic
investment in production capacity, or coordinated allocation of scarce
resources during shortages or supply chain disruptions.
Question 2. We talk a lot about the importance of health equity and
focusing on populations that have documented inequities. I have been a
vocal advocate for addressing health equity issues, particularly the
issues affecting Alaska Native and American Indian populations to die
at higher rates than other Americans in many categories, including
chronic liver disease and cirrhosis, diabetes mellitus, unintentional
injuries, assault/homicide, intentional self-harm/suicide, and chronic
lower respiratory diseases.
However, I want to discuss a different type of equity today, which
is an important part of the health equity discussion. When we are
evaluating our Federal response to COVID-19, we fail to discuss state
equity. States with larger populations, tend to have more purchasing
power for therapeutics, testing, and other medical supplies, leaving
many rural states (the majority Western states) behind. We saw this
during the COVID-19 pandemic, when Alaska was unable to compete with
New York City, California, or private investors in purchasing PPE,
therapeutics, and testing supplies.
Question 2(a). As we move to toward a new phase of COVID-19, how
are we going to ensure there is state equity when accessing these
supplies on the private market?
Answer 2(a). Equitable access to life-saving products is one of the
most challenging and critical aspects we are working through as we
transition COVID-19 vaccines and therapeutics to the commercial market.
We must ensure that vaccines and therapeutics continue to be available
to anyone who needs them. I commit to keeping you updated as we
finalize plans for commercialization. We also continue to invest in
industrial base expansion efforts to bolster domestic manufacturing of
PPE and tests. Increased domestic manufacturing will increase the
supplies in the commercial market and support states' access to these
needed tools.
Question 2(b). What is HHS going to do to address these issues of
unequal purchasing power to ensure equal access?
Answer 2(b) HHS would be happy to provide your staff a briefing to
discuss the ongoing efforts for COVID-19 product commercialization. In
short, we hope that a transition to a commercial market will rely less
on state purchases and more on the existing health care infrastructure.
However, we recognize that this presents challenges, especially for the
un-and-under insured. As noted in the prior response, we are also
supporting efforts to invest in industrial base expansion to ensure
needed products are available commercially, as and when needed.
Question 2(c). What is HHS doing to continue to conduct
surveillance of COVID-19, to ensure states can plan appropriately for
different waves to come?
Answer 2(c). I defer to my CDC colleagues who are responsible for
this function.
Question 3. The impacts of COVID-19 have exacerbated mental health
issues across the country and within the military. We've seen this
first hand in Alaska where 17 soldiers died in 2021 by suicide. Service
members and their families face difficult and unique circumstances
living in an austere and remote location, and COVID protocols increased
their isolation without providing enough access to resources such as
mental health providers. Just last week, Senator Sullivan and I
introduced the Don Young Arctic Warrior Act, which focuses increasing
the help and assistance they need and deserve.
Question 3(a). Is HHS working on any long-term solutions to address
the rise in military suicides, as exacerbated by the isolation brought
on by COVID?
Answer 3. This is a critical issue and is best addressed by
colleagues at the Departments of Defense and Veterans Affairs.
Question 3(b). Are there any lessons the military could learn from
the CDC or NIH on what strategies work in reducing suicides in highly
isolated populations?
Answer 3(b). I defer to my CDC colleagues on such strategies and
whether they are applicable.
senator tuberville
Monoclonal Antibody Treatments
Question 1. Much has been made lately about the administration's
desire for more money to combat the ongoing pandemic. I have been a big
supporter of common sense pandemic response efforts since the outset.
However, every time I have asked HHS questions about its COVID spending
decisions, I have been met with silence. For example, Ms. O'Connell, at
a hearing on November 4 of last year, I asked you why HHS wasted
$142million on a contract with accounting firm KPMG to promote a
monoclonal that HHS had stopped buying months before. You responded
that you were, ``expecting a memo any day with the team's
recommendations'' on whether the program should be kept going.
Two weeks later and you had not shared that decision with me. As a
result, I and six of my colleagues on this Committee sent Secretary
Becerra a letter asking about the purpose of the KPMG contract and who
conjured it up. No explanations were provided. Weeks of failed efforts
to receive any information from your staff led us to write another
letter on March 8. To date, more than 3 months later, your office has
provided no information. I am asking you to explain $142 million spent
at an accounting firm to administer medicine to sick Americans but you
can't justify your decisions. And now, you want more money.
Question 1(a). If you can't answer questions about past money
spent, how do you expect our support to provide you with more?
Question 1(b). Will you commit right now that you will personally
work with your staff to respond to our multiple letters about the KPMG
contract so this Committee can implement guardrails on additional
funding so it isn't similarly wasted on sham contracts?
Question 1(c). As part of that commitment, will you--at a minimum--
provide the Committee with a copy of the decision memo you alluded to
in your November 4 testimony, where you stated you were the
decisionmaker for funding this program?
Answer 1. HHS is committed to ensuring fair and equitable
distribution of COVID-19 therapeutics across the country. We partnered
with KPMG earlier this year to help improve use and increase access of
monoclonal antibody therapeutics in vulnerable communities. As part of
its agreement with DoD, KPMG facilitated onsite support in communities
across the country to help expand and/or establish capacity to
administer monoclonal antibody treatments.
The current COVID-19 therapeutics landscape is different with
different requirements than at the start of the pandemic. As such, the
specific support KPMG provided is no longer required. Overall use of
these therapies has improved across the country, and treatment and
provider options have expanded.
This contract has been terminated.
I commit to working with you and your staff to address and respond
to any pending correspondence.
Question 2. I understand that roughly 20-30 percent of high risk
COVID-19 patients cannot take oral antiviral treatments due to drug-to-
drug interactions and the 40 percent shorter treatment window.
Question 2(a). If this is the case, why is ASPR buying 10 million
more doses of the oral antivirals and only a small quantity of the
treatment monoclonal antibodies?
Answer 2. One of the benefits of the oral antivirals Paxlovid and
Legevrio is that they have not been impacted by SARS-CoV-2 variants. In
fact, both Paxlovid and Legevrio have retained activity against all
circulating SARS-CoV-2 variants to date. The mechanism of action of the
monoclonal antibodies, which depends on binding to the virus, is a
distinct disadvantage as new viral variants arise. Looking to the
future , focusing on broad acting antivirals with activity against many
viruses as well as focusing on host-targeted therapeutics that are
virus-agnostic will be high priorities.
Question 2(b). Without additional COVID-19 appropriations,
shouldn't ASPR increase the purchase of treatment mAbs and decrease the
purchase of the orals, so that hundreds of thousands of high-risk
patients who cannot take the orals are not left without a treatment
option in the fall?
Answer 2(b). COVID-19 therapeutics can be used to prevent or treat
eligible non-hospitalized patients who have tested positive for COVID-
19 and have mild to moderate symptoms and are at high risk for disease
progression. Prevention and early treatment for eligible patients can
help improve patient outcomes, reduce stress on healthcare facilities,
and even save lives. When it comes to COVID-19 therapeutics, we have
approached it like filling a medicine cabinet--we are not relying on
one type, or one brand, or one treatment. We ensured that we would
invest in and buy a broad variety of monoclonal antibody and oral
antiviral treatments. To date, over the course of the COVID-19
response, the U.S. Government (USG) has purchased the following
therapeutic products: Bebtelovimab, Evusheld, Lagevrio (molnupiravir),
Paxlovid, sotrovimab, REGEN-COV, bamlanivimab/etesevimab; and
bamlanivimab. Due to the high frequency of the Omicron variant, REGEN-
COV (casirivimab and imdevimab), bamlanivimab and etesevimab, and
sotrovimab are not currently authorized for use in any U.S. region. In
addition, the U.S. Food and Drug Administration revoked the emergency
use authorization (EUA) that allowed for the investigational monoclonal
antibody therapy bamlanivimab, when administered alone, to be used for
the treatment of mild-to-moderate COVID-19.
Currently the USG allocates Bebtelovimab, Lagevrio, Paxlovid, and
renal-Paxlovid on a weekly basis to states, territories, Federal
entities, and pharmacy partners. Evusheld is allocated monthly. Current
estimates (based on case counts and utilization rates) estimate that
the federally purchased supply of Bebtelovimab will be exhausted later
this summer; that the federally purchased supply of Evusheld will be
exhausted by the end of the year or in the first quarter of 2023; that
the federally purchased supply of Paxlovid will be exhausted in the
first or second quarter of 2023; and that the federally purchased
supply of Lagevrio will be exhausted in calendar year 2023. Our focus
remains working with state and territorial health departments as well
as national healthcare and medical organizations and associations to
get COVID-19 therapeutic products into the hands of healthcare
providers quickly, with a focus on areas of the country hardest hit by
the pandemic. However, unless Congress provides additional
appropriations, we will not have funding to purchase additional COVID-
19 therapeutics.
______
[Whereupon, at 12:14 p.m., the hearing was adjourned.]
[all]