[Senate Hearing 116-523]
[From the U.S. Government Publishing Office]
S. Hrg. 116-523
COVID-19: UPDATE ON PROGRESS
TOWARD SAFELY GETTING BACK
TO WORK AND BACK TO SCHOOL
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING COVID-19, FOCUSING ON AN UPDATE ON PROGRESS TOWARD SAFELY
GETTING BACK TO WORK AND BACK TO SCHOOL
__________
JUNE 30, 2020
__________
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
45-224 PDF WASHINGTON : 2022
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BERNARD SANDERS (I), Vermont
RAND Paul, Kentucky ROBERT P. CASEY, JR., Pennsylvania
SUSAN M. COLLINS, Maine TAMMY BALDWIN, Wisconsin
BILL CASSIDY, M.D., Louisiana CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts
LISA MURKOWSKI, Alaska TIM KAINE, Virginia
TIM SCOTT, South Carolina MARGARET WOOD HASSAN, New Hampshire
MITT ROMNEY, Utah TINA SMITH, Minnesota
MIKE BRAUN, Indiana DOUG JONES, Alabama
KELLY Loeffler, Georgia JACKY ROSEN, Nevada
David P. Cleary, Republican Staff Director
Lindsey Ward Seidman, Republican Deputy Staff Director
Evan Schatz, Minority Staff Director
John Righter, Minority Deputy Staff Director
C O N T E N T S
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STATEMENTS
TUESDAY, JUNE 30, 2020
Page
Committee Members
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening statement......................... 1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State
of Washington, Opening statement............................... 6
Witnesses
Fauci, Anthony, M.D., Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, Bethesda,
MD............................................................. 9
Prepared statement of Doctors Fauci, Redfield, Giroir, and
Hahn....................................................... 10
Redfield, Robert, M.D., Director, United States Centers for
Disease Control and Prevention, Atlanta, GA.................... 27
Giroir, Brett, Admiral, M.D., Assistant Secretary for Health,
United States Department of Health and Human Services,
Washington, DC................................................. 29
Hahn, Stephen, M.D., Commissioner of Food and Drugs, United
States Food and Drug Administration, Silver Spring, MD......... 30
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
Senator Sanders:
Testimony of Dr. Joycelyn Elders............................. 75
COVID-19: UPDATE ON PROGRESS
TOWARD SAFELY GETTING BACK
TO WORK AND BACK TO SCHOOL
----------
Tuesday, June 30, 2020
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:05 a.m., in
room G-50, Dirksen Senate Office Building, Hon. Lamar
Alexander, Chairman of the Committee, presiding.
Present: Senators Alexander [presiding], Burr, Paul,
Collins, Cassidy, Murkowski, Scott, Romney, Braun, Loeffler,
Murray, Sanders, Casey, Baldwin, Murphy, Warren, Kaine, Hassan,
Smith, Jones, and Rosen.
OPENING STATEMENT OF SENATOR ALEXANDER
The Chairman. The Committee on Health, Education, Labor,
and Pensions will please come to order.
First, some administrative matters. Based on the advice of
the attending physician and the Sergeant at Arms, after
consulting with the Department of Health and Human Services and
the Centers for Disease Control, individuals in the hearing
room are seated 6 feet apart. As a result, there is no room for
the public to attend in person.
Representatives of the press are working as a pool.
The hearing may be watched online. An unedited recording
will be available on our website, www.help.senate.gov.
All of our witnesses today are participating in person. We
thank you for that. Some Senators are participating by
videoconference.
Before I make my opening statement, I would like to say a
word about masks. The Office of Attending Physician has advised
us that we may remove our masks and talk into the microphone as
long as we are 6 feet apart. So, that is why my mask is off
right now, because I am 6 feet away from everybody else. But,
like many other Senators, when I am walking the hallways or on
the Senate floor, I am wearing a mask.
People wear masks because CDC has said, ``Simple cloth
coverings slow the spread of the virus and help people who may
have the virus and do not know it from transmitting it to
others.''
Unfortunately, this simple lifesaving practice has become
part of the political debate. It says this: If you are for
Trump, you do not wear a mask. If you are against Trump, you
do. That is why I have suggested that the President
occasionally wear a mask, even though in most cases it is not
necessary for him to do so. The President has plenty of
admirers. They would follow his lead. It would help end this
political debate. The stakes are too high for this political
debate about pro-Trump, anti-Trump masks to continue.
Around here, Senators and staff wear masks because we do
not want to make each other sick. For example, I was exposed to
COVID-19 by a pre-symptomatic staff member on my way to Dulles
Airport and, as a result, had to self-quarantine for 2 weeks.
The Senate physician told me that one reason I did not become
infected was because the staff member was wearing a mask, and
that, in the physician's word, greatly reduced the chances of
an exposure.
It is also a pretty good way to make a statement. I like to
wear my plaid mask. Dr. Fauci uses his mask to demonstrate his
loyalty to the Washington Nationals. Senator Kaine is either a
cowboy or a bandit. I am never sure which.
If you want college football to return this fall, here is
what Coach Phillip Fulmer, our athletic director at the
University of Tennessee says: ``If you really, really want to
see some football this fall, wear a mask.'' That might have
more influence than anybody else in Tennessee.
The United States is in the midst of a very concerning rise
in COVID-19 cases and hospitalizations in many states. The
experts in front of us have told us that washing our hands,
staying apart, and wearing a mask are three of the most
important ways to contain the disease and slow the spread of
the virus.
I am grateful to the Rules Committee, the Sergeant at Arms,
the Press Gallery, the Architect of the Capitol, the Capitol
Police, our Committee staff, both Democratic and Republican,
Chung Shek and Evan Griffis, and all for their hard work to
keep us safe.
Now, Senator Murray and I will each have an opening
statement, and then we will turn to our witnesses, who we thank
for being with us today. Each will have 5 minutes. We would ask
you to summarize your testimony in 5 minutes, and then the
Senators will have a chance to ask 5-minute round of questions.
We have full participation today, it looks like. It should be
an interesting morning.
Among the casualties of this dangerous and very sneaky
COVID-19 virus are the 75 million students who were sent home
from school and college in March. Add to the casualties the
teachers who were not prepared to teach remotely and the
working parents who suddenly had children at home and who were
not prepared to home school. Add the lost sports seasons and
the once-in-a-lifetime graduation opportunities. Then there
were unprecedented dilemmas for administrators and inadequate
school budgets.
Being sent home from school does not rank with the sickness
and the death that the virus has caused. The United States has
over 2.5 million cases of the virus and over 125,000 deaths,
according to Johns Hopkins. While states and communities
continue to take action to keep people safe, nothing, though,
was more disruptive to American life, and nothing would head it
back toward normalcy more rapidly than for those 135,000 public
and private schools and 6,000 colleges to reopen this fall.
Earlier this month, this Committee heard from college
presidents and school leaders about their plans for safely
reopening this fall. This hearing is an opportunity for an
update and to hear from the Nation's top health experts on how
headmasters, principals, superintendents, chancellors, and
college presidents can open their schools safely just a few
weeks from now.
This Committee last heard from today's four witnesses on
May the 12th, when three of the four were quarantined and most
of the Senators were participating virtually. That was one of
the first virtual Senate hearings in history, and surely the
best watched. Every network carried the two-and-one-half hours
of statements and questions and answers from Senators.
The question before the country today is not whether to go
back to school or college, or childcare or work, but how to do
it safely. Even though COVID-19 does not, in general, hurt
young children and college age students nearly as much as older
and more vulnerable Americans, there is some health risk. But,
in my view, the greater risk is not going back to school.
Guidance for reopening schools from the American Academy of
Pediatricians tells school administrators the following: ``Our
academy strongly believes that all policy considerations for
the coming school year should start with a goal of having
students physically present in school.''
The Academy continues, ``The importance of in-person
learning is well documented.''
There is already evidence of negative impacts on children
because of school closures in the spring of 2020. Lengthy time
away from school and associated interruption of supportive
services often results in social isolation, making it difficult
for schools to identify and address important learning
deficits, as well as child and adolescent physical or sexual
abuse, substance use, depression, and suicidal ideation. This,
in turn, places children and adolescents at considerable risk
of morbidity, and in some cases, mortality.
Beyond the educational impact and social impact of school
closures, there has been substantial impact on food security
and physical activity for children and families, says the
American Academy of Pediatricians.
Dr. Lloyd Fisher, the incoming president of the
Massachusetts Chapter of that Academy of Pediatricians, told
reporters, ``While for most children COVID-19 has not had the
devastating and life-threatening physical health effects that
have occurred in adults, the negative impact on their
education, mental health, and social development has been
substantial.'' Nothing can take the place of the daily face-to-
face interaction our children experience when attending school
in person, Dr. Fisher said.
Many American colleges, overall considered the best in the
world, will be permanently damaged or even closed if they
remain, in Brown University President Christina Paxson's words,
ghost towns.
Mitch Daniels, the President of Purdue, wrote in a
Washington Post op-ed, ``Failure to take on the job of
reopening would not only be anti-scientific, but also an
unacceptable breach of duty.''
Today, in addition to hearing more about the concerning
rise in cases and hospitalizations in some states, I would like
to ask our witnesses in their statements and answers to
questions to put yourselves in the place of one of America's
approximately 14,000 superintendents of school districts, or
the principal or headmaster of one of 135,000 schools, or as
president or chancellor of one of 6,000 colleges, and help them
answer the question of how to reopen schools and colleges
safely.
Dr. Fauci, I hope that in your opening statement or answers
to questions, you will suggest steps a superintendent might
take to open schools safely. And, not only how to keep children
safe, but to keep safe the adults--teachers, parents,
grandparents--with whom they come in contact.
Dr. Hahn, will there be treatments or medicines this fall
that will help speed the recovery from COVID-19 or reduce the
possibility of death? I believe the fear of going back to
school, or going anywhere these days, is in large part because
of the fear of severe illness or even death. If that risk can
be lessened by new treatments, it should increase confidence in
going back to school.
I would also like to commend Dr. Hahn and the work the FDA
did to get tests on the market quickly as possible to help
understand the spread of the virus. Since then, FDA has worked
out which tests have not worked as well as they should and
taken steps to remove them from the market. That is what is
supposed to happen in the urgency of a pandemic.
Admiral Giroir, at our last hearing, you said you expected
there to be 40 to 50 million diagnostic tests available each
month by September. Is that still true? And exactly how does a
school district go about making sure it gets those tests and
who pays for them? What are the prospects from the shark tank
at the National Institutes of Health that there will be new,
reliable, and inexpensive tests so we can have even more
widespread testing?
Dr. Redfield, you are continuing to work on updated
guidelines about going back to school and college safely. Are
CDC employees going to be available in our states to help work
with school districts to develop their plans? And what advice
do you have about the arrival of the flu season this fall at
the same time as COVID-19?
This is a lot to discuss, but there will be time during the
next 2.5 hours to answer most of those questions.
Let me quickly highlight three areas that have come up in
our four earlier hearings this month that I think need
clarification.
First, on contact tracing. No doubt, contact tracing is
crucially important. It identifies the people who might have
been exposed so that people who do not--so that they do not in
turn expose someone else.
According to an NPR report on June 18, states have already
hired at least 37,000 contact tracers. State officials and
Johns Hopkins Center for Health Security issued a report
estimating the need for as many as 100,000 contact tracers.
Several reports suggested Congress appropriate money to pay
for those tracers. The reality is Congress already has. On
April 24th, Congress appropriated $11 billion, which has been
sent to states and tribes for the expenses of testing. That
legislation explicitly said the money could be used for contact
tracing. This is in addition to $755 million from the first
emergency appropriations legislation on March 6th that could be
used for contact tracing, and that is in addition to the March
27 legislation in which Congress appropriated $150 billion--I
mean $1.5 billion in the CARES Act for states, territories, and
tribes to use for COVID preparedness and response.
The CARES Act also included the $150 billion to states, but
a significant amount of that $150 billion has not been spent,
even though it is all designated for expenses related to COVID-
19, which include contact tracing.
For example, Tennessee's Governor has told me he is
reserving as much as $1 billion of that so that he can
determine what flexibility he has in spending the money.
Washington State has not spent as much as $1.2 billion.
Missouri State Treasury says they have not spent about $1
billion.
According to the report by state health officials and Johns
Hopkins, an average salary for a contact tracer would be a
little more than $35,000. This adds up to about $3.5 billion
for 100,000 contact tracers. So, the point is, Congress has
already sent to states plenty of money to hire all the contact
tracers that are needed.
Second, who pays for the testing? In the CARES Act,
Congress voted to make all COVID-19 tests available to patients
at no cost. This meant insurers would cover diagnostic tests,
which detect whether a person is currently infected with the
virus, and also antibody tests, which indicate whether a person
has had COVID-19 in the past and now may have some protection
in the future.
Guidance from the Labor Department, Treasury Department,
and Centers for Medicare and Medicaid Services said last week
that insurers are only required to pay for tests without
patient cost sharing if a doctor orders it. I agree with that.
But, given that the CDC specifically recommends doctors order
tests in two situations--when a person has signs or symptoms of
COVID-19 or recently had contact with someone known or
suspected to have COVID-19--who pays for the testing at other
times? I believe Congress will need to take action to further
clarify who pays for the testing at other times.
For example, a school may want to do random testing.
Perhaps it should make an arrangement with the state to pay for
that. Or, perhaps Congress needs to provide more money to pay
for that.
If an automaker wants to test all of its employees at the
plant every 2 weeks, perhaps the automakers should pay for
that. Or, perhaps the state would want to pay for that. That
needs to be clarified.
Finally, flu shots. CDC has said more people need to get
flu shots this fall so healthcare workers can better
distinguish between COVID-19 and the flu. CDC says a priority
is for all children over the age of 6 months to be vaccinated
for the flu so they do not become sick and pass it to more
vulnerable populations, who can have more severe consequences.
On January 24th, Senator Murray and I hosted our first
bipartisan briefing on coronavirus at a time when there were
only four cases in the United States. Since then, this
Committee has had four more briefings. Today is our eighth
hearing on coronavirus and U.S. preparedness.
Last week's hearing was about steps to take this year while
our eye is on the ball to better prepare for the next pandemic.
I have issued a white paper outlining five recommendations for
Congress to prepare Americans for the next pandemic, and that
paper has received more than 350 substantive comments that are
available to all Members of the Committee.
After all Senators have had a chance to ask their
questions, I will conclude the hearing by asking our witnesses
if they have two or three suggestions about steps Congress
should take this year to deal with the next pandemic, most of
which will also help with this one.
But, this hearing is about what happens now as
administrators prepare to reopen schools and colleges. Experts
underestimated this dangerous and sneaky virus, and there is
still much we do not know about it.
But, we do know the basic steps to take to reopen schools
and colleges in 2020, before there is a vaccine, and those are
these: social distance, wear a mask, wash your hands, test,
contact trace, and isolate those exposed or sick. And,
hopefully, by the fall, there will be treatments to make the
consequences of the disease less severe.
I look forward to hearing from our distinguished witnesses
how school leaders and college presidents can safely reopen
135,000 schools and 6,000 colleges, and also learning the
latest developments on testing and treatments that we can
expect during the year 2020 before vaccines arrive.
Senator Murray.
OPENING STATEMENT OF SENATOR MURRAY
Senator Murray. Well, thank you very much, Mr. Chairman.
Thank you to all of our witnesses for joining us here today.
And, of course, thank you to our staff for setting up the
technology so we can hold this hearing safely.
I want to get to the point quickly, and I am going to be
blunt about it. The COVID-19 response in our Country is still a
disaster. One hundred and twenty-six thousand lives lost was
once considered an estimate on the high end of the spectrum,
but the year is just half way over and it is now a grim
reality. We have lost more Americans to COVID-19 than we lose
to the flu each year, than we lost to the opioid crisis last
year, and more lives than we have lost in every American war
except the Civil War and World War II.
Despite what President Trump claims, this pandemic is not
fading. Far from it. Several states are seeing rapid, record-
setting increases, and the Country just saw its largest single-
day increase to date.
While this public health crisis rages across the Country,
we have seen a leadership crisis raging in the White House. As
the President proves time after time, he cares less about how
this pandemic is impacting families and communities and more
about how it makes him look.
Just consider his appalling, continued failure on testing.
President Trump said anyone that wants a test can get a test.
They still can't.
He said testing was overrated. It is not.
He said we prevailed on testing. We have not.
Now he is saying we should be doing fewer tests, and
testing makes us look bad. Well, it clearly does not, and we
clearly need to be doing more.
The most honest thing he has said about testing is that he
does not take responsibility at all, and that is exactly the
problem. It is why Congress actually took bipartisan action in
the last COVID-19 response bill to require the Trump
administration to submit a comprehensive, national testing
plan. That is why I am still pushing for this Administration to
include more details in that plan and take more steps to ramp
up testing. Because we are still nowhere close to the testing
and tracing capacity we need to safely reopen our Country, and
ending support for Federal testing sites, while sitting on
billions in testing funds Congress provided, is not going to
get us there.
The ongoing struggle to get President Trump to take testing
seriously should be a stark warning to Congress that, when it
comes to vaccines, we cannot just leave this Administration to
its own devices. We have to hold it accountable.
We know this pandemic will not end until we have a vaccine
that is safe and effective, that can be widely produced and
equitably distributed, and that is free and accessible to
everyone, which is why we need a comprehensive, national
vaccine plan from the Trump administration as soon as possible.
Given the testing plan, which Congress only received after
forcing the Administration's hand, was too little, too late, we
need to take the opportunity we have right now to get a vaccine
plan much earlier and avoid the missteps we have seen with
testing.
I hope Republicans will work with me in a bipartisan way
once again to require this Administration to put forward a
plan. We need the Trump administration to show us how they will
ensure a vaccine is safe and is effective. I am as eager as
anyone for a vaccine. But this is not just about doing
something fast; it is about doing it right. That is why we need
to know the process for developing a vaccine is rigorous, it is
inclusive, it is transparent, and it is science-driven.
But, in light of the hydroxychloroquine debacle and the
removal of Dr. Bright from BARDA for questioning the
Administration's efforts to promote that unproven treatment, we
cannot take for granted this process will be free of political
influence. We have to demand serious oversight.
In order to give the public full confidence that a vaccine
is safe and effective, the Administration needs to commit now
to being fully transparent about the standards a vaccine will
be expected to meet and releasing the clinical trial data that
FDA uses to evaluate safety and effectiveness.
We also need a plan detailing how to produce and distribute
vaccines nationwide and make sure everyone can actually get
them. We saw with testing how avoidable bottlenecks create
damaging delays when the Federal Government refuses to step in
and lead like it needs to do in a time of crisis. And,
unfortunately, we saw how existing health disparities are
exacerbated without a plan to overcome them as even the
incomplete data we currently have shows Black, Latino, and
Tribal communities have significantly less access to testing
than White communities. This is an injustice that we must not
repeat when it comes to vaccines.
We also need a plan to guarantee vaccines are free so that
cost is not a barrier for patients. And, it is worth noting, we
still need to act to make COVID-19 treatment available at no
cost, too. And the plan must address barriers, like vaccine
hesitancy and misinformation, especially when one of the most
prominent sources of misinformation so far has been the
President of the United States.
While the discovery of an eventual vaccine may still be far
off, these are issues we need the Administration to answer now.
So, I hope Republicans will work with me to require the
Administration to submit a comprehensive vaccine plan and
address many of the other urgent issues stemming from this
pandemic.
Our businesses, our workers, teachers, students, and
families do not have what they need to safely return to work or
school, period.
Our medical system, doctors, nurses, frontline workers
continue to face unimaginable risk, stress, and fatigue. They
need Congress to step up to help them continue to save lives.
Families need us to continue to ensure they have basic
services and can keep food on their tables.
The House passed the HEROES Act 46 days ago to get more
relief to frontline workers, to families, and businesses. It is
well past time for Leader McConnell and Senate Republicans to
sit down with fellow Democrats and get to work. There is no
question our Country is still in crisis, and every day the
Senate fails to take action is a day we allow it to get worse.
I also hope, Mr. Chairman, that we will be able to have
another hearing on this crisis soon with Administration
officials, whose testimony is long overdue--Secretary Azar,
Secretary DeVos, and Secretary Scalia.
Thank you, Mr. Chairman. I look forward to our witnesses
today, and testimony, and the questions that we have for them.
The Chairman. Thank you, Senator Murray.
We would ask each witness now to summarize his testimony in
5 minutes. I am pleased to welcome our witnesses. Each of you
are making significant contributions to our Government's
response to COVID-19, helping us go safely back to school, back
to work. We are grateful for your service to our Country.
Our first witness is Dr. Anthony Fauci. He is director of
the National Institute of Allergy and Infectious Diseases at
the National Institute of Health. He has held this position
since 1984. He has led the Agency's research related to HIV-
AIDS, influenza, malaria, Ebola, and other infectious diseases.
He has advised six presidents on domestic and global health
issues. He is one of the principal architects of the Emergency
Plan for AIDS Relief. In 2014, he was involved in treating
Ebola patients at NIH and worked on vaccine trials for Ebola.
Next, Dr. Robert Redfield, director of the U.S. Center for
Disease Control and Prevention, CDC. For more than 30 years, he
has been involved with clinical research related to chronic
human viral infections and infectious diseases, especially HIV.
He was founding director of the Department of Retroviral
Research within the U.S. Military's HIV Research Program and
retired after 20 years of service with the U.S. Army Medical
Corps.
Third, Admiral Brett Giroir. Admiral Giroir is the
Assistant Secretary for Health at the U.S. Department of Health
and Human Services. He oversees the development of the
Department's public health policy recommendations. Specific to
COVID-19 response, Admiral Giroir has taken on testing and
focused on increasing the number of tests we can do with
existing technology. His Federal service includes directing the
Defense Sciences Office of the Defense Advanced Research
Projects Agency and a variety of other important
responsibilities.
Finally, we will hear from Dr. Stephen Hahn. Dr. Hahn is
commissioner of the U.S. Food and Drug Administration, the FDA.
Before joining FDA, he held leadership positions as chief
medical executive at the University of Texas MD Anderson Cancer
Center and as chair of the Department of Radiation Oncology at
the University of Pennsylvania. Early in his career, he was
senior investigator at the National Cancer Institute at the
National Institutes of Health. He has been commander of the
U.S. Public Health Service Commission Corps in 2005.
We welcome our witnesses.
Dr. Fauci, welcome. Let us begin with you.
STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE
OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF
HEALTH, BETHESDA, MD
Dr. Fauci. Thank you very much, Mr. Chairman, Ranking
Member Murray, Members of the Committee. Thank you for giving
me the opportunity to discuss briefly with you today the role
of the National Institutes of Health in research addressing
COVID-19. And, as you indicated, Mr. Chairman, I will, during
the question period and alluding to in the presentation,
address some of the issues regarding schools.
The NIAID NIH Strategic Plan for COVID Research involves
four major components. The first is to improve the fundamental
knowledge of understanding the biology of the virus and the
immune response to the virus in order to better inform us in
the development of diagnostics, therapeutics, and vaccines.
Some of the work that has come out of that program right now
informs very greatly how we will address vaccine development,
particularly understanding the confirmation of the components
of the virus that induce an appropriate immune response.
In addition, we will develop and are developing animal
models. Apropos of what you mentioned about children in school,
we have a program called HEROS, which is Human Epidemiology and
Response to SARS coronavirus, which is determining the
incidence and transmissibility among children--a very important
issue when you talk about opening schools and the impact that
might have. In addition, the development of diagnostics, point-
of-care sensitive and specific diagnostics under the RADx
Program, including the RADx-UP for underserved populations.
Third, to characterize and test therapeutics. You mentioned
the importance of this as we open up schools. There are a
number of programs very active that have already shown efficacy
or not in some drugs, as well as a number of clinical trials
that are ongoing. One in particular was the first randomized
placebo-controlled trial showing that the drug Remdesivir
diminishes by about 32 percent the time it takes to get to
recovery in people with advanced disease, pulmonary
involvement. In addition, we have another study combining this
with an anti-inflammatory agent.
Next, we have vaccines. As several have mentioned, it is
extremely important to have safe and effective vaccines
available for everyone in this Country, as well as globally. In
that regard, we put together, myself and some of my colleagues,
and published in Science Magazine a few weeks ago what we call
a Strategic Approach to Coronoavirus-19 Vaccine Research and
Development. It is not a comprehensive plan about every aspect
of vaccine, but it is a strong plan regarding the research and
development pathway. And, what we have done in this is that we
have what is called a harmonized effect because we know there
are many vaccines that are in trial now at various stages.
What we did, and the Federal Government, thanks to the
generosity of the Congress, has put a considerable amount of
money in order to harmonize the trials of multiple candidates
from different companies so that we have common endpoints,
common data and safety monitoring board, and common
immunological parameters that are being funded and are being
pursued.
In addition, there are a number of different platforms that
are being pursued so that we do not have all our eggs in one
basket. As you know, one of those is right now getting ready as
we approach next month of going into Phase 3 trials, and others
will be staggered along the way in the middle of the summer,
end of the summer, early on.
There is no guarantee, and anyone who has been involved in
vaccinology will tell you, that we will have a safe and
effective vaccine, but we are cautiously optimistic looking at
animal data and the early preliminary data that we will at
least know the extent of efficacy sometime in the winter and
early part of next year. Again, working with the companies and
the investment made by this Congress, hopefully there will be
doses available by the beginning of next year.
These are the things that we feel aspirationally hopeful
about, and we will continue to pursue this.
I will stop there, Mr. Chairman, and be happy to answer
questions later.
Thank you.
[The prepared statement of Doctors Fauci, Redfield, Giroir,
and Hahn follow:]
prepared statement of doctors fauci, redfield, giroir, hahn
Introduction
Chairman Alexander, Ranking Member Murray and distinguished Members
of this Committee. It is an honor to appear before you today to discuss
the Department of Health and Human Services' ongoing response to the
COVID-19 pandemic. We are grateful for this opportunity to address how
each of our agencies and office are harnessing innovation to prevent,
diagnose, and treat the novel coronavirus SARs-CoV-2.
COVID-19 is a new disease, caused by a novel (or new) coronavirus
that has not previously been seen in humans. This new disease,
officially named Coronavirus Disease 2019 (COVID-19) by the World
Health Organization (WHO), is caused by the SARS-CoV-2 virus. There are
many types of human coronaviruses including some that commonly cause
mild upper-respiratory tract illnesses. Coronaviruses are a large
family of viruses. Some cause illness in people, and others, such as
canine and feline coronaviruses, only infect animals. Rarely,
coronaviruses that infect animals have emerged to infect people and can
spread between people. This is suspected to have occurred for the virus
that causes COVID-19. Middle East Respiratory Syndrome (MERS) and
Severe Acute Respiratory Syndrome (SARS) are two other examples of
coronaviruses that originated in animals and then spread to people.
The Department of Health and Human Services (HHS) is working
closely with all of our government partners in this response. We thank
Congress for supporting our efforts through the passage of the
Coronavirus Preparedness and Response Supplemental Appropriations Act,
2020; the Families First Coronavirus Response Act; the Coronavirus Aid,
Relief, and Economic Security (CARES) Act; and the Paycheck Protection
Program and Health Care Enhancement Act. These laws have provided
additional resources, authorities, and flexibility. Within HHS, the
Centers for Disease Control and Prevention (CDC), the National
Institute of Allergy and Infectious Diseases (NIAID), the Assistant
Secretary for Health, and the Food and Drug Administration (FDA), along
with additional components not represented today, play critical roles
in the response to this public health emergency as discussed below.
Centers for Disease Control and Prevention
CDC is America's health protection agency, and works 24/7 to save
lives and protect America from health, safety and security threats,
both abroad and in the United States. CDC has a key role in
preparedness and response, and addressing infectious diseases like
COVID-19 is central to our mission. CDC is building upon decades of
experience and leadership in responding to prior infectious disease
emergencies, including SARS, MERS, Ebola, Zika, and the H1N1 pandemic
influenza, to meet new challenges presented by COVID-19. These
challenges are many, and they are historic. Every single American is
affected by this pandemic, and CDC is leaning into this public health
crisis with every applicable asset we have. CDC is drawing on its
emergency response capacity and its relationships with state, tribal,
local, and territorial (STLT), global, and private sector partners; and
is leveraging our workforce's strengths in public health surveillance,
prevention, and laboratory capacity, to develop and provide the Nation
with the science-backed information and analysis needed to address this
public health emergency. CDC has developed and continues to update
guidance for healthcare professionals and the public to encourage safer
practices, improve health outcomes, and save lives. CDC is also working
with partners to develop guidance and decision tools to assist state
and local officials and other stakeholders in adjusting mitigation
strategies. Importantly, CDC is collaborating to prepare the Nation's
public health system and the private sector to disseminate rapidly a
vaccine to the American people when one is available. Abroad, CDC is
leveraging investments in global health security, pandemic influenza
preparedness and public health infrastructures and capacities built
through Presidential initiatives, including the President's Emergency
Plan for AIDS Relief to support countries in mitigating and containing
COVID-19. In addition, CDC has staff in over 60 countries, who work
very closely with host governments. Since the beginning of the
outbreak, they have been providing technical assistance, and now
programmatic funding, to help countries mitigate the effects of COVID-
19 and stop the disease from spreading. The emergence and rapid spread
of COVID-19 confirms that an infectious disease threat anywhere is a
threat to Americans everywhere, including here at home.
When, in late December 2019, Chinese authorities announced a
cluster of pneumonia cases of unknown etiology centered in Wuhan,
China, CDC began monitoring the outbreak. At the beginning of January,
CDC began developing regular situation reports, including input from
our respiratory disease experts in the CDC Country Office in China,
which were shared with HHS, and reaching out to the Chinese Center for
Disease Control and Prevention to offer CDC support. By January 7,
2020, CDC began expanding its incident management (IM) and response
structure to facilitate staffing and communications. On January 21,
2020, CDC officially activated its Emergency Operations Center for
COVID-19. Using the IM structure, CDC immediately set up task forces to
address key needs, reach out to our state and local partners, and
deploy staff where needed to support state and local screening and
investigation efforts. CDC is an integral part of the COVID-19 response
and coordinates with other agencies through the Joint Coordination
Center (JCC) led by Secretary Azar. Addressing COVID-19 is an all-of-
government effort.
Congress has addressed the urgent need to respond to this pandemic
at home and abroad and has allocated substantial resources for CDC's
COVID-19 activities through the statutes mentioned above. This funding
supports a federally guided, state managed, and locally implemented
response to COVID-19 in the United States. With support provided by
Congress for global disease detection and emergency response through
COVID-19 appropriations, CDC is supporting prevention, preparedness,
and response efforts in partnership with public health agencies, health
ministry counterparts, and multilateral and non-governmental agencies
worldwide. Here in the United States, CDC is working with STLT partners
to focus use of these resources to establish and enhance case
identification; conduct contact tracing; implement appropriate
containment and community mitigation measures; improve public health
surveillance; enhance testing capacity; control COVID-19 in high-risk
settings; protect vulnerable and high-risk populations; and work with
healthcare systems to manage and monitor capacity. As of June 22, 2020,
CDC has announced or obligated $12.1 billion in direct awards to
jurisdictions across America from the funds provided by Congress,
including $10.25 billion from the Paycheck Protection Program and
Health Care Enhancement Act.
CDC is providing direct technical assistance and support to STLT
partners as they consider approaches to mitigate and contain COVID-19.
CDC has deployed 149 teams at the request of state, tribal, local, and
territorial partners to provide infection prevention and control
consultation and epidemiological expertise in support of those on the
front lines of this battle. The White House, and Federal partners
including CDC, have convened calls with all 50 states, Puerto Rico and
the District of Columbia to identify state capacities and needs. The
Federal Government has committed to ensuring that states can meet
testing objectives for the month of June, as identified by each state.
Through these calls and other outreach efforts, CDC has worked with
jurisdictions to identify needs and develop plans to enhance testing
capacity, state surveillance, contact tracing, and surge staffing.
These discussions and plans for action will emphasize the need to serve
vulnerable populations and include focused efforts for long-term care
facilities, federally qualified health centers, and Tribal Nations,
among others.
In addition, CDC has launched a multifaceted approach to enhance
and complement STLT efforts and expand support to communities during
the current public health emergency, including deploying over 1,500
individuals to over 100 locations across the United States. These
support staff will augment health department teams and engage in core
public health functions including contact tracing, testing, infection
prevention and control, call center activities, COVID-19 education, and
public health surveillance.
CDC relies on timely and accurate public health surveillance data
to guide public health action and inform the nationwide response to
COVID-19. This crisis has highlighted the need to continue efforts to
modernize the public health data systems that CDC and states rely on
for accurate data. Public health data surveillance and analytical
infrastructure modernization efforts started in fiscal year 2020 using
funds provided by Congress, which have been augmented by $500 million
provided for these efforts under the CARES Act. Timely and accurate
data are essential as CDC and the Nation work to understand the impact
of COVID-19 on all Americans, particularly for populations at greater
risk for severe illness, such as older Americans, those with chronic
medical conditions, and some racial and ethnic minorities.
CDC is working with and providing support to STLT partners as they
develop plans to conduct contact tracing. Contact tracing is a core
disease control strategy that involves case and contact investigation
followed by the implementation of an intervention (for example,
isolation and quarantine) that interrupts disease transmission. Case
investigation and contact tracer staff have been employed as local and
state health department personnel for decades to address other
infectious diseases, and contact tracing is a key strategy for
preventing further spread of COVID-19 as well as a key component of
state plans to reopen. As of June 5, 2020, CDC has posted 12 different
guidance documents including case investigation guidelines, checklists
for developing a case investigation and contact tracing plan, digital
contact tracing tools, and a Contact Tracing Communications Toolkit for
Health Departments.
CDC is also working to understand the impact of COVID-19 on
healthcare workers, first responders, and other essential workers.
Accurate data are critical as we continue to assess the burden placed
on the American healthcare system to inform reopening. CDC is
capitalizing on multiple existing surveillance systems run in
collaboration with STLT partners, including influenza and viral
respiratory disease systems. In collaboration with STLT partners, CDC
is committed to making data available to the public, while protecting
individual privacy. CDC's population-based COVID-NET system monitors
COVID-19 associated hospitalizations that have a confirmed positive
test in greater than 250 acute care hospitals in 99 counties in 14
states. Data gathered are used to estimate age-specific hospitalization
rates on a weekly basis and describe characteristics of persons
hospitalized with COVID-19 illness. CDC also is augmenting the existing
National Healthcare Safety Network to monitor and analyze the capacity
of the healthcare system daily--including hospitals and nursing homes--
so that Federal, state, and local officials can adjust their response
and mitigation efforts as needed.
CDC is using these data to monitor hospitalizations by race,
ethnicity, underlying condition, age, and gender, and is now including
this information in CDC's weekly COVIDView summary. CDC is now
receiving more granular data on deaths by state and locality, allowing
us to identify and work with individual jurisdictions to address where
there may be racial and ethnic disparities in morbidity and mortality.
CDC is leveraging all available surveillance systems to monitor COVID-
19 and protect vulnerable communities. CDC is using diverse systems to
define a more complete picture of the outbreak, including race/
ethnicity data and is working with communities of color to protect
communities at risk. CDC has recently updated the COVID-19 Case Report
Form (CRF) to allow for better collection of data on populations that
have previously been under-represented in reporting. The initial CRF
included questions for sex, age, race and ethnicity and whether the
case is part of a recognized outbreak. The revised form includes
additional variables for populations that may be at higher risk for
severe illness (e.g., tribes) and risk factors (e.g. homelessness,
disabilities, and other factors). States have improved the completeness
of their CRF reporting in the past two months; in particular, the
percentage of reports that include race/ethnicity data has increased
from 18 percent in April to 43 percent in early June. While progress
has been made, CDC will continue to work with states to improve
completeness of the data. Additionally, new reporting requirements that
accompanied more than $10 billion in funding for states from the
Paycheck Protection Program and Healthcare Enhancement Act require
states to report race, ethnicity and other important demographic
information with test results providing information on those impacted.
Furthermore, race and ethnicity data for hospitalizations captured in
CDC's COVIDNET has increased to more than 80 percent providing a much
stronger picture of the different levels hospitalizations from COVID.
Regarding laboratory support, from the outset, CDC laboratories
have been applying sequencing technologies to SARS-CoV-2 and have made
the data available through domestic and global data bases. CDC is
leading the SARS-CoV-2 Sequencing for Public Health Emergency Response,
Epidemiology and Surveillance (SPHERES), a new national genomics
consortium to coordinate SARS-CoV-2 sequencing across the United States
to do large-scale, rapid genomic sequencing of the virus. These
advanced molecular detection and sequencing activities are being ramped
up at the state and local levels to give us a clearer picture of how
the virus outbreak is evolving and how cases are connected. CDC is
engaged with the National Institutes of Health (NIH), the FDA, and the
Biomedical Advanced Research and Development Authority (BARDA) to
evaluate serology tests, and CDC is supporting serological surveys to
help determine how laboratory testing can contribute to decisions about
enabling Americans to return to work.
CDC has developed a new serologic laboratory test to assist with
efforts to determine how much of the U.S. population has been infected
with SARS-CoV-2, the virus that causes COVID-19. The serology test
looks for the presence of antibodies, which are specific proteins made
in response to infections. It typically takes one to three weeks after
someone becomes sick with COVID-19 for their body to make antibodies;
some people may take longer to develop antibodies. The antibodies
detected by this test indicate that a person has had an immune response
to SARS-CoV-2, regardless of whether symptoms developed from infection
or the infection was asymptomatic. However, it is important to point
out that, at this point, we do not know whether the presence of
antibodies provides immunity to the virus. Currently, CDC's serologic
test is designed and validated exclusively for broad-based surveillance
and research that is giving us information needed to guide the response
to the pandemic and protect the public's health. The test is currently
not designed to test individuals who want to know if they have been
previously infected with COVID-19.
During the week of March 30, CDC and public health partners began
the first stage of antibody studies of community transmission of SARS-
CoV-2. These initial studies use serum samples collected in the State
of Washington and New York City. In April, the second stage expanded to
include serologic testing in more areas with high numbers of people
with diagnosed infections. It also includes studies of households in
some states. By using seroprevalence surveys, CDC can learn about
people who have been infected, including those infections that might
have been missed due to lack of symptoms or testing not being performed
for other reasons. These surveys can also track how infections progress
through the population over time. This is done by taking ``snap shots''
of the percentage of people from the same area who have antibodies
against SARS-CoV-2 (also called the seroprevalence) at different time
points.
On April 27, 2020, CDC updated testing prioritization and focused
testing guidelines for those who may have or who are at risk for active
SARS-CoV-2 infection. Clinicians considering testing of persons with
possible COVID-19 should use commercial or hospital clinical laboratory
viral tests for COVID-19 that have been issued an Emergency Use
Authorization (EUA) by FDA or are being offered as outlined in FDA's
policy regarding COVID-19 tests or continue to coordinate testing
through public health laboratories and work with their local and state
health departments. Increasing testing capacity will allow clinicians
to consider the medical necessity of COVID-19 testing for a wider group
of symptomatic patients and persons without symptoms in certain
situations. CDC recommends that clinicians should use their judgment to
determine if a patient has signs and symptoms compatible with COVID-19
and whether the patient should be tested. Other considerations that may
guide testing are epidemiologic factors such as known exposure to an
individual who has tested positive for SARS-CoV-2, and the occurrence
of local community transmission or transmission within a specific
setting/facility (e.g., nursing homes) of COVID-19. People with COVID-
19 have had a wide range of symptoms reported, ranging from mild
symptoms to severe illness. Most patients with confirmed COVID-19 have
developed fever and/or symptoms of acute respiratory illness (e.g.,
cough, difficulty breathing) but some people may present with other
symptoms as well.
CDC has developed a new laboratory test that checks for three
viruses at the same time, two types of influenza viruses (A and B) and
SARS-CoV-2, the virus that causes COVID-19. Testing for all three
viruses simultaneously will allow public health laboratories to
continue surveillance for influenza while testing for COVID-19. This
will save public health laboratories both time and resources, including
testing materials that are in short supply. Another benefit of the new
test is that laboratories will be better able to find co-infections of
influenza and SARS-COV-2, which is important for doctors to diagnose
and treat people properly. CDC requested emergency use authorization
(EUA) for this combined laboratory test from the U.S. Food and Drug
Administration (FDA) on June 18, 2020. CDC expects that private sector
laboratory test developers may be creating similar multiplex assays to
meet clinician needs during influenza season. The American people,
communities, public health professionals, medical providers,
businesses, and schools look to CDC for trusted guidance on responding
to COVID-19. CDC develops and disseminates guidance for a range of
audiences, individuals and communities, including business, schools,
and healthcare professionals. These recommendations include actions
that every American should take, such as following good personal
hygiene practices, staying at home when sick, and practicing social
distancing to lower the risk of disease spread. CDC guidance is
available here https://www.cdc.gov/coronavirus/2019-ncov/prevent-
getting-sick-prevention.html.
CDC released consideration documents to help businesses and
community organizations operate as safely as possible during the COVID-
19 pandemic, including K-12 schools and universities. These documents
complement other CDC resources, including interim guidance documents
that are posted online and the decision tools that help communities
make decisions about resuming and gradually scaling up operations.
These decision tree tools quickly walk through some key questions that
should be answered in preparation for phased opening of schools,
businesses, mass transit, and other settings. These suggestions are
updated as we learn more about COVID-19 and as state and local leaders
continue to decide how to adjust mitigation strategies in their
communities. School administrators and officials can consult with state
and local health officials to determine how to put these considerations
into place. In addition, schools may need to make adjustments to meet
their unique needs and circumstances.
First responder and healthcare guidance documents cover a range of
topics--from addressing potential work-related exposures, implementing
infection prevention and control measures in health facilities, and
optimizing the supply of personal protective equipment to clinical
evaluation, testing, and clinical care. CDC is providing these
recommendations to support communities' efforts, while recognizing that
each sector and community is unique and will need to consider these in
the context of their community-level data and circumstances. CDC teams
on the ground and those aiding from Atlanta are and will continue
working with state and local officials to integrate these
recommendations into COVID-19 plans. CDC offers a framework for
providing non-COVID-19 clinical care that outlines key considerations
for healthcare systems and health care providers. Key considerations
include monitoring trends in local cases and deaths, consulting with
state or local health departments for region-specific information and
recommendations, following recommended infection control practices,
screening all patients for COVID-19 symptoms and expanding services
gradually.
Mitigation and containment of COVID-19 are the key to public health
strategies, and CDC is committed to using our expertise and partnering
with others on the frontlines. While surveillance, testing, contact
tracing, and community mitigation interventions are the best tools we
have right now, looking to the future, CDC continues to work to prepare
our Nation's public and private health systems to deliver effectively a
COVID-19 vaccine once it is available. This includes working with CDC's
64 immunization grant recipients to help ensure that the U.S.
immunization system can mount an effective vaccine delivery program,
including vaccine distribution and tracking.
While it remains unclear how long the pandemic will last, COVID-19
activity will likely continue for some time. It is also unclear what
impact the ongoing COVID-19 pandemic will have on health care and
public health systems during the upcoming influenza season. If there is
COVID-19 and flu activity at the same time, this could place a
tremendous burden on the health care system related to bed occupancy,
laboratory testing needs, personal protective equipment and health care
worker safety. In the context of likely ongoing COVID-19 activity,
getting a flu vaccine is more important now than ever. Getting a flu
vaccine will help keep you and your loved ones out of a doctor's
offices and hospitals and help conserve scarce medical resources to
care for COVID-19 patients.
CDC works with public health and clinical partners each year to
increase the number of people who get the flu vaccine and eliminate
barriers to vaccination. Ongoing COVID-19 activity may affect where and
how flu vaccines are given. CDC is working with manufacturers to
maximize flu vaccine supply and with providers and health departments
to develop contingency plans so that people can be vaccinated in a safe
environment.
In addition, on June 4, CDC awarded $140 million to 64
jurisdictions through CDC's existing immunization cooperative agreement
to enable state health departments to launch an initial scale up for
influenza season, given the increased risk of COVID-19. Funds will,
among other activities, begin to support staffing and preparedness
early this summer and focus on ensuring flu coverage for these
vulnerable populations. Due to the risk of COVID-19, the goal is to
increase flu coverage for vulnerable populations during the 2020-21 flu
season, ensure Americans are aware of the importance of getting
vaccinated this flu season, and increase access to flu vaccines for
uninsured, high-risk adults.
COVID-19 is the most significant public health challenge to face
our Nation in more than a century. CDC is providing the American public
with the information and assistance it needs to address COVID-19 head
on. As we work together to fight COVID-19 and end this pandemic, CDC is
committed to its mission to protect all Americans from disease threats
and to save lives.
National Institute of Allergy and Infectious Diseases
NIH is the HHS agency leading the research response to COVID-19 and
the novel coronavirus that causes the disease, SARS-CoV-2. Within NIH,
NIAID is responsible for conducting and supporting research on emerging
and re-emerging infectious diseases, including COVID-19.
NIAID responds rapidly to threats of emerging infectious diseases,
by accelerating fundamental basic research efforts, engaging a domestic
and international basic and clinical research infrastructure that can
be quickly mobilized, and leveraging collaborative and highly
productive partnerships with industry. NIAID also provides preclinical
research resources to scientists in academia and private industry
throughout the world to advance translational research on emerging and
re-emerging infectious diseases. These research resources help bridge
gaps in the product development pipeline, thereby lowering the
scientific, technical, and financial risks incurred by product
developers and incentivizing companies to partner with us in developing
safe and effective countermeasures including vaccines, therapeutics,
and diagnostics.
NIAID has a longstanding commitment to coronavirus research,
including extensive efforts to combat two other serious diseases caused
by coronaviruses: SARS and MERS. This research has enhanced our
fundamental understanding of coronaviruses in general and provides a
strong foundation for our accelerated efforts to address the specific
challenge of COVID-19 by developing vaccines, therapeutics, and
diagnostics.
Developing Vaccines to Prevent SARS-CoV-2 Infection
A safe and effective vaccine for SARS-CoV-2 will be essential to
stopping the spread of infection, reducing rates of morbidity and
mortality, and preventing future outbreaks. NIAID is supporting
development of several SARS-CoV-2 vaccine candidates, including
vaccines based on platform technologies that have shown promise against
the coronaviruses that cause SARS and MERS.
As part of a longstanding collaboration, the NIAID Vaccine Research
Center worked with the biotechnology company Moderna, Inc., to develop
a vaccine candidate using a messenger RNA (mRNA) vaccine platform
expressing the SARS-CoV-2 spike protein. On March 16, 2020, NIAID
initiated a Phase 1 clinical trial of this experimental vaccine at the
Kaiser Permanente Washington Health Research Institute, and later added
clinical sites at Emory University and the NIH Clinical Center. This
trial was recently expanded to enroll older adults to better define the
safety of and immune response to the vaccine across various age groups.
On May 18, 2020, Moderna announced encouraging interim findings from
the Phase 1 clinical trial and, on May 29, 2020, a Phase 2 clinical
trial was initiated to further study safety and the immune response to
the experimental mRNA vaccine. NIAID and BARDA are working with Moderna
to launch a Phase 3 clinical trial as early as July 2020, pending
positive results from this Phase 2 trial. The Coalition for Epidemic
Preparedness Innovations (CEPI) funded the manufacture of the vaccine
candidate for the Phase 1 trial, and BARDA is supporting advanced
development of the candidate.
Scientists at NIAID's Rocky Mountain Laboratories (RML) in
Hamilton, Montana, are collaborating with University of Oxford
researchers to develop a SARS-CoV-2 chimpanzee adenovirus-vectored
vaccine candidate AZD1222, formerly known as ChAdOx1, now in a Phase 2/
3 clinical trial supported by the University of Oxford. BARDA recently
announced plans to support advanced development and production of
AZD1222. RML investigators also have partnered with University of
Washington scientists to investigate another mRNA vaccine candidate
against SARS-CoV-2. NIAID is working with additional academic and
industry partners to develop several other vaccine concepts.
The rigorous clinical testing required to establish vaccine safety
and efficacy means that it might take some time for a licensed SARS-
CoV-2 vaccine to be available to the general public. The COVID-19
response currently is focused on the proven public health practices of
containment and mitigation.
Identifying Therapeutics to Treat COVID-19
Effective therapeutics for COVID-19 are critically needed to treat
patients who have been infected with SARS-CoV-2. On February 21, 2020,
NIAID launched a multicenter, randomized placebo-controlled clinical
trial, the Adaptive COVID-19 Treatment Trial (ACTT), to evaluate the
safety and efficacy of therapeutics for COVID-19, initially examining
the antiviral drug remdesivir for treatment of severe COVID-19 in
hospitalized adults (ACTT-1). The adaptive design of this trial will
enable the evaluation over time of additional promising therapies, such
as the anti-inflammatory drug baricitinib, which was recently added to
the next iteration of the study (ACTT-2). An analysis of preliminary
data from 1,063 patients enrolled in the ACTT-1 indicated that those
who received remdesivir had a 32 percent faster time to recovery, a
median of 11 days compared with 15 days for those who received placebo.
Additionally, the analysis found that remdesivir may benefit survival,
although the mortality data did not reach statistical significance. A
mortality rate of 7.1 percent was observed for the group receiving
remdesivir versus 11.9 percent for placebo. These initial findings were
published on May 22, 2020, in the New England Journal of Medicine.
NIAID is developing and testing other novel and repurposed therapies. A
study to evaluate monoclonal antibodies (mAbs) in outpatients with
mild-to-moderate COVID-19 is planned for launch in early July. NIAID
also is planning separate clinical trials to assess hyperimmune
intravenous immunoglobulin (IVIG) and mAbs for treatment of COVID-19 in
hospitalized adults.
On April 6, 2020, the National Heart, Lung, and Blood Institute
(NHLBI) launched a clinical trial of HCQ in hospitalized COVID-19
patients through its Prevention and Early Treatment of Acute Lung
Injury (PETAL) clinical trials network. NHLBI also sponsored the
addition of a U.S. site for a Canadian Institutes for Health Research-
funded trial of colchicine--an anti-inflammatory drug commonly used to
treat gout--for treating COVID-19 in the outpatient setting.
Additionally, NHLBI is leveraging the NIH-funded Strategies to Innovate
Emergency Care Clinical Trials Network (SIREN) to study whether
convalescent plasma, or blood plasma from individuals who have
recovered from COVID-19, can help reduce the progression of COVID-19 in
patients with mild symptoms.
The National Center for Advancing Translational Sciences (NCATS) is
leveraging the NCATS Pharmaceutical Collection, a compilation of every
drug approved for human use by major regulatory agencies worldwide, and
other collections of small molecules and compounds to identify
potential SARS-CoV-2 therapeutics for further investigation. Other
Institutes and Centers across NIH also are working concurrently with
partners in academia and industry to pursue the development and testing
of mAbs, antiviral, and anti-thrombotic drugs for potential treatment
of COVID-19. NIAID, NCI, NHLBI, NCATS, the National Institute of
Arthritis and Musculoskeletal and Skin Diseases, and the National
Institute of Neurological Disorders and Stroke (NINDS) are all engaged
in this critical effort.
NIH, in collaboration with the Foundation for the NIH, recently
launched an innovative public-private partnership to speed the
development of COVID-19 therapeutics and vaccines. The Accelerating
COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private
partnership brings together stakeholders from across the U.S.
Government, industry, and the European Medicines Agency to develop an
international strategy for a coordinated research response to the
COVID-19 pandemic. Other Federal partners include BARDA, DOD, the
Department of Veterans Affairs, CDC, and FDA. NIAID has been asked to
lead the effort of U.S. government-supported clinical trials for
certain vaccine candidates and some therapeutic interventions that have
been considered by ACTIV.
NIH also has convened the COVID-19 Treatment Guidelines Panel,
comprised of representatives of NIH and five other Federal agencies
along with representatives of eight professional organizations,
academic experts, and treating physicians including providers from high
COVID-19 incidence areas. On April 21, 2020, the panel issued the first
release of COVID-19 treatment guidelines for clinicians. The guidelines
provide recommendations regarding specific treatments currently
available and address considerations for special populations, including
pregnant women and children. On May 12, 2020, in response to the
preliminary analysis of ACTT-1, the Panel updated these treatment
guidelines to recommend remdesivir for the treatment of COVID-19 in
hospitalized patients with severe disease requiring supplemental
oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.
The guidelines are updated regularly as new evidence-based information
emerges.
Enhancing Diagnosis and Understanding the Pathogenesis of COVID-19
NIH is supporting an HHS-wide effort to promote the development and
commercialization of diagnostic tests to detect current SARS-CoV-2
infection. On April 29, 2020, NIH announced the Rapid Acceleration of
Diagnostics (RADx) initiative, which is working to identify, support,
and make innovative strategies for COVID-19 testing widely accessible,
in collaboration with FDA, CDC, and BARDA. RADx is leveraging the
Point-of-Care Technologies Research Network established by the National
Institute of Biomedical Imaging and Bioengineering (NIBIB) to allow for
the potential roll out of new products by fall 2020. This initiative
expects to award up to $500 million to support development of point-of-
care and home-based diagnostic devices, as well as innovations that
make current laboratory tests faster, more efficient, and more widely
accessible. Innovators will be matched with technical, clinical,
regulatory, business, and manufacturing experts to increase the odds of
success. In addition, NIAID is using CARES Act funds to support diverse
SARS-CoV-2 diagnostic platforms including RT-PCR and enzyme-linked
immunosorbent assays, and facilitating development of sensitive,
specific, and rapid diagnostic tests by providing critical SARS-CoV-2
isolates and reagents to the developers of tests.
NCI is coordinating with FDA and NIAID to assess the sensitivity
and specificity of certain SARS-CoV-2 serological tests, which can
detect antibodies indicative of a prior exposure to SARS-CoV-2. NCI and
NIAID also are working to establish a collaborative national network to
increase national capacity for high-quality serological testing with
return-of-results to subjects. In addition, they will conduct research
to increase the understanding and application of those results and
support related clinical efforts, including clinical trials of
convalescent serum and the creation of registries of tested subjects
for sero-protection studies.
NIAID, NCI, NCATS, and NIBIB also are partnering on a new study to
investigate whether adults in the United States without a confirmed
history of infection with SARS-CoV-2 have antibodies to the virus,
indicating prior infection. In addition, NIH is supporting COVID-19
natural history studies to understand the incidence of infection in
specific populations, including children and their household contacts,
and aspects of the clinical course of infection, including incidents of
thrombosis, strokes, heart attacks, and other sequelae of infection.
Some of these studies will examine the quality and durability of the
immune response to SARS-CoV-2 and evaluate whether unique immune
responses may be associated with clinical disease trajectories; this
information may be leveraged to develop SARS-CoV-2 therapeutics or
vaccines. Natural history studies also will inform our understanding of
COVID-19 pathogenesis, including factors that may predict disease
progression and help to identify individuals or groups at high risk.
In order to improve understanding of neurological consequences of
SARS-CoV-2 and inform potential treatment strategies, NINDS is
supporting development of a data base that would collect data on the
prevalence and spectrum of neurological symptoms observed in patients
with SARS-CoV-2 infection. NHLBI and the Eunice Kennedy Shriver
National Institute of Child Health and Human Development are leading a
trans-NIH effort, with participation from NIAID, to coordinate research
into the multisystem inflammatory syndrome in children (MIS-C), an
extremely serious inflammatory condition that has been associated with
SARS-CoV-2 infection in children and adolescents.
NIH continues to expand efforts to elucidate the viral biology and
pathogenesis of SARS-CoV-2 and employ this knowledge to develop the
tools needed to diagnose, treat, and prevent disease caused by this
virus. NIH is focused on developing and evaluating safe and effective
COVID-19 vaccines and therapeutics, and sensitive, specific, and rapid
point-of-care molecular diagnostic and serological tests. These efforts
will improve our response to the current pandemic and bolster our
preparedness for the next, inevitable emerging disease outbreak.
Office of the Assistant Secretary for Health
Diagnostics and Testing
Testing for the presence of SARS-CoV-2 is an essential component of
our Nation's response to the COVID-19 pandemic; its importance is now
further magnified as states continue in their various stages of
reopening. The indications for viral testing depend heavily on the
stage of the pandemic and the extent of mitigation employed. In
general, testing may be indicated for diagnosis of those who are
symptomatic, tracing of those in contact with those who are infected,
and surveillance testing of those who are asymptomatic or mildly
symptomatic to achieve infection control and/or other public health
objectives.
The Administration has produced numerous documents that establish
the strategy and specific tactics for testing in America. These
include:
White House: Testing Blueprint Opening Up America
Again
White House: Addendum to the Testing Blueprint
HHS: Report to Congress COVID-19 Strategic Testing
Plan
CDC: Priorities for Testing Patients with Suspected
COVID-19 Infection
CMS: Long Term Care Facilities (Skilled Nursing
Facilities and/or Nursing Facilities): CMS Flexibilities to
Fight COVID-19
CMS: Nursing Home Reopening Recommendations for State
and Local Officials
These will be followed soon with a number of additional guidance
documents that apply the strategic principles to specific situations.
In addition, the Administration is now reviewing testing plans from
each state, territory, and major city public health unit, as a
requirement of $10.25 billion in cooperative agreement funding
distributed by the CDC.
Currently, there are tests for the presence of the virus and tests
for the presence of antibody to the virus. The former determines
whether the individual is actively infected, and presumably infectious.
The latter determines whether the individual has been infected, has
developed an immune response, and may be protected from subsequent
SARS-CoV-2 infections; however, research is ongoing in determining if
past infection confers immunity. Today I will focus mostly on
widespread testing for the presence of the virus, which has represented
the primary challenge the Nation has faced since the onset of the
pandemic.
It is useful to understand the overall testing strategy in terms of
its chronology and sequential objectives, and to understand that this
virus was a new human pathogen for which no diagnostic tests had
previously been developed. In addition, the predominant type of test
relies on sophisticated RNA amplification technology that can only be
done in a laboratory certified to perform moderate or high complexity
testing. Point-of-care (POC) tests are an exception in that they are
low complexity; however, this class of test still represents a minority
of available testing capability and has a defined role because of its
low throughput and relatively limited sensitivity especially early or
late in the infection. Finally, the pandemic caused an unprecedented
demand for all supplies and materials, such that overall demand in a
single month approximated total annual demand of some essential
supplies and materials. This reality represented substantial
challenges, but Federal leadership has guided efforts to combat these
challenges in close collaboration with states, local jurisdictions, and
the private sector. Our overall strategy for testing includes:
Assuring that those who need testing, receive
testing;
Prioritizing testing to meet the stage of the
pandemic;
Increasing the number, diversity, and quality of
tests;
Enhancing states' ability to collect specimens
through novel ``front ends'' like drive-through community-based
testing sites;
Organizing and galvanizing the industry on an
unprecedented scale;
Enhancing testing to underserved communities;
Providing surge testing capacity during local
outbreaks;
Supporting critical infrastructure and national
security needs; and
Enhancing reimbursement for tests to stimulate the
private sector, and providing additional incentives for testing
in nursing homes and vulnerable communities
Stage 1: Launch: Engaging the Emerging Crisis
In the early stages of the COVID-19 pandemic, the Centers for
Disease Control and Prevention (CDC) was engaged in building the
foundation for diagnostic testing in the United States. On January 10,
2020, Chinese researchers deposited the 2019-nCoV genome sequence to
GenBank and CDC began development of the CDC 2019-nCoV Real-Time PCR
Diagnostic Panel. On January 24, CDC publicly posted its assay for the
CDC's newly developed diagnostic panel, allowing the global community
to develop their own assays using the CDC design. On February 3, CDC
submitted an emergency use authorization (EUA) request, and the Food
and Drug Administration (FDA) issued an EUA on February 4, just 24
hours after receiving the complete package, enabling use of the CDC's
COVID-19 diagnostic panel.
Understanding the importance of increased testing, the FDA engaged
test developers from the beginning of the pandemic. Any developer,
including labs, could introduce tests through the EUA process, as they
had during previous emergencies; and FDA encouraged labs and commercial
manufacturers to do so swiftly, engaging with more than 550 test
developers since January who indicated their intent to submit requests
for EUAs. In mid-January, the Biomedical Advanced Research and
Development Authority (BARDA) within ASPR convened a meeting of leading
diagnostic companies from across America to encourage development of
COVID-19 tests. In the ensuing months, multiple funding opportunities
for the development of COVID-19 diagnostic tests were announced and the
NIH provided COVID-19 RNA to diagnostic companies to expedite private-
sector test development. With a desire to ensure high quality
diagnostic testing but also ensure rapid development and dissemination
of COVID-19 tests, the FDA has provided voluntary EUA templates for
laboratories and manufacturers in an effort to streamline the entire
process, and works with developers who wish to use alternate approaches
to the templates. FDA has issued a record number of EUAs for COVID-19
tests. This has contributed greatly to the dramatic increases in
testing the Nation has seen in the past months. The amount and
expediency in which EUAs were issued for COVID-19 tests far exceed past
viral outbreaks. For example, in response to the 2016 Zika Virus
outbreak, FDA issued 20 test EUAs; in response to the 2009 H1N1
outbreak, FDA issued 17 test EUAs. As of June 25, 2020, FDA has issued
more than 150 COVID-19 test EUAs. The timeliness and number of EUAs
issued by FDA for COVID-19 tests is unprecedented and has been critical
to improving the testing scale and capacity in our country, while
providing enough oversight to assure patients can depend on the results
of these tests.
Throughout the COVID-19 outbreak, the Administration has encouraged
and worked collaboratively with diagnostic test manufacturers,
commercial laboratories, public health laboratories, and professional
societies to expand capacity and scale for existing nucleic acid
testing platforms. Through the efforts of the Administration, the
United States has developed a multilayered, multifaceted approach to
testing that can provide the right test to the right person at the
right time. This approach includes contributions from state public
health labs, high-throughput commercial labs, academic and hospital
labs, labs at CDC, the Indian Health Service, the Department of
Defense, and the Department of Veterans Affairs. In addition, the
ecosystem now includes POC testing that can be done in rural areas at
high risk without sophisticated supporting infrastructure, or as a tool
to investigate outbreaks in nursing homes or other confined settings.
As of June 25th, our Nation has performed over 30 million tests,
and now at a rate of between 400,000 and 500,000 tests per day; and
this number will continue to increase. Commercial laboratories are
working more efficiently, processing tests in rapid succession, which
ensures patients receive their results, on average, within 3 days.
Hospital and academic laboratories typically provide results within 2
days, and often much sooner. POC tests provide results within 15
minutes.
To expand capacity and scale without impinging on the traditional
health care system like emergency rooms and urgent care clinics, HHS
worked closely with FEMA, interagency, and state and local partners to
establish Community Based Testing Sites (CBTS). At the inception of
this effort, the 41 federally supported sites were developed and
established by the U.S. Public Health Service Commissioned Corps
(Corps), in CDC-prioritized locations across the country. The Corps had
unique expertise in COVID-19 testing, since many officers had deployed
to Japan and elsewhere to assist in infection control, diagnosis, and
eventual repatriation of American citizens. The initial objectives of
CBTS were to screen and test healthcare facility workers and first
responders, as prioritized by local jurisdiction. The CBTS model has
been a success, having tested over 318,000 individuals, and with an
overall COVID-19 test positive rate of approximately 13.5 percent,
meaning that the CBTS are testing the right individuals at the right
time. This effort has also supported and co-evolved with technological
advances such as the validation of the FDA authorized use of nasal
self-swabbing, which minimizes the need for trained health
professionals and personal protective equipment. The CBTS initiative
was an early example to states and localities on how to conduct
community based COVID-19 testing, and this model has been replicated
throughout the country to screen and test hundreds of thousands more
Americans. Majority of the federally supported community based testing
sites have been transitioned to be state led efforts and the few
remaining sites will be transitioned in the weeks to come.
From the onset in January, and continuing to the present, the
President, Vice President, and senior Administration officials have
held numerous briefings with Governors and their state leadership. Many
of these briefings have focused on joint Federal-state efforts to
expand testing throughout the country. In addition to these calls with
the Nation's Governors, the White House and senior Administration
officials have organized numerous calls to enhance state, local,
territorial and tribal testing coordination efforts. The constant
communication between the Administration and state leadership has
helped provide guidance to states on how to best utilize testing
capacity in their own states. Another product that was produced by the
Administration to assist the states to leverage the full testing
capacity at their disposal was a data base of nationwide lab locations
and capacity, including the specific testing platforms at each
laboratory.
Stage 2: Scaling and Technological Innovation
The identification and expansion of public and private sector
testing infrastructure has been, and continues to be, a priority. One
example of expanding testing infrastructure through public-private
partnerships is the engagement of the Administration with well-known
retailers that have a regional or nationwide footprint. As of June 26,
and with the assistance of the Federal Government, U.S. retailers have
opened and are operating 624 testing sites in 48 states and the
District of Columbia, and they have tested over 774,000 individuals.
The Federal Government built public-private partnerships to increase
the number of testing sites offered at commercial locations across the
country. The public-private partnerships with these retailers are being
expanded to support many more testing sites that will be opened and
operating in the coming weeks. These commercial testing locations are
uniquely situated to meet the testing needs of communities with
moderate to high social vulnerability, which was the focus of the
original sites. Going forward, retailers have indicated their intent to
open at least one thousand more of these sites depending on local
needs.
Another effort of the Administration to further support and expand
the testing infrastructure in the United States has been strengthening
the testing supply chain. The Administration has massively increased
the availability of laboratory and testing supplies by engaging
directly with distributors and manufacturers to increase production
capacity through direct procurement, application of the Defense
Production Act, formation of various public-private partnerships, and
improved allocation criteria that ultimately help ensure that supplies
meet the state's needs and reach the locations where the supplies are
needed most. In addition, validation of additional supply types has led
to a dramatic broadening of available supplies and reagents.
In May alone, working collaboratively with FEMA and utilizing their
logistics, the Federal Government has procured and began to distribute
to states--according to their needs and plans--over 12.8 million
specimen collection swabs and more than 8.9 million tubes of transport
media. To meet state needs, this procurement and distribution will
continue in June and the following months, as necessary.
Stage 3: Support Opening Up America Again
Current efforts are focused on further scaling up testing
capabilities to guarantee that each state has the testing supplies and
capabilities they need to reopen according to their own individual
state plans. For example, the Federal Government procured over 20
million swabs and tubes of transport media (or saline) in June. These
supplies will be shipped out to states over the course of the next few
months. ThermoFisher, which has more than 3,000 lab machines across the
country, will be producing more than 10 million laboratory testing
extraction and PCR kits per month, enabling states to complete millions
of additional tests starting in May. In mid-March, the FDA issued an
EUA for Hologic's Panther COVID-19 test, which runs on more than 600
lab machines across the United States. Beginning in early May, Hologic
began shipping several million test kits per month to labs across the
Nation.
The Administration will continue to work hand in hand with
Governors to support testing plans and rapid response programs. The
Opening Up America Again guidelines, provided by the Administration,
describe roles and responsibilities as well as elements of the robust
testing plans and rapid response programs called for in the President's
Guidelines.
The Laboratory Testing Task Force is providing technical assistance
to all 50 states, tribes, and territories through calls with every
state public health team to discuss their testing goals and the best
mechanisms to achieve them. The Federal Government is assisting states
to develop testing plans, supplying resources to help meet these
testing plans, and deploying teams to states that need additional
subject matter expertise.
On May 24th, HHS delivered a COVID-19 strategic testing plan to
Congress. This Plan is a direct outgrowth of the work done by the
Laboratory Testing Task Force and Community Based Testing Task Force,
both under the leadership of HHS and supported by FEMA personnel within
the NRCC. It outlines how HHS increased domestic testing capacity
across the United States and provides additional guidance and
information about diagnostic technologies, platforms and inventory that
states, territories and tribes can utilize to develop flexible,
adaptable, and robust COVID-19 testing plans. This report fulfills a
requirement of the Paycheck Protection Program and Health Care
Enhancement Act, signed into law on April 24th. Furthermore, HHS
recently distributed $11 billion in support to states, territories, and
tribes to support implementation of jurisdictional testing goals as
well as a broad array of activities associated with testing, as
indicated in the Paycheck Protection Program and Health Care
Enhancement Act.
Because of the Administration's success in rapidly scaling up of
the testing ecosystem, states will be fully equipped to conduct more
COVID-19 tests per capita each month than most countries have tested
cumulatively to this date.
The Federal Government will continue to support Americans by
providing expedited regulatory approvals for tests and equipment as
necessary and appropriate, updating guidance for administering
diagnostic testing, and catalyzing technological and scientific
innovation. The process of reopening the United States will be one that
is federally supported, state-led and locally executed.
We recognize that vulnerable populations in many underserved
communities are among the highest risk of suffering devastating health
and economic impacts of COVID-19. The Office of Minority Health issued
a Notice of Funding Opportunity on May 1. On June 23rd, the HHS Office
of Minority Health (OMH) announced the selection of the Morehouse
School of Medicine as the awardee for a new $40 million initiative to
fight COVID-19 in racial and ethnic minority, rural and socially
vulnerable communities. The Morehouse School of Medicine will enter
into cooperative agreement with OMH to lead the initiative to
coordinate a strategic network of national, state, territorial, tribal
and local organizations to deliver COVID-19-related information to
communities hardest hit by the pandemic. The three-year initiative will
include the development and coordination of a strategic and structured
network of national, state, territorial, and local public and community
based organizations that will help mitigate the impact of COVID-19 on
racial and ethnic minorities as well as rural and socially vulnerable
communities across the Nation. The initiative also includes a national
multi-media outreach and education effort. One of the primary goals of
these information dissemination efforts is to provide additional
education and community-level information on resources to help fight
the pandemic to those who need it most.
On June 4th, using authorities provided to the Secretary under the
CARES Act, HHS released new mandatory laboratory data reporting
guidance for COVID-19 testing. This guidance standardizes reporting to
ensure that public health officials have access to comprehensive and
nearly real-time data to inform COVID-19 response efforts, including
data on demographic information such as race, ethnicity, age and
gender. This will help ensure that all groups have equitable access to
testing, and will equip public health professionals with the data to
determine accurately the burden of infection on vulnerable groups.
To further support testing efforts in underserved communities, in
May the Health Resources and Services Administration (HRSA) awarded
$583 million to 1,385 health centers to support COVID-19 testing
efforts. Health centers serve over 28 million patients in 12,000
service delivery sites across the Nation and in the territories. They
provide care to 1 in 5 of those uninsured, 1 in 5 rural Americans, 1 in
3 individuals below the poverty line, more than 1.4 million homeless
individuals, and nearly 1 million migrant agricultural workers. Health
centers are uniquely situated in communities to serve those that are
most vulnerable and 93 percent of these centers offer COVID-19 testing.
As of June 26, health centers have reported testing nearly 1.3 million
individuals in total and racial and/or ethnic minority patients
represent 55 percent of those tested in the past week.
United States Public Health Service Commissioned Corps
Since the early stages of the COVID-19 outbreak, the Corps has been
an indispensable asset leveraged to address the public health needs of
the Nation in response to this crisis. The Corps is one of the eight
uniformed services of the United States and the only uniformed service
committed to protecting, promoting, and advancing the health and safety
of the Nation. Corps officers serve throughout the Nation in
communities that are most in need by providing essential healthcare
services to underserved and vulnerable populations.
In January, the Corps deployed officers to provide expert outbreak
response in direct support of CDC. Deployment expanded rapidly from 38
officers on February 1, 2020 to more than 4,532 officers as of June 24,
2020, with many of them undertaking multiple or consecutive
deployments. Corps officers have been deployed across our country and
internationally to assist with the outbreak response, to support the
return of American citizens, to assist in the management of
hospitalized U.S. citizens with COVID-19 abroad, and to support
clinical trials related to COVID-19. Corps officers provided critical
assistance to community-based testing sites throughout the Nation and
their contributions to this effort are immeasurable. In response to the
escalating crisis, the Corps established COVID-19 Clinical Strike
Teams, which include officers from the variety of disciplines needed on
the frontlines. This kind of ready-made unit allows the Corps to deploy
a ``cavalry'' to support healthcare systems under stress in states
across the country. COVID-19 Clinical Strike Teams have deployed to a
long-term care facility in Kirkland, Washington, to the Javits Center
in New York City, and to the TCF Center in Detroit. At the end of
March, the Navajo Nation requested CDC assistance to provide care
amidst a surge of COVID-19 cases. Since that time, the Corps has
deployed teams to support the response. The Corps has also deployed two
teams, totaling more than 70 officers, to the Pennsylvania and the
Florida State Health Departments to provide infection control, personal
protective equipment (PPE) training, and consultation to long term care
facilities.
The United States Public Health Service Commissioned Corps stands
ready and willing to respond to the public health needs of our country
and to provide essential healthcare services.
Food and Drug Administration
From the beginning of this public health emergency, FDA has taken
an active leadership role in the all-of-government response to the
COVID-19 pandemic, inspired by the resiliency of the American people
and our great innovators. FDA stood up an internal cross-agency group
that continues to ensure we are doing everything possible to protect
the American public, helps ensure the safety and quality of FDA-
regulated products, and provides the industries we regulate the tools
and flexibility to do the same. Work has focused on facilitating the
development and availability of medical countermeasures to diagnose,
treat, and prevent COVID-19, surveilling the medical product and food
supply chains for potential shortages or disruptions and helping to
mitigate such impacts, as necessary to protect the health. This work is
a key component of the Federal Government's efforts to address this
pandemic and reopen the economy so Americans can get back to work and
school.
Diagnostic Testing
An important part of FDA's role concerns determining whether the
tests developed for clinical use in the United States provide accurate
and reliable results and to help provide timely access to such tests.
In general, during an emergency, including this pandemic, FDA oversees
the validity of tests developed by others through the Emergency Use
Authorization (EUA) process. Every action FDA has taken regarding
testing during this public health emergency to address the COVID-19
pandemic has balanced the urgent need to make tests available with a
level of oversight to help ensure accurate tests are being deployed.
COVID-19 has created a demand for new tests that is unprecedented
in both volume and urgency. FDA has been extremely proactive and
supportive of diagnostic test development by all comers, laboratories,
and large and small commercial manufacturers. Even prior to any
diagnosed U.S. cases of COVID-19, FDA proactively reached out to
developers to encourage the development of tests and to offer
assistance from the Agency to help facilitate development. To balance
the urgent need to increase diagnostic testing capacity in the U.S.
with the need to provide adequate oversight to help ensure that
patients can depend on the results of these tests, FDA has announced
several policies to facilitate oversight. These include engaging in
rolling reviews of EUA submissions, and authorizing tests that have the
necessary data to support that the criteria for issuance are met. To
date, we have authorized more than 150 EUAs for COVID-19 tests. States
that have the capacity and expertise to do so have been authorizing
tests for use within a laboratory in that state.
In a public health emergency, getting an accurate test is important
not only for the individual patient, but for the public at large. False
positive or false negative results can contribute to the spread of
COVID-19, so all tests used for COVID-19 should be validated before
use. FDA's public health emergency policies do not change that. As with
medical treatments, we want tests to be safe and, accurate. FDA is
monitoring imported test kit products and where appropriate detaining
and examining them at the ports and border and is engaging in outreach
when we become aware that test developers are making false or
misleading claims about their tests. We are monitoring the market for
fraudulent tests and are not issuing EUAs for tests that do not meet
the EUA standards. FDA has and will continue to take appropriate action
against firms and individuals that place the public health at risk. FDA
updates its website continually to make clear which tests have been
authorized by the Agency, and which tests have not.
FDA has been working around the clock to (1) encourage and support
test development for the U.S. market, working with over 500 developers
since January; (2) issue EUAs for diagnostic tests, including those for
home self-collections; (3) research and mitigate shortages of test
components, including identifying and sharing scientifically acceptable
alternatives for components on FDA's website; (4) arrange with the
Department of Defense weekly airlifts of swabs to the United States;
(5) engage nontraditional device manufacturers to support use of new
swabs and other supplies that are needed in the United States; and (6)
offer support to developers through a hotline and key resources,
including FAQs that are updated regularly and serve as a clearinghouse
for scientific information that helps everyone increase testing
capacity.
Serological Testing
Serological tests measure the amount of antibodies or proteins
present in the blood when the body is responding to a specific
infection, like the virus that causes COVID-19. Such a test detects the
body's immune response to an infection. These tests do not diagnose a
current COVID-19 infection; however, they can play a critical role in
the fight against COVID-19 by helping healthcare professionals identify
individuals who may have overcome an infection in the past and may have
developed an immune response. These tests may also aid in identifying
individuals with antibodies to the virus that causes COVID-19 so they
may donate convalescent plasma as a possible treatment for severely ill
COVID-19 patients, which is a potential treatment currently being
researched.
In March, FDA issued a policy providing regulatory flexibility for
developers of certain serological tests to market or use their tests
once they have performed the appropriate evaluation to determine that
their tests are accurate and reliable, without FDA authorization and as
further recommended in the policy. The policy was intended to allow for
early patient access and flexibility for developers, with appropriate
transparency regarding the limitations of these tests. At the time FDA
issued this policy, flexibility was important to allow for early use of
antibody tests to begin to answer some of the critical population-level
questions about the prevalence of COVID-19 infections in different
communities, whether the presence of antibodies conveys immunity and,
if so, for how long, while also encouraging test developers to seek an
EUA, as many did. Answering these questions is critical for informing
how best to use these tests, but we could not answer these questions
without tests being available.
Once FDA had authorized more serology tests, we built on this
policy by updating it on May 4th and again on May 11th to outline key
expectations for antibody test developers, including that commercial
manufacturers would submit EUA requests, with their validation data,
within 10 business days from the date they notified FDA of their
validation testing or from the publication date of the policy,
whichever was later. FDA also provided specific performance
recommendations for serology test developers. The policy for
laboratories certified under the Clinical Laboratory Improvement
Amendments (CLIA) to perform high-complexity testing regarding their
developing and performing their own serology tests was not changed.
Such laboratories perform their own validation and provided
notification to FDA while following other recommendations with respect
to labeling as described in the policy.
FDA has also introduced a more streamlined process to support EUA
submissions and review. Two voluntary EUA templates for antibody tests
have been made available--one for commercial manufacturers and one for
CLIA certified high-complexity labs that decide to seek FDA
authorization. These templates can help facilitate the preparation and
submission of an EUA request and can be used by interested developers.
Also, as we do for diagnostic tests, we are happy to work with
developers of serology tests on other approaches if they do not want to
use one of the templates.
We are continuing to provide updated information and educational
materials to states and health care partners. When particular
commercial manufacturers that are currently marketing serology tests
under the May 4th and May 11th policy fail to submit an EUA within 10
business days of notification or policy publication (whichever is
later), we have been removing those tests from our website notification
list and are sharing this information publicly. We will also keep up
our work to stop illicit tests from entering the U.S. and to keep
fraudulent products off the market.
In addition, FDA issued an umbrella EUA for certain antibody tests
that undergo a validation evaluation at NCI or another government
agency designated by FDA. Tests that FDA confirms meet the performance
and labeling criteria, among other conditions outlined in the umbrella
EUA, can be authorized under this umbrella EUA, streamlining the
submission and review of these important tests.
FDA will continue to appropriately balance assurances that an
antibody test is accurate and reliable with timely access to such tests
as the continually evolving circumstances and public health needs
warrant. Importantly, we continue to work with developers of
serological tests and are reviewing submitted EUA requests to authorize
even more of these tests. I continue to work closely with my fellow
Coronavirus Task Force members in examining the role testing will play
as we look to reopen our country's schools, businesses, and public
services.
Vaccine and Therapeutic Development
At this time, there is no FDA-approved vaccine to prevent being
infected with COVID-19, nor are there any FDA-approved drug products to
treat COVID-19. FDA is working closely with Federal partners, vaccine
developers, researchers, manufacturers, and experts across the globe to
help expedite the development and availability of vaccines and drugs to
prevent or treat COVID-19 infections. FDA intends to use regulatory
flexibility to help ensure the most efficient and timely development of
safe and effective vaccines to prevent COVID-19.
Since the beginning of the COVID-19 pandemic, FDA has been working
tirelessly to facilitate the development and availability of
therapeutics for use by patients, physicians, and health systems as
expeditiously and safely as possible. FDA announced on March 31, 2020
the creation of an emergency review and development program for
possible therapies for COVID-19: the Coronavirus Treatment Acceleration
Program, or ``CTAP''. The Agency is supporting the program by
reassigning staff and working continuously to review requests from
companies, scientists, and doctors who are working to develop
therapies. Under CTAP, FDA is using every available authority and
regulatory flexibility to facilitate the development of safe and
effective products to treat patients with COVID-19.
Further, FDA is partnering with the NIH in its efforts to develop a
national strategy for a coordinated research response to the pandemic.
The Accelerating COVID-19 Therapeutic Interventions and Vaccines, or
ACTIV, partnership is developing a framework for prioritizing vaccine
and drug candidates, streamlining related clinical trials, coordinating
regulatory processes, and leveraging assets among all partners to
rapidly respond to COVID-19 and future pandemics.
There are a variety of therapeutic products being evaluated,
including antiviral drugs and immunotherapies, that may be helpful in
reducing lung inflammation and improving lung function in COVID-19
patients. All this work is beginning to pay off, and we have announced
the positive results of the NIAID trial of remdesivir in patients with
severe COVID-19. On May 1, FDA issued an EUA for remdesivir for the
treatment of suspected or laboratory-confirmed COVID-19 in adults and
children hospitalized with severe disease.
Another potential approach for treatment is the use of antibody-
rich products such as convalescent plasma and hyperimmune globulin.
These blood products are manufactured from plasma donated by people who
have recovered from the virus and such products are being studied to
determine if they could shorten the length, or lessen the severity, of
the illness. We are evaluating convalescent plasma in the context of
clinical trials and facilitating a national expanded access program and
emergency access for individual patients, as appropriate. A key to
ensuring the availability of convalescent plasma to those in greatest
need, as well as to supporting clinical development of convalescent
plasma and hyperimmune globulin, has been by persuading fully recovered
COVID-19 patients to donate plasma if they meet FDA's donor eligibility
criteria. To that end, FDA continues to work with blood collectors to
facilitate the collection of convalescent plasma, and to work with
developers of these therapies to move forward with clinical
evaluations. Thousands of COVID-19 patients have received
investigational COVID-19 convalescent plasma under FDA's pathways for
use of investigational products, including expanded access and clinical
trials.
Medical Product Supply
FDA monitors and proactively adjusts to the worldwide demand and
supply chain disruptions for medical products caused by the COVID-19
pandemic. We are working closely with manufacturers to help ensure they
continue to notify the Agency of any permanent discontinuance or
interruption of drug, biological product, and device manufacturing in a
timely manner. In addition to our usual communication with drug
manufacturers, we are working closely with healthcare and pharmacy
systems, hospitals, providers, and others on the frontlines of COVID-19
patient care to identify current or emerging regional shortages of
critical care drugs used to treat COVID-19.
FDA understands the significant impact shortages can have on
patient care and is doing everything within our authorities to help
prevent and alleviate this impact. For example, we issued temporary
policies under which outsourcing facilities registered with FDA and
pharmacists in state-licensed pharmacies or Federal facilities can
compound certain drugs used to treat patients with COVID-19 under
particular conditions explained in FDA guidance.
In addition, when we identify a shortage, we react swiftly to
mitigate the impact to U.S. patients and health care professionals, and
quickly share that information with the public. For example, the Agency
quickly identified the need for making hand sanitizers available as
demand spiked. FDA has published and updated three guidances to
facilitate the production of alcohol-based hand sanitizer in non-
traditional settings such as pharmacies or distilleries. As another
example, the Agency granted an EUA to authorize use of propofol
approved in the European Union, thus alleviating a shortage of this
critical drug for COVID-19 patients who need to be on a ventilator.
We are working to increase the supply of personal protective
equipment (PPE) and other critical devices that patients and those on
the front lines of the U.S. response rely upon. FDA has reached out to
over 1000 manufacturers since January and has helped facilitate an
increase of the availability of PPE while taking steps to ensure that
patients and our health care workers on the front lines can depend upon
these products to protect them. FDA has issued several EUAs to help
make more respirators available to health care personnel and ease
burdens on the health care system. These allow for the emergency use of
NIOSH-approved respirators in health care settings for healthcare
personnel and the importation of non-NIOSH approved respirators that
meet certain specified criteria, as set forth in the various EUAs. FDA
has also issued several guidances to provide flexibility for those
manufacturing PPE for the COVID-19 response, and we have published
conservation strategies for gloves and masks and gowns. To support
these efforts further, FDA has issued several EUAs for devices used to
decontaminate respirators for reuse by health care workers in hospital
settings, where appropriate.
FDA has also issued guidances for several other critical devices
including ventilators, clinical electronic thermometers, and imaging
systems, as well as remote digital pathology and remote monitoring
devices intended to help facilitate remote care that puts patients and
health care providers at less risk for exposure to COVID-19.
FDA has worked steadily to support those manufacturing PPE, as well
as those who are dealing with limited supplies and shortages, to
provide alternatives when there are no other options available. This
includes initiating biweekly virtual town hall meetings for those
seeking and manufacturing respirators to ask questions and discuss
challenges they are facing.
FDA's policies and active engagement with the medical product and
healthcare community have helped to accelerate patient access to
critical devices. FDA appreciates Congress including provisions in the
CARES Act for additional device shortages authority during or in
advance of a declared public health emergency and looks forward to
continuing to work with Members of Congress to expand further these
authorities, consistent with the fiscal year 2021 Budget so that we can
address shortages in other situations as well.
Food Supply
FDA is working with our Federal, state, and local partners as well
as industry to help ensure a safe and adequate food supply for both
people and animals. I want to reassure you there is no evidence of food
or food packaging being associated with transmission of COVID-19.
Although food production and manufacturing in the United States
remains strong, resilient, and is for the most part dispersed
throughout the United States, some components are under stress. We are
monitoring these situations closely and identifying mitigation
strategies.
There has been a significant shift in where consumers are buying
food, because of the pandemic. We have taken steps to provide temporary
guidance to provide flexibility in packaging and labeling requirements
to help industry divert products manufactured for food service and
institutional use to retail grocery stores.
FDA recognizes that the food supply chain is dependent on the
safety of the Nation's food and agricultural workforce. Along with our
Federal partners, we have provided best practices for food and
agricultural workers, industry, and consumers on how to stay safe, and
help ensure the continuity of operations in the food and agriculture
critical infrastructure sector during the pandemic and as retail
establishments begin to reopen. FDA's Coordinated Outbreak Response and
Evaluation team has been working throughout the pandemic, is fully
staffed, and on-the-job looking for signs of foodborne illness
outbreaks. FDA continues to monitor closely the overall safety of the
Nation's food supply. Importantly, we continue to work with CDC, the
U.S. Department of Agriculture, and our state and local partners to
protect consumers from foods contaminated with pathogens. For example,
in March, FDA found and detained Salmonella-contaminated tahini
products at the port of entry; products that were already in U.S.
distribution were recalled. Earlier this month FDA started
investigating a multistate outbreak of Cyclospora illnesses potentially
linked to store brand garden salads; three retailers have recalled the
product.
Fraudulent Products
FDA exercises its regulatory authority to protect consumers from
firms and individuals selling unproven products with false or
misleading claims to prevent, treat, mitigate, diagnose, or cure COVID-
19, including by issuing warning letters and pursuing civil and
criminal enforcement actions, where appropriate. For example, FDA has
sent hundreds of abuse complaints to domain name registrars and
internet marketplaces, which in most instances have voluntarily removed
listings for products that fraudulently claim to diagnose, cure,
mitigate, treat, or prevent COVID-19. The Agency also has sent more
than 50 warning letters to sellers of such fraudulent products. Working
with the Department of Justice, FDA has sought and obtained several
preliminary injunctions that require defendants to halt the sale of
fraudulent products claiming to treat or prevent COVID-19, including
one product that, when used as directed, is equivalent to industrial
bleach.
In addition, FDA investigators remain on the front lines at ports
of entry, quickly examining, reviewing, and sampling import entries,
and refusing admission where appropriate. We protect the supply chain
in two equally critical ways: first, we help ensure safe products are
coming in and second, that illegal, dangerous and fraudulent products
do not get into the country. As FDA import staff screen medical
products entering our country, we also find and block the entry of
fraudulent products that falsely claim to prevent, treat, mitigate,
diagnose, or cure COVID-19. For example, in March, at the border, FDA
intercepted fraudulent COVID-19 ``treatment kits'' that were falsely
declared as ``water treatment.'' Import examination of these shipments
found misbranded ``kits'' intended to treat SARS-CoV-2. This joint
investigation, which included FDA's Office of Criminal Investigations,
led to an arrest in the UK by law enforcement partners there. In
addition, in April, FDA intercepted a bulk shipment of
hydroxychloroquine coming from China going to a physician in
California. The physician was charged with smuggling hydroxychloroquine
from China to make his own pills and concealed the shipment from CBP by
misdeclaring it as yam extract. In May, FDA worked with U.S. Customs
and Border Protection (CBP) to intercept several shipments of
counterfeit facemasks, with the result that they were refused and
destroyed before getting into U.S. commerce.
We are in close communication with our partners at U.S. CBP to
proactively identify and mitigate any potential backlogs. FDA
participates in FEMA Supply Chain Task Force meetings, providing
regulatory support and subject matter expertise to respond to questions
concerning medical products identified by FEMA, to facilitate the
lawful entry and use of imported medical products coordinated through
FEMA, and to inform medical product supply chain discussions.
Conclusion
HHS appreciates the support and interest of Congress in our work
related to COVID-19. We look forward to continuing to work together as
the Country continues to open safely again. Thank you for the
invitation to testify today and we look forward to answering your
questions.
______
The Chairman. Thank you, Dr. Fauci.
Dr. Redfield, welcome.
STATEMENT OF ROBERT REDFIELD, M.D., DIRECTOR, UNITED STATES
CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA
Dr. Redfield. Good morning, Chairman Alexander, Ranking
Member Murray, and distinguished Members of the Committee. I
want to thank you for the opportunity to testify before you
today with my HHS colleagues.
The COVID-19 pandemic is the most significant global public
health challenge that we have faced as a Nation in more than a
century. In the United States, daily cases are increasing after
an extended decline. We are seeing significant increases in the
southeast and southwest regions of this Nation. The number of
jurisdictions in upward trajectory has continued to increase.
Now 29 of 55 jurisdictions fall into this category.
The evidence tells us that these cases are driven by many
factors, to include increased testing, community transmission,
and outbreaks in the settings, such as nursing homes and
occupational settings. Hospitalizations now are going up in 12
states. And, as of this weekend, daily death now has increased
in the State of Arizona.
CDC is closely monitoring these increases and have 48 teams
with more than 140 staff currently deployed in 20 states and
two territories. CDC is providing technical expertise to the
health departments in epidemiology, contact tracing, infection
prevention and control, and communication.
Beyond providing this critical boots on the ground, CDC is
working with your states and community in other ways. CDC is
speaking with the states, tribal, local, and territorial health
departments on a daily basis to develop strategies to stop
COVID while reopening businesses and schools. The initial
guidance for institutes of higher learning was shared in March,
and the K through 12 setting was shared in February. Both these
guidances have been updated since and over the past several
months. As more information becomes available, we will continue
to disseminate that more broadly.
CDC released consolidated recommendations for COVID
testing, including interim testing guidelines for nursing
homes, as well as testing options for high-density, critical
infrastructure workplaces after a COVID case is identified.
Testing guidance for higher education and K through 12: the
higher education should be posted today, and K through 12 later
this week. These recommendations are consistent with previously
published testing guidelines and are meant to supplement, not
replace, the guidance of local jurisdictions.
CDC continues to advance science around the COVID-19 impact
in certain populations and those who are at heightened risk for
severe outcomes. Our most recent analysis of the United States
case data from the pandemic, hospitalizations were six times
higher and death 12 times higher among those with reportedly
underlying conditions compared to those who did not have these
conditions.
We have expanded the list of underlying conditions where
the evidence is clear that they put people at higher risk of
severe illness. These conditions include chronic kidney
disease, COPD, having a weakened immune system from a solid
organ transplant, obesity, serious heart disease, sickle cell
disease, and Type 2 diabetes.
Our analysis also provides further evidence that racial and
ethnic populations are disproportionately affected by this
epidemic.
While data is the backbone of this response, containing the
outbreak depends on four core interventions: readily available
testing, comprehensive contact tracing, timely isolation of
known cases, and quarantine to break the transmission.
We are not defenseless against this disease. We have
powerful tools at our disposal--social distancing, wear a face
cover in public, and be disciplined about the frequent hand
washing.
It is critical that we all take the personal responsibility
to slow the transmission of COVID-19 and embrace the universal
use of face coverings. Specifically, I am addressing the
younger members of our society, the Millennials, and the
Generation Zs. I ask those that are listening to spread the
word.
Before I close, I would like to speak briefly about how CDC
is assisting the frontlines of our health departments to fight
COVID. With your support, CDC has awarded $12 billion to 64
jurisdictions. Data modernization is underway. Public health
laboratories are building resilience. Number of contact tracers
have grown 345 percent.
The disease impacts us all, and it is going to take all of
us working together to stop it. Together, I believe we can
achieve the possible.
Thank you, and I look forward to your questions.
The Chairman. Thank you, Dr. Redfield.
Admiral Giroir, welcome.
STATEMENT OF ADMIRAL BRETT GIROIR, M.D., ASSISTANT SECRETARY
FOR HEALTH, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN
SERVICES, WASHINGTON, DC
Admiral Giroir. Chairman Alexander, Ranking Member Murray,
and distinguished Members of the Committee, it is good to see
all of you again.
First, I want to clarify my current role. On March 12th,
Secretary Azar requested that I lead the coordination of COVID-
19 testing efforts within the Department. To be clear, although
I am assuming some of my traditional duties as the assistant
secretary, I am maintaining my role of coordinating testing,
including now the NIH RADx Diagnostics Program, along with Dr.
Collins, to assure that innovations are immediately translated
into practice.
In order to get back safely to work and school, the
overarching, most critical, and essential action we must first
accomplish is to control the virus, meaning rapidly
extinguishing any outbreaks and minimizing community
transmission. All of us are concerned about recent data from
several states, indicating rising infections, and now an uptick
in hospitalizations and deaths even as other states and the
majority of counties are maintaining a low infection burden.
Knowing what we know now about asymptomatic transmission,
and the fact that we are in a much better position today in
terms of our mitigation strategies, PPE, and testing, we can
reverse these concerning trends if we work together.
First, we must take personal responsibility and be
disciplined about our own behavior. Maintain physical
distancing. Wear a face covering whenever you cannot physically
distance. Wash your hands. Stay at home if you feel sick. If
you have been in close contact with someone infected or at a
gathering without appropriate precautions, get tested. Shield
the elderly and the vulnerable of any age. And, follow the
guidelines for opening up America again. The criteria are very
specific and are as relevant today as when we released them.
In addition, this week we are initiating surge testing in
multiple communities of highest concern in coordination with
state and local officials.
Now, back to schools and businesses. As Dr. Redfield
stated, the CDC will release recommendations on K through 12,
institutions of higher education, and general business
reopening. These will include considerations for integrating
testing, especially surveillance testing, into a comprehensive
strategy.
As you asked me, Mr. Chairman, if you are a superintendent
of a school system or a president of a university, No. 1, apply
the CDC guidelines in consultation with your state and local
public health officials so that testing is a part of your
comprehensive plan, which should also include prevention and
clear mechanisms to isolate positive students.
No. 2, assure your testing needs are incorporated into your
state testing plans. As we outlined in the national testing
strategy, each state has developed and will continue to build
upon a customized-to-state testing plan developed in full
coordination with the Federal Government.
The next iteration, covering July to December, is due on
July 10th. These state plans drive the allocation of certain
scarce resources. For example, in May and June, the Federal
Government has distributed nearly 26 million collection swabs
and over 19 million tubes of transport media.
HHS also prioritizes allocation of certain key laboratory
tests, like point-of-care tests, according to state-specific
needs.
There are also strategies particularly relevant to
surveillance testing, especially in universities and
businesses. For example, pooling of samples, meaning combining
two or more samples, and possibly up to 10, into a single test
makes sense where the prevalence of infection is low, and such
pooled surveillance testing can be conducted in a university
research lab outside of a CLIA environment. But, if a pooled
sample is positive for COVID, every individual in that pool
would need to be tested through a health system.
I would like to close by recognizing my fellow officers in
the United States Public Health Service Commission Corps, the
uniformed service that I lead. Four thousand, five hundred, and
thirty-six officers have deployed to support the pandemic
response, exemplifying the care and compassion that all of us
feel for those who have suffered during this pandemic. I thank
each and every one of these officers and their families. And,
on their behalf, sincerely thank all of you in Congress for
supporting our training needs in establishment of a ready
reserve corps to supplement our rank during inevitable future
national emergencies.
Thank you for the opportunity to provide these remarks.
The Chairman. Thank you, Admiral Giroir.
Welcome, Dr. Hahn.
STATEMENT OF STEPHEN HAHN, M.D., COMMISSIONER OF FOOD AND
DRUGS, UNITED STATES FOOD AND DRUG ADMINISTRATION, SILVER
SPRING, MD
Dr. Hahn. Thank you, Chairman Alexander, Ranking Member
Murray, and Members of the HELP Committee. I appreciate very
much the support that you all have provided for our efforts
during this time of COVID-19.
FDA has a vital role in the Federal Government's response
to the pandemic. One of our core missions is to advance the
public health by helping to speed medical products that are
safe and effective. We have provided appropriate regulatory
flexibilities to assure that the American public has access to
critical medical products and safe food, and confidence that
our decisions are based on medicine and science.
Since the public health emergency was declared, FDA has
issued more than 100 Emergency Use Authorizations for
diagnostic tests, personal protective equipment, ventilators,
other devices, and drug products. And, we have issued more than
50 guidance documents to ensure the continuity of healthcare in
the food supply.
I am pleased to announce that today, FDA is taking action
to aid the timely development of a safe and effective vaccine
to prevent COVID-19 by providing guidance for developers with
recommendations on the data needed to facilitate manufacturing,
clinical development, and approval. We recognize the urgent
need to develop a safe and effective vaccine to prevent COVID-
19, and we want to work collaboratively with industry,
researchers, and other partners to accelerate these efforts.
While the FDA is committed to help expedite this work, we
will not cut corners in our decisionmaking. And, we are making
clear in our guidance what are the data that we need that
should be submitted to meet our regulatory standards of
approval. This is particularly important as we know that some
people are skeptical of vaccine development efforts.
The FDA strongly encourages the inclusion of all--of
diverse populations in all phases of clinical development,
including populations most affected by COVID-19, and
specifically racial and ethnic minorities, as well as adequate
representation in late-phase trials of elderly individuals and
those with medical comorbidities. We also have information in
this guidance about including women who are pregnant, as well
as for pediatric assessments of safety and effectiveness.
The American people should know that we have not lost sight
of our responsibility to maintain our regulatory independence
and ensure that our decisions related to all medical products,
including COVID-19 vaccines, are based on sound science and the
available data. This is a commitment that the American public
can have confidence in and that I will continue to uphold
personally.
While vaccine research is ongoing, rapid testing and
therapeutic development can aid in the safe return to school,
college, and the workplace. FDA is constantly evaluating new
data we receive on testing so that we can promote the
development of new and better tests, and remove tests that are
not reliable from the market.
We have put into place an initiative to accelerate the
development of treatments called the Coronavirus Treatment
Acceleration Program, or CTAP. We have seen some of the
consequences of that program, such as the authorization of
Remdesivir and the recent information regarding other
therapeutics that might be of benefit to patients with COVID-
19.
We are working day and night to provide guidance to and
review proposals from companies, scientists, and researchers,
who are developing therapies for COVID-19.
We are now preparing for the next phase of addressing this
evolving crisis. It is mission-critical that the Agency
constantly evaluate whether our processes are maximal to
promote and protect the public health, and therefore, we are
beginning a comprehensive real time review and assessment of
our actions to date to address the COVID-19 pandemic, and I am
glad to answer questions about that review.
I want to thank the more than 17,000 FDA employees, who
have been working night and day to help expedite medical
products, but also to provide the necessary oversight with the
appropriate science and data. We know that the virus remains
with us. FDA is committed to doing the critical work that will
get the Country to the point at which Americans judge it safe
to return to work and school as quickly as possible. I am
incredibly proud of the dedicated women and men of the FDA,
whose commitment to defeating this pandemic has been
unwavering.
I can assure you the FDA will continue to provide
leadership, expertise, guidance, and information as we continue
to address this unprecedented challenge and fulfill our mission
to protect and promote public health.
Thank you, and appreciate and look forward to your
questions.
The Chairman. Thank you, Dr. Hahn. And thanks to each of
our witnesses.
We will now begin a round of 5-minute questions. All the
Senators are participating today--almost all--and so I would
ask the Senators and the witnesses to try to keep each segment
within 5 minutes.
Dr. Fauci, assume I am superintendent of one of 14,000
school districts. In our community, we understand that there
are health risks for children going back to school, but we have
concluded that the risks of--to their education, mental health,
and social development is a greater risk if they don't go back
to school.
What would your advice be to a school superintendent about
what he or she should be thinking about as children go back to
school in a few weeks to keep it safe?
Dr. Fauci. Thank you for that question, Mr. Chairman. It is
an important question, but I think we need to point out that it
really will depend on the dynamics of the outbreak in the
particular location where the school is. And one of the things
we want to emphasize, and have been emphasizing, is to take a
look at where you are in the particular area of the so-called
opening America again. Are you at the gateway? Phase 1? Phase
2? Phase 3? The CDC has guidelines about the opening of schools
at various stages of those checkpoints.
The basic, fundamental goal would be, as you possibly can,
to get the children back to school and to use the public health
efforts as a tool to help get children back to school.
Let me explain what I mean. In other words, if we adhere to
guidelines of what we have heard in many of these presentations
you just heard about--the physical distancing in the community,
the use of masks, things like that--that will help to keep the
level of infection in the community down, which will then make
it easier to get the children back to school.
If you are in an area where you have a certain amount of
infection dynamics, there are things that can creatively be
done about modifying things like the school schedule--alternate
days, morning versus evening, allowing under certain
circumstances online, virtual lessons. Those are the kind of
things that we need to consider.
But, also importantly, always make the goal that it is very
important to get the children back to school for the
unintended, negative consequences that occur when we keep them
out of school.
The Chairman. Thank you, Dr. Fauci.
Dr. Redfield, one of the concerns would be that children,
who have--who, generally speaking, have not been damaged nearly
as much as adults, particularly elderly adults, by this virus
might carry the virus to their teachers, administrators, or
parents or grandparents at home.
It seems to me that the availability of treatments this
fall, medicine for the environments that reduce the risk of
sickness and death, could be very important in increasing
confidence in going back to school. You mentioned some of those
in your testimony. Are there others? What would the
availability of treatments be this fall? And, specifically,
what about so-called antibody cocktails of the kind that were
developed for Ebola and approved by the FDA?
Dr. Redfield. Well, I think that would be a great question
also for Dr. Fauci. I am going to make a small statement. He
may want to add to it.
Clearly, we do have Remdesivir, as you mentioned. We have
now evidence that steroids can improve therapy. And, as you
mentioned, we have convalescent plasma, that Steve Hahn could
comment on, that is using the antibodies from individuals that
have gotten better from COVID, that are currently under
evaluation and potentially be available.
The Chairman. I have just a minute, Dr. Redfield. Let me go
to Dr. Hahn and let him answer that question, too. Thank you.
Dr. Hahn. As I mentioned, Remdesivir has been authorized
based on its reduction in hospitalization days. The steroids
were mentioned. Convalescent plasma, we have evaluated the
safety through a large, expanded access program at the Mayo
Clinic and it has been found to be safe in over 20,000 patients
administered it. We are waiting for the safety data, and we
will be passing those data along to BARDA, who is the sponsor
of that program.
I think that antibody data will help us in terms of the
development of monoclonal antibodies. We have a number of
sponsors who have come in for monoclonal antibody studies. We
are already well into that treatment. Monoclonal antibodies are
synthetic antibodies that will provide--that the theory is will
provide protection against the infection of the virus. And, we
are hopeful that those studies by the late summer, early fall
will provide us information about their effectiveness and
safety. And as you----
The Chairman. You are optimistic that there will be more
than one treatment available this fall for teachers,
administrators, older adults?
Dr. Hahn. Yes, sir, I am optimistic.
The Chairman. Thank you very much.
Senator Murray.
Senator Murray. Thank you very much to all of our
witnesses. We all very much appreciate your service and your
work.
Dr. Fauci, last time you testified before this Committee,
you warned us of needless suffering and death if states begin
reopening too early. And just over a month later now, we are
seeing a record number of cases. We do not have enough tests
and we do not have enough contact tracers. And just yesterday,
CDC's Dr. Schuchat said we have too much virus to control in
the U.S., arguing, and I quote, ``This is really the
beginning.''
Our strategy has not worked. I wanted to ask you, what do
the Federal Government and the more than 30 states with rising
case numbers need to do to reverse this trend?
Dr. Fauci. Thank you very much for that question, Senator
Murray. I am also quite concerned about what we are seeing
evolve right now in several of the states. As you know, in four
of the states--in Florida, Texas, California, and Arizona--more
than 50 percent of the new infections are in the those areas
where we are seeing surges.
The things we need to do I think you alluded to in your
question to me. We have to make sure that when states start to
try and open again, they need to follow the guidelines that
have been very carefully laid out with regard to checkpoints.
What we have seen in several states are different iterations of
that. Perhaps maybe in some, going too quickly and skipping
over some of the checkpoints.
But, even in states in which the leadership in the form of
the Governors and the mayors did it right with the right
recommendations, what we saw visually in clips and in
photographs of individuals in the community doing an all-or-
none phenomenon, which is dangerous. And by all-or-none, I mean
either be locked down or open up in a way where you see people
at bars, not wearing masks, not avoiding crowds, not paying
attention to physical distancing.
I think we need to emphasize the responsibility that we
have both as individuals and as part of a societal effort to
end the epidemic, that we all have to play a part in that.
I think if you look at the visuals, what we saw were a lot
of people who maybe felt that because they think they are
invulnerable--and we know many young people are not because
they are getting serious disease--that therefore, their getting
infected has nothing at all to do with anyone else when, in
fact, it does. Because if a person gets infected, they may not
be symptomatic, but they could pass it someone else, who passes
it someone else, who then makes someone's grandmother or
grandfather, sick uncle, or a leukemic child on chemotherapy
get sick and die.
We have got to get that message out, that we are all in
this together. And if we are going to contain this, we have to
contain it together.
Senator Murray. Well, I assume that would mean that elected
and community leaders need to model good public health behavior
and wear a mask.
Dr. Fauci. We recommend masks for everyone on the outside,
anyone who comes into contact in a crowded area. You should
avoid crowds where possible. And when you are outside and not
have the capability of maintaining distance, you should wear a
mask at all times.
Senator Murray. Thank you.
Dr. Redfield, last week Dr. Julie Gerberding, who served as
the CDC director under President George W. Bush, testified to
our Committee that if she were in charge, one of her top
priorities would be the creation of a national vaccine plan
that addresses the science, development, allocation, uptake,
and monitoring of a vaccine, saying, ``We know this is in our
future, and we are not ready for it.''
I could not agree more. And that plan has to detail how the
Federal Government will scale up manufacturing, coordinate the
supply chain so we avoid the missteps we saw with testing. It
needs to combat misinformation and vaccine hesitancy, and make
sure that vaccine distribution addresses health disparities,
and a lot more.
Dr. Redfield, do you agree a plan like that is needed?
Dr. Redfield. Senator, I think it is very important that we
have an integrated plan for this vaccine.
Senator Murray. When can we expect to see one?
Dr. Redfield. Well, I am going to ask Dr. Hahn if he would
like to comment. I know recently they had a vaccine plan for--
at least for the FDA's perspective. CDC is working on the
issues that you said that I think are so important in building
vaccine confidence----
Senator Murray. Well, can you tell me----
Dr. Redfield [continuing]. In this Country.
Senator Murray [continuing]. When the CDC will be giving us
their plan since CDC would be writing the comprehensive plan?
Dr. Redfield. We are developing a plan as we speak. And
again, depending--building on the efforts that we have to
rebuild what I call vaccine confidence in this Country, which
is really critical. And then on top of that, there will be a
very defined plan for distribution of this vaccine,
prioritization of this vaccine----
Senator Murray. But you cannot tell----
Dr. Redfield [continuing]. Monitoring for safety of this
vaccine.
Senator Murray [continuing]. Us if it will be a couple
weeks? A couple months? The end of the year? Do you have any
estimate on when we will see that plan?
Dr. Redfield. Well, it is currently in development within
the group, and, I would anticipate that we will see that plan
in the near weeks ahead, Senator.
Senator Murray. Weeks, not days or months?
Dr. Redfield. In the weeks ahead. It is a collective effort
that we are doing together within the concept of Operation Warp
Speed. But, CDC has been working on this plan literally for
probably the last 10 to 12 weeks.
Senator Murray. Well, Mr. Chairman, I would just say we
need to see that plan. We need to know what it is. The American
public needs to know what that is. Communities need to know
what that is. So, I hope that we urge that plan to be public as
soon as possible so we all know what to expect.
Dr. Redfield. Thank you, Senator.
The Chairman. Thank you, Senator Murray.
Senator Burr.
Senator Burr. Thank you, Mr. Chairman.
After working on pandemic policy now for 17 years, I am
reminded this morning, Tony Fauci has been doing it twice as
long as I have, and most of you at the dais have been doing
that, as well.
I urge my colleagues, pay attention to what each of these
individuals say. Because some things are predictable up here.
Congress is a full-fledged partner and funds things when there
is an urgent need, a threat that is out there. And I know,
Tony, you have seen over the years when there is not that
threat out there, things get shelved, like platforms, that we
could have developed and had better countermeasures today,
platforms that then could address vaccines at a much faster
pace than maybe what we are doing. But, we spend more time with
the blame game than we do with focuses on how the future should
look.
While all of us, Members of Congress and people within
Government, wish that we could get back to normalcy, your
agencies and Members of Congress are also charged with making
sure that we map the future so the future generations have
better protections than what we have, and that is why I applaud
the Chairman for his white paper. And I would encourage every
member of that dais to be brutally honest with us about where
changes need to be made and where they don't need to be made.
Dr. Redfield, I think you would agree with me that testing
and surveillance on this has not been the best performance by
CDC. I do not want to dwell on where we have come up short.
Share with these Members and myself, what can we expect over
the next several months from CDC that will be different than
what the past has looked like?
Dr. Redfield. Well, thank you, Senator, for your question.
I think CDC will continue to work with the state, local,
tribal, territory health departments to build their capacity.
I think we all know that for decades, there has been
consistent underinvestment in public health in this Nation and
the core capabilities to do that job. Data, data modernization,
predictive data analysis, laboratory resilience, workforce--
very appreciative for the emergency response fund that Congress
provided--these are critical infrastructure issues that the
reality are have been underinvested.
CDC is right now probably providing 50 to 70 percent of all
public health funding to each state. We need to have a much
more robust investment in these core capabilities.
What you are going to see, because of the Congress acting,
CDC has provided now $12 billion to the local, state,
territorial, tribal health departments to begin to build that
core capability that we would have liked to build over the last
several decades so that there is enhanced testing.
It has been mentioned, it is complicated here because this
virus is so asymptomatic for so many, so the traditional
methods of diagnosis, contact tracing, isolation are going to
be inhibited for many individuals, and that is going to require
broader community-based surveillance strategies.
Those plans, as was mentioned by the Admiral, are--we have
received them for June and July. We are working with the local
jurisdictions. They are going to have them in middle July for
the plans for the rest of the year. And we are going to be
working side by side with them to continue to augment the
public health capacity to respond to the COVID virus with
basically enhanced surveillance and enhanced early diagnosis,
contact tracing, isolation to begin to bring this outbreak
under control.
Senator Burr. I hope some of that money will be used to
upgrade the systems at CDC that are antiquated.
Dr. Redfield. Sir, I agree with you there. I mean, I think,
as those of you know, when I was given the opportunity to do
this job, very early on, within a month, I recognized that the
core capabilities of our public health infrastructure is not
there, particularly the one that I know you have been very
supportive of--data, data modernization, predictive data
analysis--and that is in progress. It cannot happen too soon.
We are appreciative of the support that Congress has given.
And I do think it is fundamentally critical to bring our data
system, and, as you know, the data personnel that we have, and
we thank you for your efforts there. And as we need to hire
those individuals strategically, we will continue to do that to
make sure that the premier public health agency in this Country
has the personnel and data systems that it does need.
But, I will say, the other big issue we have to correct is
to make sure our public health--state, local, territorial and
tribal--have that integrated health system of data.
Senator Burr. Dr. Hahn, I think you have used your
authorities under PAHPRA at FDA in a very effective way, and
the FDA has risen to the challenge during the public health
emergency, cutting red tape and maintaining the Agency's gold
standard for review of lifesaving medical products. You have
specifically mentioned innovative trial--clinical trial designs
and the use of real-world data as areas where the FDA has
gained ground during the response to COVID. How do you plan to
ensure that this progress is maintained long after the
coronavirus response is over?
Dr. Hahn. Thank you, Senator Burr. Critical issues that you
bring up. In addition, some of the things that we are doing on
the review side to actually expedite review and work with
innovators and developers, we will continue. Part of our review
of our actions to date, so a mid-action review, will inform how
we move forward.
No question, the fact that real-world evidence and
modernization of our data systems are needed, particularly
around supply chain and demand for medical products, but also
on the review cycle and the innovative clinical design trials,
as you just--as you mention.
Senator Burr. Thank you for that.
Mr. Chairman, I do hope that you or another member will
allow Dr. Fauci at some point today to make any comments on the
reports that there is a new swine flu that the Chinese have
apparently identified and how that might affect us in the
future in this Country.
The Chairman. Well, Dr. Fauci, why don't you do that now if
you have anything to say about a swine flu.
Dr. Fauci. The Chinese, over the last week or two, have
identified a virus in the environment. It is not yet shown to
be infecting humans, but it is exhibiting what we call re-
assortment capabilities. In other words, when you get a brand
new virus that turns out to be a pandemic virus, it is either
due to mutations and/or the re-assortment or exchanges of
genes.
They are seeing virus in swine, in pigs, now that have
characteristics of the 2009 H1N1, of the original 1918, which
many of our flu viruses have remnants of that in it, as well as
segments from other hosts like swine. When they all mix up
together and they contain some of the elements that might make
them susceptible to being transmitted to humans, you always
have the possibility that you might have another swine flu-type
outbreak as we had in 2009.
It is something that still is in the stage of examination.
It is not so-called an immediate threat where you are seeing
infections, but it is something we need to keep our eye on,
just the way we did in 2009 with the emergence of the swine
flu. It is called G4, is the name of it.
The Chairman. Thank you.
Senator Sanders.
Senator Sanders. Thank you very much, Mr. Chairman. And let
me thank all of our panelists for being here and for the great
work that they are doing on this pandemic.
Let me ask a question that has just bothered me lately. All
of you, and I think most Americans, understand how important
social distancing is. We are told over and over again, and the
Chairman told us at the beginning of this meeting, stay apart,
at least 6 feet apart, if you can.
Just the other day, however, American Airlines announced
that they were going to fill up all of their planes, and other
airlines have done the same. So, you are going to have people
going from New York to California, 5, 6 hours, sitting inches
apart from each other. And then you have buses all over America
where people are kind of packed in like sardines.
But, my question is, why hasn't the Government, whether it
is the CDC or the Department of Transportation, issued
guidelines prohibiting those violations of what we all know to
be commonsense?
Who wants to--Dr. Fauci, you want to start on that one or--
--
Dr. Fauci. Thank you, Senator. Well, I am not the CDC, but
I would be happy to make a comment on that, and maybe Bob
would, also. I mean, obviously, that is something that is of
concern. I am not sure exactly what went into that
decisionmaking. I would hope there would be something to
mitigate against that because I know, as we have said and I
continue to repeat it, that avoiding crowds, staying distant,
and when in a situation like that, wear a mask. I think in the
confines of an airplane, that becomes even more problematic.
Senator Sanders. But generally, I agree--I understand the
mask thing, but doesn't it sound a little bit silly and little
bit in violation of everything you guys have been talking about
to have people sitting next to each other for 5 or 6 hours in
an airplane or crowded into a bus? And my question is, why
hasn't, the President issues a lot of executive orders. Why
haven't we stopped that type of activity and told the airlines
and bus companies that is unhealthy?
Dr. Redfield. Senator, I appreciate your question, and I
think it is a critical area. I can tell you that when they
announced that the other day, obviously there was substantial
disappointment with American Airlines. A number of the airlines
had decided to keep the middle seat thing. I cannot say this is
under critical review right now by us at CDC. We do not think
it is the right message, as you pointed out. Again, we think it
is really important in individuals that are in whether it is a
bus or a train or a plane are social distancing to the degree
that it is feasible and at least have a reliable face covering.
So----
Senator Sanders. Okay. Well, thank you, and I--I just hope
very much that the CDC or the appropriate agency basically
tells these companies that is unacceptable behavior. They are
endangering the lives of the American people.
Let me go to another question. And I just have a few more
questions and not a lot of time, so I would appreciate brief
answers.
At the University of Washington, the Institute of Health
there indicated that if 95 percent of the American people were
to wear masks, we could save some 30,000 lives. A number of
countries, including South Korea, France, Turkey, and Austria,
have provided low-cost or free masks to all of their people--
something that I believe in. Would you support an effort to
greatly increase the production of high-quality masks in this
Country and distribute them free of charge to every household
in America?
Dr. Fauci. Yes.
Senator Sanders. Dr. Fauci, or anybody else wants to jump
in on that?
Dr. Fauci. Yes, of course. I think masks is--are extremely
important, and we keep hammering home. And I think what you
just mentioned is as important. There is no doubt that wearing
masks protects you and gets you to be protected. So, it is
people protecting each other. Anything that furthers the use of
masks, whether it is giving out free masks or any other
mechanism, I am thoroughly in favor of.
Dr. Redfield. I just want to echo that, Senator. In my
opening statement, again, I called on an environment that we
have universal masks. I think it is fundamentally----
Senator Sanders. Good.
Dr. Redfield [continuing]. The most important thing we can
do.
Senator Sanders. That is great. But when you refer to
``universal masks,'' which I agree with you on, would you be
supporting the increased production of high-quality masks and
basically distributing free of charge to every household in
America? Because I think that is going to save tens of
thousands of lives. Would you agree?
Admiral Giroir. Senator Sanders, this is Brett Giroir. Yes,
sir. I agree that is very important because we need to support
mask wearing.
I would also point out that Dr. Kadlec, the ASPR, has
contracted for hundreds of millions of cloth face coverings
to--that could be distributed around the Country, and those
kinds of processes are being thought of. When I am not in
uniform, I wear them. They are white. They work very
effectively, and I think they are a great investment for the
American people.
Senator Sanders. Good. Thank you.
My very last question. It is an issue I have raised now for
the last couple of months. All of us hope to God that a good,
safe vaccine will be developed as soon as possible, but that
vaccine may not mean anything to a lower income person who
might not be able to afford it. I happen to believe that we
should make these vaccines--and by the way, as you all know,
Federal Government, our tax dollars, are going to the tune of
billions of dollars into drug companies to help develop this
vaccine. That is okay. But don't you--do you--would you agree
with me that after that kind of investment, we should make sure
that every American, every person in this Country, can get a
vaccine regardless of their income?
Dr. Fauci. Yes.
Senator Sanders. Okay. Anybody else want to comment on
that?
Admiral Giroir. Yes, Senator. Agreed.
Dr. Redfield. Yes, Senator.
Dr. Hahn. Yes, Senator.
Senator Sanders. Well, good. Thank you all very much.
The Chairman. Thank you, Senator Sanders.
Senator Paul.
Senator Paul. Thank you.
Fatal Conceit is the concept that central planning with
decisionmaking concentrated in a few hands can never fully
grasp the millions of complex, individual interactions
occurring simultaneously in the marketplace.
It is a fatal conceit to believe any one person or small
group of people has the knowledge necessary to direct an
economy or dictate public health behavior. I think Government
health experts during this pandemic need to show caution in
their prognostications.
It is important to realize that if society meekly submits
to an expert and that expert is wrong, a great deal of harm may
occur when we allow one man's policy or one group of small men
and women to be foisted on an entire nation. Take, for example,
Government experts who continue to call for schools and daycare
to stay closed, or that recommend restrictions that make it
impossible for a school to function. For a time, there may not
have been enough information about coronavirus in children, but
now there is. There are examples from all across the United
States and the world that show that young children rarely
spread the virus.
Let's start in Europe. Twenty-two countries have reopened
their schools and have seen no discernible increases in cases.
These graphs behind me show no surge when schools open. The red
line is where the schools opened. There is data from Austria,
Belgium, Denmark, France, Germany, Netherlands. No spike when
schools are opened.
Contact tracing studies in China, Iceland, Britain, and the
Netherlands failed to find a single case of child-to-adult
infection.
Here at home, childcare for essential workers continued to
be available in some states throughout the pandemic. Brown
University researchers collected data on daycares that remained
open during the pandemic. Over 25,000 kids in their study,
found that only .16 percent got COVID. And when you look at the
confirmed cases for staff, there was about 1 percent of more
than 9,000 staff.
The YMCA also has put forward statistics. Forty thousand
kids at 1,100 sites, there were no reports of coronavirus
outbreaks or clusters.
Dr. Joshua Sharfstein of Johns Hopkins writes, ``There is
converging evidence that the coronavirus doesn't transmit among
children like the flu,'' that it is a lower risk.
Just yesterday, the American Academy of Pediatrics says we
have to get kids back in school. We want them physically
present in school. They even cite mounting evidence that
children are less likely to contract the virus.
Ultimately, this all comes down to the fatal conceit that
central planners have enough knowledge somehow to tell a nation
of 330 million people what they can and cannot do.
Perhaps our planners might think twice before they weigh in
on every subject.
Perhaps our Government experts might hold their tongue
before expressing the opinion whether we can play NFL football
or major league baseball, not in October.
Perhaps our experts might think twice before telling the
whole world that a COVID vaccine likely won't provide herd
immunity.
We don't know. Why weigh in with these opinions that we
have no knowledge of? These are forecasts that may well be
wrong.
Perhaps our experts might consider the undue fear they are
instilling in teachers who are now afraid to go back to work.
No one knows the answers to these questions. We should not
presume that a group of experts somehow knows what is best for
everyone.
Hayek had it right. Only decentralized power and
decisionmaking based on millions of individualized situations
can arrive at what risks and behaviors each individual should
choose. That is what America was founded on, not a herd with a
couple of people in Washington all telling us what to do and
we, like sheep, blindly follow.
This all begs the question, when are we going to tell the
people the truth, that it is okay to take their kids back to
school?
Dr. Fauci, every day, virtually every day, we seem to hear
from you things we cannot do, but when you are asked can we go
back to school, I don't hear much certitude at all. I hear,
well, maybe, it depends.
All of this body of evidence about schools around the world
shows there is no surge. All of the evidence shows that it is
rare. I mean, we have so politicized this and made it
politically correct that the WHO releases that it is rare. And
you have a scientist up there honestly giving her opinion. What
happens to her? She is blackballed and her report that she
refers to is taken off the website. When you go to that
scientist's speech and you try to click on the link, the WHO
has now streamed it from us because it said something that is
not politically correct; that guess what, it is rare for kids
to transmit this.
But, I hear nothing of that coming from you. All I hear,
Dr. Fauci, is we can't do this, we can't do that, we can't play
baseball. Well, even that is not based on the science. I mean,
flu season peaks in February. We don't know that COVID is going
to be like the flu season. It might, but we don't know that.
But we wouldn't ban school in October. You might close some
schools when they get the flu. We need to not be so
presumptuous that we know everything.
But, my question to you is, can't you give us a little bit
more on schools, that we can get back to school? That there is
a great deal of evidence and that it is actually good--good
evidence that kids are not transmitting this? It is rare and
that kids are staying healthy and that yes, we can open our
schools?
Dr. Fauci. Mr. Chairman, do I have a little bit of time
to----
The Chairman. I will give you a little. That was well over
5 minutes, but we will----
Dr. Fauci. Thank you, Senator.
The Chairman. Go ahead and answer the--please answer the
question.
Dr. Fauci. Yes. So, very quickly, Senator Paul. I agree
with a lot of what you say about, this idea about people having
to put their opinions out without data. And sometimes, you have
to make extrapolations because you are in a position where you
need to at least give some sort of recommendation.
But if you were listening, and I think you were, to my
opening statement and my response to one of the questions, I
feel very strongly we need to do whatever we can to get the
children back to school. So, I think we are in lock agreement
with that.
The other thing that I would like to clarify very briefly
is that I--when things get into press of what I supposedly
said, I didn't say. I never said we can't play a certain sport.
What happens is that people in the sport industry--they could
either be people from players association, owners, people
involved in the health of the players--ask me opinions
regarding certain facts about the spread of the virus, what the
dynamics are. I give it, and then it gets interpreted that I am
saying you can't play this sport or you can't play that sport.
I agree with you. I am completely unqualified to tell you
whether you can play a sport or not.
The only thing that I can do is, to the best of my ability,
give you the facts and the evidence associated with what I know
about this outbreak.
Thank you.
Senator Paul. Thank you. We----
The Chairman. Senator Paul----
Senator Paul [continuing]. Just need more optimism. There--
--
The Chairman. Thank you, Senator Paul.
Senator Paul [continuing]. Is good news out there. We are--
--
The Chairman. We will now go to Senator Casey.
Senator Paul [continuing]. Not getting it.
Senator Casey. Mr. Chairman, thank you very much for the
hearing, and I want to thank our witnesses for their public
service.
Mr. Chairman, let me start with Dr. Hahn. Then I will move
to Admiral Giroir.
Dr. Hahn, I wanted to ask you about vaccines. And as your
testimony indicates, and as we have been discussing over time,
as researchers work to develop vaccines to protect against
COVID-19, it is important that the final FDA-approved products
have the full confidence of the American people. A vaccine
doesn't help if people don't choose to in fact be vaccinated.
My first question is, given that we have seen very high
rates of both vaccine refusal, as well as skepticism, what role
can the FDA play in the coming months to earn the public's
trust that the COVID-19 vaccines are safe and effective? That
is question No. 1, what role the FDA can play.
Then the second question is, what steps can you take as FDA
commissioner to bolster public confidence?
Dr. Hahn. Thank you, Senator, for that question. I could
not agree more that public confidence in vaccines is so
important.
To your first question, we have an obligation to use all of
our scientific knowledge, our regulatory framework, to ensure
that any vaccine that comes before us, whether for
authorization or approval, meets our stringent standards for
safety and effectiveness.
One of the reasons that we issued that guidance that I
mentioned in my opening statement was to provide regulatory
clarity around what FDA expects with respect to those data. We
want to see certain parts of those data so that we can
demonstrate to the world, to the Nation, to the American
people, that we are following our rigorous standards with
respect to safety and efficacy.
The other thing that we have done is draw a very bright
line between FDA and our regulatory independence and all the
sponsors who are putting forth vaccine applications to us, and
that includes Operation Warp Speed. So, we are providing
technical assistance to those sponsors, but we are not part of
the decisionmaking process, and we will maintain our regulatory
independence. I will not prejudge. The Agency will not prejudge
any decision with respect to this. We will use the science and
the data.
With respect to what I can do personally, Senator, I commit
to you that I will continue to be a voice emphasizing the
regulatory independence. We have a number of communications in
progress to communicate to the American people that the
standards we are going to uphold are firm, they are rooted in
science and data, and that they will ensure that we meet the
usual high standards of FDA with respect to safety and
efficacy.
Senator Casey. Thanks very much, Doctor. I might submit a
question for the record to Dr. Redfield, as well, but just so I
can get my second question in to the Admiral.
Admiral, I want to ask you about testing and insurance
coverage. Testing, as you know and as we have emphasized in
these hearings, is so fundamental in order to prevent the
spread of COVID-19. Congress, I think, acted upon that
knowledge by mandating total coverage of COVID-19 diagnostic
and antibody testing, both in the Families First bill, as well
as the CARES Act. We made it clear that Americans should not
have to pay a dime for COVID-19 testing, but we are hearing
alarming reports of people not being tested often for one of
two reasons: because they are under the impression they will
have to pay for testing, and patients who have been tested are
receiving surprise medical bills.
The Administration has issued guidance that appears to be
in conflict with congressional intent and public health
guidance, and so we have some confusion here. I would ask you,
Admiral, can you assure the American people that the Department
of Health and Human Services will fulfill the intent of both
the Families First bill and the CARES Act and ensure that the
American people will be provided wide access to COVID-19 tests
without cost or limitation?
Admiral Giroir. Thank you, Senator. And I want to thank all
of you for emphasizing the importance of testing and
eliminating any barriers that there could be.
I cannot speak for the Department. I certainly speak as the
assistant secretary and as the testing person that we firmly
believe and support the concept of no-cost testing. There
should not be a disincentive in any single way to get the
diagnostic test that you need to get tested during screening or
the serology test as Congress intended. So, thank you for that.
We do need to keep getting that message out. It is a very
important one to have.
Senator Casey. Thank you, Admiral. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Casey.
Senator Collins.
Senator Collins. Thank you very much, Mr. Chairman. And I
want to thank all of our witnesses today for your dedication
and hard work. It has really been important.
The Chairman raised a very important question about who
pays for the testing when a person has no symptoms and no known
exposure to the virus. And I would add another key question,
and that is how are such tests even accessed?
These are critical questions for the reopening of schools
and for the thousands of jobs in the tourism industry, upon
which Maine's economy depends. In Maine, for a tourist to come
and visit, that out-of-state visitor, one option is to show a
recent negative COVID test. The problem is that when hotel
owners in Maine surveyed testing sites in 10 states, they found
that 90 percent of requests for a test for travel purposes were
denied.
Now, this lack of access to tests is devastating for
reopening Maine's tourism businesses. One innkeeper told me
that last year in the month of June, she had an occupancy rate
of 94 percent. This year, it was 6 percent, so you can imagine
the impact on employment at that inn.
Given the impact on reopening schools and on jobs in the
tourism and other industries, how is the Federal Government
working with states to better match demand for testing with
supply and to overcome these geographic variations? Admiral, I
would direct that question to you.
Admiral Giroir. Thank you, ma'am. I will try to be brief
and not to take much of your time. But, we were very careful in
our prioritization that we do prioritize persons without
symptoms who are prioritized by health departments or
clinicians for any reason, including public health monitoring,
surveillance, or screening of other asymptomatic individuals
according to state and local plans. So, that is a priority that
if it is important for the state, those asymptomatic
individuals can be screened.
The second issue, just again to be brief, is we work--we
have worked individually with every single state to determine
what their state testing needs are, how are they organizing in
the context of the CDC, and we are supplying them with the
supplies they need to meet that. So, every week, shipments of
the basic supplies go to every single state according to their
state testing plans. And we keep a little bit in reserve,
right, because when there is an outbreak somewhere that we need
to surge, we do have that. So, for example, the state testing
goals for July are somewhere--across the Country are about 13.9
million tests is their first-line goals, and we will match
those state by state.
Senator Collins. I hope that you will help us get that word
out to testing sites in states from which--a lot of tourists
usually come to Maine. That would be very helpful to us.
Dr. Fauci, let me turn to you. Earlier this month, higher
education leaders in Maine issued a framework for safely
returning to campuses this fall that recognizes the importance
of testing and the need to include financially struggling
institutions in partnerships in order to make sufficient
testing protocols possible.
You, last week, spoke about the possibility of the
development of pool testing strategies. And, as I understand
this, this would allow more people to be tested using fewer
resources.
The medical director of Stanford's clinical virology lab
suggests that this makes particular sense in areas with low
rates of COVID-19 where you would expect the large majority of
tests to be negative. Could you expand on the possibility of
expanding pool testing and tell us more about that?
Dr. Fauci. Yes. Thank you for the question, Senator. What
that really is, if you want to get a feel for the penetrance of
infection in a community, rather than testing multiple, each
individual person, which takes resources and time, what you
do--and you can do a statistical analysis of--not losing
sensitivity by pooling let us say 10 or 15 or five together.
You put all the tests together and you do one test. If that
test is negative, then those 10 people are all negative. So,
instead of utilizing 10 tests, you have utilized one test.
Then you get another batch of we will say 10 or so. And if
you then find one is positive, then you go backtrack and figure
out who that person is. And if you do the mathematical
calculation, you can save a lot of time, a lot of resources,
and use the testing for a variety of other things that you
would need.
It is a really good tool. It can be used in any of a number
of circumstances at the community level, or even in school if
you wanted to do that. So, apropos of what you started your
comment off with, it clearly can be extrapolated to that.
Senator Collins. Thank you so much. That sounds like an
excellent technique for our schools to use.
The Chairman. Thank you, Senator Collins.
Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman. I want to thank
all of our witnesses today for joining us.
Like so many Members of this Committee, I am concerned
about new outbreaks and increasing cases. Certainly, I have
seen them in my home State of Wisconsin, and I know we are
seeing that nationally.
Now, CDC and OSHA have issued recommended safety guidance
for businesses, but this guidance is not enforceable. Many
businesses are truly trying to do the right thing in protecting
workers and customers and the public that interacts with those
businesses.
We also had a previous discussion. I think Senator Sanders
raised the issue of American Airlines filling up their planes,
versus others that are still not trying to push to do so
because of safety concerns.
We also had--I think it was Admiral Giroir pulled up the--
what he called critical guidance. Please follow this critical
guidance.
Dr. Redfield, should we be supporting businesses that have
taken the steps to protect their workers and customers by fully
implementing CDC's and OSHA's recommended safety guidance? Yes
or no.
Dr. Redfield. Yes. We should be supporting those
businesses.
Senator Baldwin. Now, can you confirm, yes or no, that all
businesses have adopted and implemented this guidance as they
have opened up?
Dr. Redfield. I think, Senator, you know that,
unfortunately, that has not been the case.
Senator Baldwin. It is an uneven playing field, and it
hurts businesses that are trying to do the right thing by
voluntarily adopting CDC and OSHA safety guidelines because
their competitors don't have to incur the same safety and
health costs. And, if you believe that we should be supporting
the good actors, then shouldn't we create a level playing field
by issuing an emergency, temporary standard to require all
business to adopt and comply with enforceable safety standards?
Dr. Redfield. I make two comments, Senator. First one, it
is so important that we have tried to say is that this is a
time that everyone in our Nation accept the responsibility that
Dr. Fauci and I spoke about to recognize they have the
fundamental responsibility not just to protect themselves, to
protect others, by the social distance, face mask, and hand
washing.
Second, again, is we look at the local jurisdictions,
again, to see where, in fact, that enforceability would be,
whether it is in the local health department, the state health
department, or the Federal Health Department. I think, again,
we see that the community can get behind that responsibility.
Those businesses that support that responsibility may find, in
fact, their business is better than those businesses that
don't.
I can tell you that----
Senator Baldwin. I want to interrupt you. I apologize, Dr.
Redfield, but my time is limited. The panel right now is
composed of people representing public health and public health
institutions. OSHA is our lead Federal agency for protecting
workers' safety and health. Have you had communication with the
Department of Labor and OSHA about issuing mandatory,
enforceable standards rather than this voluntary guidance?
Dr. Redfield. Secretary Scalia is a member of the task
force, and he is in the discussions with us that the Vice
President chairs. That specific topic----
Senator Baldwin. The answer is yes?
Dr. Redfield [continuing]. We have not had a discussion
directly, but we have had discussions in review of the guidance
that we put to businesses, both critical infrastructure and
non-critical infrastructure businesses, with OSHA.
Senator Baldwin. I have limited time left, but I do want to
say that the University of Wisconsin announced that they will
be reopening for classes in the fall. They have released a plan
called start--Smart Restart. It calls for about 2,000 tests per
week on campus. They will need supplies to do this, including
PPE, reagents, and swabs. At every hearing on COVID-19, we have
heard about shortages of these supplies, and it is why I
introduced the Medical Supply Transparency and Delivery Act to
unlock the full authority of the Defense Production Act to
increase production of critical supplies, the things that are
needed to conduct widespread testing.
Admiral Giroir, can you describe how you are working to
make sure that universities and others will have access to
these supplies needed to conduct this testing in the fall?
Admiral Giroir. Thank you so much, Senator. And I want to
communicate this, and I am happy to work with any university.
We coordinate what we give to the states through the state
plan, so it is very important that universities coordinate
through the states. And we supply those materials directly to a
single point of contact in the state, who distributes them.
We have been through a lot, but we have a lot of swabs now,
partially because of increased domestic production using the
DPA. We are distributing about 20 million swabs per month. We
are going to do a lot more than that.
Senator Baldwin. What about reagents?
Admiral Giroir. Reagents, we do not purchase centrally
because the market is a little bit more mature, so we can trust
with an allocation strategy that we allocate--we support the
allocation to different states depending on their needs.
We have mapped every single machine in every single state,
every single county, every single city, and unfortunately,
there is not enough of one thing that everybody if they want
that can get it. So, we really do a matching game to understand
specific state needs. For example, in Alaska, it is very rural
and there is varied limitations to what they have, so we need
to make sure they get what they absolutely need, versus other
states that can be a little bit more flexible. So, we do have
this control----
Senator Baldwin. With respect----
The Chairman. Senator Baldwin, I am afraid we are----
Admiral Giroir. I am so sorry.
The Chairman [continuing]. Well over time. We have a large
number of Senators who want to ask questions, so I would renew
my----
Senator Baldwin. Thank you, Mr. Chairman.
The Chairman [continuing]. Request that Senators and
witnesses try to keep the questions and answers within 5
minutes.
Senator Cassidy.
Senator Cassidy. Thank you, gentlemen, for all that you are
doing.
I have a couple slides. Can you--can I ask for the staff to
show the first two slides?
[Slides shown.]
Senator Cassidy. Here it shows that we are doing poorly
relative to the countries that are doing it best. And you can
argue that Taiwan is much smaller than we, but Taipei is a very
congested city. So, consider our cities just a collection of
Taipeis, for example, than our Seoul, South Koreas. It would
suggest that what we are currently doing is less robust and
less whatever adjective you want to use than the countries that
are doing it best.
Could I have the next slide, please?
[Slide shown.]
Senator Cassidy. This is developed out of a group by
Harvard. And, just so I can put a plug in it, they will be
speaking at a roundtable we have Thursday morning, and you can
get details from my office if you wish.
But, kind of that interplay between collecting--doing the
testing, tracing those, compiling your data, knowing where your
hotspots are, and then tracing. And everyone on this panel
knows this is how it is done.
You mention that you are going to have a strategy that is
coming out later on. It does beg the question, why has it been
so long? And I am not accusing. I am just curious. But this has
been developed----
You can take the slide down, please.
Knowing that you are going to develop this strategy, and
kind of building upon what Senator Burr mentioned, what is the
goal of the strategy? Is the goal of the strategy to achieve
suppression? That is No. 1.
No. 2, what metrics will you use?
Knowing that CDC is the one who really gives guidance to
state and local governments--I am hoping, Dr. Redfield, since I
will direct this to you, that it won't be up to the states and
locals to put this plan together; it will be the considerable
intellectual fire power of the CDC that gives a pretty
detailed--if you have this kind of community, this is what you
do. If you have that kind of community, that is what you do.
Because that is the kind of role that CDC is expected to play.
Dr. Redfield, any thoughts on this?
Dr. Redfield. Thank you very much, Senator. A very
important question.
First--on your first slide, just as a quick comment, and I
will try to be quick. I think it is really important because it
does illustrate back to the comment that we tried to make of
the importance of personal responsibility, to really practice
the social distancing and----
Senator Cassidy. That is a given, Dr. Redfield. I want to
ask you just to go quickly because I have limited time. That is
a given. But there has to be a testing aspect of this because
people don't--you awaken people to their responsibility if they
know they have been exposed. If they don't know they have been
exposed, they tend to be more complacent. So, please focus upon
the testing data and tracking aspect.
Dr. Redfield. Yes, Senator. Initially, obviously, the--it
was early case identification, contact tracing, isolation.
Obviously, testing and contact tracing without isolation has
little value. The challenge has been when we learned in March
that this virus is significantly asymptomatically
transmissible, and then, therefore, requiring alternative
strategies.
The strategy that we are evaluating now is more of a
community-led testing strategy where you go into a broader
community and you actually test a wide number of individuals as
opposed to----
Senator Cassidy. But do you have--what metrics are you
following? And is there a specific strategy that is going to be
given to state and locals as to how to implement this? That is
very high level. What we need is granularity. That is my
question.
Dr. Redfield. Yes. We did the initial strategy, and as I
said, we are currently evaluating this community test-led
strategy in a number of communities now.
The metrics are simple. It is the percent cases that are
positive. We were doing well there for a while. You know----
Senator Cassidy. But now--again, sorry to interrupt. But,
of course, if you take the entire city of New Orleans or
Shreveport, you are going to have some that are hot spots and
some that are really fairly safe. And, so, I guess I am
pointing to the granularity. Should it be a census track?
Should it be a hot spot--a building with multifamily housing,
et cetera? So, I----
Dr. Redfield. You are exact----
Senator Cassidy [continuing]. Guess I am just frustrated
because when I speak to my state and locals, they are not
getting that granularity from CDC. That seems to be where we
get to where Seoul, South Korea is, and I have not yet heard
that is kind of what we are doing.
Dr. Redfield. We are sharing right now at the county level
the exact kinetics. We have about 130 counties in this Country
out of the more than 5,000--more than 3,000 are having trouble.
And, continuing to get that granularity--I think you have said
it, Senator. It is critical. It has got to be a very local,
focal response at the granular level. We are trying----
Senator Cassidy. But, Dr. Redfield, do we have that
granularity? We have been at this for 3 months. We have all
these data systems. We know where the people live who are
tested. You know, we have a federated system, which you alluded
to earlier. Is the plan coming out tonight, this afternoon,
going to implement that granularity?
I am over time, but if you would allow, Mr. Chairman, for
an answer, then I will cease. I apologize for going over.
Dr. Redfield. My comment would be that is where we are
going with that granularity. We appreciate some of the changes
in reporting to CDC in terms of testing that Congress recently
did. We are now looking at the granular level. We don't
disagree with the premise behind you. It is that granular
response to control those mini outbreaks, which is going to be
fundamental to get this under control.
The Chairman. Thank you----
Senator Cassidy. Thank you.
The Chairman [continuing]. Senator Cassidy.
Senator Murphy.
Senator Murphy. Thank you very much, Mr. Chairman.
Mr. Chairman, if this were the policy of the United States
of America, the recommendations and guidelines being given by
our panelists today, we would likely not be in the situation we
are with a virus back on the march, spreading at rapid rates
throughout big parts of the Country.
The problem is our four panelists do not set the policy of
the United States of America. The President of the United
States does. And, so, while our panelists tell us about the
importance of wearing masks, the President of the United States
is re-Tweeting articles, for example, entitled ``Mandatory
Masks Aren't About Safety, They're About Social Control.'' He
re-Tweets people that are criticizing how folks look when they
wear masks.
Though our panelists today are telling us about the
effectiveness of social distancing, the President of the United
States is holding rallies all across the Country, in which he
deliberately prevents people from distancing. His staff ripped
signs off of chairs encouraging people to separate from each
other.
The President's allies are out there on TV every day saying
that wearing masks are dehumanizing. Somebody said the other
day, a Member of the House, that viruses do what viruses do;
the only way you are going to get immunity is to get exposed.
These are the President's allies trying to curry favor with
him.
We have these two parallel messaging operations, and I just
think it is worth stipulating that everything we are hearing
today is responsible. It is based on evidence.
But, the agencies represented here today have social media
followings of about five million people. The President of the
United States has a social media following of 82 million. And,
so, you can understand why folks are confused out there. They
hear the recommendations from Dr. Fauci and Dr. Redfield, but
then they hear the President of the United States criticizing a
reporter for wearing a mask because that reporter is being
social--is being politically correct.
That is why we are in the position we are in today where
you see large numbers of people not complying with
recommendations because they are hearing something very
different from the Chief Executive, and they are watching him
behave in a manner and encourage behavior that is directly
contrary to what we are being told today. And it just probably
requires saying that out loud at this hearing.
Let me ask a few questions, Mr. Chairman, if I can, about
global public health because we have not covered that here
today.
Dr. Fauci, this virus got here really quickly, and what we
learned is that while travel restrictions can help or give you
time, they cannot fully prevent a disease from arriving here.
And, so, even if we do turn the corner in the United States in
a meaningful way, so long as this virus exists in large
quantities outside of the United States, we are still
vulnerable. Is that right?
Dr. Fauci. That is correct, sir.
Senator Murphy. Dr. Redfield, what is your understanding of
why the United States has not joined the global vaccine effort?
Why are we not in something like CEPI, an organization that is
working with other nations to try to coordinate not only the
development of the vaccine, but also the distribution of the
vaccine?
Dr. Redfield. Well, I think the U.S. has obviously
developed an aggressive, comprehensive program, but, Senator,
it would not preclude being part of these international
organizations, also, from my perspective.
Senator Murphy. We have legislation pending right now
before the Foreign Relations Committee that would put the
United States into these global vaccine efforts. It just
doesn't make a lot of sense to many of us on both sides of the
aisle as to why the Trump administration has not joined.
Finally, Admiral, just maybe help us understand what our
relationship with the WHO is today. Right around the time that
the President declared that we were pulling out of the WHO--not
just that we were not going to fund it, but his announcement
was actually we were going to sever our relationship with the
WHO--you were confirmed to a seat on the executive board. And,
so, have you been recalled from the WHO? Are you attending
meetings? Are you participating? What are the details
surrounding our withdrawal from the WHO? Which, by the way, is
maybe one of the most dangerous things in my opinion that the
Administration has done in the middle of a global pandemic.
What is our status and what is your status as a confirmed
member of that board?
Admiral Giroir. Thank you, Senator, and I really do
appreciate the confirmation.
I was confirmed on May 7th, and I did attend the executive
board on May 22d. The executive board, it was virtual. I did
participate and support our multilateral commitments. I have
not been recalled. I have not been given any direction to
recall myself in any way. There would be another executive
board meeting probably in October.
I believe all of us on our public health standards still
work with the WHO as a WHO partner. For example, we
participated with the WHO on a global sickle cell meeting just
2 days ago.
We work--we certainly work from the public health aspects
direction on the official--whether we are going to be a member
or whether I am not going to go to the executive board, I have
not gotten that direction yet.
Senator Murphy. Okay. Thank you. The announcement was that
we are terminating our relationship with the WHO, so probably
some additional clarification would be helpful.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Murphy.
Senator Murkowski.
Senator Murkowski. Thank you, Mr. Chairman. And, gentlemen,
thank you for not only your testimony today, but all that you
have been doing.
I think I have had conversations with each one of you about
the Alaska-specific issues, most notably with regards to our
seafood processing. This is the time of year where we typically
welcome a million plus tourists, as well as many thousands that
come up from the Lower 48 and other places to help with our
seafood processing.
It has been a very anxious time, I think, for all of us in
Alaska as we see outsiders coming in. We have seen obviously
elevated cases of confirmed COVID. Our numbers, I think, are
enviable when other states look at us to know that we are
working about 500 active cases right now. About double that in
terms of what we have seen throughout this whole pandemic.
But, again, we know, and you have stated, that we don't
have resources that we can look to, to neighboring states. We
are kind of on our own island there in terms of resourcing. So,
what you have done to help facilitate, whether it is the plans
with the seafood processors, the guidance, the ability to come
in on an as-needed, if the situation so demands, we appreciate
that.
We have seen the benefit of how these very rigorous plans
have worked. An individual who comes up to work in a seafood
processing facility is tested before they come to the state.
They are tested when they get to the state. They are put in a
14-day quarantine. We have seen positive cases once people have
arrived, but we have been able to do what the plan calls for,
which is that contact tracing and then isolation and keeping
things to a minimum. So, I think it does demonstrate that these
tough plans really can work.
They are expensive, though. If you are bringing in several
hundred or perhaps a thousand workers and you have to put them
up in a hotel for 14 days, with pay, when you have to provide
for the health protocols, this is costly. I would ask for your
input, and probably a question for the record, just in terms of
which agencies can best help facilitate these seafood
processors with not only implementation of this specific
guidance, but how we can be dealing with the cost. We do
receive some benefit from the discretionary funds provided to
the states.
But, I think we would all recognize, like the meatpacking
facilities, our seafood processors are an important and a
critical industry, not only to Alaska, but to the Country, so
we want to work to address that.
I do want to speak very quickly, though, to the public
health infrastructure. I am told that in Alaska, as we are
doing our contact tracing, it is still a paper copy Excel
spreadsheet faxed to the epidemiology labs. This is how we are
doing our tracing. I thought, well, maybe that is just Alaska,
and I am told by Dr. Zink, who you have all had conversations
with, that, well, this is actually going on in California, as
well.
That, to me, is not a contact tracing system that works and
is sufficient. So, I want to ask about not only your view of
the sufficiency of contact tracing--and this is probably to
you, Dr. Redfield.
But, then, Dr. Fauci, I want to ask you about the concern
that we have with certain parts of the Country where you have
public mistrust of vaccines in general. My fear is that we may
get to the place where--we will get to that place where we have
that successful vaccine, but we still have the concern from
many, and a mistrust. And whether it is vaccine hesitation or
vaccine confidence--I don't know what the buzz word is, but I
am worried that we don't have a plan for how to deal with that.
First, contact tracing, and then the vaccine.
Dr. Redfield. Thank you very much, Senator. I think it is
really important just to highlight what you said about the
current state of data systems for public health in the United
States, that they really are in need of aggressive
modernization. And, again, thank Congress for the funding
there. But, it is a substantial investment that needs to take
place. There are a number of counties that are still doing this
pen and pencil, as you commented, and we need to have a
comprehensive, integrated public health data system that is not
only able to do something that is in real time, but actually
can be predictive. And it would be one of the great, I think,
investments of our time to make that happen once and for all.
Senator Murkowski. Agreed.
Dr. Redfield. That is really fundamental to be able to
operationalize contact tracing, et cetera.
Contact tracing in this case, and I will be very quick,
really does not have any value unless you can do it in real
time. It doesn't help, like I just did with the airlines, where
we had the people that were flying infected from Afghanistan
and we didn't get the information until Day 14, Day 15, Day 16.
It is irrelevant.
Again, we love the partnership to get an integrated public
health data system, not just for CDC, but for all of our
jurisdictions across the Nation, into one timely, integrated
system.
Dr. Fauci. Senator, thank you for the question about----
The Chairman. If you could be succinct, we are----
Dr. Fauci. Yes.
The Chairman [continuing]. Well over time.
Dr. Fauci. We will be quick. We have a community engagement
program that is embedded within the sites where the vaccine
trials will be done because we are thoroughly aware of what you
are concerned about. And it is a reality--a lack of trust of
authority, a lack of trust in Government, and a concern about
vaccines in general.
We need to engage the community by boots on the ground and
getting community--particularly those populations that have not
always been treated fairly by the Government--minority
populations, African Americans, Latinx, and Native Americans.
And we have a program that is already operable right now to do
that.
Thank you.
Senator Murkowski. Thank you.
The Chairman. Thank you, Senator Murkowski.
Senator Warren.
Senator Warren. Thank you very much, Mr. Chairman.
Dr. Fauci, you came before the HELP Committee 7 weeks ago
to discuss the Country's response to the COVID-19. And at the
time, you told me that the U.S. did not ``by any means have
total control over this outbreak.'' But, you also told me that
we were ``going in the right direction.''
Now, on the day you testified before the Committee--that
was May 12th, 2020--there were about 21,000 new cases of
coronavirus. Yesterday, there were about 40,000 new cases of
coronavirus.
Dr. Fauci, do these numbers show that the Country is still
moving ``in the right direction'' and that the coronavirus
pandemic is under control?
Dr. Fauci. Well, I think the numbers speak for themselves.
Although we do have a number of parts of the Country that are
doing well, I am very concerned about what is going on right
now, particularly in the four states that are accounting for
about 50 percent of the new infections, but the other
vulnerable states.
I would have to say the numbers speak for themselves. I am
very concerned and I am not satisfied with what is going on
because we are going in the wrong direction if you look at the
curves of the new cases. So, we have really got to do something
about that, and we need to do it quickly. Short answer to----
Senator Warren. So----
Dr. Fauci [continuing]. Your question is that clearly we
are not in total control right now.
Senator Warren. Thank you. Thank you very much. You know,
our case numbers are getting worse, and our death rates are
going to get worse soon.
During this same period of time, some other countries
around the world have controlled the virus. They are reporting
fewer cases each day, and they are able to provide targeted
testing and to keep it up so that they can tell what is
happening and follow-up if there is an outbreak. In other
words, controlling the coronavirus can be done. But because of
bad Federal leadership, we have not been able to do this here
in the United States.
Dr. Fauci, the last time you were before this Committee,
you told me that if the U.S. did not have ``an adequate
response'' that the Country would ``have the deleterious
consequences of more infections and more deaths.'' Now, I know
that we have made some progress, but half measures won't save
lives.
Dr. Fauci, I am asking you to be very direct with all of us
on this. If we don't fully implement the widespread testing,
contact tracing programs, and social distancing practices that
everyone seems to agree that we need, can we expect these
spikes in infection to keep happening in different places
around the Country?
Dr. Fauci. Thank you, Senator. I am always direct with you.
And I will tell you in direct answer to your question that, if
you look at what is going on and just look at some of the film
clips that you have seen of people congregating, often without
masks, of being in crowds and jumping over and avoiding and not
paying attention to the guidelines that we very carefully put
out, we are going to continue to be in a lot of trouble, and
there is going to be a lot of hurt if that does not stop. And
that gets back----
Senator Warren. Okay. If----
Dr. Fauci. No. I was----
Senator Warren. If we don't get our act together, more and
more communities around the Country are going to see these
dangerous surges----
Dr. Fauci. Right.
Senator Warren [continuing]. Of COVID-19. Dr. Fauci, back
in March, you also said, ``Looking at what we are seeing now,''
you expected there to be between 100,000 and 200,000
coronavirus deaths and millions of infections in the U.S. So,
let's flash forward to late June. Here we are, at the end of
June. We have already seen 126,000 deaths with infection rates
rising rapidly.
Dr. Fauci, based on what you are seeing now, how many
COVID-19 deaths and infections should America expect before
this is all over?
Dr. Fauci. I cannot make an accurate prediction, but it is
going to be very disturbing--I will guarantee you that--because
when you have an outbreak in one part of the Country, even
though in other parts of the Country they are doing well, they
are vulnerable. I made that point very clearly last week at a
press conference. We cannot just focus on those areas that are
having the surge. It puts the entire Country at risk.
We are now having 40-plus thousand new cases a day. I would
not be surprised if we go up to 100,000 a day if this does not
turn around, and, so, I am very concerned.
Senator Warren. Can you make any kind of estimate on what
we are looking at overall on the number of deaths before this
is over? You made an estimate back in March, between 100,000
and 200,000----
Dr. Fauci. Right.
Senator Warren [continuing]. But we have a lot more
information now, and we are already at 126,000 deaths.
Dr. Fauci. Right. I can't make an estimation because that
would have to be modeled out. Because when models are done--and
that is where those original numbers came from, Senator. As I
have said very often, models are as good as the assumptions
that you put into the model, and those assumptions often
change, depending upon what your response is. So, I would
really be hesitant to give a number that will come back and
either be contradicted and overblown or underblown.
But, I think it is important to tell you and the American
public that I am very concerned because it could get very bad.
Senator Warren. Alright. I appreciate that, Dr. Fauci.
The Chairman. Okay. We are----
Senator Warren. We all want our economy----
The Chairman. We are well over time, Senator Warren.
Senator Warren [continuing]. To recover.
I would just like the same time that my Republican
colleagues got. Because I want to say----
The Chairman. Alright. Then your----
Senator Warren [continuing]. That we want our economy----
The Chairman. Then your time is up. Senator Warren.
Senator Warren [continuing]. To recover.
The Chairman. Senator Warren.
Senator Warren. But we can't keep pretending----
The Chairman. Senator Warren, now, I am being just as----
Senator Warren. I need to get the----
The Chairman [continuing]. Fair to you as I was----
Senator Warren. Our Republican----
The Chairman [continuing]. To Senator Sanders and the
others.
Senator Warren [continuing]. Colleagues got a lot more
time.
The Chairman. Senator Warren.
Senator Warren. Mr. Chairman.
The Chairman. I always treat you fairly, and I would
appreciate your respecting the Chairman's rules. If you would
like to make a closing statement, go ahead and do it, but I
don't appreciate your----
Senator Warren. Thank you.
The Chairman [continuing]. Questioning my fairness in----
Senator Warren. I appreciate that, Mr. Chairman.
The Chairman [continuing]. Presiding over the hearing.
Senator Warren. I just was under the understanding----
The Chairman. Because I have been scrupulously fair.
Senator Warren [continuing]. Based on what others had done
that you were allowing more time since we had such important
witnesses.
The Chairman. Well, when----
Senator Warren. I appreciate--time.
The Chairman [continuing]. Are chairman, you can make
that--you can make those decisions.
Senator Warren. Thank you.
You know, I just want to make the point that we can't keep
pretending this virus is getting better when it isn't. That is
how we end up with messes like the situation in Texas. Racing
to reopen too soon; then scrambling to close down before the
hospitals get completely overwhelmed.
If we don't get our act together, this is our future, see-
sawing back and forth between too few restrictions and then
exploding cases and repeated shutdowns.
In this future, thousands more Americans will die and our
economy will be brought to its knees. We have got to have a
national strategy that makes testing available to every school,
every business, every hospital, every church, anywhere that
Americans come together.
We need to expand contact tracing, and we need leaders,
starting with President Trump, who have enough backbone to face
reality, distribute our resources, set our standards, and stick
to them. Because if we don't, the result is going to be more
economic wreckage and more death.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Warren.
What I have tried to do in this hearing is to ask Senators
to stay within 5 minutes and the answers within 5 minutes. And,
if the answers go beyond that, I have tried to be respectful of
that. But to--but I would ask Senators not to ask their
questions into well past 5 minutes and then expect to make a
speech at the end.
Senator Scott.
Senator Scott. Thank you, Mr. Chairman, and I will
certainly respect your time limits. I think we all should do
that.
Frankly, as we were asking Dr. Fauci for an estimate of how
many lives may be lost, I recall the first estimates were
between one and 2.4 million lives, so I am certainly glad that
we are not there.
Perhaps one of the reasons why we should be thankful for
where we are now and force ourselves to have a serious
conversation about continuing to flatten the curve is because
the all-hands-on-deck approach is effective. We just need as
much cooperation from as many people as conceivably possible in
every state around the Country in order for us to see these
numbers continue to make a dive in the right direction as
opposed to spike in the wrong direction.
I think about the Operation Warp Speed, along with the
crucial support from BARDA and other Federal agencies, public-
private partnerships, and accelerating groundbreaking
technologies that could eradicate COVID-19 and revolutionize,
frankly, the vaccine development landscape. Because of these
efforts by industry, academia, and Government working in
concert, we could see a viable candidate or candidates in a
matter of months for a vaccine.
Because of the growing number of large-scale manufacturing
agreements with companies like Moderna, Pfizer, and J&J
producing hundreds of millions of doses at risk, which means in
advance, we are already working to address issues of access.
And this is critical, especially for our most distressed
communities.
That said, effective development and widespread access,
while essential, are only part of the equation. If and when--
and I feel optimistic that it is when and not if--we get a
viable vaccine, we need to encourage folks to choose to get
vaccinated.
I was really concerned when I saw a recent AP survey that
showed that only 49 percent of American adults plan to get
vaccinated once the COVID-19 vaccine came to market. A full 20
percent said that they did not plan to get vaccinated, and one-
third of Americans were not sure.
Given the public's recent and vital focus on health
disparities, it is worth noting that among certain groups,
these figures are even more alarming. Just 25 percent of Black
Americans, 37 percent of Hispanic Americans plan to get
vaccinated against the coronavirus.
My question to the full panel, what steps can we take at
every level of Government and in the private sector with
healthcare providers to ensure a proactive education campaign
and outreach strategy on the importance of getting vaccinated,
both for COVID-19 and, frankly, even more broadly?
Dr. Fauci. I will take a shot at it first, Senator. As I
mentioned in response to another question, that we have a
community engagement program that actually operates out of
Operation Warp Speed, the vaccine development program component
of that.
Also, there needs to be engagement of people who the
community trusts, particularly individuals who are noted sports
figures or whomever. When we were involved, and continue to be
involved, in community engagement with HIV, we used people in
the community, boots on the ground, to go out who looked and
lived and are like the people they are trying to engage. It is
very critical, because I share with you the concern that we get
to the hoop and we get through it of getting a safe and
effective vaccine only to find that a substantial proportion of
the population do not want to get vaccinated.
Of particular concern is that it is that proportion of the
population that generally are the most vulnerable in the sense
of the minority communities--African Americans, Latinx, Native
Americans, who, in fact, because of underlying conditions, make
it more likely that if they do get infected, they would have a
poor outcome. So, it is extremely important to engage them at
the local level.
Thank you.
Senator Scott. Thank you very much for your answer, Dr.
Fauci.
Let me just close with my 40 seconds that I have left and
respecting the time, and I hope that we continue to do so.
The pandemic has triggered a drop of 60 to 80 percent of
immunization rates among children. And even now that states are
reopening, we are not seeing the rebound in these rates as--
that are necessary. This creates a real risk of secondary
infections and disease outbreaks that are not on the general
public's radar as we reckon with the chief crisis at hand.
I think it is incredibly important that we follow your
strategy, Dr. Fauci, as it relates to engaging community
leaders and perhaps people with notoriety to challenge us to
get involved in taking the vaccines.
Thank you, Mr. Chairman. I apologize for being 4 seconds
over my time.
The Chairman. Thank you, Senator Scott, for respecting the
time. We have eight Senators remaining who have questions, and
we should have time for all of them to have a chance to ask
their questions.
Senator Kaine.
Senator Kaine. Thank you, Mr. Chairman, and thank you to
the witnesses.
Dr. Fauci, I saw an interview with you last week where you
talked about a concern that there is too sizable a percentage
of our population that sort of doesn't like science and
scientists and advice from scientists. And I hear real emotion
in your voice as you express concern about people gathering in
large groups and without masks, and I gather that is the kind
of anti-science concern that you were worrying about when you
had that interview last week.
Dr. Fauci. Yes. That is part of it, Senator, yes, because a
disregard of recommendations that come from authorities only
because it is a recommendation. I think the attitude of pushing
back from authority and pushing back on scientific data is very
concerning. We are in the middle of a catastrophic outbreak,
and we really do need to be guided by scientific principles.
Senator Kaine. This could cause problems down the road if
we get to a vaccine, but people don't want to get the vaccine,
so we all have to message this pretty strongly.
Dr. Redfield, I want to thank you. I was going to ask you a
question today that I have been asking over and over again: Why
does the CDC's guidance for institutions of higher education
not even mention the word testing?
But as soon as your testimony was done this morning, the
CDC website changed and there are now guidelines for the
institutes of higher education with fairly extensive
recommendations and guidance, not mandates, about testing. I
didn't have a chance to read them, but I saw them popped up on
the CDC website, and I wanted to thank you for that.
Your testimony, Dr. Redfield, today in some of the written
testimony talks about the fact that the public health system
relies on timely and accurate data systems, but that we have
underinvested in them and the crisis has ``highlighted the need
to continue efforts to modernize the public health systems.''
Last year, I introduced a bill called the Saving Lives
Through Better Data Act. It was with Senator Isakson and
Senator King, and colleagues were helpful in this. We were able
to get $50 million in December in the appropriations deal, and
then another $500 million in the CARES Act. But, I would urge
my colleagues to do even more because the request from our
public health communities is significantly more sizable. I hope
we might be able to get that into the next COVID package.
Dr. Fauci, this is a challenging question, challenging how
to figure it out. The CDC last week said that a new group that
we have to consider at risk is pregnant women and lactating
women. The NIAID's Remdesivir testing and vaccine testing often
does not include pregnant women, I think for some safety
reasons. But, we would want to make sure that pregnant and
lactating women have access to treatments and access to
vaccines. So, how will we be trying to do research and testing
so that women can safely access these----
Dr. Fauci. Yes.
Senator Kaine [continuing]. Treatments or vaccines?
Dr. Fauci. Yes. That is a great question. It applies also
to children. So, what we are doing with the vaccine is you do a
Phase 1 trial in normal, healthy adults--not pregnant, not
children--and you show initial safety. Then when you move into
the Phase 2 and 3 studies, if you get even the slightest
glimpse of efficacy and safety in that population, you go back
and do a Phase 1 in pregnant and lactating women, as well as in
children. And, if that is safe there, you bridge the data so
that you could use the efficacy data that you already started
to apply back to pregnant women.
Senator Kaine. I see.
Dr. Fauci. That is how you do it.
Senator Kaine. Let me ask you this. At this point, is the
Nation's goal with respect to coronavirus to mitigate it or
suppress it?
Dr. Fauci. Vaccines right now--are you talking about
vaccines, sir?
Senator Kaine. No. I am just talking about what is our
goal? Are we----
Dr. Fauci. Yes.
Senator Kaine [continuing]. Trying to mitigate or are we
trying to suppress?
Dr. Fauci. It depends on where you are. There is
containment and mitigation. So, if you have a level of virus
that is low enough that you can adequately contain by the
standard way of identification, isolation, contact tracing,
particularly if you make sure you link the identification with
isolation--because if you just do contact tracing without
isolation, it is not going to work. When you get into a
situation----
Senator Kaine. If I could, Dr. Fauci, because I don't want
to go over time. I want to say just one thing about testing
real quick.
Admiral Giroir, when you were here last, you said we would
have capacity to do 40 to 50 million tests a month in
September. That is about 1.3 to 1.7 million a day. On May 12th,
we had done about 310,000. Yesterday, we did 560,000. Are we
going to get to 1.3 to 1.7 million tests a day by September?
Admiral Giroir. Thank you for asking that. We will
absolutely have the capacity to do that. It is depending on the
need. And, again, as you might expect, a few weeks ago, the
need for testing was much less than it is now.
We had a good system that--it was actually very good that
we were able to identify an increase in positivity very early.
But, obviously, with the outbreaks we are having now, we need
to massively surge testing in those areas.
We will have that capability across the board. Yes, we will
have that, and that is assuming no pooling. When we start
pooling these together, three, four tests, then you do the
math. So, I am never going to be happy until we have more
tests, that we never have to say the word test again, but we
are going to be in reasonably good shape given those
parameters.
Senator Kaine. Thanks, Mr. Chairman.
The Chairman. Thank you, Senator Kaine.
Senator Romney.
Senator Romney. Thank you, Mr. Chairman, and thank you to
each of the panelists for the sacrifice and the effort that you
have been making over these past several years--past several
months, as well as years.
As you know, because we didn't know a great deal about this
virus when it first came on the scene in America, we asked the
American people to basically shut down their lives. Cut back on
flying, family reunions, funerals, church services,
restaurants, bars, theaters. Everything got shut down.
Well, now it is end of June, and hopefully we have learned
something about how this disease actually spreads, and the
American people need to go back out. They are going to go back
out, and they are going back out. We saw, for instance, at the
Lake of the Ozarks, all these people and we said, oh, my
goodness, this is going to be a major problem. But, my
impression was because people were outside or who knows what
other reason, it wasn't a major problem.
My question is this: Where is the risk greatest? How is it
that it is spreading? Is it spreading indoors? Is it spreading
more in restaurants and bars? Is it okay to be outdoors and
perhaps not socially distance? Are family reunions okay?
Could you give us some guidance based on what hopefully we
know as to where the risks are greatest? I know you keep saying
social distance and masks, but, people are getting in
airplanes, they are going to restaurants. Where is the risk
greatest and where are we relatively safe? Can you help us
through that? Family reunions? Can we get together with family
reunions, outdoors? Is it safer outdoors than indoors?
Give us some guidance. Can you do that, Dr. Fauci and Dr.
Redfield?
Dr. Redfield. Thank you, Senator. I think first and
foremost, the most important thing in that assessment is
knowing at the granular level what the kinetics of transmission
are in that community. As I mentioned, we have 130 counties
right now in the United States where we consider them ``hot
spots.'' We have many other areas where there is very limited
transmission. So, first and foremost, it is knowing the--if you
are in that area of active transmission.
Then second, it is knowing what you do when you are in that
area of active transmission and what precautions one takes. I
think these----
Senator Romney. Got to be brief. You got to be brief,
Doctor. I have only got 5 minutes.
Dr. Redfield. Alright. Well, I think those are the two
things. I will say that there is just more and more data
showing that the use of face coverings and masks are an
effective way to prevent transmission in these gatherings. And
I think we are just going to come back and tell you the most
important thing, if you are within a community with limited
transmission and you are wearing face masks, or if there is
significant transmission and you are wearing face masks, and
you practice the social distance and hand washing, that is the
best thing, best recommendations, I can tell you.
Dr. Fauci. Yes. In addition, Senator, outdoor better than
indoor. Bars, really not good. Really not good. Congregation at
a bar inside is bad news. We have really got to stop that right
now when you have areas that are surging like we see right now.
But in answer to your question a little bit more granular,
outdoor is always better than indoor. If you are outdoor,
distance, as Bob said. Wear a mask if you can. But you can have
some social interaction.
The one point I want to make very briefly is that we should
not look at the public health endeavors as being an obstruction
to opening up. We should look at it as a vehicle to opening up
so that you don't want to just restrict everything because
people are not going to tolerate that.
You can get outdoors. You can interact. Wear a mask. Try to
avoid the close congregation of people. Wash your hands often.
But don't just make it all or none. We have got to be able to
get people to get out and enjoy themselves within the safe
guidelines that we have. So, make public health work for you as
opposed to against you.
Senator Romney. I very much appreciate those responses. I
think it would be extraordinarily helpful for all of us, as we
are going about our lives, if there was data that indicated
where people are getting infected. Were they in a bar? Were
they in a restaurant? Were they outdoors at a pool?
I have heard reports that virtually nobody has been
infected if they are outdoors. Is that true or not true?
We--given how long we have been at this, we have got to
have more granular data so people know where there is greater
risk. How many people, for instance, have been infected as a
result of flying on airplanes? We have to know that. If we
could publish that information for the American people, they
will know where they can be safe and go back. Of course,
continuing social distancing and wearing masks, but we need
that data.
Finally, I will just ask one--an answer. Who is responsible
for distributing the vaccine? What person or what agency
determines how the vaccine, when it is available, will be
distributed?
Dr. Redfield. Well, since--thank you, Senator. This is a
central function of CDC where we really help with vaccine
distribution throughout the Nation. Childhood vaccines----
Senator Romney. That is--so that is the CDC. That is on
your shoulders. Thank you.
Mr. Chairman, back to you.
The Chairman. Thank you very much, Senator Romney.
Senator Hassan.
Senator Hassan. Well, thank you, Mr. Chairman, and thank
you to all the witnesses for being here and for the teams you
lead. I know how hard everybody is working.
Dr. Redfield, I want to start with a question to you.
Forty-three percent of the deaths in this Country have been in
nursing homes or long-term care facilities. In my State of New
Hampshire, 80 percent of our deaths are attributed to residents
of nursing homes and long-term care facilities.
In mid-May, the White House urged states to complete COVID-
19 testing on every nursing home worker and resident within 14
days. A month and a half later, that still has not happened.
CDC has since put out different guidance on nursing home
testing, calling for a baseline test for residents and weekly
testing for nursing home workers.
Given the widespread outbreaks within nursing homes and
unique risks posed to residents, what is CDC doing to ensure
that states carry out the recommendations for nursing home
testing issued by CDC on June 13th? And, how many states have
met these guidelines so far?
Dr. Redfield. Thank you, Senator. We are working in close
contact with CMS on that issue. As you say, we are not an
enforcement agency. We make recommendations.
Senator Hassan. But I am asking, and my time is short. I am
asking what you are doing to keep track of compliance with
guidelines. Forty-three percent death rate nationwide is huge,
and people are looking to you all for granular guidance here.
So, what are you doing to find out who is in compliance and who
is not?
Dr. Redfield. I was trying to emphasize that we are working
in partnership with CMS, which has that regulatory oversight.
We are there to continue to reinforce the guidances you
mentioned, which we think is critical. And we think we do have
to get everyone screened in these nursing homes, and the
employees every week.
Unfortunately, we still think that we need to keep visitors
isolated from the homes right now, particularly in areas with
high jurisdictions. But, the regulatory function of this is
CMS, but we are really meeting with them daily to see what more
we can do to try to ensure that there is greater compliance.
Senator Hassan. I thank you for that. People are looking to
the CDC for not only very clear and granular guidelines--and
you have heard that all throughout the questioning--but
particularly with nursing homes and long-term care facilities.
There is a lot more work to be done, and we are still hearing
that they are not getting usable personal protective equipment
all the time, either.
Let me go to another question. And, Dr. Fauci, I will start
with you. We have heard discussion already today about the
difference in the effectiveness of measures taken, for
instance, in Europe and the United States. This is a graph that
shows the disparities between new confirmed cases per million
residents over the previous 7 days to the United States,
Europe, Canada, and Japan. The disparity is eye-popping.
[Slides shown.]
Senator Hassan. Surveys suggest that mask-wearing in the
United States occurs less frequently than in Europe. You and
our witnesses have been very clear on the importance of mask-
wearing in public places. Do you attribute the improvements in
Europe to more widespread use of masks? Or are there also other
specific Government policies or individual behavioral
differences that you believe should be incorporated into our
national strategy?
Dr. Fauci. It certainly--masks play a role, but there are a
number of other multifaceted things in each of those very
disturbing graphs that you show.
Senator Hassan. Yes.
Dr. Fauci. One of the things that became clear, when we
shut down as a Nation, in reality, only about 50 percent of the
Nation shut down with regard to other things that were allowed.
In many of the European countries, 90, 95 percent of all
activities were shut down. So, that is one of the reasons why
you saw, particularly in Italy, which shut down to a much
greater extent than we did, the cases came way down in a sharp
curve downward and then stayed.
It is not only masks. It is the fact that the countries in
Europe and the other countries you have there had a much more
uniform response. We are a very heterogeneous Country, and we
had a heterogeneous response, depending whether you are in the
northeast, southern, west, or what have you.
There is a number of other factors, probably some that we
still don't even understand.
Senator Hassan. Well, thank you.
I am going to move onto just one other issue, and it is
really just to urge Dr. Redfield and the CDC to issue
additional guidance for schools, in particular on reopening. I
understand that you are continuing to do that.
I appreciate that the CDC has released FAQ--frequently
asked questions--documents on things like youth sports, which
provide more concrete, useful information for families. And, I
am hoping that you will do the same kind of FAQ documents for
parents and teachers that directly address practical questions
and concerns about school reopening plans. Simply like, what
happens? What should a school do specifically if one or two
positive cases come up in a classroom or in a teacher? What
should parents and teachers expect school administrations to
do?
We can follow-up with that. I appreciate the Chairman's
indulgence.
The Chairman. Thank you, Senator Hassan.
Senator Braun.
Senator Braun. Thank you, Mr. Chairman.
I have two sets of questions and would like for Dr. Fauci
and Redfield to give about a minute each to the first.
I want to get the broad numbers. I think, Dr. Redfield, you
might have been on record that you think there is 10 times as
many cases out there as--and I know that is a guess. I would
like to know because, if that is the case, all the sudden, the
fatality rate goes from 5 percent down to five-tenths a
percent; 20 times as many cases, of course, 2.5 down to .25.
What is your--start with you Dr. Redfield. How many cases
do you think we actually have out there? And then, how many
vaccinations in our herd immunity combinations, as a percentage
of our total population, do we need to get to for this thing to
be in the rearview mirror? So, we have a few big numbers to
kind of relate to the journey ahead.
Dr. Redfield. Thank you very much, Senator. Quickly, we now
know that this virus began to really spread in the United
States in March. And between March and the end of May, we have
been able to do antibody testing, and that is what allowed us
to understand how many people were really infected. So, during
that period, it was our best estimate about 10 to one, so we
are probably talking over 20 million, 22 million Americans have
been infected.
I don't want people to assume that is the same ratio now in
June and July going forward because there is----
Senator Braun. You think it is more than that or less than
that?
Dr. Redfield. No. I think it is going to be less because we
are doing more and more testing. Okay? But, clearly, it gives
us a good idea the extent of infection was more in March,
April, and May. Not two million individuals, but more closer to
20 million individuals.
Senator Braun. What is your opinion of how many individuals
we need vaccinated and/or having herd immunity before this
thing goes into the rearview mirror?
Dr. Redfield. Yes. Tony may comment on that, too. It has
really got to be over 70 percent of the population----
Senator Braun. Okay.
Dr. Redfield [continuing]. Has got to be immune before we
even see any impact of herd immunity.
Senator Braun. Dr. Fauci.
Dr. Fauci. Yes. I totally agree. Given the
transmissibility, which is highly efficient, you are going to
need somewhere between 70 and 85 percent. I would say 70 at the
lowest.
Senator Braun. Okay. Second set of questions would be on
the issue of herd immunity. Because, of course, we have the--we
don't know how long it is going to take to have an effective
vaccine. And, I am guessing when you are talking about herd
immunity, it has to actually confer immunity if you get it, and
there might be some uncertain--let's assume you do get the
immunity.
What is the--how do we go about--the approaches that we
have used to this point, is herd immunity going to be something
that you think will march through if we take the strategy of
having a different approach for younger people that seem to
have lower hospitalization rates and less significant
consequences? Because I think--that is another thing we need to
know because I think that is already going to be done by each
individual in a way as they seize up their own personal risk.
So, how much can we count on herd immunity?
Dr. Redfield. I can answer quickly and then turn it to
Tony.
I think it is important to realize even now, we are
probably looking at somewhere between five and 8 percent of the
American public has experienced this virus. So, for me, herd
immunity as a basic strategy, you are talking about a multi-
year strategy. This is why it is so important that the
alternative strategy is a biological countermeasure in the
development of a vaccine.
Dr. Fauci. One of the issues that might be complicating--I
don't think it is going to be something that is going to be any
kind of a show-stopper, but we have got to realize and, as
Senator Paul said, we have to be humble and know there is a lot
we don't know.
What we don't know is what the durability is. In other
words, so, if you wound up getting herd immunity to 75, 80
percent, what we need to learn, and only time will teach us
this, is how long this immunity lasts. Is it a year? Two?
Three? Four? Or is it even less? Is it months? We don't know.
When we find out, then that will inform us as to whether or
not if you get a vaccine, how often you need to boost it. So,
we have to realize, we don't really know the answer to your
question in any definitive way.
Senator Braun. At least that gives some clarity, some
parameters to live within.
Senator Hassan stressed the point of protecting the most
vulnerable. Because, to me, the one thing it looks like we
could certainly do is to take that highest-risk group from the
data we have already got and build, in essence, an iron dome
around them. That is the one thing that would seem to be the
most important thing to do where you get certain results. And I
think that has to be in place as we--the uncertainty of herd
immunity, and when we get an effective vaccine, actually
converge.
Dr. Fauci. I might add, just--we always think about herd
immunity with regard to natural infection and/or vaccination.
But, when you want to talk about protecting the vulnerable, we
want to see if some of the other programs that are more
prophylactic treatment programs, like passive transfer of
plasma, or monoclonal antibodies, or hyperimmune globulin.
Those are some of the things that you can do to protect the
vulnerable until we do get an effective vaccine.
Senator Braun. Thank you.
The Chairman. Thank you, Senator Braun.
Senator Smith.
Senator Smith. Thank you, Chairman Alexander, Ranking
Member Murray. It is good to see all of you today. And thank
you again to our panelists.
We need robust surveillance and occupational testing if we
are going to safely reopen our economy and our schools, our
nursing homes and our group homes, to make sure that they are
not a conduit for infection. And we are seeing this. A good
example of this is in New York State, where employees in
nursing homes are required to get a COVID-19 test twice a week.
Here is the problem if you are a worker. Who pays for that
test? Is it my employer? Is it my private insurance, if I have
insurance? Or, do I have to pay for it out of my pocket? So, I
am thinking about that low-wage worker working in childcare or
food processing or maybe a security, worker, or a janitor. And,
the average cost of a test is somewhere in the neighborhood of
75 to $150, though there are reports of people being charged
over $6,000 to be tested, assuming you can find a test.
This is my first question. Last week, Federal agencies
posted guidance on this question, and the guidance said that
health plans are not required to cover the full cost of tests
for surveillance or occupational reasons. And, the Federal
testing plan, which talks about the value of surveillance
testing and occupational testing, is silent on this.
Let me ask you, Dr. Fauci, do you agree that we are going
to be better able to contain the spread of COVID-19 and save
lives if we have surveillance testing?
Dr. Fauci. No doubt surveillance testing is going to be a
very important part of the program to understand not only the
current penetrance of the virus to society, but where it is
going.
Short answer to your question is it is going to be very
important in our public health measure.
Senator Smith. Would not also the price of these tests or
the ability to pay for these tests be a pretty significant
barrier to having that surveillance happen?
Dr. Fauci. I think common sense tells you that if people
cannot pay for it, they are not going to do it. That is one of
the reasons we have got to figure out how we can do it without
having the stress of people who cannot afford it to be part of
that process.
Senator Smith. Of course, the worry, of course, is that
this ability to pay for these surveillance tests or this kind
of surveillance testing, that could really tend to exacerbate
underlying inequities since a lot of frontline workers and
essential workers, who don't have the privilege of working from
home, are much more likely to be Black and Brown and indigenous
people, people of color. Is that not right?
Dr. Fauci. As in all cases that people who are economically
not able to engage in some of the things that benefit others,
they always, in general, get a short end of the stick on that,
and that is what we have to be concerned about.
Senator Smith. Right. Well, colleagues, I think this is a
really important place where we have the potential to work
together to make sure that, as we expand surveillance testing
and occupational testing, as we look at our schools, our higher
institutions of higher education coming back, that we have the
ability to do this and that the ability to pay for that test is
not a barrier.
I appreciate--Chairman Alexander, you mentioned this at the
beginning, others of my colleagues have mentioned this, and I
think this is a place where we could work together in a
constructive way.
I want to ask a question specifically related to vaccines
because there has been a lot of discussion about this, a lot of
discussion about how we can make sure that people trust these
vaccines, that they are safe, that they work, and that the
long-term consequences, potential negative side effects, we
understand those.
Let me just ask--maybe I will ask you again, Dr. Fauci. How
do we trust a vaccine that has only had a short number of
months potentially being tested in a human body?
Dr. Fauci. There are a couple of ways to overcome that.
First is that you have a large number of people in the trial.
The trials that we are talking about now are going to have
30,000 people in the trial, and maybe even more in some of
them. You can get a considerable amount of safety data.
But, then there is a process, after a vaccine maybe would
show efficacy to do further studies following licensure,
availability. I will let Dr. Hahn maybe comment on that more
because that becomes something very much involved with the
FDA's authority in making sure we do have safe vaccines. So,
Steve?
Senator Smith. Let me just--if I could maybe put a finer
point on this question for you, Dr. Hahn. I mean, what if a
manufacturer were to say that they could get a vaccine to
market in January, but only if they were released from
liability? What is the FDA policy on that? How would you
resolve that question?
Dr. Hahn. Thank you, Senator. So, we would not get into the
issue of liability for an individual sponsor. And, what we
would do, and that is why we released the guidance this
morning, is we would ensure that our normal regulatory approach
and our standards for safety and efficacy are met. So, while we
are all----
Senator Smith. You would not release that manufacturer from
liability?
Dr. Hahn. That is not an FDA authority that----
Senator Smith. Okay.
Dr. Hahn [continuing]. We would use.
Senator Smith. How do you guard against----
The Chairman. Senator Smith, we are running----
Senator Smith [continuing]. The possibility----
The Chairman. We are running a little late. Go ahead with
your question, but let's--the witnesses have to----
Senator Smith. This should be--hopefully this will be an
easy one. I mean, what I am worried about is that there is some
sort of October surprise and that there is pressure put on the
decisionmakers here to announce the vaccine in October 2020.
Dr. Hahn, can you just tell us how we can have transparency
so that people can trust that is not happening?
Dr. Hahn. Senator Smith, a very good question and really
important and leads to the issue of public confidence. It is
why we released our guidance today. We want to be clear about
what the standards and the data that we will need to make a
decision and what factors go into this decision. I want the
American people to hear me when I say we will use the science
and data from those trials, and we will ensure that our high
levels of standards for safety and efficacy are met.
The Chairman. Thank you, Senator Smith.
Senator Smith. Thank you, Mr. Chairman.
The Chairman. Senator Loeffler.
Senator Loeffler. Good morning. Thank you all for being
here. Sorry I cannot be there in person.
I wanted to ask, Dr. Redfield, can you outline what steps
the CDC is taking to, look at, as we prepare for handling both
the flu and COVID-19 season simultaneously this fall? I know
the CDC recently developed a test that diagnoses both COVID-19
and the flu, but what other activities is the Agency engaged
in? And, are there any novel approaches that you see in terms
of implementing this? I would love to hear about the Agency's
process for approaching the season this fall and your thoughts
there.
Dr. Redfield. Thank you very much, Senator. I think it is
really important to recognize that it is going to be difficult
with the flu and COVID this fall.
First and foremost is to try to increase the American
public's acceptance of flu vaccine. As you know, less than 50
percent accept it. We are working hard to begin to reach out,
particularly to groups that have been under-represented, to try
to build that confidence in vaccination.
We have worked with the manufacturers to see if they could
boost the amount of vaccine that would be available. They have
now increased their commitment to almost 189 million doses. CDC
bought another 7.1 million doses. Normally, we buy about
500,000 to be able to be available to the states and local
health departments for uninsured adults. We have--we increased
that to 7.1 million doses.
We have augmented our commitment to the children's vaccine
program, anticipating that there is going to be more children
that will qualify in light of the unemployment.
Those are some of the areas that we have begun to prepare
for.
Senator Loeffler. Thank you. And this question is for Dr.
Hahn.
The pandemic has exposed our vulnerabilities in the medical
supply chain, and obviously we have a reliance on imports from
countries like China that can quickly pose a national security
risk in the face of an outbreak of infectious disease. We need
to come up with a strategy to boost our production here of
pharmaceuticals and supplies.
I have introduced some legislation entitled the BEAT CHINA
Act to offer incentives to companies that bring manufacturing
back to the United States, but would like to hear from you,
what additional steps can policymakers take to boost our
capability to produce these supplies and pharmaceuticals
domestically?
Dr. Hahn. Thank you, Senator Loeffler, and thank you for
your leadership on this. I think one issue that we can all
agree upon is the lack of redundancy in the supply chain and
the dependency that we have seen during the COVID-19 pandemic
has been a problem.
The Agency's primary focus has been on instilling
redundancy in the supply chain, particularly of
pharmaceuticals, by diversifying that supply chain and really
looking for opportunities to encourage domestic manufacturing.
We, of course, on the regulatory side provide guidance, as
well as regulations, around the manufacturing specifications to
ensure quality of pharmaceuticals and other medical products.
We will continue to do that, particularly in the advanced
manufacturing space, in order to encourage domestic
manufacturing.
We look forward very much to working with you and other
Members of Congress to see how we can create the proper
incentives to have that redundancy, and particularly to have as
much domestic manufacturing as possible.
Senator Loeffler. Thank you, Dr. Hahn.
No further questions. I yield my time.
The Chairman. Thank you, Senator Loeffler.
Senator Jones.
Senator Jones. Thank you, Mr. Chairman. Thank you all for
being here today. I really appreciate your testimony, your
consistency over the last few months. It has got to be somewhat
discouraging to all of you, as it is to us, to see these
numbers.
I want to kind of focus a little bit on schools as we will
start opening schools up in Alabama in August. And, let me give
you a little chronology here.
The State of Alabama kind of began to open up its economy
more in May, a little bit more toward the end of May, and then
in--for Memorial Day, we saw the photographs and videos that
Dr. Fauci referred to with everybody just having a big time
over the Memorial Day holiday.
Now, at the end of June, we are at our highest levels. The
last 14 days have shown over 10,000 cases, which is 28 percent
of the cases that we have seen have occurred just in the last
14 days.
At the end of this week, we have the July 4th holiday
coming up. And, we are going to see a delay in hospitalizations
from right now. If we do the same thing on July 4th, we are
going to have a huge problem at the end of July and early
August when we start opening schools up.
Our state school superintendent this week said that it
would cost about $1.8 million for the average school system to
do those things necessary to try to protect kids and the
faculty. But, I heard Senator Paul in his comments and
discussing a number of things to where you would get the
impression that we could just open schools back up without
spending any of that money.
My question, primarily to Dr. Fauci and Dr. Redfield, could
you comment on some of the statistics and some things that you
heard about children transmitting this disease and whether or
not we need to spend some extra, additional moneys for our
schools to do things like have extra PPE? To do things like
hiring--potentially hiring additional health officers,
temperature screenings, those kind of things? Are those going
to be necessary, based on what I have heard from Senator Paul
and what happened on his charts in other countries?
Dr. Fauci and Dr. Redfield?
Dr. Fauci. I will quickly give it a shot and then hand it
over to Dr. Redfield.
We don't know precisely. I think the data that was very
interesting that Senator Paul showed about school openings and
not seeing any real obvious surge in cases is important, but we
don't really know exactly what the efficiency of spread is.
First of all, how many children get infected. That was the
reason why in my opening statement I mentioned the study that
we are doing at the NIH of 6,000 families, looking at children,
what is the rate of their infection and how often did they
infect their families. Because if it is true that the rate is
down, we would know that they don't get seriously ill with
hospitalizations when they get infected. But, if the rate of
infection is down and they don't readily transmit to their
parents and family members, that is going to be very important
in the decisionmaking process of opening schools. Hopefully, we
are going to find that out reasonably soon by this study that
we are doing.
Bob.
Dr. Redfield. I would echo what Dr. Fauci said. CDC has a
number of what we call household studies going on to try to get
a better understanding of how does the virus get into a
household, who brings it in, what happens with--when it is in
the household, how does transmission vary depending on how the
household responds in terms of social distancing, et cetera.
So, there is information that we are gathering. I think--we
don't know the impact that children have yet on the
transmission cycle, so I think we should just acknowledge that.
The greater threat, obviously, is, again, the children to
the vulnerable, but I think one can actually have social
behavior that can prevent that. So, I think that would be just
to emphasize. I think it is really important.
It has been said already that we move forward and work to
reopening schools in a safe way. I think it is of note that CDC
never really recommended closing schools. It sort of just
happened, as you know. We can do targeted school closings if we
have to in a particular region like we have done for other
viral diseases.
But, I think we really need to move forward now and work to
how to reopen these schools safely.
Senator Jones. Thank you. Admiral Giroir, just--I want to
make sure you are--we are tuned in, and we have talked about it
a little, about are we going to be able to make sure that we
get vaccines distributed in the most vulnerable of communities?
Because that seems to be where so much is happening right now,
in the rural south. And, are you making specific plans to make
sure that we get that into the rural areas?
Admiral Giroir. Thank you very much. So, we all work on
parts of this problem, right? So, the CDC actually controls the
distribution. But, what my office does, running the national
vaccine program, does things like the Morehouse Grant that--the
cooperative agreement that we announced last week. That really
reaches into the rural, into the Hispanic, into African
American, to really have the community, the people who are in
that community, not only linked to services like testing, but
to lay the groundwork for vaccine acceptance. Because we know
that the burden of disease is fundamentally burdened on these
individuals. So, these are the people, assuming the science
works out, that we want to get vaccinated first.
Senator Jones. Alright. Great. Thank you.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Jones.
We know the witnesses need to leave about 1. We are going
to try to respect that.
Senator Rosen.
Senator Rosen. Hold on. Can you hear me?
The Chairman. Yes, we can.
Senator Rosen. Well, good morning. I will try to be as
quick as I can, talking about antibodies this morning. Thank
you Chairman Alexander, Ranking Member Murray, all of our
witnesses, for being here today.
As our communities focus on how to safely get back to work
and school, just like we are all talking about, we know we have
to follow the science and adapt to new information to be sure
that we are making timely, targeted, and thoughtful decisions
to protect both lives and livelihoods.
Dr. Fauci, the last time you were here, we talked about the
monoclonal antibody treatments, and I would just like to
follow-up on that conversation if we could.
As we have learned more about the virus, how it functions,
how it is different from other respiratory illnesses, what
updates can you tell us about the development of preventative
treatments that block the virus from attaching to the cells
that it is targeting?
Dr. Fauci. Thank you for the question, Senator. You
mentioned monoclonal antibodies. Monoclonal antibodies are
going into trials right now in a number of trials sponsored by
a number of groups. Hopefully, within a reasonable period of
time, we will get information as to whether or not that is
effective both in the prevention, as well as in the treatment.
Those antibodies are directed against a component of the virus
that is--what is called the spike protein, and that protein is
the one that binds to the now well-established receptor in your
body for the virus, and that is the receptor called ACE2.
There are a number of other studies that are not
necessarily antibody studies, but studies that have an effect
on the virus itself and its initial replication.
In answer to a question that the Chairman mentioned just a
bit ago is that there will be therapies that we will be giving
some for treatment early on and others for prophylaxis. And,
as--we hope, as we get into the fall and winter, we will have
everything from small molecule treatments and prophylaxis to
the kinds of antibodies that you are talking about.
There is a lot of activity going on to do that early in
disease, both for prevention and for the treatment of early
disease.
Senator Rosen. I know that you have been doing a lot of
serology testing and that individuals are presenting with
antibodies. So, out of the five types of antibodies that people
are most likely to have, which ones do most recovered
patients--which ones do they show? And, if one of these
specific antibodies are present, does that make a difference in
if the patient can be re-infected or not? Are they effectively
immune at least for some period of time? What kind of answers
does this give us if you do have the presence of certain
antibodies?
Dr. Fauci. I am--I would like--I would love to give you a
really precise, scientifically based answer, but the fact is,
we don't know. Standard wise, when you get an acute infection,
you get an IgM antibody. As you go off in time and develop a
more mature immune response, it becomes an IgG. There are
subclasses of IgGs, some more protective than others.
The thing we don't know, Senator, that we--we will know in
time, but it is going to take time to know it, is what the
relationship between the neutralizing antibody and binding
antibodies that don't neutralize, what is the relationship
between the titer and degree of protection, and what is the
durability of protection.
We have seen some puzzling things. We have seen people
recover from COVID infection and find out they don't have very
high numbers of antibody. Could it be a cell mediated response
that got them through the illness? And, some other individuals
have very high levels, and we don't know how long those levels
last.
We are getting there with regard to our knowledge, but it
is going to take several more months to a year to really be
able to definitively answer your question about the role of
antibodies in protection following natural infection.
Senator Rosen. Well, building upon that, I would like to
ask this question then. We know that this virus affects--it is
multi organ. It can affect your kidneys, your lungs, your
heart, producing strokes, all kinds of things, your digestive
system, your sense of smell. So, on the science that you are
talking about and the antibodies, is the science of stopping
the virus from causing harm the same regardless of which organ
it attacks? And how do we help direct funding for the kind of
research that you are going to need to look at this multi organ
attack of this virus, if you will?
Dr. Fauci. This is a very perplexing virus because it is a
respiratory virus and it gets in through the respiratory tract.
If the virus stays in the respiratory tract and doesn't go
systemic to involve other organs, that is good news because you
don't get very sick.
The other side of the coin is your antibody response is not
as potent because when you get systemic involvement,
invariably, you will have a more potent and robust immune
response. So, many people, and probably the people who are the
asymptomatic carriers, they have a reasonable titer of virus in
their nasopharynx, but the virus doesn't go any other place in
their body.
People who get multi system disease that get triggered by
the virus, those are the ones that, unfortunately, get more
sick, but also the ones that make a more potent immune
response.
Senator Rosen. Thank you so much. I appreciate you all
being here today.
The Chairman. Thank you, Senator Rosen. Very interesting
questions.
Senator Murray, do you have closing remarks?
Senator Murray. I have one additional question, if I might,
and then some closing remarks. I wanted to ask Admiral Giroir
one question.
Admiral Giroir. Yes, ma'am.
Senator Murray. Thank you. Despite some of the limited
data, we do know that COVID-19 is infecting and killing Black,
Latino, and Native American people at a much higher rate than
White people. I wanted to ask you how HHS is going to adjust
its response to reduce cases and deaths in communities of
color. And, specifically, can you commit to redirect some of
the $14 billion that is in unspent funds Congress provided to
address those disparities?
Admiral Giroir. Let me answer the two parts of the
question. First, as you know, and we really appreciate your
support, we have tried to focus our testing into high social
vulnerability communities. So, 70 percent of our over 600
pharmacy sites are in high SVI communities. That means racial
and ethnic minorities, language disparities, socioeconomic.
FQHCs: We have made a major push that the federally
qualified health centers that take care of one out of three of
those in poverty, over 1,300 of those are now offering testing.
Of course, we are super excited about the award to
Morehouse School of Medicine last week that has a large
coalition to create a national infrastructure to reach
minorities and underserved.
That is what we are really doing. And, my office, this is
what we do on a daily basis, but even without a pandemic.
Your second question is, I don't commit the money. So, I
certainly think we need continued investment in this area,
continued significant investment in this area, that the $40
million is a down payment on how we could best reach the
underserved community, but you are going to have to talk to OMB
about how the money is spent.
Senator Murray. Well, actually, HHS oversees that, so we
will ask them. But, I think that is an important question. I
will keep following up and tracking that.
Admiral Giroir. Yes, ma'am.
Senator Murray. Thank you, Mr. Chairman.
I appreciate all of our witnesses taking the time to join
us today to update our Committee on the course of this pandemic
and all of our efforts to respond to it.
I hope we will continue to have an opportunity to hear from
all of you, as well as other key Administration officials,
about this because the absolute worst thing we could do right
now is to pretend this crisis is over when it is painfully
obvious that is not true. The reality is that the losses in
this pandemic so far are nearly unthinkable, and any further
delays in our response is really unacceptable. We need to
take--this President to take this crisis seriously and lead,
and we need Congress to act.
I hope we can all get back to work as soon as possible. We
need to support our families, our frontline workers, our
businesses, our schools, our communities. We need to get
testing where it needs to be. We need to make sure we are
making progress toward a safe, effective, widely available
vaccine, and we need to strengthen our ties with the global
community rather than cut them.
There is a lot left to do, Mr. Chairman. I look forward to
working with you on this.
The Chairman. Thank you, Senator Murray.
I know our witnesses have a meeting they need to go to, so
I will abbreviate my remarks. But, one thing I want to ask
you--perhaps you can each do it in a minute or less.
I put out a white paper in recognition of what some of you
have said, which is that in between pandemics, we have found it
difficult to do some of the things we need to do to prepare for
the next pandemic. So, if there were one or two things that you
thought we should try to do now in order to be prepared for the
next pandemic, what would those one or two things be? Dr.
Fauci?
Dr. Fauci. One of the things that I would like to see is an
appreciation on the part of our entire Nation of the importance
of responding as a Nation as a whole and not have a situation
where, when you have a challenge such as we have right now, we
have very disparate responses. We have got to do it in a
coordinated way because we are all in this together.
The other thing I would like to do now is to cement in our
minds as we bridge to the future the fact that we cannot forget
that what was thought to be unimaginable turned out to be the
reality that we are facing right now. So, it relates to the
kind of appreciation that outbreaks happen, and you have to
deal with them in a very aggressive, proactive way.
The Chairman. Dr. Redfield.
Dr. Redfield. Thank you, Mr. Chairman. I think the most
important thing that I could say is that when it comes to
public health threats, our Nation needs to be over-prepared,
not under-prepared.
As I mentioned before, decades of under-investment in the
core capabilities of public health, data modernization,
laboratory resilience, workforce, emergency response, I think
is fundamental. We have really been hit with this simple virus,
and I think at the end of the day, it is going to cost our
Nation trillions of dollars.
I think that we have a moment in time where I think people
are attuned, and I would say now is the time to make the
necessary investment in our public health at the local,
territorial, tribal, state, and Federal level so that this
Nation finally has the public health system not only that it
needs, but that it deserves.
The Chairman. Admiral Giroir.
Admiral Giroir. Of course, I agree completely with my
colleagues and we are all singing from the same hymnal here.
I will say three things. No. 1, data infrastructure is
really important. When we came into this, we didn't know how
many ventilators were in use, how many tests were out there,
were the tests positive or negative, who was being tested. I
mean, the complete soup to nuts infrastructure that we need to
make decisions. You need those data to make decisions and to
allocate resources. And now that--we have built this on the
fly, but we absolutely have to invest in that.
Second, I would say resiliency of the healthcare system.
Yes, we need to attack COVID, but what happens to everything
else? We have seen cancer screenings go down by 80 percent.
Childhood immunizations plummet. Just about every other thing
in the healthcare system was sacrificed for our COVID response.
So, it is not just the pandemic response, but it is everything
else we need to do.
The third thing I would say is we continue to have to focus
on health disparities. If everyone was healthier in the
Country, if we invested into those--to hypertension, diabetes,
obesity, all the things that could bring the general health up,
you would not see as horrible of outcomes as we have in any
pandemic. So, working on health disparities that have been here
for decades is, I think, critical to raise our general health
and prepare us for whatever is going to hit us.
The Chairman. Dr. Hahn, you can have the last word.
Dr. Hahn. Thank you, Mr. Chairman. First of all, thank you
for your leadership and your white paper. I think that is
really important to put this conversation forward.
There are two things I want to emphasize. One is the data
modernization, but from an FDA perspective. It is a very manual
process to, No. 1, collect data on demand, and also, the supply
chain. We need a very robust system to understand that.
We also need a robust, real world evidence approach so that
when we make decisions in real time during an emergency--
doctors do that all the time, agencies do that, particularly
during public health emergencies--we have the appropriate data
infrastructure to collect real world evidence and feedback into
our decisions, and then revise those decisions as needed.
Critically important for the Agency.
The second thing is linked, and that is to my previous
comments that Senator Loeffler asked about. We absolutely need
redundancy in the supply chain. We need redundancy in
manufacturing. And, we need to emphasize the importance of
domestic manufacturing.
Thank you.
The Chairman. Thank you, Dr. Hahn.
Well, the one thing this sneaky, dangerous virus has
reminded us is that there will be another sneaky, dangerous
virus one day. And, we know from experience that it may be
easier to take the steps you have just described while our eye
is on the ball rather than between pandemics because we get
interested in other issues.
I am grateful to the witnesses for your time. I thank the
Senators on both sides of the aisle for really careful,
insightful, and courteous questioning.
The hearing record will remain open for 10 days. Members
may submit additional information within that time if they
would like. Thank you for being here. The Committee will stand
adjourned.
ADDITIONAL MATERIAL
testimony of dr. joycelyn elders
15th U.S. Surgeon General
Co-Chair African American Health Alliance
Good morning Chairman Alexander, Ranking Member Murray and Members
of the Senate Committee on Health, Education, Labor, and Pensions. I am
Dr. Joycelyn Elders the 15th Surgeon General of the United States. I am
also co-chair of the African American Health Alliance a nonprofit
organization working to help eliminate racial and ethnic health
disparities and the social determinants thereof. We thank you for
convening this special hearing on COVID-19 Update on Progress Toward
Safely Getting Back to Work and Back to School as well as the hearing
on COVID-19 lessons learned to Prepare for the Next Pandemic, along
with the many other coronavirus hearings held by this Committee.
COVID-19 continues to take its deadly toll, especially across the
Black community and other vulnerable populations. As the United States
seeks to send workers back to work and children back to school, among
the major missing factors to date remains: safe and effective treatment
and vaccines, and an overall safe, effective and sustained public
health response that includes ongoing robust reliable testing, contact
tracing, care and treatment, and isolating. This is just basic
responsible operating requirements for opening the workplace and
schools.
In a whirlwind of disasters, Americans remain barraged by a
worldwide pandemic of a new virus and medical unpreparedness; shortages
of PPE, hospital space and medical personnel; government
unpreparedness, economic recession and unemployment; huge numbers of
hungry and homeless people; police brutality and systemic racism.
Our Nation's underbelly has been exposed in COVID-19, brutal
policing, racism and income insecurity. People are taking to the
world's streets to demand peace with justice and an end of racism. The
world has awakened to discover that huge numbers of people are
dissatisfied with disparities that are obvious in all areas of
economics, social justice, education, housing, medicine and more. Black
lives do matter.
It is crystal clear that the events of the past few weeks and
months have revealed the awful truth about the impact made by racial,
health and economic disparities in our country. Standing there naked in
view of the world, we are humbled. However, being humble is not enough.
We can see clearly how unfavorably we compare to other countries in the
world, and they can see it, too. The people of the United States have
not fared as well as other developed countries. Our nation's responses
to the coronavirus pandemic including its disease rates are higher and
our ability to mobilize resources, identify the presence of the virus,
isolate and support people while they do, is miserably deficient.
Our Nation's infection rates and death numbers are higher than many
other industrialized countries. While our Nation offers hope of a
vaccine that remains out there on the horizon the immediate need is for
safe, effective, lifesaving treatments that are accessible to all that
need it. This must be coupled with an effective ``Test-Trace-Treat-
Isolate-Repeat'' package. People across the Nation and around the world
are asking how, when, where, why, and what went wrong in United State,
that America has been bent so low? Especially with regard to
coronavirus, it seems ridiculous, since America has the best doctors,
nurses, medical teams, and research laboratories in the world. However,
being the best professionals doesn't cover all our bases in providing
the best health care for all our people. Because, all our people do not
have access to this remarkable world of medicine that we have built.
Mr. Chairman, Ranking Member Murray and Members of the Committee
surely you can understand my deep concerns regarding access to safe,
effective and accessible treatments and vaccines to the Black community
and other vulnerable communities. Even before COVID-19, our Nation's
delivery system, for all its wonderful medical know-how, was and
remains broken. And, doctors scarcely have a word in the way health is
delivered to all our people. While doctors provide medical expertise,
the organizational power is given over to others in the corporate and
political world.
At least for 30 years, we have been ``working'' on eliminating
healthcare disparities. When Healthy People 2000 came out in 1990,
eliminating Disparities in Health Care was an objective. Then, it was
an objective in Healthy People 2010; then it was an objective in
Healthy People 2020. In these 30 years, we have not made much of a dent
in the actual disparities. The Affordable Care Act is helping and it
must be protected and strengthened. Additionally, we must address the
social determinants of health. Clearly, a person is only as healthy as
the least healthy person.
Health care must be extended to everyone for public health to be
good. Without it, the risk to opening America including its schools--is
too risky. It is unsafe without the appropriate tools, resources,
medical and mental health teams, PPE, safe and effective coronavirus
treatments as well as access to safe, effective and affordable
medications for pre-existing health conditions and more. The unintended
negative consequences are real and must not be ignored. Instead, we
must ``test-trace-treat-isolate-repeat''.
The compounding coronavirus pandemic, the economic collapse, police
brutality and systemic racism, individually and collectively take their
toll. Again, while these epidemics are truly humbling, being humble is
not a solution. As a Nation, we are at a dangerous low point in society
and humanity. Know that when there is a vacuum, someone and/or
something will fill it good or bad. We are all in this together:
doctors, scientists, clergy, elected officials, frontline workers, the
public and private sectors, and we the people. Equity is important to
the well-being of every man, woman and child and to our Nation on every
front.
Disparities must not only be addressed; they must be eliminated.
COVID-19, racism, excessive policing and the economic disaster,
continue to show us that we can no longer just re-arrange the deck
chairs on the Titanic. We must conquer coronavirus, put an end to
racism, reform our policing and healthcare system, and build a life
sustaining economy for all. Among these, that includes developing a
healthcare system that provides healthcare to all and eliminates
disparities in health and health care.
Now, our Nation only has a sick-care system for all, with a
healthcare system for some. The United States cannot stop at only
healthcare access and delivery; we must also address all the
disparities in the social determinants of health. They are the backbone
on which to develop the most effective response. America has not wanted
to spend the money investing in health care for all and public health.
Now, America is reaping the negative consequences of her reluctance to
invest in people. The United States will continue paying until our
Nation invests in eliminating racial and ethnic disparities.
The compounding intersecting adverse outcomes come as no surprise.
Either we will invest in people now or pay later. The Committee will
recall the findings of the 2002 Institute of Medicine Report ``Unequal
Treatment'' that urged the Nation to confront racial and ethnic
disparities in health and healthcare. The African American Health
Alliance strongly believes that if the recommendations of that report
had been implemented the burden of coronavirus and other health
disparities would not be so dire. Nevertheless, we are once again at
the urgency of now and must effectively deal with this deadly novel
coronavirus head-on.
While Coronavirus has been declared a National Emergency, the void
is clear racial and ethnic health disparities elimination and racism
elimination have not. Surely, the deadly extent of coronavirus in the
Black community and the impact of the virus across communities of color
demands that racial and ethnic health disparities elimination and
racism elimination must be declared national emergencies, and
effectively addressed as such. To that end, from lessons learned to the
opening of places of work, schools, entertainment and more, the African
American Health Alliance submits recommendations via my testimony to
this distinguished Committee to help our Nation better address the
COVID-19 epidemic.
It is against this collective backdrop that the African American
Health Alliance urges implementation of the recommendations coupled
with the accelerated development of safe, effective, accessible and
affordable to all COVID-19 treatments and vaccines and the required
wrap around services people need to benefit from them.
Recommendations Details and Justification:
The coronavirus pandemic requires a comprehensive response. Black
lives do matter. Declare Racism a National Emergency: Declaration to
provide for inclusion of racism elimination and prevention provisions
in all policies, practices, and programs. This action systematically
takes into account the adverse consequences of racism in policing and
all social determinants impacting the quality of life. For all, the
declaration limits and helps to prevent the harmful effects of racism
across the lifespan. Black lives do matter.
The elimination and prevention of racism is vital to helping to
ensure that all persons achieve their fullest potential, freedom and
justice. Conduct racism impact assessments, elimination efforts
including engaging state and local and community workgroups for the
purpose of informing decisions that promote elimination thereof as well
as those that prevent elimination. Racism's consequences and protests
nationwide and worldwide against racism support this declaration.
[Within, that is AAHA's recommendation for the declaration of
``Racism'' and the ``Elimination of Racial and Ethnic Health
Disparities'' national emergencies.'']
Disease Detection, Manage, Control and Monitor
Coronavirus Testing: Provide Testing, Contact Tracing, Isolate,
Treat, Social Distance, Repeat: Remove barriers and provide accessible,
robust rapid accurate and timely testing with accurate rapid results:
priority testing must be targeted especially for those African
Americans with chronic pre-existing health conditions that place them
at increased risk for coronavirus deaths and disease. Lack of testing
remains a major missed opportunity to help control the spread and
reduce coronavirus cases and deaths, and for making informed decisions
about re-opening. This requires testing of not just those with symptoms
but also those without.
Provide both COVID-19 mobile testing labs along with mobile health
units. This companion effort provides for continuity of care for pre-
existing chronic health conditions. Together, they are absolutely
essential especially in high-risk communities, pre-existing health
condition, hot spot breakout areas, crowded public housing and
frontline jobs/workplaces. Additionally, re-energize the DHHS health in
public housing program. DPA: Robust test production, testing, contact
tracing and isolation are essential to help control this deadly
pandemic and treat and manage pre-existing health conditions.
Coronavirus test to also include the serology test. Negatives must
continue precautions including social distancing and isolation.
Effective contact tracing requires that tracers also include African
Americans and others from communities of color. Coronavirus testing
coupled with contact tracing, monitoring, identification, isolation,
diagnosis and immediate coronavirus care, treatment and management
coupled with ongoing testing and treatment for pre-existing health
conditions is a must solution.
State and local health departments must be supported also to help
do the contact tracing and follow-up that is necessary to be effective.
Directly fund each state and territory to do contact tracing and robust
testing. The CDC's respiratory surveillance system is not adequate to
the task. States must demonstrate a system where data is collected from
all populations indicating the ability to provide rapid diagnostic
services to all residents and ongoing serologic monitoring the state's
population including unserved and underserved areas (MUAs).
Responsible opening, care, treatment and control are them care. Do
not open schools without testing. Without it, the approach is reckless.
National robust testing requires releasing the full powers of the
Defense Procurement Act; that act exists to help save lives; do it now.
Engage/ Command / Control /Preparedness / Emergency Response /
Resilience Expert: We strongly urge you to work with retired General
Russell Honore to develop a comprehensive Coronavirus Resilience
National Strategy with emphasis on public health, the supply chain,
economic security, vulnerable populations, cyber security, broad band
and more including a build-back-better approach. General Honore has
tremendous expertise that is needed to help improve the coronavirus
response.
Extent of Need: Pre-existing Health Conditions
Pre-existing Health Conditions: Provide Healthcare Access for Care
and Treatment: Expand and ensure access to care and treatment: include
Medicaid expansion; allow Medicare enrollment at age 45, allow
``special open ACA enrollment season now'' and permit young adults to
remain on their parents' health care plan to age 30. In addition,
expand existing community health centers and continue to increase the
number of new centers especially in unserved and underserved
communities. There must also be mobile community health satellite
centers with full or near full array of services. Coronavirus and
chronic health conditions together require immediate, short and long-
term care, treatment and follow-up.
Continuity of care is vital. Expansions in access to care and
treatment with wrap around services is necessary to respond to both the
coronavirus medical, mental health conditions and to chronic pre-
existing health conditions that the virus further complicates. Overall,
make sure everyone has some form of affordable health care coverage
with facilitated access to it, and that effective responds to their
needs.
Concern abounds about rationing: care, treatment, medications and
testing, including that for chronic pre-existing health conditions.
Unserved and underserved communities need reliable connectivity
technologies to effectively accommodate and benefit from telemedicine,
tele-health, tele-mental health, tele-dental, and tele-nutrition to
name a few. Stable reliable internet/broad band services are essential
for health, home schooling, higher education, training in the trades
and more.
These deficiencies adversely limit health, education and employment
opportunities. In addition to care, treatment, and dire testing
shortages, medication shortages are also on the rise. Addressing the
overall twin conditions: coronavirus and ongoing health needs of people
in public housing, nursing homes, prisons, assisted living, the
homeless and similarly situated environments is paramount.
Data Collection Analysis and Reporting
Extent of the Coronavirus: Provide Data Collection, Analyses,
Monitoring and Reporting: Racial and ethnic health disparities are well
known to Federal, national, state, local leaders, officials and
community gate-keepers and agencies. Data must be collected and
documented at point of medical system and testing entry. Agencies must
collect, analyze, monitor and publically report coronavirus racial and
ethnic demographic data. Months into the coronavirus pandemic and
national emergency race and ethnic data are insufficient to
appropriately inform the medical, the Nation's and community's response
to the deadly and highly contagious coronavirus.
The Department of Health and Human Services and its agencies must
collect, compile, analyze, release, and report race and ethnic
demographic data including but not limited to that on cases, deaths,
location, zip code, outbreaks, hospitalizations, and testing. Data is
extremely limited and seriously life-threatening-insufficient.
National, state and local coronavirus reporting must be accurate,
timely, complete and transparent. Additionally, data is an essential
factor helping to identify where services and resources must be
targeted and concentrated. Testing, care and treatment data help inform
efforts to improve outcomes.
Workforce
Provide Hazardous Pay, Worker Protections and Whistle Blower
Protections: Provide hazardous pay to coronavirus frontline workers,
double existing pay/salary. Months into this deadly contagious
coronavirus the shortages of staff, personal protective equipment and
gear continue to place workers and their family at increasing risk for
disease and death. The frontline workforce includes nurses and doctors,
non-medical hospital staff; home health and nursing home workers;
grocery store, postal, transportation, medical technicians, meat
packing plant workers; the list goes on and on. Direct OSHA to update
issue and monitor coronavirus worker protection guidelines. Provide
whistle blower protections.
Coronavirus frontline and essential workers across all fields must
be paid hazard pay, double current pay. Every day, they put their life
on the line to serve the public . . . facing the deadly coronavirus
head-on without hazardous pay. Months into this deadly pandemic,
despite dire working conditions, still the full powers of the DPA have
not been released and that deficiency has now spilled over into the
extreme deadly shortage of coronavirus tests. Essential materials,
equipment, test and test material remain in short supply including
medical equipment, cleaning supplies, gowns, gloves, masks and
medications.
Care and Treatment
Establish Coronavirus Community Access Points: Because of the
highly contagious nature of COVID-19, the fact that it may spread
before the individual becomes symptomatic, the severity of its illness,
and the fact that many individuals will be at risk of becoming infected
for years to come, the health system must adopt modifications
immediately to respond to medical, mental health, social determinant
requirements and complications stemming from coronavirus in immediate,
short-and long-term.
Without national testing and within it African American priority is
testing, the coronavirus is more deadly for all. Community Access
Points must be developed to provide unserved and underserved
communities with sites which will be: highly accessible loci for
services and for the provision of information regarding COVID-19; sites
providing immediate testing and informing of virus status; care entry
points for those testing positive; and loci for isolating, counseling
and contact tracing staff in the community. [Test-trace-treat-isolate-
repeat.]
Access points must have separate waiting areas for patients and
address (treat, manage and control) pre-existing chronic health
conditions. These facilities must have: up to date laboratory test and
equipment; access to the most up to date COVID-19 information provided
by DHHS; ability to diagnose and quickly report COVID-19 status; a
waiting room separate from non-COVID-19 patients; and ability to
transport positive patients to an in-patient facility which serves
symptomatic COVID-19 patients. Staffing team minimum requirements: a
physician or nurse practitioner; nurse, technicians, counselor with
social work training; and contact tracing staff. The unit/entity/
facility should be located on the site of an established community
health facility and operated by that facility collaborating with local
or state health departments.
Establish Prison Coronavirus Systems: The Federal Bureau of Prisons
must develop a coronavirus plan for each of its regions. Each plan must
specify mechanisms for: identifying positive staff and inmates;
separation of positive staff and inmates from the general population;
isolation, contact tracing, and also ongoing identification of staff
and inmates missed in the initial screening; and screening of all
incoming staff and new inmates and separation of positives.
Collaborating with state health departments for contact tracing
purposes: each region must designate a COVID-19 coordinator, preferably
a physician. A COVID-19 counselor must be designated within the staff
of each prison's clinical facility. This counselor must have direct
communication with the regional coordinator. Regions must also
designate a clinical facility for patients who must be hospitalized and
specific systems for transportation to the facility and management of
the hospitalized inmates.
State Grants: Make grants to each state to develop systems to
manage COVID-19 within its prisons. Each plan must specify mechanisms
for: identifying positive staff and inmates; separation of positive
staff and inmates from the general population; contact tracing; and
ongoing identification of staff and inmates missed in the initial
screening; and screening of all incoming staff and new inmates and
separation of positives. Collaborating with the state health department
for contact tracing purposes:
States must designate a COVID-19 coordinator, preferably a
physician, for its prison system. A COVID-19 counselor must be
designated within the staff of each prison's clinical facility. This
counselor must have direct communication with the state's coordinator.
States must also designate a clinical facility for patients who must be
hospitalized and specify specific systems for transportation to the
facility and management of the hospitalized inmates. Oversight of these
state systems must be shared by the Federal Bureau of Prisons and the
Department of Health and Human Services. [Test-trace-treat-isolate-
repeat.]
Small Businesses and Community Investment
Provide for Small Businesses: Continuing to struggle, African
American businesses are among the hardest hit. Low cash and weaker
banking connections threaten their existence as they compete for PPP
against much larger businesses. The combination compounding crises
income, pay checks, unemployment insurance, job instability, and others
seriously threaten small businesses and their staff. The disadvantage
conditions collide and escalate in the coronavirus national emergency
requiring automatic triggers and path ways to help save families and
businesses during this national emergency that is no fault of their
own. They did not choose the deadly coronavirus health and financial
crises.
Invest in Community Development: Increase investments in jobs (with
living wages); quality education Pre-K through 12th grade; safe
schools; meaningful employment training; job creation and placement;
entrepreneurial opportunities; creation of avenues for innovation;
grocery stores and transportation; business development, growth and
sustainability; safe affordable housing; convenient access to quality
affordable healthcare; safe communities; and affordable quality
daycare.
These interlinking investments are absolutely essential for viable
productive communities. Establish and make available to communities a
team of Federal Government experts from Department of Justice, to
Department of Education, DHHS to EPA, to Office of Preparedness and
Response, to Department of Labor, SBA, DHS and others to work in
partnership with local agencies, community leaders, business and
others. Provide technical assistance focused on helping communities
identify and establish linkages and partnerships with business and
industry. Fund at such sums as necessary.
Community Empowerment Zones: Provide community partnership grants
to establish community empowerment zone programs in communities that
disproportionately experience over-policing. Funding provided for Black
communities that seek to improve economic, race relations, health,
education, environment and policing to help reduce disparities, and
other highly coronavirus vulnerable communities. Assist community in
accessing Federal programs; to obtain and coordinate the efforts of
governmental and private entities regarding the elimination of racial
and ethnic justice disparities and over-policing crisis.
Communities to be served by the empowerment zone program are those
that disproportionately experience over-policing and economic
opportunity deserts. The community establishes an empowerment zone
coordinating committee: determine priorities, establish measurable
outcomes, obtain technical assistance and utilize but not limited to
community and evidence-based strategies including goals, management,
implementation, monitoring, assessment and evaluation. Submit to the
Congress community empowerment zone reports. Fund at such sums as
necessary.
Training and Education
Conflict Resolution Training: Include conflict resolution in the
education curriculum Pre-K through 12. The techniques learned in
conflict resolution training would be beneficial across the life span.
They would be helpful in encounters with police and all other
relationships. Fund at such sums as necessary.
Expand Academic Opportunity and Achievement: Have school systems,
courts and police work with the community and academic institutions to
implement mentorship programs focused on youth including troubled youth
to provide them with insight and opportunity to better benefit from the
powerful value of education and training beyond high school. Tie
college and training scholarships to these programs, and help to ensure
that free community college becomes a real accessible opportunity. This
investment in the individual's and America's future helps to further
innovation, entrepreneurial development, research, business, industry
and technology advances on all fronts in all fields. Fund at such sums
as necessary.
Provide Summer Enrichment and Afterschool Programs: After school
and summers is the most unsupervised period of time facing latchkey
children and teenagers. Effective programs must be implemented that
provide that supervision ranging from summer jobs, to summer education
and training, to sports and arts, to innovation and business, to
enrichment programs and Junior Achievement. For young children, provide
summer Pre-K. Overall, programs must also provide meals and
transportation for those in need. Fund at such sums as necessary.
Establish National Teaching-Learning-Tutoring Corp: [Establish,
Provide, Conduct, Monitor and Fine-tune as necessary] Provide students
and parents the academic assistance needed to bring students up to
grade level and beyond. This must be a joint goal. The portfolio must
include but is not limited to materials, computers, technologies,
skilled supplemental personnel and other resources needed. Students and
parents must not be penalized for the education and stress crises
created by the Pandemic. Additionally, establish a family support
hotline professionally staffed to address family stress, mental and
behavioral health control and management support.
Compile, train and provide techniques and exercises that parents
and students need to help control and manage stress. Also, identify and
provide parents and students the privacy tools needed to help keep
online schooling and socializing safe. Remain mindful that our Nation's
children and parents sudden thrust into full scale home schooling,
online learning/educating has placed students at increased academic
disadvantage and to successfully close the void they must be provided
the necessary resources. Fund at such sums as necessary. Additionally,
increased online use by the elderly also places them at increased
online fraud. Fund at such sums as necessary.
Enhance Community Participation
State and Local Offices on Community Relations: Establish Offices
on Community Relations to help communities empower themselves: make
available technical expertise, linkages, and resources. Create and make
available community relations improvement resource toolkits that
communities can tailor to fit their needs.
Voting: The African American Health Alliance would be remiss to not
highlight voting. Voting no matter what form or forms it takes must be
protected, voter-friendly and facilitated, and funded at such sums as
necessary. Voter registration and rolls must also be respectively
facilitated and protected. Every vote counts and must be counted. Also,
as a Nation, we can and must improve the response to all aspects of the
coronavirus national emergency. The response deficiencies are life
threatening especially for Blacks. Clearly, everyone must be a part of
the solution to the Nation's emergencies racism, policing, COVID and
the economy.
In closing, Mr. Chairman, Ranking Member and Members of the
Committee our collective purpose must hold us accountable to the
reality that we are all in this together and we must do our part. As
Dr. King's quote continues to remind us: ``We are caught in an
inescapable network of mutuality, tied in a single garment of destiny.
Whatever affects one directly, affects all indirectly.''_Martin Luther
King Jr., Why We Can't Wait The coronavirus pandemic requires a
comprehensive response. The African American Health Alliance thanks you
for this opportunity to provide testimony and recommendations. We
deeply appreciate your ongoing leadership and support. Black lives do
matter.
AAHA Board Members: Co-Chairs: M. Joycelyn Elders, MD, 15th U.S.
Surgeon General and Lucille Perez, MD, President and CEO, The Cave
Institute, Past President, National Medical Association; Members: Clive
Callender, MD, Professor of Surgery, College of Medicine, Howard
University, Howard University Hospital Transplant Center; Founder,
National Minority Organ/Tissue Transplant Education Program; Fredette
West, Director, African American Health Alliance; Rev. Fred Williams,
President and CEO SYF Associates; Allan S. Noonan, MD, MPH, Founding
Dean, School of Community Health and Policy, Morgan State University,
Assistant Surgeon General (RET), U.S. Public Health Service Point of
Contact: Fredette West.
______
[Whereupon, the hearing was adjourned at 1:11 p.m.]
[all]