[Senate Hearing 117-406]
[From the U.S. Government Publishing Office]
S. Hrg. 117-406
STOPPING THE SPREAD OF MONKEYPOX:
EXAMINING THE FEDERAL RESPONSE
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING STOPPING THE SPREAD OF MONKEYPOX, FOCUSING ON THE FEDERAL
RESPONSE
__________
SEPTEMBER 14, 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
48-917 PDF WASHINGTON : 2024
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
WEDNESDAY, SEPTEMBER 14, 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........................... 4
Witnesses
Walensky, Rochelle, M.D., M.P.H., Director, United States Centers
for Disease Control and Prevention, Atlanta, GA................ 9
Prepared statement........................................... 11
Fauci, Anthony, M.D., Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, Bethesda,
MD............................................................. 15
Prepared statement........................................... 17
Califf, Robert, M.D., Commissioner, United States Food and Drug
Administration, Silver Spring, MD.............................. 19
Prepared statement........................................... 21
O'Connell, Dawn, Assistant Secretary for Preparedness and
Response, Administration for Strategic Preparedness and
Response, Washington, DC....................................... 26
Prepared statement........................................... 27
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
Smith, Hon. Tina:
Prepared statement from AIDS United, submitted for the Record 60
Baldwin, Hon. Tammy:
``Fact Check of Fauci's 2004 Comments Do not Contradict His
Pandemic Stance'', submitted for the Record................ 63
STOPPING THE SPREAD OF MONKEYPOX:
EXAMINING THE FEDERAL RESPONSE
----------
Wednesday, September 14, 2022
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:03 a.m., in
room 216, Hart Senate Office Building, Hon. Patty Murray, Chair
of the Committee, presiding.
Present: Senators Murray [presiding], Casey, Baldwin,
Murphy, Kaine, Hassan, Smith, Rosen, Hickenlooper, Burr, Paul,
Collins, Cassidy, Braun, Marshall, Romney, and Tuberville.
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 Federal response to the
monkeypox outbreaks, as we work to stop the spread of this
virus.
I will have an opening statement followed by Senator Burr,
and then we will introduce our witnesses. Before we start, I
do--I want to take a moment to congratulate one of our
witnesses, Dr. Fauci, on announcing his upcoming retirement.
Dr. Fauci, you have served through multiple decades and
Presidents and public health threats, and worked to save
countless lives, and I hope you know that you have the thanks
of a grateful nation for your incredible service to this
country. So, thank you and thank you for being here today.
After the witnesses give their testimony, Senators will
each have 5 minutes for a round of questions. And while we are
unable, again, to have this 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 is in need of
accommodations including closed captioning, please reach out to
the Committee or the Office of Congressional Accessibility
Services.
According to the Centers for Disease Control and
Prevention, the U.S. now has over 21,000 confirmed cases of
monkeypox, more than anyone else in the world, and my home
State of Washington has over 500 cases. I have heard from
families who are rightly concerned about how bad this has
gotten.
Public health officials, including back in Washington
State, who are frustrated to see the response, run into issues
we should be prepared for by now. That is why I have continued
to push the Biden administration about my concerns with the
monkeypox response and urge quick action on testing, on
treatments, on vaccines, and on clear guidance to the public,
to their health care providers, and state public health
officials.
It is reassuring to see that we are making progress on
testing, capacity has increased 1,000 percent, and FDA just
approved a faster track for additional tests. On vaccines,
BARDA is helping to stand up a new vaccine fill and finish site
in Michigan. HHS is working to expand the number of
distribution sites and states, and the Administration's advice
for splitting doses has greatly stretched our vaccine supply.
On outreach, the Administration has started working with
states to make vaccines available at events with many people
from the LGBTQ community in attendance. And perhaps most
importantly, the rate of new cases is going down. Now, that is
all encouraging news, but let me be clear, we must remain
vigilant in our response.
These promising improvements do not excuse the issues I
have been hearing about from communities, from state health
officials, and advocates from the very start of this outbreak.
Patients have spoken out about how hard it is to get tested.
Some even waited days despite having clear symptoms. Providers
have had to jump through hoops to get their patients
treatments.
I am constantly talking to public health officials in my
state who have told me how communications with states could
have been far clearer and faster, and how the challenges in
accessing tests and vaccines have delayed the response. I know
states have especially struggled with the Federal Government's
decision to forgo the system we typically use to distribute
vaccines, the one we are already using for COVID vaccines.
When it comes to vaccine distribution, some shipments have
been sent to the wrong state and even spoiled after storage at
the wrong temperature. There have been issues with vaccine
supply as well, like when thousands of vaccine doses were
delayed because FDA had yet to inspect the new plants they were
coming from, or when the Biden administration missed an
opportunity to procure more vaccines at a crucial point in this
outbreak.
Again, we are seeing inequities worse in this outbreak for
some communities. Advocates in the LBGTQ community, who face
the vast majority of cases, have also made clear they feel they
are being overlooked or in some instances, stigmatized.
We need to keep focusing and improving on outreach, and on
getting information and resources like vaccines to those who
are most in need and most at risk. And that must include
communities of color who we know do not have equitable access
to vaccines. This is especially important, as early data
suggests that Black and Latino communities are
disproportionately burdened by this outbreak.
We have to do better. We need to be applying what we
learned from the COVID response and providing the resources
communities have made clear they need. Of course, there is an
enormous difference between this and the COVID pandemic, which
is thanks to decades of investment in smallpox research, we
already had tests and treatments and vaccines ready to go
before this crisis began.
That should serve as a reminder to all of us about the
immense value of investing in public health preparedness. But
it is also why the stumbles in getting these tools deployed
were especially frustrating and inexcusable. To learn from
this, we need to be clear eyed about what went wrong, not just
on the challenges we faced in the last several months, but that
we have faced for decades.
Challenges that, to be frank, has spanned many
Administrations, not just this one. For example, we had over 20
million vials of smallpox vaccine in our national stockpile,
but they were not replaced as they expired over the course of a
decade. I know I join my Ranking Member and Members of this
Committee when I say we have got to do better, not just on
COVID, not just on monkeypox, but on public health threats,
period, because we know there will be more.
Just last week, New York declared an emergency due to
polio, yet another public health risk we need to watch closely.
I want to hear from our witnesses today about not just what
they are doing right now to improve our response to the
monkeypox outbreak and fast, but also how we can fix this in
the long term and make sure the stumbles of the past couple of
months never happen again.
I want to know what you and the Administration are doing to
make sure we have enough tests and treatments and vaccines for
this outbreak and get them where they need to go, while also
maintaining an adequate stock of supplies for any smallpox
threats.
What you are doing to improve outreach to the LGBTQ
community, address disproportionate harm to Black and Latino
communities, fight stigma and misinformation, and right the
inequities we have seen in our response so far?
How are we making the most of new research to develop
promising vaccines and therapeutics, and then make them more
quickly available, while continuing to uphold the gold standard
of safety and effectiveness? And are we getting schools and
colleges everything they need to stay open and keep students
and schools, communities safe?
I am glad CDC has provided guidance for K-12 schools. And
fortunately, the science tells us elementary and secondary
school kids are not at high risk. And CDC has also released
resources for colleges, which is critical with students
returning to campus this fall. We need to make sure that
colleges and universities are equipped to prevent potential
outbreaks as students move into dorms and live in close
quarters with each other.
I realize you have got your work cut out for you in all of
this, especially with COVID still raging, but there is no
reason for us to fall behind. I am going to keep pushing you
here because families back in Washington State and across the
country are counting on all of you to get it right. That is
also why I am going to keep pushing my colleagues here in
Congress about the need for funding to support all of this
work.
I know I am not the only one here with concerns about the
monkeypox response, but we can't just say this isn't working
without providing the funding to end this outbreak and build
the public health system Americans deserve. I will continue to
work with colleagues on both sides of the aisle and push to
deliver the resources that will help get families the testing,
treatments, and vaccines they need.
I am interested in hearing from the witnesses on what the
needs are when it comes to investing in our monkeypox response.
It is also important to me we continue to keep our eyes on the
horizon when it comes to future outbreaks and pandemics and
build a stronger public health system for whatever threat comes
next.
As the saying goes, an ounce of prevention is worth a pound
of cure, and that starts with building a world class public
health system rather than one that lags behind our peers. Our
communities deserve to be as safe as anyone in the world, which
is why Senator Burr, and I are continuing to work to pass our
Prevent Pandemics Act.
Our bipartisan legislation implements the lessons from our
COVID response and improves our policies and processes on
issues like strengthening supply chains, improving management
of our national stockpile, modernizing data systems, and other
items which would address many of the challenges we faced with
monkeypox.
But a strong public health system also requires strong
investments, because our public health system was underfunded
before COVID struck, and it has been overwhelmed ever since. We
have to end the cycle of crisis and complacency by making
sustained investments that allow us to build and maintain
robust public health infrastructure at all levels.
I will keep pushing for all of these steps because we
should all know by now just how much is at stake. I can tell
you that families in Seattle know, parents in Spokane know,
nurses in Yakima know, workers in Olympia know, people across
Washington State and across the country know.
COVID was never going to be the last public health crisis
we face, and neither is monkeypox. The question is not whether
there will be a new threat, it is when it will strike and
whether we will be ready. The truth is, the monkeypox response
so far has not been encouraging.
But there are some clear signs of progress, and there are
clear steps that we can and should take to improve. I don't
want to just hear today about the steps we will be taking, I do
want to see action, and I will be watching closely.
I hope we can work together to build on the progress and
end this crisis and make the kind of improvements we need to
put our public health security on solid footing once and for
all. Thank you very much, and I will turn it over to Senator
Burr for his opening remarks.
OPENING STATEMENT OF SENATOR BURR
Senator Burr. Thank you, Madam Chair.
Good morning. I am glad that we are finally here having a
hearing on monkeypox outbreak, and it is--as it hits our
Nation.
Well, monkeypox is now a public health emergency. It didn't
have to become one. I think the one promising thing that can be
said this morning is the infection rate has slowed. That may be
the only thing.
Since May, when the first transmission was reported in the
UK, in Europe, I have been pressing the Administration for
strategy and a plan. After almost 3 years of the COVID
pandemic, you would think that the public health agencies
responsible for our preparedness and response would be prepared
for anything, particularly a threat like monkeypox, which we
have known about for decades, and for which we have vaccines
and treatments.
Dr. Fauci has talked to this Committee before about
monkeypox. It is almost definition--It is almost a definitional
case of what CDC and ASPR, and their sister agencies, should be
prepared to tackle, a virus that spreads through physical
contact, a virus that spreads when one--when an infected person
has an obvious sign of infection.
This is not like COVID, which was a newly emerged virus
that spreads asymptomatic infection. But by any measure, in
fact by every measure, the response from the Biden
administration on monkeypox crisis has been a catastrophic
failure.
You repeated each of the mistakes from the early days of
COVID response, and the cultural arrogance from public health
officials, who were supposed to be at the forefront of our
response, let this country down again. Since the COVID pandemic
started, this Committee has held 13 hearings on the response
during both the Trump and the Biden administrations. I think
you were sick of being called to the carpet and us having to
hold you accountable for systematic failures.
But it seems that nothing has changed. You can't blame the
last Administration on this failure. The first confirmed
monkeypox case in 2022 was May 7th in the United Kingdom. The
first case of monkeypox in this outbreak was reported in the
U.S. on May 18th. We had warning. We had warning that this was
coming. We should have been prepared to manage what came when
it arrived.
Let's review. We failed testing. Although you eventually
made testing available through laboratory response networks,
these tests were too hard to access. It took weeks before
doctors were able to get their patients tested without having
to first consult public health officials.
There was also a significant delay in engaging the private
sector on testing at the beginning of the outbreak. We waited
until June 22d to announce that engagement with the private
sector. Still, after that, companies interested in developing
additional diagnostic tests, that could help address some of
the slow turnaround times and improve access, had been left
waiting months for samples needed to develop those test.
Without delay--upon delay, you failed on vaccines. An
enhanced strategy to offer vaccines to at risk individuals
known--in known contact was announced June 28. But this was
already after some local jurisdictions had already taken upon
themselves to use the vaccine in this manner, and a full month
after the UK Joint Committee on Vaccines and Immunizations met
to discuss a similar strategy for their citizens.
Why do we continue to be behind? Meanwhile, decisions about
vaccine administration in the U.S. have made--seem to have been
made seemingly on the fly. Even when FDA issued an emergency
use authorization last month, allowing vaccines to be
administered intradermal injections, there were no public
meetings of FDA, CDC, outside experts to discuss relevant
questions on the minds of impacted Americans and inform these
decisions.
Health professionals were confused about the initial
decision and patients were scared that they were being
experimented on. To make matters worse, states had no time to
prepare for this change in vaccine administration. Right after
the FDA made its decision, ASPR reduced state vaccine
allocations under the assumption that every vial would yield
five doses.
Yet you know that this has not been the case in every
state, resulting in some vaccine--some vaccinating fewer, not
more at risk people. You failed at having a plan. Monkeypox
outbreaks have been occurring in Nigeria and other places with
increasing frequency. It was identified a threat under our
threat matrix, and a threat for which we had countermeasures in
our stockpile.
I might also add that our earliest purchase of the Bavarian
Nordic vaccine in bulk was in 2017. But it seems there was no
real plan on how to respond and what information and research
we needed to understand this outbreak. Only after both I and
the Chair sent separate letters asking for a plan, that the
Office of Science Technology Policy blogged about their
research priorities.
But the priorities were vague. It is not clear what
research activities HHS has actually undertaking in response.
These failures have allowed the disease spread. 31 cases in May
quickly turn into 650 cases in June, more than 6,000 cases in
July and more than 12,000 cases in August, and near 22,000 so
far in September.
It should have been obvious to all of us that the timing of
these early cases, coupled with evidence that the cases were
not linked, would create a perfect storm for a large outbreak.
Monkeypox is a virus that largely transmits through skin to
skin contact, most easily and frequently transmitted between
sexual partners.
Monkeypox arrived just before the Pride celebrations across
the country, and after 2 years of lockdown and social
distancing, your agency should have been screaming from the
rooftops about what you knew or suspected about how monkeypox
was spread. Instead, we remain silent. People got sick because
of that silence.
This isn't rocket science. But consenting adults need to be
told what behavioral changes they should consider to avoid
getting a preventable disease like monkeypox. You failed at a
time when the communities most at risk needed you. Disease
control and prevention and preparedness and response is
literally in the name of two of your agencies.
Yet you did none of that. It was no surprise to me that the
Administration, after months of floundering, appointed a new
czar at the White House to coordinate the response. It shows
why this Committee passed the PREVENT Act to create a mission
control. Secretary of HHS has been totally absent, and when he
has been involved, it only seems it makes matters worse.
But new ad-hoc groups within Government are exactly the
problem. We need a consistent, coherent, Government wide
response to be effective, and that can only be led by the White
House. I hope that in the coming weeks we will be able to get
that legislation over the finish line, and I will commit to
spending my remaining weeks in the U.S. Senate doing everything
I can to help the White House set up the new office with a
lasting mission and clear agenda.
If I were not retiring, I would spend the next several
years conducting a thorough examination of each of your
agencies, highlighting each and every one of the systematic and
bureaucratic failures that we have seen now and seen in
response after response and demand accountability for the
American people. This isn't a question of authority. You have
the authority. It is a question of--it isn't a question of
money.
You have been given astonishing amounts of money. It is a
question of leadership. It is a question of focus. It is a
question of squashing the typical bureaucratic roadblocks,
arrogance and ineptitude. You need to do better.
We learned in Operation Warp Speed that when you press
outside the box, when you focus on public-private partnerships,
when you get bureaucracy tamed so that it serves the American
people and doesn't try to control them, we can actually make
Government work.
I would ask you for your plan, but you don't have one. I
would ask you for what you changed, but your agency seem to
think that they are doing everything right. I would ask you who
you are going to hold accountable, but failures at each of your
agencies show that you don't believe in that type of
accountability.
Instead, I will express my outrage and hope that eventually
we will get people in your agencies who will do the job to
protect the American people instead of protecting their
bureaucracies. Madam Chair, before I close, I want to address a
serious issue. The last time we were here, there was a
coordinated assault pretending that somehow Republicans were at
fault for there not being additional money for the pandemic.
Let's revisit some of the facts, if we can. The Senate on a
bipartisan basis actually passed extra funding for COVID, $15.6
billion, in March in the omnibus for testing, treatment,
vaccines, and global aid. But the Speaker of the House either
couldn't pass that legislation or didn't think pandemic money
was a priority so she stripped it out.
I have worked with her for a long time, and I am pretty
sure she is a Democrat. Then Democrats--then Senator Romney and
Blunt and myself engaged in deep negotiations with the Majority
Leader and the Chair of the Committee, and we reached a deal
for $10 million in domestic funding for COVID.
But the Majority Leader didn't want to take a vote against
lifting a COVID restriction on the Southern border, probably
because he knew it would pass so the deal was killed. I am
pretty sure Chuck is a Democrat. So then at our last meeting,
the Chair and each of you got together and pretended that
somehow Republicans were at fault.
The Republicans tried twice to provide additional funding
for COVID, but Democrats couldn't take yes for an answer. Then
last month, Democrats conducted a partisan spending exercise
where Republicans weren't even in the room. They dramatically
raised taxes by hundreds of billions of dollars, provided
funding for 87,000 IRS agents to audit the middle class, and
spent hundreds of billions of dollars on green new deals that
will mostly impact billionaires and millionaires.
Those same Democrats who complain about no COVID spending
didn't spend a dime of those new taxes on pandemic expenses. I
often hear my colleagues say that your budget shows your
priorities. But Democrats have the power to spend money on
pandemic and chose not to. I guess making energy more expensive
was more important.
I think all of you know, I have had in my jacket pocket a
card with four simple requests from this Administration and
told them all they needed to do for me to get my Senate
colleagues, my Republican colleagues to support additional
funding was to provide answers to those four things.
Give us a detailed plan for COVID. Detailed accounting of
where the money has been spent. Offsets to match new spending
for pandemics. And a simple vote on a COVID restriction at the
border. I first started that in April. Today, none of those
four things have been presented. So to date, the Administration
has failed to deliver.
Maybe they don't want to actually have transparency on what
they have spent. Or maybe they don't want to come clean to the
American people what their plan is until after the election.
Not sure what it is. I am tired of being the one that is
blamed. I have got just as much as invested as anybody on this
Committee in making sure that your agencies are successful for
the American people. I will continue to do that, whether I am
in Congress or not.
Tony, I can't thank you enough for your years of service.
It has been incredibly beneficial to the American people and to
the health care of this country. I hate to see you go, but I
also look forward to that day in January where we both are on
the other side of this mountain, and I can actually not have to
plan to fly on a Monday and I can spend some time with my wife
and grandchildren.
Having said that, Madam Chair, let's have a reset this
morning. Let's quit blaming everybody and let's start showing
some leadership. If the Administration needs money, then send
us a budget requests money. There is no increased spending for
COVID in next year's request.
They believe that this is all going to happen by an
emergency, that the American people shouldn't be held
accountable. That's wrong. Get the Administration to request
the money. Let's work through the normal appropriations
process. My hope is that there is a plan and someday they will
share it with us. 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, the Director of the National
Institute of Allergy and Infectious Diseases and the Chief
Medical Adviser on President Biden's COVID-19 response team.
Dr. Robert Califf is the Commissioner of the Food and Drug
Administration. Don O'Connell is the Assistant Secretary for
Preparedness and Response. Dr. Walensky, Dr. Fauci,
Commissioner Califf, and Assistant Secretary O'Connell, thank
you all for being here today. We all look forward to your
testimony.
With that, 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, and
Members of the Committee, I appreciate the opportunity to
discuss monkeypox and CDC's response to this global outbreak.
To date, there have been over 59,000 cases of monkeypox
reported globally, including over 22,000 cases and one
confirmed death in the United States.
In the current outbreak, the first cases were diagnosed in
the United Kingdom on May 14th, and within days, additional
countries began identifying case clusters. On May 17th, a case
was reported in Massachusetts and was confirmed by CDC the
following day.
CDC immediately began its work searching for additional
cases, educating clinicians and the public about this disease,
and supporting our state and local public health partners in
their response. In less than 1 week, CDC reached out to
commercial labs to increase testing capacity and began to scale
up an incident response.
Over the last several weeks, we have been pleased to see a
decline in the growth of new cases here and abroad, though
there are areas in the United States where the rate of rise in
new cases is still increasing. We approach this news with
cautious optimism, recognizing that we must continue to
aggressively respond to our--use with our entire toolkit,
including vaccination, testing, and education about risk to
inform behavior change.
This outbreak has been notable for transmission primarily,
but not exclusively, through sexual contact. It has
disproportionately affected gay, bisexual, and other men who
have sex with men, with a large majority of cases in this
population. CDC has been studying monkeypox for decades and has
contributed to the creation of the test, experimental
therapeutics, and vaccines that are available today.
But as a relatively rare disease, almost no providers in
the U.S. have seen or even heard of monkeypox. Provider
education has been a key component, indeed a remarkable
challenge, but critical to our response.
CDC has issued four health advisories, each reaching over a
million people, and host clinician outreach calls joined by
tens of thousands of clinicians. We have also shared monkeypox
information for congregate living and K-12 schools to prevent
monkeypox spread in these settings.
Initially, our public health laboratory response network
labs across the country were able to collectively test up to
6,000 clinical specimens each week using a diagnostic test
developed to detect orthopox viruses, including monkeypox.
CDC worked with our public health partners to quickly
expand testing capacity and engage commercial laboratories to
increase capacity to 80,000 tests per week. While weekly
testing volume is currently 14 percent of total testing
capacity, we are working with academic medical centers,
commercial and public health laboratories to make testing even
more accessible to all who need it.
From the beginning of this response, CDC has worked closely
with ASPR to make JYNNEOS vaccine available to jurisdictions
based on their case numbers and underlying population at
increased risk. Based on data from 39 jurisdictions reporting
to CDC, a total of over 540,000 JYNNEOS vaccine doses have been
administered.
Collaboration with communities most affected by the
outbreak, including the LGBTQ+ community, is critical to our
response. We rely on our partners across public health and
LGBTQ+ advocates and community based organizations to
contribute to their expertise to our response, to challenge us
to continue to do better, and to amplify our public health
messages.
In recent weeks, CDC has provided technical assistance and
support for vaccination efforts and other monkeypox response
activities at large events serving LGBTQ+ audiences like
Charlotte Pride and Atlanta Black Gay Pride weekend. These
efforts and others have facilitated delivery of vaccines to
those who may face unique barriers to access, including racial,
ethnic, and geographically diverse populations.
The robust response required for public health threats like
monkeypox underscores the importance of sustained investments
in the core capabilities that should constitute the foundation
of a 21st century public health system. In addition, CDC needs
additional policy levers to enable the timely reporting of data
necessary to take the informed action the public expects of us.
Despite having a vaccine distribution strategy since June
28th, it took until early September to complete all 61 data use
agreements needed to receive vaccine administration data. While
we work to control this outbreak in the United States, we
anticipate that monkeypox will continue to be a global threat.
Once this outbreak is controlled, we will need to maintain
vigilance, education, and vaccination efforts so that another
outbreak does not emerge. That is why now it is important for
Congress to act upon the supplemental request.
CDC will use the additional resources to support testing
and laboratory capacity expansion, vaccination efforts,
surveillance, epidemiologic investigations, outreach,
education, and global efforts.
Together, we can meet the fast evolving threat of
monkeypox, successfully end the current outbreak, and prepare
for any future outbreaks. Thank you. I look forward to your
questions.
[The prepared statement of Dr. Walensky follows:]
prepared statement of rochelle walensky
Chair Murray, Ranking Member Burr, and distinguished Members of
this Committee, it is my honor to appear before you today to discuss
the Centers for Disease Control and Prevention's (CDC) response to the
global outbreak of monkeypox. The world is experiencing an
unprecedented outbreak of monkeypox, with tens of thousands of cases
reported worldwide, predominantly in countries where this disease is
not endemic. We are still learning more about this outbreak every day
but are relying on the tools we have--diagnostics, vaccines,
therapeutics, and community education and outreach--to continue our
public health response efforts.
State of the Outbreak
On May 17, 2022, the Massachusetts Department of Public Health
contacted CDC about a case of suspected monkeypox in the United States.
CDC's Laboratory Response Network (LRN) testing confirmed orthopoxvirus
infection and, the next day, testing at CDC confirmed the patient was
infected with monkeypox virus. The case was identified as Clade II
(formerly known as the West African strain), which is associated with
less severe disease than Clade I (formerly known as Congo Basin
strain). This case, and many of the first cases identified in the
United States in this outbreak, were among persons with a history of
international travel to Europe or Canada, countries that were also
reporting clusters of cases. From detection of the first case, CDC
immediately began enhancing surveillance and testing to identify
additional cases; supporting jurisdictions in post-exposure
prophylactic vaccination of close contacts; educating clinicians,
public health partners, and the public; conducting outreach to LGBTQ+
organizations, and advocates to share information and amplify
messaging; and preparing for community spread of monkeypox within the
United States. On June 28, 2022, CDC elevated its response to monkeypox
by activating its agency-wide Emergency Operations Center. On July 23,
2022, the World Health Organization declared the current outbreak and
Public Health Emergency of International Concern, and Department of
Health and Human Services (HHS) Secretary Xavier Becerra declared a
U.S. Public Health Emergency on August 4. In the United States, as of
September 12, there have been 21,985 reported monkeypox cases, one
confirmed death, and two additional deaths currently under
investigation. Globally, there have been 57,016 cases reported with 19
deaths.
Monkeypox can be transmitted through close, personal contact. This
is often skin-to-skin-contact, including hugging and intimate activity,
but also through respiratory secretions during prolonged face-to-face
contact and skin contact with fabrics and surfaces used by persons with
monkeypox--although respiratory droplet and indirect transmission do
not appear to be significant drivers of the current outbreak. While
anyone who comes into close contact with an infected person or
contaminated items like bedding or clothing could contract monkeypox,
the current outbreak is disproportionately affecting gay, bisexual, and
other men who have sex with men. The characteristic rash of monkeypox
can initially look like pimples or blisters and can appear on the
hands, feet, chest, face, mouth, or anogenital region, and may
sometimes occur with other flu-like symptoms. Monkeypox is
transmissible from the time symptoms begin until the rash has healed,
all scabs have fallen off, and a fresh layer of skin has formed.
Infection typically lasts for two-to 4-weeks. CDC recommends people
with monkeypox isolate at home, keep rashes covered until they have
fully healed, and notify close contacts, including sexual partners. The
clinical presentation in this outbreak is atypical. The characteristic
rash is still common, but lesions associated with this outbreak have
often occurred in the anogenital region or in the mouth, and rash may
be confined to only a few lesions or even a single lesion. In addition,
prior to and after the rash, other symptoms may be mild or non-
existent.
Similar to COVID-19 and many other public health challenges before
it, the burden of monkeypox is not distributed equitably. In this
outbreak, and based on available data, over 90 percent of U.S. cases
have occurred among gay, bisexual, and other men who have sex with men.
Although case data for race and ethnicity are incomplete, Hispanic/
Latinx and Black men have represented more than 50 percent of cases in
recent weeks among those case reports for which we have data on race
and ethnicity. Where the data is clear, we know that we must act to
address the monkeypox outbreak in communities that are
disproportionately impacted. And where a lack of complete data
constrains our ability to understand the full extent of these
disparities, we are working to better understand these impacts.
The monkeypox response is impacted by one of the fundamental
constraints CDC faces in its response to public health threats--we are
often limited in our ability to quickly and reliably access the data we
need to maximize the impact of our public health response. We need to
bring the Nation's public health data infrastructure into the 21st
century so that CDC and state, Tribal, local and territorial health
agencies may review, analyze, and report data in real time. The public
health workforce is stretched thin, and sustained investment in the
workforce is needed to provide Americans with a data-fluent, pandemic-
ready public health system. Our nation's public health laboratories are
essential to early detection, and equipping these labs with the best
available resources enables a faster response. Committing to rebuilding
public health infrastructure through a revitalized public health
workforce, modern data pathways, and strong laboratories supports the
foundation for an immediate and robust response to public health
emergencies like monkeypox.
Diagnostic Testing
Since 2003, CDC's LRN has provided state and local health
departments with a way to test and identify orthopoxvirus cases,
including monkeypox. CDC has a Food and Drug Administration-cleared
test capable of detecting non-variola orthopoxviruses like monkeypox
pre-positioned within the LRN due to previous work in smallpox public
health preparedness supported by investments from Congress. These
nearly 70 laboratories that are part of the LRN could test about 6,000
specimens per week at the start of the outbreak, a capacity which CDC
worked quickly to expand to about 10,000 tests per week. A positive
orthopoxvirus test result is enough for clinicians and patients to act
to prevent additional spread. States may also send samples to CDC for
further viral characterization and genomic sequencing.
Even while testing capacity through LRN labs greatly exceeded
demand, CDC and FDA began working with five U.S. commercial laboratory
companies to improve the accessibility of orthopoxvirus testing to the
Nation's providers. In June 2022, CDC began shipping orthopoxvirus
tests to these five commercial laboratories. By July, testing capacity
in the United States increased to 80,000 tests per week. As of
September 7, orthopoxvirus testing throughput is at about 14 percent of
total capacity. This Administration is preparing for potential
increased demand for testing in the future and is exploring all
available avenues to make testing more accessible.
Vaccines and Therapeutics
Through Federal investments in public health preparedness, the U.S.
supported the development of vaccines and therapeutics for
orthopoxviruses, like monkeypox, before detection of the first U.S.
case associated with the 2022 outbreak. The FDA-cleared non-variola
orthopoxvirus test, antiviral tecovirimat (also known as TPOXX), and
ACAM2000 and JYNNEOS vaccines were all developed as part of the
Smallpox Research Agenda. Under this ongoing U.S. smallpox preparedness
work, CDC has collaborated with other U.S. public health officials to
work to ensure medical countermeasure tools are available in the event
of a smallpox outbreak. Unlike COVID-19, the monkeypox virus is not a
novel pathogen, and our response benefited from our ability to mobilize
existing countermeasures and move swiftly to acquire more.
From the beginning of the outbreak, CDC has worked closely with the
Administration for Strategic Preparedness and Response and its
Strategic National Stockpile to make vaccines available quickly,
efficiently, and equitably. CDC's role in the monkeypox response
vaccine strategy is to prioritize the allocation of our limited supply
of the JYNNEOS vaccine to maximize public health impact. Allocations to
jurisdictions are based on two factors: recent population-adjusted case
incidence and the number of people who have the highest risk for
disease in the current outbreak, as estimated by the number of gay,
bisexual, and other men who have sex with men who are living with HIV
or are eligible for HIV pre-exposure prophylaxis within a jurisdiction.
In light of FDA's August 9, 2022 Emergency Use Authorization for
the JYNNEOS vaccine allowing for intradermal administration for
individuals 18 years of age and older who are determined to be at high
risk for monkeypox infection, CDC released interim clinical
considerations with relevant information on how to administer the
JYNNEOS vaccine intradermally. This approach provides a level of immune
response comparable to that achieved by subcutaneous administration
without compromising safety and can extend the vaccine supply by
administering 0.1mL doses, allowing multiple doses to be administered
from one 0.5mL vial.
Equitable allocation of vaccines and therapeutics for those at
greatest risk of monkeypox is not possible without robust data. Vaccine
and therapeutic administration data are important to verify that
vaccines and therapeutics are going to the populations most affected by
this outbreak. Other data, such as race and ethnicity data or HIV
status, are also important to contextualize the distribution and
administration. For example, we know that in the current monkeypox
outbreak, more than one third of U.S. cases are occurring in people
living with HIV. CDC has published Clinical Considerations for
Treatment and Prophylaxis of Monkeypox Virus Infection in People with
HIV and, with additional data, will continue to share treatment and
prophylaxis considerations with clinicians. CDC is building on the
approach and infrastructure established for COVID-19 to receive
monkeypox vaccine administration data, including race and ethnicity,
and has a data use agreement in place with every state to receive these
data. On August 15, 2022, we began receiving vaccine administration
data from high-burden jurisdictions and currently, a total of 35
jurisdictions are reporting these data to CDC.
CDC also is committed to increasing access to therapeutics for
monkeypox patients. We acted quickly on reports from our state, local,
and territorial health partners to reduce the burden of administering
the FDA-approved smallpox treatment, tecovirimat or TPOXX, through the
Expanded Access Investigational New Drug protocol. We did this because
TPOXX has shown promising efficacy in preventing serious illness from
monkeypox based on animal studies. To balance the need for safety and
efficacy information with the need for timely administration, we worked
closely with FDA to revise the protocol to allow for telemedicine
check-ups, make laboratory sample collection optional, and streamline
regulatory reporting.
Community Outreach and Public Awareness
While anyone--irrespective of age, gender identity, or sexual
orientation--can contract monkeypox if they are exposed, engaging with
populations currently disproportionately affected by the monkeypox
outbreak is a cornerstone of the government-wide response. CDC is
committed to collaborating and sharing timely knowledge with members of
the LGBTQ+ community, especially gay and bisexual men. We know that
successful public health efforts depend on authentic collaboration
where the community is at the table, leading discussions, informing and
grounding decisions based in the reality of those affected, and
otherwise making vital contributions to our public health response. We
are working closely with partner organizations and offices like AIDS
United, UnidosUS, the Ryan White HIV/AIDS Program, Southern AIDS
Coalition, and event organizers who bring LGBTQ+ people together across
the country. Trusted community leaders are providing a voice to amplify
messages for prevention, testing, and treatment. We are also working
with our core public health partners at the local and state level to
provide technical assistance on engaging local community partners to
support prevention, vaccination, and testing. HHS launched pilot
programs to provide additional vaccine allocations to state and local
health departments in jurisdictions that are hosting large events that
attract gay, bisexual, and other men who have sex with men and to
ensure more vaccines reach populations that face additional barriers to
access through support for equity interventions. CDC will continue to
provide technical assistance and support to jurisdictions for these
large events and equity interventions, such as helping to develop
testing and vaccine strategies, providing messaging and communication
resources, and developing tools for information-gathering from event
participants.
Stigmatization of diseases and groups of people hinders public
health efforts and contributes to poorer health outcomes. CDC is
drawing on what we have learned through decades of work in sexually
transmitted infections (STIs) and HIV to ensure that CDC messaging does
not contribute to the stigmatization of gay, bisexual, and other men
who have sex with men. CDC is conducting community listening sessions
and working closely with LGBTQ+, sexual health, and HIV advocacy
organizations to take our fight against stigma to the next level by
creating messaging that is sex-positive and LGBTQ-affirming. We will
work with healthcare providers, organizations of all kinds, and public
health partners to support better approaches that reach affected
communities.
CDC uses a variety of mechanisms including the Morbidity and
Mortality Weekly Report to disseminate information to public health
partners and healthcare providers about outbreaks of rare pathogens
like monkeypox. Our monkeypox clinical considerations have received
hundreds of thousands of page views. On May 20, 2022, CDC released the
first Health Alert Network Health Advisory on the monkeypox outbreak,
and we have issued three subsequent advisories, each reaching over 1
million people. CDC regularly hosts Clinician Outreach and
Communication Activity calls where subject matter experts provide the
latest information and considerations for tens of thousands of
clinicians. The agency continues to work closely with clinical and core
public health partners to amplify messaging to their members, including
the American Medical Association, Infectious Disease Society of
America, American Academy of Pediatrics, American Academy of HIV
Medicine, Council of State and Territorial Epidemiologists, Association
of State and Territorial Health Officials, National Association of
County and City Health Officials, Association of Public Health
Laboratories, National Coalition of STD Directors, Big Cities Health
Coalition, and National Indian Health Board.
CDC is also providing information to a wider U.S. audience about
the symptoms of monkeypox and how to mitigate the spread of the
disease. Because of how monkeypox is transmitted, CDC recognizes that
individuals may be concerned about the spread of monkeypox in group
settings. CDC has developed recommendations for reducing infection risk
in group settings and will continue to adapt and refine these
recommendations based on what we learn about virus transmission. A
priority of our response to monkeypox is to support early
identification of monkeypox spread in congregate living settings, like
dormitories, correctional facilities, shelters, and others.
Informational resources for populations that could be at increased risk
continue to be developed. CDC has also posted responses to frequently
asked questions from facilities serving children to provide
administrators, parents, and caregivers with information as their
students return to school.
Looking Ahead
There is much more research to be done to better understand this
unique monkeypox outbreak and other diseases with pandemic potential.
Flexible, disease-agnostic investments are critical to inform our
efforts to respond to emerging public health threats. Additionally,
sustained support for core capabilities--such as modernized data
systems, public health infrastructure, and a diverse public health
workforce--are critical for an effective and equitable disease response
at the national, state, Tribal, local, and territorial levels.
Epidemiologic studies on the characteristics of monkeypox and spread in
this outbreak can provide better understanding to improve the efficacy
of prevention and intervention efforts.
Access to timely and actionable data has been a challenge during
the initial stages of the monkeypox outbreak given our Nation's
fragmented streams of data collection and reporting. The COVID-19
pandemic demonstrated and the monkeypox outbreak has reaffirmed that
nothing about public health data in the United States is easy--it is a
complex, de-centralized landscape with many points of friction that can
keep data from getting from its source to where it is needed to inform
public health action. CDC's new Center for Forecasting and Outbreak
Analytics is already enabling timelier, more effective decision-making
in responding to monkeypox, but its work in modeling and analytics
hinges on our ability to collect and integrate high-quality data.
CDC has deep collaborative partnerships with state and local
jurisdictions to help navigate these challenges, but the fact remains
that ongoing modernization and support from Congress is needed to
provide CDC additional policy levers to enable timely reporting of
actionable data before the next threat arrives. In particular, COVID-19
and monkeypox have showed the importance of timely and comprehensive
data to support decision-making at Federal, state, and local levels.
This data is most effective when collected before and during an
outbreak to mount a fully effective response. To achieve this goal, CDC
will need support from Congress for an updated authority to set a
common framework for how data is reported to support Federal, state,
and local decision-making. In the absence of this authority, CDC must
spend precious time negotiating bespoke data use agreements with many
dozens of jurisdictions and rely on voluntary data reporting--a process
that took months for both the COVID-19 and monkeypox responses for key
data elements.
As COVID-19 demonstrated, and as we see again now with monkeypox,
the American public health system is fragile due to years of
underinvestment in national preparedness and in state, Tribal, local,
and territorial public health agencies. And yet, our Nation's security
depends on the strength of its public health system. It is for this
reason that long-term, foundational investments must be made to ensure
we are prepared to respond rapidly and effectively to future pandemics
and other public health threats. Moving from reliance on unpredictable
supplemental resources to reliable multi-year funding will enable us to
transition the infrastructure built for the COVID-19 response to a
sustained core infrastructure--including data, workforce, and
laboratories--capable of addressing current and future public health
challenges. Investment in laboratory capacity and standards across the
country, regardless of the diseases they are used for, ensures that
laboratories can process tests quickly and effectively when a health
threat arrives. Workforce funding gives health departments the
personnel they need to pivot and respond to new threats, untethered to
a specific funding line or program activity. The fiscal year 2023
President's Budget included a 5-year request for $88 billion for
pandemic preparedness, including $28 billion for CDC to transform our
public health capacities nationwide, which is urgently needed to ensure
we are prepared for any infectious disease threat that comes our way.
Conclusion
As CDC continues to contribute to a robust whole-of-government
response to this outbreak, we are working with governmental and non-
governmental partners to ensure easy, safe, and equitable access to
diagnostic tests, vaccines, and therapeutics. We will continue to
educate healthcare providers and the American public on monkeypox, with
a particular emphasis on the disproportionately impacted community of
gay, bisexual, and other men who have sex with men. We are working to
share scientific findings and data faster; to translate science into
practical, easy-to-understand policy; and to optimize public
communications. The current outbreak demonstrates that the work of
public health is never done and that we must continue to make
investments and structural changes now to address the long-standing
vulnerabilities in our public health system. We must stay vigilant in
global disease surveillance and efforts to modernize the public health
data landscape. Resources to support public health preparedness and
infrastructure, including at the state, Tribal, local, and territorial
levels, remain as necessary as they have been during and prior to the
COVID-19 pandemic. I am committed to working with Congress to advance
these efforts and build a more resilient public health system that
contributes to a healthier, safer, and more secure future for all
Americans.
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 to
address the ongoing monkeypox public health emergency.
I will outline how long standing NIAID supported research
efforts have enhanced our preparedness for, response to the
emergence of monkeypox virus. First, I want to provide some
historical context that relates to past, current, and future
NIAID research efforts. It is worth noting that the emerging
epidemiological pattern of monkeypox cases bears a striking
resemblance to the early cases of HIV/AIDS.
In the United States and other non-endemic countries,
monkeypox is disproportionately affecting men who have sex with
men. However, anyone exposed to the circulating virus can get
infected with monkeypox regardless of their age, gender
identity, or sexual orientation.
Thus, we would be wise to heed an observation I made 40
years ago in an article I published in the Annals of Internal
Medicine in 1982 during the first year of the HIV/AIDS pandemic
when I referred to what we would soon call AIDS, a disease that
did not even have a name at that time.
I quote from that publication, ``any assumption that it
would remain restricted to a particular segment of our society
is truly an assumption without a scientific basis.'' And so
although we must focus our efforts on the group that is most
predominantly afflicted and at risk, there is still much we
must learn about this disease.
Additional epidemiological and observational cohort
studies, surveys, ongoing surveillance for new cases are of
critical importance. In addition, much work needs to be done in
virology, immunology, transmission, and animal reservoirs, as
well as diagnostics, therapeutics, and vaccine, which I will
address in a moment.
There are certainly some sharp differences between the
early years of AIDS and our current situation with monkeypox.
Unlike the situation at the start of the AIDS outbreak, the
etiologic agent of monkeypox has been known for decades and
medical countermeasures have been developed, namely a vaccine,
JYNNEOS, and an antiviral, tecovirimat or TPOXX.
This is the result of decades of NIAID supported research
on monkeypox virus and other orthopox viruses, including the
variola virus that causes smallpox. NIAID supported research
was essential to the development of the JYNNEOS vaccine.
We funded a number of studies of JYNNEOS from the pre-
clinical stage through phase two clinical trials to evaluate
safety, immunogenicity, duration of protection, and route of
administration. We then transitioned the vaccine to BARDA,
which supported advanced clinical evaluation, and we have
recently launched a clinical trial further evaluating
alternative routes of administration.
In the area of therapeutics, NIAID funded the discovery of
tecovirimat and the preclinical studies to determine the
mechanisms of action and its safety and efficacy in animals.
Again, together with BARDA, we also funded phase one and phase
two clinical trials of tecovirimat.
Clinical trials to evaluate this drug in humans with
monkeypox are needed to gather additional data about the safety
and efficacy of the drug in the context of the current
outbreak. NIAID supported investigators have recently launched
a phase three clinical trial of tecovirimat, focused on
outpatient setting in the United States through the AIDS
clinical trials group.
A separate NIAID clinical study of tecovirimat in
collaboration with researchers in the Democratic Republic of
the Congo will begin imminently. It is worth noting that the
study in the DRC was planned prior to the current global
outbreak as part of our preparedness efforts to study high
consequence pathogens in key international locations where they
are endemic.
Lessons learned during the response to AIDS and COVID-19,
such as avoiding stigma and ensuring the medical
countermeasures get to where they are needed most, should help
us in our efforts to respond to the ongoing monkeypox
emergency.
In addition, the U.S. response to monkeypox should in turn
help to inform our response to the inevitable next emerging or
reemerging infectious disease of pandemic potential. Thank you
for your attention. I would be happy to answer your questions
following the presentation of my colleagues.
[The prepared statement of Dr. Fauci follows:]
prepared statement of anthony 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 the ongoing monkeypox public health emergency. 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 monkeypox. As the Director of NIAID and
the Chief Medical Advisor to the President, I am pleased to discuss
NIAID research addressing the U.S. monkeypox outbreak. NIAID is
committed to accelerating efforts to answer critical monkeypox research
questions in alignment with the U.S. Monkeypox Research Priorities
identified by the White House Office of Science and Technology Policy.
Pandemic Preparedness and Prototype Pathogen Approaches for Medical
Countermeasures
The monkeypox virus is part of the Orthopoxvirus genus, which
includes the variola virus that causes smallpox. Available medical
countermeasures against monkeypox were made possible by decades of
NIAID-supported research on orthopoxviruses. Our orthopoxvirus research
is an example of the NIAID prototype pathogen approach to pandemic
preparedness, in which basic research and countermeasures for a
prototype pathogen within a given family of viruses can be used to help
treat and prevent diseases caused by closely related pathogens within
that family.
As part of its longstanding investment in biodefense research,
NIAID supported early stage development of the second-generation
smallpox vaccine ACAM2000. NIAID further identified the need for a
vaccine to overcome the limitations of ACAM2000, which cannot be used
by individuals with weakened immune systems. In close collaboration
with the Biomedical Advanced Research and Development Authority (BARDA)
and the U.S. Food and Drug Administration (FDA), NIAID played a key
role in developing a third-generation vaccine against smallpox and
monkeypox now known as JYNNEOS (Imvamune or Imvanex).
NIAID-supported research also facilitated the development of an
antiviral for smallpox called tecovirimat (TPOXX). This drug is now
being used to treat patients with monkeypox under an expanded-access
investigational new drug protocol. NIAID is supporting new clinical
trials of tecovirimat to gather additional safety and efficacy data to
inform clinical and regulatory decision-making on the use of
tecovirimat for the treatment of monkeypox. In addition, NIAID-
supported scientists continue to conduct basic research to better
understand monkeypox virus transmission and disease, and to identify
additional antiviral candidates. NIAID researchers at the Vaccine
Research Center (VRC) are isolating antibodies for evaluating vaccine-
induced immune responses as well as the development of immune assays,
diagnostic reagents, and therapeutics in the form of monoclonal
antibodies.
Vaccines to Prevent Monkeypox Disease
As noted, NIAID-supported research was essential to the development
of the JYNNEOS vaccine made by Bavarian Nordic A/S and approved in the
United States and other countries for the prevention of monkeypox (and
smallpox). JYNNEOS features a weakened form of live vaccinia virus
(modified vaccinia Ankara-Bavarian Nordic [MVA-BN]) that does not
replicate or cause disease. MVA is an orthopoxvirus related to the
viruses that cause monkeypox and smallpox. NIAID provided significant
support for the research and development of JYNNEOS as an alternative
to the ACAM2000 smallpox vaccine, which contains replication-competent
vaccinia virus and can cause severe adverse events in people with
weakened immune systems and individuals with eczema. NIAID has funded
studies of JYNNEOS from the preclinical stage through Phase 2 clinical
trials to evaluate safety, immunogenicity, duration of protection, and
route of administration. NIAID then transitioned the vaccine to BARDA,
which supported advanced clinical evaluation.
In 2019, FDA approved JYNNEOS for individuals at high risk for
smallpox or monkeypox virus infection. On August 9, 2022, FDA issued an
emergency use authorization (EUA) for JYNNEOS to allow healthcare
providers to administer the vaccine by intradermal injection, an
alternative to the standard subcutaneous route of administration. The
FDA EUA will increase the total number of available JYNNEOS vaccine
doses by up to five-fold. The EUA decision was informed by an NIAID-
supported clinical study of the vaccine published in 2015 demonstrating
that the intradermal route of administration--using just one fifth of
the vaccine volume--produced a similar immune response to subcutaneous
administration.
NIAID recently launched a clinical study of the JYNNEOS vaccine via
different routes of inoculation, including intradermal administration,
in adults 18 years of age and older at high risk for monkeypox virus
infection. This study may be expanded to provide data to support use of
the vaccine against monkeypox for individuals who are pregnant or under
the age of 18 years, or to inform potential Centers for Disease Control
and Prevention (CDC) Advisory Committee on Immunization Practices
(ACIP) recommendations for a lower dose vaccination regimen.
NIAID VRC scientists are developing mRNA-based monkeypox vaccines
in collaboration with Moderna, Inc., and will conduct efficacy studies
in animal models to select lead vaccine candidates. Blood samples from
these and other VRC studies will be used to isolate monoclonal
antibodies for vaccine antigen design and for evaluation as potential
monkeypox therapeutics and diagnostic reagents.
Therapeutics to Treat Monkeypox Disease
Currently, no specific treatment is approved by the FDA for
monkeypox virus infection. However, the antiviral tecovirimat (TPOXX),
developed to treat smallpox, is being used to treat patients with
monkeypox under an expanded-access investigational new drug protocol.
NIAID funded the discovery of tecovirimat as well as preclinical
studies to determine its mechanism of action and its safety and
efficacy in animals. NIAID and BARDA also have funded Phase 1 and Phase
2 clinical trials to test the safety and pharmacokinetics of an oral
formulation of tecovirimat. The FDA approved the oral formulation of
tecovirimat in 2018 for treating smallpox in adults and children and
this formulation is part of the U.S. Strategic National Stockpile. An
intravenous formulation of tecovirimat subsequently received FDA
approval. Although this antiviral was approved for the treatment of
smallpox, the drug's FDA approval was based on studies in animals
infected with monkeypox virus. Clinical trials to evaluate tecovirimat
in humans with monkeypox are needed to gather additional data about the
safety and efficacy of the drug in the context of the current outbreak
to aid clinical and regulatory decision-making.
In this regard, NIAID-supported investigators have launched a Phase
3, randomized, placebo-controlled, double-blind trial of tecovirimat
for the treatment of monkeypox in outpatient settings in the United
States through the AIDS Clinical Trials Group (ACTG). Using this
established and successful HIV clinical trials infrastructure will
facilitate community engagement and help researchers ensure that vital
community input is reflected in the conduct of the study. The study
also has an open-label component to ensure that certain high-risk
populations (e.g., pregnant or breastfeeding individuals, those who are
heavily symptomatic, and those with severe immune deficiencies) are not
randomized to placebo, while also providing a means to collect
important data on the safety and pharmacokinetics of tecovirimat in
these populations.
NIAID, in collaboration with Institut National de Recherche
Biomedicale of the Democratic Republic of Congo (DRC), also is planning
a double-blind, randomized controlled trial of the safety and efficacy
of tecovirimat for treating adult and pediatric patients diagnosed with
monkeypox. The study in the DRC was planned prior to the current global
outbreak as part of NIAID preparedness efforts to study high-
consequence pathogens in key international locations where they are
endemic.
NIAID also supports early stage research to help identify
additional candidate antivirals for monkeypox. It is possible that
monkeypox virus will develop resistance to tecovirimat. This is one of
the reasons NIAID-supported scientists are screening novel compounds to
help find new antiviral candidates to treat monkeypox.
Understanding Monkeypox Transmission and Reservoirs
Monkeypox is disproportionately affecting men who have sex with men
in non-endemic countries. However, anyone exposed to the circulating
virus can get monkeypox regardless of their age, gender identity, or
sexual orientation. Of note, the previous outbreak of monkeypox in the
United States in 2003 was driven by animal-to-person spread and
involved domesticated prairie dogs that were infected by small mammals
imported from West Africa. NIAID scientists are conducting animal
studies to understand the human-animal interface with monkeypox virus
and its suspected reservoir hosts, such as Gambian pouched rats, rope
squirrels, and dormice. NIAID also is supporting the development of
animal models to evaluate vaccine-induced immune responses to monkeypox
virus.
In addition, NIAID-supported scientists are performing genomic
sequencing to better understand the monkeypox virus and its various
strains. Investigators with the NIAID-funded Centers for Research in
Emerging Infectious Diseases (CREID) are supporting clinical
surveillance in the DRC, Nigeria, and Sierra Leone. CREID investigators
also are providing validated molecular primers and probes to help
strengthen diagnostic capacity in Kenya, Tanzania, Panama, and Brazil.
In addition, the NIAID International Centers for Excellence in Research
(ICER) program has helped enhance diagnostic capacity in Mali, Ghana,
Republic of the Congo, and Cambodia.
NIAID scientists also are developing a high-throughput serologic
assay that can distinguish between individuals infected with monkeypox
virus and people who may have received a vaccinia-based vaccine, such
as JYNNEOS or ACAM2000. In collaboration with the CDC and other U.S.
and international researchers, NIAID will use this assay to conduct
retrospective and prospective serological studies to better understand
the extent of monkeypox virus circulating in the United States and
worldwide. In addition, NIAID is making viral isolates available, free-
of-charge, for distribution to the global research and surveillance
community via the NIAID-funded BEI Resources repository. Distribution
of these resources will facilitate additional priority research
throughout the broader scientific community, particularly in the areas
of diagnosis and surveillance.
Conclusion
NIAID continues to expand research on the biology, pathogenesis,
and clinical manifestations of monkeypox virus infection as well as
studies of existing and potential interventions to diagnose, treat, and
prevent monkeypox. NIAID also is committed to working in partnership
with those populations, including men who have sex with men, that
currently are most at-risk of monkeypox to help identify and address
key monkeypox research questions. These efforts will improve our
response to the ongoing public health emergency.
______
The Chair. Thank you.
Dr. Califf.
STATEMENT OF ROBERT CALIFF, M.D., COMMISSIONER, UNITED STATES
FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD
[Technical problems.]
The Chair. Turn on your mic.
Dr. Califf. There we go. Chair Murray, Ranking Member Burr,
Members of the Committee, thanks for the opportunity to provide
information on FDA's ongoing work related to the monkeypox
virus public health emergency. FDA has been actively working
with our Government and private sector collaborators to respond
to the continuing public health threat since the first
monkeypox case came to the U.S.
We have been working diligently to help ensure access and
proper information regarding vaccines, diagnostics, and
treatments for those who need the most. There is currently one
FDA licensed vaccine, JYNNEOS, available for the prevention of
monkeypox. We originally approved this Modified Vaccinia Ankara
vaccine for the prevention of smallpox.
Following reports of monkey pox in May, FDA recognized that
production for this vaccine would need to be accelerated. FDA
and BARDA worked together to expedite the submission of a
manufacturing supplement that would allow more doses to be used
in the United States.
FDA approved that supplement in July, following an
inspection of the manufacturing facility in Europe. In August,
we granted an emergency use authorization for intradermal
Administration of the vaccine, which has helped to increase the
supply of vaccine available to Americans up to five fold.
The authorization allowed additional review of a 2015
clinical study that evaluated a two dose series of JYNNEOS,
given intradermal versus subcutaneously in individuals aged 18
years or older.
Consistent with previous studies, and extensive experience
with a similar vaccine in Germany, data indicated that
intradermal administration produced a similar immune response
to subcutaneous administration with a modestly different
reaction profile at the injection site.
The combination of vaccination and preventive measures to
reduce the risk of contact with the virus remains the best way
to prevent the spread of monkeypox. The vaccine is available
via intradermal administration for individuals 18 years of age
and older, determined to be at high risk for monkeypox
infection, and available via subcutaneous administration to
those under the age of 18 determined to be at high risk for
monkeypox infection.
It is important to recognize that we do not have clinical
data on safety and efficacy, so FDA continues to monitor safety
data we are receiving following the administration of JYNNEOS
nationwide. Additionally, as you have heard from Dr. Fauci, NIH
has initiated a clinical trial to obtain further data. FDA has
also worked closely with CDC, manufacturers, and laboratories
to support diagnostic test development.
Currently, CDC has an FDA cleared test that can detect non-
variola orthopox viruses, including monkeypox, by a swab from
the lesion. This test is available through 67 CDC laboratory
response network labs, as well as through five large commercial
labs. On September 7th, following an emergency declaration from
HHS, FDA issued an EUA for an additional test from a commercial
developer.
We also issued guidance on the development of diagnostic
tests and hope it will increase the diversity and availability
of tests for monkeypox. Currently, there are no FDA approved
treatments for monkeypox. TPOXX or tecovirimat is an FDA
approved treatment for smallpox currently made available to
monkeypox patients under a CDC expanded access investigational
new drug protocol.
TPOXX was originally approved for smallpox using FDA's
animal rule. The animal rule is an approval pathway that relies
on animal studies and can be used only when human trials are
not ethical or feasible.
Because monkeypox remains endemic in countries around the
world, and we now have a large outbreak in the U.S., human
clinical trials are both ethical and feasible in a way that
they were not feasible for smallpox, and smallpox has been
eradicated and has a 30 to 50 percent mortality rate.
Without human trials, we don't know if TPOXX is beneficial
for patients with monkeypox. Drugs that show efficacy in
animals are not always effective in humans. Therefore, clinical
trials, one of which is now underway, as Dr. Fauci has
mentioned, through the NIH, will be necessary for FDA to
determine if TPOXX is safe and effective to treat monkeypox.
In the meantime, because there is a significant risk of the
development of our resistance to TPOXX, judicious use of TPOXX
and careful monitoring for the development of resistance are a
paramount importance for stewardship of this potentially
beneficial drug while we study it in clinical trials.
FDA has dedicated staff continue to work to ensure an
appropriate and robust response to the monkeypox outbreak.
Thanks for the opportunity to testify today and I look forward
to answering your questions.
[The prepared statement of Dr. Califf follows:]
prepared statement of robert califf
Chair Murray, Ranking Member Burr, distinguished Members of the
Committee, thank you for this opportunity to testify before you today
to describe the Food and Drug Administration's (FDA's or the Agency's)
monkeypox disease 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 monkeypox virus public health emergency.
We are closely monitoring the situation and responding
aggressively, while also preparing for potential changes and shifts as
the public health emergency continues. The Agency is using lessons
learned from the coronavirus disease 2019 (COVID-19) response effort to
inform our decision-making going forward and aid in our response to
monkeypox disease. For eligible Americans, getting vaccinated and
following Centers for Disease Control and Prevention (CDC) guidance
remain the best way to protect themselves and their families.
Presently, JYNNEOS is the only FDA-licensed vaccine in the United
States that is approved for the prevention of monkeypox disease.
JYNNEOS, the Modified Vaccinia Ankara (MVA) vaccine, is approved for
the prevention of smallpox and monkeypox disease in adults 18 years of
age and older determined to be at high risk for smallpox or monkeypox
infection. JYNNEOS was approved in 2019. The recent Emergency Use
Authorization (EUA) allowing for intradermal administration of JYNNEOS
for individuals 18 years of age and older determined to be at high risk
of monkeypox infection will increase the supply of available doses by
up to five-fold.
In addition, the CDC has an FDA-cleared test that can detect non-
variola orthopoxviruses, including monkeypox. FDA also recently granted
the first EUA for a monkeypox test, and we have issued policy guidance
to support development of additional validated monkeypox tests and
expand access to tests. \1\
---------------------------------------------------------------------------
\1\ U.S. Food and Drug Administration, ``Monkeypox Update: FDA
Takes Significant Action to Help Expand Access to Testing,'' September
7, 2022, available at https://www.fda.gov/news-events/press-
announcements/monkeypox-update-fda-takes-significant-action-help-
expand-access-testing.
While there is no FDA-approved treatment for monkeypox, through the
use of existing FDA authorities, tecovirimat (TPOXX), an antiviral
medication, is available to patients under an Expanded Access
---------------------------------------------------------------------------
Investigational New Drug protocol (EA-IND).
Since the first positive case of monkeypox disease in the United
States, FDA has taken an active role in responding to the ongoing
public health threat posed by the spread of monkeypox. This testimony
is only a snapshot of the continued work the Agency is doing to address
the monkeypox outbreak.
Supporting Timely Access to Monkeypox Vaccines
FDA's Center for Biologics Evaluation and Research (CBER) continues
to use every tool available to help facilitate the development of
biological products to aid in the Agency's larger effort to respond to
the monkeypox public health emergency.
JYNNEOS is the only vaccine that is FDA-approved for the prevention
of monkeypox disease. JYNNEOS is a live virus vaccine that contains
MVA-Bavarian Nordic, a weakened, non-replicating orthopoxvirus, and was
developed for use in certain populations (e.g., immunocompromised
individuals) as an alternative to ACAM2000, a licensed vaccine, in the
event of a smallpox bioterrorist attack. This virus strain has been
safely administered to thousands of individuals intradermally in the
past, both as a smallpox vaccine and in investigational studies for
other zoonotic orthopoxviruses and variola viruses. \2\ Further,
JYNNEOS may be safely used in significantly immunocompromised
individuals, including individuals with Human Immunodeficiency Virus
(HIV), for whom it may not be advisable to receive certain live
vaccines.
---------------------------------------------------------------------------
\2\ For detailed information on the study, please visit Sharon E.
Fry et al., ``Comparison of lyophilized versus liquid modified vaccinia
Ankara (MVA) formulations and subcutaneous versus intradermal routes of
administration in healthy vaccinia-na--ve subjects,'' Vaccine, 33:39,
September 22, 2015, pp. 5225-34, available at https://
www.sciencedirect.com/science/article/pii/S0264410X15008762--via
percent3Dihub.
ACAM2000 is an FDA-licensed live replicating vaccinia virus vaccine
approved for the prevention of smallpox disease. It is associated with
a higher risk of certain serious adverse reactions compared to JYNNEOS,
including myocarditis and pericarditis, which are inflammation and
swelling of the heart and surrounding tissues, respectively. The risk
of accidental infection by someone who just received ACAM2000 can also
present serious health complications in certain populations, including
those who are pregnant. The ACAM2000 vaccine also causes a blister to
develop at the vaccination site. Exposure to the blister and its
contents may lead to accidental infection. This risk of accidental
infection following vaccination does not occur with JYNNEOS, as the
---------------------------------------------------------------------------
vaccination does not cause a blister to form at the injection site.
In late May 2022, following reports of monkeypox in the United
States, FDA worked with the Biomedical Advanced Research and
Development Authority (BARDA) to expedite the submission of a
manufacturing supplement to FDA to facilitate JYNNEOS production at an
additional site that was originally planned for fall 2022. After
receiving the supplemental application for the additional facility, FDA
immediately expedited our evaluation of the application and
corresponding inspection of the facility. FDA evaluated the information
required to validate product quality and determined that the vaccine
meets our quality standards. The evaluation and inspection were
necessary to help ensure the quality and safety of the vaccine.
On July 26, 2022, FDA approved a supplemental biologics license
application for JYNNEOS, which allowed for additional doses
manufactured at a facility in Europe to be further distributed and
administered in the United States to help address the monkeypox
outbreak.
Given the emerging public health need, FDA facilitated advance
shipments of manufactured doses to the United States for prepositioning
so that they would be onshore and ready to be distributed once we
completed our inspection and approved the manufacturing changes.
On August 9, 2022, FDA issued an EUA for JYNNEOS to allow
healthcare providers to administer the vaccine intradermally (between
the layers of the skin) for individuals 18 years of age and older
determined to be at high risk for monkeypox infection. The EUA also
allows for use of the vaccine in individuals younger than 18 years of
age determined to be at high risk for monkeypox infection; in these
individuals, JYNNEOS is administered by subcutaneous injection. For all
age groups, JYNNEOS is given as a two-dose series, 4 weeks apart. In
issuing this EUA, FDA determined that the known and potential benefits
of JYNNEOS outweigh the known and potential risks for the authorized
uses.
A 2015 clinical study \3\ evaluated a two-dose series of JYNNEOS
given intradermally compared to subcutaneously in individuals 18 years
of age and older. Individuals who received the vaccine intradermally
received a lower volume (one-fifth) of the vaccine than individuals who
received the vaccine subcutaneously. The results of this study
demonstrated that intradermal administration produced a similar immune
response to subcutaneous administration. Administration by the
intradermal route resulted in more redness, firmness, itchiness, and
swelling at the injection site, but less pain.
---------------------------------------------------------------------------
\3\ Ibid.
---------------------------------------------------------------------------
The JYNNEOS EUA will increase the total number of doses available
for use by up to five-fold.
To support FDA's authorization of two doses of JYNNEOS administered
by the subcutaneous route of administration in individuals younger than
18 years of age, FDA considered the available JYNNEOS safety and immune
response data in adults as well as the historical data with use of live
vaccinia virus smallpox vaccine in pediatric populations.
Following the EUA, the Agency has participated in calls with
healthcare providers to discuss the newly authorized administration
method and provide the most up-to-date information to those
administering the vaccine. \4\ It is important to recognize that we do
not have clinical data on safety and efficacy of JYNNEOS, so FDA will
continue to monitor the safety data received from jurisdictions as
administration of JYNNEOS increases across the United States.
Additionally, NIH has initiated a prospective clinical trial to obtain
these data.
---------------------------------------------------------------------------
\4\ The most up-to-date information can be found on FDA's
monkeypox homepage: U.S. Food and Drug Administration, ``FDA Monkeypox
Response,'' updated continuously, available at https://www.fda.gov/
emergency-preparedness-and-response/mcm-issues/fda-monkeypox-response.
---------------------------------------------------------------------------
Supporting Monkeypox Test Development and Timely Test Access
Since the first case of monkeypox was detected in the United
States, FDA's Center for Devices and Radiological Health (CDRH) has
been working closely with CDC, laboratories, and commercial
manufacturers to support test development and help make monkeypox tests
more readily available to consumers who need them. CDC has an FDA-
cleared test that can detect non-variola orthopoxviruses, including
monkeypox, by a swab from a lesion (rash or growth). The Agency engaged
early with CDC and other agencies to support 67 CDC Laboratory Response
Network laboratories' use of the FDA-cleared test. FDA and Federal
authorities subsequently worked with industry to help make this test
available through five large commercial laboratories (LabCorp, Mayo,
Aegis, Sonic, and Quest). Presently, more testing capacity for
monkeypox exists than is being used. \5\ However, FDA knows the value
of assuring patients have test options and timely access to test
results--and we have continued working toward expansion of testing
capacity nationwide in an effort to stem the spread of the virus.
---------------------------------------------------------------------------
\5\ For the latest data on testing capacity and positivity rates
please visit CDC's website: Centers for Disease Control and Prevention,
``Monkeypox Signs and Symptoms,'' available at https://www.cdc.gov/
poxvirus/monkeypox/index.html.
---------------------------------------------------------------------------
FDA has been working proactively with commercial manufacturers on
the development and validation of both laboratory-based molecular
diagnostic tests and rapid molecular or antigen tests for use at the
point-of-care (such as clinics) or at home.
As part of this close work with CDC and the private sector, FDA has
undertaken additional efforts that are critical to support test
developers, laboratories, and patients as the Nation responds to the
monkeypox virus outbreak. To increase the availability, accessibility,
and throughput of the CDC test, FDA has updated the test's clearance
and provided temporary enforcement discretion as needed regarding the
test's use with additional instruments, extraction reagents, and
automated extractions. FDA has also been monitoring the availability of
test components and testing supplies and provided temporary enforcement
discretion regarding the use of substitute components to help address
shortage issues. Subsequently, these laboratories have had additional
options and flexibility, which helps to improve timely patient access
to monkeypox tests throughout the country. FDA also has provided
temporary enforcement discretion regarding laboratories' reporting of
test results from the CDC test, allowing results reported as
``detected,'' and ``positive,'' rather than ``presumed positive,'' so
that samples do not need to be sent to CDC for confirmation prior to
initiating treatment.
In addition, FDA has reached out to commercial control
manufacturers to encourage them to produce orthopoxvirus and monkeypox
control material that can be used for test development and test
validation as well as batch testing once clinical testing has been
launched. Control material is now available from at least two sources--
the National Institute of Standards and Technology and a commercial
provider. This control material is another important resource for
laboratories that are working to develop additional tests for
monkeypox.
On September 8, 2022, Secretary Xavier Becerra signed a declaration
under section 564 of the Federal Food, Drug, and Cosmetic Act to allow
the FDA Commissioner to issue emergency use authorizations for in vitro
diagnostics to expand the availability of tests for monkeypox. On the
same day, FDA issued the first EUA for a monkeypox in vitro
diagnostic--the Quest Diagnostics Monkeypox Virus Qualitative Real-Time
PCR \6\ intended to detect monkeypox and other non-variola
orthopoxvirus DNA using lesion swab specimens.
---------------------------------------------------------------------------
\6\ 1A U.S. Food and Drug Administration, letter (EUA) to Quest
Diagnostics Incorporated, September 7, 2022, available at https://
www.fda.gov/media/161454/download.
As part of the guidance, FDA has provided voluntary templates that
test developers may use when validating a test or when submitting an
EUA request. These templates include recommendations--not
requirements--for how a developer could validate a test to help ensure
it is appropriately accurate and reliable. FDA intends to update its
---------------------------------------------------------------------------
recommendations, as needed, in response to the developing emergency.
FDA will also continue its partnership with the National Institutes
of Health's (NIH) Independent Test Assessment Program (ITAP), \7\ which
helped streamline validation and authorization of COVID tests. ITAP
showed the great value of an independent validation program for tests
and, based on this experience, we will partner with NIH/ITAP to help
streamline validation and authorization of point-of-care and home
monkeypox virus tests. On September 7, 2022, ITAP announced it is
accepting proposals. \8\
---------------------------------------------------------------------------
\7\ U.S. Department of Health and Human Services, ``New HHS
Actions Add to Biden administration Efforts to Increase Access to Easy-
to-Use Over-the-Counter COVID-19 Tests,'' October 25, 2021, available
at 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\ National Institute of Biomedical Imaging and Bioengineering,
``Independent Test Assessment Program (ITAP): Announcement: See New
Opportunity for Monkeypox Virus Diagnostics Below,'' available at
https://www.nibib.nih.gov/covid--19/radx-tech-program/ITAP.
FDA continues actively working with private and public entities on
monkeypox test development and availability. This includes meeting
regularly with the CDC, academic, commercial, and public health
laboratories and addressing monkeypox during FDA's monthly virtual town
hall series for test developers. \9\ FDA is also fully engaged with CDC
and key stakeholders in the laboratory community under a memorandum of
understanding to collaborate on enhancing diagnostic surge testing
capacity during public health emergencies. \10\ This has helped
facilitate communications between FDA, our Federal partners, and
laboratory professional associations and large commercial laboratories,
including, for example, helping gain an understanding of willingness to
participate in developing increased testing capacity, any barriers to
such participation, and suggestions on next steps.
---------------------------------------------------------------------------
\9\ U.S. Food and Drug Administration, ``Virtual Town Hall
Series--Coronavirus (COVID-19) Test Development and Validation,''
August 24, 2022, available at https://www.fda.gov/medical-devices/
workshops-conferences-medical-devices/virtual-town-hall-series-
coronavirus-covid-19-test-development-and-validation-07272022.
\10\ MOU 225-22-020, ``Memorandum of Understanding for Diagnostic
Surge Capacity for Public Health Emergencies,'' effective May 6, 2022,
available at https://www.cdc.gov/csels/dls/documents/2022-revised-mou-
for-surge-capacity--final--signed.pdf.
FDA will continue working with our U.S. Government partners,
laboratories, and commercial manufacturers to support access to the CDC
test and the development of additional tests. FDA's efforts are
critical to help ensure patients can depend on their test results and
receive care as needed, and to avoid or mitigate further spread of
monkeypox.
Supporting Timely Access to and Careful Evaluation of Monkeypox
Therapeutics
Currently there are no FDA-approved products for the treatment of
monkeypox. Tecoviramat, or TPOXX, was approved for the treatment of
smallpox in adults and children in 2018 under FDA's ``Animal Rule'' and
is being made available for the treatment of monkeypox under an EA-IND
through FDA's Expanded Access program.
The Animal Rule \11\ allows efficacy to be established based on
adequate and well-controlled animal efficacy studies when the results
of those studies establish that the drug is reasonably likely to
produce clinical benefit in humans for the disease of interest and when
conducting clinical trials in humans is not feasible or ethical.
Smallpox is caused by the variola virus. Animal studies using variola
virus are not consistently reproducible and do not mimic human disease.
They are extremely challenging to conduct as research is restricted to
two maximum-containment laboratories located in the United States and
Russia. TPOXX's efficacy for the treatment of smallpox was established,
and the drug approved, based on studies in animal models using
orthopoxviruses related to the smallpox virus--specifically, nonhuman
primates infected with monkeypox virus and rabbits infected with
rabbitpox virus. Safety data was obtained in healthy human volunteers
without monkeypox virus infection.
---------------------------------------------------------------------------
\11\ For more information on the Animal Rule, please visit U.S.
Food and Drug Administration, ``Animal Rule Approvals,'' June 2, 2022,
available at https://www.fda.gov/drugs/nda-and-bla-approvals/animal-
rule-approvals.
The Animal Rule can be used only when it is not feasible or ethical
to conduct human clinical trials, as was the case with smallpox. Human
studies of TPOXX's efficacy against smallpox disease were not ethical
or feasible as smallpox has been eradicated. The Animal Rule was not a
viable regulatory pathway to approve tecovirimat for the treatment of
monkeypox as the disease was endemic in West and Central Africa, and it
---------------------------------------------------------------------------
was both feasible and ethical to conduct clinical trials in humans.
It is important to note that drugs that show efficacy in animal
studies are not always effective in humans. Currently there are no
human data demonstrating the efficacy of TPOXX for the treatment of
monkeypox or its safety and pharmacokinetic profile in patients with
monkeypox; therefore we do not know if TPOXX will be beneficial in
treating patients with monkeypox.
Thus, conducting randomized, controlled trials to assess
tecovirimat's safety and efficacy in humans is essential.
In parallel with planning for a randomized controlled trial, access
to TPOXX for the treatment of monkeypox has been made available through
an EA-IND held by CDC under FDA's Expanded Access program. FDA has
worked closely with CDC to streamline the protocol based on input from
stakeholders to reduce data collection and reporting requirements.
We understand, however, that challenges remain with the current EA-
IND mechanism, and we continue to consider all potential regulatory
options to best address this situation. Regardless of the regulatory
mechanism used to facilitate access to TPOXX, it is important that
access does not compromise the ability to conduct randomized,
controlled trials that can establish whether TPOXX helps patients with
monkeypox. Such clinical trials will be key to any potential
consideration of approval of TPOXX.
It is also critical to note that viral resistance to tecovirimat is
a concern. TPOXX works by inhibiting a protein called VP37 that all
orthopoxviruses share. Even a small change to the VP37 protein can have
a large impact on the antiviral activity of tecovirimat. Therefore,
judicious use of TPOXX and careful monitoring for the development of
viral resistance are of paramount importance for stewardship of this
potentially beneficial drug while we study it in clinical trials.
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 the monkeypox public health emergency. FDA and our HHS
partners are working tirelessly to ensure a robust and comprehensive
response to monkeypox that considers the ever-changing nature of the
outbreak. We continue to communicate with the American public and make
regulatory decisions based on data and sound science. The Agency looks
forward to working with sponsors to increase vaccine supply, increase
testing options and capacity, and increasing the number of available
treatments, while ensuring that the products meet applicable standards
for safety and effectiveness. I hope to continue working with the
Committee on these efforts. 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, ADMINISTRATION FOR STRATEGIC
PREPAREDNESS AND RESPONSE, 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 ASPR's work and the ongoing
monkeypox response. Let me start by sharing the work ASPR has
done to procure and distribute vaccines. The Strategic National
Stockpile stores vaccines that can be used in a smallpox
outbreak.
Among the vaccines it stores is a small stockpile of
JYNNEOS, a relatively new vaccine for those that are
immunocompromised and unable to tolerate the live replicating
virus and the other smallpox vaccines. And since JYNNEOS is
also licensed for monkeypox, we have deployed these vaccines
for the current response.
When the first case of monkeypox in the U.S. was
identified, the SNS had 2,400 vials of JYNNEOS in its on hand
inventory, and immediately deployed vaccine to support the
first cases. And when there were still only two known cases in
the U.S., ASPR requested 36,000 JYNNEOS vaccine vials be
shipped to the SNS from our U.S. Government owned reserve
stored by Bavarian Nordic. When there were only 13 known cases,
ASPR ordered an additional 36,000 vials from its reserve. And
when there were only 35 known cases, ASPR ordered an additional
300,000 vials from its reserve. All of this was done to stay
ahead of the virus.
Though case counts were very low in the United States, we
were watching the quick spread of cases in Europe, which was
about 2 to 3 weeks ahead of us, and we moved out quickly,
anticipating similar spread in the U.S. in the weeks to come.
ASPR has made over 1.1 million vials of JYNNEOS available
to states and jurisdictions for use against the current
outbreak, and we have purchased 5.5 million more to arrive over
the next months. Bringing JYNNEOS manufacturing capability
onshore has been another focus of mine at ASPR.
This summer when we purchased the second 2.5 million doses
from BN to be filled and finished, our contract required that
those doses be filled and finished in the U.S., and we have
been pleased to support BN's arrangement with GRAM to do that
fill finish in Michigan. We have provided GRAM with $11 million
to secure the equipment and staff it needs to ramp up quickly.
I visited GRAM 2 weeks ago as they are bringing on this new
line and was pleased with the progress that I saw, and to hear
that they will be adding over 70 new jobs in Michigan to
support this work. Vaccines are not the only medical
countermeasure ASPR has made available in this outbreak. We
have also made available the therapeutic TPOXX.
Prior to the start of the outbreak, the SNS held more than
1.7 million courses of TPOXX. To date, over 37,000 courses have
been distributed. I have been pleased to make both of these
medical countermeasures available for the current monkeypox
outbreak. It is the right thing to do. But I have not lost
sight of the fact that both JYNNEOS and TPOXX were developed
and stockpiled for use in a smallpox outbreak.
I have consulted with the PHEMCE, the inter-agency body
responsible for advising HHS on medical countermeasures,
development, and procurement, and they have agreed with the
approach we have taken. It is important, however, that as we
move forward with our response, we consider ways to preserve
our smallpox capability.
We have also applied several lessons learned from the
COVID-19 response to our work in monkeypox. As we digitized the
SNS countermeasure ordering system, we opted to use a program
that allows states to order both vaccines and therapeutics from
the same system, rather than using separate non-interoperable
systems for each as they have had to do in the COVID-19
response.
Using this multi-platform ordering system is a step toward
modernizing our public health infrastructure for the current
response and for future responses. We have also expanded the
number of sites to which the SNS delivers. At the start of the
outbreak, the SNS only delivered to five sites in each
jurisdiction.
This was more than enough for the high consequence, large
scale events the SNS has been deploying to, such as hurricanes
and tornadoes. However, after seeing the advantage of multiple
distribution sites and the COVID-19 vaccine and therapeutics
effort, the SNS contracted to create a similar distribution
network for its countermeasures.
These are just two of the examples of the lessons we have
taken from the ongoing COVID-19 response and applied to the
current monkeypox response. Responses cannot be static. They
must continue to evolve and calibrate to the current set of
circumstances and regularly account for new information and
evolving scientific understanding.
This has been true of the monkeypox response thus far and
will be true as it continues. Thank you again for inviting me
to testify before you on efforts within ASPR to support the
ongoing monkeypox response. 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 the efforts
within the U.S. Department of Health and Human Services (HHS)
Administration for Strategic Preparedness and Response (ASPR) to
support the ongoing response to the monkeypox outbreak. I am grateful
for this opportunity to address this Committee and appreciate your
continued support for the ongoing response efforts.
ASPR's core mission is to ensure that we are prepared and able to
respond to public health and medical emergencies. In ASPR's 16-year
history, ASPR has invested in a range of efforts to prepare for threats
identified by the Department of Homeland Security (DHS). One of the key
identified threats--by DHS, ASPR, and Congress--is smallpox. ASPR and
other Federal partners have invested in preparing for the threat of
smallpox for over a decade. We have a number of countermeasures within
the Strategic National Stockpile (SNS) to aid in a response, should
this country experience any sort of smallpox attack. Certain medical
countermeasures we procured and stockpiled for smallpox also protect
against and treat the symptoms of monkeypox. We are grateful to be in a
position where our existing smallpox medical countermeasure portfolio
can be leveraged against monkeypox. In doing so we must not lose sight
of the need to maintain a strong smallpox preparedness posture and
replace those countermeasures intended for smallpox that we have
distributed in response to the current monkeypox outbreak.
Since becoming the ASPR in the summer of 2021, one of my priorities
has been to ensure that programs within the organization are
appropriately resourced. The SNS has played a large role in the current
response. One of the biggest challenges ASPR faces is fully funding the
SNS. Despite growing responsibilities, the SNS has had a relatively
flat budget for a number of years. The Administration requested $975
million in the fiscal year 2023 President's Budget to ensure SNS could
better carry out its mission. As this Committee knows well, ASPR's
authorizing structure is such that the Biomedical Advanced Research and
Development Authority (BARDA) advances the development of medical
countermeasures, the Public Health and Emergency Medical
Countermeasures Enterprise--or PHEMCE--makes a recommendation regarding
their usefulness in our stockpile, and then SNS is supposed to be able
to purchase the products PHEMCE determines to be needed within
available resources.
While BARDA has been successful in supporting the advanced
development of a number of medical countermeasures to aid our
preparedness and response portfolio, the SNS's flat budget has made it
challenging to fully meet PHEMCE-identified goals for these
countermeasures. We are fortunate to have products in the SNS to combat
the ongoing monkeypox outbreak, but there will be lasting impacts on
overall preparedness against other threats, such as smallpox, because
of the realignment of medical countermeasures for this outbreak.
The Administration's continuing resolution proposal requests $3.9
billion for HHS to aid in the continued monkeypox response and ensure
stockpile preparedness is restored. I look forward to continuing to
brief Congress on preparedness levels and the impact that the current
response is having on our overall future preparedness efforts.
For the current response to the monkeypox outbreak, ASPR is
partnering with many sister agencies within HHS and across the Federal
Government, industry representatives, as well as state, tribal, and
other jurisdictional health leaders to accelerate progress on vaccines
and treatments--and strengthen our response. I will now highlight
ASPR's efforts to support development, procurement, and distribution of
vaccines and therapeutics and how we are disseminating information
relevant to these efforts.
National Vaccine Strategy
Since the first reported case of monkeypox in the United States on
May 18, 2022, ASPR has worked tirelessly to accelerate the acquisition
and delivery of vaccines and therapeutics to jurisdictions.
This important work first started with an examination of our
holdings within the SNS. As reported publicly, the SNS contains both
ACAM2000--our first line of defense to vaccinate Americans in the event
of accidental or intentional release of smallpox--and JYNNEOS, for
which we keep a small stockpile to routinely vaccinate laboratory
workers at risk of exposure to smallpox and other orthopoxviruses such
as monkeypox. In addition to the 2,400 doses the SNS kept on-hand for
rapid deployment, ASPR kept an additional 1.4 million vials of JYNNEOS
in -50 degree storage at Bavarian Nordic (BN) to be available if needed
for response to a larger outbreak. Those doses are now being deployed
for use in the current outbreak. ASPR also had an additional 16.5
million vial equivalents in bulk drug substance to be lyophilized (or
``freeze dried'') in the coming years for easier storage and longer
shelf-life. 5.5 million vial equivalents of that bulk drug substance
are being filled and finished now and in the coming months to respond
to the current outbreak.
ACAM2000, which is not approved or authorized by the U.S. Food and
Drug Administration (FDA) for emergency use to prevent monkeypox
disease, contains live, replicating virus and may not be advisable for
those who are immune compromised. Given the potential of monkeypox
cases in persons who may also have HIV or other immune compromising
conditions, ASPR worked with other HHS agencies and offices to
determine the JYNNEOS vaccine was our best line of defense against this
monkeypox outbreak.
On Wednesday, May 18, the first case was identified in the United
States. By Friday, May 20, there were two known cases of monkeypox in
the United States, and CDC recommended those known to be exposed to the
virus get vaccinated. On Sunday, May 22, the SNS deployed the first
vials of JYNNEOS vaccines to Massachusetts to be used as post-exposure
prophylaxis for those first exposures.
At this time, while there were still only two known cases of
monkeypox in the US, ASPR requested 36,000 JYNNEOS vaccine vials be
shipped to the SNS from our U.S. government-owned reserve stored by BN
in Denmark. When there were only 13 known cases, ASPR ordered an
additional 36,000 vials from its reserve. And when there were only 35
known cases, ASPR ordered an additional 300,000 vials from its reserve.
All of this was done to stay ahead of the virus. Though case counts
were very low in the United States, we were watching the quick spread
of cases in Europe, which was about 2-3 weeks ahead of us, and moved
out quickly anticipating similar rapid transmission in the weeks to
come.
Ultimately, of the additional 5.5 million vials we have ordered
filled and finished, we anticipate that deliveries will begin arriving
at the SNS in the next few weeks and will continue through early 2023.
To support this effort, 3 million vials will be manufactured at BN's
line in Denmark and 2.5 million will be manufactured here in the United
States at Grand River Aseptic Manufacturing (GRAM) in Grand Rapids,
Michigan. The GRAM facility is the first fill and finish line for the
JYNNEOS vaccine in the U.S. and not only supports our current response
to monkeypox but enhances preparedness for smallpox as well. Within
ASPR, we helped spur this agreement and the technology transfer that
was necessary for this production at GRAM and have invested $11 million
in securing supplies and staff to ensure the line is up and running as
quickly as possible. The transfer is on track to start manufacturing
later this year. I was pleased to visit GRAM on August 29, where I met
with the CEO and leadership team, and observed the hard work being done
to bring the line up as quickly as possible.
ASPR has made over 1.1 million vials of JYNNEOS available to states
and jurisdictions for use against the current outbreak--the largest
JYNNEOS monkeypox vaccine program in the world. Moving fast and
distributing the product ensures equity and access for those who
require the product. To support the allocation and distribution of
vaccine, in late June 2022, HHS announced an enhanced National Vaccine
Strategy (Strategy) to mitigate the spread of monkeypox. This Strategy
outlines efforts to ensure that those at higher risk of monkeypox
disease receive vaccine, vaccines are prioritized for areas with the
highest numbers of cases, and that guidance is provided to state,
territorial, tribal, and local health officials to aide their planning
and response efforts. Using this strategy we have made vaccine
available in phases throughout the summer. Phase 4 of the Strategy that
focuses on distribution and allocation efforts is well underway.
Currently, allocation amounts are based on a combination of case counts
and population (population is based on the estimated size of the
underlying population in the jurisdiction that might benefit from
expanded vaccination at this point in the outbreak). Jurisdictions are
eligible to draw down doses against their allocations once they have
attested to adequate utilization of their currently allocated vials.
Requiring jurisdictions to inform HHS of their administration data
plays an important role in informing the response and ensuring
monkeypox doses make it into the arms of those most at risk, rather
than sitting on shelves. Once jurisdictions receive vaccine, they are
responsible for distributing vaccine within the jurisdiction and
setting their eligibility criteria for vaccination. Jurisdictions may
choose to expand eligibility in the future depending on the state of
the outbreak and the available supply of the JYNNEOS vaccine as it
continues to increase.
Currently, doses are held in a small stockpile within the SNS and,
as such, distribution of the product has been managed by the SNS. The
SNS' traditional distribution framework is based on getting material
into jurisdictions quickly to respond to high-consequence events such
as hurricanes and other large-scale disasters. Having access to five
distribution points in any given jurisdiction has been satisfactory
under these traditional circumstances to move the necessary medical
units and countermeasures into place. As the SNS is now being asked to
distribute vaccines nationwide from its stockpile, something it has not
traditionally done, it is in the process of making arrangements with a
large distributor to increase distribution to more sites. This is not a
static response effort. At each point that I receive feedback from
jurisdictions on ways to make the response easier for them to manage, I
have worked with the programs here to adjust and incorporate the
feedback just as we are doing now with SNS distribution efforts. You
have my commitment that I will continue to do that throughout this and
future responses.
We are also providing a portion of vaccine for distribution through
existing Federal channels (the Departments of Veterans Affairs and
State, and agencies within HHS including the Health Resources and
Services Administration, the Indian Health Service, and the National
Institutes of Health). ASPR is working closely with HRSA to ensure they
are able to vaccinate individuals via their Ryan White networks; IHS is
able to vaccinate tribal members, often in rural and remote areas of
the country; VA is able to vaccinate our Nation's veterans; NIH is
receiving doses to conduct research; and DoS is able to ensure at-risk
personnel serving overseas are protected.
Treatment to Combat Symptoms of Monkeypox
Tecovirimat (TPOXX), a therapeutic drug licensed for smallpox
treatment, was developed with BARDA support and can be used to treat
individuals with monkeypox with an appropriate regulatory mechanism.
CDC currently holds, through FDA's Expanded Access program, an Expanded
Access Investigational New Drug (IND) protocol that allows its use for
monkeypox.
Prior to the start of the outbreak, the SNS held more than 1.7
million courses of TPOXX, or tecovirimat, in its immediate holdings. In
addition to deploying bottles directly to those who qualify under CDC's
IND protocol, on August 18, ASPR made available 50,000 patient courses
of TPOXX for pre-positioning throughout the country. Jurisdictions have
been allocated courses of TPOXX using a formula based 75 percent on the
number of cases in their jurisdiction and 25 percent on the number of
individuals who are at the highest risk of contracting the virus,
including individuals who are living with HIV or who could benefit from
HIV pre-exposure prophylaxis. This allocation is in addition to the
over 20,000 courses ASPR deployed to jurisdictions from the SNS prior
to August 18.
Engaging Those at Highest Risk for Severe Disease
HHS has launched two pilot programs to provide additional vaccine
allocations to state and local health departments. The first provides
doses to jurisdictions that are hosting large events that attract gay,
bisexual, and other men who have sex with men in the coming weeks and
months and the second provides doses to smaller more targeted outreach
efforts. The larger pilot program is setting aside 10,000 vials of
vaccine from the SNS that jurisdictions can request to order on top of
their existing vaccine allocations and supply. The number of additional
doses made available to a jurisdiction will be based on the size and
nature of the event, and the ability to reach attendees at highest risk
for monkeypox. The smaller pilot program is setting aside 10,000 vials
of vaccine from the SNS that jurisdictions can also request on top of
their existing vaccine. Working with CDC, ASPR is pleased to provide
these additional doses for targeted equity interventions.
Conclusion
Thank you again for inviting me to testify before you on efforts
within ASPR to support the ongoing monkeypox response. I look forward
to answering your questions and working with my team at ASPR and our
colleagues across HHS to mitigate the impact of this virus.
______
The Chair. Thank you. Thank you very much to all of our
witnesses for your testimony and for being here today. We will
now begin a round of 5 minute questions of our witnesses, and I
ask my colleagues to keep track of your time. As always,
hopefully you can stay within those 5 minutes.
I know each of your agencies have worked relentlessly to
respond first to COVID and now monkeypox, but I have to say,
frankly, too many missteps were made early on in the response
and a couple hundred cases turned into 21,000. It is
unacceptable to communities who already experience barriers to
accessing health care, like the LGBTQ+ and the Black and Latino
communities that are hardest hit by this outbreak.
Access to testing was an early challenge in the monkeypox
response, with many people reporting significant delays in both
accessing the tests and learning their results. To continue to
have these challenges around testing is just simply
unacceptable.
Dr. Walensky, let me start with you. How is the CDC working
to make sure tests are more accessible and results are
available earlier?
Dr. Walensky. Thank you, Senator, for that question. One of
the big challenges that we had in terms of access to testing
was both patients understanding what they--that they were
presenting with a new infection, and providers understanding
that this was a new infection that they had to test for.
Indeed, another important clinical consideration was that
people were coming in requesting a test when they had no
symptoms, and they had no rash. As Dr. Califf noted, the test
for this infection is a swab of the rash.
In fact, there is no other FDA approved test. We need to
have a rash in order to conduct those tests. So much of what we
have done--and I should mention that we have always had more
capacity than we have had tests coming in. To date where we
have used about 14 to 20 percent of our capacity.
But to address these access issues, we had to work with
clinicians, we had to work with patients. We had to do an
extraordinary amount of outreach so that providers would
understand how to test patients, would understand when to come
in for a test, and our public health partners would know not to
gatekeeping those tests.
That was the work that we did early on as we were scaling
up testing, knowing that we may need more testing coming
forward. So through the laboratory response network, we
increased our capacity to test through expanding the manual
extraction to automated extraction.
Then we worked, as you heard, through our commercial labs
to expand testing across the country, and simultaneously
working with outreach and education to providers, clinicians,
patients, and public health. Thank you.
The Chair. Thank you. Dr. Califf, Secretary Becerra
recently declared that FDA can use the emergency use
authorization pathway for monkeypox tests. How will that
improve the availability of new tests, and what steps are you
taking to improve on the progress that you have made?
Dr. Califf. First of all, let me concur with Dr. Walensky.
There has never been a shortage of tests but there has been a
shortage of access to tests because of inefficiencies in the
system. So the EUA authority has enabled us--we have given one
EUA already, but we also have five commercial labs which are
offering the tests at this point.
We issued a guidance just the other day which makes it
clear that individual institutions that are developing
laboratory developed tests should proceed ahead. And we have
given people clear guidance and templates for developing their
test and figuring out if they work.
I would say on all fronts, the gates are open under a
watchful eye because we also must keep in mind that one of the
lessons from COVID was that when the gates were open, a lot of
tests turned out not to be so good, got out there, and we had
to rein them back in.
The Chair. Well, look, I am encouraged by the decline in
cases, but it really is imperative that we remain vigilant. And
despite efforts by HHS to increase access to vaccines, some
people in my home State of Washington still go to great lengths
to get one, including crossing the border into Canada.
Now people, understandably, want to be vaccinated before
they get exposed, but that needs we need more vaccines. Ms.
O'Connell, some serious stumbles were made this year when it
came to our vaccine supply. What have you done to make sure
that never happens again, and what are you doing to increase
the supply and distribution of vaccines right now?
Ms. O'Connell. Chair Murray, thank you so much for that
question. What is most important to us is that those that need
access to this vaccine get it. So if you continue to hear from
constituents that are unable to access a vaccine or having to
cross the border, please let us know.
We are in the business right now of knocking down those
hurdles and making sure the vaccine can be accessed. We did
take a very small stockpile that was intended for smallpox,
that was eventually intended to be lyophilized, freeze dried
for smallpox, and converted it to this active monkeypox
response.
That required a couple of challenging problems to solve. We
moved the first 372,000 vials, as I mentioned in my opening
statement, immediately. We needed FDA to approve, and they were
terrific partners moving quickly, to approve that second
manufacturing line that began--drew the 800,000 vials we were
waiting for.
That is what it manufactured on. We needed that approval to
happen before we could deploy those. FDA worked quickly and we
got those out in July. We have also ordered an additional 5.5
million vials of the bulk drug substance that was intended to
be lyophilized for smallpox.
We have ordered that to be filled and finished and shipped
to the United States. 2.5 million of those will be manufactured
in the United States. By adding a second line in GRAM, one that
is onshore, domestic manufacturing, we will be able to access
these vaccines much quicker in the future.
It is a critical step forward in our preparedness, both for
this monkeypox response and for future smallpox programs.
The Chair. Senator Burr.
Senator Burr. Thank you, Chair. Tony, last time you spoke
on monkeypox here, you made it very clear that monkeypox is a
result of animal to human transmission, and that happened
abroad. Here is my question.
If we allow monkeypox to circulate in our population
indefinitely in the United States, what are the chances and has
it been studied whether there can be a transmission from human
to animal in the United States where we could have a threat
that is--animal to human transmission then that is domestic?
Dr. Fauci. It is certainly possible, Senator Burr. Whenever
you have a situation where you have an animal reservoir, and
the virus has already shown you from the standpoint of
transmission that it can infect animal species and you actually
have an individual who is infected, there is no real reason why
that not could go the other way. I don't believe that we have
seen that. But I would not be surprised if we do see a
essentially going back and forth. That is possible.
Senator Burr. That would present a real problem.
Dr. Fauci. Well, that would present a problem of the
propagation. I mean, when you want to eliminate an infection--I
mean, there is eradication, there is elimination, and there is
control. The best way to eradicate or eliminate it is if you
keep it out of the realm of an animal reservoir which continues
to re-feed into the human population.
Senator Burr. Great. Thank you. Dawn, news outlets recently
reported the Administration is evaluating whether some doses of
JYNNEOS should be held back in the stockpile to meet our
requirements for smallpox rather than distributed to support
the current monkeypox response.
This seems to conflict with FDA's recent decision to
implement dose sparing strategies, which indicates that we need
to maximize the number of available doses. Can you square this
up for me?
Ms. O'Connell. Thank you, Ranking Member, for that
question. So we continue to maintain our smallpox preparedness.
That is critical. Our front frontline vaccines continue to be
available and have not been impacted by our monkeypox response.
But we have added the capability to be able to provide the
JYNNEOS vaccine to those that are immunocompromised in the case
of a smallpox outbreak. And we are evaluating with each dose
that we make available to the monkeypox outbreak what it means
for that preparedness and smallpox.
I have met with the PHEMCE. I have consulted with them to
understand whether we need a separate monkeypox stockpile so we
can pull those vaccines off the shelf and not worry about the
preparedness for the immunocompromised in a smallpox outbreak.
Senator Burr. Have you ever thought about the message you
send to the at risk population when you suggest to them that
though they are in the midst of an infection problem, that we
are going to--we are discussing holding back in case we have an
outbreak of smallpox.
Let me just explain. We know that we have 13 to 15 million
gay men in this country, in the United States. Tony, we have
about 1.9 million HIV/AIDS positive gay men. There is your
immunocompromised population, 1.9 million. Your risk pool of
sexual for sexually transmitted monkeypox, about 13 to 15
million. And somehow we are cheering the fact that we put out
700,000 vaccines.
If I am in that community, and then on top of that we have
the subdermal decision, I am going to cut the amount that you
get, and there is not sufficient public transparent information
about that, you have got a population that is a little bit
questioning whether you are doing everything to help them.
That may be a reason that we have only had 461,000 people
vaccinated out of a pool, a defined pool, of up to 15 million
people, of which 1.9 million are immunocompromised because they
are HIV positive. Dr. Califf, currently the FDA--I switched
gears just real quick.
Currently, the FDA authorizes COVID-19 vaccines and
antiviral treatments to be purchased only by the Federal
Government, prohibiting anyone else that is not Government from
purchasing these vaccines.
I believe we all agree on the crucial role vaccines and
treatments play in stopping and reducing the spread of the
virus. So why must every dose pass through the bureaucracy of
Washington before it reaches a patient, and why are we still
restricting access like that?
Dr. Califf. Well, thank you, Senator Burr. It is--by the
way, I am glad you are fully functional after your recent
surgery, and you are definitely spry. You are showing good
evidence of that.
Let me just say that we have the vaccine. It is available.
It is everywhere. You can just make your appointment and get
it. And we expect that this will transition, as there has been
much discussion, over the next period of time. But for right
now, those are the rules under which we operate.
Senator Burr. That is why a plan is somewhat important. Ms.
Chairman, just one last question for Dr. Fauci, if I can. Tony,
the pediatric immunization schedule recommends four doses of
polio vaccine before one reaches the age of 6 years old.
With new cases of polio being detected in New York State, I
am wondering, do we know how long immunity for the vaccine
lasts? To what extent is someone protected if they were
completely polio vaccinated as a child?
Dr. Fauci. It is not necessarily life long, but it is
measured in decades and decades. So the--if a person has the
full series of vaccinations, you could expect that they would
be fully protected.
The situation that we are concerned about are those who
have either had no vaccination, like we saw with the case in
Rockland County in New York, or individuals who have incomplete
or did not complete their full course.
But if you have a full course--however, since it isn't
necessarily life long, when a person goes into a zone where
there is a lot of polio, you would recommend that they would
get a boost. But I would refer to perhaps that Dr. Walensky has
something further to add to that.
Dr. Walensky. I have nothing to add. That is exactly right.
Senator Burr. I thank the Chair. Thank you.
Senator Casey. Thank you, Senator Burr. I wanted to start
by thanking the witnesses, and obviously thank you for their
public service. I will start with Dr. Walensky. Part of the
success of the COVID-19 vaccination campaign was the gradual
shift from large vaccination sites to hyperlocal sites where
people could find vaccines in their own neighborhood, for
example, like at a local pharmacy.
We have seen the way in which convenient and local access
to vaccines can help with uptake, whether they are--whether we
are talking about a vaccine for a new treatment like COVID-19--
or a new threat, I should say, like COVID-19, or for routine
vaccines like influenza and childhood vaccines.
Obviously people know and trust their own doctor and their
providers, and they respond to community based and community
member led efforts that meet them where they are.
Doctor, how are you working with state and local partners
to make sure we reach everyone who is at risk for infection, to
make sure that they have the opportunity to get vaccinated if
they so choose?
Dr. Walensky. Thank you, Senator. A really important
question in terms of outreach. So early on as vaccines were
being distributed, we were doing it in places where people were
seeking care. Many of that--many of those places were in sexual
health clinics or state run clinics where people were receiving
care. It is the case that not all members of this community
have told their own clinicians about their sexual activity.
It is very important that we do this in a sensitive and
non-stigmatizing, affirming manner. So we were doing it in
places initially where people were receiving care, but then
many of the lessons again learned from COVID, as we have rolled
out these vaccines and delivered over a half a million to
members of these community, is that we need to do more and more
outreach.
We learned that we need trusted messengers, we need
community based organizations. I am pleased to say that over
the last several weeks, we have sponsored vaccine activities in
several large scale distribution sites like Atlanta Black Gay
Pride, like Charlotte Pride, like Boise Pride, and like
Southern Decadence. When we have done so, we have had really
successful campaigns.
In the Atlanta Gay Pride, we vaccinated over 4,200 people.
Similarly with Southern Decadence, around 4,000--3,000 people.
What we need to do now is do those in smaller scale, and we are
actively doing that scale up in smaller scale.
Rather than these big events, we need to meet people where
they are with community based organizations, trusted
messengers, exactly as you say. Thank you.
Senator Casey. Thanks, doctor. Next question will be for
both you and Assistant Secretary O'Connell.
We know that in the aftermath of the pandemic and now with
the emergence of monkeypox as a public health threat, the need
for ongoing, dedicated investment in our Nation's public health
infrastructure, similar to what Chair Murray has called for and
her Public Health Infrastructure Save Lives Act--our state and
local health departments have been struggling for years after
two and a half years of the COVID-19 pandemic and now with
monkeypox in addition to that.
They simply don't have the resources they need for routine
public health work. So when an emergency comes up, they have to
move funds around and sacrifice from their core programing.
Other programing, like the ongoing opioid epidemic, lead
screenings, anti-tobacco efforts, cancer screenings, routine
vaccinations, on and on. So how would additional sustained
funding for local public health infrastructure help us be
better prepared for new threats like a new viral outbreak?
Maybe I will start with you, Assistant Secretary O'Connell.
Ms. O'Connell. Thank you so much, Chair, for this question.
We continue to see states, jurisdictions, or public health
departments worn out, tired, exhausted.
We know they have been working for two and a half years
around the clock, and we have been relying on them to
distribute vaccines and therapeutics, both in the COVID-19
outbreak, as well as this new monkeypox outbreak. So one of the
most critical investments we can make would be in additional
staffing and not just throwing supplemental funds out that hire
people but don't sustain them.
It is important that we have multiyear funding that
supports our public health departments. It is also critical
that they can build these systems. I talked about the HPOP
system that we put in place for the SNS digitized ordering,
which is interoperable.
That we are no longer having them trained on something
called VTrckS that CDC sets up, and then HPOP that H-CORE sets
up, but we have it on one system that talks to each other. They
can order their vaccines and their therapeutics.
By introducing that in this outbreak, we knew that the
states were tired, and we worked very carefully with them on
making sure they understood why we made this decision. And
while it was hard, it does push us forward in a supportive way
as we face this current outbreak and future ones.
Dr. Walensky, I know that you might want to say more.
Dr. Walensky. Thank you. If I could just briefly add that
the core public health infrastructure is key. This needs to be
disease agnostic and long term sustainable rather than from
crisis to complacency. I will just give you the example that
our public health partners in the states and local
jurisdictions do not have a line item for monkeypox resources.
They have had to respond, trying to be flexible with other
resources that sometimes are not legally allowed. So as you
know, the key core public health infrastructure are the
workforce, diverse as the communities they serve, laboratory
infrastructure so we can scale up new labs swiftly, and then
data infrastructure, so we have interoperable data, just as the
ASPR noted. Thank you.
Senator Casey. Thanks very much.
Senator Paul.
[C-SPAN video clip playing].
LNews Anchor. ``--But she has had the flu for 14 days.
Should she get a flu shot?''
LDr. Fauci. ``Well, no. If she got the flu for 14 days,
she is as protected as anybody can be because the best
vaccination is to get infected yourself.''
LNews Anchor. ``And--''.
LDr. Fauci. ``If she really has the flu--if she really
has the flu, she definitely doesn't need a flu
vaccine--if she really has the flu.''
LNews Anchor. ``She should not get it again?''
LDr. Fauci. ``She doesn't need it because it is the
best--it is the most potent vaccination is getting
infected yourself.''
[End of video clip.]
Senator Paul. This is an ongoing question. And we have had
ever evolving opinions from you, Dr. Fauci. Currently, antibody
surveys show that 80 percent of children, approximately 80
percent of children have had COVID.
Yet there are no guidelines coming from you or anybody in
the Government to take into account their naturally acquired
immunity. You seem quite certain of yourself in 2004, but in
2022 there is a lot less certainty. One of the things that we
also know after looking at this for 2 to 3 years, is that the
mortality from COVID is very similar, if not less than
influenza.
When we look at this, we wonder why you seem to really
embrace basic immunology back in 2004, and how you or why you
seem to reject it now.
Dr. Fauci. Well, I don't reject basic immunology, Senator,
and I have never denied that there is importance of the
protection following infection.
However, as we have said many times and as has been
validated by the authorization of the--by the FDA through their
committee and the recommendation by the CDC through their
committee, that a vaccination following infection gives an
added extra boost, and that film that you showed is really
taken out of context.
I believe that was when someone called in who had a
reaction to a vaccine and asked me through a telephone in the
interview if they should get vaccinated again. So it was in the
context of someone who had a reaction.
As a matter of fact, Reuters fact check looked at that and
said, Fauci's 2004 comments do not contradict his pandemic
claim.
Senator Paul. Actually, words don't lie. If you look at the
words behind me, we can go over them a little bit at a time.
``She doesn't need it because the most potent vaccination is
getting infected yourself.''
Dr. Fauci. It is true. It is true, Senator. It is a very
potent way to protect.
Senator Paul. When you are trying to tell us that kids need
a third or a fourth vaccine, are you including the variability
or the variable of previous infection in the studies? No, you
are not. Because when you have approved vaccines in recent
times, in the committees that have approved it for children,
don't report anything on hospitalization or death or
transmission.
They only report that if you give them the jab, they will
make antibodies. And you can give kids hundreds of jabs and
they will make antibodies every time, but that does not prove
efficacy. So what you are doing is denying the very fundamental
premise of immunology that previous infection does provide some
sort of immunity. It is not in any of your studies.
Almost none of your studies from the CDC or from the
Government have the variable of whether or not you have been
previously infected. So let's look at adults. I have had three
infections. Should I get a fourth one?
If you are going to measure whether you get a fourth one,
you need a category that has a fourth one in it and you need
one that has nothing in it, no vaccine or the fourth vaccine.
But you also need to know whether they have been infected. If
you ignore whether they have been infected, you are ignoring a
vaccine basically, so you are ignoring a variable.
What you are giving us is this--you decry, and people decry
vaccine hesitancy. It is coming from the gobbledy-gook that you
give us. You are not paying attention to the science. The very
basic science is that previous infection provides a level of
immunity.
If you ignore that in your studies, if you don't present
that in your committees, you are not being truthful or honest
with us.
Dr. Fauci. Senator, if I might respond, I have never, ever
denied fundamental immunology. In fact, I wrote the chapter in
the textbook of medicine on fundamental immunology. You know--
--
Senator Paul. Is it--any of the guidelines for vaccines--
any of the guidelines for vaccines from the Government include
previous infection as something to base your decision-making on
with vaccines? Do any of the guidelines involve previous
infection?
That is why you are ignoring previous infection, because it
doesn't involve any of the guidelines. And furthermore, we have
been asking you and you refuse to answer whether anybody on the
vaccine committees gets royalties from the pharmaceutical
companies.
I asked you last time and what was your response? We don't
have to tell you. We have demanded them through Freedom of
Information Act, and what have you said? We are not going to
tell you.
But I tell you this, when we get in charge, we are going to
change the rules and you will have to divulge where you get
your royalties from, from what companies, and if anybody in the
Committee has a conflict of interest. We are going to learn
about it, I promise you that.
Dr. Fauci. Mr. Chair, can I respond to that, please?
Senator Casey. You may.
Dr. Fauci. Okay. There are two aspects for what you said.
You keep saying, you approve, you do this, you do that. The
committees that give the approval are FDA through their
advisory committee.
The committees that recommend are CDC through their
advisory committee. And you keep saying I'm the one that's
approving a vaccine based on certain data. I don't really
understand, with all due respect, Senator----
Senator Paul. You are the one that said you would not
reveal--you would not reveal what company gave you royalties or
what company gave the other scientists royalties----
Senator Casey. We have got to move on.
Senator Paul. That is what you told the Committee.
Senator Casey. Senator Paul----
Dr. Fauci. Sir, could I please answer that?
Senator Casey. Briefly, yes.
Dr. Fauci. You keep asking committees--they are not my
committee. They are the VRBPAC committee for the FDA and the
ACIP for the CDC. I don't have any idea what goes on----
Senator Paul. They won't reveal, as well as you, won't
reveal what companies----
Senator Casey. We are going to move on. We are over time.
Senator Paul [continuing]. royalties from.
Senator Casey. Senator Paul, you are over. Everyone is over
a little bit. I just want to make sure we keep on time here.
For the record, I know Chair Murray and previous Chairs of this
Committee of both parties, both parties have found videos to be
out of order, and I will note for the record, the video is out
of order.
We will move to Senator Smith.
Senator Smith. Thank you, Mr. Chair.
Mr. Chair, I ask unanimous consent to submit a letter from
AIDS United, the AIDS Institute, the National Alliance of State
and Territorial AIDS Directors, the National Coalition of STD
Directors, and the National Minority AIDS Council outlining
recommendations for a comprehensive approach to the monkeypox
response...Mr. Chair, can I have unanimous consent for that,
please?
Senator Casey. Yes. So ordered.
[The following information can be found on page 60 in
Additional Material:]
Senator Smith. Thank you very much. Thank you to our
witnesses. I want to add my gratitude to Dr. Fauci for your
service to our Country during some of our Country's most
challenging times.
Thank you so much. I want to also start by associating
myself with Senator Murray's remarks about the importance of
Congress coming together to make sure the Administration has
the resources that it needs to respond to the monkeypox public
health emergency.
I also agree on the need to sharpen our response and to
work effectively with public health departments, including in
Minnesota. Assistant Secretary O'Connell, we had a good
discussion last week about distribution of the monkeypox
vaccine, and I want to follow-up on that.
We talked about some of the challenges that the Minnesota
Department of Health has experienced. The issue is that ASPR
has opted to use the HPOP system, the health partner order
portal, as I understand it, to distribute vaccines rather than
the VTrckS system, which is how COVID vaccines were distributed
and what the Department is used to.
As I understand it from ASPR's perspective, the HPOP system
works better for distributing both monkeypox vaccines and
treatments directly from the Strategic National Stockpile.
There are also some challenges with interoperability, as I
understand it, with the VTrckS system.
But of course, the issue, as we discussed, is that by using
two different systems, one for COVID vaccines and one for
monkeypox vaccines, this is a real challenge for the Minnesota
Department of Health, and I suspect that this is a challenge
for other agencies as well.
Of course, this is happening at a time when these
challenges are falling on public health departments and staff
that are exhausted and burned out after the last two and a half
years of responding to COVID-19 and learning a new system in
the midst of all of this is really a challenge.
It is sort of exacerbated, I think, by the Department
having trouble tracking shipments of vaccines through VTrckS
and sometimes monkeypox doses just showing up unexpectedly. So
could you just address for me--I appreciate you talked about
this in your written testimony.
Could you address what steps you are taking to work with
state health departments that are in similar situations to
Minnesota's to help improve how this distribution process is
working?
Ms. O'Connell. Senator Smith, thank you and thank you for
the good conversation we had last week, and an opportunity to
talk about some of these challenges. So most important to us is
that those that need vaccines can get them.
If anyone continues to find this to be a difficult system,
please reach out and let me know. We want to knock down these
hurdles to ensure that folks have access. We now have enough
vaccine supply to meet demand, so it is important that people
are able to access it.
We have a similar challenge that Dr. Walensky mentioned it
with the states. The states aren't able to use their COVID
funding for the monkeypox response. We haven't been able to use
our COVID funding for the monkeypox response either. So when it
came to digitizing the SNS process, we were going to have to
put new money into either the VTrckS system or the HPOP system.
The HPOP system is currently being used in COVID-19 to
order therapeutics, so states do have familiarity with HPOP,
VTrckS was being used for the vaccines. Only HPOP could do
both. And we were faced with putting annual budget funding into
one of these systems in order to digitize the SNS ordering.
We chose to put it into the system that could actually do
both. We believe that was an important step in moving forward.
But we do acknowledge, Senator Smith, that our public health
department colleagues are worn out and tired.
We have had countless office hours with them to make sure
they understand the system. If they are running into any
problems, we are available to answer them. And as hard as this
changed management is in the middle of two responses, it was
the right thing to do to move forward to an interoperable
system.
We also have added additional distribution sites. That is
one of the things we did with the SNS. We could not just
piggyback on the COVID-19 distribution network. That was funded
with COVID dollars. We had to go with the SNS, do an entirely
new contract with a different distributor with annual funds,
and set that up.
That was one of the reasons why there was a delay. We have
needed to overcome this, and we will look forward to working
with Congress on making response dollars more fungible in the
future.
Senator Smith. I know that would be helpful, and I
appreciate your continuing to work the Department. And you
know, obviously getting the distribution right is everything
when it comes to getting vaccines and making sure that people
have access to vaccines.
Mr. Chair, I am out of time, but I will submit a question
for the record about the importance of tribal consultation to
our witnesses and look forward to your response.
Senator Casey. Thank you, Senator Smith.
Senator Collins.
Senator Collins. Thank you, Mr. Chairman. Secretary
O'Connell, I want to follow-up on the statement you just made.
I don't recall any requests from the Administration to use
leftover COVID money for monkeypox.
Moreover, it is not at all clear to me that you could not
submit a reprograming request to the Senate Appropriations and
House Appropriations committees for those--that purpose.
What exactly are you implying when you say that you haven't
been able to transfer funds? You have taken funds for other
purposes, including sending it to the border.
Ms. O'Connell. Senator Collins, thank you so much for your
question and for the conversations we have had recently about
issues. We have been advised by our legal counsel and by our
appropriations team, our budget and finance team, that the
money that is currently in the contract for McKesson, which is
our distribution network that each H-CORE is managing, could
not be--we could not piggyback on that same contract to set up
a monkeypox distribution network.
The way those funds work, we were restricted to supporting
COVID response efforts and not additional response efforts. But
I would be more than happy to meet with you and your team again
and see if it is possible to do a reprograming.
But that was what we were advised, and so we took
additional funds, different funds, non-COVID funds, and set up
a different contract with AmerisourceBergen for the SNS to set
up a distribution network.
Senator Collins. Let me turn to another issue that we have
discussed several times, and I do appreciate the fact that you
have made yourself available. We have statements from Dr. Jha
from OMB back in March that laments the decline of domestic
manufacturing for COVID tests.
It talks--OMB in its March supplemental request talks about
the volatility, which makes it difficult to preserve
manufacturing, domestic manufacturing of tests. Dr. Jha says
the U.S. Government put a lot of efforts and resources into
building up domestic manufacturing.
What we are seeing day by day, week by week, is that is
beginning to go away. I would suggest that it is the
Administration's contracting policies that have weakened our
domestic manufacturing of COVID tests. As you and I have
discussed before, the majority of the at home tests the
Administration purchased for COVID were manufactured outside
the United States.
For example, the Administration awarded a Chinese company,
iHealth, a $1.3 billion contract. That is roughly four times
the size of the contract that was awarded to an American
company, AVID, which has a considerable presence in my state.
How is it that the Administration is working with domestic
testing manufacturing when you are at the same time awarding
contracts to Chinese companies? That does not help to preserve
domestic manufacturing.
Ms. O'Connell. Senator Collins, thank you. Domestic
manufacturing of tests is a critical mission of ours in ASPR,
making sure it is supported and an enduring part of the COVID-
19 response. When it moves from an acute response to a steady
state, we will always want to know whether we have had COVID,
whether someone we have interacted with had COVID.
Testing is critical and domestic manufacturing of tests are
also critical. And regarding the iHealth contract, you will
recall when the President made the announcement that he was
going to make 1 billion tests available through the U.S. Postal
Service distribution system, the covidtest.gov.
He also vowed at the time that he would not interrupt the
commercial market, that he would not take tests that were
currently going to the pharmacies and into other stores, he
would not take them out of the market and put them into the
covidtest.gov program
In order not to disrupt that, the domestic manufacturers at
the time were seeding the local pharmacies, we pulled in tests
internationally so as not to interfere with what was available
at the pharmacies.
As soon as that leveled out, we made a commitment in the
spring to only support domestic tests moving forward, but that
initial decision was to not interrupt the domestic tests that
were currently feeding the schools, the pharmacies, and the
other pieces of the response. We wanted those to remain
available.
Senator Collins. Dr. Fauci, I just want to wish you well in
your retirement. And a very quick question for you. And it is
based on what you have written recently about the lessons of
the AIDS pandemic.
Though monkeypox cases are overwhelmingly related to sexual
transmission and men who have sex with other men, should we be
doing more to look at community spread and cases in the broader
community, such as, for example, testing anyone with an
atypical case of herpes or shingles regardless of their sexual
history?
Dr. Fauci. Thank you for that question, Senator. The answer
is yes, we are doing now sero surveys and surveillance that go
beyond the well-established high level of infection in certain
demographic groups.
That was part of the five pillars that I mentioned in my
statement about virology, immunology, transmission, reservoirs,
and serosurveillance. We are doing that in some of our studies,
but the CDC is also doing that.
We are actually doing it in collaboration with them, using
some of our cohorts in collaboration with the CDC's capability
to do that. Perhaps you want to comment.
Dr. Walensky. Yes, maybe I will add, and thank you Dr.
Fauci, that among our health advisory networks that we send to
clinicians and our outreach, for example, to the American
Academy of Pediatrics, we make recommendations just like that
say, if there is an atypical rash, please consider monkeypox
and test for it on your differential diagnosis. We make those
recommendations. Thank you.
Senator Collins. Thank you.
Senator Casey. Thank you, Senator Collins.
We will turn next to Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chair.
First, I would like to ask unanimous consent to enter into
the record an April 11th, 2022, article from Reuters entitled,
Fact Check of Fauci's 2004 Comments Do not Contradict His
Pandemic Stance.
Senator Casey. Without objection.
[The following information can be found on page 63 in
Additional Material:]
Senator Baldwin. Thank you. I want to join my colleagues,
Dr. Fauci, in wishing you very well in your retirement and
thank you so much for your service to this country. I want to
start with you for a question on basic research.
I think we are falling short when it comes to providing
sustained investments in preparedness. That is why I led the
Disease X Act to provide sustained funding for BARDA to focus
on medical countermeasure development for viral families of
concern.
We can't just keep on responding to the threat in front of
us. Dr. Fauci, can you explain how investments in smallpox
research have made us better prepared for this outbreak had
we--than had we not made those investments?
Dr. Fauci. Thank you very much for that very important
question, because it relates not only to smallpox and the
extrapolation of knowledge to monkeypox, but it relates to
virtually all elements of fundamental basic research, that
ultimately when you get to a problem that is a public health
problem, it can be applied.
As I mentioned in my written and in my oral statement, the
original work that had been done on orthopox viruses dating
back to 2001 and 2002 following the anthrax attacks, when we
put a lot of work into developing the countermeasures that
Assistant Secretary O'Connell mentioned regarding smallpox,
allowed us by getting another type of vaccine that is less
reactogenic and has less adverse events, which led to JYNNEOS,
which is now the primary vaccine for monkeypox.
The relationship between the smallpox research that had
been done for decades on orthopox viruses and the acceleration
of that research when we had the bioterror threat in 2001 and
2002, allowed us to respond rapidly with already developed
countermeasures in the form of TPOXX and JYNNEOS.
Senator Baldwin. Thank you. Dr. Walensky, for me, as we had
a chance to speak earlier, monkeypox is all too reminiscent of
our initial response to HIV/AIDS. I actually started my career
in 1986 on the Dane County Board of Supervisors. In that year,
the first cases of HIV/AIDS were reported in Wisconsin.
There was a tremendous amount of fear and paranoia and
sorrow in our community. We had to fight both the disease, and
the fear and the stigma and the discrimination that was present
in the community.
Dr. Walensky, can you describe CDC's efforts to work with
the LGBTQ+ community to combat misinformation, to reduce
stigma, and to ensure that folks have access to care?
Dr. Walensky. Thank you, Senator, for that question. Their
involvement and integration into our response has been
critical.
One of the first thing that we did when we heard about the
case on May 17th was outreach between our smallpox branch and
our HIV branch, because we knew that it was--both those
communities, both those scientists that were going to need to
come together to make our--to make a robust response. We have
had extraordinary outreach with the LGBTQ community.
We have met several times with the Human Rights Campaign,
the LGBTQ serving FQHCs, inter-pride and pride organizers. We
have facilitated best practice exchanges with tourism hubs. We
have palm cards for Provincetown, Fire Island, Palm Springs.
And then we have supported these large events like Black Gay
Pride, and Boise Pride, Charlotte Pride.
Importantly, one of the things that we did early on, and
this was one of the lessons learned from HIV decades ago, was
that on May 27th, we first published an iteration of sexual
health information on monkeypox for the LGBTQ community, so
they would understand what practices would decrease their risk
of monkeypox.
All of this engaging a very robust, very active, and very
helpful and informed LGBT community that have been essential in
not only working with us, but in educating their own community.
Thank you.
Senator Baldwin. Thank you. I will enter my last question
into the record for Secretary O'Connell on what ASPR is doing
to ensure this delay in vaccine availability is not a problem
in the future, and anything you need from Congress to help
address this.
Thank you, Mr. Chairman.
Senator Casey. Thank you, Senator Baldwin.
I will be turning the gavel over to Senator Baldwin, and
our next Senator, Senator Cassidy.
Senator Cassidy. Thank you, Mr. Chair. I was a medical
resident in 1983 to 1986 during the HIV epidemic when HIV just
exploded, so I am very aware of the need to have a robust
research and public health response to infectious diseases.
Now, Dr. Walensky, part of this has got to be predicated
upon trust between the American people and the agencies, that
the agencies are functioning as best as they can. I feel like
that trust is frankly been dissipated. I am sorry to say that
because I respect you as a clinician, as a person.
But I have asked you on multiple occasions as to what
percent of the CDC workforce is actually showing up. Frankly,
you have always blocked that. You have never given a straight
answer. I would like to enter for the record an article from
the Epoch Times in which they did a FOIA request to find out
how many folks at CDC were actually working, showing up, so to
speak.
Roughly 2,772 out of roughly 13,000 employees are showing
up every day, but 78 percent are working completely remotely or
come in maybe only twice every 2 months. Now, why is that
important? First, that was a knowable fact, but it was not
shared with Congress, we the representatives of the American
people. I think the American people would like to know that if
CDC is not functioning well, how many of the people are
actually showing up?
Now, I mentioned CDC is not functioning well because I now
reference an article which I will enter for the record from New
York Times on August 17th, in which you frankly, to your credit
point out, CDC has not been working well and that there is need
for wholesale change.
At the end of the article, they quote an acting director
of--under President Obama, Dr. Besser, who says that it is
hard--first pointing out that you are still working remotely,
you, yourself are working remotely, at least of August 17th,
and then he says, but it is hard to see how Dr. Walensky could
execute wholesale changes when she only sees most of her staff
at a distance.''
I don't know how you motivate and inspire culture change
when people aren't together.'' Now CDC is requesting billions
of dollars for public health initiatives in an agency which, by
your assessment, is not functioning well, in which only about
22 percent of the people are showing up every day, and in which
previous Obama officials are doubtful that you are going to
affect change because you don't show up every day.
I say that kind of painfully because I want the CDC to
work. And yet--and one example, and I am sure there is a reason
for it, but there has been a lot of talk about the need for
local agencies to have to modernize.
But the CDC was given $200 million under the CARES Act for
data modernization to be awarded to 64 different state,
territorial, local jurisdictions. And maybe this is HHS, maybe
it is not CDC, but most of it has not yet been spent or
allocated.
This is according to the CRS. So it is incredibly
frustrating that a deliberate decision was made to not be
transparent with the American people as regards the amount of
people who actually shown up for work. It takes a FOIA request
from a newspaper and now you are asking for billions more, why
should we trust?
Dr. Walensky. Thank you, Senator, for that comment. I will
say that we are an agency of 13,000 people. The people who need
to be at CDC are at CDC, of course, our laboratory workers. We
have many people in the field. We have people in 60 different
countries.
Senator Cassidy. Yes, but the article points out that there
are many--that it is just wide open. That there is nobody
showing up. That the offices are empty. So to suggest that all
these people are field workers, I think, again, is another
example of being opaque.
Dr. Walensky. I don't imply that they are all field
workers. I am saying that many of them are field workers. Many
of them are working at CDC and then deployed in responses, and
many of them are on the road. I myself was in Atlanta last week
for a day, but I was in New Mexico with tribal visits and doing
a Secretaries tribal advisory committee meeting. So many of us
are on the road. I am here today, and I am working----
Senator Cassidy. I am sorry, what percent of CDC employees
before the pandemic actually showed up for work every day as
opposed to the only 22 percent now?
Dr. Walensky. I don't have those numbers for you.
Senator Cassidy. Yes, that is--I just feel like, how
should--and let me go back to, why should we trust CDC with
billions when it is very difficult to get, I would say, a
straight answer on what is the workforce in-person effort, and
particularly when by your own assessment, the agency is working
so poorly?
Dr. Walensky. The review that we did on August 17th was to
demonstrate the lessons learned from the COVID-19 response.
That people of the CDC are working well, they are working hard,
and they don't necessarily need to be onsite in Atlanta. In
fact, oftentimes they are more productive offsite, in the
field, doing the work of public health.
Senator Cassidy. I would just--we are out of time but let
me just say that the former Acting Director of CDC from
President Obama, when he said in the last paragraph of The New
York Times article, he did not see how you were going to be
able to, speaking of you in particular, affect change when you
only see people every now and then.
He was both suggesting that it was not a work completed,
but it was something that had to happen now, and that when
people not working together made that more difficult to
execute.
I don't think anybody in here or anybody watching really
thinks that only 22 percent of the CDC employees showed up for
work at the building every day before the pandemic. They think
it was probably 78 percent and now the number is reversed.
It is going to be hard for me to support more
appropriations until we have a better relationship, a more
trusting relationship, a more transparent relationship between
the agency and Congress, which you are asking to fund your
activities. With that, I yield.
Senator Baldwin. Next, Senator Hickenlooper.
Senator Hickenlooper. Great. Thank you, Madam Chair. And
thank all of you for your service through obviously one of the
great challenges this country has ever faced in its public
health history, the pandemic.
Then coming out of the pandemic, now we see other
challenges. Let me talk a little bit about COVID-19 and the
lessons learned. And we learned what to do and also what not to
do. Again, we are back here with another public health
emergency.
I guess I would ask you, Dr. Fauci, and I would want to
echo also my gratitude and salutations for--I know that you
won't really retire because I don't think you are capable of
not contributing to the public good, but I know you will try.
But the pathogen research at NIAID was critical to the
development of orthodox vaccines and treatments, obviously a
big help with monkeypox. But we may not have stockpiled
vaccines for the next pandemic similar to COVID.
I am just asking, in terms of the next public health
emergency, how concerned are you that this next one, the next
public health emergency will be one that we don't have vaccines
or therapeutics for?
Dr. Fauci. Thank you for that question, Senator. We always
are concerned when you get a brand new infection that you have
had no experience with, that you are not going to have
countermeasures, particularly vaccines, that are ready in a
timely fashion. So there are two approaches to that.
We have described in detail in several publications and in
some of our white papers what is called the prototype pandemic
and prototype pathogen response. In other words, to look at
multiple families, and there are about seven or eight high
priority families.
By families we mean alphaviruses, arenaviruses,
filoviruses, flaviviruses, and to do fundamental core research,
for example, to get commonalities among the pathogens within a
family, and to start to develop vaccines, put them in phase
one, and have them ready to go. With the new mRNA technologies,
it is very simple to switch one epitope or one antigen in and
out of the vaccine.
That is the core of our approach right now, and I think you
will probably be hearing more about it, because that is the
thing that we are putting forth as the NIH's contribution to
the Government wide pandemic preparedness, is the prototype
pathogen approach.
Senator Hickenlooper. I support that approach. I think that
is the right direction to go and to be make sure that we are as
prepared as one can be for what is unknowable and respect the
challenges of that preparation but also the urgency.
We can agree and argue about--I think that the Government
agencies across the board are going through the issues of how
many people are going to work and how many of people are
working remotely. Every large corporation is dealing with this
right now and we are going to have to process through that.
But in the meantime, we have got to make sure that we have
the funding for pandemic preparedness because that is essential
to the long term future of this country in almost every way.
Let me switch to this outbreak of monkeypox. When it broke out,
we had almost 800,000 vials sitting at the manufacturers
facility in Denmark. But the shipment of these critically
needed vaccines to the U.S. was held up pending.
There was an FDA inspection of the facility even though
European regulators had approved it. Dr. Califf, I would ask
you, how do--how can we help the FDA better balance safety
protocols with the urgency and the need to respond quickly to
these emergencies?
Dr. Califf. Thanks, Senator. You know, the issue that
occurred in this case was there was a new plan that the BN had
switched to. It had not been inspected by the FDA. I probably
don't need to remind you that we had more than one incidence in
COVID times of a manufacturing facility not being up to par,
which created a lot of difficulty and trouble. So we felt it
was essential to get there.
In fact, we got there very quickly after the application
came in from the company to do it and the outbreak occurred.
But I think the balance here is the risk of a vaccine which is
not up to par with the time it takes to make sure that the
vaccine coming out actually will do the job that is intended.
I would also just add, Europe doesn't have a central
inspections team for vaccine facilities. Each country does its
own, and we have had some discordance historically between
findings in some of those facilities and what we found in our
inspection. So we really felt we had to get this right, even if
it took a bit more time.
Senator Hickenlooper. Okay, fair point, great.
I yield back to the Chair.
Senator Murphy. Senator Marshall.
Senator Marshall. Thank you, Mr. Chair.
To my panelists, as I read your testimony, listen to your
testimony, what you described to me as an academic response to
a problem. As opposed to being proactive, we are being
reactive.
I would challenge you all to change your culture so that we
are more proactive, a more of a military response to a problem
like this. When I look back through the history of this virus,
July 2021, there was a case in Texas from Nigeria, November
2021, a case in Maryland from Nigeria.
In May 2022 of those cases in multiple countries, all
linked to Nigeria. And there was a moment in time before the
horse was out of the barn that we could have stopped this. And
now I fear that this virus is being transmitted from human to
animal. Once it is in the animal kingdom, we will never be able
to get ahead of this.
My question for Secretary O'Connell is, did you ever
consider a travel ban or requiring vaccinations from people
that have traveled from Africa before they get back in this
country?
Then you made a statement on June the 3d of 2022 that you
said, I want to say we have enough on hand to manage this
current outbreak. Do you still think that was the case then?
And if so, why is it still exploding?
Ms. O'Connell. Thank you. Senator Marshall, I would like to
take the second one first, and then invite Dr. Walensky, who
has----
Senator Marshall. We don't have much time but go ahead.
Ms. O'Connell. Okay. At the time that I made that
statement, we were using the ring vaccination strategy, which
is a strategy that has been effective in monkeypox outbreaks,
including the ones that you just mentioned previously. It
requires vaccine being administered to the person that has the
virus and their close contacts.
As the spread of the current outbreak began to indicate
that anonymized partners would make it difficult for contact
tracing to happen, we pivoted to those that were likely to be
exposed and we expand----
Senator Marshall. There is plenty of vaccines, and the
problem was the execution and getting the vaccines to where
they were needed?
Ms. O'Connell. The strategy that we were using to vaccinate
the at risk population changed as we were seeing the
transmission change.
Senator Marshall. Okay. Dr. Walensky, just briefly, yes or
no, did you all consider some type of a travel ban or requiring
people to have a vaccine before they came to this country?
Dr. Walensky. Maybe if I could just clarify. The two cases
in 2021, one in Texas, one in Maryland we were aware of, there
were no contacts that ultimately had monkeypox. Those were
isolated cases and----
Senator Marshall. But they traveled to Nigeria--from
Nigeria.
Dr. Walensky. Yes. And we have known that monkeypox is
endemic in Nigeria as well as DRC. And intermittently over
years, including two last year, we have intermittent travel
cases that have led to no further cases. That happened in 2021.
This is a different outbreak. This is May 17th was our
first case, when we had our first case. I spoke to the
clinician who made the diagnosis. We called Public Health
Canada as that patient had traveled from Canada and we
immediately started outreach with our colleagues in UK as well.
Senator Marshall. I think it is a no. But there was
multiple cases across Europe already with most of them
connected to Nigeria. I want to turn to fentanyl poisoning just
a second, Dr. Walensky.
Probably two people, one or two people have died with
monkeypox in the United States that I am aware of, but everyday
hundreds of Americans die from fentanyl poisoning. Why have you
not declared this a public health emergency? Why have you not
asked the Administration to shut down the border where 90
percent of this fentanyl comes from?
Dr. Walensky. The declaration of a public health emergency
is under the Secretary, so I would have to defer that comment.
I will say that----
Senator Marshall. But you could recommend to him that would
be done.
Dr. Walensky. We have those conversations. But what I will
say is that our ability to shut down the border at the CDC
level is related to communicable diseases. And while the
fentanyl challenge----
Senator Marshall. You are turning your back on the
fentanyl----
Dr. Walensky. Not at all. I just said I don't have the
authority----
Senator Marshall. More people have died of the poisoning--
more Americans have died from fentanyl poisoning than we lost
in Vietnam. This is what is killing Americans every day, is
fentanyl. Do you not have a heart for these people, for these
moms and dads and these kids?
Dr. Walensky. I absolutely do. And in fact, through my
career, I have cared for many of them. And it is tragic. And we
are doing a lot at CDC----
Senator Marshall. What are we doing?
Dr. Walensky. But we do not at CDC have the authority to
shut down the border on anything except a communicable disease.
Senator Marshall. What are we doing?
Dr. Walensky. We are doing outreach. We are doing mental
health. We are doing community violence. We are doing
surveillance. We are doing----
Senator Marshall. But tons of fentanyl continue across the
border. Really quickly, in 2017, there had been no cases in
Nigeria for 40 years. Suddenly there was an outbreak, I guess
218 cases since then.
The CDC, Echo Health, UC Davis, funded by USAID were all
doing research in Nigeria at the time. I think it is for Dr.
Walensky as well as Dr. Fauci. Were you aware of this research?
What was the purpose of the research? Was it just collecting or
were we doing more than collecting? Were we concerned about lab
outbreaks?
I have got a list of questions related to that research,
but Dr. Fauci, were you aware of that research in 2017?
Dr. Fauci. No, I am not. But I could get that information
to you, if--I will have to check with the staff. I was not
aware of it myself personally.
Senator Marshall. Dr. Walensky were you aware----
Dr. Walensky. We have been conducting monkeypox research in
Nigeria for years, and I would be happy to get you the details.
Senator Marshall. You know what the purpose of that
research is?
Dr. Walensky. I would be happy to get you the details.
Dr. Fauci. As I mentioned in my remarks, we are conducting,
will be imminently conducting a clinical trial of JYNNEOS--of
TPOXX, excuse me, in the Democratic Republic of the Congo. That
is not fundamental basic research, that is a clinical trial in
the Democratic Republic of the Congo.
Senator Marshall. Thank you, and we look forward to your
answers. I yield back.
Senator Murphy. Senator Hassan.
Senator Hassan. I want to thank the Chair and Ranking
Member for this hearing, and all of our witnesses for your
work. Ms. O'Connell, I want to start with a question for you to
really just give you an opportunity to build on earlier
testimony.
The Department of Health and Human Services has been
responding to COVID-19 now for over 2 years. You address this
to some extent in your testimony, but could you just explain
further how the Department's experience with COVID-19 is
informing its monkeypox response?
Ms. O'Connell. Thank you so much, Senator, for that
opportunity. So we are continuing to actively respond to COVID-
19 but are continuing to pick up lessons as we go.
One of the critical lessons is making sure that we have
systems, when countermeasures are ordered, where states can
order both the therapies and the vaccines on a same
interoperable system.
We have done that now as we have digitized the SNS's
ordering process. It was also important that the SNS have
multiple distribution sites across jurisdictions and states.
Jurisdictions and states got used to that in our COVID-19
response.
The SNS up until this point has really only been able to do
five distribution points in any state, consistent with the
large scale high consequence incidents it has been responding
to, like hurricanes, tornadoes. But now that we move to this
national vaccine strategy, where we are trying to get vaccine
out quickly to the high risk populations, having those
additional distribution sites is critical.
We have, the SNS has entered into a contract now with
AmerisourceBergen, which will allow it to distribute to
multiple places, 500 ambient, 500 frozen distributions a day
for 5 days a week. So up to 5,000 distribution points. Another
thing that we have done is we have created a framework to
ensure that the vaccines aren't going to the wrong place.
One of the things we saw when we seeded the country in
COVID and made sure we were giving it out on a prorata basis,
that sometimes it would end up in the wrong place and was not
being administered.
We have asked states to self-attest to 85 percent usage. Is
it going to the right places? That has not been a barrier. We
are continuing to work with states to ensure that their second
courses don't count against their 85 percent, and that those
that are in the field don't count against their 85 percent.
But it has been a good framework for us to make sure shots
are getting in arms, most important thing right now, and not
sitting on shelves.
Senator Hassan. Thank you very much. I am going to switch
to a different topic with Dr. Califf. I want to build, Dr.
Califf, on conversations we have had before to discuss another
public health emergency, which is the opioid crisis. During
your confirmation hearing, we discussed how the FDA helped fuel
this crisis by approving and labeling opioids for long term
use, despite a lack of strong evidence supporting those labels.
I was encouraged when you told this Committee that under
your leadership, the FDA would aggressively look at relabeling.
But in the 6-months into your confirmation, the FDA has yet to
change any labels.
The opioid epidemic continues to ravage communities in New
Hampshire and all across the country, as we have all
acknowledged this morning, and your agency needs to move
swiftly to correct its previous mistakes.
You, yourself have repeatedly said that the FDA needs high
quality evidence to support the long term use of opioids. The
agency has the authority to remove labels from drugs now, given
the absence of this evidence. So why is the process taking so
long?
Dr. Califf. I want to express appreciation for your
question. And to mirror what has already been said here today,
we are currently losing more people from opioids than we are
from COVID. So this is a national issue that we need to all
take seriously.
I have taken the first 6 months to get an assay of
everything that is going on inside the FDA and all of
Government response, and also in the face of the fentanyl mail
order issues that are going on with high dose fentanyl.
None of that obviates the need to get back to the basics of
the prescription of opioids. We published our framework last
week. You will see changes over the next few months within the
context of that framework.
Senator Hassan. Are you telling me that you are considering
that the framework calls for relabeling opioids?
Dr. Califf. It is under active consideration and discussion
within the FDA, yes.
Senator Hassan. Because look, I just was at a recovery
rally in my state with people who have engaged in peer to peer
recovery. People who are helping pregnant women with their
recovery, people, parents who have lost two children to
fentanyl and to opioids.
The FDA first approved and labeled opioids for long term
use more than 25 years ago. That means that they have been on
the market for more than 25 years without substantial evidence
that they are effective for that purpose and with plenty of
evidence about the harm that these drugs can cause.
I appreciate that there is a framework out there, but what
people are looking for right now is action. I will continue
working with my colleagues on both sides of the aisle to ensure
that it happens. And again, I thank you for your service and
your attention to this.
Dr. Califf. I appreciate that.
Senator Murphy. Senator Rosen.
Senator Rosen. Thank you, Chair Murphy, and for holding
this important hearing. Thank you for everyone being here,
doing all that you do in these trying times, that is for sure.
I want to talk a little bit, though, however, about clinical
guidance for all our practitioners, of course, their support
staff, to prevent and treat monkeypox.
Because I would say many clinicians, maybe a majority of
clinicians, have not directly treated monkeypox and may have
not seen a wide range of cases, so it is critical for clear
guidance to be widely available to all medical professionals,
and I would also say their support staff who don't--do answer
the phones, take the questions in the room when they are doing
their own histories and physicals. It is important for
treatment and prevention.
Regarding monkeypox prevention, I have concerns about the,
not just the slow rollout of vaccines to vulnerable
populations--and I appreciate that you have been doing
significant work to make the vaccines more available.
But with all these vaccines rolling out, there is a new
COVID vaccine, the flu vaccine, there is a pneumonia, there is
a shingles, of course, then there is other things that people
might get, tetanus, this or that--for adults. I am talking
about adult population. So a lot of confusion about boosters.
Can I combine vaccines?
I am really, really concerned that the CDC, Dr. Walensky,
what are you doing to mount this public information campaign on
the wide variety of vaccines, important ones available--we
don't want someone and maybe not get a shingles.
My parents both had it. It is very painful. How are we
going to do that at pharmacies and public spaces, even besides
our doctors--people may not be going to a doctor or a clinic,
but maybe they are going into their local drugstore or grocery
store every week, right?
Dr. Walensky. Yes. So thank you, Senator, for that
important question. I think one of the things you raise is one
of the challenges that we have seen first with COVID, now with
monkeypox, and one of the places I would really welcome
Congress's help. We don't have a mechanism in this country by
which we inform our clinicians of a new outbreak or a new
disease.
This has been through a lot of public education. We have
had a massive amount of outreach. We have health advisory
networks that we reach out to. When we put out a health
advisory, and we have done four for monkeypox, they reach about
a million clinicians.
We have done what we call clinician outreach webinars and
calls, COCA calls. They reach about 6,000 clinicians. We put
them online, they are reaching about another 10,000 each one
that we do. We have done several of those. I personally have
sent a letter to all board of clinicians through the AAMC.
I am working with each state to try and send letters out to
inform people of a disease that they may have never heard of
and may have never seen but tomorrow might walk into their
clinic.
What do they need to know, what are the protections that
they need to take, and how would they diagnose, treat, and care
for a patient with this infection. So that has been a lot of
the work that we have had to do during this outbreak. I will
say from a health worker safety standpoint, at least as far as
monkeypox is concerned, we have seen very little outbreak in
health care workers.
We have had one diagnosed health care worker after a needle
stick injury, but we have seen very little health care worker
outbreak due to our personal protective equipment and the
outreach that we have done in telling healthcare workers how to
protect themselves.
Senator Rosen. What about the broader idea of that we have
this fall so many vaccines that are available, we will just say
to the adult population, preventative vaccines for--that we
normally have, flu, shingles, pneumonia for a few of those, now
a COVID booster, now potentially a monkeypox shot. How are you
going to just get this out to patients and consumers, people in
general?
Dr. Walensky. We do a lot of provider calls for that as
well. Our advisory committee----
Senator Rosen. What if you are not going to a provider, how
are you going to get it to the average person?
Dr. Walensky. Well, so we have been doing public--we have
been doing press conferences, we have been doing advisories as
we have rolled out both the BIVALENT booster. We have a massive
flu campaign that we roll out in early October, which we will
again do this year.
One important thing I want to just highlight, though, is
that we at CDC and we in this country do not have a mechanism
like we do with children. You listed adult vaccines. I believe
there are 13 of them that are advised. Adult vaccines, we do
not have a mechanism in this country to finance adult vaccines
the way we do it at Vaccines for Children's Program.
When we look at the equity of getting vaccines to rural
populations, to other populations, we do not have a mechanism
by which to do that in an equitable fashion the way we do for
children, and that is a big constraint that we have right now.
Senator Rosen. Thank you. I know I only have 20 seconds
left, but Dr. Fauci, I just want to ask you quickly, we have
monkeypox, so medication to treat the infection, but their
symptom management.
We hear a lot of talk about opioids. I know it is very
painful, monkeypox. I don't know what the treatment might be,
but what kind of guidance are you giving the medical community
about effective pain management as it relates to the
neuropathy, I would imagine, that monkeypox causes.
Dr. Fauci. There are medications for the neuropathy, but
importantly, particularly when it is on the mucosal surface, be
it the anal, rectal, mucosal, or the urethral mucosal, they can
be extraordinarily painful. We recommend, and the hospitals do
this anyway, I think that is pretty common knowledge--it is an
acute not a chronic pain.
It is the kind of thing that you would not hold back on any
type of pain medication just because you are concerned about
addiction. The discussion that we have been having about
fentanyl and the opioids is not using it for chronic pain.
This is not chronic pain. This is very acute pain that
usually resolves itself within a period of a couple of weeks,
but you certainly don't want your patient to suffer
inordinately by holding back pain medications.
Senator Rosen. Similar to that pain of shingles in that
same way. Thank you. My time has expired. Thank you very much.
Senator Murphy. Thanks, Senator Rosen. I will recognize
myself for questions. I have two. One for you, Dr. Walensky,
and one for Dr. Fauci. Dr. Walensky, one of the things I panic
about is your access to data. And you have talked to this
Committee about it. We have talked personally about it.
But outside of emergency authorities, you are stuck in a
position today in which you have to negotiate 50 different data
sharing agreements with states all over the country. And we
expect a lot of the CDC, but it is hard to expect too much of
the CDC when you don't have the authorities, as I understand
it, to get the data you need absent an emergency.
When we look at what is happening today with monkeypox, you
are getting data, but it is patchy. For instance, you are not
getting full demographic data. So there is a lot of states that
aren't reporting to you, for instance, breakdowns of cases on
race or ethnicity. And that really hurts our ability to target
who gets the vaccine, right, who gets resources.
It is certainly in the context of monkeypox, but maybe more
broadly, what position does it leave you in when you don't have
the authorities to be able to compel states in a uniform way to
get you good data?
Dr. Walensky. Thank you, Senator, and thank you for the
question and for your leadership in working with Senator Kaine
and Senator Baldwin in trying to get us the authority so that
we can provide these data to you.
We have been working closely, tirelessly with state and
local public health staff who have been doing the same to
extract data on this outbreak specifically. We have actually
negotiated now 61 data use agreements. We have navigated
bureaucratic approvals for data to get flowing. We have set up
voluntary arrangements directly with large commercial labs to
send their data.
But it has been hard, and it should not be this hard. And
if we can't make informed decisions based on the best possible
data coming into us, we are not making the best decisions for
the American people. The existing patchwork of data systems is
not working. It is not working to the best ability of the
American people.
For monkeypox specifically, I can tell you that I don't
know the total number of people hospitalized with monkeypox,
the data on laboratory testing in the United states, complete
demographic data, as you noted. Which people with monkeypox
have been vaccinated? We can't then link the monkeypox vaccine
data to the laboratory data.
Demographic data, as you noted, we get 27 percent of our
demographic data on testing. We have received 47 percent of our
demographic data on cases. 91 percent of our demographic data,
because of these data use agreements, on vaccination.
Senator Murphy. I would just much rather have you be in the
business of fighting the public threats presented to the
country than in constant negotiation over data sharing
agreements. It seems like an essential function of the Federal
Government to set up a uniform way in which you get data,
rather than putting you in the position of negotiating over and
over and over again these data use agreements.
My hope is that soon we will be able to find a consensus on
that here. Scary that you don't know how many people are
hospitalized with monkeypox today because of your inability to
get that data.
Dr. Fauci, in the minute and a half remaining, I just want
to talk a little bit about what we learned, what you learned
over the course of the information distribution campaign for
the COVID vaccine, and how that relates to what we are
communicating about JYNNEOS. Because there has been some amount
of information regarding questions about the level of
protection, the duration of the immunity when it comes to the
monkeypox vaccine.
I don't know that this was necessarily your fault, but in
the euphoria of the sort of early news of the COVID vaccine, we
probably got out a little bit ahead of ourselves in terms of
what level of protection it could provide.
What did we learn about how to talk about a vaccine in its
early distributions stages, and how does that inform how we
should talk about the monkeypox vaccine?
Dr. Fauci. Well, first of all, they are two entirely
different pathogens. And the response and the durability of
response to each is really quite different. It was a rather
unique situation with COVID vaccine, where there was no doubt
that the initial protection against symptomatic disease as well
as severe disease, was well into the 90's.
That was the really good news. The sobering news was the
durability of protection, particularly against infection and
symptomatic disease. Fortunately, the durability against severe
disease lasted.
But if you look at coronaviruses in general, which is
usually a good parameter of what the response to a vaccine is,
even with a coronavirus infection, the durability of protection
against reinfection long before COVID came along, just the
typical common coronaviruses, did not last very long.
We see instances of reinfection with the same coronavirus.
That poses a very different situation, which leads to the need
for and the importance of updating vaccines and giving the
boosters that are part of the regimen in addition to the
primary regimen. When you are dealing with a pox virus,
inherently pox viruses have a much greater durability of
protection.
We know that because smallpox itself, once you get
infected, you are essentially protected for life, against
reinfection. Once you get vaccinated with the standard smallpox
vaccination, you can be sure that the durability is measured at
least in decades and maybe lifetime.
What we are dealing with now with JYNNEOS is that it likely
is going to have a durability of protection if you get the two
doses, not just one. We want to make sure people get their two
doses. The durability very likely is going to be much greater
than that shorten durability of the COVID because they are
really fundamentally two different viruses.
Senator Murphy. Thank you very much, Dr. Fauci.
Senator Braun.
Senator Braun. Thank you, Mr. Chairman. I have two
questions. First for Dr. Walensky and then for Dr. Fauci. Over
the last two decades, HHS has issued only four public health
emergency declarations, H1N1, Zika, opioid crisis, and COVID-
19. On August 2d, declared monkeypox a nationwide public health
emergency.
Of the over 20,000 people diagnosed with monkeypox, since
May 2022 there has been one fatality. I am concerned that the
public health emergency declarations will not be taking
seriously if it is a litany for every new challenge that comes
along, the way we are going to get the public to buy into it.
I guess I would like to ask, what are the criteria used for
determining whether a disease or a disorder constitutes a
public health emergency?
Dr. Walensky. Thank you for that question, Senator. What we
were seeing in late May, early June, was a doubling time of
this, of new cases of about every 8 days. So increased number
of new cases.
Among the things that is important, I think, is we
understand when a public health emergency--and in fact, I will
invite the Secretary, Assistant Secretary O'Connell to maybe
chime in here as well, is what are the things that public
health emergency unlocks for us to be able to do, whether it be
in flexibility of funding in resources, whether it be in
emergency use authorizations, whether it be in other
flexibilities, so that we have the capacity as an agency to
deliver as much health as possible.
I don't know if Dr. Califf or Secretary O'Connell want to
chime in there.
Ms. O'Connell. Just to concur with what Dr. Walensky said.
The public health emergency created an atmosphere in which FDA
was willing to use its emergency use authorization authority,
on which it was easier for states to give us the data that
Senator Murphy and Dr. Walensky just talked about.
It makes it easier for local public health departments to
shuffle employees around in order to put them toward the
current response. So it created some flexibility. That was also
an important signal to the community that we were paying
attention, that this is an emergency in our view, and that we
want to provide as much countermeasures and response mechanisms
as possible.
It also aligned with what WHO did. It declared a public
health emergency of international concern. We have the most
cases in the world. So it was consistent with what their
determination was. Ultimately, it is the Secretary's decision,
and he made that decision in August, as you said.
Dr. Califf. Senator Braun, I would just chime in quickly. I
agree on all the things that were unlocked. And the point is,
we need to keep looking at our emergency capacity and our
planning for it. I think we all agree we need to keep looking
at this as a continuum because with climate change and
everything else, there are going to be a lot more of these that
come along.
Senator Braun. I basically agree with that
conscientiousness, that kind of a being ready for it. But you
do have to keep in mind that if it does enter some kind of a
sequence where it gets dismissed because it is being declared
too often, to me it looks like you would want to develop some
criteria that I know it is difficult to get everything into a
subset, but I worry about how people will view it if it is a
litany of public health crises.
When we went through the COVID-19 journey, I learned so
much about it along the way. And of course, it was the last
time, I think, Dr. Fauci, you and I spoke. We were talking
about shutting down the economy. And you said that we did that
out of uncertainty.
We probably never would want to do that again. And that
cost trillions and trillions of dollars along the way. So we
surely have learned a lot with that experience that we might
use on others. Dr. Fauci, a lot of Americans are worried about
the power of social media. And it was back over a year ago or--
yes, in July that we talked about, had there been any contact
with your office?
I know that here recently a Federal judge in Louisiana
ruled that the Biden administration, including yourself, must
turn over external communications with social media companies.
So we will see what happens there.
You said there had not been a contact up to that point. Had
any social media company contacted you since July when we spoke
last? I know it has been a decent amount of time, so I was just
curious.
Dr. Fauci. I don't believe that I said there was no
contact. I have had over a period of time, and I would have to
check the date, Senator--honestly, I would have to get the
correct dates. That Mark Zuckerberg of Facebook had contacted
me to make some Facebook live discussions about encouraging
people to get vaccinated and how we can make sure that people
understand the importance of vaccination.
There has been, and that is public record. I think anybody
who has access to the public face of that Facebook would see, I
think there were three conversations that I had back and forth
with him about promoting the use of vaccinations as a public
health intervention.
Senator Braun. I think on that particular public health
advice about the benefits of a vaccine, it is probably not
where that contention arises. I want to narrow in on this, and
it would be the original discussion of where it came from, the
leak. And then they used from a lab or from a wet market. And
was there ever discussion on that? And to me, that is a
different kind of issue to----
Dr. Fauci. To my knowledge, there was not. I mean, I would
want to make sure I get correct your question. If the question
is, do we influencing social media in any way, the answer is a
categorically no at that. And any communications that are made
in that regard, as far as I am concerned, are an open book and
available.
The lawsuit that you mentioned, I think it is Missouri and
Louisiana versus Biden and HHS and CDC and FDA and the entire
Government, because it involves the President is under the
Department of Justice right now.
I have handed, and my staff have handed over every document
that the Department of Justice has asked for, and it is up to
them to make it available. But I have held nothing back from
anything that I was asked to provide.
Senator Braun. Thank you----
Senator Murphy. Senator Braun, we have got a vote pending,
so I want to turn it over to Senator Burr.
Senator Braun. Thank you.
Senator Murphy. Thank you.
Senator Burr.
Senator Burr. Thank you, Mr. Chairman. Let me conclude, if
I can. I want to thank all of you and more importantly, thank
your workforces for the work they have done over the last 3
years. Tony. I wish you well in the transition. I want to state
this, and I want to be perfectly clear, we don't act or react
fast enough. I will say it again. We don't act or react fast
enough.
We have been focused on monkeypox. Let me do a recap real
quick. May 17th, infection in the United States. 2 weeks prior,
10 days prior, or 11 days prior we see this in the UK. We
already owned a big bulk storage of vaccines sitting at BN in
Denmark.
BN apparently speeds up their fill finish line that wasn't
supposed to go online until sometime in the fall. They apply.
FDA on June 30 inspects. It is July 27th before the approval is
made. Here is the concerning part. It is April 18th when we
signed a deal for domestic fill finish somewhere else.
Let me say that again. We start with May. We know we have
got domestic infection. We are concerned with our ability to
deal with this. And there is a big period that we don't look
for domestic fill finish. I am not asking for a response, I am
just making a point. That if we have a pandemic response plan,
things like this get resolved.
I don't know what the limitations that have been placed on
any of you about sharing the specific plan, whether it was on
COVID or whether it was on monkeypox. I don't really care
today.
What I do care about is that if you are in the role of
leadership in your agency, or if somebody else is in the role
of leadership in the future, the first thing they ought to be
saying is, let's sit down as a group and let's put together a
plan. Let's know what everybody is going to do. This BS of
working independently, the turf wars that exist, we own
testing, we own this, we own that, to hell with it.
These are--when you declare a national emergency, this is
no time to protect territorial turf. And every response to us
is about money. Dawn, if you need something changed to
reprogram, for God's sakes, ask us. Don't use it as an excuse
as to why you couldn't do something. Rochelle, we have reached
out many times, and the only thing I hear, data, data, data,
money, money, money.
Listen, take it to heart what the doctor said to you, when
78 percent of the employees aren't coming in the office, you
don't get much sympathy from us. Rob, it may be the wrong time
to do a demonstration project about working remotely. You know,
the biggest trouble we have got is putting people back in the
office.
Congress did it. The Government is not capable of doing it.
Private sector is struggling with it. Post-COVID is very
different, but the responsibilities that you have as the
emergency response components haven't changed. You have got to
look at your workforce. You have got to look at the challenges.
You have got to look at the procedures that you have got in
place and say, have we really learned from the last one? Now, I
am not going to be here to see you probably again. I am not
sure Patty will hold another hearing before now and the end of
the year.
But I want you to know, I look forward to working with you
and I will continue to be a resource to any of you because I
only have one goal, and that is that I know for the next one,
we have got to respond a hell of a lot faster than we did for
COVID, and we have got to do much better than we did on
monkeypox.
Because on the other side of this potentially is one that
gets out of control with massive amounts of loss of life. Mr.
Chairman, I thank you for your indulgence. I probably missed
the vote, but that is okay, because I think this is more
important. I yield back.
Senator Murphy. Thank you very much, Senator Burr. Thanks
all the Members of the Committee for participating. To all of
our witnesses, Dr. Walensky, Dr. Fauci, Dr. Califf, Ms.
O'Connell, thanks for this really important and thoughtful
discussion about the response to the monkeypox outbreak.
For any Senators who wish to submit additional questions,
the record will be open for 10 business days. The HELP
Committee is pretty generous. 10 business days. So you got
until September 28 at 5.00 p.m. for additional questions for
the record.
With that, this Committee stands adjourned.
------
ADDITIONAL MATERIAL
AIDS United
September 13, 2022
Senator Patty Murray, Chair
Senator Richard Burr, Ranking Member
U.S. Senate Committee on Health, Education, Labor, and Pensions,
217 Russell Senate Office Building,
Washington, DC 20510.
Dear Chair Murray and Ranking Member Burr:
As the Administration and Congress respond to the ongoing monkeypox
(MPV) outbreak in the United States, the Partnership to End HIV, STDs,
and Hepatitis is concerned that opportunities to take a syndemic and
comprehensive approach are not being utilized due to the urgency of the
situation. Since the first days of the outbreak, we have heard of
``lessons learned from HIV and COVID-19''; yet many of those lessons
remain unimplemented--to the detriment of public health in the United
States.
Some of the lessons from the COVID-19 pandemic are positive ones.
The creation and mass-distribution of easy-to-use diagnostics and
vaccinations via partnerships with local trusted leaders and community
providers proved very effective in ensuring testing and vaccinations
were widely available. We hope the Department of Health and Human
Services (HHS) will move quickly to replicate that approach as much as
possible, and we applaud Secretary Becerra's decision to declare MPV a
public health emergency. Yet, the early days of the pandemic also laid
bare our Country's continued struggle with health inequities, ill-
equipped health care infrastructure, and conflicting and poorly
disseminated communications. We must learn from these mistakes, lest we
repeat them.
Based on its current presentation, MPV is most similar to the HIV
and STD epidemics in this country. Our collective experience with these
epidemics gives our organizations a unique perspective and expertise,
and we would like to take this opportunity to offer these
recommendations for creating a more thoughtful and comprehensive
response to MPV.
Resources should follow the disease.
Right now, the vast majority of MPV cases is within the gay,
bisexual, and other men-who-have-sex-with-men (GBM) community, with
Black and Latino men experiencing the brunt of the outbreak. We ask
that you continue to dedicate resources, education, vaccines,
treatment, etc. within the GBM community, with specific attention to
mitigating racial inequities.
However, limited data collection on testing and treatment inhibits
the government's ability to know where resources are most needed.
Therefore, we also ask that you take swift and necessary action to use
the recent declaration of a public health emergency to instruct the
Centers for Disease Control and Prevention (CDC) to expand the
collection of national demographic and geographic information beyond
case counts, and vaccinations, to include testing and treatment
information. We are specifically concerned, as evidenced in CDC data,
that Black, Brown, and younger GBM are being disproportionately
impacted. Whereas only 21 percent of first doses of the vaccine have at
this point been administered to Black individuals, the same population
makes up nearly 40 percent of cases. \1\ We ask that the Administration
operate based on existing data showing that racial health inequities
are present and work diligently to counter them. As with COVID-19,
communities of color are going to be hardest hit, and the
Administration must correct for that in the response.
---------------------------------------------------------------------------
\1\ https://www.cdc.gov/poxvirus/monkeypox/response/2022/
index.html accessed September 12, 2022
---------------------------------------------------------------------------
Take a syndemic approach.
The National Coalition of STD Directors (NCSD) conducted a survey
of sexual health clinics early in the outbreak and found that 60
percent of people presenting for monkeypox testing had an STD that was
not MPV. \2\ This number has more recently been confirmed by the CDC,
which found that 61 percent of MPV patients had either HIV or an STI.
This is unfortunately not surprising. HIV and STD testing dropped
dramatically during COVID-19, with testing for HIV dropping by nearly
50 percent in 2020, \3\ which allows infections to move through the
American population undetected and leads to rising rates. STD rates,
for example, are at an all-time high for the sixth year in a row.
---------------------------------------------------------------------------
\2\ https://www.ncsddc.org/wp-content/uploads/2022/06/Clinic-
Monkeypox-Capacity-Survey-Handout.pdf
\3\ https://www.cdc.gov/mmwr/volumes/71/wr/mm7125a2.htm's--cid--
mm7125a2--w
---------------------------------------------------------------------------
There is an opportunity, as individuals seek out testing and
vaccination for MPV, to also educate on HAV, HBV, and meningitis
vaccinations and conduct testing and treatment for HIV, hepatitis, and
STDs, especially since--at this time--the communities being targeted
for testing and treatment also ought to be offered HIV and STD testing.
We ask HHS to create protocols and dedicate resources to incentivize
providers to offer HIV, hepatitis, and STD testing alongside MPV
testing and vaccination.
Additionally, the very population currently being targeted for
vaccination and education on MPV is the same population targeted for
pre-exposure prophylaxis (PrEP). Right now, GBM across the country are
seeking out care providers for vaccinations, testing, and information
about the disease. This is a significant opportunity to simultaneously
screen and educate for PrEP and increase uptake. And we ask that HHS
create protocols and dedicate resources to incentivize providers to
offer PrEP counseling and linkage to PrEP services at vaccination and
testing appointments whenever feasible.
Engage in accurate, honest, and culturally competent communication.
Since the first days of the MPV outbreak, the public health field
has worked scrupulously to mitigate stigma against GBM and monkeypox.
However, in service of this work, national communications efforts to
the GBM population have been muddled, leaving the most affected
population without the information they need to make informed choices
about their health. We ask the Administration to prioritize
streamlining and improving culturally competent communication--in
multiple languages--related to MPV for those most at risk.
Properly equip the people doing the work.
As you know, for decades, the United States has asked our public
health infrastructure to do more with less. Currently, we are hearing
from sexual health clinics around the country that they have
essentially become MPV clinics. One provider shared that they spent an
entire 10-hour shift enrolling four patients in TPOXX due to the still
time-intensive administrative requirements. This is unacceptable.
We ask that you immediately support the frontline public health
employees and health care providers by expediting the creation and
dissemination of provider trainings and education; funding public
health departments and clinics' increased staffing and supplies needs;
protecting health care providers with sufficient PPE and prioritizing
those that work with MPV patients for vaccination; and lifting
administrative burdens, such as the time-intensive protocols for TPOXX.
These recommendations are intended to build upon other
recommendations that have been made in response to the MPV outbreak,
including greater access to vaccinations and testing, reduced
administrative burdens, and increased funding.
We are in an emergency situation, but it is also an opportunity to
demonstrate the Administration's ability to respond agilely--and
ultimately build on the lessons learned from HIV, STDs, and COVID-19 to
create a stronger public health system. The partnership stands ready to
help the Administration do so. If you have any questions or would like
to discuss our recommendations, please reach out to the National
Coalition of STD Directors' director of Federal policy, Rachel Deitch,
via email at [email protected] or by phone at 847-804-6672, or Rachel
Klein, Deputy Executive Director of The AIDS Institute by email at
[email protected] or by phone at 202-815-2973.
Sincerely,
Jesse Milan, Jr.
President and CEO
AIDS United
[email protected]
Michael Ruppal
Executive Director
The AIDS Institute
[email protected]
Stephen Lee
Executive Director,
NASTAD
[email protected]
David Harvey
Executive Director
National Coalition of STD Directors (NCSD)
[email protected]
Paul Kawata
Executive Director
NMAC
[email protected]
______
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
------
[Whereupon, at 12:21 p.m., the hearing was adjourned.]
[all]