[Senate Hearing 116-531]
[From the U.S. Government Publishing Office]
S. Hrg. 116-531
COVID-19: AN UPDATE ON
THE FEDERAL RESPONSE
=======================================================================
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 THE FEDERAL RESPONSE
__________
SEPTEMBER 23, 2020
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
45-228 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
----------
STATEMENTS
WEDNESDAY, SEPTEMBER 23, 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............................... 5
Witnesses
Fauci, Anthony, M.D., Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, Bethesda,
MD............................................................. 9
Prepared statement of U.S. Department of Health and Human
Services................................................... 11
Redfield, Robert, M.D., Director, United States Centers for
Disease Control and Prevention, Atlanta, GA.................... 33
Giroir, Brett, M.D., Admiral, Department of Health and Human
Services, Washington, DC....................................... 35
Hahn, Stephen, M.D., Commissioner Of Food and Drugs, United
States Food and Drug Administration, Silver Spring, MD......... 36
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
Baldwin, Hon. Tammy:
Strategies to reduce COVID-19 transmission at the Smithfield
Foods Sioux Falls Pork Plant April 21, 2020................ 75
Strategies to reduce COVID-19 transmission at the Smithfield
Foods Sioux Falls Pork Plant April 22, 2020................ 90
Letter to Hon. Eugene Scalia................................. 105
Letter to Senator Alexander, Senator Murray and Senator
Collins.................................................... 107
Developing Safe and Effective Covid Vaccines--Operation Warp
Speed's Strategy and Approach.............................. 111
Bridging the Gap at Warp Speed--Delivering Options for
Preventing and Treating COVID-19........................... 114
QUESTIONS AND ANSWERS
Response by Anthony Fauci to questions of:
Senator Murray............................................... 117
Senator Sanders.............................................. 118
Senator Collins.............................................. 120
Senator Warren............................................... 120
Senator Kaine................................................ 123
Senator Rosen................................................ 123
Response by Robert Redfield to questions of:
Senator Sanders.............................................. 125
Senator Baldwin.............................................. 128
Senator Warren............................................... 130
Senator Kaine................................................ 139
Senator Smith................................................ 141
Senator Rosen................................................ 141
Response by Admiral Brett Giroir to questions of:
Senator Sanders.............................................. 143
Senator Collins.............................................. 144
Senator Warren............................................... 144
Senator Murkowski............................................ 145
Senator Smith................................................ 146
Senator Rosen................................................ 147
Response by Stephen Hahn to questions of:
Senator Murray............................................... 148
Senator Sanders.............................................. 149
Senator Burr................................................. 151
Senator Warren............................................... 154
Senator Kaine................................................ 161
COVID-19: AN UPDATE ON
THE FEDERAL RESPONSE
----------
Wednesday, September 23, 2020
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10 a.m., in room
G-50, Dirksen Senate Office Building, Hon. Lamar Alexander,
Chairman of the Committee, presiding.
Present: Senators Alexander [presiding], Enzi, Burr, Paul,
Collins, Cassidy, Murkowski, Romney, Braun, Loeffler, Murray,
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, I would like to
welcome everyone and go through some administrative things. We
have taken the advice of the Attending Physician, the Centers
for Disease Control, Health and Human Services so we are all
seated six feet apart. There is no room for the public in this
arrangement, the press is operating by pool, although this can
be watched by streaming or later in an unedited fashion. And
our witnesses are all here in person. We welcome them. Some
Senators are in person. Some are participating by video
conference. I would like to say this about masks.
We have consulted with the Attending Physician. He says,
since we are six feet apart, we can--we do not need to wear
masks when we are here, although you are free to if you want
to. I wear my mask when I am outside of this room, according to
the recommendation of all four of the witnesses who are here
today. I am grateful to the Rules Committee, Sergeant at Arms,
the Press Gallery, the Architect of the Capitol, the Capitol
Police, and Chung Shek and Evan Griffis for all their hard work
to keep us online and safe.
Senator Murray and I will each have an opening statement.
Then we will turn to our witnesses. We would like to ask you to
summarize your remarks in 5 minutes. Then we will recognize
each Senator for 5 minutes of questioning. We have full
participation today so I expect a very good hearing. This will
be the final hearing during my 6 years as Chairman of the
Committee. Last week at our hearing, I thanked Senator Murray
and her staff for their friendship and diligence and
cooperation, without which our Committee would not have
accomplished all the things we have been able to accomplish.
This week, I would like also to thank the most senior
Republican Member, Senator Mike Enzi, and all other 20 Senators
on the Committee, both Democrat and Republican.
Senator Ted Kennedy used to say that our Committee had the
broadest jurisdiction in the Senate. You only have to look
around the room at a hearing and see that we also have the
broadest range of views in the Senate and some of the ablest
advocates of those views. But thanks to our Committee Members
and to Senator Murray, most of our hearings have been
bipartisan, which means we have agreed on a broad range of
witnesses to present points of view. And while the questioning
and the statements of Senators has been probing, there has
always been a high level of courtesy, both to the witnesses and
to the other Senators, which I am grateful for.
I believe this ability to work together during such a
rancorous time is a big contributor to why we have been able to
accomplish so much. The work of this Committee represents my
view that, as far as the U.S. Senate goes, it is hard to get
here, it is hard to stay here, and while you are here, you
might as well try to accomplish something good for the country,
which this Committee has done on numerous occasions. The Trump
administration's program to develop and deploy a vaccine
against COVID-19 is on track to be an unprecedented sprint to
success. The program called Operation Warp Speed will save
lives without cutting corners on safety and efficiency. The
COVID-19 vaccine development process is likely to produce its
first tens of millions of doses within 1 year.
The United States has never produced a vaccine that
rapidly. When I was a child, I saw classmates in iron lungs. We
waited 10 years for a polio vaccine to be--so we would not be
afraid of polio. Many existing vaccines for other diseases that
children take routinely before they go to school, like chicken
pox and measles, have taken 10 years to develop. The secret to
the success of this effort is that the Government, in
partnership with private industry, is for the first time
developing and manufacturing vaccines in parallel. Now, what
that means is that Operation Warp Speed is manufacturing tens
of millions of doses of the six vaccine candidates at the same
time the clinical trials are ongoing and the Food and Drug
Administration works to determine whether those vaccines are
safe and effective. If the FDA does not approve the vaccine, it
will not be distributed. So the risk is taxpayer money, not the
safety and efficacy of the vaccine.
The Administration had set a stretch goal that once seemed
impossible but now seems likely. The Administration hopes to
have as many as 300 million doses of vaccines available to be
deployed by mid-2021, according to an August 26 article by
Operation Warp Speed program's principal adviser, Dr. Monsef
Slowey, and vaccine expert, Dr. Matthew Hepburn, that was
published in the New England Journal of Medicine. The authors
also wrote, ``no scientific enterprise could guarantee success
by January 2021, but the strategic decisions and choices we
have made, the support the Government has provided, the
accomplishments to date make us optimistic that we will succeed
in this unprecedented endeavor.''
Mr. Paul Mango with the Department of Health and Human
Services said recently in a meeting that if all goes well, it
is possible that up to 700 million doses will have been
manufactured by April of next year, 2021. The Department of
Health and Human Services, Department of Defense, private
sector, public health and medical professionals also are
working together to lay the groundwork for deciding who gets
the first doses, such as health care workers and certain high-
risk populations, and how to get those doses to those
individuals. The Centers for Disease Control has asked states
to submit plans by the middle of October of this year, next
month, to begin distribution. Now, there has been a lot of back
and forth over exactly which date the first vaccine doses,
which remember are already being manufactured and made ready
for distribution, when will they be available for distribution
to the public?
The answer, of course, is that the only people who know
when a vaccine will be ready are the scientists at FDA who will
review the science and the clinical trial data and determine
whether the vaccine is safe and it works. Even Dr. Stephen
Hahn, the Commissioner of the FDA who is testifying today, does
not know when that date will be because the FDA will not
approve a vaccine until three things happen. One, independent
experts overseeing clinical trials determine there is enough
data available to the FDA to make a decision. Two, after
demonstrating safety and efficacy based on clinical trials, the
vaccine manufacturer submits an application to the FDA. And
then three, FDA experts conduct their review and make the final
determination the vaccine is safe and that it works.
Now, as to treatments, the second unprecedented story of
the United States response to COVID-19 is the development of
treatments. There are five products authorized for emergency
use today to help treat and manage COVID-19 symptoms, including
Remdesivir, certain steroids, blood thinner, convalescent
plasma. Operation Warp Speed officials are optimistic, they
say, that more treatments will be identified or developed and
in clinical trials this fall with potential for approval or
authorization by the end of the year. The most promising appear
to be monoclonal antibody cocktails, which have been used to
prevent and treat other diseases like Ebola. Three companies
are in clinical trials of antibody cocktails. Knowing there is
some medicine that will help treat COVID-19 should greatly
relieve the anxiety of Americans who want to go back to
college, back to school, back to child care, back to work and
out to eat.
Third, a third success story is the explosion of fast,
cheap, reliable diagnostic tests. After initial missteps, our
country lost several crucial weeks in distributing the
diagnostic tests that would help to identify and isolate those
who contracted the virus. But since then, an unprecedented
effort of public and private research has created capacity this
month for administering more than 90 million tests, about half
of them rapid tests, according to Admiral Giroir, who is here
today. Abbott Laboratories says that it is on track to produce
50 million of those tests--of its tests--50 million of its
tests a month by October, which can produce a result in 15
minutes and cost $5 a test.
The Government has purchased 150 million of Abbott's tests
to help expand testing in places like schools and nursing
homes, and I am sure we will hear something about how that will
be distributed today. Congress funded the so-called Shark Tank,
or Rapid Acceleration of Diagnostics Initiative at NIH with the
objective of developing and deploying tens of millions of new
rapid diagnostic tests. Dr. Francis Collins, Director of NIH,
has reported that combined, these new technologies have the
potential to add at least 60 million new tests a month by
December. Dr. Collins has told me, ``this is not the end of the
story. There are lots of additional technologies coming through
the pipeline, many of which are rapid, inexpensive point of
care and home based tests.''
Until vaccines and treatments are widely distributed, this
explosion of many cheap, reliable, rapid diagnostic tests is
our best weapon to build confidence among the American people
that it is safe to go back to school, back to work and out to
eat. There should be plenty of tests. In fact, there are now to
do surveillance testing of those without symptoms in certain
settings like colleges and child care centers. It is important
to give credit to this Congress and this President for funding
this unprecedented effort to develop and manufacture vaccines
before they are all approved, knowing full well that one or all
of them might fail with a considerable loss of money. Since
March, Congress has appropriated more than $47 billion for
tests, treatments, and vaccines, a large amount that pales in
size, though, to the $3 trillion spent to try to ease the pain
by shutting down the economy. And it is important to give
credit to the previous Presidents and previous Congresses for
the bipartisan work they have done over the last 20 years to
make possible the remarkable successes I just described
earlier.
Dr. Slowey, for example, told me that the Government today
could not be manufacturing four of the vaccines that are
currently being developed if Congress had not provided the
Department of Health and Human Services with funding to make
awards in 2012, 8 years ago, to build three manufacturing
plants that would be on standby for the next epidemic. The
decision to look ahead then to the next pandemic and some on
this Committee, Senator Burr specifically, had a role in that.
Dr. Slowey said that was visionary. On March 1, The New York
Times reported that the United States is among the countries
best prepared to prevent or manage such an epidemic, focused on
COVID. Why would they say that on March the 1st? Well, let's
look at the NIH.
For five consecutive years, this Congress has significantly
increased investment in the National Institutes of Health for
Biomedical Research and NIH's Infectious Clinical Research
Consortium, which was established last year, was able rapidly
to shift ongoing clinical trials and quickly enroll volunteers
for COVID-19 trials and treatments and vaccines--or look at the
FDA. Congress provided FDA with specific authorities beginning
in 2004, 16 years ago, to review and issue emergency use
authorizations for test, treatments, and vaccines to respond to
public health emergencies. Dr. Hahn has used that authority.
FDA has used that authority to authorize 250 tests and 5
treatments as quickly as possible, and also to remove tests and
treatments when additional evidence showed they did not work as
well as they should--or look at BARDA.
Congress established the Biomedical Advanced Research and
Development Authority in 2006, 14 years ago, to help companies
work with FDA to get safe and effective tests, treatments and
vaccines out. BARDA was able to announce awards for potential
COVID-19 treatment and vaccine candidates just over 1 month
after the vaccine was first reported in China. As I said
earlier, four of the first six vaccines are being manufactured
in facilities built in 2012 for this purpose, for a future
pandemic. And then there has been Federal support over the
years for state, local and hospital preparedness, $21 billion
between 2002 and 2017. CDC has used existing programs to help
states retrain workforces, expand lab capacity, planning for
future pandemics from pandemics during the last several years.
And even with supercomputing, these Congresses, the last few,
have increased funding in the Department of Energy so that the
United States is first in the world in supercomputing. They are
in our national laboratories and they are being used to help
develop treatments and vaccines.
I go through all of that to show that several Congresses
and several Presidents have done things to help us get ready
for this unprecedented sprint toward success in vaccines,
treatments and tests. Now, finally, I would like for this
Congress to be visionary as well. And while we are in the midst
of this pandemic, to be ready, help get ready for the next one.
Former Senator Frist, the Majority Leader, testified before
this Committee that the next pandemic is not a question of if,
but when. Jared Diamond, the author of Guns, Germs and Steel,
says the main thing that is different about this and this germ
is the jet plane, that people can travel around the country and
around the world and spread it. And so he concludes that the
next pandemic could be next year. Congress should take stock
now, while our attention is on the current crisis, of what we
have learned during COVID-19 and address some of the problems
we know we can solve just like previous Congresses and previous
Presidents did.
Many of the witness that have appeared before this
Committee have agreed we have three things to do. One, sustain
onshore manufacturing of test, treatments, and vaccines. Two,
create and sustain state stockpiles of supplies so they will be
available in a public health emergency. And strengthen the
strategic national stockpile. We have seen time and time again,
attention spans are short. We must act now to stop the cycle of
panic, neglect, panic.
I look forward to hearing from all of our witnesses today
about how the Federal Government is continuing to respond and
to help states respond, how soon we can expect more treatments
and a vaccine for COVID-19, and what steps we can take now to
prepare for the next pandemic. I will now recognize Senator
Murray for her opening statement.
OPENING STATEMENT OF SENATOR MURRAY
Senator Murray. Well, thank you very much, Mr. Chairman.
And thank you so much to our witnesses for joining us once
again today. Before we begin, I do want to take a personal
moment to acknowledge the passing of Justice Ginsburg, a
friend, a role model, and a woman who opened doors for all of
us with her genius and her relentless pursuit of justice,
freedom, and equality.
This appointment to our Nation's highest court could not be
more pivotal, especially as we face down an historic public
health crisis. We are in the middle of a pandemic that has cost
more than 200,000 American lives on this administration's
watch, has left nearly 7 million people across our country with
new preexisting conditions and 5.4 million people without
coverage, yet none of that has stopped Republicans from using
every tool at their disposal, including the Supreme Court, to
attack healthcare and protections for families across our
country. I am not going to let anyone forget. Many of the same
Republicans who are considering filling this vacancy with a
nominee virtually guaranteed to tip the balance of the court
against people's healthcare in the critical case coming up this
year previously said in March 2016, the American people should
have a voice in the selection of the next justice, and said
many times over the past few years they support protections for
preexisting conditions.
The entire country is going to be hearing about what
another Supreme Court nominee handpicked by President Trump
would mean for their healthcare and their rights. Now to
today's hearing. Back in January, I worked to help organize the
first bipartisan briefings with the Administration officials
about the COVID-19 threat. And I wrote to Secretary Azar
shortly after asking what steps we were taking and specifically
asking about our diagnostic testing capacity. At a hearing in
February, I pressed him directly about issues with those tests
and I asked him point blank if our Country was ready.
Tragically, the clearest answer I got to that question did not
come from the Trump administration. It came back from families
in my home State of Washington, and it came as a resounding no.
By March, I was hearing from people in my state who believed
they had been exposed but could not get tested and who had been
tested but were left waiting for results.
I was hearing from schools in my state, including my
granddaughter's, that they were canceling classes and closing
schools. And I was seeing nothing from the Trump administration
to inspire confidence or to act with urgency. Let's be clear,
we had a window to prepare for this and the Administration
missed it. We had a pandemic playbook that warned against some
of the very problems we were facing. They ignored it. We had a
clear understanding of how dangerous this disease could be and
they downplayed it. So much has changed since those early days
of this crisis. Now, the number of people infected in our
country has passed 6.5 million. The number of people killed
passed 200,000. The number of people without a job and without
health insurance has skyrocketed and businesses have been
shuttered. Gatherings from weddings to birthdays to graduations
to funerals have been delayed or canceled.
But one thing has not changed. President Trump is still
putting politics ahead of public health. He is still
downplaying this crisis and falsely claiming it will just go
away or we are turning the final corner when the reality is
cases and deaths are still alarmingly high. Testing and
contract tracing are frustratingly inadequate. The health
disparities in Black, Latino and Tribal communities and other
communities of color face are still severe. And we need to
prepare for the upcoming flu season when experts warn us we
could see another wave of cases. And yet, President Trump is
still trying to sabotage the work of our scientists and public
health experts for his own political ends.
As the leaders of health agencies on the frontline of our
response to this pandemic, our witnesses have an important
firsthand perspective on this interference. Dr. Hahn, the Food
and Drug Administration has a critical role to play in
evaluating the safety and efficacy of treatments, diagnostics
and vaccines. The American people are counting on you to uphold
sound, scientific principles and the work of agency
specialists, scientists. So it is incredibly alarming that this
administration has undermined public trust in the work of your
agency by spreading conspiracies and pressuring the agency to
ignore the science. Earlier this year, the Administration
dangerously promoted hydroxychloroquine, an unproven treatment
for COVID-19. But even more recently, the Administration
pressured FDA to rush through an emergency use authorization
for convalescent plasma therapy.
Last month, Secretary Azar reportedly overruled you
directly and undermined FDA's authority when he loosened
oversight of lab developed tests, a move that allows unreliable
tests to flood the market. Then last week, Secretary Azar
further undercut your agency by completely barring FDA from
signing any new rules without his approval, an alarming power
grab for a political appointee to make in the middle of a
pandemic. Dr. Redfield, the Centers for Disease Control and
Prevention plays a critical role, providing data and science
based public health guidance that our families, public health
professionals, researchers and health care providers rely on
for life and death decisions. Yet the Trump administration has
repeatedly and recklessly interfered with those efforts. We
have seen the White House block and contradict critical
guidance on reopening poor communities and returning to school.
We have seen the President spread conspiracies about the death
count and misinformation about masks. And the Trump
administration officials have reportedly taken unprecedented
steps to hijack the CDC's trusted voice and undermine its
credibility.
The Administration ignored the objection of CDC scientists
and posted guidance under CDC's name advising restricted access
to testing, a move that was immediately criticized by public
health experts and has since thankfully been reversed.
Political appointees have demanded to oversee and manipulate
the agency's morbidity and mortality weekly reports. And last
week, you confirmed the Administration took hundreds of
millions of dollars out of your budget for a feel good pandemic
ad campaign spearheaded by a Trump official that believed CDC
was part of a, ``deep state conspiracy,'' in which CDC
inexplicably has no role and which they have not even indicated
will be reviewed by your agency to make sure it is based on
facts and science.
If this weren't all bad enough, after your testimony before
Congress last week, the President said you were, ``confused,''
that you made a mistake and given incorrect information. All of
this raises serious concerns about the agency's decision Monday
to put out guidance with new information on how this virus is
transmitted only to immediately reverse course and pull it
down. And Dr. Fauci, you have been a trusted voice on public
health issues in this country for decades. Yet, the Trump
administration officials have tried unsuccessfully to dictate
talking points to you and undermine your credibility through
opposition research. And in an Op-ed, the President himself
even retweeted a message calling for you to be fired.
Any of these examples of political pressure would be
alarming on their own, but together, they paint a clear pattern
of interference that is downright terrifying. The Trump
administration did not just start its political interference
yesterday, and we are not going to expect them to cut it out
tomorrow. So Congress has to make it stop. The President has
made it painfully clear where he stands when it comes to
picking between politics and science, politics and public
health, politics and the safety of our country. Now, each of us
has to do the same. Yesterday, Senator Schumer and I, along
with over 30 of our Democratic colleagues, introduced the
Science and Transparency over Politics Act. It will create a
task force to conduct a thorough investigation into political
interference in our public health agencies.
I do hope every Republican who has spoken out about how
important it is we stick to the science will support that bill,
because you cannot stand for science if you will not stand
against political interference. I am also going to be asking
our witnesses more about this as well because it is so critical
that we know what political pressure they have been under and
what is being done to resist it.
Finally, Mr. Chairman, as this may be our last hearing this
Congress, I want to recognize again the work we have done
together on this Committee in your time as Chairman. The list
of major bipartisan bills we have gotten signed into law over
the past few years, you know them, every Student Succeeds Act,
21st Century Cures Act, Opioid Crisis Response Act, Perkins CTE
Reauthorization and more. The kind of bipartisan approach we
used to get those bills passed is going to be critical if we
are finally going to take the steps we need to take to address
the pain of this pandemic, which is why the current state of
discussions to pass more much needed relief is so frustrating.
Republicans did not offer anything for months, and after they
finally put forward a proposal, they did not even sit down with
us to move toward common ground. Instead, they moved further
away from us with their next proposal.
After all the success we have had on this Committee, I
think we have shown by example that is just not how bipartisan
negotiating works. So I am not done pushing for Republicans to
come back to the table on a new COVID-19 package, put
partisanship aside, put our families first and work together to
respond to this pandemic with the kind of sweeping response
that is so clearly needed. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Murray. We will now
introduce our witnesses. We ask them to summarize their
comments in 5 minutes each. Our first witness is Dr. Anthony
Fauci, Director of the National Institute of Allergy and
Infectious Diseases at the National Institute of Health. He has
held this position since 1984, led the agency's research
related to HIV, AIDS, Influenza, Malaria, Ebola and other
infectious diseases.
Dr. Fauci has advised six Presidents on domestic and global
health issues. He was one of the principal architects of the
President's emergency plan for AIDS Relief.
Next, Dr. Robert Redfield. He is Director of the U.S.
Centers for Disease Control and Prevention. For more than 30
years, he has been involved with clinical research related to
chronic human viral infections and infectious diseases,
especially HIV. He served as the Founding Director of the
Department of Retroviral Research within the U.S. Military's
HIV research program, retired after 20 years of service in U.S.
Army Medical Corps.
Third witness, Admiral Brett Giroir. Admiral Giroir is the
Assistant Secretary for Health in the U.S. Department of Health
and Human Services. He oversees the Commission Corps of the
United States Public Health Service and key public health
programs. Specific to COVID-19, he has taken on testing and
focused on increasing the number of tests that we can do with
existing technology. His Federal service includes directing the
Defense Services Office of the Defense Advanced Research
Projects Agency, and several other important responsibilities.
Finally, we will hear from Dr. Steven Hahn, Commissioner of
the U.S. Food and Drug Administration, the FDA. Before joining
FDA, he held leadership roles as Chief Medical Executive at the
University of Texas M.D. Anderson Cancer Center and is Chair of
the Department of Radiation Oncology at the University of
Pennsylvania. Early in his career, he was a senior investigator
at the National Cancer Institute at NIH. Additionally, he held
the rank of Commander in the U.S. Public Health Service
Commission Corps. Welcome again to our witnesses. Dr. Fauci,
let's 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. Mr. Chairman, Ranking Member Murray, Members of
the Committee, thank you for giving me the opportunity to speak
with you today briefly on the role of the National Institutes
of Health research in addressing COVID-19. As I mentioned to
this Committee in a prior hearing, the NIH and NIAID has a four
part strategic plan for research to address COVID-19. The first
is to improve the fundamental knowledge of the virus itself,
viral biology, and the clinical manifestations resulting from
infection.
We have continued to push the frontier of understanding
this virus, particularly with regard to the confrontational
structure of the spike protein, which serves as the basis for
all of the vaccines that are being pursued now, which I will
get to in a moment. In addition, there have been a number of
important clinical observations that we will be pursuing in the
future. I bring to your attention the fact that a number of
individuals who virologically have recovered from infection in
fact have persistence measured in weeks to months of
symptomatology that does not appear to be due to persistence of
the virus. They are referred to as long haulers. They have
fatigue, myalgia, fever and involvement of the neurological
system, as well as cognitive abnormalities, such as the
inability to concentrate.
In addition, we found to our dismay that a number of
individuals who have completely recovered and apparently are
asymptomatic, when they have sensitive imaging technologies
such as magnetic resonance imaging or MRI, have found to have a
disturbing number of individuals who have inflammation of the
heart. These are the kind of things that tell us we must be
humble and that we do not completely understand the nature of
this illness. Next, with regard to diagnostics, we have the
RADx program that is going to in the next several months, allow
us to have a considerable number of point of care testing.
Moving on to therapeutics, I mentioned to this Committee some
time ago that the NIH put together an expert panel for
treatment guidelines, which is a living document that reviews
the literature, as well as the areas of expertise that are
prepublication to help clinicians throughout the world to
address the clinical components of this outbreak.
I must tell you that as of last night, there have been 4.5
million views of these treatment guidelines so it clearly is
helping people throughout the world. I want to mention two of
the drugs that have actually now--be part of these guidelines.
Remdesivir, which you have heard about, has been shown in a
randomized placebo controlled trial to diminish the time to
recovery in individuals who are hospitalized who have lung
disease. In addition, dexamethasone, a commonly used steroid,
has been shown in a randomized placebo controlled trial
involving more than 6,000 individuals, has been shown to
clearly and significantly reduce the 28 day mortality.
In addition, there are a number of other treatments,
including antiviral convalescent plasma, which is still being
tested in randomized controlled trials. And you mentioned
appropriately and correctly that we feel optimistic about
monoclonal antibodies, which are currently being tested in an
outpatient setting, in an inpatient setting, family
prophylaxis, which means when an individual in a given family
gets infected. If you give monoclonal antibodies to the rest of
the family, can you prevent the spread within the family unit?
And finally, nursing home prophylaxis. As you mentioned, there
are three companies involved in this.
Finally and importantly, the issue of vaccine. We have put
together what is called a strategic approach to COVID vaccine
development. As you mentioned, Mr. Chairman, there are six
companies that the Federal Government is playing a role in
either helping to develop, subsidizing or supporting the
clinical trials. We are harmonizing the trials so that
information from one can be applicable to another. Currently,
there are three platform candidate vaccines that have entered
into phase 3 trial. Very soon there will be a fourth. As I
mentioned to this Committee, we feel cautiously optimistic that
we will be able to have a safe and effective vaccine, although
there is never a guarantee of that. Early studies in animals
and in human, phase 1 and phase 2, indicate that individuals
induce a response that is comparable to, if not better than
natural infection.
As these trials go on, we predict that sometime by the end
of this year, let's say November or December, we will know
whether or not these are safe and effective. And as you
mentioned, Mr. Chairman, right now, doses of this vaccine are
being produced so that they will be ready to be distributed.
I will close with the comment that we feel strongly that if
we have a combination of adherence to the public health
measures together with a vaccine that will be distributed to
people in this country and worldwide, we may be able to turn
around this terrible pandemic that which we have been
experiencing. Thank you, Mr. Chairman. Happy to answer
questions later.
[Prepared statement of U.S. Department of Health and Human
Services:]
prepared statement of u.s. department of health and human services
Introduction
Chairman Alexander, Ranking Member Murray and distinguished Members
of 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 offices 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. Congress
passed 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 Food
and Drug Administration (FDA), and the Assistant Secretary for Health,
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
prevent illness, save lives and protect America from health, safety,
and security threats. CDC has a key role in preparedness and response
in the United States and abroad, and addressing infectious diseases
like COVID-19 is central to our mission.
When there is an emerging pathogen like the SARS-CoV-2 virus, CDC
expertise lies in our ability to study the new pathogen to understand
how it is transmitted, and translate that knowledge into public health
action. Since first learning of the cluster of cases in Wuhan, China,
CDC has rapidly advanced the science around this new human pathogen,
SARS-CoV-2. CDC has been both on the forefront of understanding this
new disease and led the Nation's efforts to protect Americans from
infection. Currently, over 6,700 CDC employees have been engaged in the
agency's COVID-19 response, and over 1,200 of these staff have been
deployed to nearly 200 different locations in the United States and
abroad. CDC staff have conducted rapid investigations of outbreaks that
identified highest-risk priority populations and settings.
Understanding specific population-level vulnerabilities and how
infections spread in various types of settings has been instrumental in
the development of guidance that will help keep the American people
healthy and allow critical infrastructure services to be provided
safely. For example, after data emerged that contrary to expectation,
SARS-CoV-2 could be transmitted by people without symptoms, CDC
recommended that people wear masks around others who do not live in
their households, especially in settings where it is difficult to
maintain a distance of six feet. There is increasing evidence that
masks help prevent people who have COVID-19, including those without
symptoms, from spreading SARS-CoV-2 to others.
The Morbidity and Mortality Weekly Report (MMWR), sometimes called
the ``voice of CDC,'' has published more than 100 COVID-19 reports
since the beginning of the pandemic, providing cutting-edge scientific
articles that have been viewed by tens of millions of readers. These
reports have provided the public, scientists, healthcare workers, and
policymakers critical information about the virus, how it spreads, and
the communities it has impacted. MMWR publications yielded the earliest
descriptions of asymptomatic and pre-symptomatic transmission of the
virus and elucidated the substantial risk of transmission at large
gatherings, choir practices, and congregate living situations,
including nursing homes, prisons and jails, meat processing plants,
homeless shelters, and camps for children. They have described the
disparate impact of COVID-19 in racial and ethnic minorities and
identified the elevated risk of severe outcomes for older adults and
people with underlying conditions. Finally, the MMWR has indicated what
successful control of the virus looks like, through careful mitigation
efforts in everyday high-risk settings such as hair salons and
childcare centers. In short, MMWR's rapid publication of the highest
quality science has laid the foundation of what we know about COVID-19
and illuminated the way forward.
In addition to publishing our own scientific information on SARS-
CoV-2 and COVID-19, CDC scientists are monitoring in real time the
rapidly expanding scientific literature and have reviewed over 100,000
scientific papers thus far. This ensures that CDC responders are armed
with the best information available. This comprehensive understanding
of the emerging science base helps direct CDC's scientific agenda and
informs CDC guidance, and helps guide CDC's direct support of
clinicians and the public. Since January 20, 2020, CDC's hotline for
public inquiries has responded to nearly 500,000 calls and e-mails,
including 32,000 from clinicians.
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 carry out research and share new knowledge related to this
novel pathogen and its consequences. CDC provides guidance for
healthcare professionals, essential workers, businesses, schools, and
the public to encourage safer practices, improve health outcomes, and
save lives. CDC works with partners to develop decision tools to assist
STLT officials and other stakeholders with mitigation strategies.
Importantly, CDC is preparing the Nation's public health system and the
private sector to disseminate a safe and effective vaccine when one is
available. CDC is leveraging investments in global health security and
pandemic influenza preparedness infrastructures in over 60 countries to
mitigate the effects of COVID-19 and stop the disease from spreading.
As of September 20, 2020, there have been 6,748,935 COVID-19 cases
reported and 198,754 deaths attributed to the virus in the United
States. The latest data can be found on CDC's website: https://
www.cdc.gov/covid-data-tracker/index.html. The U.S. Government has
taken unprecedented action to address the public health threat posed by
this new coronavirus. CDC has substantial supplemental funding to help
respond to this pandemic at home and abroad. This funding supports a
federally guided, STLT government managed, and locally implemented
response to COVID-19 in the United States.
With funds provided by the Coronavirus Preparedness and Response
Supplemental Appropriations Act and the CARES Act, CDC is providing
jurisdictions with resources needed to detect, respond, and prevent the
spread of SARS-CoV-2 and to inform community mitigation strategies.
CDC's highest priority is to ensure that STLT public health
programs have the resources they need to address the COVID-19 pandemic.
These jurisdictions are best positioned to understand the unique
situation of each community, including the status of their public
health infrastructure and workforce and its needs for enhancement. CDC
is supporting STLT partners who are working to identify cases; conduct
contact tracing; implement containment measures and mitigate spread of
the virus in the community. CDC is working alongside these health
departments to improve surveillance and reporting and enhance testing
capacity. Together, STLT and CDC teams are responding to COVID-19
outbreaks in high-risk settings and implementing best practices to
control the spread of the virus.
As a public health agency and the Nation's primary resource for
STLT health departments on managing disease outbreaks, CDC provides
guidance and support for the development and implementation of
effective containment and community mitigation strategies. The goal is
for all jurisdictions to have robust public health systems, which
include a contact tracing infrastructure that meets their unique needs.
As of September 2020, CDC has posted over 30 contact tracing 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. To support these activities, CDC has awarded $12.1
billion to these entities in fiscal year 2020, including $10.25 billion
in funds executed on behalf of HHS to be used primarily to support each
jurisdiction's testing goals (as outlined in state testing plans).
Testing Strategy
Beginning in April, the White House, and Federal partners including
CDC, convened calls with all 50 states, Puerto Rico, and the District
of Columbia to identify testing capacities and needs. Through these
calls and other outreach efforts, CDC, under the leadership of the
Office of the Assistant Secretary for Health (OASH), has worked with
individual jurisdictions to identify needs, develop plans, and offer
technical assistance to enhance testing capacity. From June 30 to July
17, following an initial review by CDC and OASH, the Association of
Public Health Laboratories (APHL) reviewed individual state testing
plans with a focus on achieving increased monthly testing targets.
These discussions and plans for action emphasize the need to serve
disproportionately affected populations and include focused efforts for
long-term care facilities, federally qualified health centers, American
Indian/Alaska Native serving health facilities, and urban health
facilities, among others.
CDC is working with STLT health departments to support forward-
looking testing strategies that ensure that populations at higher risk,
such as persons of color, have adequate access to testing. For example,
CDC worked with the Health Resources and Services Administration (HRSA)
and federally Qualified Health Centers (FQHCs) to survey FQHCs and
better understand the populations they are serving. Approximately 60
percent of responding FQHCs are in urban areas, where persons of
Hispanic or Latino ethnicity were the largest proportion of individuals
testing positive for SARS-CoV-2. This information allows STLT health
departments to implement strategies to increase testing in FQHCs and
provide them with the tools and resources to diagnose, treat, and
monitor COVID-19 illness in the populations they serve.
CDC has developed a new multiplex 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, using a single
sample collected from an individual. Testing for all three viruses will
allow public health laboratories to continue surveillance for influenza
while testing for SARS-CoV-2. 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. The FDA
issued an Emergency Use Authorization (EUA) for this combined
laboratory test on July 2, 2020, and CDC released these reagents for
distribution to states' public health laboratories on August 5, 2020.
As of August 17, 2020, 135 multiplex kits were shipped to more than 100
laboratories. Each kit provides approximately 500 tests. Adjusting for
the controls, 135 kits provides approximately 67,000 tests. CDC has
provided these kits to each state's or territory's main public health
laboratory, as well as any regional or local laboratories that are
approved to provide SARS-CoV-2 surge testing support. Importantly,
multiplex assay technical information is publicly available on CDC's
website so that commercial developers can use this information in
developing proprietary tests. CDC also granted assay manufacturers a
right of reference to the data submitted in its EUA request to FDA,
allowing developers to use the data to streamline their efforts when
requesting an EUA. CDC took these steps to catalyze the development and
validation of assays that can detect and differentiate SARS-CoV-2 from
influenza by the commercial sector.
In March 2020, CDC and public health partners began seroprevalence
surveys of community transmission of SARS-CoV-2. Seroprevalence surveys
help identify infections that might be missed due to lack of symptoms
or testing not being performed. Serology studies can also help
determine risk factors associated with SARS-CoV-2 infection, including
transmission in health care settings, and inform guidance and
mitigation strategies. For example, CDC has published the results from
one of the seroprevalence studies that used remnants of samples
collected during routine clinical care. This was done in conjunction
with two commercial companies and results suggested that greater than
10 times more SARS-CoV-2 infections occurred than the number of
reported COVID-19 cases. Another study on healthcare personnel who
routinely cared for COVID-19 patients found that 6 percent had evidence
of previous SARS-CoV-2 infection. This study identified two factors
potentially associated with SARS-CoV-2 infection among health care
personnel: personal protective equipment (PPE) shortages and not
wearing a mask while interacting with patients.
Data Collection, Analysis and Understanding of the Pandemic
CDC, in concert with HHS, continues to focus on data modernization
efforts including expanding core data, informatics, and IT capacity;
advancing interoperable systems and tools; strengthening and expanding
collaboration with and support for partners and; coordinating data and
IT investments and governance.
Accurate data are critical as we continue to assess the burden
placed on the American healthcare system to inform reopening. CDC is
leveraging all available surveillance systems, including influenza and
viral respiratory disease systems, to monitor COVID-19 and protect
disproportionately affected communities. These data collected by CDC
help target critical COVID-19 interventions. In collaboration with STLT
public health partners, CDC is committed to making data available to
the public, while protecting individual privacy.
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.
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. Modernization efforts include support for the
surveillance and data workforce, a key asset of the public health
system. For example, CDC is working closely with our partners to help
STLT health departments implement the Sara Alert system. Sara Alert is
a standards-based, open source tool that automates the process of
public health monitoring and reporting individuals exposed to, or
infected with, COVID-19. To date, nine states and two territories,
along with eight counties and one Tribal Council, have adopted the Sara
Alert system. Almost 350,000 individuals have been monitored since
April 8. During an average week, close to 80,000 individuals roll in
and roll back off of monitoring through Sara Alert.
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 provide weekly estimates for age-specific hospitalization
rates and describe characteristics of persons hospitalized with COVID-
19 illness as well as predictors of those with more severe outcomes.
CDC's existing National Healthcare Safety Network (NHSN) continues to
collect COVID-19 data from nursing homes and other long-term care
facilities. NHSN also continues to collect data from hospitals across
the United States to address healthcare-associated infections and fight
against antibiotic resistance.
The COVID-19 Case Report Form includes variables such as race and
ethnicity to enable identification of populations that may be at higher
risk for severe illness and risk factors. Though states are not
required to report demographic information in the Case Report Form,
they have improved the completeness of their reporting. In particular,
the percentage of reports that include race data has increased from 21
percent in April to 63 percent in mid-September, while the percentage
of reports that include ethnicity data increased from 18 percent to 52
percent during the same time period. While progress has been made, CDC
will continue to work with states, tribes, territories, and other
health system partners to improve completeness of the data.
Health Disparities
COVID-19 has disproportionately impacted many racial and ethnic
groups. CDC continuously looks to enhance our COVID-19 outreach and
mitigation efforts for communities identified as highest risk. For
example, CDC is supporting local activities in Black and African
American, Hispanic/Latino, American Indian and Alaska Native, and Asian
American, Pacific Islander, and Native Hawaiian communities to deliver
COVID-19 prevention messages and community mitigation strategies. CDC
recently released a COVID-19 Health Equity Strategy (www.cdc.gov/
coronavirus/2019-ncov/community/health-equity/cdc-strategy.html) that
provides an evidence-based, comprehensive and coordinated framework for
reducing COVID-19 disparities. The Strategy includes expanded plans for
collecting and reporting timely, complete, representative, and relevant
data on testing, incidence, vaccination, and severe outcomes among
populations at highest risk. Additionally, CDC is working with existing
program grantees, such as Racial and Ethnic Approaches to Community
Health (REACH), and tribal grantees through a number of programs, to
enhance outreach to populations at increased risk of complications from
COVID-19. These broad-based community engagements and strategies are
working with the aim of ensuring equitable access to testing, health
care, and future COVID-19 vaccines.
American Indian and Alaska Native communities are some of the most
affected by COVID-19. As of August 2020, CDC has provided $206.4
million to tribal nations, consortia, and organizations for responding
to COVID-19 across tribal communities. This amount exceeds the minimum
of $165 million directed by Congress through the Coronavirus
Preparedness and Response Supplemental Appropriations Act and the CARES
Act. CDC is using a multifaceted approach, guided by data, to allocate
COVID-19 funding to tribal communities, enabling broad access to COVID-
19 resources through a variety of direct and indirect supports.
Children
We are learning more about how COVID-19 impacts children every day.
Although children are less likely than adults to develop severe illness
when infected with SARS-CoV-2, household studies and outbreak
investigations confirm that children can transmit the virus and often
have the same or higher viral loads in their nasopharynx compared with
adults. Though the mortality rate is low for children aged 18 years and
younger, COVID-19--associated hospitalization rates increased among
this age group during the summer. From March 1, 2020 to July 25, 2020,
one in three hospitalized children was admitted to an intensive care
unit.
CDC is committed to providing schools, teachers, staff, parents,
and caregivers with information and guidance to help keep our children
as safe and healthy as possible as schools reopen. CDC has developed
enhanced guidance based on the most recent science, including
considerations for operating schools during COVID-19, considerations
for Institutions of Higher Education regarding the appropriate use of
testing, and a school decisionmaking tool for parents, guardians, and
caregivers. These resources provide students, school administrators,
and parents the information they need to guide decisionmaking and how
to adapt to local conditions.
Vaccine Planning
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 a safe and effective COVID-19 vaccine
once available. CDC is working closely with the Advisory Committee on
Immunization Practices (ACIP), a group of medical and public health
experts who develop recommendations on the use of vaccines to control
disease in the United States. ACIP members have expertise in areas such
as vaccinology, immunology, internal medicine, family medicine,
virology, public health, infectious diseases, and/or preventive
medicine, and one member is a consumer representative who provides
perspectives on the social and community aspects of vaccination. An
August ACIP meeting focused on post-marketing vaccine safety
surveillance, epidemiology of individuals at increased risk of COVID-
19, and modeling allocation strategies of the initial COVID-19 vaccine
supply. Any recommendations ACIP makes and CDC adopts for who should
get COVID-19 vaccine and in what order will be grounded in guidance
from the country's foremost experts on immunization science.
CDC is using its expertise in public health preparedness and
response, along with its immunization infrastructure, to support
Operation Warp Speed in vaccine promotion, distribution,
administration, and monitoring. On September 10, CDC and its Operation
Warp Speed partners conducted a vaccine implementation tabletop
exercise in Washington, DC. The exercise walked through end to end
stages of vaccine implementation for different scenarios.
CDC is working closely with state, local and tribal health
departments and community organizations to prepare a detailed yet
flexible plan for vaccine distribution that will be informed by a
prioritization framework recommended by ACIP and adopted by the CDC
Director. These efforts include 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. State and local health departments have
conducted pandemic vaccination planning with immunization and
preparedness funding from CDC for over a decade. Updating these
vaccination response plans for implementation of COVID-19 vaccines will
build readiness for timely administration when a vaccine becomes
available. During August 2020, CDC completed in-person and virtual site
visits to assess needs as vaccine planning intensifies. Lessons learned
during these site visits will inform CDC's provision of technical
assistance to all jurisdictions to aid in the development of state-
specific COVID-19 vaccination plans.
In addition, some state and local health departments utilized
supplemental resources to build infrastructure that would address
current COVID-19 response needs and incorporated planning for future
phases. One example is in Chicago, where the health department has
developed the Chi COVID Coach app to communicate directly with
Chicago's residents who may be COVID-19 positive. The forward-thinking
app, built by private sector companies, can be adapted throughout the
course of the pandemic. It now allows users to register to receive a
vaccine once they become available.
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 and beyond.
Circulation of SARS-CoV-2 and influenza virus at the same time could
place a tremendous burden on the health care system. Therefore, getting
a seasonal flu vaccine is especially important. It is important that
Americans have confidence in all vaccines. CDC will leverage its
immunization program to help maintain high coverage in routine
childhood immunizations, to increase coverage for flu vaccinations, and
prepare for a potential COVID-19 vaccine.
CDC works with public health and clinical partners each year to
increase the number of people who get a flu vaccine and eliminate
barriers to vaccination. Ongoing COVID-19 activity may affect where and
how flu vaccines are given. On June 4, CDC awarded $140 million to 64
jurisdictions through CDC's existing immunization cooperative agreement
to launch a scale up for influenza season, given the increased risk of
COVID-19. Funds are supporting staffing and preparedness with a focus
on ensuring flu vaccine coverage for populations most at risk.
Conclusion
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 defeat COVID-19. 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, now and in the future.
National Institute of Allergy and Infectious Diseases
The National Institutes of Health (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 and Monoclonal Antibodies to Prevent SARS-CoV-2
Infection and/or COVID-19
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 recently established the COVID-19 Prevention Network (CoVPN)
by leveraging four existing NIAID-funded clinical trials networks: the
HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network
(HPTN), the Infectious Diseases Clinical Research Consortium (IDCRC),
and the AIDS Clinical Trials Group (ACTG), in partnership with the
Department of Defense (DOD). The CoVPN aims to enroll thousands of
volunteers in large-scale clinical trials testing a variety of
investigational vaccines and monoclonal antibodies intended to protect
people from SARS-CoV-2 infection and/or COVID-19. The CoVPN is a
functional unit of ``Operation Warp Speed'' (OWS), a public-private
partnership led by HHS to invest in and coordinate the development,
manufacture, and distribution of safe and effective COVID-19 vaccines,
therapeutics, and diagnostics. The CoVPN is participating in harmonized
protocols developed in collaboration with the Accelerating COVID-19
Therapeutic Interventions and Vaccines (ACTIV) public-private
partnership, vaccine manufacturers, and Biomedical Advanced Research
and Development Authority (BARDA). The network is participating in
numerous trials at more than 100 clinical trial sites across the United
States and internationally. The CoVPN has developed an extensive
community engagement framework to reach out to the diverse communities
most affected by COVID-19; to understand their interest in, and
concerns about, research participation; and to partner with them to
ensure their input is reflected in study implementation.
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. On July
14, 2020, interim findings from the Phase 1 clinical trial were
published in the New England Journal of Medicine. The investigational
mRNA-1273 vaccine was generally well tolerated and induced robust
neutralizing antibody responses in healthy adults in this interim
analysis of data from the ongoing trial. This trial also enrolled older
adults, and Moderna recently presented encouraging interim safety and
immunogenicity data that suggested the immune responses in older adults
were consistent with those reported in younger adults. On May 29, 2020,
a Phase 2 clinical trial, sponsored by Moderna, was initiated to
further study the safety and immune responses to the experimental mRNA
vaccine. On July 8, 2020, Moderna announced that the Phase 2 trial was
fully enrolled, with one cohort of younger adults and a separate cohort
of older adults. NIAID and BARDA are working with Moderna on a Phase 3
clinical trial with the CoVPN that launched on July 27, 2020. The
vaccine efficacy trial was the first to be initiated under OWS. 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.
On August 31, 2020, NIAID announced the launch of a Phase 3
clinical trial with AstraZeneca of the AZD1222 COVID-19 vaccine
candidate, which uses a chimpanzee adenovirus-vectored vaccine approach
developed by researchers at the University of Oxford in collaboration
with scientists at NIAID's Rocky Mountain Laboratories in Hamilton,
Montana. On September 8, 2020, AstraZeneca paused enrollment in this
and other studies of its candidate vaccine to allow for the review of
safety data following a serious adverse event in a single trial
participant in the United Kingdom. This pause is consistent with
standard practice for such events and is a sign that safeguards for
volunteers are robust. The U.S. trial will resume when the independent
Data and Safety Monitoring Board overseeing the trial and the FDA
determine that it is safe to proceed. This event and subsequent review
exemplify how OWS is working with industry partners to ensure the
safety of COVID-19 vaccine candidates.
NIAID expects to announce the launch of an OWS-supported Phase 3
clinical trial with the CoVPN for the Janssen-developed Ad26-vectored
vaccine candidate shortly. Along with the Pfizer-supported study of its
mRNA vaccine candidate (developed with BioNTech), four candidate COVID-
19 vaccines will have entered Phase 3 clinical trials in the United
States. An OWS-supported Phase 3 study with the CoVPN for the Novavax,
Inc., candidate vaccine, an adjuvanted recombinant protein vaccine, is
expected to begin in October 2020.
The rigorous clinical testing required to establish vaccine safety
and efficacy means that it might take some time for an FDA-licensed
COVID-19 vaccine to be available to the general public, but there is
growing optimism that one or more of these vaccine candidates will
prove safe and effective by late 2020 or early 2021.
In addition to vaccine candidates, the CoVPN is evaluating
monoclonal antibodies directed against SARS-CoV-2 as tools to prevent
transmission and spread. On August 10, 2020, NIAID scientists,
collaborating with Regeneron Pharmaceuticals, initiated a Phase 3
clinical trial to evaluate the investigational monoclonal antibody
combination known as REGN-COV-2. The trial will enroll approximately
2,000 volunteers to determine whether REGN-COV-2 can prevent infection
or disease symptoms in asymptomatic adults who are household contacts
of persons with SARS-CoV-2 infection. In addition, NIAID scientists are
collaborating with Eli Lilly and Company in conducting a Phase 3
clinical trial of the monoclonal antibody LY-CoV555 to prevent SARS-
CoV-2 infection in people at high risk of exposure due to living or
working in skilled nursing or assisted living facilities.
Identifying Therapeutics to Treat COVID-19
Safe and effective therapeutics for COVID-19 are 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 investigational therapeutics for COVID-19,
initially examining the antiviral drug remdesivir for treatment of
severe COVID-19 in hospitalized adults (ACTT-1). An analysis of
preliminary data from 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. The
adaptive design of ACTT has enabled the evaluation over time of
additional promising therapies, such as the anti-inflammatory drug
baricitinib. This drug was added to the second iteration of the study
(ACTT-2); enrollment for ACTT-2 is now complete. On September 14, 2020,
Eli Lilly and Company and Incyte announced the preliminary finding that
ACTT-2 participants receiving baricitinib in combination with
remdesivir showed a modest benefit in recovery time versus those
treated with remdesivir alone. On August 5, 2020, NIAID launched a
clinical trial to evaluate the use of interferon beta-1a, which is used
to treat individuals with multiple sclerosis, in combination with
remdesivir in the third iteration of the study (ACTT-3).
In addition to the prevention studies described above, monoclonal
antibodies also are a promising approach for the treatment of COVID-19.
On August 20, 2020, NIH and OWS convened a scientific summit to explore
the current scientific evidence and future opportunities for monoclonal
antibodies that neutralize SARS-CoV-2 as possible treatments for COVID-
19. On August 4, 2020, as part of the ACTIV partnership and in
collaboration with other NIH Institutes, NIAID launched two OWS-
supported studies, ACTIV-2 and ACTIV-3, to evaluate the use of the
monoclonal antibody LY-CoV555 to treat COVID-19 in outpatient and
hospitalized settings, respectively. The ACTIV-2 and ACTIV-3 clinical
trials utilize master protocols that allow for inclusion of additional
investigational therapeutics as the trials continue. NIAID also is
planning separate clinical trials to assess hyperimmune intravenous
immunoglobulin for treatment of COVID-19 in both outpatients and
hospitalized adults.
The National Heart, Lung, and Blood Institute (NHLBI) has
established the Collaborating Network of Networks for Evaluating COVID-
19 and Therapeutic Strategies (CONNECTS) to better understand the
impact of COVID-19 on the heart, lungs, blood, and blood vessels, and
to identify therapies that will slow or halt disease progression and
speed recovery. CONNECTS will leverage existing NIH-funded clinical
trial networks to conduct adaptive trials, in which researchers can
test a variety of interventions simultaneously, easily share their
data, and quickly identify the most promising treatments. CONNECTS also
will bring together ongoing NIH-funded epidemiological cohort studies
to examine the characteristics of individuals who do and do not develop
SARS-CoV-2 infection and to help shed light on who is at risk for
developing severe illness due to COVID-19. This knowledge will identify
risk factors, inform strategies for primary and secondary prevention,
and suggest biomarkers of infection and adverse outcomes. It also will
inform us about the natural history and long-term consequences of the
disease. Among the first trials to be conducted through CONNECTS, and
as part of the ACTIV initiative, on September 10, 2020, NHLBI launched
two adaptive Phase 3 clinical trials evaluating the safety and
effectiveness of varying types of blood thinners (antithrombotics) to
treat adults diagnosed with COVID-19. Researchers have noted that many
patients who died from COVID-19 had formed blood clots throughout their
bodies, including in their smallest blood vessels. This unusual
clotting (thrombosis) has caused multiple health complications, from
organ damage to heart attack and stroke. Collectively known as ACTIV-4
Antithrombotics, the trials will provide critical insights to help
guide the care of patients with COVID-19, hoping to prevent life-
threatening blood clots that occur in many COVID-19 patients. The
trials will be conducted at more than 100 sites around the world; one
trial focuses on hospitalized COVID-19 patients and the other focuses
on outpatients. A third clinical trial to start later will focus on
recovering patients discharged after hospitalization for moderate to
severe COVID-19.
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, NHLBI, NCATS, the National Cancer Institute (NCI),
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 has established the COVID-19 Treatment Guidelines Panel,
comprised of representatives of NIH and five other Federal agencies
along with representatives of nine professional organizations, academic
experts, and treating physicians including providers from high COVID-19
incidence areas, and community representatives. On April 21, 2020, the
panel issued the initial iteration of the COVID-19 treatment guidelines
for clinicians. The guidelines provide recommendations regarding
specific treatments and address considerations for special populations,
including pregnant women and children. Based on a randomized controlled
trial of the antiviral drug remdesivir compared to placebo, the Panel
updated these treatment guidelines to recommend remdesivir for the
treatment of COVID-19 in hospitalized patients who require supplemental
oxygen with the caveat that due to insufficient data, the panel could
not recommend for or against the use of remdesivir for those patients
who require oxygen delivery through a high-flow device, noninvasive,
ventilation, invasive mechanical ventilation, or ECMO. On June 25,
2020, based on a preliminary analysis of the data from the Randomised
Evaluation of COVID-19 Therapy (RECOVERY) study sponsored by the
University of Oxford, the treatment guidelines were updated again to
recommend the glucocorticoid dexamethasone for the treatment of COVID-
19 in hospitalized patients with severe disease requiring supplemental
oxygen, including those on high flow oxygen or mechanical ventilation.
Recently the treatment guidelines were updated to emphasize that
potentially effective treatments for COVID-19 not be withheld from
pregnant women. The guidelines are updated regularly as new evidence
emerges.
In addition, the Pediatric Trials Network, funded by the Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD), has incorporated testing of 12 drugs in its
ongoing clinical trials that may prove helpful specifically for
treating children with COVID-19 and/or multisystem inflammatory
syndrome in children (MIS-C).
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 drive the
development of new products by fall 2020. This $500 million initiative
supports 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. To date, NIH has awarded more than $370 million in
Phase 2 contracts to 16 organizations for technology validation,
clinical studies, scale-up, and manufacturing. These funds, combined
with additional pending projects in the RADx pipeline, are projected to
produce millions of new tests per day for a total of more than 6.5
million tests per day by the end of the year. 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.
The RADx Underserved Populations (RADx-UP) initiative will augment
the reach and power of technologies developed and enhanced through RADx
by identifying and addressing implementation factors that present
barriers to testing and follow-up in vulnerable populations. On June
12, 2020, NIH announced four new funding opportunities for community-
engaged projects within RADx-UP. The goal of this is to better
understand factors that have led to a disproportionate burden of the
pandemic on underserved and vulnerable populations so that
interventions can be implemented to decrease these disparities. Awards
are expected to be made in late September or early October 2020.
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 establishment of registries of tested
subjects for seroprotection studies.
NIAID, NCI, and NHLBI, along with scientists from CDC, BARDA, FDA
and DOD, convened the COVID-19 Serology Studies workshop to bring
together over 300 scientists and clinicians from the Federal
Government, industry, and academia on May 7, 2020. Participants
discussed the role of serology testing in understanding and responding
to the COVID-19 public health crisis and explored strategies to address
key scientific opportunities and knowledge gaps in this emerging field.
On July 14, 2020, a report of the conclusions and recommendations from
the workshop was published in the journal Immunity. The group
recommended that additional research is needed to determine whether,
and to what extent, a positive antibody test means a person may be
protected from reinfection with SARS-CoV-2. Additional research also is
needed to determine the duration of protection. They also emphasized
that serology tests should not be used as a stand-alone tool to make
decisions about personal safety related to SARS-CoV-2 exposure until
additional information about SARS-CoV-2 immunity is available.
NIAID, NCI, NCATS, and NIBIB also are partnering on a 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. Public interest in participating was
extremely robust and recruitment was significantly expanded by
leveraging the NCATS Clinical and Translational Science Awards (CTSA)
program. Enrollment is now complete. 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 a data base that is collecting data on the prevalence and
spectrum of neurological symptoms observed in patients with SARS-CoV-2
infection. NHLBI and NICHD are leading a trans-NIH effort, with
participation from NIAID, to coordinate research into MIS-C, an
extremely serious inflammatory condition that has been associated with
SARS-CoV-2 infection in children and adolescents. This centralized
effort will permit data to be shared across studies to determine the
spectrum of illness in children and predict the long-term consequences
of infection.
To improve participation of minority communities in research on
vaccines and therapeutics for COVID-19, NIH established the Community
Engagement Alliance Against COVID-19 Disparities (CEAL) initiative led
by NHLBI and the National Institute on Minority Health and Health
Disparities. The initiative is bringing together community leaders to
act as ``champions'' to share information with their communities about
COVID-19 research, how to participate, and the importance of having
diverse participants who represent all people in need of vaccines and
treatments. NIH intramural and NIH-funded extramural researchers are
helping to provide authoritative, expert information that champions can
tailor to their communities. Together, these champions and researchers
are leading CEAL research teams in African American, Hispanic or
Latino, and Native American communities that are hardest hit by COVID-
19 to provide timely, accurate information about COVID-19 prevention
and treatment, and to ensure that COVID-19 clinical studies include
appropriate representation of the racial and ethnic minority
populations that have been disproportionately affected by the pandemic.
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 (Added 9/11)
Diagnostics and Testing
Testing is an essential component of the public health response to
SARS-CoV-2 (the virus that causes COVID-19). It enables clinical
decisionmaking, informs resource allocation and disease prevalence
monitoring, and is necessary to minimize community and economic
disruption through targeted infection prevention and control measures.
The indications for viral testing depend on the stage of the pandemic
and the extent of community spread. In general, testing is indicated
for diagnosis of those who are symptomatic or asymptomatic, tracing of
those in contact with those who are infected, screening of specific
employees (for example nursing home staff), and surveillance testing of
those who are asymptomatic to achieve infection control and/or other
public health objectives.
Repeated testing of a majority of the U.S. population is not
feasible at this time, nor necessary to ensure a safe return to work,
school, and other activities. Rather, a targeted testing strategy that
rapidly diagnoses those who are ill, protects the vulnerable, and
identifies emerging outbreak areas--when combined with public health
mitigation measures like mask wearing--is proven to reduce the spread
and flatten the curve.
To date, the United States has realized over 95 million tests, at
an average current rate of between 700,000-800,000 tests per day, with
enough tests in the market to perform three to four times that amount.
Since early March, we have increased our daily testing by over 30,000
percent. In June, July, and August, states far surpassed their goals
for testing. Specifically, state goals for June were 12.9 million
tests, and nearly 16 million were actually performed. The goals for
July were 13.7 million tests; again, states far exceeded their goals by
conducting over 25 million tests. In August the Nation completed over
25.2 million tests, far exceeding the August goal of 21.1 million
tests. Over the next several months, the Nation's testing capacity will
continue to increase. We anticipate that supplies and reagents will be
sufficient to conduct approximately 90 million tests in September. If
pooling of specimens from different individuals occurs today even for a
fraction of these tests, there is capacity to perform more than 100
million tests per month. Pooling allows for more people to be tested at
once in a ``batch'', using fewer testing resources. Turnaround time in
providing test results continues to improve. Currently, 97 percent of
American Clinical Laboratory Association tests ordered in the previous
week received results within 3 days, and 99 percent received results
within 5 days.
The role of the Federal Government is to set the overall testing
strategy and requirements, provide technical guidance, secure the
supply chain, scale scarce resources, enable innovation, and support
state plans to achieve the overall national objectives as well as any
specific state objectives. States, territories, and tribes are
responsible for formulating and implementing testing plans that meet
national objectives and additional goals for their state. The academic,
commercial, and private sectors will continue to develop and produce
technologies, supplies, and services to meet the needs of the states
and the Nation at large.
The national strategy for testing was formally outlined in the
Testing Blueprint: Opening Up America Again, and the Addendum to the
Testing Blueprint. The immediate objectives of the strategy are to:
Identify newly emergent outbreaks
Support public health isolation and contract tracing
Diagnose COVID-19 rapidly in hospitalized patients
Protect the vulnerable
Support safe reopening of schools and businesses
Enable state testing plans
The national strategy for testing was further enumerated in the
COVID-19 Strategic Testing Plan Report to Congress initially submitted
to Congress on May 24th. On August 22nd, HHS submitted the first update
to the Strategic Testing Plan. The report 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.
Identifying Newly Emergent Outbreaks
In addition to public health surveillance systems monitored by the
CDC, the Nation is currently maintaining sufficient baseline testing
for SARS-CoV-2 in order to detect early changes in percent positivity.
At present, a minimum target of testing 2 percent of a state's
population per month has been sufficient to detect early changes in
percent positivity, and thus enable state and local officials--with the
technical assistance of the Federal team--to implement mitigation steps
rapidly to curb the emerging outbreak.
In order to ensure that states meet this 2 percent threshold to
detect any threat of emergence in that state, the Federal Government
will continue to:
Assist states with the procurement of collection
supplies to achieve a minimum of 2 percent population testing
per month; and if possible, provide more supplies if needed to
meet the approved state plan targets. To date, the Federal
Government has procured and delivered 95 million swabs and 77
million tubes of media;
Ensure sufficient supply of reagents to achieve
testing goals in the context of point of care utilization and
use of commercial referral labs;
Prioritize states with outbreaks or potential
outbreaks, if needed, and;
Continue to expand the availability and use of point
of care tests.
Support Public Health Isolation and Contact Tracing
A key function of testing is to support identification of SARS-CoV-
2 of infected individuals, many of whom may be asymptomatic, in
communities identified with outbreaks or emerging outbreaks. In
response to ``hotspot areas'', the Federal Government has set up surge
testing to increase baseline testing 2X-5X for short periods of time.
Surge testing sites have been implemented in Miami, FL; Jacksonville,
FL; Edinburg, TX; Yuma County, AZ; Pima County, AZ; Coconino, AZ;
Phoenix, AZ; Atlanta, GA; Birmingham, AL; Cochise County, AZ; Mohave
County, AZ; Yavapai County, AZ; Baton Rouge, LA; New Orleans, LA;
Bakersfield, CA; Houston, TX; Harris County, TX; Clark County, NV; and
Honolulu, HI, and these 19 sites have conducted approximately 290,000
tests. Surge testing is a supportive adjunctive activity; it cannot
substitute for disciplined adherence to mitigation measures including
masking, hygiene, social distancing, avoidance of indoor crowded areas
and crowds, and protection of the vulnerable. These mitigation
techniques, when combined with selective surge testing, have proven
highly effective in reversing recent community outbreaks.
In order to support public health isolation and contact tracing,
and to reduce turnaround time, the Federal Government has:
Provided massive surge testing to localities
prioritized by the White House Coronavirus Taskforce, and
agreed to by state and local officials;
Augmented testing, both baseline and surge, for FQHCs
and retail sites;
Supported local testing efforts with surges of
collection supplies and reagents;
Worked collaboratively to validate and promote EUAs
for pooling across all laboratory platforms;
Worked collaboratively to validate and promote EUAs
for new extraction methods to increase productivity;
Invested in new testing technologies that improve
sensitivity, specificity, and/or turnaround time, including new
point-of-care tests, and;
Provided point-of-care testing to all nursing homes
in America.
Diagnose COVID-19 Rapidly in Hospitalized Patients
Because there are now treatments authorized by the FDA for
hospitalized patients with COVID-19, including remdesivir, convalescent
plasma, and steroids, it is critical to diagnose patients as soon as
possible. Currently, large commercial labs are prioritizing inpatient
samples to ensure diagnosis within 24-36 hours. Our best information
also suggests that the great majority of individual hospitals are able
to meet this timeframe for patients within their hospital systems.
Protect the Vulnerable
The elderly, particularly those in nursing homes, are much more
likely to suffer serious consequences, including death, from COVID-19.
In addition to the elderly, racial and ethnic minorities are also
disproportionately affected.
To ensure that specimens are collected without overburdening the
traditional health care system, and to ensure testing in the most
vulnerable communities, in mid-March, the Federal Government
established Community-Based Testing Sites (CBTS) in White House Task
Force on Coronavirus-prioritized locations across the country based on
CDC data. The CBTS model was developed for states, local public health
agencies, healthcare systems, and commercial partners as they work
together to stop the spread of COVID-19 in their communities, focusing
initially on healthcare facility workers and first responders. The CBTS
federally supported, state managed, locally executed model has been a
profound success, testing approximately 400,000 individuals. For the
initial 41 sites, CBTS 1.0, the Federal Government provided a Federal
physician who ordered all of the COVID-19 tests, the Federal contracts
for shipping the specimens, laboratory processing, patient
notification, and logistics (to include supplies, personal protective
equipment, and language translation services). The Federal Government
also utilized U.S. Public Health Service personnel to provide data
management, safety, and quality control checks at each site.
Building on the initial success of the CBTS model, the Federal
Government next leveraged public-private partnerships with pharmacy and
retail companies (CVS, Health Mart, Kroger, Rite Aid, Walgreens, and
Walmart), also known as CBTS 2.0, to accelerate testing for more
Americans in more communities across the country. The public-private
partnership model operates on the federally supported, state managed
model.
As the transition of CBTS federally run sites to state-run sites
has been completed, the Federal Government has broadened its community
testing support to a more sustainable model--specifically by continued
support of retail and pharmacy partnerships in more than 800 locations
in all 50 states and the District of Columbia, which collectively have
conducted over 2 million tests to date. The Federal Government focused
on communities with high social vulnerability using the CDC's Social
Vulnerability Index (SVI) as one of the main factors to select site
locations. Approximately 65 percent are located in communities with
moderate to high social vulnerability. The SVI measures the resilience
of communities when confronted by external stressors along four main
themes: socioeconomic status, household composition and disability,
minority status, and housing type.
This pharmacy and retail partnership provides convenient access to
COVID-19 testing, but it is also a bridge for retailers to implement
new regulatory flexibilities and expanded reimbursement options HHS has
provided through private insurance, Medicare, and Medicaid. This
partnership also leverages the newly expanded authority given to
pharmacists to order and administer COVID-19 testing; this effort is
also known as CBTS 3.0. Now, CVS and Walmart have over 1,900 sites
utilizing these new regulatory and reimbursement options with over 2
million tests performed.
HRSA supported health centers are community-based and patient-
directed organizations that deliver affordable, accessible, quality,
and cost-effective primary health care to medically underserved
communities and vulnerable populations across the United States.
Nationwide, nearly 1,400 HRSA-funded health center grantees operate
approximately 13,000 sites, providing primary and preventive care to
more than 28 million patients each year. Over 91 percent of health
center patients are individuals or families living at or below 200
percent of the Federal Poverty Guidelines and nearly 63 percent are
racial and/or ethnic minorities. Health centers are uniquely situated
in communities to serve those that are most vulnerable and 97 percent
of these centers offer COVID-19 testing. As of September 4, 2020,
health centers have administered 3,690,098 COVID-19 tests (including
215,231 antibody detection tests), with over 49 percent of tests
provided to racial and/or ethnic minority patients. Of these tests,
444,186 returned positive, and among racial and/or ethnic minorities,
59 percent tested positive.
To prevent further spread and deaths in nursing homes, CDC and the
Centers for Medicare & Medicaid Services (CMS) recommended that nursing
homes perform baseline testing of all residents and staff, followed by
routine testing of residents and/or staff to reduce outbreaks,
morbidity, and mortality, based on additional factors. CMS requires a
regimen of staff and resident testing based on the degree of community
spread.
To protect the vulnerable and to assist states in meeting these
recommendations and requirements, on July 14, 2020, the Trump
administration announced that HHS would embark on a one-time
procurement of rapid point-of-care testing instruments and tests to be
distributed to nursing homes using the Defense Production Act. Through
this aggressive action, nursing homes will be able to augment their
current capacity for coronavirus testing, bolstering their response and
helping to prevent the spread of SARS-CoV-2. This will facilitate
baseline testing among nursing home residents and staff, and enable a
pathway to conduct ongoing testing according to public health
guidelines.
I am pleased to announce that all 13,850 initially eligible nursing
homes have received one or more point-of-care (POC) instruments, and
nearly 5 million tests. Following this initial distribution, we will
facilitate nursing homes being able to reorder supplies via their
normal commercial distribution channels. Additional billions of dollars
in funding have been provided by HHS to support this effort.
Vulnerable populations in many underserved communities are
suffering disproportionate health impacts resulting from COVID-19,
including numbers of infections, hospitalizations, and deaths. As part
of the HHS response to this crisis, on June 23, 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.
Morehouse School of Medicine has entered into a 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.
Support Safe Reopening of Schools and Businesses
While we must be prudent to protect those most vulnerable, we must
also be mindful of the prolonged effects that school and business
closures have on millions of children and parents. The efforts of the
Federal Government to galvanize the testing infrastructure in the
United States, and the efforts to reduce turnaround times, have
provided communities with the resources they need to safely reopen
schools and businesses.
Enable State Plans
To enable states to achieve the testing goals developed in
coordination with the Federal Government, the Federal Government has
worked with manufacturers to gain insight into diagnostic instrument
install bases; procured and shipped collection supplies; and determined
reagent inventory. The Federal Government then provided this
information to states so they could better determine how to optimize
their testing strategy. The Federal Government also purchased and
allocated POC devices and over 2.3 million tests; developed,
implemented, and facilitated community-based testing sites across the
country; and provided significant guidance and technical assistance for
state plans. The increase in the numbers of tests performed since early
March is a direct reflection of these efforts.
States and territories have now submitted two iterations of their
testing plans. These plans were developed in collaboration with Federal
multidisciplinary experts through teleconferences and other meetings.
Plans were reviewed by a multidisciplinary Federal team that included
leadership from CDC, the Immediate Office of the Secretary, and the
Office of the Assistant Secretary for Health.
The first iteration of the jurisdictional testing plans for May and
June were released to the public on July 10, 2020, and are available
for viewing on the following website: https;//www.hhs.gov/coronavirus/
testing-plans/index.html. The Federal team provided feedback to each
state, and each state incorporated this feedback into detailed plans
covering July through December. The state plans for July-December have
been reviewed and scored and were released to the public on August 10,
and are available for viewing on the following website: https://
www.hhs.gov/coronavirus/testing-plans/index.html.
To ensure states meet their testing goals, the Federal Government
procured FDA-authorized swabs and transport media, and is distributing
these supplies to a single location in each state determined by the
Governors' offices. Starting in May and through September 11, the
Federal Government has distributed over 95 million swabs and more than
77 million tubes of transport media.
Moving forward, jurisdictions should use the $10.25 billion
provided to states, territories, and localities by the Federal
Government to support the purchase of tests and related supplies,
personnel for contact tracing, and reporting infrastructure, etc., for
their jurisdictions, as needed to fulfill their approved testing plans.
Other Initiatives
In order to capture feedback and foster communication between
Federal officials and the private sector, HHS created the National
Testing Implementation Forum (Forum). The Forum brings together
representatives from key stakeholder groups to share information and
provide input to Federal leaders about SARS-CoV-2 testing. Members of
the Forum provide their perspectives on how HHS can best identify and
address end-to-end testing supply chain issues across commercial,
public health, academic, and other sectors and define optimal testing
in various settings (diagnostic, screening, surveillance, others).
Members also provide input to improve technical assistance across the
Nation to prioritize testing among the vulnerable and underserved and
create a sustainable diagnostics ecosystem that is sustainable and
fully capable for future public health challenges. The first Forum
meeting was held on July 30th and the principal topic of discussion was
the testing supply chain. On August 13th the second meeting was held
and surveillance and reopening strategies were discussed. The third
forum, with the topic of engaging minority and underserved communities,
was held on September 3rd.
On August 27th, the Administration announced that a $760 million
contract was awarded to Abbott for the delivery of 150 million rapid
BinaxNOW COVID-19 Ag Card point-of-care tests. This initiative will
expand strategic testing in the United States. The Abbott BinaxNOW
COVID-19 Ag Card, which recently received an EUA from the FDA, does not
require instrumentation and will deliver COVID-19 test results in 15
minutes or less. This test uses nasal swabs and can be easily deployed
in many settings across the country.
United States Public Health Service Commissioned Corps
Since the early stages of the COVID-19 pandemic, 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 53
officers on January 24, 2020 to 4,170 officers deployed as of September
8th, with many officers being deployed numerous times. 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, Michigan. 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 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, help ensure the safety, efficacy, and quality of
FDA-regulated medical products, and provide the industries we regulate
with 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 public 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
This pandemic has created a demand for new tests that is
unprecedented in both volume and urgency. FDA's important role in
testing includes determining whether the tests developed for use in the
U.S. provide sufficiently accurate and reliable results and helping to
provide timely access to such tests.
Even prior to any diagnosed U.S. cases of COVID-19, FDA proactively
reached out to developers to encourage and facilitate the development
of tests and to offer assistance from the Agency. FDA has been
proactive and supportive of test development by all interested parties
to speed development and quickly authorize tests that the science
supports. The Agency has worked with over 500 developers since January
and has been working around the clock to issue over 240 Emergency Use
Authorizations (EUAs) for tests. The sheer volume and variety of
available tests is a testament to FDA's support of innovative test
design and our commitment to public health. From molecular diagnostic
tests, to rapid antigen tests, to antibody tests, to tests run in
clinical labs, to tests run in emergency rooms, pharmacies and nursing
homes (point-of-care, or POC, tests), to samples self-collected at
home, FDA has authorized a multitude of options. We have also been
working with developers on tests that can be administered and delivered
entirely outside of a lab or health care setting, such as in a
patient's home.
In a public health emergency, obtaining an accurate test result is
important not only for the individual patient, but for the public at
large. Similarly, timely access to diagnostic tests is critically
important. To best address these dual, and sometimes competing, needs,
FDA has used its EUA authorities. EUAs permit the emergency use of a
product, in this case a test, when FDA determines that certain criteria
are met based on the totality of the scientific evidence available. The
EUA process made it possible for molecular diagnostic tests to be
developed, validated, and offered for clinical use within weeks rather
than months or longer.
To balance the urgent need to increase diagnostic testing capacity
in the United States with the need to provide adequate oversight to
help ensure that patients can depend on the results of these tests, FDA
announced several policies to facilitate oversight. FDA has engaged in
rolling reviews of EUA submissions, authorized tests that had the
necessary data to support that the criteria for issuance are met, and
issued a policy for states that have the capacity and expertise to
authorize tests for use within a laboratory in that state.
From the beginning of the pandemic, FDA also developed several EUA
templates, which have helped to streamline the EUA submission process
as well as provide helpful information to developers that can speed
validation and authorization of new tests. FDA's EUA templates are
intended to help developers provide appropriate validation data and
other information to FDA, but alternative approaches can be used, and
FDA would consider issuing EUAs for tests if the data show that the
known and potential benefits outweigh the known and potential risks of
the tests, among other considerations. FDA developed EUA templates for
molecular diagnostic, serology, and antigen tests as well as for tests
with at-home specimen collection. On July 29, 2020, FDA published a new
template for at-home and over-the-counter diagnostic tests for use in
non-lab settings, such as homes, offices, or schools, and that could be
available without a prescription. This template helps continue to
facilitate innovation in test development, and is intended to provide
recommendations to help foster development of tests that are simple
enough to use at home and could provide results within minutes.
However, our recommendations are just that--recommendations. FDA is
always open to alternative proposals from developers and will continue
to consider those. More significant tradeoffs in test accuracy may be
appropriate where the need for availability and fast results is not
being met. Yet, even in those circumstances, steps can be taken to
protect consumers, including strategies to increase accuracy. For
example, strategies for serial testing with less sensitive diagnostic
tests, such as 70 percent sensitivity, could be considered cumulatively
rather than based on one-time testing. Any proposal for serial testing
should generally include estimated manufacturing capabilities to ensure
a sufficient supply of tests with which to conduct multiple tests per
person. As with all EUA requests, the FDA will evaluate the totality of
the evidence to determine whether the known and potential benefits
outweigh the known and potential risks, among other considerations.
FDA provided regulatory flexibility to developers of tests due to
the unprecedented nature of this public health emergency and the need
to ensure timely patient access to COVID-19 tests. However, flexibility
never meant we would allow fraud. Unfortunately, FDA continues to see
unscrupulous actors marketing fraudulent test kits and using the
pandemic as an opportunity to take advantage of Americans. Some test
developers have falsely claimed their tests are FDA-approved or
authorized. Others have falsely claimed that their serology tests can
diagnose COVID-19 or that they are authorized for at-home testing. FDA
also became aware that a concerning number of commercial serology tests
were performing poorly based on an independent evaluation by the NCI.
When we become aware of these issues, we have and will continue to
take appropriate action against firms unlawfully marketing and selling
their tests. FDA has and continues to issue Warning Letters and
continues examining shipments of tests at ports of entry, the borders,
and international mail centers, detaining and refusing fraudulent test
kits.
To date, FDA has refused admission to more than 470 shipments of
tests at the border, representing more than 460,000 tests overall,
helping to prevent fraudulent tests from entering the country in the
first place. FDA's actions have resulted in sellers of unapproved and
unauthorized products removing false or misleading COVID-19 claims. FDA
also has sent abuse complaints to online marketplaces and domain
registrars for websites or listings that were offering to distribute
fraudulent COVID-19 test kits for at-home testing. FDA has and will
continue to take appropriate action against firms and individuals that
place the public health at risk.
To further support efforts to ensure that patients and health care
providers can depend on the results of COVID-19 tests, FDA has
announced our participation in the COVID-19 Diagnostics Evidence
Accelerator, a multi-stakeholder collaborative project to advance the
development of diagnostics through the generation of real-world
evidence. Organized by the Reagan-Udall Foundation for FDA in
collaboration with Friends of Cancer Research, this initiative is
designed to allow the community to analyze both diagnostic and clinical
data in real time, which has the potential to contribute to the
scientific evaluation of diagnostic tools and medical interventions for
COVID-19.
Evidence generated by the Accelerator project is intended to be
complementary to other studies that have been conducted or are underway
as well as to provide actionable information about the prevalence of
SARS-CoV-2 in specific populations and highlight individual risk
factors for patients. This helps improve our understanding of the
disease, allows us to tailor public health interventions and strategies
to mitigate risks for individuals and communities, and will help to
stop the spread of SARS-CoV-2.
In addition, FDA also continues to work with NIH, the CDC, and
BARDA regarding the NCI's independent evaluation of certain commercial
antibody tests for the U.S. Government, including antibody tests that
are not the subject of an EUA or pre-EUA, as well as those that are
under FDA review. Where appropriate, FDA is using NCI data to inform
future decisionmaking, such as whether to authorize the test, engage
the test developer for additional information to support its continued
use, or take other action regarding tests that do not perform
adequately, including removing them from our notification list and
working with developers to stop distribution in the United States.
We are continuing to provide updated information and educational
materials to states and health care partners. When commercial
manufacturers that are currently marketing serology tests as outlined
in FDA policy fail to submit an EUA within 10 business days of
notification, we have been removing those tests from our website
notification list and are sharing this information publicly.
In parallel with FDA's engagement with developers and monitoring
the marketplace, FDA has: researched and mitigated shortages of test
components, including identifying and sharing alternatives for
components on FDA's website; arranged with DOD weekly airlifts of swabs
to the United States; engaged nontraditional device manufacturers to
support the manufacture of new swabs and other supplies that are needed
in the United States; maintained public FAQs that are updated
regularly; served as a clearinghouse for scientific information that
the community may leverage to increase testing capacity; and operated a
hotline (FDA continues to provide other means for industry to contact
the FDA directly).
The availability of accurate tests has been a priority issue for
public health authorities throughout the COVID-19 pandemic. However, it
is important to note that the specific need for tests and the evidence
available for different tests have evolved over time. At all stages of
the pandemic, FDA has sought to provide regulatory clarity to
innovators and adapt policies based on the latest available data. FDA
will continue supporting any testing proposal where, among other
criteria, the test benefits outweigh the risks based on sound science,
and we continue to work with test developers and encourage those with
novel testing ideas to reach out--by email, phone, or during our weekly
test developer town hall meetings.
FDA will continue to appropriately balance assurances that tests
are accurate and reliable with timely access to such tests as
continually evolving circumstances and public health needs warrant. FDA
continues to work closely with White House 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 Development
At this time, there is no FDA-approved vaccine to prevent SARS-CoV-
2 infection and/or COVID-19, and FDA is providing regulatory
flexibility to help ensure the most efficient and timely development of
safe and effective vaccines to prevent COVID-19. In this crisis, in
which there is so much at stake, we are facilitating expedited vaccine
development without sacrificing our standards for quality, safety, and
effectiveness.
FDA is working closely with Federal partners, vaccine developers,
researchers, and manufacturers to help expedite the development and
availability of safe and effective vaccines to prevent infection with
SARS-CoV-2 infections. Knowledge sharing is considered a key part of
the scientific process and it could efficiently advance these efforts.
We are utilizing all appropriate regulatory authorities and are
providing rapid scientific and technical advice to sponsors and
researchers to help expedite the development and availability of safe
and effective COVID-19 vaccines.
On June 30, FDA took additional action to facilitate the
development of safe and effective vaccines to prevent COVID-19 by
providing guidance that includes recommendations for those developing
COVID-19 vaccines for the ultimate purpose of licensure. The guidance,
entitled Development and Licensure of Vaccines to Prevent COVID-19,
reflects the advice and assistance FDA has been providing to companies,
researchers and others, and describes the Agency's current
recommendations regarding the data needed to facilitate the
manufacturing, nonclinical and clinical development, and approval of
COVID-19 vaccines.
The guidance provides an overview of key considerations to help
manufacturers satisfy requirements for chemistry, manufacturing and
controls, and nonclinical and clinical data needed for development and
licensure to assess the safety and effectiveness of vaccines, and for
post-licensure safety evaluation of COVID-19 vaccines. The guidance
explains that, given our current understanding of SARS-CoV-2
immunology, the goal of development programs at this time should be to
support traditional FDA approval by conducting studies to directly
evaluate the ability of the vaccine to protect humans from SARS-CoV-2
infection and/or disease.
In its interactions with vaccine developers, FDA provides sponsors
with advice regarding the data needed to support the manufacturing,
clinical development, and approval of vaccines, including such advice
to those sponsors pursuing development of vaccines to prevent COVID-19.
The size of clinical trials to evaluate the efficacy of COVID-19
vaccines will depend on a number of factors including the criteria for
demonstrating safety, efficacy, and the incidence of COVID-19 in the
population and areas where the trials are conducted. The guidance
document conveys that FDA would expect that a COVID-19 vaccine would be
at least 50 percent more effective than placebo in preventing COVID-19
or SARS-CoV-2 infection among the clinical trial participants. FDA
anticipates that clinical trials to demonstrate vaccine efficacy would
also be of sufficient size to provide an acceptable safety data base.
However, further pre-licensure safety evaluation may be needed if
safety concerns arise during clinical development.
While FDA is committed to expediting this work, we will not cut
corners in our decisions and are making clear through this guidance
what data should be submitted to meet our regulatory standards. This is
particularly important, as we know that some people are skeptical of
efforts to develop a safe and effective COVID-19 vaccine. To help
ensure an evaluation process that is as transparent as possible, and to
help the public understand the FDA's process for evaluating the safety
and effectiveness of new vaccines, FDA will convene a meeting of our
Vaccines and Related Biological Products Advisory Committee on October
22, 2020, to address the general development of COVID-19 vaccines. We
stand ready to rapidly schedule additional meetings of this Committee
after submission to discuss Biologic License Applications or request
for an Emergency Use Authorization for COVID-19 vaccines.
It is clear that manufacturing and fill finish capacity will need
to be scaled up on U.S. soil in order to have a safe and effective
vaccine widely available in a timely manner. FDA is committed to
working with sponsors by providing timely regulatory advice and
technical assistance regarding manufacturing to help support such
scale-up activities, including sponsors who may be proceeding at risk
to scale-up manufacturing while clinical trials are being completed.
We have not lost sight of our responsibility to the American people
to maintain our regulatory independence and ensure our decisions
related to all medical products, including COVID-19 vaccines, are based
on science and the available data. This is a commitment that the
American public can have confidence in and one that FDA will continue
to uphold.
Therapeutic Development
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 has supported 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 ACTIV partnership developed 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
key areas, such as in reducing lung inflammation and improving lung
function in COVID-19 patients. All this work is beginning to pay off.
For example, we saw positive results of the National Institute of
Allergy and Infectious Diseases (NIAID) trial of remdesivir in patients
with severe COVID-19. On May 1, 2020, FDA issued an EUA for remdesivir
for the treatment of suspected or laboratory-confirmed COVID-19 in
adults and children hospitalized with severe disease. On August 28,
2020, FDA broadened the EUA for remdesivir to include all hospitalized
patients for treatment of COVID-19, irrespective of their severity of
disease.
Another potential approach for treatment is the use of antibody-
rich products such as convalescent plasma and hyperimmune globulin.
These investigational blood products are manufactured from plasma
donated by people who have recovered from the SARS-CoV-2 virus, and
such products are being studied to determine if they could shorten the
length, or lessen the severity, of COVID-19. We are evaluating
convalescent plasma in the context of traditional clinical trials, and
on August 23, 2020, FDA issued an EUA for investigational convalescent
plasma for the treatment of COVID-19 in hospitalized patients. This EUA
followed FDA's extensive review of the science and data generated over
several months prior to the EUA. This data stemmed from efforts to
facilitate expanded access to convalescent plasma for COVID-19
patients. Clinical trials to definitively demonstrate safety and
efficacy of convalescent plasma remain ongoing.
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 to encourage
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 collection entities to facilitate the collection of convalescent
plasma, and to work with developers of such 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.
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 (human and animal), biological product, and device
manufacturing in a timely manner.
Drugs and Biological Products
In addition to our usual communication with drug manufacturers, we
work closely with healthcare and pharmacy systems, hospitals,
providers, and others on the frontlines of COVID-19 patient care to
identify 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 for outsourcing facilities registered with FDA and pharmacists
in state-licensed pharmacies or Federal facilities, regarding the
compounding of certain drugs used to treat hospitalized patients with
COVID-19 when approved drugs are not available. The Agency has also
published guidance to help applicants and manufacturers provide FDA
with timely and informative notifications about changes in the
production of certain drugs and biological products and urging the
submission of these notifications, which may assist in our efforts to
prevent or mitigate shortages of such products.
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. The Agency quickly
identified the need for making hand sanitizers available as demand
spiked, while also continuing our mission to ensuring these products
remain safe for consumer use by removing adulterated products from the
market. FDA has published and continues to update three guidance
documents designed to help facilitate the production of alcohol-based
hand sanitizer in non-traditional settings such as pharmacies or
distilleries. The agency has initiated several enforcement initiatives
and import alerts to stop adulterated and subpotent hand sanitizer
products from getting U.S. distribution channels through importation
into the United States. The Agency has also issued three EUAs to
authorize the emergency use of products currently authorized for
marketing in the European Union, which has helped to alleviate
shortages of some therapies that are essential for the care of
critically ill COVID-19 patients.
Medical Devices
FDA continues doing everything in our authority to help increase
the availability of PPE and other critical medical devices relied upon
by patients and those on the front lines of the U.S. response. FDA has
reached out to over 1,000 manufacturers since January and has helped
facilitate an increase in the availability of these devices, while
taking steps to ensure that patients and our health care workers on the
front lines can depend upon these products to protect them.
One way FDA has helped to increase the supply of medical devices in
the United States is by issuing EUAs. For PPE, FDA has issued EUAs to
make more respirators available by authorizing certain existing
supplies of PPE for healthcare personnel use that are not traditionally
intended for use in health care settings, authorizing imported
respirators that are demonstrated to meet comparable performance
standards so that they can be used in health care settings, authorizing
systems for decontamination of PPE so they can be reused as
appropriate. The Agency has also issued EUAs for face masks (as source
control to help stop the spread of the virus), surgical masks, face
shields, and certain gowns and other apparel for use in health care
settings in accordance with CDC recommendations (including but not
limited to shoes and shoe covers, non-surgical isolation gowns,
surgical helmets, and surgical caps). The need for PPE continues to
outpace the available supply, but these EUAs have been critical to
maximize available supply in the United States and help bolster
manufacturing of new supply to support the COVID-19 response.
FDA has seen an unprecedented volume of EUA requests for medical
devices--some of which have been for ventilators, infusion pumps,
remote or wearable patient monitoring devices, and blood purification
devices for which FDA has reviewed premarket submissions but has never
issued EUAs in prior emergencies. FDA has also seen EUA requests for
novel medical products that it has never previously reviewed under any
circumstances, such as decontamination systems for PPE.
Another way FDA has helped to support increasing the supply of PPE
and other devices during the pandemic is through issuance of several
guidance documents intended to help manufacturers develop new products
more quickly and efficiently. These guidance documents are for PPE and
other devices including facemasks (as source control to help stop the
spread of the virus), surgical masks and respirators, gowns, other
apparel and gloves, as well as guidance for sponsors requesting EUAs
for decontamination systems and bioburden reduction systems for face
masks and respirators. FDA has also published guidance documents for a
wide variety of other medical devices, including ventilators and
accessories, infusion pumps and accessories, remote ophthalmic
assessment and monitoring devices, non-invasive remote monitoring
devices used to support patient monitoring, imaging systems, and non-
invasive fetal and maternal monitoring devices used to support patient
monitoring.
In addition, FDA has provided conservation strategies intended to
outline contingency and/or crisis circumstances when reuse, extended
use, and preservation of certain devices may be necessary if supplies
are short or unavailable. To date, FDA has published conservation
strategies for gloves, masks and gowns.
In these ways, FDA has worked consistently to support those
manufacturing PPE and other devices, as well as those who are dealing
with limited supplies and shortages, to provide alternatives when other
options are not available. This includes close collaboration with many
non-traditional device manufacturers who have turned their operations
to manufacturing PPE and other devices. FDA has worked interactively
with manufacturers to continue increasing the supply of medical devices
to meet continuing unmet needs all over the country. FDA also provided
instructions for importers to facilitate the import entry process for
PPE and other devices, to help expand access to these products. To
further support these efforts, FDA initiated biweekly virtual town hall
meetings for those seeking and manufacturing respirators and other PPE
to ask questions and discuss challenges they are facing.
We are also in close communication with our partners at U.S.
Customs and Border Protection (CBP) to proactively identify and
mitigate any potential backlogs of lawfully marketed medical products
for COVID-19. FDA participates in HHS Supply Chain Advisory Group
meetings, providing regulatory support and subject matter expertise to
respond to questions concerning medical products identified by HHS, to
facilitate the lawful entry and use of imported medical products
coordinated through HHS, and to inform medical product supply chain
discussions.
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 further expand these
authorities, consistent with the fiscal year 2021 Budget.
Inspections
Despite pausing onsite domestic and foreign routine surveillance
inspections in March 2020 to safeguard the health and well-being of our
staff, our investigators continued to conduct mission critical
inspections both domestically and abroad and other activities to ensure
FDA-regulated industries were meeting applicable FDA requirements. In
July 2020, FDA resumed prioritized onsite domestic routine surveillance
inspections. To arm our investigators with the most reliable and
accurate information, the FDA developed a rating system to assist us in
determining when and where it is safest to conduct prioritized domestic
inspections. The COVID-19 Advisory Rating system (COVID-19 Advisory
Level) uses real-time data to qualitatively assess the number of COVID-
19 cases in a local area based on state and national data. We have also
made the Advisory Level data available to our state partners who carry
out inspections of FDA-regulated entities on the agency's behalf under
contract. We will continue closely monitoring reopening criteria
established at the Federal, state or county levels are planning to
identify when and where to resume domestic inspections, investigations,
sample collections and analyses, prioritizing these assignments based
on risk and other factors. Similarly, we will use data to inform
resumption of prioritized operations abroad as it becomes feasible and
advisable to do so.
FDA has determined that, for the foreseeable future, prioritized
domestic inspections will be pre-announced to FDA-regulated businesses.
This will help ensure the safety of FDA investigators and firm
employees, providing the safest possible environment to accomplish our
regulatory activities, while also ensuring the appropriate staff are
onsite to assist FDA staff with inspection activities.
Over the course of the COVID-19 pandemic we have had great success
by using a number of tools as part of the agency's risk-based approach
to ensuring safety. This includes denying entry of unsafe products
offered for import into the United States, conducting physical
examinations and/or product sampling at our borders, utilizing remote
regulatory assessment tools to verify compliance with safety
regulations, and continuing to work with Federal, state and local
partners to monitor the medical product and food supply for indications
of interruptions or shortages. As the COVID-19 pandemic continues, we
will continue to adjust our processes and guidance as necessary to
maintain the appropriate level of review to ensure the safety of
consumer products, including hand sanitizer, diagnostic tests and more.
In response to ensuing travel restrictions due to the pandemic, FDA
is utilizing its authority under section 704(a)(4) of the Federal Food,
Drug, and Cosmetic Act to request records in advance of or in lieu of
drug inspections, and is also utilizing establishment inspection
reports from capable foreign regulatory authorities under the Mutual
Recognition Agreement (MRA). Both options help inform decisions related
to drug approvals or addressing drug shortages.
Our Foreign Supplier Verification Program, or FSVP, remains a high
priority for U.S. food imports and is critical to ensuring the safety
of food received from foreign suppliers. In March of this year, we
started using remote FSVP Assessment Protocols to conduct inspections
and have found that these inspections have been effective and help
ensure compliance with the new importer requirements under FSMA during
the current pandemic.
Food Supply
FDA is working with Federal, state, and local partners as well as
industry to help ensure a safe and adequate food supply for both people
and animals. We 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 and initiating responses as needed. 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.
In July, FDA announced the New Era of Smarter Food Safety Blueprint
outlining the Agency's plans over the next decade to create a more
digital, traceable, and safer food system. The challenges that have
arisen during the pandemic have made it clear that the actions called
for in the blueprint will strengthen how we approach the safety and
security of the food supply, not just in the normal course of events
but especially in times of crisis.
Fraudulent Products
FDA exercises its regulatory authority to protect consumers from
firms and individuals selling unapproved products with false or
misleading claims that the products prevent, treat, mitigate, diagnose,
or cure COVID-19, including by issuing warning letters and pursuing
civil and criminal enforcement actions, where appropriate. In March
2020, FDA launched Operation Quack Hack, which leverages agency
expertise and advanced analytics to protect consumers from fraudulent
medical products including unproven cures, illegitimate test kits, and
substandard or counterfeit respirators. FDA has sent thousands of abuse
complaints to domain name registrars and internet marketplaces. The
Agency also has sent more than 110 warning letters to sellers of
fraudulent products. Working with the Department of Justice, FDA has
sought and obtained 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. For example, in March, at the border, FDA
intercepted at the border 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 thereafter charged with mail fraud
stemming from the allegations that he smuggled hydroxychloroquine from
China to make his own pills and concealed the shipment from CBP by mis-
declaring it as yam extract. In May, FDA worked with CBP to intercept
several shipments of counterfeit facemasks, with the result that they
were refused and destroyed before getting into U.S. commerce.
More recently, FDA has taken steps to address hand sanitizer
products that pose safety concerns, such as products that contain or
may contain toxic chemicals like methanol or 1-propanol, or that do not
meet the required alcohol levels. FDA has issued warnings to consumers
not to use these hand sanitizers, and has taken steps to help ensure
that these dangerous or subpotent products do not enter domestic
commerce. FDA has coordinated with CBP to identify such products, and
we have listed products made by more than 40 manufacturers on import
alert.
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. Let's go to Dr.
Redfield and then Admiral Giroir and then Dr. Hahn.
Dr. Redfield, welcome.
STATEMENT OF ROBERT REDFIELD, M.D., DIRECTOR, UNITED STATES
CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA
Dr. Redfield. Thank you, Chairman Alexander, Ranking Member
Murray, and Members of the Committee. And I want to thank you
for the opportunity to be here today. On behalf of the CDC, I
also want to thank you for your continued support of our public
health professionals and their lifesaving work that they are
committed to 24/7. Over 6,700 CDC staff have been engaged in
our agency's COVID-19 response so far, and more than 1,200 have
been deployed to more than 200 locations, tribal nations in the
United States and abroad. I know that you join me in expressing
our collective deep gratitude to the women and men of CDC for
their resilience, their dedication, and their service to our
Nation.
Throughout this global pandemic, CDC has brought its
science expertise to the frontlines, grounded in science and
data, conducting rapid investigations of disease outbreaks that
identify the highest risk populations and settings, and putting
in place measures to prevent further spread of COVID-19.
Understanding which populations are most at risk and how this
virus spreads in various settings is critical in developing
guidance and protecting the health of Americans. As you are
aware, in the United States, we are approaching nearly 7
million cases and sadly over 200,000 deaths. Every death means
that a loved one was lost. But there is some progress to
report. Since the pandemic peaked in July 24th of this year, we
have experienced nearly a 50 percent reduction in daily cases
and a 32 percent reduction in deaths.
There has also been significant improvement in the
mortality, particularly in the elderly. For example, during the
peak of the epidemic, April 17th, 75 year old Americans had a
mortality of about 46.8 per 100,000. And by the end of August,
the numbers had significantly declined into about 10 per
100,000. These improvements, however, do not mean that we can
let our guard down. Over last week, we had an average of over
40,000 cases and nearly 800 daily deaths. I do want to
emphasize the shift in age in these case counts. The 18 to 25
year olds currently make up over 26 percent of new infections
in more than any other group. It is imperative that these young
adults recognize that even though they are unlikely to get
seriously ill from this virus, they are major contributors to
the spread of COVID-19 in our country at this time.
In order to understand what proportion the population has
been infected with COVID-19 and what proportion remains at
risk, CDC is currently performing large scale serology testing
across the United States. Preliminary results appear to show
that most Americans have not been infected with the virus and
are still vulnerable to the infection, serious illness, and
death. We hope to be able to post the analysis of the first
round of this study in the next several weeks. As I have stated
before, the CDC encourages all Americans to embrace the
powerful public health tools that we have right now, wear a
mask, maintain social distance, practice routine hand washing
with vigilance, be smart about crowds, and stay home when you
are feeling sick. And as we move into the fall, I want to add
one more critically important step, flu vaccination. Flu
vaccination is safe. CDC encourages all Americans to embrace
the flu vaccine with confidence for themselves, their families,
their loved ones and their communities.
This year, CDC has purchased an additional 9.3 million
doses of adult flu vaccine, as well as 18.5 million doses for
children. This is a significant increase in previous years.
When combined with the tools that I mentioned above, this could
help our Nation avert a very difficult fall and lessen the
burden on our health care system and save lives. To further
strengthen our public health resilience, CDC awarded 140
million to 64 jurisdictions through the CDC existing
Immunization Cooperative Agreements to begin to scale up
staffing and preparedness for flu season.
We also developed a new multiplex laboratory diagnostic
test. It is capable of measuring both Influenza A and Influenza
B, as well as COVID 2 using a single specimen and a single
assay. This test will help our public health professionals
better identify infections with Influenza and COVID. I also am
announcing today an additional $200 million from the CARES Act,
funding that will be used as a first step to help the
jurisdictions complete their individual plans and implement
their COVID--further COVID vaccination in follow-up to the
playbook that we released last week.
CDC is an integral part of Operation Warp Speed. We are
leveraging our expertise and immunization infrastructure to
support and promote distribution, administration, and
monitoring of the future COVID-19 vaccines. In coordination
with Operation Warp Speed, CDC is working closely with state
and local community organizations on their detailed, flexible
plans for vaccine distribution. As I have emphasized in prior
hearings, now is the time to commit to sustained investment in
core capabilities of public health data, data analytics,
laboratory resilience, workforce expansion, and rapid response
capabilities.
Years of underinvestment in public health infrastructure
have led to a system that has been sorely tested in this
current pandemic. COVID-19 is the most significant public
health challenge that our Nation has faced in more than a
century. Now is the time to build not only the public health
core capability that our Nation needs, but the capability that
the people of our Nation deserve.
As we work together collectively to fight COVID-19 and the
pandemic, CDC and all of the outstanding women and men of CDC
remain strongly committed to our mission to protect all
Americans from disease, threats, and to save lives. I want to
thank you for your time 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, I am honored to
update you on our Nation's efforts to combat COVID-19, with a
specific focus on testing. Recommended public health practices
like wearing a mask, avoiding crowds especially indoors, and
washing your hands combined with smart testing is the formula
to effectively slow the spread, flatten the curve and save
lives. By providing county specific guidance to Governors on a
weekly basis, expanding and managing supplies, providing the
right test to the right person at the right time, and
developing and equitably distributing safe and effective
therapeutics, we are seeing promising results. Specifically
since the post Memorial Day peaks in community spread, the
number of new COVID cases is down, as Dr. Redfield just
testified.
The number of people hospitalized with COVID-19 is down 54
percent. The number of people in an intensive care unit due to
COVID is down 65 percent. And deaths associated are down 32
percent. But let me emphasize that to sustain these gains, we
must continue our disciplined mitigation efforts, especially
wearing masks when we can, physically distance, avoiding crowds
particularly indoors, and increasing our screening and
surveillance testing. Now, specifically regarding testing, the
Nation has performed over 106 million tests for the virus
causing COVID-19. On 10 separate days, we performed over 1
million tests per day. The Federal Government has purchased and
delivered over 106 million swabs and 88 million tubes of media
to states, tribes and Federal partners. Starting on April 7th,
we have purchased and delivered to public health laboratories
in every state and the Indian Health Service over 2.5 million
Abbott ID Now point of care molecular tests to support outbreak
control and rural testing.
We have implemented Federal surge testing sites in 20
different cities, helping to squelch emerging outbreaks,
typically among asymptomatic young adults. We are now at an
inflection point in testing. This month, we will have available
on average 3 million tests per day, nearly half of which will
be rapid point of care. We have been building toward this
inflection point and I have previously testified to its coming
several times over the past months. Now, let me discuss two
specific testing initiatives. Protecting the elderly has been,
is, and will continue to be a foremost priority for this
administration.
On July 14th, we announced that every single eligible
nursing home in America would receive a point of care
instrument and testing supplies. We have delivered on this
promise. All 13,850 eligible nursing homes have now received a
total of 13,985 instruments and over 4.9 million rapid point of
care tests ahead of schedule. On August 27th, after months of
planning and only 1 day after its FDA authorization, the
Administration announced a $760 million dollar contract with
Abbott for the delivery of 150 million rapid BinaxNOW COVID-19
point of care tests. This test is easy to perform, does not
require an instrument, delivers test results in 15 minutes or
less, and costs $5. We have already deployed 65,000 of these
tests in support of disaster operations in California, Oregon,
Texas and Louisiana.
Last week we also shipped 974,000 tests to 7,600 nursing
homes in areas of significant community transmission, 541,000
tests to over 5,500 assisted living facilities with a clear
certificate of waiver, and 300,000 tests to the Indian Health
Service. This week we will be shipping 249,000 tests to
historically Black colleges and universities and 2.6 million
tests to assisted living, nursing homes, home health, and
hospices. In the coming weeks, we will begin shipping millions
of tests per week in support of our teachers and our students
to open and keep open our K through 12 schools.
Now, I would like to close by recognizing my fellow
officers in the public health service, the uniformed service,
which I have the honor of leading. 4,172 women and men have
deployed 8,918 times in direct support of this pandemic on the
Diamond Princess cruise ship in Japan, to our community-based
testing sites, to FEMA and our task forces, and to nursing
homes and field hospitals in the hardest hit communities.
I thank each and every one of these officers and their
families, and on their behalf, thank all of you in Congress for
supporting our training needs and the establishment of a ready
reserve to supplement our ranks during inevitable future
national emergencies. Thank you for the opportunity to provide
these remarks.
The Chairman. Thank you, Admiral Giroir.
Dr. Hahn, welcome.
STATEMENT OF STEPHEN HAHN, M.D., COMMISSIONER OF FOOD AND
DRUGS, UNITED STATES FOOD AND DRUG ADMINISTRATION, SILVER
SPRING, MD
Dr. Hahn. Good morning, Chairman Alexander, Ranking Member
Murray, and Members of the Committee. Over the past several
months, I have had the honor to work shoulder to shoulder with
FDA's career staff as we fought a historic pandemic that has
altered the lives of every American. I am proud of all FDA
employees and how they have measured up to this extraordinary
challenge. The efforts of the FDA's expert workforce are
critical to ensuring the safety and health of the American
public at any time, but it is magnified during a public health
emergency. Of course, our work on COVID-19 and non-COVID issues
comes with unprecedented public scrutiny and sometimes
criticism.
Any agency that has the broad responsibilities and far
reaching impact of FDA, particularly involving issues of public
health, cannot expect to do its job without inviting
controversy and disagreement. But it is also essential that the
criticism we get never shakes the underlying faith the public
has and should have in FDA and our commitment to protecting the
public health. I am confident in the decisions that are being
made related to COVID-19 and that will be made in the coming
months as we continue to address the challenges of this
pandemic. Now, I know there has been particular attention paid
to a few of the decisions reached by FDA over the past several
months. I want to assure you and emphasize that every one of
the decisions we have reached has been made by career FDA
scientists based on science and data, not politics. FDA
represents science in action. Often we must make real time
decisions based on ever evolving data concerning a previously
unknown, highly contagious virus that we are still learning
about.
Sometimes it is necessary to reverse decisions as new data
emerge. This is inherent in the emergency use authorization
process, otherwise known as EUA, and it is akin to how a doctor
might approach a patient in an emergency situation, constantly
updating a treatment plan as new data emerge. So in the
interest of transparency, I would like to use this opportunity
today to lay out the process we will use to review vaccines for
COVID-19. When a vaccine sponsor reaches the conclusion that
the data from its phase 3 clinical trials are adequate to
submit to FDA, they will decide whether to apply for approval
or emergency use authorization. This will be based upon the
trial meeting prespecified success criteria that were
established by that sponsor.
Now, this is really important. They should also be
consistent with FDA recommendations regarding those criteria.
FDA will receive that application or submission and our career
scientists will review its safety and efficacy data, as well as
manufacturing quality and consistency data. FDA made clear
recommendations in our June 30 guidance regarding the safety
and effectiveness of vaccines so that we can see that prior to
the approval process. We will also work to provide additional
information so that it is clear what we expect to see should a
sponsor choose to submit an emergency use application--
emergency use authorization application. As we have indicated
previously, we plan on seeking advice from the Vaccines and
Related Biologics Products Advisory Committee, comprised of
independent members who have been screened for ethics
conflicts.
The safety and effectiveness data and the committee's
decision will be public, although we will need to adhere to
confidentiality requirements. The public will have an
opportunity to comment. The process will be transparent and
independent. FDA career staff will then take the committee
input into account as they make their decisions regarding the
application or EUA request. Now, before we were to issue an
EUA, if that were to happen, FDA would have to determine, among
other things, that the statutory standard is met.
We expect that this would be demonstrated based on adequate
manufacturing data to ensure a vaccine's quality and
consistency, and data from at least one well-designed phase 3
clinical trial that demonstrates its safety and efficacy in a
clear and compelling manner. Let me emphasize that again, data
from at least one well-designed phase 3 clinical trial that
demonstrates its safety and efficacy in a clear and compelling
manner. FDA also expects that an EUA request would include a
plan for active follow-up to monitor safety among individuals
who receive the vaccine. In the end, FDA will not authorize or
approve a vaccine that we would not feel comfortable giving to
our families. On behalf of the 17,000 plus employees of the
FDA, I want to make the following commitments today to the
American public and this Committee.
FDA will not authorize or approve any COVID-19 vaccine
before it has met the agency's rigorous expectations for safety
and effectiveness. Decisions to authorize or approve any such
vaccine or therapeutic will be made by the dedicated career
staff at FDA through our thorough review processes, and science
will guide our decisions. FDA will not permit any pressure from
anyone to change that. I will fight for science, Mr. Chairman.
I will fight for the integrity of the agency and I will put the
interests of the American people before anything else. Thank
you and I look forward to answering your questions.
The Chairman. Thank you, Dr. Hahn. We will now turn to
questions from Senators. We have full participation today, so I
would like to ask the Senators and witnesses to keep your
exchanges within 5 minutes so all Senators will have a chance
to participate. And for my 5 minutes, I would like to ask for
the courtesy of short answers so I can ask all my questions.
Dr. Hahn, let me go back to two things you said. Who makes
decisions about safety and efficacy at the FDA? Do you do it,
do career scientists do it, or does the White House do it?
Dr. Hahn. Career scientists at the FDA do it. We--that is
very clear. I am briefed on all major medical product
decisions. Overruling a center's decision is a very rare event.
I have expressed on multiple occasions my intention and have
done during this COVID-19 to make sure that those decisions are
made by career scientists in the centers.
The Chairman. You referred to this, but once FDA approves a
vaccine, and as we have said today we are going to have tens of
millions of doses ready, none can be distributed until FDA
approves it. Will you be willing to take that vaccine for you
and for your family?
Dr. Hahn. Absolutely, yes, Senator--Mr. Chairman. I have
the complete and absolute faith in the expertise of the
scientists who are terrific at FDA. If they were to make a
determination a vaccine would be safe and effective, I would do
that and I would encourage my family to take the vaccine.
The Chairman. Dr. Fauci, you have been around since the
Reagan years. You have seen lots of diseases, pandemics, and
lots of responses to it. Is the Administration cutting corners
in safety and efficacy in its effort to produce vaccines and
treatments rapidly?
Dr. Fauci. Not at all, Mr. Chairman. In fact, the rapidity
of where we are right now is a reflection of the technological
advances in vaccine platform technology, as well as the risks
that were taken financially so that we will have doses
available when the decision is made by the FDA as to the safety
and efficacy, as you have heard from Dr. Hahn. So there is no
cutting corners.
The Chairman. We are risking the taxpayers' money, but we
are not risking safety and efficacy. Is it your testimony?
Dr. Fauci. Yes, it is. That is absolutely correct.
The Chairman. Now, millions of students are going back to
thousands of colleges and there are inevitably outbreaks of
COVID-19, Dr. Fauci. Is the smart thing for college
administrators to do is to send those college students home
when the outbreaks occur on campus?
Dr. Fauci. Absolutely not, Mr. Chairman. They should be
able to accommodate the students in a facility, maybe a
separate dorm or a separate floor, so they do not spread among
the student body, but do not send them home to their community
because of the likelihood of then re-seeding infection in the
community.
The Chairman. Dr. Fauci, I have listened to your testimony
for the last several months. Some people say that your message
is that you want to lockdown the country in order to stop the
spread of the vaccine. Is that accurate?
Dr. Fauci. That is completely inaccurate, Mr. Chairman. I
have said multiple times we do not need to shut down. If we
follow carefully and prudently the recommendations and the
guidelines for opening America again, I believe we can do that
safely and still accomplish the goal of opening the economy
again.
The Chairman. Dr. Fauci, some people said it was political
to ask the states to get ready to distribute the vaccine in
October. Is that true or false?
Dr. Fauci. That is false. The reason that was done is
because we want to make sure that when a decision is made, that
we will be ready to distribute the vaccine.
The Chairman. Dr. Redfield, the British Ambassador told me
yesterday the Government studies in the United Kingdom said
that based on serology testing, that 5 to 25 percent of their
country's population, depending on the location, has been
exposed to COVID-19. What does--what about the American
population? How many of us have been infected by COVID-19?
Dr. Redfield. Thank you, Mr. Chairman. CDC is in the
process of a very large sequential study across the entire
United States measuring serology. As I mentioned, the
preliminary results in the first round show that a majority of
our Nation, more than 90 percent of the population, remains
susceptible. It varies in different geographic parts from
states that have less than 1 percent. With evidence of previous
infections, some that have more than 15, 20 and one as high as
24 percent. We will have that finalized and probably published
in the next week or so, but it does show that a majority of
Americans are still susceptible to this virus.
The Chairman. Just so I understand, you are saying that
based on the preliminary indications from your serological
testing and studies, that as many as 90 percent of Americans
are still--still have not had the virus yet?
Dr. Redfield. Yes, sir.
The Chairman. Thank you, Dr. Redfield.
Senator Murray.
Senator Murray. Thank you, Mr. Chairman. Dr. Redfield, we
know that a lot of patients avoid getting a necessary test or a
treatment because of cost. And I have been pushing to make sure
insurers have to cover COVID treatment at no cost to patients
as we fight this deadly disease. Meanwhile, President Trump, as
we all know, is fighting at the Supreme Court to overturn the
Affordable Care Act, which would leave 23 million more people
without health insurance and allow insurers to once again
discriminate against people with preexisting conditions,
leading to higher costs. COVID-19 actually--could become a
preexisting condition.
Dr. Redfield, let me just ask you straight out, will
increasing the number of uninsured by tens of millions and
increasing costs for the 133 million people with a preexisting
condition make it easier or harder to contain this pandemic?
Dr. Redfield. Thank you, Senator, for the question.
Clearly, access to timely healthcare is critically important in
terms of public health. And in terms of this pandemic, it is
also true access to timely and effective health care remains an
important public health measure.
Senator Murray. I would take that--case is overturned, that
this is going to make it a lot harder to control this pandemic.
Dr. Redfield, we have got to understand what happened with
CDC's testing guidance for asymptomatic people exposed to
COVID-19. I am relieved that CDC reversed course on Friday, but
I am concerned about why CDC put out guidance that contradicted
the widespread views of the medical and public health
community, was not drafted by CDC scientists and did not
undergo CDC strict scientific review process. Dr. Redfield, how
is it a document published on CDC's website was not drafted by
CDC scientists nor underwent the agency's strict scientific
review process?
Dr. Redfield. Senator, the original testing guidelines of
August 26 had full engagement of individuals at CDC, but it was
a cooperative document that included the Assistant Secretary as
well as the coronavirus task force. I will say the intent of
that document, as I mentioned before and I tried to clarify in
my statement on August 27th, was never to limit testing, never
to limit testing of asymptomatic individuals.
The attempt was to reengage the medical and public health
community as part of testing so that there was a public health
action that happens as a consequence of every test. It became
progressively apparent that the guidelines were not interpreted
in the manner in which we had intended them to be interpreted
and that is what led me to realize we had to put out a
clarification to make it explicitly clear that we believe very
much that asymptomatic transmission is an important part of the
transmission cycle of this virus. Those individuals, when they
have been exposed, should, in fact be tested----
Senator Murray. I appreciate that answer. I do not hear you
answering the question. But let me ask Dr. Giroir. You said in
an interview that coordinated editing of the guidance--that you
coordinated, editing of the guidance. The American Medical
Association, the Infectious Disease Society of America, and
state health departments recommend testing for asymptomatic
people. I want to ask you, on what scientific basis did members
of the task force take a different position? Scientific
evidence.
Admiral Giroir. Thank you, Senator Murray. I want to
reiterate what Dr. Redfield said is that the original guidance
that was published by the CDC with the approval of Dr. Redfield
and the senior scientist, did not, unequivocally it did not
recommend against testing asymptomatic individuals.
In fact, there were multiple sentences that said it is
important to test asymptomatic individuals, but in certain
circumstances, it is important to do that within the context of
public health or medical supervision. That is all it said. It
was widely misinterpreted. It was widely misrepresented. And
Dr. Redfield told the reason, we have done FDA guidance, clear
guidance, and I issued a prep back declaration to----
Senator Murray. Okay. I just have a few seconds, on Friday,
CDC quietly updates another guidance identifying aerosols as
common route of transmission of the virus that causes COVID-19.
Yet on Monday, CDC reversed course. Dr. Redfield, you told me
the earlier guidance had been posted in error, but especially
given the Trump administration's track record, the reversal
raises significant red flags. So here is my question to you. If
I want the best guidance on the latest science so I can protect
myself and my family, can I trust CDC's website to give me that
information?
Dr. Redfield. Yes. I am going to say again that my agency
and myself, we are committed to data and science and to give
the American public the best public health recommendations we
can based on that data and science, and be open, if necessary,
if the data and science changes, to modify that guidance based
on that new data. But we are committed to data and science, and
that will be the grounding of how we make these
recommendations.
Senator Murray. Mr. Chairman, I am out of time, but I am
concerned that the American public needs to be able to trust
the decisions that are made and what is posted on that website
needs to be trusted.
The Chairman. Thank you, Senator Murray.
Senator Enzi.
Senator Enzi. Thank you, Mr. Chairman, for continuing to
hold these regular hearings so that we and the American public
can check on the Federal efforts to fight the Coronavirus. I
know it can be hard for our witnesses to find the time to
testify, since they are all working very hard to respond to the
pandemic, but I appreciate them being here and their
information. I am glad to see that we are making progress in
planning how we distribute a safe and effective vaccine when it
is ready.
I am optimistic and pleased that there are all these
efforts going forward. I hope we are thinking through how to
ensure access, though, to rural areas. One of the things that I
am asked about that people have heard that some of the
vaccines--this is a question for Dr. Redfield. Some of the
vaccines in phase 3 testing, evidently need to be stored at
extremely cold temperatures. That is even by Wyoming standards.
And that would be potentially as low as -94 degrees Fahrenheit.
Hospitals and nursing homes, pharmacies, doctors' offices
might all be places where Americans go to get their shots.
However, they do not have the specialized freezers that would
be necessary to store the vaccine, especially in rural areas.
So very few of those out--is there another solution or how can
we ensure sufficient freezer and storage capacity or so there
is access to the vaccine and it isn't just limited to major
cities?
Dr. Redfield. Thank you very much, Senator. Again, there is
a total commitment to work that this vaccine is distributed in
an equitable and fair way across our Nation. The funding I
announced today that we will get out to the individual states
to be able to really begin to operationalize their plans on the
playbook is critical, and each jurisdictions going to have to
address those issues, particularly as you looked at the
importance of cold change and how they are going to maintain
that. Clearly, we have--this is not something that we do not
routinely do. I mentioned before, CDC routinely administers and
distributes over 80 million vaccine doses a year through our
routine work.
We are going to build on that. Obviously, the ability to
bring all the pharmacies in is a really important step. But
these micro plans that your state, the State of Wyoming will
do, will identify what are the gaps that are there. And over
the next four, six to eight weeks, we are going to need to
figure out strategies that are going to fill those gaps to
ensure that there is a proper cold storage for the vaccine
distribution throughout this Nation in an equitable way. We are
committed to making sure that happens.
Senator Enzi. Dr. Hahn, do you have any comment on that?
Dr. Hahn. Well, FDA's role, Senator Enzi, in this is to
ensure that the controls around manufacturing and storage are
followed. If, in fact a vaccine is authorized or approved that
requires such cold storage as you mentioned, we will provide
technical assistance and we will work with CDC to ensure that
happens.
Senator Enzi. Thank you. Director Redfield, do you
anticipate that once the Food and Drug Administration approves
the vaccine, that the Centers--you kind of touched on this, the
Centers for Disease Control and Prevention will have to work
with the states to develop new, more detailed vaccine
distribution plans or will the work the states are doing in
advance suffice?
Dr. Redfield. Senator, it is very important, and I want to
stress this is why it is so important, the playbook we put out
last week and the funding we announced today, that we get these
plans executed. We wanted to see the plans completed by October
16th so we can interact, share best practices of other states
to try to get these plans as rock solid as possible. I am
confident there will be some things that weren't thought of
that will have to be dealt with as they come upon us.
But it is my expectation that each of the plans--we have
done the micro planning now in Minnesota and North Dakota,
California, Florida and Philadelphia over the summer just to
get a sense on the complexity of it. Now we are looking for
each of the four jurisdictions to complete that by October
16th. And it is our hope that is going to really lay out the
individual plan to get this vaccine equally distributed in that
jurisdiction, recognizing that there will be things that come
up that we are going to have to work together to deal with as
we see them. But hopefully we will be 95 percent of the way
there based on the planning between now and October 16th.
Senator Enzi. Thank you, Mr. Chairman and Ranking Member.
The Chairman. Thank you, Senator Enzi.
Senator Casey.
Senator Casey. Mr. Chairman, thank you very much. I want to
thank our witnesses for appearing and for their work. This
week, we have announced to the world that we have reached the
200,000 grim milestone of deaths in America from COVID-19. That
number translates in Pennsylvania into 8,000 deaths. So as we
are thinking about those--all those we have lost, we now have
to consider the possibility that COVID-19 could be and likely
will be considered a preexisting condition.
Just as the Affordable Care Act would be struck down by the
Supreme Court in early November, at least the arguments
starting then, and at the same time, we have got to consider
the ravages of this disease, the COVID-19 disease in the
context of nursing homes. I released yesterday with Senator
Wyden a report, I will just hold up the cover of it, but the
headline on the report, the Cost of Inaction, Eleven Deaths An
Hour--11 deaths an hour.
That means that in the months of July and August of this
year, 11 nursing home residents died from COVID-19 every hour.
In total, when you look at the total number from the beginning
of the pandemic, more than 78,000 residents and workers in
long-term care facilities have died of COVID-19. And
unfortunately, the Trump administration has no effective
strategy, no effective plan in place to reduce this number,
either or to reduce the death number or the case number in
long-term care settings. This is an American tragedy. There is
no excuse for these numbers just to keep going up. We should
not allow the next couple of months to transpire and have the
number of nursing home deaths or the nursing home case number
go up again. That is not the America we should be.
Now, the majority in the Senate could be doing something
about this. The majority in the Senate has been obsessed with
confirmation votes. All kinds of confirmation votes, all summer
long. And we did a defense bill as well. But mostly, almost all
of our votes were on confirmations. Now, the Senate majority is
obsessed with getting a confirmation vote on a Supreme Court
Justice.
I just have one question for the majority, when will the
Senate Republicans and the Trump administration become
obsessed, yes, obsessed with reducing nursing home deaths? Now,
let me get to our witnesses. I want to ask a question that Dr.
Hahn was already kind enough to answer, which is about the
vaccine and his response to that in terms of his own family,
his own person. One of the most important challenges we face in
developing and then distributing and administering a safe and
effective vaccine is public confidence.
As a way to demonstrate faith in the integrity of both the
approval process and to assure the American public that
vaccines are safe, I would ask the other three members of our
panel if they will commit to receiving the COVID-19 vaccine in
public view once one becomes available and is authorized or
approved by FDA. Starting with Dr. Fauci.
Dr. Fauci. Thank you for the question, Senator Casey. Yes,
I have said that in the past that if a vaccine that is shown to
be, and proven to be, and authorized by the FDA to be safe and
effective, I certainly would take that vaccine and I would
recommend to my family that they take that vaccine. Yes.
Senator Casey. Thank you.
Admiral Giroir. I have every confidence in the FDA process
to provide us a safe and effective vaccine. I would have no
hesitancy to take that vaccine. I would have no hesitancy to
recommend my family. But I think the question is a little bit
inappropriate. People need to read that vaccine. They need to
understand, have a discussion with their physicians or
providers before you ask anyone to commit to that. But I just
want to tell you, I have complete confidence in the FDA
process.
Senator Casey. Dr. Redfield.
Dr. Redfield. Yes, Senator Casey. Yes, absolutely. As I
would with my wife, children, 11 grandchildren, I would
recommend it to all of them. And of course, myself, I would
take it. I have total confidence in the FDA, in the process of
getting us a safe--if they give an EUA, then I am confident it
will be a safe vaccine and I am ready to take it.
Senator Casey. Dr. Redfield, I have a question for you on
state immunization information systems in light of the vaccine
program interim playbook. Just have one question before my time
expires. How many jurisdictions immunization information
systems need all the standards set forth in the playbook today?
Dr. Redfield. Senator, I would have to get back to you to
be able to answer that specifically. And I will say that we are
building on, as I mentioned, the system that we regularly use
in these 64 jurisdictions to distribute 80 million vaccine
doses a year. In addition, there will be additional information
capacity that will be put in to where there are new points of
service where that technology currently does not exist. But I
will have my team put together a comprehensive answer for that
question for you.
Senator Casey. Thank you. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Casey.
Senator Burr.
Senator Burr. Mr. Chairman, thank you very much. Welcome to
all of our witnesses and our thanks to your agency and the many
workers who work on this. And let me say to Senator Casey,
answering his question, the majority has been focused on
pandemics since 2002 when we first started passing legislation
to create in many ways the architecture that we fall under
today and the protocols that allow Dr. Hahn, Dr. Fauci, Dr.
Redfield, Admiral Giroir to do, in fact, what they are doing.
We thank you for that. Dr. Hahn, have we made up new
protocols for the review of a COVID vaccine, or are we simply
following the protocols that we have used for every vaccine
that every Member of this Committee, every Member of Congress
and the American people have always seen as the gold standard?
Dr. Hahn. Well, with respect to our approval or
authorization of medical products, FDA does represent the gold
standard. Now, the statutory definition for an EUA or
authorization is different, of course, than it is for an
approval. But we are following those criteria. With respect to
our performance during COVID-19, I want to give you a few
examples, because in fact you are correct. FDA does represent
the gold standard. Our scientists are incredible. They have
done really remarkable work here. And one of the major things
that distinguishes us from other regulatory agencies around the
world is that we actually look at the primary data. We do not
just look at a paper. We just do not look at a press release.
We look at the primary data.
Our scientists analyze that data, and then we draw
conclusions from that data. We did that with remdesivir. We did
that with convalescent plasma. We are doing that with tests.
And so those are the sort of things that FDA does that I
believe represent the gold standard and allow us to have great
confidence in the decisions that our career scientists are
making.
Senator Burr. Dr. Hahn, would it be appropriate to say that
the clinical trials, phase 3 clinical trials that are currently
going on, now four, manufacture, I think the fourth one was
announced this morning, are the most expansive and diverse
trials that we have seen in recent memory just simply because
they are global trials and typically we have not picked up that
international data until post approval in many cases and
reviewed it?
Dr. Hahn. Senator Burr, it is correct to say that they are
among the most diverse and expansive trials. I think that is a
reasonable way to put this. We were very clear in our June 30
guidance about what we needed to see with respect to efficacy.
A floor, not a ceiling, a floor of 50 percent, which led to the
power calculations in these trials, and therefore 30,000 plus
volunteers in each of these trials.
If you think about the number of trials that are ongoing
and plus the studies that were done before in phase 1 and phase
2, a great, if you will, number of people who would have
received these vaccines, which will give us the data we need to
see in order to make the determination. So these have been very
robust. The private sector has responded, the Government has
responded, and I think it has been a great effort to get these
trials together.
Senator Burr. Dr. Hahn, you talked about the steps that an
applicant would go through and how it would be their decision
as to whether they applied for emergency use authorization or
for approval. The one thing I did not hear you mentioned, and I
think you just left it out, is the Data Safety Monitoring
Board, DSMB, which actually looks at the data prior to the
application coming to the FDA. Is that in fact correct and is
that another safety step?
Dr. Hahn. Senator Burr, exactly. It is another check and
balance, if you will, in addition to the others. So let me just
explain that, if you will, sir. When a sponsor, someone that is
developing a vaccine, a company performs a phase 3 clinical
trial, there is something called a Data Safety Monitoring
Board. That is an independent board and they have set check-ins
to look at the data. Now, when they meet, they can make a
couple of determinations. No. 1, if there are significant
safety issues, they could stop the trial because of safety
issues.
No. 2, they could do what is called a futility analysis,
meaning that continuing that trial won't do any good because
there is not a statistical probability that it will reach the
primary endpoint, that it will be successful. And then, of
course, they could have met the prespecified criteria around
effectiveness in the case of the vaccines, prevention of
infection.
That would be another criteria that would be used to say,
Okay, the data are mature, give it to the company, and then the
company can put that into an application to us.
Senator Burr. Thank you. Dr. Fauci, I want to turn to you
just real quick, because the Moderna vaccine works off of a
technology platform that you actually created at NAIAD. Are you
confident of the process that is going on at the FDA that will,
in fact, review the application of clinical data from that
platform? And as an add on to that, would you also answer from
Members of Congress for the husband and wife that come to us
and say, my husband got COVID and I, the wife, did not get it.
How with a highly transmittable infection like this can two
people live together and one be positive and one never get
positive? If there is an answer, I would love to be able to
know.
Dr. Fauci. Yes, I mean, that happens all the time with
infections, Senator, that although a virus can be highly
transmissible, there is a great degree of variability of a
person's natural resistance to a particular type of an
infection. So although a highly transmissible virus usually has
an attack rate that is high, we see all the time individuals
who are exposed to someone with an infection who do not get the
infection.
If you look at the population as a whole, you see the kinds
of things that we are seeing as this pandemic evolves, that it
is highly contagious. We had the same situation where you had
HIV, where individuals were living with the person who had sex
on a regular basis with someone with HIV, and they never got
infected, whereas another person could have sex one time with a
person with HIV and get infected. That is the nature of the
variability of susceptibility to infection among individuals.
So it is entirely conceivable.
Senator Burr. Your confidence in the FDA review and the
technology platform?
The Chairman. We are running well over time.
Dr. Fauci. Yes, absolutely. The answer is yes, I am quite
confident in the FDA's ability to review that technology and to
determine safety and efficacy based on the data of the trial.
Senator Burr. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Burr.
Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman. Dr. Redfield, in
April, the CDC staff conducted an investigation into a COVID-19
outbreak at a meatpacking plant in South Dakota. Following the
investigation, your staff sent a report to the state that is
South Dakota's Department of Health that included strong safety
recommendations the CDC determined were necessary to stem the
transmission of COVID-19 at the plant. That report was dated
April 21st of this year.
Last night, it was reported that your office intervened and
ordered that the safety recommendations be watered down. The
next version of that memo dated the following day or April
22nd, essentially adds the words, if feasible, to those strong
safety protocols over and over again throughout the document,
telling the plant essentially that these recommendations were
voluntary or optional. Workers continue to work shoulder to
shoulder at that plant, and the plant ignored the safety
guidelines. To date, at least 1,200 workers from that very
plant have been infected with COVID-19 virus, 34 have been
hospitalized, and 4 have died.
I will also note that in that same time period in April, on
Tuesday, April 24--or 28 excuse me, that is when President
Trump issued his Executive Order basically naming meat packing
as an essential industry and meat packing workers as essential
workers.
I would like to enter the two documents I referred to, the
April 21st and April 22d safety recommendations concerning
these meat packing plant. If that is Okay, Mr. Chairman, I
would like unanimous consent to do so.
The Chairman. Without objection.
[The information referred to can be found on page 75 and
90.]
Senator Baldwin. I think I heard somebody indicate that I
got unanimous consent. Dr. Redfield, why did your office demand
that these recommendations be watered down?
Dr. Redfield. Thank you very much, Senator. I would not
characterize it the way that you did. What I would say is that
the field teams that we had that were in on the Smithfield
plant investigation that you are referring to had a report that
they did in the field and they shared it with the local South
Dakota health department. One of the critical things that
needed to be stressed in that report was the CDC is not a
regulatory authority. These were, in fact, recommendations.
The Department of Labor and OSHA have regulatory oversight,
and their report can direct that regulatory oversight. Our
report was recommendations from an Epi-Aid, and so as that
document was reviewed, we wanted to make clarification, then
make sure people understood ours was a recommendation and not a
regulatory requirement.
Senator Baldwin. Okay. Thank you. And I will note that OSHA
and the Department of Labor have failed to issue anything that
voluntary guidance, as has CDC. There are no pandemic emergency
standards in place for workplaces in the U.S., even though they
have had eight months to work on this. But that is not your
responsibility. Did your office have any contact with
Smithfield Foods or the U.S. Department of Agriculture or the
White House concerning specifically this memo before it was
edited?
Dr. Redfield. No, not at that time. There is a multi-
interagency discussions between Labor, Agriculture and
ourselves on a variety of the issues and intersect, but in that
regard, again, it was--the purpose was to stress clarity that
we were not a regulatory agency. These were recommendations.
Senator Baldwin. Well, given that, I would ask you to
consider changing the meat packing guidance, you could simply
say we are not a regulatory agency, but these are the safety
protocols that we would recommend and not have if feasible, if
feasible, if feasible. It makes it sound like these are not
particularly important. You can do it great, if you can't--you
can say these are our safety recommendations without it being
construed as an OSHA standard. And I would ask, will you change
that meat packing guidance in light of the death toll and harm?
Dr. Redfield. I appreciate your comments, Senator.
The Chairman. Thank you, Senator Baldwin.
Senator Paul.
Senator Paul. Initially, Government officials were honest
enough to admit that the goal of mitigation efforts, a.k.a.
lockdown, was to flatten the curve. But the area under the
curve, the total deaths from the virus would likely be the
same. In other words, the lockdown was to mitigate the spike in
viral deaths so our hospitals would not be overwhelmed. But the
same amount of people would likely die with or without the
lockdown. The media, and frankly Government officials, seem to
have forgotten this important caveat.
Flattening the curve morphed into a belief that we could
change the course of the pandemic with an economic lockdown.
This is unfortunate and has led to the protracted lockdown
recession we are currently mired in. It is important that we
examine the data, learn from the data and try to avoid the
manmade aspect of this calamity in the future. To those who
argue that the lockdown flattened the curve in New York and New
Jersey, the evidence argues otherwise. New York and New Jersey
wound up with the sharpest spike or highest death rate in the
world at over 1,700 per million.
In contrast, Sweden had a relatively softer touch, few
mandates and mostly voluntary guidelines. Sweden's death rate
ended up about a third that of New York and New Jersey. Some
might argue that Sweden and New York, New Jersey are different
populations, perhaps, but even the average death rate for the
U.S. is now greater than Sweden. In fact, the U.S. death rate
is quite comparable to less developed parts of the world where
social distancing is virtually impossible, such as Brazil,
Bolivia and Ecuador. Which brings us to an important question,
is man really capable of altering the course of an infectious
disease to crowd control?
The statistics argue a resounding, no. The evidence argues
that mitigation efforts have failed to flatten the curve, that
most countries, regardless of public health policy, suffered a
significant spike in deaths and then a gradual decline. Now
some will argue, what about Hong Kong, Taiwan, South Korea,
Japan, each which have had extraordinarily low death rates?
Hong Kong, Taiwan and South Korea certainly enforced strict
quarantine and contact tracing rules in the U.S. but Japan's
rules were largely voluntary since their prime minister lacks
the legal powers to enforce a lockdown.
One explanation for the low death rate in much of Asia is
that the population may have a higher degree of exposure to
Coronavirus colds and therefore have more preexisting, cross
reactive immunity. If scientists were interested, there is a
fascinating field of inquiry looking at susceptibility of
COVID-19, an assessment of whether people not have preexisting
immunity to similar coronaviruses. In fact, preexisting cross
reactive immunity to Coronavirus may explain why we have so
many people that have very little symptoms or are asymptomatic.
While there are still many things we need to learn about
this pandemic, it is important that we, the people, not simply
acquiesce to authoritarian mandates on our behavior without
first making the nanny state prove their hypothesis. As for
now, what we do know is that New York and New Jersey and
Connecticut and Rhode Island still allow the highest death
rates in the world. We also know that Sweden, who enforced few
mandates, ended up with a death rate of one third of New York
and New Jersey.
We also know that the overall death rate for the U.S. now
is essentially equivalent to that of South America, where
social distancing and mitigation efforts are virtually
impossible. Dr. Fauci, today you said you are not for economic
lockdown down, yet your mitigation recommendations from dating
to baseball to restaurants to movie theaters have led to this
economic lockdown.
Do you have any second thoughts about your mitigation
recommendations considering the evidence that despite all of
the things we have done in the U.S., our death rate is
essentially worse than Sweden, equivalent to the less developed
world that is unable to do any of the things that you have been
promoting? Do you have any second thoughts? Are you willing to
look at the data that countries that did very little actually
have a lower death rate to the United States?
Dr. Fauci. Senator, I would be happy at a different time to
sit down and go over detail. You have said a lot of different
things. You have compared us to Sweden. And there are a lot of
differences. And you said, well, there are a lot of differences
between Sweden, but compare Sweden's death rate to other
comparable Scandinavian countries. It is worse. So I do not
think it is appropriate to compare Sweden with us. Yes, we
have--I think in the beginning, we have done things based on
the knowledge we had at the time.
Hopefully, and I am and my colleagues are humble enough and
modest enough to realize that as new data comes, you make
different recommendations, but I do not regret saying that the
only way we could have really stopped the explosion of
infection was by essentially, I would not say shutting down--I
mean essentially having the physical separation and the kinds
of recommendations that we have made.
Senator Paul. You have been a big fan of Cuomo and the shut
down in New York. You have lauded New York for their policy.
New York had the highest death rate in the world. How can we
possibly be jumping up and down and saying, oh, Governor Cuomo
did a great job. He had the worst death rate in the world.
Dr. Fauci. No, you misconstrued that, Senator. And you have
done that repetitively in the past. They got hit very badly.
They have made some mistakes. Right now, if you look at what is
going on right now, the things that are going on in New York to
get their test positivity 1 percent or less is because they are
looking at the guidelines that we have put together from the
task force of the four or five things of masks, social
distancing, outdoors more than indoors, avoiding crowds and
washing hands.
Senator Paul. Or they have developed enough community
immunity that they are no longer having the pandemic because
they have enough immunity in New York City to actually stop it.
Dr. Fauci. I challenge that, Senator. Please, sir, I would
like to be able to do this because this happens with Senator
Rand all the time. You were not listening to what the Director
of the CDC said, that in New York it is about 22 percent. If
you believe 22 percent is herd immunity, I believe you are
alone in that.
Senator Paul. There is also the preexisting immunity of
those who have cross reactivity, which is about a third of the
public in many estimates and studies, which would actually get
you to about two thirds.
Dr. Fauci. I would like to talk to you about that also
because there was a study that recently came out that
preexisting immunity to Coronavirus or that of a common cold do
not cross react with the COVID-19.
The Chairman. Thank you, Senator Paul.
Senator Murphy.
Senator Murphy. Thank you very much, Mr. Chairman. I will
stay with you, Dr. Fauci. Apologies for not giving you a break.
There was a study that got some attention regarding Big Ten in
PAC 10 athletes that found that 15 percent of them who had
COVID-19, whether or not they showed symptoms, had evidence of
myocarditis, inflammation and damage to the heart muscle. What
are the long term effects for someone with myocarditis? What is
the current understanding of the possible more general long
term effects of somebody who has had COVID and recovered? And
are these effects observable in asymptomatic COVID-19 patients?
Dr. Fauci. Yes. Senator, thank you for that question. I
actually had mentioned that in my opening comments, but thank
you for giving me the opportunity to expand on that. That is
really quite puzzling because the individuals that was--there
were two studies. There was one study, not in athletes, and
then there was the study that you mentioned, in athletes.
The study in the non-athletes were individuals who had
recovered from COVID-19 and had various degrees of involvement,
to moderate disease, to disease that would require intervention
medically. And by doing MRIs, they found that about 60 to 70
percent of them had indication of inflammatory disease in the
heart. Interestingly, they were relatively asymptomatic. So I
think we need to be careful and just watch what happens,
because one of the possibilities that could develop is that, A,
it could clear up and they have no problem for the rest of
their lives. The other things that they could wind up when you
have inflammation, you could have scarring. That could lead to
a arrhythmias later on, or that could lead to cardiomyopathy. I
have to tell you, I do not know what it would be, but it is
something we really need to keep our eye on.
Senator Murphy. Insurance companies tend to err on the side
of caution. And so what we believe is that because of this
uncertainty, because of this potential for long term health
effects, that any diagnosis of COVID, whether you are
symptomatic or not, will become a preexisting condition and
that it is likely probable that insurance companies, if they
are allowed to discriminate against people with preexisting
conditions, as will happen if the Supreme Court justice is put
on the court and the ACA is invalidated, we will see rates
skyrocket for anybody who has had COVID.
I think that is something we all need to talk about over
the course of the next few weeks. Dr. Redfield, admiral, I want
to come back to this question of the guidance on testing. I
think this is really important because, we have to take the
President at his word. He announced that he had instructed his
advisers to, ``slow the testing down, please.'' When folks
suggested he was kidding, he was asked by reporters, are you
kidding? And he said, I do not kid. Let me just tell you. Let
me make it clear. So the President made it clear he wants less
testing.
It never did not seem coincidental to us that this strange
guidance came out in August that recommended significantly less
testing. And yet that is not what you are testifying to today.
You are both saying that, in fact, that August guidance did not
recommend less testing. And all you were doing with this third
set of guidance in 30 days was to clarify. But where in the
August guidance does it tell people that they should get a test
if they are asymptomatic but in close contact?
Where in that guidance does it actually tell them that they
should proactively see a health care provider if they have been
in contact? Because I have read it 20 times and I do not see
anywhere in this guidance that it tells people they should get
a test. I do not see anywhere in this guidance where it tells
them that they should go see a doctor. It reads, you do not
necessarily need a test unless you are a vulnerable individual
or you are a health care provider or your local health
officials recommend you take one. That does not say you should
go to the doctor.
That just says if you have been recommended to get a test,
you should. So it stands to reason that when folks read this,
that they will be under the impression that they should not get
a test which seems to comport with the directions of the
President, slow the testing down, please. Where in this
guidance that you issued in August does it tell people that
they should get a test or they should proactively see a doctor?
Dr. Redfield. Thank you very much, Senator. And as I have
said before, I take the position that more tests will actually
lead to less cases, particularly if it fully engages public
health action. And when I issued the clarification on August
27th, again, I said that we are placing emphasis on symptomatic
illness issues and also, as you said, individuals with
significant exposure of vulnerable populations, critical
infrastructure workers, health care workers, and those
individuals who may be asymptomatic when prioritized by a
medical or public health official.
The reason that this came from a public health perspective,
we were seeing individuals drive up, get a test and then go on
to work. There was not a public health action associated with
testing. So we calculated that this would help bring a public
health action to testing.
Senator Murphy. But notably, you do not tell people in this
guidance that they should go see a doctor.
Dr. Redfield. When--I said when we clarified the day after,
I put very clearly what the clarification was about the
emphasis in the final category with those individuals who are
asymptomatic when prioritized by a medical or public health
individual. And again, the intent was for testing to drive an
action that was for a public health objective. It was clear,
through a variety of different reasons when we found that some
individuals were not even doing testing for contacts, the
individuals with significant exposure, we then put the further
clarification.
I had thought that the August 27th clarification statement
that I put out would carry the football over the goal line. It
did not. But I can tell you there was no intent to this
guidance to decrease testing. On the contrary, the intent was
to link testing and to drive a public health action. And again,
the manner in which it was interpreted by a number of
individuals was such that it did not accomplish that goal.
Senator Murphy. I think I am over my time. This has just
been dizzying, dizzying for public health professionals. They
are just awaiting the next correction. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Murphy. In my effort to be
fair to everybody, we are running over the 5-minutes pretty
well. So we have about 14 Senators remaining who would like to
ask questions so I would ask their colleagues to keep that in
mind, please, with the 5-minute rule.
Senator Collins.
Senator Collins. Let me begin my questions today by
thanking each of you for your hard work, your professionalism,
and your integrity. I do not think you get the appreciation
that each of you deserves. Admiral, the American people clearly
need to have confidence that all our Federal health agencies
will abide by their gold standard, rigorous protocols and
preserve scientific integrity. And we have heard this morning
just such strong assurances. Nevertheless, just last week,
Secretary Azar barred the Nation's health agencies from signing
new rules themselves regarding medicines or medical devices as
they normally would do.
Such a major change at this critical time could delay
progress and cause the American people to doubt whether the
proper protocols are being followed. Could you explain why
these changes are taking place and whether they could affect
new medical countermeasures for COVID-19?
Admiral Giroir. Thank you for that, Senator. I have spoken
to several people in the immediate office of the Secretary. And
as I understand it, and I do absolutely believe it, that this
was an administrative decision by the Secretary because
rulemaking authority in an agency that has 90,000 people gets
disseminated broadly and widely and he wanted to make sure that
whatever rules were proposed by FDA or other rulemaking
organizations had review and scientific integrity.
I do not believe that this will interrupt the process. You
have my commitment to make sure that I will provide the best
public health advice to the Secretary on all these matters. I
do not believe it will make a difference. And these can be
redistributed back out. This was an administrative process, as
I understand it, to bring them back in, to gain control so that
there aren't hundreds of different ways to make rules during
this very important time. And perhaps Dr. Hahn, as a rulemaking
agency, might have a comment on that as well.
Senator Collins. I have a different question for Dr. Hahn
that I want to make sure I get to. Let me just say that while I
appreciate your assurances, if everything is going to have to
flow up to the Secretary, it seems inevitable that it is going
to create delays and doubts, and neither of those are helpful
as we deal with this pandemic. Dr. Hahn, I want to bring up
with you an issue that we have discussed many times, and that
is the fact that so many of our active pharmaceutical
ingredients for medicines for the American market are
manufactured overseas.
In fact, 72 percent of the facilities are located overseas
in countries like China and India. India put an export ban on
some 26 APIs. We know that China hoarded PPE that our country
needed. So my question to you is, are we making any progress in
ensuring that the APIs that may be critical in therapeutics for
treating people with the Coronavirus or in the ultimate vaccine
are manufactured right here in the United States and not in
China or India or somewhere else?
Dr. Hahn. Thank you, Senator Collins. You bring up an
incredibly important topic and one that I think has been very
much highlighted during the pandemic. We have seen situations
where the lack of redundancy in our supply chain, the lack of
domestic manufacturing has led to shortages here at home. So we
have been very active and I believe we are making progress with
respect to what we are calling advanced manufacturing.
Now Senator Collins, we have spoken about this many times
and the issue of making sure that we have this redundancy
through advanced manufacturing is important. It is something
that FDA has been involved with for years. With respect to the
issue of medications, for example, and PPE, I know that the
White House task force has been particularly focused through
FEMA and now HHS on making sure that we buildup our domestic
capacity, particularly around PPE.
Yes, those are in progress. It remains a top priority for
the Food and Drug Administration. Our role in this will be to
help to create whatever regulatory path that we can so that we
can facilitate advanced manufacturing that is domestic.
Senator Collins. Thank you very much.
The Chairman. Thank you, Senator Collins.
Senator Warren.
Senator Warren. Thank you, Mr. Chairman. Vaccines are our
best chance to end this pandemic but Americans are not going to
take a vaccine if they do not trust the Federal officials who
are promoting it. If Federal officials stand to gain
financially from certain COVID vaccines and not from others,
then Americans might reasonably worry that the vaccine was
pushed for personal profit and not because it was best for our
health.
I have a question for all of our witnesses, and I think you
can answer with just a simple yes or no. Dr. Fauci, do you hold
direct financial investments like stocks in any of the
companies that are developing COVID-19 vaccines?
Dr. Fauci. No.
Senator Warren. Thank you. What about you, Dr. Redfield?
Dr. Redfield. No, Senator.
Senator Warren. Alright. Dr. Hahn?
Dr. Hahn. No, Senator Warren.
Senator Warren. Admiral Giroir?
Admiral Giroir. No, Senator Warren.
Senator Warren. Okay, thank you. So none of you stands to
get richer if any particular drug company gets money from the
Government. And I am not surprised by your answers because
Federal ethics law prevents you from owning stocks like that.
Public health, not money, guides to your work for the American
people, and that is exactly how it should be.
Dr. Hahn, the FDA is responsible for deciding whether a
COVID-19 vaccine is safe. In your opinion, if the FDA officials
making these decisions had financial conflicts, would that
increase or decrease people's confidence in a COVID-19 vaccine?
Dr. Hahn. Senator, I am not aware of anyone at FDA that has
a conflict related to vaccines who is involved in that
decisionmaking process so it would be difficult for me to
speculate on that since we have very rigorous standards in
place. We have monthly review, particularly of senior
officials. We have regular training. And we have a culture at
FDA which looks at the issue of self-declared as well as Office
of Government Ethics Review of all conflicts. So one thing I
would like to say to you, Senator, if anyone is aware of anyone
at FDA who has a conflict related these, I would personally
want to know because we will address that right way.
Senator Warren. Well, I very much appreciate this, because
what you are saying is that financial conflicts are a real
problem in the drug and vaccine development process. But here
is the problem we have got. Dr. Monsef Slowey, the man that
President Trump selected as the Government's ``vaccine czar''
is a former drug company executive.
The Trump administration used a loophole in Federal ethics
law to hire him to keep his conflicts from the public. Now, he
reportedly owns about $10 million of stock in GlaxoSmithKline
Drug Company that is working on a Coronavirus vaccine. And
according to documents released yesterday by the House, he may
own stock in Lonza Group, which is a company working with
Moderna, another pharmaceutical company that is trying to make
this vaccine. Why does this matter? Well, Operation Warp Speed,
the Federal vaccine project that Dr. Slowey heads up has
invested billions, that is billions of dollars in the companies
that Dr. Slowey hold stock in.
Dr. Hahn, you and other FDA officials involved in the
COVID-19 vaccine must comply with conflict of interest laws.
You have just told me how seriously you take that. So can you
explain to me why Dr. Slowey should get to play by a different
set of rules?
Dr. Hahn. Senator Warren, I can't explain the situation. I
do not have any knowledge of what you describe. What I can tell
you is that we have established a very bright line between
Operation Warp Speed and FDA. We do not participate in their
decisions. We provide technical assistance, just as we would
for any sponsor.
Senator Warren. With all due respect, Dr. Hahn, you just
told me that financial conflicts of interest basically
undermined the publics trust in a vaccine and Dr. Slowey has
conflicts of interest. So to boost the public's confidence,
shouldn't he eliminate these conflicts?
Dr. Hahn. Senator Warren, I am not aware of the conflicts
you are describing. And so I can't comment----
Senator Warren. Let me put it this way, hypothetically, if
these conflicts exist, and we will only know if they exist if
he makes a full disclosure, but there is much evidence that
they exist--if these conflicts exist, should he resign?
Dr. Hahn. In a hypothetical situation that you are
describing, again, I can't prejudge because I do not know the
facts. But I do take very seriously the issue of conflicts of
interest and how that might affect public perception.
Senator Warren. Well, let me put it this way, Congress
should strengthen the Federal ethics laws to root out this kind
of corruption. It should pass the Corona Virus Oversight
Recovery Ethics Act, which is a bill that I introduced in order
to prohibit conflicts of interest in the Federal COVID-19
response. And the first person to be fired should be Dr.
Slowey. The American people deserve to know that COVID-19
vaccine decisions are based on science and not on personal
greed and Congress should pass my bill today. Thank you, Mr.
Chairman.
The Chairman. Thank you, Senator Warren.
Senator Cassidy.
Senator Cassidy. Thank you, Mr. Chairman. I was distracted
when Senator Burr was given his answer, but he may have replied
to Senator Casey. It is as if Senator Casey did not hear
Admiral Giroir's testimony, when he said, what is the
Administration doing to prevent deaths in nursing homes and we
just heard how many resources were being deployed to nursing
homes.
I just want to, in case Burr was not able to raise that, I
just want to emphasize that. Second, coming in on previous
testimony, Baldwin and Redfield. Dr. Redfield, I thought you
answered Senator Baldwin's question very well, and I will say
my office has called OSHA as regards to guidelines for people
who are, for businesses in terms of how to conduct themselves
and OSHA said that they are deferring to CDC. That is not CDC's
fault.
Mr. Chairman, I would just recommend we have a hearing with
OSHA to kind of straighten that out, because I thought that is
a good point. Dr. Giroir, it is my understanding that the
Administration is granting authority to pharmacies to immunize
those between ages 3 and 18. Because of the crisis, we have had
a kind of slowdown in those children. They are missing their
vaccines that they should get. Is there going to be a
requirement that they put these vaccine records in the state's
immunization registry?
Admiral Giroir. Yes, sir.
Senator Cassidy. What about Federal facilities such as DOD,
V.A., Indian Health Service, etcetera? Will they likewise be
required to enter their data into the state's immunization
registry?
Admiral Giroir. Sir, I actually do not know about DOD. I
just do not know that specific. I know that for the
pharmacists, of course, and anyone in the civilian population,
they are required. That was a part of the Prep Act declaration
and my guidance about that.
Senator Cassidy. Just the suggestion, the DOD should be
required, because obviously many of them will be separating
from the military and it may be a condition of employment by a
health care facility that someone be vaccinated. It would be
nice to have that documented as opposed to someone just,
stating that they had been. Just to point that out.
Admiral Giroir. Yes, sir. I wasn't commenting on whether it
is good or bad. I just did not know the regulation for DOD.
Would be very happy to look that up and bring it back, sir.
Senator Cassidy. Oh, yes. And I am not fussing about it. I
am just kind of pointing that up. Now, Dr. Redfield, maybe Dr.
Giroir, I understand that the vaccine can be given without cost
to the patient, but there is a concern by the provider that
they would be compensated for all their costs associated with
administering the vaccine. So in the guidance coming out that
Americans will not have to pay, but is there still going to be
compensation for the provider who is administering the
immunization?
Admiral Giroir. Thank you, Senator. And let me speak
generally that, of course, we would assume that there are costs
for the provider. These are going to be tens or hundreds of
millions of vaccines. There are details to be worked out but
the Administration is committed to assuring that no patient has
out-of-pocket expenses, whether it is for the vaccine itself or
for the administration of that vaccine.
Senator Cassidy. Got you. Dr. Hahn, the vaccine may only
have 50 percent efficacy. I think that is the FDA's minimum as
to considering whether a vaccine is effective, is that it is
efficacious at least 50 percent of the time. Presumably, the
level of antibody response would be a marker as to whether or
not somebody has had a response.
My question is, for those folks who are at higher risk,
think the emergency room nurse, the tech or the clerk admitting
people to the E.R., will antibodies serology be required after
the vaccine is given? And do we have enough antibodies
serologic tests, which were no sufficiently accurate nor
sufficiently available, in order to conduct this?
Dr. Hahn. Senator, thanks for the question. For the first
several trials, when they mature, we will not yet have data
that bridges between a clinical outcome, which is the, of
course, primary endpoint we have required for showing its
effectiveness. That is the prevention of COVID-19 illness and
the development of antibodies. So it is unlikely in that
situation, although again I can't prejudge the data, that we
would have a requirement there. Again, the data will point us
in that direction. For subsequent trials, if in fact there are
bridging data or from the initial trials there is bridging
data, one could imagine a situation where that could occur. But
again, do not know that because we have not seen the data yet,
sir.
Senator Cassidy. Thank you all for your brief answers. I
yield back.
The Chairman. Thank you, Senator Cassidy.
Senator Kaine.
Senator Kaine. Thank you, Mr. Chairman. And I want to just
say a word to you, Senator Alexander, how much I am going to
miss you as the Chairman of this Committee. I have learned a
lot from you about how to be a good Senator, both from working
with you, but also from observing you. And I am going to miss
your friendship and I am going to miss your leadership. I also
just want to acknowledge what it means to have 200,000 people
in this country who are no longer with us. My wife and I have
four friends who died of Coronavirus. We have each had
Coronavirus so I guess we have preexisting conditions now and
hopefully some antibodies that might do something.
I agree with the Chairman. His opening comments said that
as of March 1, The New York Times said and others did to Johns
Hopkins that the U.S. was the best prepared of any Nation to
deal with this. And I believe that. And yet I think the
management, beginning with our preparation and the resources we
have as a country, the management of this crisis has been one
of the worst failures of domestic governance in the history of
this country. And do not believe me. I mean, I am just a U.S.
Senator, but when people who are staffers on the task force are
resigning and saying the same thing, I think we have got to pay
attention to that.
I am also mindful of the fact that during this crisis, not
for a second has this administration stopped its concerted four
year effort to take health insurance away from millions and
millions of people. I can only imagine how much worse this
would be in Virginia if 400,000 people did not have Medicaid
expansion, but many are hoping to see what it will be like if
we take health insurance away from millions of people so we may
have the opportunity to see that.
One of the reasons I think this has been handled so badly
is not because of the dedication of wonderful professionals. I
think we have some wonderful professionals who are very
dedicated, but I think it goes back to communication. I was a
mayor and Governor. I dealt with a lot of crises, weather
crises, hurricanes, mass shootings at Virginia Tech when I was
Governor, H1N1 when I was Governor. None were at the scale of
this.
But one thing I learned from dealing with crises is
communication. Clear communication to people who are worried is
absolutely critical. And that is where we have fallen down on
the job with a President who has preached hydroxychloroquine or
bleach or disinfectant. The day that the Administration laid
out guidelines for states on reopening, my Governor, who is a
doctor, said those are good guidelines, I am going to follow
them. The next morning the President tweeted out a tweet
against them, liberate Virginia against this tyrannical
Governor who is following my advice. And we have seen so many
other examples of poor communication or mixed messages. And
that has really confused the public.
Dr. Fauci, just this week, a key communications staffer at
the NIH had to resign when he was outed as somebody who was in
a conspiracy laden website trashing you, trashing other public
health professionals, trashing your advice about mask wearing,
suggesting that this was just a hoax or an invented crises. My
four dead friends would say it was not an invented crisis.
Dr. Redfield, I was very, very concerned when the CDC
changed its website this week about how the virus is
transmitted. I would like to ask that a slide be put up. This
is going to be very hard to read and so I will sort of bring it
to your attention, but the CDC I believe on the 18th of
September put up new guidance based on just the ongoing
analysis of this crisis about what we could do to protect
ourselves and how the virus is transmitted but then almost
immediately reversed it. What about the September 18th version
that is on that screen was incorrect?
Dr. Redfield. Thank you, Senator. I think what I tried to
comment before that this was a first draft document----
Senator Kaine. No, and I heard that so I don't want to ask
that question. What about it was incorrect?
Dr. Redfield. It is looking at the balance of the component
that aerosolized transmission plays compared to droplet
transmission.
Senator Kaine. Let me read you two examples. The version
that posted on the 18th. People who are infected but do not
show symptoms can spread the virus to others. Clear,
unequivocal. But you changed it back to some people without
symptoms may be able to spread the virus. Now is that phrase,
people who are infected but do not show symptoms can spread the
virus to others, is that inaccurate?
Dr. Redfield. Let me just set the stage here. The document
that it was reverted to was the original cleared document. It
was not a changed document.
Senator Kaine. I understand that but back to my question.
Is it accurate to say people who are infected but do not show
symptoms can spread the virus?
Dr. Redfield. Absolutely they can.
Senator Kaine. That is accurate, isn't it?
Dr. Redfield. Absolutely.
Senator Kaine. The document further said there is growing
evidence that droplets and airborne particles can remain
suspended in the air and be breathed in by others and travel
distances beyond six feet, for example, during choir practice,
in restaurants or in fitness classes. Is that statement
accurate?
Dr. Redfield. There is definitely evidence of that, sir.
Senator Kaine. There is no inaccuracy in this statement?
Dr. Redfield. There is definitely evidence of that.
Senator Kaine. But that was removed in the changed document
and it went back to its original form, which did not----
Dr. Redfield. I just want to highlight that it is not that
anything was removed----
Senator Kaine. Well, it is not on the website right now,
correct?
Dr. Redfield. Technically, the cleared document that went
through the proper channels is what was put up. I can say that
all these decisions about the aerosolize document were made by
career staff individuals far below my level as the Director.
When they saw this non-scientifically cleared document go up--
--
Senator Kaine. Well, I am over my time. I understand. But
the point I am trying to make is we need to communicate
clearly. When you put up a document at the CDC that you have
just testified is accurate and then it is changed to suggest
that the risk is more minimal by someone for some reason, it
contributes to the massive confusion that is so troubling to
scientists and so troubling to people. And then that leads to,
well, gosh, is the vaccine going to be safe?
Dr. Redfield. And again, I just want to stress for the
American public and for everyone here that document that went
up was a draft. It had not been technically reviewed by CDC. It
reverted to the document that was taken and reviewed. There is
going to be a technically reviewed document on this issue
coming on the website but the one that was posted on Friday was
not technically reviewed, and as a consequence, the career
scientists at CDC took it down, put up the technically reviewed
document until the new technology to review document can be
posted.
Senator Kaine. But you testified that the one was taken
down was accurate and that was the point that I wanted to make.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Kaine.
Senator Murkowski.
Senator Murkowski. Thank you, Mr. Chairman. And gentlemen,
I want to echo Senator Collins's comment and her thanks and
appreciation. I share that. I know that there is plenty to
argue and quibble about and whether or not communication has
been clear or not clear. I think we do owe that to the American
public. But I also know that the work that you and those that
are part of your team is hard, hard, arduous work and you have
definitely been put to the task.
I appreciate the work that you do. I want to direct my
questions to you, Dr. Redfield. And first, thank you for CDC's
effort to help our state and local public health departments.
Recently, we had a CDC team deployed to Anchorage to assist us
there with an outbreak of COVID that we had seen within our
homeless population. And you have been--you were quick when
asked, and we greatly appreciate that assistance.
I want to speak about--I want to ask you about the interim
guidance, the interim guidelines that states are considering as
they are drafting these plans to be submitted for mid-October.
And it goes to Senator Kaine's comments about the communication
and the need for additional clarity that I am hearing from my
state, specifically in the allocation, the first allocation of
the vaccine in terms of the jurisdictions and who is to receive
that. It states, but, for instance, the tribal health system is
that its own jurisdiction for purposes of allocation.
When we talk about critical populations, it is my
understanding that the first phase is going to be allocated
based on targeting these critical populations. Well, in Alaska,
we have got about one quarter of our population Alaska Native
that could be determined to be 18 percent, determined to be
critical population. And then further to additional guidance on
what qualifies as a health care worker.
In our state, our community health aides are some of those
frontline workers. Can you help me with further clarification
for purposes of the state's plan on guidance with allocation
and defining critical populations?
Dr. Redfield. Thank you, Senator. Obviously critical
questions. I will say at this moment in time, the definitive
answers in terms of the allocation process have not been
completed. I do take Senator Kaine's and your comments to heart
how important it is that when that is completed, that it is
communicated in an effective way. That we are currently going
to see the plans, as you know, from each of the states, how
they would propose to allocate. The prioritization of how this
vaccine will be distributed will depend on which vaccine and
what the data says.
But that decision, ultimately, the recommendation will be
the advisory committee of immunization practices that will give
that recommendation once they know what vaccine they are
recommending it for. But I will reiterate the comments from
this hearing back to Operation Warp Speed, as that allocation
decision is made, that it is communicated effectively.
Senator Murkowski. That allocation decision, can you
confirm that it is the CDC that is responsible for determining
that allocation?
Dr. Redfield. The allocation will be, the decision will be
made by the Operation Warp Speed is what I would believe--what
will happen, though, is that the ACIP, which is an advisory
group to me as the Director of CDC, will recommend the
prioritization of who should be vaccinated.
As you said, should it first be all the individuals that
are vulnerable in nursing homes? Should it be health care
workers? If so, what kind of health care workers? Should it be
Native Americans, African Americans, Hispanics, a greater risk?
I can't get ahead of the ACIP----
Senator Murkowski. Let me interrupt to ask just one more
question of you here. I have got the direction that you are
going with the definitions there in terms of critical workers.
We have talked before about the public health IT
infrastructure. I think we recognize that certainly in a state
like mine, it has been pretty tough when you are faxing,
literally faxing the results of your COVID tests.
It is not just Alaska, the State of California, it is a
mess out there. What is the Administration's plan to ensure
that states have the support that they need for the
requirements on reporting for this new vaccine? Because we are
concerned in our state that we are not prepared for the level
of reporting that will be required. We do not mind the
reporting, but we are not--we do not have the infrastructure,
if you will, right now on health IT--.
Dr. Redfield. Yes, that is going to be a very important
part of the plan that each of the states' jurisdictions, the 64
make. In addition, there is plans within the Operation Warp
Speed to augment IT capacity where there are gaps. But again,
in order to see that, we are going to see the states' plans. I
did release $200 million today for the states to begin to
develop those plans and really identify those gaps that they
have so then hopefully there will be further resources to begin
to fill those gaps, because it is going to be very important
that we do have the reporting for the monitoring and safety of
these vaccines, as well as to make sure that we can distribute
this vaccine in an effective way equitably to the American
public.
The Chairman. Thanks, Senator Murkowski.
Senator Hassan.
Senator Hassan. Let's see if I can get that on. Thank you.
Thank you, Mr. Chairman. I want to thank Chairman Alexander and
Ranking Member Murray for holding this hearing. I know he
stepped out to vote, but I want to thank the Chairman for his
service and his example as a Committee Chairman. And I want to
thank our witnesses for being here today. And I want to
especially thank you all for wearing your masks, even though
your six feet apart, because there has even been some confusion
in this body about what the best practices were inside with
others, so thank you for the example you are setting.
I am concerned that Americans are losing confidence in the
Federal Government's COVID-19 vaccine review process. An ABC
poll from this past weekend found that 69 percent of Americans
will not have confidence in the President vouching for a
vaccine. And we have seen other data reflecting that lack of
confidence in vaccine approval process. FDA and CDC have
existing vaccine review processes that are considered the gold
standard by public health experts all around the globe. We have
to make sure that these proven review processes take place in a
transparent way, free from political influence.
Let me start with a question to you, Dr. Hahn. There is
widespread concern about the independence of FDA's COVID-19
vaccine review process, in large part due to your own actions
and inaccurate statements over the past several months.
Last week, you received a letter from more than 90
physician groups, doctors and public health experts asking you
to ensure that any vaccine approvals or authorizations are
based on facts and science and free from political influence.
And Mr. Chairman, I would like to enter this letter into the
record, without objection.
The Chairman. Without objection.
Senator Hassan. Thank you. Dr. Hahn, I appreciate the work
that the FDA has done to draft new guidance for vaccine
products seeking emergency use authorization. I look forward to
reading that document. I would like to ask a couple of
clarifying hit questions based on what you have outlined
earlier in your testimony. In addition to the general meetings
scheduled for October, will the guidance require that FDA's
Vaccines and Related Biological Products Advisory Committee
hold meetings, review clinical trial data, and release their
findings to the public for each vaccine candidate?
Dr. Hahn. Senator Hassan, we are committed absolutely to
having meetings that will be scheduled, we will be flexible
about those, of the Vaccine Advisory Committee. And as I
mentioned in my remarks, they will be transparent. The clinical
data and summary that we provide the Committee will be
transparent and known, and it will be public.
Senator Hassan. Right. What I am asking for is will you do
it for each of the vaccine products?
Dr. Hahn. Yes, Senator.
Senator Hassan. Will the findings be made public before the
FDA approves or authorizes any vaccine product?
Dr. Hahn. It will be a public process. The vote, the
discussion, and the recommendations will be public and we will
incorporate those and then make our decision.
Senator Hassan. Alright. So it will happen before?
Dr. Hahn. Yes, ma'am.
Senator Hassan. Okay. Now to Dr. Redfield, my office has
heard from clinicians across the country about the importance
that they place on CDC recommendations when determining whether
they are comfortable giving a vaccine to their patients. I
talked with a long serving and practicing pediatrician in New
Hampshire yesterday, and one of her concerns is how will they
know about what dosages to use for children, for instance.
Will CDC's advisory committee on immunization practices
meet publicly, review data, and issue public recommendations,
again, for each COVID-19 vaccine before it enters the market so
health care providers are confident giving these vaccines to
their patients?
Dr. Redfield. It is very important that the advisory
committee accusation practice will conduct their deliberations
in public. The only caveat is when there is national security
interests, which should not be the case here, or if there is
proprietary information on the commercial side. But you should
anticipate this will be a public discussion.
Senator Hassan. I am going to ask you for the same
commitments I asked Dr. Hahn. Each product?
Dr. Redfield. Each product.
Senator Hassan. Before the approval, it will be made public
or the recommendations will be made public before the approval?
Dr. Redfield. The ACIP will make those recommendations
after the FDA recommends an EUA or BLA. Then they will
deliberate how the vaccine should be used in the United States
and that will happen in public.
Senator Hassan. Before they are distributed?
Dr. Redfield. Before it is recommended to be used for the
American public.
Senator Hassan. Thank you. Dr. Fauci, do you believe that
the existing FDA and CDC advisory committees should conduct an
independent, transparent, evidence based review of safety and
efficacy data for each vaccine product seeking approval or
emergency authorization? And could those independent meetings
help improve public confidence? We have heard commitments about
them. I just would love your comments about it.
Dr. Fauci. Yes, I agree, Senator, with Dr. Hahn, that is a
process that occurs and they do have an independent look at
that and they are advisory to the FDA. The FDA makes the
ultimate decision but what they do will be public. And I as I
have said myself, not only do you have a very qualified
advisory committee in VRBPA, but you also have the entire
scientific community that is going to be scrutinizing this
because it will be made public. And for that reason, I have
confidence in the process.
Senator Hassan. Well, I thank you. And I thank you, Mr.
Chairman. Senator Murkowski and I have legislation that would
ensure that the processes that you have committed to will be
followed. And I look forward to working with you on that. Thank
you, Mr. Chairman.
The Chairman. Thank you, Senator Hassan.
Senator Romney.
Senator Romney. Thank you, Mr. Chairman. And thanks to the
members of this panel for the work that you have done to help
safeguard as many Americans as possible from this terrible
infection. Dr. Hahn, you surely speak with the pharmaceutical
companies and get a sense of what progress they are making on
their clinical trials. When do you believe that you will
receive the first application? Is this something that is going
to come in the next couple of weeks? Are you getting any
indication it might be a couple of months? What kind of
timeline are you anticipating before you will receive your
first application?
Dr. Hahn. Senator Romney, thanks for the question. I
honestly do not know when we will receive our first
application. As I mentioned earlier----
Senator Romney. Of course not. Of course not. You would not
know. But you are speaking with them. Are they getting close to
the results from the 30,000? Are they just getting going? Is
this--have there been any applications that have been sent to
the DSMB? So is it getting close or is it going to be, a month
or two from now?
Dr. Hahn. Senator, I cannot speak to confidential
commercial information that we have. From the publicly
available data, the enrollment is going as expected in these
clinical trials, and in the case of one, has exceeded where
they expected to be with respect to the 30,000. When they
submit an application, it will be dependent upon when events
occur in this trial, including or involving prevention of
infection. When those events occur, and at prespecified time by
the DSMB, that is when the first judgment will be made about
the maturity of the data. And I can't prejudge that. I do not
know.
Senator Romney. I know you can't predict, but you are
getting an indication as to whether they are receiving those
things or not. And have any applications been received by the
DSMB at this point?
Dr. Hahn. I do not know the answer to that, sir.
Senator Romney. Well, they would not let you know that
whether they received an application?
Dr. Hahn. The--you mean the sponsor, sir?
Senator Romney. No, the DSMB.
Dr. Hahn. No, I do not know the answer to that question,
sir.
Senator Romney. Okay, let's say that tomorrow morning the
application is received, how long typically is the process
inside the FDA to go from the time you receive an application
until you make a determination of yes, let is go ahead?
Dr. Hahn. Typically that process can take weeks, sometimes
months. It really depends upon the complexity of the data and
the dataset that we are looking at. We have not made a
commitment to the timeline, per say, because we have not seen
the data and we do not know the complexity of the data or the
amount of data that will come our way. What I can tell you,
sir, is we do feel the urgency of the moment. We do take very
much--very seriously our responsibility to protect American
lives. And we will not delay, but we will not cut corners in
our process.
Senator Romney. Okay. Dr. Fauci, I think everybody is very,
very pleased with the fact that our Government has proceeded
with manufacturing vaccines, even though we do not know whether
they are going to work or not. And that is something we will be
able to have vaccines to the American people as soon as
possible.
If the FDA were to approve an application let's say on
November 1st, how long would it take for the American people to
get vaccinated? Maybe I will change that to say, what
proportion of our population, if it were approved on November
1st, what proportion of our population would be able to be
vaccinated, let's say, by the end of the year? That is a two-
month period.
I do not know whether these manufacturing facilities are
producing 100 million vaccines right now or 5 million or 10
million. So is this something that would really just go to a
small subset of the population or could we possibly inoculate
the great majority?
Dr. Fauci. Well, good question, Senator. The fact is that
the production as it is rolling out, and when you hear the
numbers, that is the totality of all of the companies, so that
in November you will probably be, maybe 50 million doses
available, by December, maybe another 100 plus million. And
then when you get into January, February, by the time you get
to April, they will be a total of about 700 million.
If you are talking about who is going to get vaccinated in
December or November, it is not going to be a large proportion
of the population. It will be, according to what we were
discussing before, namely those who are, according to the
Advisory Committee on Immunization Practices, getting the
priority. Likely it will be health care providers and likely
will be those who are vulnerable with underlying conditions.
I can't say that for certain, but if anything is the past
prologue and that likely will be the case. But we are not going
to have all of the doses available, for example, by the end of
December. They will be rolling in as the months go by and by
the time you get to maybe the third or fourth month of the
2021, then you will have doses for everyone.
Senator Romney. Thank you.
The Chairman. Senator Romney, thank you.
Senator Smith.
Senator Smith. I want to thank Ranking Member Murray and
Chairman Alexander, if you are back for your final hearing, I
understand. It is really incredible. Dr. Redman I wanted to--
Dr. Redfield, pardon me. I wanted to follow-up on something you
have said. You have said that you thought that the vaccine--
that when you have a vaccine, that it would be distributed
broadly by the second quarter or the third quarter of next
year. And you also said that you thought that masks were the
most effective tool that we had to stem the spread of the
virus. So you still think that is true, right? You stand by
that?
Dr. Redfield. Thank you, Senator, for the opportunity. When
it comes to the question about masks, first I want to say I
have total confidence in the importance of vaccines. And
ultimately, it is going to be the vaccines that are going to
get us back to the way of life as we get an effective vaccine.
What I was trying to comment, as Senator Kaine alluded to, if
the vaccine only induces an immune response in half the people,
then it is conceptual that half the people may not get
protection from the vaccine. And what really I was trying to
say maybe was just to re-emphasize how important this mask is.
We have this right now and it will protect the American public.
The second question you asked was that Dr. Fauci was very
clear in using the term doses and we should have, if projected,
about 700 million doses by April, late March. And that should
be enough to vaccinate 350 million people because you require
two doses. When I was alluding to late second quarter, early
third quarter, I was alluding to how long I felt it would take
to get those 700 million doses into the American public and
complete the vaccine process.
I can defer to Dr. Fauci for his opinion, but I think that
is going to take us April, May, June, possibly July, to get the
entire American public completely vaccinated. But we will have
the 700 million doses based on projection by late March, early
April.
Senator Smith. I appreciated that and I appreciated that
you were pointing out, as we have this sort of in some way the
sort of this political campaign against masks that masks are
going to continue to be important, contact tracing, and testing
will continue to be important as we go forward. And I
appreciate that what you were saying, actually. My question is,
Dr. Redfield, did you get any political pushback for saying
what you said?
Dr. Redfield. I stand by trying to present the data and the
science as I see it, and I will continue to do that.
Senator Smith. But did you get any political pushback from
political folks within the Administration for what you said?
Dr. Redfield. Again, I am going to just stay with my
comment that I will continue to present science and data as I
see it. And it is not going to be modulated by whether
individuals really appreciate what I say or do not appreciate
what I say.
Senator Smith. Didn't the President say that he called you
to complain to you about what you said?
Dr. Redfield. Again, I am not going to comment on my
conversations with the President.
Senator Smith. Alright. Well, that is--I think that this is
the thing that worries, I think, so many Americans. But let me
ask about something else. To the panelists, Senator Cassidy and
I are working on a bipartisan bill which is called the Suppress
COVID-19 Act, which would invest in testing and contact tracing
and what we need to do to suppress this virus. And it would do
this by empowering states to work together through interstate
compacts to accomplish this.
Mr. Chairman, I would like to enter into the record
bipartisan Op-ed that Senator Cassidy and I wrote with Dr.
Daniel Allen that appeared in The Washington Post for the
record, if I could.
The Chairman. Without objection.
Senator Smith. Dr. Fauci, will we still need COVID-19
diagnostic testing and contact tracing even after we have a
vaccine and even after that vaccine is available to the public?
Dr. Fauci. Thank you, Senator, for that question. The
answer is absolutely, because a vaccine, depending upon the
degree of efficacy and depending, as Dr. Redfield just
mentioned, depending on the people who ultimately decide they
want to get the vaccine, you are still going to have vulnerable
people in the United States, which would require not only
testing, contact tracing, but an implementation of the public
health measures that we have been talking about all along.
The vaccine availability will go a giant step to
controlling the infection, but you are not going to completely
eradicate or eliminate it, particularly if you have a vaccine
that is even moderately effective, 75 percent. If you do not
have a vaccine that is 98 percent effective and everybody takes
it, you are still going to have vulnerable people in the
population.
The presence of those vulnerable people will require the
implementation of public health practices, including testing,
identification, isolation and contact tracing.
Senator Smith. Continuing to wear masks and practice good
social distancing and other public health strategies that we
that we know work to keep us safe.
Dr. Fauci. Absolutely.
Senator Smith. Great. Thank you, Mr. Chairman. I am out of
time.
The Chairman. Thank you, Senator Smith.
Senator Braun.
Senator Braun. Thank you, Mr. Chairman. Yesterday, we
reached a sad milestone. We have recorded over 200,000 COVID
related deaths in the U.S. I want to go back to the beginning
to look at where we started and where we are now. I think it is
important for the American people to understand and remember
what the context was. When this outbreak began, where we are
now, and that the President called on the American people to
come together by shutting down the country for 45 days to avoid
the catastrophic models calling for millions of deaths by
August 1st.
On March 16th, President Trump issued guidelines for
Governors calling for a partial shutdown of 15 days to slow the
spread. By March 29, it was clear the President, again,
followed the advice of the task force and called for an
additional 30 days of shutdown to slow the spread of COVID-19.
Dr. Fauci, I have several questions for you, and a yes or no is
fine unless you want to elaborate further.
Then one final question for Dr. Hahn. During those critical
days in March, was it your recommendation and that of the task
force for President Trump to issue the guidelines to shut the
country down for 45 days?
Dr. Fauci. Yes. I would not use the word shut the country
down. It was to implement separation, avoiding contact, all the
kinds of things we did in the recommendation. The short answer
to your question is yes.
Senator Braun. Thank you. Let's look at the chart over
here. This was used by Dr. Birx at the task force briefing on
March 31st. We can all see what Dr. Birx called the giant blue
mountain that predicted over 2 million deaths without
mitigation efforts. And the stippled foothill that shows a
range of 100,000 to 240,000 deaths if we took the drastic
actions to put the mitigation into effect, which did require
some shutting down the country.
Did you and Dr. Birx explain at March 31st briefing that
initial projections from the health experts showed that if we
did not act, the death tolls by August 1st could exceed a
couple of million?
Dr. Fauci. Yes, that is what we presented based on a model,
sir. It is a model.
Senator Braun. Sure. And was the goal of the national
mitigation effort to bring the projected death tolls down from
over 2 million to the range of 100,000 to 140,000?
Dr. Fauci. Yes, with an exception, because as I mentioned
at a press conference associated with that, I said the model
would say it would go down but I do not think we should be
accepting that. That we could likely do much better. If I could
just have 20 seconds more, I will explain it, because if we had
done the kinds of things uniformly and consistently throughout
the country of the recommendations of the gateway, phase 1,
phase 2, phase 3, what would have happened is that we would
have had less than that.
We know that some states did a good job. Some states did
not so good a job. Some states tried to do a good job, but
people did not listen. We saw pictures of people congregating
at bars with no masks. So even though the models said that
likely would be the number of deaths, I and my colleagues
always said we should strive very hard to not reach that number
if we did the public health measures that we were talking
about, masks, physical separation, etcetera.
Senator Braun. Outside of that qualification, which I think
it is admirable to try to always best what you think might be
the case, do you think the actions of the American people and
the actions of President Trump and the task force at least hit
where you were hoping, notwithstanding the qualification that
you made?
Dr. Fauci. Yes. What we did show and we know the data, and
that is very important because it helps us to look ahead, that
the kinds of things that were put into effect, the mitigation
going from the control as well as mitigation, we believe have
saved a lot of lives.
Senator Braun. Would you agree that the task force and the
President took the outbreak very seriously from the beginning,
taking unprecedented action, saving millions of American lives
as a result?
Dr. Fauci. Yes. I mean, obviously, I think one of the first
things that we had said and discussed before was the shutting
off of travel, for example, from China. And then second, after
that, we did it at a time, for example, when we were getting
cases from Europe, which actually seeded the northeastern part
of a country, particularly the New York metropolitan area.
Senator Braun. I think the importance of that is
understated in terms of those early decisions, what impact they
did have. As we can see from this chart poster, quick Google
search will reveal that the President and the task force told
the American people on March 31st millions could die if we did
not follow the White House guidelines. If we did everything
optimally, then we would be where we are today.
If we want to ask the American people to continue to take
the virus seriously and keep making sacrifices in their daily
lives until we have a vaccine, then do you think the media,
politicians and scientists like you need to do a better job
reminding the American people about the blue mountain warning
of millions dead and how their collective actions will continue
to save lives?
Dr. Fauci. Yes, Senator. In fact, virtually every time I am
in public and given the opportunity to talk about this, I
continue to stress the four or five things that if we all did
and we did it consistently, we would not only prevent the
surges that we have seen, but we would also get those surges
down, as we are seeing in different parts of the country now
where cases are starting to come down.
Some of the areas of the country that are doing it well are
seeing a good control and others are not. I think we need
uniformity throughout the country of a consistent adherence to
the public health practices that we talk about.
The Chairman. Thank you, Senator Braun.
Senator Jones.
Senator Jones. Alright----
The Chairman. We will fix it.
Senator Jones. Okay. Thank you, Mr. Chairman, and thank you
for having this hearing, but also thank you for your service on
this Committee. I want to thank all of our witnesses for being
here today again. We always appreciate you being here. I want
to first comment something that Senator Kaine said. I think he
was referring to Dr. Redfield's testimony about the importance
of timely and effective health care, the ability to get health
care. And Senator Kaine noted, he would not know what 400,000
Virginians would have done had they not had the benefit of
Medicaid expansion.
I can tell you, Senator, unfortunately, I have got to
almost the same number in Alabama, 400,000 who did not have
that benefit at all because Alabama refused to expand Medicaid.
And I still can not get folks to seem to understand the
importance of giving states like Alabama that opportunity with
Federal incentives again. But that is for another day. I would
like to--I think it is pretty clear, gentlemen, that one of the
concerns a lot of people have on both sides of the aisle is
this mixed message going back and forth, and it is really
difficult.
Since the very beginning of this, I have tried to tell
people in Alabama, listen to the health care folks, do not
listen to politicians, listen to the health care folks. Every
week at the beginning in April, I had a Facebook live with
media that we broadcast. Dr. Fauci was gracious enough to join
me for one of those which I really appreciated. But it has
gotten more difficult, I am sure you can see. And it has gotten
more difficult as we approach the election.
Dr. Hahn, the President at one point said in a news
conference that the FDA wanted to limit the use of the
convalescent plasma until after the election and he tweeted
that there was a deep state within the FDA that is making it
difficult for drug companies to get people involved in order to
test vaccines. And his chief of staff said that the President
wanted to make the FDA feel the heat, which I am not sure
exactly what that meant. But, Dr. Hahn, you said that you have
every confidence in the scientists and staff at FDA. And I
appreciate that. And I do, too, by the way. Is there some kind
of deep state that you have seen in the FDA that is in any way
trying to do anything other than quickly get a vaccine, get
therapeutics to the American public?
Dr. Hahn. Senator, I will answer your question this way. I
have 100 percent confidence in the outstanding scientists,
doctors, nurses, pharmacists at FDA who have remarkably stood
up during this pandemic to help expedite getting medical
products to the American people. I have complete confidence in
their decisions and I have complete confidence in the actions
that have been taken today.
Senator Jones. That confidence is based on following the
science, not any political pressure. And that is what we are
expecting with a vaccine of approval.
Dr. Hahn. Yes, sir. And I have said that several times
today, and I appreciate the opportunity to say it again. Our
career scientists for any medical products and particularly
vaccines will follow the science and data and our rigorous
standards and it won't be politics that make any part of that
decision, sir.
Senator Jones. Great. Dr. Redfield, a similar question with
you. You said in your testimony that you--and all of you have
in one way or another continued, every time we have talked,
every time you have been here, you have continued to tell the
people wear mask, social distance, wash your hands.
Dr. Redfield, you said today you have added a fourth, be
smart about crowds, but yet we see time and time again in
political gatherings and to not be partisan here in public
protest, peaceful protests, folks aren't doing that. They are
not doing that. And in fact, some are being encouraged not to
wear masks, not to do anything. What is the public to do when
you have got public officials and others that are giving a
different message from what you guys are doing?
Everybody has been pretty consistent. But we have got clear
messages coming from the President and folks on both sides of
the aisle, in my opinion, that it is okay under the
circumstances if you want to ignore those guidelines. We do not
know whether those people are washing their hands or not, but
we know that most of them are not wearing a mask and not social
distancing, and they are certainly not being smart about
crowds. What do we do? How do we get the information to our
people?
Dr. Redfield. Thank you very much, Senator. Again, we have
to just keep stressing what I have said before that we want all
Americans, all Americans to embrace wearing a face mask, be
smart about social distancing and crowds, wash their hands, and
obviously, I have confidence in the flu vaccine. If we all wore
a mask and we were smart about social distancing, as Dr. Fauci
alluded to, this outbreak would really start to come under
control. This simple, simple decision--but unfortunately, it is
not something that 75 percent of us can do and we are going to
get the results we want.
This is something that we all have to do to get the results
we want. And we will continue to stress that. I want to add,
how disappointed I have been personally when people at HHS made
comments that they felt that there was a deep state down at
CDC. I will tell you, these are dedicated men and women that
are confronting the greatest public health crisis of our time,
working 24/7, over 6,700 of them involved in the outbreak
itself, 1,200 deploying, and it is offensive to me when I hear
this type of comment.
I think in my 21 years, 22 years in the military, you never
knew people's political perspective. I would say that is the
same about the men and women at CDC. They are dedicated to
protect the public health of this Nation. And I know that you
all appreciate that. I would obviously, people do not
understand the ability to suck energy out of people that are
working 24/7 when they get unfairly criticized or unfairly
characterized. And really, that is the real harm in all of
this.
Senator Jones. Thank you. Thank you very, very much for
that. I completely agree. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Jones.
Senator Rosen.
Senator Rosen. Thank you, Mr. Chairman. And again, I want
to thank everybody on the panel for just everything you and
your teams are doing to save us from this pandemic, move us
forward with therapeutics and vaccines and back to our regular
lives. But, my office has heard from a number of our local
health departments in recent weeks about the challenges that
they continue to face, not only in addressing COVID-19, but
appearing to combat COVID alongside the seasonal flu, which is
just about to begin.
As we enter flu season, we are again faced with that
preventable public health crisis. But this time we can avoid
catastrophe by adequately supporting our medical officials on
the ground with the resources they need. Dr. John Novak, who
leads the Washoe County District Court of Health in Northern
Nevada recently explained the critical need to address both flu
and COVID prevention, saying the flu vaccine this year is very
COVID related since they are both respiratory diseases. Initial
symptoms extremely close in pattern. The flu season fast upon
us is extremely important to reduce the number of flu patients
that need the same overtaxed medical care.
Dr. Fauci, could you just please explain, if you will, the
importance to keep current planning of flu shots and our COVID
response. And maybe we should be providing things at the same
rate before we get a vaccine or something like that,
individuals at the same location drive up. How are we going to
do that?
Dr. Fauci. Yes. Well, thank you for the question, Senator.
First of all, I want to just emphasize what your health
officials already have mentioned to you, the importance of
getting an influenza vaccine, because what we do not want is
two conflated respiratory infections at the same time as we
enter into the fall and the winter. We want to get as many
people vaccinated with the flu vaccine as possible.
The logistics of how you can get them done together, I do
not think I can comment on that right now. Perhaps Dr. Redfield
can. But one of the things I do want to mention, because we
have seen that in Australia as well as South Africa and
Argentina, is that if we continue to do what each of us have
been saying regarding the kinds of preventive measures of mask
wearing, social distancing, avoiding crowds, washing hands,
etcetera, if we do that as we get into the fall in the winter
for the purpose of COVID-19, it is likely to have a positive
impact on the infection rate of influenza because our
colleagues in the southern hemisphere, particularly in
Australia, have found because of that, they have had a very,
very low, mild influenza season.
If we could combine the vaccination as much as we possibly
can with influenza, together with the public health measures,
hopefully we can have a very, very low level of flu that would
not then complicate what will clearly be a challenge in the
winter with COVID-19. Thank you.
Admiral Giroir. Senator, I am sorry--.
Senator Rosen. I appreciate that. I want to--I just have a
minute left. I want to ask about some interesting research, and
any of you can take this if you know about it. I have been
seeing some information come out recently about the Bradykinin
peptide and how it is overactive it causes inflammation that
could be part of the reason that COVID 90 causes this fluid
buildup in the lungs. Anybody could take this. And we have been
talking about that research. And is that really going to be
helpful? I know that there are drugs out there to help reduce
this kind of--well I am not sure if it is inflammation, but
attack this kind of response. Maybe someone wants to take that
question and is that a good possibility for treatment?
Dr. Fauci. Yes. Real quickly, there are a number of
interventions to block and blunt the overactive inflammatory
response, which is relevant as you get into advanced disease.
Dexamethasone, which I mentioned in my opening comments, is a
commonly used steroid which blocks inflammation. There are a
variety of other trials that are either ongoing or being
prepared to look at blocking a variety of other inflammatory
indicators, such as cytokines, IL-6 and a variety of others.
These are things that are being actively pursued. There is
no evidence thus far, except for the dexamethasone evidence,
that by blocking inflammation you can actually help people with
advanced disease and actually decrease mortality. So it is one
of those things that are involved in blocking inflammation.
Senator Rosen. Thank you, I appreciate that. And I
appreciate everything that you are doing. I look forward to
speaking to you again and hopefully going to continue to get
positive news. Thank you.
The Chairman. Thank you, Senator Rosen. We will go to
Senator Murray now for her closing questions or remarks and if
Senator Loeffler returns from voting in time, we will go to her
next and then we will close the hearing.
Senator Murray.
Senator Murray. Well, Mr. Chairman, thank you. I will
submit my additional questions for the record. I would like to
thank all of our witnesses for joining us today. And Senator
Alexander, you announced earlier that this would be the last
hearing of the HELP Committee that you Chair and I just want to
start by saying, it has been a pleasure to work with you to
lead this Committee over the past several years and through
many critical challenges for our country. From working to
address the opioid crisis, supporting medical innovation,
replacing No Child Left Behind, there is a lot we have gone
through.
We have been able to do a lot of that by listening to each
other, and most importantly, listening to the people in our
states about what they need. So I just want to say, I think
that I speak for every one on my side of the aisle when I say I
am very proud of the work we have been able to do together with
you on the other side of the dais. And this may be our last
hearing, but just know I appreciate all you have done and will
continue to do. I want you to know I am going to continue to
follow our response to this pandemic very closely. I will
continue pressing for answers, including on issues like whether
our meat packing plants have accurate information, as Senator
Baldwin raised earlier, given what has happened in my state and
others. We need answers on that.
I am also going to continue demanding a full comprehensive
plan to finally get testing where it needs to be and fully
prepared to make sure we develop, manufacture, distribute and
administer a safe, effective and trusted vaccine. I am going to
continue to push back against every effort from this President
to interfere in our response and put politics over science and
public health. I will continue to call out misinformation or
lies or conspiracies and work to make sure we are communicating
clear, science based facts to people in this country.
I am going to urge our Republicans to come back to the
table and negotiate in earnest so we can finally pass the kind
of sweeping relief our communities really need. Despite
President Trump's careless claims that we are rounding the
final turn or that this disease affects virtually nobody, we
know the painful reality is that this crisis has tragically
killed over 200,000 Americans already and that it is far from
over. So our work to respond to it cannot be over either. Thank
you, Mr. Chairman. Thank you for the time.
The Chairman. Thank you, Senator Murray, and thanks for
your kind remarks and I expressed, again today, how much I
appreciate our friendship, your diligence, and your leadership,
which has been absolutely crucial to the considerable results
that have come out of this Committee, especially over the last
six years. So thank you very much for that.
Senator Loeffler.
Senator Loeffler. Thank you, Mr. Chairman. And I want to
start by thanking each of you here today. I want to thank you
and your workforces for the tremendous work, the effort that
has been done to combat this virus. Dr. Redfield, this question
is for you. I wanted to touch on the subject that I feel has
been overlooked as we continue to confront the pandemic. That
issue is mental health, particularly in younger populations and
the frontline.
Yesterday, I had the opportunity to be briefed by Dr.
Deborah Houry. She is the Director of the National Center for
Injury Prevention and Control and also one of your colleagues
at the CDC. And we spoke on the rising mental health issues due
to the pandemic and particularly suicidal ideation. We spoke
about the importance of comprehensive community level outreach
programs to prevent this issue from growing worse. The CDC is
funding several different programs that are aimed at this goal
and the CDC is comprehensive suicide Prevention Program is
currently funding nine grant recipients in different states to
a COVID suicide prevention funded project in Georgia, in my
state, that is being run through your Department of Public
Health.
The question for you is, what more can we do on the Federal
level to shine a light on this issue and make sure that these
communities have the resources they need to have comprehensive
outreach and to ensure that we are not turning a blind eye to
the critical issue of mental health that so many are facing due
to this pandemic? Thank you.
Dr. Redfield. Thank you very much, Senator. It is a very,
very important issue, and I am glad Dr. Houry had the
opportunity to brief you. On one of our recent survey, it was
surprising that over 30 percent of Americans are feeling
anxiety and depression as part of the COVID experience. And we
have seen, sadly, an uptick, particularly in adults in suicide.
One of the reasons I was so aggressive in reminding the
American public that the public health interest of K through 12
is best served by getting kids back to face to face learning.
Many people may not realize that over 7 million children get
their mental health services in the context of schools. We
also, unfortunately, I have seen an increase in substance abuse
and drug use disorder that has been associated with this COVID
situation, some of which has been driven by the lack of
availability of medical appointments when the health industry
basically pulled back to help manage people that had chronic
pain syndrome or were recovering from drug use disorder.
It is a very important issue. I think we do have to keep
it--we did start, you have probably seen it on TV, how right
now initiative to let people know that it is not stigmatizing
to say that you are not doing well, that you are depressed or
you are suicidal. These are medical conditions, like I have
argued about on drug use disorder. These are not behavioral
issues. These are medical conditions. They need to be treated
as medical conditions. And, I think it is one of the collateral
damages that we saw as part of the COVID pandemic.
Senator Loeffler. Thank you. I will yield my time.
The Chairman. Thank you, Senator Loeffler. We will wrap up
the hearing now. I have just three or four questions about the
vaccine, which I will start with Dr. Fauci, but any of the
others who want to answer it--pretty simple questions, but it
may be important for the American people. One is, and I have
had people say this to me, Dr. Fauci, if I take a shot to get
the vaccine, does that give me COVID?
Dr. Fauci. Absolutely not. That would be impossible.
The Chairman. That would be impossible?
Dr. Fauci. Yes, sir.
The Chairman. One of the risks of a vaccine shot is not
getting COVID?
Dr. Fauci. That is correct. That risk does not exist.
The Chairman. Will the vaccine for COVID, will it likely be
more like the polio vaccine or the flu vaccine? By that, I mean
if you take the polio vaccine, you assume you will never get
polio. If you take the flu vaccine each year, it is sort of a
guess about whether the vaccination really will be effective.
And I think it also helps speed the cure, if you do get sick,
but it may not be more than 50 percent effective. So is it more
like the polio vaccine or the flu vaccine or do we know that
yet?
Dr. Fauci. We do not know that yet, Mr. Chairman. And that
is one of the things that we will learn. Polio is a highly,
highly effective vaccine that gives long lasting protection.
What we do not know yet is how effective the COVID-19 vaccine
will be nor do we know the durability of the protection, how
long it will last. We will find out the answer to those
questions through the clinical trials and the follow-up of the
clinical trials.
The Chairman. Will the vaccine be free when it is
distributed and administered to Americans?
Dr. Fauci. We have been assured that, in fact, the American
public will not have to pay for the vaccine. We have been told
that at the level of the task force.
The Chairman. When we are talking about vaccines, are we--
most of the six vaccines, we are anticipating that you would
have to take two shots about 4 weeks apart. And then the
effectiveness of the vaccine might be 2 weeks after that, or is
that wrong?
Dr. Fauci. It varies from candidate to candidate. For
example, the Moderna and the Pfizer, which are out there now,
are two shots, a prime and a boost. One is the boost at 28
days. One is a boost at 21 days. Whereas the J and J, or
Johnson is a single shot.
The Chairman. Well, I want to thank all four of you for
what many of the Senators said today, which is extraordinarily
able and dedicated service to our country. And what I have
heard today is that we are in an unprecedented sprint toward
success in terms of first vaccines. The polio vaccine took more
than 10 years. Other vaccines we are familiar with took a long
time. But what the Administration is telling us is that we
likely will have a vaccine approved within a year from the time
it was first developed.
We know that we will have tens of millions of doses of a
total of six vaccines ready for distribution once it is
approved. We have also heard that we have five treatments, that
if you get COVID-19, there are five medicines for it and that
there are more coming, likely. And the most promising may be
the so-called antibody cocktails that were used so effectively
with Ebola. And we have also heard that despite a bumpy start
with a diagnostic test at CDC at the beginning of the year,
that we have had an explosion of quick diagnostic tests. And
the Administration, for example, has bought up 150 million of
the Abbott tests, which is $5, 15 minutes, more specific
results.
We will begin to distribute those to schools or is
beginning to distribute those to schools, colleges, and to
states, and that Dr. Collins Shark Tank at NIH is producing
even more. Dr. Hahn, when I ask him who makes the decisions.
Dr. Hahn, the scientists at FDA or the White House? He said the
scientists at FDA in terms of safety and efficiency, and all of
you have said that you would take the test or the vaccine when
is produced and recommend it to your families, although Admiral
Giroir said, it is wise--you should talk to your doctor before
you take any type of shot, I assume. But they said they had
great confidence in the FDA.
We have also heard, and I think this is most important, Dr.
Fauci, as did all of you say, but Fauci has been involved with
these things since 1984, the Reagan years or even before. Are
we cutting corners on safety and efficiency? And he said no.
And the risk we are taking is to the taxpayers because of the
new way we are doing things. We could lose a lot of money if
these vaccines are not approved. But I think the Congress and
the President decided that was well worth it if it saves lives
by having a vaccine ready in a year rather than two, three,
four years.
Finally, I asked whether it was a good idea, having been a
college president, to send home the students who get sick with
COVID if an outbreak comes out, as it is on many college
campuses. And Dr. Fauci said, no, that is not the right way to
do it. The right way to do it is to manage your campus in such
a way that you can isolate the sick students. Send them home
and they will just infect grandma, grandpa, everybody else in
the community.
It has been a very useful and effective hearing. It was
widely carried on live on television for a couple of hours so
the American people had a chance to see the Administration's
top health experts, answer tough questions from Democrats and
Republicans, and give straightforward answers. I thank you for
your service and I thank you for today's hearing.
The hearing record will remain open for 10 days. Members
may submit additional information for the record within that
time if they would like. Thank you for being here. The
Committee will stand adjourned.
ADDITIONAL MATERIAL
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
QUESTIONS AND ANSWERS
Responses by Dr. Anthony Fauci, to Questions of Senator Murray, Senator
Sanders, Senator Collins, Senator Warren, Senator Kaine, and Senator
Rosen.
senator murray
Question 1.
Dr. Fauci, I'm glad FDA issued official guidance on the emergency
authorization of vaccines, as I have urged, but there are still a lot
of pieces missing when it comes to the kind of comprehensive national
vaccines plan I have pushed for--including when it comes to research.
You and other experts have made clear the importance of greater
enrollment of people of color, particularly due to the disproportionate
impact of COVID-19 on Black, Latinx, and Tribal communities. However,
these communities remain underrepresented in ongoing trials and in the
online registry of volunteers for NIH's own COVID-19 Prevention
Network. We must ensure communities who are suffering the most from
this pandemic are included and equitably represented in clinical trials
to ensure we have a comprehensive understanding of how well vaccines
will work.
(a) Now that certain manufacturers are releasing their study
protocols for COVID-19 vaccine trials, what specific goals has
NIH outlined to ensure diversity in clinical trial enrollment
and participation?
Answer 1 (a). Ensuring a diverse group of study volunteers is a
major focus of recruitment and community engagement activities for
clinical trials of investigational COVID-19 vaccines coordinated and
overseen by the National Institute of Allergy and Infectious Diseases
(NIAID) and Operation Warp Speed (OWS) team members. NIAID recognizes
that increasing the diversity of study participants in clinical trials
is needed to build public trust and ensure equitable access to a safe
and effective vaccine to prevent COVID-19, when one becomes available.
To demonstrate that COVID-19 vaccine candidates protect individuals
in communities disproportionately affected by SARS-CoV-2 infection,
NIAID is specifically seeking to recruit an ethnically and racially
diverse study population. NIAID is capitalizing on long-term
investments in clinical research sites, many of which serve diverse
populations, to enhance trial participation of communities of color
through the COVID-19 Prevention Network (CoVPN). The CoVPN has
developed an extensive community engagement framework to reach out to
diverse groups of potential research volunteers and explain the
specific details involved in participating in clinical studies
evaluating COVID-19 vaccine candidates. NIAID also is applying novel
real-time data tracking tools and outbreak data analytics to inform
trial design, site selection, and recruitment of at-risk individuals.
Throughout the clinical trials process, NIAID will continue to engage
with communities who have been disproportionately affected by the
COVID-19 pandemic.
Question 2.
Dr. Fauci, our country recently surpassed an extremely grim
milestone: over 210,000 deaths due to COVID-19. This heartbreaking
statistic is directly linked to the failure of this Administration to
take the pandemic seriously, especially when compared to the rest of
the world.
(a) Do you believe this indescribable death toll could have
been avoided? If so, what specific Federal actions could have
prevented the staggering number of deaths due to COVID-19 in
the United States?
Answer 2 (a). The ongoing spread of SARS-CoV-2 is affected by
multiple complex and interrelated factors and considerations. It is
impossible to determine what effect different actions earlier in the
pandemic may have had on the current case counts. I believe it is
important that we, as a Nation, continue to follow the advice of the
Centers for Disease Control and Prevention (CDC), including taking
measures such as physical distancing, mask wearing, and washing hands
in order to mitigate the spread of SARS-CoV-2 as much as possible. I
will continue to provide expert medical and scientific advice to the
White House Coronavirus Task Force. In addition, I am committed to
leading NIAID in conducting and supporting research to better
understand SARS-CoV-2 and to develop safe and effective medical
countermeasures against the virus.
senator sanders
Question 1.
It is clear that there is a commitment to bring a safe and
effective COVID-19 vaccine to market as soon as possible. It also is
clear that there is a commitment across agencies to work together not
only to try to increase diversity in ongoing clinical trials, but to
educate the public about the importance of getting vaccinated,
especially with flu season upon us. Do you commit to leveraging your
expertise and influence to ensure that a COVID-19 vaccine is available
at no cost to every person in the U.S.?
Answer 1. As a public health official in the Administration, I am
charged with supporting the Federal response to infectious disease
threats on behalf of the American people. I will continue to provide
expert medical and scientific advice to the White House Coronavirus
Task Force. In addition, I am committed to leading the National
Institute of Allergy and Infectious Diseases (NIAID) in conducting and
supporting research to better understand SARS-CoV-2 and to develop safe
and effective medical countermeasures against the virus.
The Administration has stated it is committed to providing free or
low-cost, safe, and effective COVID-19 countermeasures to the American
people as quickly as possible. Any COVID-19 vaccine or therapeutic
doses purchased with U.S. taxpayer dollars will be given to the
American people at no cost. As is customary with government-purchased
vaccines, healthcare professionals could charge for the cost of
administering the vaccine. Information on health care provider
reimbursement for vaccine administration for the uninsured is available
here: https://www.hrsa.gov/CovidUninsuredClaim.
Question 2.
In addition to making sure that a future COVID-19 vaccine is free
to every person in the country at the point of service, it is critical
that health providers and states can afford to purchase the vaccine in
bulk and distribute it to the public and, in particular, to vulnerable
populations such as seniors and those who are living in rural areas.
(a) What specific plans does the Federal Government have to
directly purchase the COVID-19 vaccine and distribute it to the
public, or to help health providers and states purchase the
vaccine for distribution?
Answer 2 (a). In order to facilitate the distribution of free or
low-cost, safe, and effective COVID-19 vaccines to the American people
as quickly as possible, the Administration has made purchasing
arrangements with manufacturers receiving Phase 3 clinical trial
support through Operation Warp Speed (OWS). The Administration has
committed to providing any vaccine purchased with U.S. taxpayer dollars
to the American people at no cost and has partnered with AstraZeneca to
make at least 300 million COVID-19 vaccine doses available to the
Federal Government. Similar partnerships were formed with Novavax (100
million doses), Pfizer (100 million doses), Sanofi and GlaxoSmithKline
(GSK; 100 million doses), Johnson & Johnson (Janssen; 100 million
doses), and Moderna (100 million doses).
The Department of Health and Human Services (HHS) and Department of
Defense have released the Administration's COVID-19 Vaccine
Distribution Strategy, which provides a strategic distribution overview
along with an interim playbook for state, tribal, territorial, and
local public health programs and their partners on how to plan and
operationalize a vaccination response to the COVID-19 pandemic within
their respective jurisdictions (https://www.hhs.gov/about/news/2020/09/
16/trump-administration-releases-covid-19-vaccine-distribution-
strategy.html). In addition, at the request of the National Institutes
of Health (NIH) and the Centers for Disease Control and Prevention
(CDC), the National Academies of Sciences, Engineering, and Medicine
formed a committee to produce a consensus study to assist policymakers
in the U.S. and global health communities in planning for equitable
allocation of vaccines against COVID-19. The National Academies
Committee on Equitable Allocation of Vaccine for the Novel Coronavirus
has since released the Framework for Equitable Allocation of COVID-19
Vaccine (https://www.nationalacademies.org/our-work/a-framework-for-
equitable-allocation-of-vaccine-for-the-novel-coronavirus).
NIAID defers to the CDC and the HHS Assistant Secretary for Health
to provide additional information on COVID-19 vaccine purchasing and
distribution arrangements.
Question 3.
It is well documented that African Americans, Indigenous Peoples,
and other racial and ethnic minorities have experienced harm and trauma
when participating--both voluntarily and involuntarily--in medical
research. These populations are also most at-risk for contracting
COVID-19 and experiencing more severe outcomes from the disease. As
history has taught us, vaccines are only effective in eventually
eradicating a particular disease when there is widespread use. A lack
of trust, however, can stall efforts to defeat a pandemic. Please
provide specific details about the steps you are taking, and have
already taken, to build public trust--especially among the most
vulnerable and often hard-to-reach populations, including low-income
individuals, people who live in rural communities, older individuals,
and racial and ethnic minorities--so that when a safe and effective
vaccine is available, it is successfully adopted?
Answer 3. NIAID recognizes that an important component of building
public trust and ensuring equitable access to a safe and effective
COVID-19 vaccine, when one becomes available, is the inclusion of a
diverse group of participants in clinical trials. To determine if
COVID-19 vaccine candidates protect individuals in the communities
disproportionately affected by SARS-CoV-2 infection, NIAID is
specifically seeking to recruit an ethnically and racially diverse
study population. NIAID and NIH leadership have engaged directly with
the congressional Asian Pacific American Caucus, the congressional
Black Caucus, the congressional Hispanic Caucus, and the congressional
Native American Caucus to discuss the importance of including
communities of color in each of the OWS-supported Phase 3 clinical
trials of COVID-19 candidates. In addition, NIAID and NIH leadership
have conducted a wide range of outreach efforts through social media,
television, and radio appearances to engage with community leaders,
artists, faith-based organizations, and athletes on the topic of
vaccine safety and the importance of having a diverse group of
participants in ongoing clinical trials.
NIAID also is capitalizing on long-term investments in clinical
research sites, many of which serve diverse populations, to enhance
trial participation of communities of color through the COVID-19
Prevention Network (CoVPN). The CoVPN has developed an extensive
community engagement framework to reach out to diverse groups of
potential research volunteers and explain the specific details involved
in participating in clinical studies evaluating COVID-19 vaccine
candidates. In addition, NIAID is applying novel real-time data
tracking tools and outbreak data analytics to inform trial design, site
selection, and recruitment of at-risk individuals. Throughout the
clinical trials process, NIAID will continue to engage with communities
who have been disproportionately affected by COVID-19.
Question 4.
It is clear that this pandemic is far from over. However, even as
COVID-19 infections spread among our government officials,
misinformation continues to spread regarding the severity of COVID-19
and the steps we all need to take to limit the spread of the virus.
(a) What are your recommendations for how our government
leaders can ensure the American people are receiving
consistent, accurate, and science-based information about
COVID-19?
(b) Given the rampant misinformation that has been spread by
the President and some in the Administration since this
hearing, what steps are you taking now to minimize the negative
impact of this misinformation so that the public has accurate,
reliable and credible information from which to base their
decisions on regarding (1) consistently wearing masks; (2)
giving COVID-19 the serious consideration that it deserves; and
(3) ultimately taking the forthcoming vaccine when it comes to
market?
Answer 4 (a)-4 (b). As a public health official in the
Administration, I am charged with supporting the Federal response to
infectious disease threats on behalf of the American people. I will
continue to provide expert medical and scientific advice to the White
House Coronavirus Task Force. In addition, I remain committed to
leading NIAID in conducting and supporting research to better
understand SARS-CoV-2 and to develop safe and effective medical
countermeasures against the virus. NIAID also will continue to
facilitate public availability of NIH-supported research via
publication in peer-reviewed scientific journals and NIH press
releases.
The dissemination of accurate information to the public is a
crucial aspect of the response to the COVID-19 pandemic. Public
education campaigns have been a significant part of the
Administration's continuing efforts to promote and explain the
importance of developing COVID-19 countermeasures and public safety
measures to individuals and their communities. Once a candidate vaccine
to prevent COVID-19 is authorized for emergency use or approved for use
by the U.S. Food and Drug Administration, OWS and its partners
including CDC will continue to engage individual communities through
public communication and outreach campaigns to provide information
about the vaccine and how to access it as plans for vaccine
distribution are finalized.
In addition, the NIAID-supported CoVPN, a functional unit of OWS,
includes an extensive community engagement framework to reach out to
the diverse communities most affected by COVID-19 to better understand
their interest in, and concerns about, participation in clinical
research and to partner with them to ensure their input is reflected in
study design and implementation. This engagement also may lead to
increased uptake of a safe and effective COVID-19 vaccine by
individuals in these communities once it becomes available.
senator collins
Question 1.
Dr. Fauci, can you discuss any goals set by Operation Warp Speed to
include older adults in vaccine trials and why proper representation in
trials is so important? To what extent have older adults been included
in the clinical trials for COVID-19 therapies?
Answer 1. The development and availability of a safe and effective
COVID-19 vaccine would be an invaluable tool in our efforts to end the
COVID-19 pandemic. As older adults have been shown to be particularly
vulnerable to this disease, the National Institute of Allergy and
Infectious Diseases (NIAID) has supported the evaluation of promising
vaccine candidates in this demographic group. NIAID, in collaboration
with Moderna, expanded the Phase 1 clinical trial of the mRNA-1273
vaccine candidate to include adults age 56 and older in April 2020.
Interim results from this Phase 1 study suggested the immune responses
in older adults were consistent with those reported previously in
younger adults. Older adults also are included in all Operation Warp
Speed (OWS)-supported Phase 3 clinical trials of investigational COVID-
19 vaccine candidates. The results of these studies will provide
valuable data about the efficacy of vaccination in older adults and
will be used to assess the need for adjuvants or other strategies that
could be used to boost the immune response in older populations.
The U.S. Food and Drug Administration (FDA) also strongly
encourages enrollment of all people--including older adults--in
clinical trials to test COVID-19 vaccine candidates, as outlined in the
recommendations in the FDA's Development and Licensure of Vaccines to
Prevent COVID-19 guidance. This FDA guidance can be found at the
following web link: https://www.fda.gov/regulatory-information/search-
fda-guidance-documents/development-and-licensure-vaccines-prevent-
covid-19. Studies involving older adults supported by the National
Institutes of Health (NIH) are following the FDA's guidance. NIH will
work to support vaccine developers as they expand clinical trials of
vaccine candidates into older populations.
NIAID also is supporting the development of prophylactic treatments
such as monoclonal antibodies that could be used to protect individuals
who are at increased risk of disease, need immediate protection, or do
not mount an effective immune response to a vaccine. Older adults are
participating in ongoing NIAID-supported clinical trials of monoclonal
antibodies to prevent or treat COVID-19. NIH-supported clinical trials
evaluating other therapeutic approaches to COVID-19, such as
antivirals, immune modulators, and antithrombotics, also continue to
enroll older individuals.
senator warren
Question 1.
Long Term Health Effects of COVID-19 There is evidence of patients
continuing to feel the effects of COVID-19 well after they are
discharged from hospitals or beyond the average known time of recovery,
and some may face long-term health problems long after the pandemic is
over. It is critical that the Federal Government conduct appropriate
research and collect and disseminate appropriate data about the
potential chronic health impacts of COVID-19--and do so without
muzzling public health officials and medical professionals--in order to
adequately inform decisions about reopening schools and businesses and
assess the ongoing risks of the pandemic. As NIH continues to conduct
and coordinate research efforts, it is critical that it collect,
analyze, and disseminate data on the long-term impacts and severity of
the disease, conduct research to understand the risks, and
appropriately inform policymakers, the public and medical professionals
of them. To help us understand how the CDC is researching, monitoring,
and evaluating the chronic long-term health impacts of COVID-19, we
request answers to the following questions:
(a) How is the NIH evaluating the long-term health risks of
COVID-19 for the millions of Americans that will survive the
disease?
(b) How are NIH and its partner Federal agencies conducting
long-term surveillance or other research on survivors of COVID-
19, including those who presented with nonsevere symptoms and
those who presented with severe symptoms?
(c) Please provide a list of studies that NIH is currently
undertaking or funding to understand the non-mortality related
impacts of the disease, and, if publicly available, the
findings or preliminary findings from these studies.
(d) How is NIH collaborating with other Federal agencies
regarding studies into the morbidity and long-term impacts of
COVID-19?
(e) What additional resources or authorities are needed from
Congress to ensure that the agencies can effectively conduct
this type of research?
Answers 1 (a)-1 (e).The National Institute of Allergy and
Infectious Diseases (NIAID) is the lead Institute at the National
Institutes of Health (NIH) responsible for conducting and supporting
research on emerging and re-emerging infectious diseases, including
COVID-19. NIAID is supporting a broad portfolio of research to
understand the incidence and prevalence of SARS-CoV-2, the virus that
causes COVID-19; characterize the clinical course of COVID-19 and
identify predictors of disease severity; characterize immunologic
responses to SARS-CoV-2 infection; and understand SARS-CoV-2
transmission mechanisms. We continue to learn more about the duration
and manifestations of the disease as additional data are collected from
patients who recover from COVID-19 or who transition from acute to
post-acute phases of the disease.
NIAID is leveraging existing research networks and working with
Institutes, Centers, and Offices across NIH, as well as with our
partners in the Federal Government, industry, and academia, to expand
surveillance of outcomes in patients across all ages, genders, co-
morbid conditions, and acute disease experience. These studies can
inform our understanding of the long-term health effects of COVID-19
and the development of relevant prevention and treatment interventions
or strategies. A current list of research on post-acute COVID-19
syndromes conducted and supported by NIAID is below:
NIAID intramural scientists have initiated the
Longitudinal Study of COVID-19 Sequelae and Immunity to better
understand any long-term medical problems that people who have
recovered from acute SARS-CoV-2 infection might have, and
whether they develop an immune response to SARS-CoV-2 that
provides protection against reinfection.
NIAID intramural scientists have extended their SARS-
COV2 Pandemic Serosurvey to include longitudinal serological
testing. This study, in collaboration with the National
Institute of Biomedical Imaging and Bioengineering, and with
additional support from the National Center for Advancing
Translational Sciences and the National Cancer Institute, is
open for recruitment and follows participants over time to
evaluate the durability of immunity and further explore
correlates of protection. The study aims to enroll 15,000
participants.
The NIAID International Network for Strategic
Initiatives in Global HIV Trials has initiated a prospective
observational cohort study of 10,000 outpatients with COVID-19
to determine the incidence of hospitalization or death over a
28-day period after an initial outpatient visit.
Investigators in the NIAID-supported Human Immunology
Project Consortium, in collaboration with researchers in the
Asthma and Allergic Diseases Cooperative Research Centers and
other NIAID-supported investigators, established the
Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC).
IMPACC aims to determine how integrated immunological measures
correspond to, or may even predict, the clinical severity of
COVID-19. The researchers are collecting detailed clinical data
along with blood and respiratory samples from approximately
1,000 hospitalized COVID-19 patients of diverse race and
ethnicity at approximately 20 hospitals across the country.
Patients will be followed throughout their hospitalization and
for up to one-year post hospital discharge to assess several
measures of both functional and immunologic recovery.
NIAID is supporting the Corona infectious virus
epidemiology team (CIVET), which will leverage the previously
established North American AIDS Cohort Collaboration on
Research and Design to bring together epidemiologists,
statisticians, and data scientists to analyze extremely large
clinical data bases (i.e., millions of patients) to better
understand the clinical epidemiology of SARS-CoV-2. Due to its
large size and access to complete medical records in some
medical systems, the CIVET will be able to evaluate the natural
history and treatment history of SARS-CoV-2 in hospitalized and
non-hospitalized patients and adjust for the impact of
underlying medical conditions. To date, the CIVET has more than
200,000 persons with a history of COVID-19 illness in their
data base. This will enable assessments of post-acute COVID
syndrome in patients across the lifespan, demographic
characteristics, and initial disease presentations.
NIAID funds the Big Data Driven Clinical Informatics
& Surveillance (BDD-CIS) project, which will develop a de-
identified linked data base system that will collate data on
both COVID-19 patients and health care workers treating COVID-
19 patients in South Carolina. This data base will be used to
examine the natural history of SARS-CoV-2 including
transmission dynamics, disease progression, and geospatial
visualization of infected individuals. The data base, used in
conjunction with machine learning algorithms, also may help to
identify important predictors of short-and long-term clinical
outcomes, including for multisystem inflammatory syndrome in
children (MIS-C) and post-acute COVID-19 syndrome in the study
population.
NIAID funds investigators at the South Texas Veterans
Health Care System, a part of the Department of Veterans
Affairs, to assess patients with SARS-CoV-2 infection. This
study is assessing the immune response to the virus and
developing an index to predict clinical outcomes of these
patients. This study has enrolled more than 500 patients and
will continue to follow them for long-term complications.
NIAID is participating in a trans-NIH effort, led by
the National Heart, Lung, and Blood Institute and the Eunice
Kennedy Shriver National Institute of Child Health and Human
Development, to research MIS-C, an extremely serious
inflammatory condition that has been associated with SARS-CoV-2
infection in children and adolescents. A collaboration between
investigators from two NIAID supported networks, the
Autoimmunity Centers of Excellence and the Clinical Trials in
Organ Transplantation in Children, have developed an
observational cohort study known as the Pediatric Research
Immune Network on SARS-CoV-2 and MIS-C to assess 6 and 12 month
clinical outcomes and immunological responses after infection
with SARS-CoV-2 in children with and without MIS-C.
NIAID Intramural scientists are developing a study
with Children's National Medical Center for long-term follow-up
of 1,000 children with SARS-CoV-2 infection ranging from those
who are asymptomatic to those with severe manifestations. This
research will provide critically needed data on SARS-CoV-2
infection in children including demographics and disease
presentation, duration, and outcome, as well as identify
factors associated with protection and disease severity.
The NIAID Division of Clinical Research, in
collaboration with the Partnership for Research on Vaccines and
Infectious Diseases in Liberia, has initiated an observational,
prospective cohort study of individuals testing positive for
SARS-CoV-2, and controls who test negative, with enrollment
over a two-year period and follow-up for 3 years after
enrollment.
NIAID funds the CHASING COVID Cohort study, which
prospectively enrolled more than 7,000 participants between
March 28th and April 20th from across the United States,
including Puerto Rico and Guam. Participants performed a dried
blood spot test for SARS-CoV-2 antibodies in early summer and a
second test is planned for fall 2020. Subsequent interviews
intend to collect data on long-term symptoms of SARS-CoV-2. The
cohort represents a geographically and socio-demographically
diverse sample of the adult U.S. population: 23 percent of
participants were 60 years or older at enrollment; 24 percent
are Black or Hispanic; and 52 percent are men. At least 24
percent of participants are frontline workers, either in
healthcare or other essential employment sectors such as
police, first responders, food services, or transportation.
The studies listed above are designed to answer specific critical
research questions about SARS-CoV-2 and COVID-19 and will contribute to
general knowledge on the long-term effects of SARS-CoV-2 infection.
These studies are ongoing and have not yet reported results. NIAID will
continue to facilitate public availability of the results of this
NIAID-supported research as it becomes available through publication of
data in peer-reviewed scientific journals and NIH press releases.
NIAID, in collaboration with several NIH Institutes and Centers, also
is planning a workshop on post-acute COVID-19. The goal of this meeting
is to characterize post-acute COVID-19 and identify key knowledge gaps.
NIAID is using the $1.5 billion in supplemental appropriations
provided by the Congress to aggressively accelerate and broaden
research activities to address the COVID-19 pandemic and expedite the
development of medical countermeasures. This investment will allow us
to better understand virus biology, pathogenesis, and natural history,
as well as to develop diagnostics, vaccines, and therapeutics.
senator kaine
Question 1.
Dr. Fauci, what is the domestic and global public health benefit to
not collaborating with other nations through the COVAX Facility? Why
shouldn't we participate?
Answer 1. Vaccine development activities undertaken by COVAX, the
vaccine-focused program of the Access to COVID-19 Tools Accelerator
(ACT Accelerator) initiative, are complementary to vaccine development
activities supported by the National Institutes of Health (NIH) and the
Department of Health and Human Services. NIH and other U.S. experts
provide advice and guidance on numerous planning, coordination, and
oversight entities associated with the ACT Accelerator initiative, and
NIH participates in regular coordination calls with World Health
Organization (WHO)-affiliated scientific leadership to facilitate
scientific cooperation and to help avoid duplication of effort. Under
the leadership of the White House Office of Science and Technology
Policy, NIH also participates in regular SARS-CoV-2 research
coordination calls with senior science advisors from approximately 20
countries.
The NIH, along with the Foundation for the NIH, also has launched
the Accelerating COVID-19 Therapeutic Interventions and Vaccines
(ACTIV) international public-private partnership to speed the
development and clinical evaluation of COVID-19 vaccine and therapeutic
candidates. The ACTIV partnership has brought 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. ACTIV is coordinating clinical
trials in order to maximize trial capacity and expedite COVID-19
clinical trials. This includes the development of harmonized master
protocols for adaptive trials of multiple COVID-19 candidate vaccines.
The NIH has taken steps to ensure the ACTIV partnership is closely
interconnected and complementary with other COVID-19 efforts, including
those led by the U.S. Food and Drug Administration and the Biomedical
Advanced Research and Development Authority's Medical Countermeasures
Task Force, in addition to international initiatives.
NIH also is supporting Phase 3 clinical trials of COVID-19
candidate vaccines through Operation Warp Speed (OWS), the
Administration's national program to accelerate the development,
manufacturing, and distribution of COVID-19 vaccines, therapeutics, and
diagnostics. OWS aims to have initial doses of a safe and effective
vaccine available for Americans by January 2021. Activities supported
by ACTIV and OWS will help inform ACT Accelerator efforts, including
the support of the shared U.S. Government and COVAX goal of developing
safe and effective vaccines for COVID-19. NIH will continue to engage
with international partners through bilateral, multilateral, and
regional efforts; to coordinate SARS-CoV-2 research; and to
expeditiously advance the development and testing of candidate vaccines
and other medical countermeasures that will urgently address the
clinical and public health response to the COVID-19 pandemic.
senator rosen
Question 1.
With regards to effective prevention, it is clear that wearing a
mask, social distancing, and washing our hands are all critical. Dr.
Fauci, I've heard that there may be some confusion among the public
about the effectiveness of a face shield instead of a face mask. I'm
sure many Americans have seen employees in stores and restaurants wear
a shield instead of a mask, thinking it offers the same protection. Can
you please address this?
Answer 1. At the present time, there are no definitive data to
determine whether face shields provide any benefit as source control to
protect others from the spray of respiratory particles that can
transmit SARS-CoV-2. However, it is reasonable to assume that wearing
face shields may provide additional protection for the wearer along
with the use of face coverings. The Centers for Disease Control and
Prevention (CDC) does not recommend using face shields as a substitute
for masks. For CDC's latest information on masks, please visit https://
www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-
cover-guidance.html.
Question 2.
Dr. Fauci, when news about an approved vaccine comes out, many
families may assume the vaccine is available for their whole family.
Can you please discuss what needs to be clearly communicated regarding
the populations included in trials, and who a vaccine might initially
be approved for? Considering the lack of children in current studies,
can you please discuss the best practice for including children and
youth in clinical trials for COVID-19 and when it would be appropriate
to include them? What recommendations do you have for COVID-19 vaccines
that are found safe and effective in healthy adults to then transition
to trials that include children, and how would age differences be
addressed? What about underlying health conditions? Considering what we
are learning about how children can spread the virus, along with at
least 3,240 school-aged children in our country being hospitalized so
far due to COVID-19, it is so important that we have a clear path
forward for a vaccine that is safe, effective, and tailored for our
pediatric population. Can you also please address similar concerns for
pregnant and lactating women, and what scientific guidelines should be
followed to ensure both safety and efficacy for this population as
well?
Answer 2. The National Institute of Allergy and Infectious Diseases
(NIAID) recognizes the importance of analyzing the safety and efficacy
of candidate vaccines and other prevention interventions in pediatric
patients as well as in pregnant and lactating women. These studies,
which generally occur once safety and efficacy have been well-
established in healthy adult populations, are essential to ensuring
equitable access to medical countermeasures in these important
populations. As the National Institutes of Health (NIH) responds to the
current COVID-19 pandemic, scientists leading the development of
medical countermeasures against COVID-19 are working closely with
pharmaceutical companies, manufacturers, and biotechnology firms to
ensure that special populations are being considered for inclusion in
upcoming clinical studies.
NIAID currently is discussing plans to assess COVID-19 vaccine
candidates in studies that will include both pregnant women and
pediatric participants. NIAID also is evaluating the natural history of
COVID-19 disease in children, including research on 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. These studies, and others
performed in collaboration with current vaccine manufacturers, will
provide important new insights into both the short-and long-term
effects of COVID-19 on pregnant women and pediatric patients. In
addition, the results of these studies may further inform the inclusion
of pregnant women and children in clinical trials for candidate
vaccines, as well as other candidate preventive strategies and
therapeutics.
The U.S. Food and Drug Administration (FDA) also strongly
encourages enrollment of all people--including racial and ethnic
minorities, older adults, pregnant women, women of childbearing age,
and, as appropriate, children--in clinical trials to test COVID-19
vaccine candidates, as outlined in the recommendations in the FDA's
Development and Licensure of Vaccines to Prevent COVID-19 guidance.
This FDA guidance can be found at the following web link: https://
www.fda.gov/regulatory-information/search-fda-guidance-documents/
development-and-licensure-vaccines-prevent-covid-19. NIH-supported
studies involving special populations are following the FDA's guidance.
NIH will work to support vaccine developers as they expand clinical
trials of vaccine candidates into additional groups, including children
and pregnant women.
Question 3.
As you know, our Tribal communities have been especially hard hit
by the COVID-19 pandemic. According to the CDC, they are around three
and a half times more likely to contract this virus and are also at a
high risk for severe outcomes. In Nevada, we have over 27 Tribal
Nations, Bands and Colonies, with more than 32,000 members. Ninetyseven
percent of our Tribes are rural and are spread across over a million
acres of land.
(a) Given that our Tribal communities are especially vulnerable
to COVID-19, are all too often populations with high rates of
comorbidities such as diabetes, and frequently live in very
rural areas, what else should the Federal Government be doing
to address the immediate health needs of these communities, and
what steps should be taken to ensure robust Federal support for
COVID-19 vaccine distribution to be done in an equitable,
effective, and culturally competent manner? What lessons were
learned from the H1N1 response so we can improve upon past
efforts?
Answer 3 (a). In order to support the equitable distribution of a
safe and effective COVID-19 vaccine, the NIH and CDC requested a
consensus study from the National Academies of Sciences, Engineering,
and Medicine (NASEM) to assist policymakers in the U.S. and global
health communities in planning for equitable allocation of vaccines
against COVID-19. The National Academies Committee on Equitable
Allocation of Vaccine for the Novel Coronavirus has since released the
Framework for Equitable Allocation of COVID-19 Vaccine (https://
www.nationalacademies.org/our-work/a-framework-for-equitable-
allocation-of-vaccine-for-the-novel-coronavirus).
In addition to the NASEM study, the Department of Health and Human
Services and Department of Defense have released the Administration's
COVID-19 Vaccine Distribution Strategy, which provides a strategic
distribution overview along with an interim playbook for tribal, state,
territorial, and local public health programs and their partners on how
to plan and operationalize a vaccination response to the COVID-19
pandemic within their respective jurisdictions (https://www.hhs.gov/
about/news/2020/09/16/trump-administration-releases-covid-19-vaccine-
distribution-strategy.html).
The CDC will support COVID-19 vaccine distribution, drawing on
planning experience with five states and local jurisdictions. CDC also
will utilize their years of experience with past outbreaks, including
H1N1 influenza, as they plan and work with state and local public
health partners. We understand that CDC's responses to questions for
the record from this hearing include additional information on vaccine
distribution efforts and efforts to respond to immediate health needs
in these communities.
______
Responses by Dr. Robert Redfield, to Questions of Senator Sanders,
Senator Tammy Baldwin, Senator Warren, Senator Kaine, Senator Smith,
and Senator Rosen.
senator sanders
Question 1.
It is clear that there is a commitment to bring a safe and
effective COVID-19 vaccine to market as soon as possible. It also is
clear that there is a commitment across agencies to work together not
only to try to increase diversity in ongoing clinical trials, but to
educate the public about the importance of getting vaccinated,
especially with flu season upon us. Will you use your expertise and
influence to ensure that a COVID-19 vaccine is available at no cost to
every person in the U.S.?
Answer 1. COVID-19 vaccine will be provided at no cost to enrolled
vaccine providers and at no cost to the public. The Administration has
stated it is committed to providing free or low-cost, safe, and
effective COVID-19 countermeasures to the American people as quickly as
possible. Any COVID-19 vaccine or therapeutic doses purchased with U.S.
taxpayer dollars will be given to the American people at no cost. As is
customary with government-purchased vaccines, healthcare professionals
could charge for the cost of administering the vaccine. Information on
health care provider reimbursement for vaccine administration for the
uninsured is available here: https://www.hrsa.gov/CovidUninsuredClaim.
Question 2.
In addition to making sure that a future COVID-19 vaccine is free
to every person in the country at the point of service, it is critical
that health providers and states can afford to purchase the vaccine in
bulk and distribute it to the public and, in particular, to vulnerable
populations such as seniors and those who are living in rural areas.
(a) What specific plans does the Federal Government have to
directly purchase the COVID-19 vaccine and distribute it to the
public, or to help health providers and states purchase the
vaccine for distribution?
Answer 2 (a). As stated above, COVID-19 vaccine will be provided at
no cost to enrolled vaccine providers and at no cost to the public. In
addition, as of October 22, more than $500 million has been invested in
the COVID-19 vaccination effort to support distribution, vaccine safety
and effectiveness, and investment in tracking systems. On June 4, 2020,
CDC awarded $140 million to 64 jurisdictions through CDC's existing
immunization cooperative agreement to enable state health departments
to enhance their immunization programs, including launch an initial
scale-up for influenza season, given the increased risk of COVID-19. On
September 23, 2020, CDC also awarded $200 million to 64 jurisdictions
through the existing Immunizations and Vaccines for Children
cooperative agreement. These funds, along with the previous support CDC
has provided, will help states plan for and implement COVID-19
vaccination services. In addition, CDC invested $180 million in a
centralized depot for distribution of 200 million refrigerated vaccine
doses and $21 million in vaccine safety surveillance ramp up.
Question 3.
As you know, there were recently mixed messages from the CDC
regarding the airborne transmission of the novel coronavirus. This
caused a great deal of confusion among many people and may have
contributed to the public's general lack of trust in our public health
agencies. In fact, according to a recent Kaiser Family Foundation
survey taken before the latest miscommunication, 54 percent of people
surveyed said that they ``would not get vaccinated'' if one was
available before the November election. And, this lack of confidence in
a vaccine cuts across the political field, with 46 percent of
Democrats, and a full six in ten (60 percent) Republicans reporting
that they would not get vaccinated.
(a) What concrete steps are being taken now, as the research
continues to move forward, to ensure accurate, consistent, and
scientifically reviewed messaging about COVID-19, including the
severity of the disease, how the virus is transmitted and how
people can protect themselves and each other? Specifically, how
are you measuring and evaluating the impact of these efforts?
Answer 3 (a). CDC continues to provide the American public with the
information and assistance it needs to address COVID-19 head on. Our
guidance and recommendations are based on the best available science
and data and undergo a rigorous review and clearance process. 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.
COVID-19 is thought to spread mainly through close contact from
person to person, including between people who are physically near each
other (within about 6 feet). People who are infected but do not show
symptoms can also spread the virus to others. Some infections can be
spread by exposure to virus in small droplets and particles that can
linger in the air for minutes to hours. This kind of spread is referred
to as airborne transmission. These viruses may be able to infect people
who are further than 6 feet away from the person who is infected or
after that person has left the space. There is evidence that under
certain conditions, people with COVID-19 seem to have infected others
who were more than 6 feet away. These transmissions occurred within
enclosed spaces that had inadequate ventilation. Sometimes the infected
person was breathing heavily, for example while singing or exercising.
Under these circumstances, scientists believe that the amount of
infectious smaller droplets and particles produced by the people with
COVID-19 became concentrated enough to spread the virus to other
people. However, available data indicate that it is much more common
for the virus to spread through close contact with a person who has
COVID-19 than through airborne transmission (https://www.cdc.gov/
coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html).
Question 4.
It is clear that this pandemic is far from over. However, even as
COVID-19 infections spread among our government officials,
misinformation continues to spread regarding the severity of COVID-19
and the steps we all need to take to limit the spread of the virus.
(a) What are your recommendations for how our government
leaders can ensure the American people are receiving
consistent, accurate, and science-based information about
COVID-19?
Answer 4 (a). CDC is providing the American public with the
information and assistance it needs to address COVID-19 head on and
continues to issue guidance and recommendations (https://www.cdc.gov/
coronavirus/2019-ncov/index.html) based on the best available science
and data. 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. CDC resources also emphasize the importance
of state, tribal, local, and territorial public health recommendations
that help meet the unique needs and circumstances of local situations,
and the importance of individual jurisdictions having the authority and
local awareness needed to protect their communities.
(b) Given the rampant misinformation that has been spread by
the President and some in the Administration since this
hearing, what steps are you taking now to minimize the negative
impact of this misinformation so that the public has accurate,
reliable and credible information from which to base their
decisions on regarding (1) consistently wearing masks; (2)
giving COVID-19 the serious consideration that it deserves; and
(3) ultimately taking the forthcoming vaccine when it comes to
market?
Answer 4 (b). CDC is providing the American public with the
information and assistance it needs to address COVID-19 head on and
continues to issue guidance and recommendations based on the best
available science and data. 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.
On April 3, 2020, the White House Coronavirus Task Force and CDC
recommended that persons wear a cloth face covering in public to slow
the spread of COVID-19. A CDC report (https://www.cdc.gov/mmwr/volumes/
69/wr/mm6928e3.htm's-cid=mm6928e3-w) analyzing data from an internet
survey found that, after the initial recommendation was released, high
rates of cloth face covering use were reported in the United States.
The rate of cloth face covering use increased from about 62 percent of
adults in April to more than 76 percent in May. The increase was driven
largely by a significant jump in mask use by white, non-Hispanic
adults, from 54 percent to 75 percent. Approval among Black, non-
Hispanic adults went up from 74 percent to 82 percent, and remained
stable among Hispanic/Latino adults at 76 percent and 77 percent. There
was also a large increase in mask use among respondents in the Midwest,
from 44 percent to 74 percent. Approval was greatest in the Northeast,
going from 77 percent to 87 percent.
Understanding public confidence in any and all vaccines is
necessary for promoting high vaccine uptake, and CDC is adapting its
strategic framework, Vaccinate with Confidence (https://www.cdc.gov/
vaccines/partners/vaccinate-with-confidence.html), to strengthen public
trust in COVID-19 vaccines. The framework emphasizes three key
priorities: reinforcing communication to the public about the vaccine's
rollout and its safety and benefits, empowering healthcare providers to
communicate effectively with patients about the vaccine, and engaging
with individuals and communities. Building confidence is inherent to
all our work and CDC will continue to build upon the investments of our
immunization program as we prepare both the Nation's public health
system and the private sector to disseminate a safe and effective
COVID-19 vaccine. As COVID-19 vaccine developments continue, CDC is
working with Operation Warp Speed (OWS) to ensure community groups,
physicians, and the general public receive the most up to date guidance
and data on available prevention measures that can help reduce COVID-19
infection and spread. Adapting from approaches used with similar past
threats, CDC will work with its public health partners to deliver
resources on COVID-19 vaccine that assists physicians with proper
vaccine administration and enhances public confidence in COVID-19
vaccine uptake.
Question 5.
It is well documented that African Americans, Indigenous Peoples,
and other racial and ethnic minorities have experienced harm and trauma
when participating--both voluntarily and involuntarily--in medical
research. These populations are also most at-risk for contracting
COVID-19 and experiencing more severe outcomes from the disease. As
history has taught us, vaccines are only effective in eventually
eradicating a particular disease when there is widespread use. A lack
of trust, however, can stall efforts to defeat a pandemic. Please
provide specific details about the steps you are taking, and have
already taken, to build public trust--especially among the most
vulnerable and often hard-to-reach populations, including low-income
individuals, people who live in rural communities, older individuals,
and racial and ethnic minorities--so that when a safe and effective
vaccine is available, it is successfully adopted?
Answer 5. Understanding public confidence in any and all vaccines
is necessary for promoting high vaccine uptake, and CDC is adapting its
strategic framework, Vaccinate with Confidence (https://www.cdc.gov/
vaccines/partners/vaccinate-with-confidence.html), to strengthen public
trust in COVID-19 vaccines. The framework emphasizes three key
priorities: reinforcing communication to the public about the vaccine's
rollout and its safety and benefits, empowering healthcare providers to
communicate effectively with patients about the vaccine and engaging
with individuals and communities. Building confidence is inherent to
all our work and CDC will continue to build upon the investments of our
immunization program as we prepare both the Nation's public health
system and the private sector to disseminate a safe and effective
COVID-19 vaccine. As COVID-19 vaccine developments continue, CDC is
working with OWS to ensure community groups, physicians, and the
general public receive the most up to date guidance and data on
available prevention measures that can help reduce COVID-19 infection
and spread. Adapting from approaches used with similar past threats,
CDC will work with its public health partners to deliver resources on
COVID-19 vaccine that assist physicians with proper vaccine
administration and enhances public confidence in COVID-19 vaccine
uptake.
CDC is enhancing communications efforts to target special
audiences, including older Americans, people of any age with underlying
health conditions, workers in long-term care facilities, and other
essential workers. Targeted communication and education efforts will be
implemented for African American and Hispanic/Latino communities
realizing that these groups have lower rates of influenza vaccination,
yet higher risk for COVID-19 complications.
CDC will also be working with the National Association for
Community Health Centers to implement evidence-based strategies to
increase adult vaccination coverage among underserved priority
populations. In addition, CDC will be consulting individually with 15
national leaders in the field of health disparities, health equity, and
social determinants of health to develop strategies to address racial
and ethnic disparities in adult immunization.
CDC is testing influenza vaccine messages to learn what impacts the
pandemic may have on the intent to vaccinate, including fears about
getting vaccinated in a safe environment, and CDC will continue to work
with our public health and clinical partners to eliminate barriers to
vaccination.
CDC also is committed to ensuring rural populations can access the
vaccine. We have decades of experience working with public health
partners addressing the needs of hard to reach populations. We will
work with communities, government, and other local partners to identify
the best places and times to reach this population and utilize
strategic distribution points via community health centers, schools,
workplaces, mobile clinics, and pharmacies. Our immunization programs
have built a strong public health immunization infrastructure,
including through the provision of a safety net for those with no
health insurance and through response to outbreaks of vaccine
preventable diseases and other urgent public health issues.
In July, CDC released a Health Equity Strategy (www.cdc.gov/
coronavirus/2019-ncov/community/health-equity/cdc-strategy.html) that
provides an evidence-based, comprehensive, and coordinated framework
for reducing COVID-19 disparities. The strategy includes building on
plans for collecting and reporting timely, complete, and representative
data on testing, incidence, vaccination, and severe outcomes among
populations at highest risk.
senator baldwin
Question 1.
Dr. Redfield you have said numerous times that your agency is not a
regulatory agency. Do you think an Emergency Temporary Standard (ETS),
enforced by the Occupational Safety and Health Administration,
requiring workplaces to implement comprehensive infectious disease
exposure control plans, could help protect workers, and the general
public from exposure to COVID-19?
Answer 1. CDC defers to the Occupational Safety and Health
Administration.
Question 2.
As you know, between April 16-17, an Epidemiologic Assistance (Epi
Aid) team consisting of CDC and NIOSH staff was sent to investigate the
COVID outbreak at the South Dakota Smithfield meatpacking plant at the
request of the South Dakota (SD) Health Dept. On April 21 CDC and NIOSH
staff cleared a report summarizing that Epi-Aid team's findings and
safety recommendations and that report was then sent to the SD Health
Dept. on April 21. On April 22, the CDC asked the SD Department of
Health to retract that report. On April 22, the South Dakota Department
of Health received an edited report that included language weakening
the original safety recommendations by adding the phrases ``if
feasible'' and ``if possible''.
(a) How did you become aware that there were concerns with the
language included in the original report sent on April 21 to
the SD Health Department?
Answer 2 (a). On April 20, 2020, CDC provided a pre-clearance
version of its draft site visit memo to the South Dakota Department of
Health. This is consistent with CDC's practice of partnering with state
health departments in this kind of Epi-Aid. On April 20, 2020, the CDC
team received an e-mail from an executive vice president with
Smithfield Foods indicating that they had received a copy of the
recommendations from the Governor's office and wished to discuss the
draft. On April 21, 2020, the USDA requested a call to understand the
recommendations and clarification on whether the recommendations were
binding. Given the public health implications and the engagement from
USDA, the CDC Director was made aware.
(b) Who asked you to change or edit that report language, and
why did you change it?
Answer 2 (b). CDC issues evidence-based guidance and
recommendations, which are cleared through the U.S. Government
interagency policy process. All CDC interim guidance for workplaces
regarding COVID-19 is reviewed and updated based on three key inputs:
stakeholder feedback, what is learned from our field teams, and the
evolving science around COVID-19. When CDC staff conduct site visits, a
memo describing observations and recommendations is written and
provided to the requesting organization, typically the health
department. It is important to note that CDC does not have enforcement
authority and thus, CDC-developed memos and recommendations are
advisory, not regulatory, in nature.
The South Dakota Department of Health requested assistance to
develop strategies to help reduce infections from SARS-CoV-2, the virus
that causes COVID-19, among Smithfield Foods Sioux Falls pork
processing plant employees. The CDC team traveled to Sioux Falls, South
Dakota on April 14, 2020. One component of this effort was to visit the
Smithfield Foods pork processing plant to evaluate existing health and
safety controls and provide recommendations for improvement.
On April 21, 2020, CDC issued a cleared memo to the South Dakota
Department of Health. On April 22, 2020, CDC updated the memo to
clarify that the CDC recommendations are non-binding. CDC recalled the
April 21 cleared memo, and the final cleared memo, Strategies to Reduce
COVID-19 Transmission at the Smithfield Sioux Falls Pork Plan, was
issued on April 22, 2020. CDC, in partnership with the South Dakota
Department of Health, provided Smithfield Foods and United Food and
Commercial Workers Local 304A Union recommendations that can be used to
help management, employees, the union, the South Dakota Department of
Health, and community stakeholders limit the potential spread of COVID-
19 in the plant.
CDC and the Occupational Safety and Health Administration (OSHA)
then released the joint guidance on April 26, 2020, Meat and Poultry
Processing Workers and Employers: Interim Guidance from CDC and OSHA
(www.cdc.gov/coronavirus/2019-ncov/community/organizations/meat-
poultry-processing-workers-employers.html). Information from the Sioux
Falls plant evaluation was considered in the development of the CDC/
OSHA guidance document, as was information gained from CDC assistance
(also occurring at that time) to other meat and poultry facilities and
health departments around the country. Subsequent to the date of the
hearing, this guidance was most recently updated on November 12, 2020.
(c) In your role as Director of the CDC, do you normally review
the wording of Epi-Aids? If not, why was did this particular
Epi Aid warrant your attention?
Answer 2 (c). While the CDC Director does not typically get
involved in editing reports from Epi-Aids, the CDC Director was
provided with frequent updates from both investigations because of the
rapidly evolving information and public health implications. Based on
feedback from USDA about potential for a significant impact on the food
supply chain, the Director reviewed the language in the Epi-Aid.
(d) Did you review the Epi Aid done for the JBS facility in
Colorado before it was sent out? If not, why?
Answer 2 (d). The JBS facility in Colorado and the Smithfield
facility in South Dakota were the first and second, respectively,
COVID-19 Epi-Aids in meatpacking and poultry facilities conducted by
CDC. The CDC Director was provided with frequent updates from both
investigations because of the rapidly evolving information and public
health implications. The CDC Director wanted to make clear that CDC is
not a regulatory agency and therefore does not have the authority to
enforce recommendations.
(e) The Epi Aid done for the JBS facility in Colorado didn't
include language like ``if feasible'' ``if possible'' preceding
the safety recommendations. What differed in process from the
Colorado JBS Epi Aid to the Smithfield Epi Aid?
Answer 2 (e). The JBS and Smithfield field investigations were
conducted very early in the pandemic response. The development and
clearance processes for the reports from the site visits was still
evolving. As those processes were formalized, along with the
publication of the guidance for meat processing, the reports became
more standardized. While CDC/NCEZID has a history of conducting food-
borne investigations and CDC/NIOSH has experience in workplace health
hazard evaluations, these site visits were a new activity that required
merging the experiences of both of those functions. That meant that CDC
had to create protocols for how these site visits would be run and what
the final site-visit reports should include.
senator warren
Political Interference at CDC
Question 1.
Numerous public reports have revealed that political appointees at
HHS and the White House have repeatedly interfered with, undermined,
and even overruled career experts at the CDC. In August, guidance
reportedly developed by HHS and the White House Coronavirus Task Force
was published to the CDC's website--reportedly without approval from
the CDC--recommending that asymptomatic individuals do not need to be
tested, even after exposure to someone with COVID-19. This guidance
contradicted clear advice from career CDC officials and other public
health experts. Further, according to public reports, political
appointees at HHS have sought to review, alter, and delay the CDC's
Morbidity and Mortality Weekly Reports (MMWR), which provide the latest
information and recommendations on public health threats, including
COVID-19. This interference, which reportedly began in May, also
appears to have occurred in other CDC reports. In order to better
understand the extent of political interference at CDC, we request
answer to the following questions:
(a) What impact has political interference had on the work of
public health experts at CDC, including career officials, and
COVID-19 response efforts?
Answer 1 (a). The COVID-19 pandemic is the most significant public
health challenge to face our Nation and the world in more than a
century. Approaches to the pandemic must be coordinated across the U.S.
Government to keep pace with the needs of the American people and the
world. CDC, along with the Food and Drug Administration (FDA),
Assistant Secretary for Preparedness and Response (ASPR), Federal
Emergency Management Agency (FEMA), Department of State, US Agency for
International Development (USAID), and the White House Coronavirus Task
Force, and others, is an integral part of that. CDC works hand-in-hand
with our colleagues throughout the Administration to ensure a
coordinated approach that leverages each agency's strengths.
(b) Has all public guidance issued on the CDC's website or
otherwise attributed to the CDC--including guidance pertaining
to testing for the virus that causes COVID-19 and re-opening
schools for in person learning--been developed and approved by
CDC personnel and gone through the standard CDC scientific
review process?
Answer 1 (b). The requested information could be considered
deliberative, pre-decisional, or otherwise implicate other executive
branch privacy equities and cannot be produced at this time.
(c) How has the editorial and publication process for MMWRs
changed from years past, and to what extent have political
appointees attempted to alter or delay MMWRs? What has been the
impact of these interventions on the timing and content of MMWR
reports?
Answer 1 (c). COVID-19 reports published in CDC's Morbidity and
Mortality Weekly Report (MMWR) follow a rigorous scientific review and
clearance process from the inception of a manuscript to the final
publication. Scientific review and clearance for COVID-19 reports
mirrors the same process for standard non-COVID-19 reports published in
MMWR, with additional steps added to include CDC's COVID-19 emergency
response structure and to obtain concurrence from CDC's Director Dr.
Robert Redfield and the White House Coronavirus Task Force Coordinator
Dr. Deborah Birx to publish. The concurrence requirement started in
late spring 2020, and neither Dr. Redfield nor Dr. Birx has ever
withheld concurrence for a COVID-19 MMWR report.
The MMWR, sometimes called the ``voice of CDC,'' has published more
than 100 COVID-19 reports since the beginning of the pandemic,
providing cutting-edge scientific articles that have been viewed by
tens of millions of readers. These reports have provided the public,
scientists, healthcare workers, and policymakers critical information
about the virus, how it spreads, and the communities it has impacted.
MMWR publications yielded the earliest descriptions of asymptomatic and
pre-symptomatic transmission of the virus and elucidated the
substantial risk of transmission at large gatherings, choir practices,
and congregate living situations, including nursing homes, prisons and
jails, meat processing plants, homeless shelters, and camps for
children. They have described the disparate impact of COVID-19 in
racial and ethnic minorities and identified the elevated risk of severe
outcomes for older adults and people with underlying conditions.
Finally, the MMWR has indicated what successful control of the virus
can look like, through careful mitigation efforts in everyday high-risk
settings such as hair salons and childcare centers. In short, MMWR's
rapid publication of the highest quality science has laid the
foundation of what we know about COVID-19 and illuminated the way
forward.
CDC declined to make any suggested change to MMWRs that was
inconsistent with the best available science.
(d) What role, if any, have entities outside of HHS--including
the White House, the Office of Management and Budget, or the
Office of Science and Technology Policy--played in developing,
revising, and issuing guidance, reports, or policy changes at
CDC?
Answer 1 (d). The COVID-19 pandemic is the most significant public
health challenge to face our Nation and the world in more than a
century. Approaches to the pandemic must be coordinated across the U.S.
Government to keep pace with the needs of the American people and the
world. CDC, along with FDA, ASPR, FEMA, Department of State, USAID, and
the White House Coronavirus Task Force, and others, is an integral part
of the pandemic response. CDC works hand-in-hand with our colleagues
through the Administration to ensure a coordinated approach that
leverages each agency's strengths.
Long Term Health Effects of COVID-19
Question 2.
There is evidence of patients continuing to feel the effects of
COVID-19 well after they are discharged from hospitals or beyond the
average known time of recovery, and some may face long-term health
problems long after the pandemic is over. It is critical that the
Federal Government conduct appropriate research and collect and
disseminate appropriate data about the potential chronic health impacts
of COVID-19--and do so without muzzling public health officials and
medical professionals--in order to adequately inform decisions about
reopening schools and businesses and assess the ongoing risks of the
pandemic. As CDC continues to conduct and coordinate research efforts,
it is critical that it collect, analyze, and disseminate data on the
long-term impacts and severity of the disease, conduct research to
understand the risks, and appropriately inform policymakers, the public
and medical professionals of them. To help us understand how the CDC is
researching, monitoring, and evaluating the chronic long-term health
impacts of COVID-19, we request answers to the following questions:
(a) How is the CDC evaluating the long-term health risks of
COVID-19 for the millions of Americans that will survive the
disease?
Answer 2 (a). CDC is actively working to learn more about the whole
range of short-and long-term health effects associated with COVID-19.
As the pandemic unfolds, we are learning that many organs besides the
lungs are affected by COVID-19 and there are many ways the infection
can affect someone's health. CDC will continue to assess and provide
updates as new data emerge.
CDC is funding several cohort studies to assess long-term
consequences and sequelae of COVID-19. For example:
CDC is funding a cohort study designed to follow 3,600 patients
with COVID-19 and 1,200 matched controls from 8 different sites across
the United States that will allow comparison of long-term sequelae
(consequences) in comparison to a control subgroup who test negative.
Complications of COVID-19 will be assessed using health record data and
validated survey instruments, for 18 months after infection.
Participants will include vulnerable populations such as race/ethnic
minorities, individuals from low income communities, and those with
pre-existing underlying conditions.
CDC is also funding a large cohort study that is designed to
integrate syndromic, serologic, and health record data for 65,000
participants with or without infection, to be followed for 6 months to
1 year. This will enable assessment of health outcomes including for
patients who report symptoms and seroconvert but do not receive
clinical care for the initial illness.
Among inpatients with COVID-19 in Louisiana, a cohort study is
underway with plans to enroll 400-500 participants. An additional
cohort of approximately 400 individuals who had tested positive for
COVID-19 from outpatient settings will be enrolled. A subgroup of 100-
200 participants is to be followed up for 1 year to assess clinical
outcomes and ability to perform usual activities.
Additionally, CDC is funding a study that will enroll patients with
COVID-19 and their household contacts. Clinical sequelae will be
assessed up to 1 year after infection, including neurocognitive
outcomes of infection in a subgroup of participants. This study will
focus on American Indian populations.
Each of the above studies will examine race and ethnicity trends to
better understand high risk populations.
(b) How are these risks being factored into CDC actions and
recommendations alongside the mortality risks of the disease?
Specifically, how does the CDC evaluate and assess these risks
with regard to reopening schools, businesses, and the economy?
Answer 2 (b). Very little is known at this time about long-term
sequelae for children and adolescents, which makes it even more
critical to do everything we can to prevent the spread of the virus
within this population. CDC recommendations are based on the best
available science and CDC will adjust interventions and guidance as
more information becomes available.
CDC has been working with both health departments and education
partners and stakeholders since the beginning of the COVID-19 pandemic
to provide helpful and actionable information to schools, parents and
caregivers, and the public based on local situations. Recognizing that
schools are an important part of the infrastructure of communities and
play a critical role in supporting the whole child, CDC has established
a dedicated team to prioritize and develop additional guidance and
resources for communities, schools, and institutions of higher
education; these are based on the best available science to protect the
health, safety, and well-being of students, teachers, other school
staff, families, and communities. CDC is conducting surveys of parents
and educators to identify key information needs and inform development
of resources. CDC is also conducting behavioral and epidemiologic
research to fill information gaps and is updating guidance as new
information becomes available.
Further, CDC has provided information and resources for employers
(https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-business-
response.html) as they consider how best to decrease the spread of
COVID-19 and lower the impact in the workplace. This should include
activities to prevent and reduce transmission among employees, maintain
healthy business operations, and maintain a healthy work environment.
(c) How is the CDC working with other Federal agencies
conducting long-term surveillance or other research on
survivors of COVID-19, including those who presented with non-
severe symptoms and those who presented with severe symptoms?
How is this information being transmitted to and used by other
Federal agencies?
Answer 2 (c). See response to part a.
(d) What data are CDC and its partner agencies collecting from
patients, health care providers, and other sources, and how are
the agencies using this data to understand and inform long-term
risk assessments?
Answer 2 (d). CDC uses several different surveillance systems to
gather information to provide as complete a picture as possible to
inform our public health response. CDC has been working quickly with
states, counties, cities, territories, tribes, and other partners to
improve data collection and reporting and continues to make progress to
ensure key data are available to identify those most affected by this
pandemic.
Various laws, regulations, and policies in public health
jurisdictions require healthcare providers, hospitals, laboratories,
and others to provide information on reportable conditions to public
health authorities. COVID-19 is a mandatory reportable condition in all
U.S. states, several territorial health departments, and local health
departments. These entities voluntarily send case reports to CDC
through the National Notifiable Diseases Surveillance System (NNDSS) to
help monitor and mitigate the adverse effects of this pandemic. On June
4, 2020, HHS announced new guidance that specifies additional data that
must be reported to HHS by laboratories submitting COVID-19 test
results, including race, ethnicity, and sex. The guidance, COVID-19
Pandemic Response, Laboratory Data Reporting: CARES Act section 18115
(www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-
guidance.pdf), which took effect August 1, 2020, standardizes reporting
to give public health officials access to comprehensive and nearly
real-time data to inform decisionmaking and public health action in
their response to COVID-19.
CDC's existing National Healthcare Safety Network (NHSN) continues
to collect COVID-19 data from nursing homes and other long-term care
facilities. NHSN also continues to collect data from hospitals across
the U.S. to address healthcare-associated infections and fight against
antibiotic resistance.
CDC's population-based COVID-NET system monitors COVID-19-
associated hospitalizations that have a confirmed positive test in more
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 is also currently working with a few Institutes of Higher
Education (IHEs) to rapidly gather data on mitigation measures employed
and the occurrence of COVID-19 to increase understanding of the best
practices for reducing or preventing COVID-19 transmission. CDC is also
developing a list of core variables, including key demographic
information, that IHEs could collect. This approach of defining core
variables for this setting can facilitate aggregating data across
multiple states; CDC will issue a data call to our partners in state,
tribal, and territorial health departments to request submission of de-
identified IHE data to summarize data across states and provide a
national picture. This is similar to the approach CDC has used to
rapidly gather information on COVID-19 transmission in other settings,
such as high-density worksites. CDC is also monitoring school outbreaks
and school closures using publicly available information.
In addition, CDC continues to work with state, tribal, local, and
territorial health departments and healthcare systems to collect data
on the number of COVID-19 cases, hospitalizations, and deaths, which is
used to better direct resources to address target populations. CDC also
supports partnerships among researchers, professional groups, community
groups, tribal medicine leaders, and community members to share
culturally tailored information which allows for messaging to be more
applicable to specific groups. Additionally, CDC continues to publish
and update COVID-19 guidance that is designed for specific target
populations including occupational, racial and ethnic, and regional
populations.
(e) How is the CDC collaborating with state, local, Tribal, and
territorial public health officials, universities, and other
governments and international organizations to research and
understand the long-term impacts of COVID-19?
Answer 2 (e). CDC works closely with state, local, and territorial
health departments and Tribal leaders through regular engagement
between these groups and subject matter experts supporting the agency's
response to COVID-19. CDC works with partners to respond to COVID-19 in
the areas of community health, workplace safety and health, and
epidemiology and data analysis. CDC provides both direct support
through the physical deployment of staff to state, tribal, local and
territorial jurisdictions and virtual support by providing teams to
assist jurisdictions remotely from Atlanta. CDC is working with health
departments to research critical questions, including:
1. How well are prevention and control strategies performing
(feasibility, implementation, effectiveness) in schools,
congregate settings, and critical infrastructure settings?
2. What are the health impacts of infection with special
consideration for long-term sequelae, pediatric populations,
and persons with co-morbidities?
3. How do antigen assays perform relative to presence of
transmissible virus, including in asymptomatic individuals?
CDC is working with Institutes of Higher Education to understand
the impact of COVID-19, and the mitigation strategies put into place to
address it, on students. A survey has been created and is being shared
with colleges and universities who express an interest in better
understanding the impacts on their students. This survey addresses
personal experiences with COVID-19, social support, school experiences
during COVID-19, changes to daily routines, relationships with family
and friends, other protective factors like school connectedness, mental
health, use of health services, academic performance, and substance
use.
(f) What additional resources or authorities are needed from
Congress to ensure that the CDC can effectively conduct this
type of research?
Answer 2 (f). The COVID-19 pandemic put a spotlight on the needs
and disparities in the public health infrastructure across the country.
CDC's mission depends on a strong public health system with robust core
capabilities like data and analytics, laboratory capacity, a top-tier
workforce, rapid response capabilities, and a broad global footprint to
stop disease at its source. The Administration worked closely with
Congress to ensure that State and local public health departments had
necessary resources to respond to COVID-19. The investments supported
with COVID-19 Supplemental funds will help improve public health
infrastructure at all levels across the country.
(g) On July 14, 2020, HHS announced changes to hospital
reporting protocols, under which data on COVID-19 in hospitals
will now be reported directly to an HHS contractor rather than
to CDC.7 Will this change affect CDC's ability to obtain and
analyze data on the medium-and long-term health risks from
COVID-19?
Answer 2 (g). As the department leading the Federal pandemic
response, HHS recognized it needed a central way to make data collected
by various operating divisions, including CDC, Centers for Medicare &
Medicaid Services, and the Health Resources and Services Administration
(HRSA), accessible in real-time to first responders at the Federal,
state, and local levels. The HHS Protect ecosystem allows HHS to create
a single portal with over 3.5 billion data elements across 200
different data sets in real time to drive HHS's response to the COVID-
19 pandemic. HHS reports HHS Protect data publicly on HealthData.gov
and the HHS Protect Data Hub (available at: https://protect-
public.hhs.gov/). Following the change in systems, CDC staff revised
data analysis methods to make necessary adjustments for the change in
variables reported within the two systems and differences in how the
systems were constructed.
While hospital capacity and patient impact data are no longer
collected by the CDC, the surveillance systems for cases, mortality,
nursing homes, studies, and clinical data continue to be led by CDC,
including population-based surveillance data on hospitalization through
COVID-NET. The joint analysis of all this data remains within the
domain of the CDC and the other Federal agencies in the COVID-19
response. NHSN continues to collect COVID-19 data from nursing homes
and long-term care facilities, leveraging authority from CMS to require
reporting from 100 percent of CMS-certified nursing homes across the
country. NHSN continues its efforts around data collection from
hospitals across the U.S. for the fight against healthcare-associated
infections and antibiotic resistance. The U.S. healthcare system relies
on NHSN to track healthcare-associated infections, improve patient
safety, and fulfill Federal and state reporting requirements to track
and improve patient safety related to healthcare-associated infections,
antibiotic-resistant infections, and antibiotic use. Though CDC does
not directly collect COVID-19 hospital capacity and patient impact
data, CDC staff have access to it in HHS Protect.
Nursing Homes and Long Term Care Facilities
Question 3.
The COVID-19 pandemic has had a deadly impact on nursing homes and
other long-term care facilities, with disproportionately negative
consequences borne by residents of color. On July 15, 2020, my
colleagues and I sent a letter to the CDC and the Centers for Medicare
and Medicaid Services urging you to fully inform the national response
to this crisis by expanding COVID-19 data collection for nursing home
residents and staff to include race, ethnicity, sex, age, primary
language and disability status. Specifically, we urged you to follow
the data collection standards set by the Office of Minority Health at
the Department of Health and Human Services, and add questions about
race, ethnicity, sex, age, primary language, and disability status to
the COVID-19 nursing home data collection under 42 CFR Sec. 483.80(g);
publicly release this demographic information aggregated at the state
and Federal level; and devise reliable methods to collect this
information retroactively.
(a) What specific steps has CDC taken to collect demographic
data from residents living in nursing homes who test positive
for COVID-19?
Answer 3 (a). Long-term care facilities (LTCF) report COVID-19 data
through CDC's National Healthcare Safety Network (NHSN). CDC released
the COVID-19 Point-of-Care Testing module for LTCF in NHSN on October
15, 2020. This module includes data fields for race and ethnicity for
facilities to report testing results from nursing homes and other long-
term care facilities. Initially the HHS decision made on October 15,
2020 required CMS-certified LTCFs to report antigen testing data in
NHSN; however, that decision has been updated to recommend CMS-
certified LTCFs report antigen testing as of December 22, 2020. CDC is
working with CMS to communicate the CDC-and CMS-preferred pathway for
reporting POC SARS-CoV-2 testing data, including antigen testing data,
through NHSN.
Additionally, CDC is examining methods for developing internal
estimates of COVID-19 burden in long-term care facilities by race and
ethnicity, such as incorporating demographic data from CMS; however,
these will not be as accurate as comprehensive data reporting.
(b) What specific steps has CDC taken to collect demographic
data and other information pertaining to COVID-19 cases and
deaths in other congregate settings, including intermediate
care facilities and psychiatric hospitals?
Answer 3 (b). CDC is committed to making COVID-19 case surveillance
data available for public use to inform the public health and research
communities while meeting our legal and ethical responsibilities to
protect privacy. The most recent public use case surveillance data can
be found at: https://data.cdc.gov/Case-Surveillance/COVID-19-Case-
Surveillance-Public-Use-Data/vbim-akqf. This site provides a download
link to access a de-identified dataset of COVID-19 case surveillance
records that includes 11 different data fields (when available),
including sex, age group, race and ethnicity, presence of an underlying
condition, hospitalization, ICU admission, and death.
In addition to case-based reporting, CDC uses two other primary
sources of data to report on race and ethnicity information: The
Coronavirus Disease 2019 (COVID-19)-Associated Hospitalization
Surveillance Network (COVID-NET) and the National Vital Statistics
System (NVSS). COVID-NET conducts population-based surveillance for
laboratory-confirmed COVID-19 hospitalizations in 14 states (CA, CO,
CT, GA, IA, MD, MI, MN, NM, NY, OH, OR, TN, and UT) and provides weekly
updates on rates of hospitalization as well as data on the race and
ethnicity, underlying medical conditions, gender, and age of
hospitalized patients (https://gis.cdc.gov/grasp/COVIDNet/COVID19-
5.html). COVID-NET draws from a carefully selected group and covers
approximately 10 percent of the U.S. population (about 32 million
people) to create a nationally representative sample of the U.S.
population from which we can extrapolate broader information about
hospitalizations.
NVSS reports provisional counts of deaths related to COVID-19 based
on death certificate data, which includes race and ethnicity. This
information is collected by the National Center for Health Statistics
(NCHS) from state vital statistics offices for all deaths occurring in
the United States. Current estimates indicate that at least 75 percent
of certificates are complete within eight weeks of when the death
occurred.
NCHS is releasing provisional aggregate public-use data sets with
counts of COVID-19 deaths through the NVSS daily (https://data.cdc.gov/
NCHS/Provisional-COVID-19-Death-Counts-by-Week-Ending-D/r8kw-7aab) and
more detailed demographic and geographic aggregate public use data on a
weekly basis (www.cdc.gov/nchs/nvss/vsrr/covid-weekly/index.htm).
Public-use micro data files for annual (complete) mortality data from
NVSS are provided for all causes of death in a year when the data for
that year are finalized. NVSS COVID-19 mortality data for 2020 are
provisional and cannot be finalized until 2021, so NCHS is unable to
produce a complete public-use micro data file containing individual-
level death records on COVID-19 mortality until the data are finalized.
(c) In what way has CDC coordinated with state and local health
departments to improve data collection of COVID-19 cases,
particularly concerning the collection of demographic
information, including race, ethnicity, sex, age and disability
status?
Answer 3 (c). Clear and accurate demographic data allow for more
precise determinations of the burden of infection and illness severity
on populations who are at high risk for poor outcomes from COVID-19.
CDC has been working quickly with states, counties, cities,
territories, tribes, and other partners to improve data collection and
reporting and continues to make progress to ensure key data are
available to identify those most affected by this pandemic. CDC uses
several different surveillance systems to gather information to provide
as complete a picture as possible to inform our public health response,
including case-based reporting, laboratory testing data, the
Coronavirus Disease 2019 (COVID-19)-Associated Hospitalization
Surveillance Network (COVID-NET), and the National Vital Statistics
System (NVSS).
Case-Based Reporting
Various laws, regulations, and policies in jurisdictions require
healthcare providers, hospitals, laboratories, and others to provide
information on reportable conditions to public health authorities.
COVID-19 is a mandatory reportable condition in all U.S. states,
several territorial health departments, and local health departments
and these entities voluntarily send case reports to CDC through the
National Notifiable Diseases Surveillance System (www.cdc.gov/nndss) to
help monitor and mitigate the adverse effects of this pandemic. Case-
based reporting uses standardized case definitions and defined
demographic and clinical variables. However, while case report forms
for notifiable diseases are required by state law, completion of
demographic data, including race/ethnicity, is voluntary; there is no
mandate requiring that healthcare providers or health departments fill
out all data fields, including race/ethnicity, in the case report form.
As of October 13, 2020, CDC has received a total of 5,832,737 case
report forms (inclusive of about 75 percent of all cases). Among these
case reports, 48 percent contain race and ethnicity data. Overall, from
April 2 to October 13, there was an improvement in completeness of race
and ethnicity in the case reports, from 21 percent to 65 percent for
race and from 18 percent to 54 percent for ethnicity. However, this
improvement has slowed since late June. In August, CDC recommended that
states focus case notifications to CDC on a core set of data elements
in order to improve the completeness of reporting on this core set,
which includes race and ethnicity but does not include disability. CDC
expects to see continued improved in demographic reporting in the
future, including for race and ethnicity.
In fiscal year 2020, CDC began a multi-year effort to modernize the
public health data system. This work will help enhance the capabilities
of state and local health departments and improve data collection to
inform decisionmaking related to COVID-19 and future public health
emergencies. Among the priority investments in CDC's public health data
modernization initiative is an effort to scale up electronic case
reporting--that is, digitally automating the provision of COVID-19 case
reports from electronic health records to public health without placing
extra burden on healthcare workers. This electronic reporting provides
more consistently complete data than manual reporting so public health
can have a comprehensive view of the pandemic's impact in near real-
time. It is part of a broader effort to automate all mandated disease
reporting to state and local jurisdictions.
Laboratory Testing Data
On June 4, 2020, HHS announced new guidance that specifies
additional data that must be reported to HHS by laboratories submitting
COVID-19 test results, including demographic data, such as sex, race,
and ethnicity. The guidance, COVID-19 Pandemic Response, Laboratory
Data Reporting: CARES Act Section 18115 (www.hhs.gov/sites/default/
files/covid-19-laboratory-data-reporting-guidance.pdf), which took
effect August 1, 2020, standardizes reporting to give public health
officials access to comprehensive and nearly real-time data to inform
decisionmaking and public health action in their response to COVID-19.
As of October 11, 2020, de-identified individual-level data from 45
jurisdictions had been included in the COVID-19 electronic lab
reporting (CELR) testing reporting dataset. Both race and ethnicity
were identified in only about 18 percent of reported tests in the 45
jurisdictions, and race/ethnicity completion was over 40 percent in
seven jurisdictions. CDC continues to work with laboratories to improve
completion of race and ethnicity data. Disability data are not included
in laboratory reports.
NHSN LTCF COVID-19 Module
CDC's NHSN LTCF COVID-19 module Point-of-Care Testing form released
October 15, 2020 includes required data fields for race and ethnicity
when facilities report testing results from nursing homes and other
long-term care facilities. CDC provided support to LTCFs as they began
providing resident-level data and has been working with LTCFs to update
their security access levels to provide case level data. Around two-
thirds of LTCFs now meet these higher-security criteria. CDC is working
with CMS, health departments, and other public health partners to
promote use of the NHSN LTCF COVID-19 module to meet CMS reporting
requirements for testing conducted by CMS-certified LTC facilities.
COVID-NET
COVID-NET conducts population-based surveillance for laboratory-
confirmed COVID-19 hospitalizations in 14 states (CA, CO, CT, GA, IA,
MD, MI, MN, NM, NY, OH, OR, TN, and UT) and provides weekly updates on
rates of hospitalization as well as data on the race and ethnicity,
underlying medical conditions, gender and age of hospitalized patients
(https://gis.cdc.gov/grasp/COVIDNet/COVID19-5.html). COVID-NET draws
from a carefully selected group and covers approximately 10 percent of
the U.S. population, approximately 32 million people to create a
nationally representative sample of the U.S. population from which we
can extrapolate broader information about hospitalizations.
Completeness of race and ethnicity data in COVID-NET is 95 percent as
of October 3, 2020. Conclusions about persons with a disability cannot
be drawn from COVID-NET data because they are based on retrospective
chart review and do not include a comprehensive list of all ICD-10
codes from each hospitalization.
NVSS
NVSS reports provisional counts of deaths related to COVID-19 based
on death certificate data, which includes race and ethnicity
information. This information is collected by the National Center for
Health Statistics from state vital statistics offices for all deaths
occurring in the U.S. These provisional counts are based on death
certificates that contain COVID-19 as a cause of death and are over 99
percent complete for race and ethnicity data. NVSS does not include
data collection items on disability.
(d) What plans have been developed to perform reliable
retroactive reporting of COVID-19 data to the beginning of the
public health emergency on January 31, 2020, including
demographic variables such as race, ethnicity, sex, age,
primary language, and disability status, in nursing homes and
other settings?
Answer 3 (d). CDC has provided guidance to nursing homes and other
LTCFs on how to submit retrospective data in the NHSN. In addition, CDC
has worked with health departments, LTC organizations, and other public
health partners to promote reporting of COVID-19 data from the
beginning of the public health emergency period. Facilities can enter
these data any time during the response. Thus, CDC continues to provide
technical support to those LTCFs that are reporting retrospective data
to NHSN. The purpose of the CDC collecting retrospective data is to
gain a comprehensive understanding about the impact of COVID-19 on
nursing homes using a systematic reporting mechanism and standard data
definitions. Standard data definitions enable more fair comparisons
across facilities and states. CDC plans to review these data to perform
facility-level trend analysis to better track the burden of COVID-19
cases.
(e) In what ways has CDC utilized COVID-19 data to inform
treatment and prevention strategies in nursing homes and other
congregate settings?
Answer 3 (e). CDC utilizes COVID-19 data to inform and develop
guidance and technical assistance resources to assist nursing homes and
public health authorities with COVID-19 prevention and response
activities. For example, CDC has developed and published guidance to
help nursing homes implement effective strategies for testing residents
and staff in response to outbreaks, as well as cohorting residents with
confirmed COVID-19 infections in designated COVID-19 care units.
Similarly, CDC developed a COVID-19 Infection Control Assessment and
Response (ICAR) tool to help nursing homes and other long-term care
facilities take steps to assess and improve their preparedness for
responding to COVID-19. As new evidence accumulates, CDC will continue
to adjust its COVID-19 infection prevention and control guidance for
nursing homes and other long-term care facilities. Based on data and
lessons learned during the COVID-19 response, CDC is also working with
CMS to identify structural changes and practices to improve nursing
home infection prevention and control program development, management,
and monitoring.
CDC and CMS also use the NHSN LTCF COVID-19 module data to generate
weekly summaries and lists that are shared with state survey agencies,
health departments, and CDC-funded state healthcare-associated
infection and antibiotic resistance (HAI-AR) programs to help them
identify long term care facilities with new or growing outbreaks to
better focus and support state and local investigation and control
efforts. This includes information provided to state survey agencies to
identify facilities for focused infection control surveys. CDC also
uses these data to identify states with worrisome trends and to engage
health department HAI-AR programs to alert them and identify areas
where assistance is needed.
CDC has outlined a range of specific mitigation strategies (https:/
/www.cdc.gov/coronavirus/2019-ncov/community/community-mitigation.html)
for people and communities to consider to slow the spread of COVID-19
by level of mitigation required. Such strategies include promotion of
healthy behaviors (e.g., social distance, masks, hand hygiene),
maintaining healthy environments (e.g., cleaning and disinfecting,
modifying layouts, ventilation, closing communal spaces), and
maintaining healthy operations (e.g., by staggering scheduling,
cohorting), and preparing for when someone gets sick. Factors to
consider for determining mitigation strategies include the epidemiology
of COVID-19 in the community and community characteristics (such as
size and population density, congregate settings in the community,
healthcare capacity, and public health capacity). Levels of mitigation
needed, stratified by level of community transmission and community
characteristics, are described on CDC's website (https://www.cdc.gov/
coronavirus/2019-ncov/community/community-mitigation.html). CDC has
provided specific considerations for schools and childcare settings,
correctional settings, community-based organizations, and communities
of faith to provide additional information on factors more commonly
encountered in those settings.
(f) In what ways has CDC or its partner agencies utilized
COVID-19 data to direct resources such as funding and personal
protective equipment to the facilities most in need?
Answer 3 (f). Because no single system can capture all parameters
of the pandemic, CDC has implemented multiple, complementary
surveillance systems. For example, CDC's National Healthcare Safety
Network (NHSN) is collecting COVID-19 data from nursing homes since
long-term care residents (and the staff who care for them) are often at
high risk for infection, serious illness, and death from COVID-19. NHSN
provided the first national lens into the burden of disease in nursing
homes and its impact on staffing and supplies, including personal
protective equipment (PPE) and ventilator use. CDC uses these COVID-19
data to work with CMS, other Federal agencies such as ASPR and FEMA,
and state and local health departments to take action to address PPE,
testing, staffing, and other supply shortages. Other key COVID-19 data
systems include case-based reporting through the National Notifiable
Diseases Surveillance System (NNDSS), laboratory-based surveillance,
and syndromic-surveillance data reported through the National Syndromic
Surveillance Program (NSSP). Additional systems, such as COVID-Net,
provide rich, publicly available information for meeting secondary
objectives. CDC continues to explore emerging and experimental
surveillance platforms with a critical eye toward proven utility.
To address PPE shortages due to the COVID-19 pandemic and help
healthcare facilities optimize the use of PPE and other equipment
during this time, CDC has also developed tools and guidance documents
which can be found the CDC website. For example, CDC has developed a
Personal Protective Equipment (PPE) Burn Rate Calculator, which
healthcare facilities can use to plan and optimize the use of PPE in
response to COVID-19. In addition, CDC's optimization strategies and
guidance for PPE offer healthcare facilities a continuum of options
when PPE supplies are stressed, running low, or exhausted.
(g) When will CDC collect and publicly release COVID-19
demographic information aggregated at the state and Federal
level for residents in nursing homes and other congregate
settings?
Answer 3 (g). CDC's National Healthcare Safety Network (NHSN) is
the Nation's system for healthcare facilities and the government to
track and take actions to address healthcare-associated and antibiotic-
resistant infections. The experts use the data to help healthcare
facilities and health departments take action and have an impact on
care. It dramatically improves patient outcomes and stops the spread of
infections.
Begun in 2005, NHSN is used by almost every hospital in the Nation
(66,200), more than 7,500 dialysis facilities, and about 3,000 nursing
homes--over 25,000 facilities in total. Since its pivot to meet the
needs of the COVID-19 response, an additional 12,000 nursing homes now
use NHSN--bringing the total number of healthcare facilities that use
NHSN to approximately 37,000.
Beginning in April, all 615,400 CMS-certified nursing homes began
reporting COVID-19 case and facility staffing and supply data to NHSN.
NHSN was able to provide the first national lens into the burden of
disease in nursing homes. NHSN continues to collect COVID-19 data from
nursing homes and long-term care facilities. These NHSN nursing home
data are key for transparency and are publicly reported on CMS's
webpage. On October 15, CDC's NHSN LTCF COVID-19 module Point-of-Care
Testing form was released that includes required data fields for race
and ethnicity when facilities report testing results from nursing homes
and other long-term care facilities. CDC is working with CMS, health
departments, and other public health partners to promote use of the
NHSN LTCF COVID-19 module to meet CMS reporting requirements for
testing conducted by CMS-certified LTC facilities. As more data becomes
available, CDC will analyze this data to provide additional estimates
of the burden in nursing homes, including by race and ethnicity.
(h) To what extent can Medicare claims be used to analyze the
demographics and other characteristics of COVID-19 patients in
nursing homes and other congregate settings?
Answer 3 (h). As mentioned previously, CDC is discussing methods
for developing internal estimates of COVID-19 burden in long term care
facilities by race and ethnicity, including the use of Medicare claims
and facility demographic data. However, these will not be as accurate
as comprehensive data reporting. As reporting of nursing home COVID-19
testing data expands, CDC will reassess possible methods for developing
aggregate estimates of burden based on race and ethnicity.
senator kaine
Question 1.
What is the domestic and global public health benefit to not
collaborating with other nations through the COVAX Facility? Why
shouldn't we participate?
Answer 1. The United States does not plan to procure vaccine doses
for domestic use through participation in the COVAX facility. CDC is
supporting efforts to ensure that high risk populations in every
country--including health care workers, older adults, and persons with
chronic illnesses--have access to safe and effective COVID-19 vaccines.
Question 2.
Dr. Redfield, should the U.S. vaccine candidates prove viable and
this Administration decides to hoard surplus doses domestically while
other countries go without, isn't it true that Americans would still be
susceptible to imported cases as the world reopens?
Answer 2. CDC's global efforts focus on enabling countries to
prevent, detect, and respond to infectious disease outbreaks and other
public health threats within their borders. Building partner countries'
core public health capabilities so they can stop disease transmission
at the source is the most effective way to protect Americans from
COVID-19 and other infectious disease threats.
Question 3.
Dr. Redfield, do you believe that at a minimum the U.S. should
pledge surplus doses of any successful federally funded vaccine to
international efforts like COVAX to ensure a strategic, fair, and
rational allocation of vaccines to the rest of the world?
Answer 3. CDC does not plan to procure vaccines for use
internationally. Building on CDC's longstanding global immunization
efforts focused on polio, measles, influenza, and other priorities, CDC
is using COVID-19 funding to provide technical assistance and help
ensure that select low-and middle-income countries are ready and able
to deploy and evaluate COVID-19 vaccines when they become available.
Question 4.
Dr. Redfield, what steps is CDC taking to ensure that appropriated
funds for public health data modernization from fiscal year 2020 and
the CARES Act goes toward the critical long-term modernization that our
public health systems require? Please provide an update on how funds
have been spent and what plans have been made to allocate the remainder
of appropriated funds.
Answer 4. Congress has supported CDC's data modernization
initiative, including $50 million in CDC's fiscal year 2020
appropriation and $500 million in the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, which will support efforts to modernize
the Nation's public health data capabilities. These investments will
help CDC enhance the capabilities of state and local health departments
so they can marshal fast, targeted responses to disease outbreaks;
enhance syndromic surveillance to serve as a national early warning
system of emerging health threats; and build out laboratory data
exchange to enhance rapid and accurate transmission of critical
laboratory information, among other improvements. The vision is a real-
time, interoperable networked health data system capable of moving
faster than the health threats we combat, and we are moving toward that
goal.
The investment in data surveillance and analytics will modernize
public health data systems across the U.S. at all levels of government.
By modernizing public health data systems, CDC will be better equipped
to identify, track, and respond to emerging health threats, diseases,
and pandemics. Rather than discrete, one-off projects or a narrow focus
on individual capacities, CDC has looked at the entire surveillance and
data ecosystem and identified the areas most in need of investment and
modernization. The initiative will focus on three core parts of the
public health data landscape:
1. Data Sharing Across the Public Health Ecosystem: Automate
data collection and support multidirectional data flows among
state, territorial, local, and tribal public health
jurisdictions and CDC.
2. Enhancing CDC Services and Systems for Ongoing Data
Modernization: Adopt enterprise-wide infrastructure and
services that enable data linking, sharing, analysis, and
visualization.
3. New Standards and Approaches for Public Health Reporting:
Conduct real-world testing of new standards for accessing data
in electronic health records and assess the policy implications
of these new approaches.
CDC and its state and local health partners have made important
strides in ensuring the Nation's public health surveillance
infrastructure is up to the demands of this moment.
Question 5.
Dr. Redfield, what was the role of the CDC versus the White House
and the Department of Homeland Security in drafting the March 20 order
providing for expulsions of asylum-seekers and unaccompanied children
at the border, as well as its April and May extensions? What less
restrictive alternatives were considered and why were they rejected?
Answer 5. CDC cannot respond because the subject is an issue of
ongoing litigation.
Question 6.
Dr. Redfield, a recent CNN article cited CDC officials stating that
the White House asked CDC to conduct research about migration in light
of COVID-19, and the team conducting this research raised concerns
about the political, rather than public health, motivations of the
research with you. Did you elevate those concerns within the
Department, including to Secretary Azar? If so, what response did you
get?
Answer 6. The COVID-19 pandemic is the most significant public
health challenge to face our Nation and the world in more than a
century. Approaches to the pandemic must be coordinated across the U.S.
Government to keep pace with the needs of the American people and the
world. CDC, along with FDA, ASPR, FEMA, Department of State, USAID, and
the White House Coronavirus Task Force, and others, is an integral part
of that. CDC works hand-in-hand with our colleagues throughout the
Administration to ensure a coordinated approach that leverages each
agency's authorities and strength.
Question 7.
Dr. Redfield, Acting Customs and Border Protection (CBP) Director
Mark Morgan publicly stated last week that the CDC order shutting down
asylum may extend after COVID-19 eases, saying ``it's not going to go
back to the way it was pre-COVID overnight.'' Why is the Acting CBP
Director making such a statement about an order ostensibly issued by
CDC? What is the role of the CDC in determining whether the order will
be extended, versus DHS and/or CBP?
Answer 7. CDC defers to CBP regarding any statements made by CBP
officials. The Order Suspending the Right To Introduce Certain Persons
From Countries Where a Quarantinable Communicable Disease Exists
(https://www.cdc.gov/coronavirus/2019-ncov/order-suspending-
introduction-certain-persons.html) was issued pursuant to public health
authorities under Title 42 of the United States Code delegated to CDC.
As stated in the Order itself, it remains effective until the CDC
Director determines that the danger of further introduction of COVID-19
into the United States has ceased to be a serious danger to the public
health, and continuation of this Order is no longer necessary to
protect public health. The Order is subject to review by CDC every 30
days and may be extended, modified, or terminated at any time as needed
to protect public health.
Question 8.
DHS is allegedly expelling children under Title 42 because of the
risk of these children bringing Covid-19 into the country. However,
children are returned to home countries if they test negative for
Covid-19, thus undermining the stated reason for denying them entry. On
what grounds do you justify expulsion of children who test negative? If
children test negative for Covid-19 why aren't they being transferred
to ORR?
Answer 8. CDC cannot respond because the subject is an issue of
ongoing litigation.
senator smith
Question 1.
COVID-19 vaccine should be free for all Americans, no matter their
insurance status, once it is available.
(a) If I'm an uninsured adult or an adult on Medicaid, will my
vaccine be free? Will it depend on where I go to get my
vaccine? b. Does Congress need act to make sure people in these
situations don't pay anything?
Answer 1 (a). COVID-19 vaccines and ancillary supplies will be
procured and distributed by the Federal Government at no cost to
enrolled COVID-19 vaccination providers and no cost to the public.
Question 2.
Are you and the Centers for Disease Control and Prevention (CDC)
working with Admiral Brett Giroir so that testing is readily available
while a vaccine is being distributed? Please provide specific details
and plans on these efforts.
Answer 2. CDC is providing resources to communities to enhance and
expand testing and epidemiologic activities to control the spread of
COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/downloads/php/
funding-update.pdf). The Paycheck Protection Program and Health Care
Enhancement Act provided $11 billion to HHS to support testing for
COVID-19/SARS-CoV-2. CDC provided $10.25 billion to 64 state,
territorial, and local jurisdictions through the existing Epidemiology
and Laboratory Capacity (ELC) cooperative agreement. In coordination
with HHS/OASH, the funding will support testing, case investigation,
and contact tracing.
senator rosen
Question 1.
As you know, our Tribal communities have been especially hard hit
by the COVID-19 pandemic. According to the CDC, they are around three
and a half times more likely to contract this virus and are also at a
high risk for severe outcomes. In Nevada, we have over 27 Tribal
Nations, Bands and Colonies, with more than 32,000 members. Ninetyseven
percent of our Tribes are rural and are spread across over a million
acres of land.
(a) Given that our Tribal communities are especially vulnerable
to COVID-19, are all too often populations with high rates of
comorbidities such as diabetes, and frequently live in very
rural areas, what else should the Federal Government be doing
to address the immediate health needs of these communities, and
what steps should be taken to ensure robust Federal support for
COVID-19 vaccine distribution to be done in an equitable,
effective, and culturally competent manner? What lessons were
learned from the H1N1 response so we can improve upon past
efforts?
Answer 1 (a). CDC's COVID-19 Tribal Support Section (TSS) is
working closely with tribal nations, state and local public health
officials, and other Federal agencies to implement a comprehensive
public health response to the COVID-19 pandemic. TSS provides technical
assistance, training, tools, and field support to tribes and tribal-
serving organizations to assist them in addressing COVID-19
(www.cdc.gov/coronavirus/2019-ncov/community/tribal/index.html). Areas
of technical assistance include data collection and analysis, incident
command structure, increasing access to safe water, community
mitigation, and contact tracing. As of October 15, 2020, TSS has
completed 30 deployments in tribal communities to provide onsite
technical assistance and support, has six active teams deployed and is
actively planning to deploy teams to 8 tribes and tribal organizations.
Technical assistance for each tribe is tailored to their respective
situations, needs, and priorities.
In September 2020, CDC published the COVID-19 Vaccination Program
Interim Playbook for Jurisdiction Operations (https://www.cdc.gov/
vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim--
Playbook.pdf), a document for state, tribal, territorial, and local
public health programs and their partners on how to plan and
operationalize a vaccination response to COVID-19 within their
jurisdictions. The document covers specific areas of COVID-19
vaccination program planning and implementation and provide key
guidance documents and links to resources to assist those efforts. The
playbook also recommends that jurisdictions review their 2009 H1N1
pandemic vaccination response plans and lessons learned. After-action
reports and improvement plans from that time provide an opportunity for
jurisdictions to build on prior strengths and determine any gaps that
may need to be addressed. CDC's COVID-19 Response Vaccine Task Force
(VTF) continues to review plans, standard operating procedures (SOPs),
and reports from the 2009 H1N1 response to incorporate lessons learned
into COVID-19 vaccination planning.
The Indian Health Service COVID-19 Pandemic Vaccine Plan (https://
www.ihs.gov/coronavirus/vaccine) further details how the Indian Health
Service (IHS) health care system will prepare for and operationalize
vaccine distribution for IHS Direct, Tribal, and Urban Indian Health
Programs. CDC is working directly with IHS on vaccination planning. It
is important that jurisdictions include tribal leaders and tribal
organizations in their planning efforts.
CDC has a strong vaccine delivery infrastructure connecting public
health departments, health care providers, community groups,
pharmacists/chain drug stores, and others that can be used to
efficiently reach the population. During an emergency, this proven
system can be scaled up and expedited to manage and distribute many
more doses of vaccine than in a typical year.
CDC is enhancing communications efforts to target special
audiences, including older Americans, people of any age with underlying
health conditions, workers in long-term care facilities, and other
essential workers. Targeted communication and education efforts will be
implemented for African American and Hispanic/Latino communities as
these groups have lower rates of influenza vaccination, but higher risk
for COVID complications. CDC is testing influenza vaccine messages to
learn what impacts the pandemic may have on the intent to vaccinate,
including fears about getting vaccinated in a safe environment, and CDC
will continue to work with our public health and clinical partners to
eliminate barriers to vaccination. CDC has expanded outreach to
populations at high-risk of severe COVID-19 by working with new and
existing partners, including leveraging existing partnerships with
National Association of Community Health Centers (NACHC) and state and
local immunization programs to distribute 9.3 million supplemental
influenza vaccine doses to those seeking care at community health
centers.
Using resources appropriated through the Coronavirus Aid, Relief,
and Economic Security Act, CDC provided its immunization awardees $140
million in supplemental funding to support and enhance their
immunization programs.
In addition, CDC has been working with influenza vaccine
manufacturers to maximize influenza vaccine supply; CDC is projecting
this will increase available doses to 194-198 million this season,
about 12 percent more than last year. CDC is also increasing the length
of the vaccination season through the duration of flu season, into
spring 2021. CDC also purchased an additional 2 million pediatric doses
and 9.3 million adult doses to enhance influenza vaccine coverage in
under-vaccinated communities. This includes optimizing the use of
federally procured vaccine through promotion of influenza vaccination
within the Vaccine for Children (VFC) program and expanding
partnerships to increase vaccine utilization by community health
centers.
CDC is providing increased support and resources for immunization
programs and partners, including disseminating guidance for safe
immunization services, encouraging vaccination where it is most
convenient to maximize vaccine uptake, and developing and disseminating
guidance for planning vaccination clinics held at satellite, temporary,
or offsite locations.
Question 2.
Dr. Redfield, I've heard from Tribes in Nevada that they are
especially concerned about the eventual vaccine distribution process.
Given that so many of our Tribal communities are located in rural
areas, how is CDC currently ensuring timely and targeted relief, and
how will it equitably deliver COVID-19 vaccines to these communities?
Does CDC plan to ship vaccine and ancillary supplies directly to Indian
Health Service facilities or directly to Tribes themselves?
Additionally, many Tribes lack the financial resources to help their
members if there are costs associated with vaccine distribution. How
will CDC and other Federal agencies work to ensure there is no cost
sharing for Tribal communities to receive vaccines? What else do you
need from Congress to ensure we do not leave our Tribal communities
behind?
Answer 2. CDC is currently working with the Indian Health Service
(IHS), state, territorial, and local public health programs to ensure
that tribal communities located within their boundaries have full
visibility of COVID-19 vaccine supply and vaccination activities.
Tribal subject matter experts at CDC are integrated in the review
process for COVID-19 vaccination plans submitted by States and Federal
Entities to ensure plans incorporate considerations for vaccine
implementation in tribal populations efficiently and equitably.
Tribal Nations are required to decide on their preferences for
vaccine allocation--that is, for health facilities serving the
communities to either receive vaccine through the state or through the
IHS. Tribal Consultation calls occurred in September to review these
options. Tribal Nations were asked to assess existing immunization
program operations to determine how this can be leveraged for the
COVID-19 strategy and communicate the decision to IHS and states. This
process will require strong collaboration and close communications
between tribal populations, urban Indian organizations, IHS, and the
jurisdiction.
While IHS may provide vaccination services to the populations they
serve, plans are currently in development regarding vaccine
distribution to tribal health facilities, including urban facilities,
that are not officially connected to IHS. Those facilities will have
the option to work through IHS or work through their jurisdiction to
receive vaccine. It is also critical that jurisdictions reach out to
any non-federally recognized tribes in their area to ensure they have
access to vaccination services, since these groups will likely not be
served by IHS. One way tribal communities can ensure close coordination
with their jurisdictions is to include a representative or liaison in
the Vaccine Task Force or equivalent coordination entity within the
jurisdictions COVID-19 response framework.
COVID-19 vaccines and ancillary supplies will be procured and
distributed by the Federal Government at no cost to enrolled COVID-19
vaccination providers.
______
Responses by Admiral Brett Giroir, to Questions of Senator Sanders,
Senator Collins, Senator Warren, Senator Murkowski, Senator Smith, and
Senator Rosen.
senator sanders
Question 1.
It is clear that there is a commitment to bring a safe and
effective COVID-19 vaccine to market as soon as possible. It also is
clear that there is a commitment across agencies to work together not
only to try to increase diversity in ongoing clinical trials, but to
educate the public about the importance of getting vaccinated,
especially with flu season upon us. Will you use your expertise and
influence to ensure that a COVID-19 vaccine is available at no cost to
every person in the U.S.?
Answer 1. The Administration has stated it is committed to
providing free or low-cost, safe, and effective COVID-19
countermeasures to the American people as quickly as possible. Any
COVID-19 vaccine or therapeutic doses purchased with U.S. taxpayer
dollars will be given to the American people at no cost. As is
customary with government-purchased vaccines, healthcare professionals
could charge for the cost of administering the vaccine. Information on
health care provider reimbursement for vaccine administration for the
uninsured is available here: https://www.hrsa.gov/CovidUninsuredClaim.
Question 2.
In addition to making sure that a future COVID-19 vaccine is free
to every person in the country at the point of service, it is critical
that health providers and states can afford to purchase the vaccine in
bulk and distribute it to the public and, in particular, to vulnerable
populations such as seniors and those who are living in rural areas.
(a) What specific plans does the Federal Government have to
directly purchase the COVID-19 vaccine and distribute it to the
public, or to help health providers and states purchase the
vaccine for distribution?
Answer 2 (a). Ensuring that high risk and vulnerable populations
receive the vaccine is of paramount importance. Operation Warp Speed
and its private partners are developing a plan for delivering a safe
and effective product to Americans as quickly and reliably as possible.
Experts from HHS are leading vaccine development, while experts from
the Department of Defense are partnering with the Centers for Disease
Control and Prevention (CDC) and other parts of HHS to coordinate
distribution and administration of vaccines. On September 16, 2020 HHS
released documents developed by HHS in coordination with DoD, that
provide a strategic distribution overview along with an interim
playbook for state, tribal, territorial, and local public health
programs and their partners on how to plan and operationalize a
vaccination response to COVID-19 within their respective jurisdictions.
The CDC can provide more information on vaccine distribution as needed.
Question 3.
As you know, there were recently mixed messages from the CDC
regarding the airborne transmission of the novel coronavirus. This
caused a great deal of confusion among many people and may have
contributed to the public's general lack of trust in our public health
agencies. In fact, according to a recent Kaiser Family Foundation
survey taken before the latest miscommunication, 54 percent of people
surveyed said that they ``would not get vaccinated'' if one was
available before the November election. And, this lack of confidence in
a vaccine cuts across the political field, with 46 percent of
Democrats, and a full six in ten (60 percent) Republicans reporting
that they would not get vaccinated.
(a) What concrete steps are being taken now, as the research
continues to move forward, to ensure accurate, consistent, and
scientifically reviewed messaging about COVID-19, including the
severity of the disease, how the virus is transmitted and how
people can protect themselves and each other? Specifically, how
are you measuring and evaluating the impact of these efforts?
Answer 3 (a). Presenting accurate and consistent information to the
American people is essential. Ensuring that the American people are
equipped with the most up to date and scientifically accurate
information is of the utmost importance. As more is discovered about
this virus and as research continues to move forward, we will continue
to provide the public with that information in an accurate and
appropriate method so people can continue to make informed decisions on
how best to protect themselves and those around.
senator collins
Question 1.
Rapid instrumented molecular point-of-care testing has played an
important role in combatting the spread of the COVID-19 virus because
they yield results in minutes rather than hours or days. They can also
be deployed in settings that enable more convenient patient access to
testing. Currently, there is a significant gap in Medicare
reimbursement for rapid instrumented molecular point-of-care tests
compared with lab-based PCR tests. I understand that this inequity has
created a disincentive for health care providers to offer these tests,
and I encourage CMS to look at making reimbursement more equitable for
these tests to ensure that providers choose the test system that best
suits the needs of their patients. Dr. Giroir, how does the
Administration plan to address this issue?
Answer 1. Point of care testing is an essential part of our testing
strategy and continues to expand in its use throughout the country.
These testing modalities are a very important tool in our testing plan
and we will work with our colleagues across the Federal Government to
ensure that the issues you have raised are addressed. Ensuring access
to point of care testing and promoting that access through equitable
reimbursement will continue to be explored with the appropriate
agencies.
senator warren
Political Interference at HHS
Question 1.
Numerous public reports have revealed that political appointees at
HHS and the White House have repeatedly interfered with, undermined,
and even overruled career experts at the scientific agencies within
HHS, including the CDC and FDA. In August, HHS Secretary Azar
reportedly overruled FDA when he revoked the agency's ability to
regulate lab-developed diagnostic tests, including COVID-19 tests,
potentially undermining the accuracy of the results that patients
receive from these tests. That same month, guidance reportedly
developed by HHS and the White House Coronavirus Task Force was
published to the CDC's website--reportedly without approval from the
CDC--recommending that asymptomatic individuals do not need to be
tested, even after exposure to someone with COVID-19. This guidance
contradicted clear advice from career CDC officials and other public
health experts. At least one public health expert--Rick Bright, the
former Director of the Biomedical Advanced Research and Development
Authority--has alleged that he was retaliated against for emphasizing
the threat of COVID-19 and resisting political pressure in making
certain purchases or approvals pushed by White House and other
Administration officials.3 In order to better understand the extent of
political interference at HHS, we request answer to the following
questions:
(a) What is the extent of political interference at CDC, FDA,
and other key public health agencies involved in the response
to COVID-19?
(b) What impact has political interference had on the work of
public health experts at HHS, including career officials at its
operating divisions, and COVID-19 response efforts?
(c) Have all applicable laws, rules, regulations, and
policies--including the requirements of HHS's, CDC's, and FDA's
scientific integrity and communications policies--been followed
in the development and issuance of public guidance, reports, or
policy changes?
(d) What role, if any, have entities outside of HHS--including
the White House, the Office of Management and Budget, or the
Office of Science and Technology Policy--played in developing,
revising, and issuing guidance, reports, or policy changes at
CDC or FDA?
Answers 1 (a)-1 (d). All response efforts across the Federal
Government have been conducted in the best interest of the American
people and all of these efforts have been guided by data and grounded
in science. Through the entire response, all laws, rules, regulations,
and policies have been followed and scientific integrity is supreme in
all public communications. There have been no instances of political
influences on any actions taken, all actions that have been taken have
been based in the most up to date data and science.
senator murkowski
COVID-19 Testing Supply Issues:
Question 1.
First, I'd like to thank the administration, and particularly you
Admiral Giroir for all of the support you have provided in getting
testing supplies to Alaska, this support has been critical in making
sure the unique needs of hyper-rural areas are taken into account.
However, I am concerned about what a declining focus from HHS on the
distribution of testing supplies, as the private industry capacity
increases, could mean for states like Alaska. I have been pleased to
see the growth in testing capacity across the United States, and
understand that, as the private supply has increased, states are being
told to go through traditional private industry channels to access
supplies, rather than working through HHS. I'm concerned what this
might mean for small, rural states, many of whom are still experiencing
high levels of COVID19 transmission. I have been told that larger
states are able to put in bulk orders to private industry, and that
officials in smaller states such as Alaska are concerned that their
orders will not be prioritized going forward. We saw this early on in
the outbreak, where states with lower numbers or limited industry
presence struggled to get supplies from manufacturers, and the help of
the administration was critical in getting supplies to these
communities.
(a) Can you reassure me that the administration will continue
to support the distribution of testing supplies to rural areas?
What advice do you have for smaller states without large
industry presence worried about being left behind?
Answer 1 (a). The Federal Government will continue to help all
states procure the materials and supplies they need to conduct testing
and meet the goals laid out in each state testing plan. In addition,
the Federal Government announced on September 28, 2020 and began
distributing Abbott BinaxNOW tests to states.
Subsequent to the date of the hearing, on October 13, HHS in
collaboration with the Department of Defense (DOD) awarded a $481
million to Cue Health, Inc. to expand U.S. production capacity for a
cartridge-based point-of-care COVID-19 molecular test that produces
results in about 20 minutes.
HHS has launched a pilot program with five states to use portable,
cartridge-based COVID-19 molecular test kits that provide rapid
results. The pilot program will assess how to best integrate diagnostic
technology developed by Cue Health, Inc., into strategies for disease
surveillance and infection control in institutions such as nursing
homes.
During the week of November 9, HHS distributed 27,000 test kits,
which include the Cue Sample Wand (nasal swabs) and the Cue COVID-19
Test Cartridges, and 600 Cue Health Monitoring Systems (Cartridge
Readers) as follows: 4,500 test kits and 100 cartridge readers each to
Florida, Louisiana, New Jersey, and Texas, and 9,000 test kits and 200
cartridge readers to Alaska. Alaska received a greater quantity of
components due to the remote nature of access.
Military Vaccine Distribution Issues:
Question 1.
Admiral Giroir, in the guidance issued by the administration
regarding a COVID-19 vaccine and its distribution, military members
were not identified as a critical population for the vaccine. This is
despite that the Department of Defense and military hospitals having
assisted in the development of the vaccine.
(a) How will military members and their families will be
prioritized due to the transit nature of military members with
travel, deployments and moves?
(b) Additionally, how will the military work with state and
local health departments in coordination on distributing a
COVID-19 vaccine?
Answers 1 (a)-1 (b). Ensuring that high risk, vulnerable, and
critical populations receive the vaccine is of paramount importance.
Operation Warp Speed and their private partners are developing a plan
for delivering a safe and effective product to Americans as quickly and
reliably as possible. Experts from HHs are leading vaccine development,
while experts from the Department of Defense are partnering with the
CDC and other parts of HHS to coordinate distribution and
administration of vaccines. On September 16, 2020 HHS released
documents developed by HHS in coordination with DoD, that provide a
strategic distribution overview along with an interim playbook for
state, tribal, territorial, and local public health programs and their
partners on how to plan and operationalize a vaccination response to
COVID-19 within their respective jurisdictions.
DOD would be in the best position to provide additional information
on their plans for vaccine distribution.
senator smith
Question 1.
The New York Times recently reported that Americans are receiving
surprise medical bills for their COVID-19 tests and related office
visits. However, Congress worked in the coronavirus relief packages to
make sure Americans would not have to pay for their COVID-19 tests or
associated office visits.
(a) Why are Americans getting charged for COVID-19 tests?
(b) Should Americans get charged for these tests?
(c) Should Congress act to stop these testing charges?
Answer 1 (a)-1 (c). HHS is working to ensure that testing is
available across the country and has provided funding to states and
tribes through the CDC, IHS and to health centers across the country to
ensure that testing is affordable or at no cost to Americans. HHS
Office of Inspector General will continue to investigate any instances
of fraud or abuse. OASH defers to CMS for further inquiries.
Question 2.
Are you working with the Centers for Disease Control and Prevention
(CDC) so that testing is readily available while a vaccine is being
distributed? Please provide specific details and plans on these
efforts.
Answer 2. Yes, I am working with the CDC constantly to ensure that
our efforts are complementary. Testing remains a critical component to
the response efforts. Testing will continue and the amount of testing
available to the American public will continue to increase as we have
seen throughout this pandemic. Since March 2020, testing in the United
States has increased over 30,000 percent. As more testing technologies
are developed and the investments in the supply chain continue to
provide more materials, the testing capacity of the United States will
continue to increase. Subsequent to the date of the hearing, as of
December 1, the United States is conducting an average of over 1
million tests a day. As of December 17, 2020, over 94 percent of COVID-
19 tests results are received within 3 days.
Question 3.
You have previously acknowledged the need to expand testing to
asymptomatic individuals since they are known to spread the virus.
(a) Do you still believe that we should test asymptomatic
individuals to suppress COVID-19?
(b) How many COVID-19 tests are we running per day?
(c) What is our daily testing capacity?
(d) If we are not running at capacity, what is impacting our
ability to do so?
(e) Should Congress act to increase daily testing capacity?
Answers 1 (a)-1 (e). As previously stated, testing of asymptomatic
individuals is important and CDC guidance (https://www.cdc.gov/
coronavirus/2019-ncov/testing/diagnostic-testing.html#who-should-get-
tested) enumerates when this is recommended. Subsequent to the date of
the hearing, as of December 1, on average, we are conducting over 1
million tests per day, our daily testing capacity is constantly
increasing as new technologies, and other testing modalities are
introduced. As of December 17, 2020, over 94 percent of COVID-19 tests
results are received within 3 days. Testing capacity does exceed the
number of tests conducted each day and we will continue to encourage
testing as indicated by CDC guidance.
senator rosen
Question 1.
Admiral Giroir, doctors and nurses across the country continue to
report issues with still not having enough PPE. There is a lack of
transparency regarding how much is being produced, and where. We need a
stronger Federal response, and we needed it yesterday. What steps do
you recommend to ensure that every front-line worker has exactly what
they need to stay safe as they care for the critical needs of this
country?
Answer 1. Specific to the current COVID-19 response, as of August
18, 2020, and in coordination with interagency partners including the
Department of Defense and the Department of Homeland Security, the
Strategic National Stockpile (SNS) has provided more than 18.5 thousand
tons of personal protective equipment (PPE) and other medical material
to support States to aid in medical response as well as the Federal
repatriation effort to bring American citizens back from abroad. Since
the start of the pandemic, orders have been placed for approximately
800 million N95 respirators and face masks for delivery to the SNS. HHS
has leveraged and utilized actions under the Defense Production Act
(DPA). Title I of the DPA allows the President, among other
authorities, to require businesses and corporations to prioritize and
accept government contracts for materials and services. HHS has
exercised Title I DPA authorities using the Health Resource Priority
and Allocations System (HRPAS) in order to prioritize contract action
to compel a direct response to the places of greatest need. A number of
health resource materials have been identified that are essential to
respond to the COVID-19 pandemic; however, these items, like PPE and
ventilators, are in high demand. A priority rating has at times proved
necessary to provide the requested quantities and qualities of these
health resources within a specified time period or delivery date. These
rated orders are filled first when there are both commercial demands
and government demands for the same product, or component(s) of a
product. Utilizing this authority has enhanced national preparedness
and is helping ensure there is product available if and when it is
needed. HHS is working with DoD to expand domestic manufacturing
capacity. The partnership between DoD and HHS, which allowed SNS to tap
into DoD's contracting resources and experience with industrial based
expansion projects, was critical for the success of the U.S.
Government's efforts to expand domestic production capacity of medical
supplies during the COVID-19 pandemic. More information about
distribution of PPE and investments to support these efforts can be
provided by HHS ASPR.
Question 2.
As you know, our Tribal communities have been especially hard hit
by the COVID-19 pandemic. According to the CDC, they are around three
and a half times more likely to contract this virus and are also at a
high risk for severe outcomes. In Nevada, we have over 27 Tribal
Nations, Bands and Colonies, with more than 32,000 members. Ninety 7
percent of our Tribes are rural and are spread across over a million
acres of land.
(a) Given that our Tribal communities are especially vulnerable
to COVID-19, are all too often populations with high rates of
comorbidities such as diabetes, and frequently live in very
rural areas, what else should the Federal Government be doing
to address the immediate health needs of these communities, and
what steps should be taken to ensure robust Federal support for
COVID-19 vaccine distribution to be done in an equitable,
effective, and culturally competent manner? What lessons were
learned from the H1N1 response so we can improve upon past
efforts?
Answer 2 (a). The CDC can provide additional information in regards
to Tribal communities and the distribution of a COVID-19 vaccine. The
Indian Health Service (IHS) continues to support an all-of-government
COVID-19 response that is locally executed, tribally and state managed,
and federally supported. The IHS has a robust system-wide testing
strategy that is aligned with the strategy laid out by the White House
Coronavirus Task Force. The IHS seeks to continue to maintain a per
capita testing rate (by IHS user population) that exceeds the US all
races rate AND to maintain positivity of <10 percent. As part of the
HHS response to this crisis, on June 23, 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 a
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. One of the primary goals of these
information dissemination efforts is to provide additional education
and community-level information, which is culturally competent, on
resources to help fight the pandemic to those who need it most.
______
Responses by Dr. Stephen Hahn, to Questions of Senator Murray, Senator
Sanders, Senator Burr, Senator Warren, and Senator Kaine.
senator murray
Question 1.
Dr. Hahn, just in the last few weeks, Secretary Azar tried
repeatedly to undermine the FDA and its public health mission: first,
declaring that FDA could not regulate laboratory developed tests,
abruptly overruling precedent during a pandemic without any apparent
public health justification, and second, stripping the agency's
authority to issue any new rules without his sign off.
(a) You said nothing after Secretary Azar stripped FDA of its
ability to regulate tests in the middle of a pandemic. What
concrete actions will you take the next time Secretary Azar
interferes with FDA's ability to protect the public health?
Answer 1 (a). FDA's role is to make independent, science-based
decisions and base its review decisions on legal and scientific
standards with the overriding objective to help with the development of
safe and effective medical products for American patients. FDA review
decisions will continue to be based on the statutory requirements and
available scientific data.
(b) On October 6, FDA published guidance containing criteria
the agency intends to apply in considering whether to issue an
emergency use authorization (EUA) for a COVID-19 vaccine. The
criteria set forth in the guidance are more rigorous than the
legal standard for issuance of an EUA. The same day FDA
published the guidance, President Trump tagged you in a tweet
in which he asserted that the guidance makes it more difficult
for FDA to ``speed up vaccines for approval before Election
Day'' and is ``another political hit job.'' What specific steps
will you take if Secretary Azar or the White House attempts to
interfere with FDA scientists' review of a COVID-19 vaccine for
emergency use or approval?
Answer 1 (b). We ate the data with only the public health in mind.
If FDA approves or authorizes a vaccine it will do so when we have
determined that it meets the applicable legal standards (set forth in
statute for both licensure and authorization) for efficacy and is safe
enough to give to our own families.
We at FDA do not permit politics to enter into our scientific
decisions. FDA will remain data driven in making public health
decisions. On behalf of FDA's 18,000 career employees, we want to
reassure the American public about this commitment. It is important
that the American people continue to have confidence in the FDA and the
decisions we make. Our strength comes in part from the fact that we are
a science based, science focused agency, and that we base our decisions
only on the best available science.
senator sanders
Question 1.
It is clear that there is a commitment to bring a safe and
effective COVID-19 vaccine to market as soon as possible. It also is
clear that there is a commitment across agencies to work together not
only to try to increase diversity in ongoing clinical trials, but to
educate the public about the importance of getting vaccinated,
especially with flu season upon us. Will you use your expertise and
influence to ensure that a COVID-19 vaccine is available at no cost to
every person in the U.S.?
Answer 1. FDA's regulatory functions and role in reviewing and
authorizing or approving vaccines are distinct from the other HHS
operating divisions responsible for determining vaccine accessibility.
The following response has been provided by other components of the
Department of Health and Human Services (HHS).
On September 16, 2020, HHS and Department of Defense released the
Trump administration's detailed strategy to deliver safe and effective
COVID-19 vaccine doses to the American people as quickly and reliably
as possible through Operation Warp Speed.
In accordance with the plan, the Federal Government is procuring
hundreds of millions of doses of vaccines, and has contracted with
McKesson Corporation for purposes of vaccine distribution, such that
vaccine providers will not be charged for the distribution of the
COVID-19 vaccine and recipients will not be charged for its cost.
Various plans, supported by the CARES Act and the Families First
Coronavirus Response Act, are under development with the objective of
ensuring no one will be charged any out-of-pocket costs for the
administration of the vaccine either. The objective is to ensure no one
desiring vaccination will face an economic barrier to receiving one.
Section 3203 of the CARES Act (P.L. 116-136) requires health insurance
issuers and plans to cover any Advisory Committee on Immunization
Practices (ACIP)-recommended COVID-19 preventive service, including
vaccines, without cost-sharing within 15 days of such recommendation to
the CDC. Once an authorized or licensed COVID-19 vaccine is recommended
by ACIP, and the recommendation is adopted by the CDC Director,
required coverage for vaccines as preventative services for Medicaid
Early and Periodic Screening, Diagnostic and Treatment beneficiaries
and the Affordable Care Act provisions for most private insurance
coverage and for the Medicaid expansion populations will also apply.
As part of efforts to make administration sites easily accessible,
the vaccination program will make maximum use of all healthcare
professionals licensed to administer vaccines, including allied health
professionals such as pharmacists. HHS is also committed to ensuring
that rural populations can receive the vaccine, and has decades of
experience working with public health partners addressing the needs of
hard-to-reach populations. CDC will work with local communities,
governments, and other partners to identify the best places and times
to reach this population and utilize strategic distribution points via
community health centers, schools, workplaces, mobile clinics, and
pharmacies.
Question 2.
In addition to making sure that a future COVID-19 vaccine is free
to every person in the country at the point of service, it is critical
that health providers and states can afford to purchase the vaccine in
bulk and distribute it to the public and, in particular, to vulnerable
populations such as seniors and those who are living in rural areas.
(a) What specific plans does the Federal Government have to
directly purchase the COVID-19 vaccine and distribute it to the
public, or to help health providers and states purchase the
vaccine for distribution?
Answer 2 (a). Please see the response to #1 above.
Question 3.
It is well documented that African Americans, Indigenous Peoples,
and other racial and ethnic minorities have experienced harm and trauma
when participating--both voluntarily and involuntarily--in medical
research. These populations are also most at-risk for contracting
COVID-19 and experiencing more severe outcomes from the disease. As
history has taught us, vaccines are only effective in eventually
eradicating a particular disease when there is widespread use. A lack
of trust, however, can stall efforts to defeat a pandemic. Please
provide specific details about the steps you are taking, and have
already taken, to build public trust--especially among the most
vulnerable and often hard-to-reach populations, including low-income
individuals, people who live in rural communities, older individuals,
and racial and ethnic minorities--so that when a safe and effective
vaccine is available, it is successfully adopted?
Answer 3. CDC contributed to this response (first seven
paragraphs), followed by FDA's response to address the question.
Understanding public confidence in any and all vaccines is
necessary for promoting high vaccine uptake, and CDC is adapting its
strategic framework, Vaccinate with Confidence (https://www.cdc.gov/
vaccines/partners/vaccinate-with-confidence.html), to strengthen public
trust in COVID-19 vaccines. The framework emphasizes three key
priorities: reinforcing communication to the public about the vaccine's
rollout and its safety and benefits, empowering healthcare providers to
communicate effectively with patients about the vaccine, and engaging
with individuals and communities.
Building confidence is inherent to all our work, and CDC will
continue to build upon the investments of our immunization program as
we prepare both the Nation's public health system and the private
sector to disseminate a safe and effective COVID-19 vaccine. As COVID-
19 vaccine developments continue, CDC is working with Operation Warp
Speed (OWS) to ensure community groups, physicians, and the general
public receive the most up to date guidance and data on available
prevention measures that can help reduce COVID-19 infection and spread.
Adapting from approaches used with similar past threats, CDC will work
with its public health partners to deliver resources on COVID-19
vaccine that assist physicians with proper vaccine administration and
enhances public confidence in COVID-19 vaccine uptake.
CDC is enhancing communications efforts to target special
audiences, including older Americans, people of any age with underlying
health conditions, workers in long-term care facilities, and other
essential workers. Targeted communication and education efforts will be
implemented for African American and Hispanic/Latino communities
realizing that these groups have lower rates of influenza vaccination,
yet higher risk for COVID complications.
CDC will also be working with the National Association for
Community Health Centers to implement evidence-based strategies to
increase adult vaccination coverage among underserved priority
populations. In addition, CDC will be consulting individually with 15
national leaders in the field of health disparities, health equity, and
social determinants of health to develop strategies to address racial
and ethnic disparities in adult immunization.
CDC is testing influenza vaccine messages to learn what impacts the
pandemic may have on the intent to vaccinate, including fears about
getting vaccinated in a safe environment, and CDC will continue to work
with our public health and clinical partners to eliminate barriers to
vaccination.
CDC also is committed to ensuring that rural populations, including
tribes, can access the vaccine. We have decades of experience working
with public health partners addressing the needs of hard to reach
populations. We will work with communities, government, and other local
partners to identify the best places and times to reach this population
and utilize strategic distribution points via community health centers,
schools, workplaces, mobile clinics, and pharmacies. Our immunization
programs have built a strong public health immunization infrastructure,
including through the provision of a safety net for those with no
health insurance and through response to outbreaks of vaccine
preventable diseases and other urgent public health issues.
In July, CDC released a Health Equity Strategy (www.cdc.gov/
coronavirus/2019-ncov/community/health-equity/cdc-strategy.html) that
provides an evidence-based, comprehensive, and coordinated framework
for reducing COVID-19 disparities. The strategy includes building on
plans for collecting and reporting timely, complete, and representative
data on testing, incidence, vaccination, and severe outcomes among
populations at highest risk.
At FDA, we recognize that certain populations are more vulnerable
to COVID-19 and that there may be unique challenges to building vaccine
confidence in racial and ethnic minority and other diverse communities,
for example. We also recognize that transparency around FDA's
decisionmaking with respect to COVID-19 vaccines is likely to affect
public confidence in these vaccines, and vaccines to prevent other
infectious diseases that follow. FDA remains committed to principles of
transparency, consistent with our statutory authority and regulations.
To help ensure an evaluation process that is as transparent as
possible, and to help the public understand FDA's process for
evaluating the safety and effectiveness of new vaccines, FDA has issued
guidance related to the Development and Licensure of Vaccines to
Prevent COVID-19 (June 2020) and Emergency Use Authorizations for
Vaccines to Prevent COVID-19 (October 2020). In addition to outlining
our expectations for vaccine sponsors, we also hope the agency's
guidance on COVID-19 vaccines helps the public understand our science-
based decisionmaking process that assures vaccine quality, safety and
efficacy for any vaccine that is authorized or approved. Additionally,
FDA convened a meeting of our Vaccines and Related Biological Products
Advisory Committee (VRBPAC) on October 22, 2020, to address the general
development of COVID-19 vaccines. The VRBPAC consists of a panel of
outside independent technical experts from various scientific
disciplines that provides input on scientific data and its public
health significance in a public forum. We stand ready to promptly
schedule additional meetings of VRBPAC to discuss specific vaccine
candidates prior to the approval of a Biologic License Application or
issuance of an Emergency Use Authorization for a COVID-19 vaccine.
FDA's Office of Minority Health and Health Equity (OMHHE) has also
continued to support efforts to advance racial and ethnic minority
representation in clinical trials. FDA OMHHE has increased
amplification of clinical trial diversity messages, provided tailored
FDA COVID-19 communications to racial and ethnic minority stakeholders,
and held a listening session with diverse stakeholders to learn more
about the gaps in communication with and needs of racial and ethnic
minority communities and to share information on FDA's COVID-19
activities.
FDA OMHHE has also increased outreach by disseminating COVID-19
health education materials for consumers in multiple languages. The
agency's official COVID-19 webpage: including the FDA COVID-19
Frequently Asked Questions \1\ has been translated into Spanish FDA has
also created a COVID-19 Multilingual Resources webpage that features a
growing collection of educational materials in Spanish, Simplified
Chinese, Korean, Vietnamese, and Tagalog, among other languages.
---------------------------------------------------------------------------
\1\ https://www.fda.gov/emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19/covid-19-frequently-asked-questions.
To further enhance outreach and dissemination, FDA launched a
COVID-19 Bilingual (English/Spanish) Social Media Toolkit that features
---------------------------------------------------------------------------
consumer friendly messages and culturally appropriate graphics.
FDA has also engaged in considerable outreach with different
stakeholder groups to help enhance understanding about the agency's
science-based and objective regulatory review process for vaccines. As
part of these efforts, FDA's Center for Biologics Evaluation and
Research has provided a grant to the Reagan-Udall Foundation for the
FDA to assist us in better understand the communication and perception
barriers that lead so many Americans to feel hesitant about receiving a
COVID-19 vaccine, when available, specifically perceptions related to
FDA's role in vaccine review and authorization and approval. A key part
of this effort has been a series of listening sessions to gather
insight from different communities, as concerns may be specific to
those communities' context and history. Listening sessions are
prioritized for racial and ethnic minority and other diverse
communities, the socio-economically disadvantaged, and essential
personnel who may be in greater danger of being exposed to SARS-CoV-2,
such as those working in retail and health care settings. The
information gained from these sessions will help to inform FDA, build
public confidence in COVID-19 vaccine development for the U.S.
population, and contribute to adequate COVID-19 vaccine uptake once one
or more such vaccines are available. More details regarding the Reagan-
Udall Foundation COVID-19 Vaccine Confidence Project can be found on
FDA's website. \2\
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\2\ Reagan-Udall Foundation COVID-19 Vaccine Confidence Project:
https://www.fda.gov/media/142838/download.
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senator burr
Question 1.
The FDA has started the process of a mid-action review of the
agency's activities and efficiencies gained during the COVID-19
pandemic. Please provide additional information on the FDA's processes
and practices during the COVID-19 pandemic to--
Answer 1. FDA remains focused on our public health mission of
protecting the health and safety of the American people. The agency has
provided regulatory flexibilities and issued temporary policies to help
accelerate access to critical medical products, help ensure food safety
and address public health issues. FDA's COVID-19 Pandemic Recovery and
Preparedness Plan (PREPP) initiative is driven by the agency's
commitment to continuous improvement to further its public health
mission. PREPP is intended to facilitate learning and adaptation across
the Agency as appropriate. The initiative is aimed to support real-time
adjustments as needed and will inform recommendations to improve
policies and processes as necessary to strengthen the agency's public
health impact for future crisis preparedness. The initiative is
continuing and ongoing.
A. Accelerate the drafting and publication of guidance
documents;
FDA is committed to providing timely recommendations,
regulatory advice, guidance, and technical assistance on an
agency-wide basis on issues related to COVID-19, including to
clarify our policies to support response efforts to this
emergency. In accordance with FDA's good guidance practices
regulation (GGPs), to facilitate issuance of agency
recommendations and policies related to the COVID-19 public
health emergency, in March 2020, FDA announced procedures for
making available FDA guidance documents related to the COVID-19
public health emergency. In light of the need to act quickly
and efficiently respond to the COVID-19 public health
emergency, FDA has implemented immediately in effect COVID-19-
related guidance documents where prior public participation
would not be feasible or appropriate. Although FDA has
implemented COVID-19-related guidance documents without prior
comment, in accordance with GGPs, the agency solicits comments,
will review all comments received, and will revise the guidance
documents as appropriate. Each guidance specifies the docket
number(s) to which comments can be submitted. These procedures
were published in the Federal Register on March 25, 2020, 85
Fed. Reg. 16949.
FDA has issued \3\ more than 60 COVID-19 related guidance
documents and has revised COVID-19 related guidance documents
to provide updated policies, transparency, and regulatory
flexibility to address the vital medical products and public
health issues facing the American public during this pandemic.
These guidance documents provide clarity on diagnostics,
personal protective equipment, other medical devices, treatment
with investigational convalescent plasma, conduct of clinical
trials of medical products, blood donor deferrals, hand
sanitizer, food safety and supply, telemedicine and other
topics.
---------------------------------------------------------------------------
\3\ https://www.fda.gov/emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-
industry-fda-staff-and-other-stakeholders.
B. Enhance the communications between FDA review staff and
sponsors (or potential sponsors) of medical products for COVID-
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19;
In response to the urgent nature of the pandemic, in April 2020
FDA launched a new program called the Coronavirus Treatment
Acceleration Program (CTAP) to move new treatments to patients
as soon as possible, while at the same time finding out whether
they are helpful or harmful. CTAP aims to enable the FDA's
Center for Drug Evaluation and Research (CDER) and Center for
Biologics Evaluation and Research (CBER) to leverage cross-
agency scientific resources and expertise to bear on COVID-19
therapeutic development and review. FDA realized there would be
a need for early and frequent discussions between the agency
and potential sponsors, thus CTAP was also designed to allow
inquiries from researchers and developers to be triaged by a
team of experienced clinical reviewers, other scientific
reviewers, policy experts, and regulatory project management
staff to help with proposals, provide additional information,
and to quickly direct the proposal to the appropriate
organization unit for review.
When CTAP was initially launched, 72 clinical trials of
potential therapies for COVID-19 were underway with FDA
oversight. As of September 30, 2020, there are more than 550
drug development programs in planning stages, more than 350
clinical trials have been reviewed to determine that an
Investigational New Drug (IND) trial is safe to proceed, and
five COVID-19 treatments received authorization for emergency
use. These numbers are updated monthly and made available to
the public at: https://www.fda.gov/drugs/coronavirus-covid-19-
drugs/coronavirus-treatment-acceleration-program-ctap.
C. Expedite the regulatory decisionmaking processes at the
agency;
As a critical threshold matter, FDA remains steadfast in its
commitment to protect and promote the health and well-being of
the American public, and to base regulatory decisions in
support of our public health mission on sound science and
adequate data. FDA is dedicated to addressing emerging public
health issues and promoting innovation while ensuring safety of
the products regulated by the agency. In addition to COVID-19
related guidance documents and CTAP, as described in (A) and
(B) above, pursuant to section 564 of the FD&C Act, the HHS
Secretary has issued Emergency Use Authorization Declarations,
\4\ allowing FDA to issue Emergency Use Authorizations (EUA),
as outlined in the declarations, for (1) the emergency use of
an unapproved drug, an unapproved or uncleared device, or an
unlicensed biological product; or (2) an emergency unapproved
use of an approved drug, approved or cleared device, or
licensed biological product. To issue an EUA, FDA must
determine, among other things, that the product may be
effective for its intended use and that its known and potential
benefits outweigh its known and potential risks. As legally
required, FDA periodically reviews the circumstances and
continued appropriateness of an EUA, including review of
emerging data. If warranted by the data, FDA may revoke or
revise an EUA. Subsequent to the date of the hearing, as of
October 14, 2020, FDA has six EUAs for therapeutics to treat
COVID-19 and serious conditions caused by COVID-19. \5\
---------------------------------------------------------------------------
\4\ https://www.federalregister.gov/documents/2020/03/27/2020-
06541/emergency-use-authorization-declaration;https://
www.federalregister.gov/documents/2020/02/07/2020-02496/determination-
of-public-health-emergency;.https://www.federalregister.gov/documents/
2020/04/01/2020-06905/emergency-use-authorization-declaration.
\5\ https://www.fda.gov/emergency-preparedness-and-response/mcm-
legal-regulatory-and-policy-framework/emergency-use-
authorization#coviddrugs.
Given the unprecedented demand for diagnostic tests, PPE, and
other devices, FDA has authorized over 475 devices for
emergency use to respond to the current health crisis. The
number of device EUAs for COVID-19 dwarfs the total number of
device EUAs issued for other public health emergencies. At the
same time, the volume of ``traditional,'' non-COVID-19
submissions (e.g., PMAs, 510(k)'s, de novo request, etc.)
received has not changed, resulting in over 10,000 COVID and
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non-COVID submissions received by CDRH since January 1, 2020.
D. Utilize real world evidence and real world data to generate
data to support and accelerate the development and review of
products to treat, prevent, or diagnose COVID-19;
Given the large global population infected with COVID-19, the
availability of digital health data holds promise to inform
product development for the disease. For example, understanding
the natural history of COVID-19 can inform clinical trial
design. In addition, as many of the drugs being used for COVID-
19 are already on the market, approved for use for other
conditions, real world evidence (RWE) has the potential to
generate hypotheses for future study.
FDA has been an active participant in the COVID-19 Evidence
Accelerator, which brings together experts in RWE to answer key
questions about COVID-19, including questions related to
natural history and the use of therapeutics, to inform further
research. The COVID-19 Evidence Accelerator is run by the
Reagan-Udall Foundation and Friends of Cancer Research. This
collaborative activity focuses on understanding the data,
developing consensus around best practices and methodologies
and determining which questions such data can most
appropriately answer.
In addition, real world data (RWD) may also be collected as
part of clinical trials as these trials are capturing clinical
endpoints that are recorded during clinical practice, such as
discharge from the hospital.
The sharing of data on COVID cases across the globe has also
led to insights into risk factors, unusual presentations, and
unexpected outcomes for patients infected with this novel
respiratory pathogen.
E. Utilize decentralized clinical trials and alternative
clinical trial designs to support marketing applications; and
With respect to decentralized clinical trials, recognizing that
COVID-19 would disrupt traditional trial operations due to
self-isolation, site closures, and travel limitations, among
others, FDA promptly issued guidance to assist sponsors
conducting clinical trials during the COVID-19 public health
emergency in meeting their regulatory requirements. See FDA
Guidance on Conduct of Clinical Trials of Medical Products
during COVID-19 Pandemic. \6\ This guidance was issued on March
18, 2020 and has been updated multiple times, most recently on
September 21, 2020. FDA has added 25 questions and answers,
many in response to the over 500 inquiries to the mailbox
[email protected] that FDA set up with
the issuance of the first guidance to assist the clinical trial
community. The topics addressed by the guidance include use of
technology and local providers and facilities in ways that can
help decentralize the conduct of clinical trials. In April, a
survey of pharmaceutical companies, research participants,
investigators and academia done by the Clinical Trials
Transformation Initiative, a public-private partnership
supported by FDA, reported that 85 percent transitioned to
using virtual visits in one or more clinical trials. \7\
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\6\ http://wcms-internet.fda.gov/media/136238/download.
\7\ https://www.ctti-clinicaltrials.org/briefing-room/webinars/
adapting-clinical-trials-during-covid-19-solutions-switching-remote-
and.
F. Exercise available authorities to conduct remote or virtual
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assessments and inspections and document-based inspections
In March 2020, FDA postponed onsite domestic and foreign
routine surveillance inspections due to concerns around the
pandemic, although FDA investigators have continued to conduct
mission-critical inspections both domestically and abroad,
along with other activities, to ensure FDA-regulated industries
are meeting applicable FDA requirements. In July, we resumed
prioritized domestic surveillance inspections. To help ensure
FDA-regulated industries are meeting applicable FDA
requirements, FDA's Office of Regulatory Affairs (ORA) is also
using FDA's authority under section 704(a)(4) of the Federal
Food, Drug, and Cosmetic Act to request records in advance or
in lieu of inspections of establishments that manufacture
drugs. ORA is, where appropriate, relying on inspection reports
by European regulatory authorities as specified in an agreement
between the European Union and FDA. With regard to imported
products, FDA is expanding the use of other tools and
approaches to help ensure the quality of medical products,
including using its statutory authority to refuse admission if
a product does not appear to meet applicable FDA standards
based on records requested directly from manufacturing
facilities, reviewing the compliance histories of facilities
information, information shared by trusted foreign regulatory
partners through mutual recognition and confidentiality
agreements, and physical examinations of products arriving at
U.S. borders or product sampling and testing before release
into commerce. In furtherance of FDA's commitment to learning
from our experiences during this public health emergency, we
are evaluating how we can optimize the agency's inspection
program, including studying how we might incorporate new
technologies and tools to support our inspections.
senator warren
Transparency in Vaccine Review Process
Question 1.
Full transparency throughout the review and authorization process
for COVID-19 vaccines is essential to countering real or perceived
politicization and building public confidence in any approved vaccine.
Due to the speed of the vaccine development process, consistent
political pressure on FDA from Trump administration officials, and
longstanding mistrust of the medical establishment in communities of
color, there is currently significant public skepticism about an
eventual COVID-19 vaccine. A recent poll found that only 49 percent of
American adults plan to accept a coronavirus vaccine, with 20 percent
not planning to be vaccinated and 31 percent unsure. A poll from the
Kaiser Family Foundation found that 62 percent of Americans are worried
that ``the political pressure from the Trump administration will lead
the FDA to rush to approve a coronavirus vaccine without making sure
that it is safe and effective.'' In order to understand how the FDA is
addressing these concerns, my colleagues and I wrote to you on
September 14, 2020, requesting answers to the following questions:
(a) Will all meetings of the Vaccine and Related Biological
Products Advisory Committee (VRBPAC) to discuss COVID-19
vaccine products, as well as documents reviewed during these
meetings, be open to the public?
Answer 1 (a). An open session of FDA's VRBPAC will be convened
prior to the issuance of any EUA for a COVID-19 vaccine, to publicly
discuss whether the available safety and effectiveness data support
issuance of an EUA or a license for the specific vaccine under review.
Such discussions, which will be specific to the particular vaccine that
is the subject of the EUA request or Biologics License Application
(BLA) submission, will be separate from, and in addition to, any
general discussion by the VRBPAC regarding the development,
authorization, and/or licensure of vaccines to prevent COVID-19. A
VRBPAC meeting may also include a closed session, if it is deemed
necessary, to discuss proprietary manufacturing information.
FDA intends to provide briefing materials to the VRBPAC members as
far in advance of any scheduled meeting as practicable and intends to
post a publicly available version of the briefing materials on the FDA
webpage no later than two full business days before the day the
advisory committee meeting is scheduled to occur.
FDA recommends that, in order to facilitate discussion by the
VRBPAC, an EUA request or BLA submission be accompanied by briefing
materials summarizing data to support the safety and effectiveness of
the vaccine and that the sponsor submissions be fully releasable to the
public to be considered at the open session of the VRBPAC. In addition,
if requested by FDA, separate briefing materials addressing proprietary
manufacturing information for the vaccine should be provided for a
closed session. The purpose of any closed session would be limited to
the review and discussion of manufacturing information that is
considered confidential commercial or trade secret information exempt
from public disclosure.
(b) What steps has the FDA taken to prevent political
interference in the agenda or discussions at the October 22
meeting of the VRBPAC, in light of its timing shortly before
the Presidential election?
Answer 1 (b). Commissioner Hahn and Secretary Azar have repeatedly
noted that the evaluation process to determine the safety and
effectiveness of a vaccine will not be politicized, and that FDA's
professional career staff will be making the required legal and
scientific decisions.
(c) Will data generated by COVID-19 vaccine clinical trials be
made available to the public? What steps will the FDA take to
ensure that enough data are made available to allow the public
to evaluate the outcome of the clinical trials, including data
used to inform a decision to issue an EUA, while protecting
participant privacy?
Answer 1 (c). As noted above, FDA intends to convene an open
session of our Vaccines and Related Biological Products Advisory
Committee prior to the issuance of any EUA, or approval of a BLA, for a
COVID-19 vaccine, to discuss whether the available safety and
effectiveness data support issuance of an EUA or approval of a BLA for
the specific vaccine under review. As part of this process, sponsors
and FDA provide to the Advisory Committee members briefing materials
that summarize the data to support the safety and effectiveness of the
vaccine under discussion; these briefing materials are made publicly
available on FDA's webpage at least 2 days prior to the meeting. FDA's
guidance titled ``Advisory Committee Meetings--Preparation and Public
Availability of Information Given to Advisory Committee Members,''
recommends that sponsors provide fully releasable briefing materials to
facilitate a timely and thorough discussion during the Advisory
Committee meeting.
Outside of the Advisory Committee process, there are limits on what
FDA can disclose. We are aware that several sponsors have disclosed
protocols for their phase 3 trials, and we encourage sponsors to be as
transparent as possible during the development and review process.
(d) Will the FDA require public disclosure of the design
details of Phase 3 clinical trials for a COVID-19 vaccine,
including the procedure for ongoing monitoring of severe side
effects and the criteria under which the trial would be ended
early?
Answer 1 (d). FDA is encouraging companies to provide maximal
transparency into their clinical trial programs. FDA intends to be as
transparent as possible, consistent with applicable laws and
regulations about what FDA can disclose about pending applications and
EUA requests.
(e) How will the FDA assess safety and efficacy for groups with
limited participation in early stage clinical trials, including
pediatric patients and pregnant people?
Answer 1 (e). With respect to vaccines, FDA supports the inclusion
of pregnant women in clinical development programs for vaccines against
emerging infectious diseases, including vaccines to prevent COVID-19.
Studying such vaccines in pregnant women is important to obtain data
pertaining to the safety and effectiveness of use during pregnancy,
including data on safety outcomes in infants whose mothers received
such vaccines during pregnancy. The Agency is engaging with vaccine
manufacturers in planning for the inclusion of pregnant women in pre-
licensure clinical trials with COVID-19 vaccine candidates.
Before clinical trials in pregnant women proceed, it is important
that adequate nonclinical studies, including reproductive and
development toxicity studies in animal models, are conducted, and that
safety and immunogenicity data for the vaccine are available from early
Phase 1 and 2 clinical studies conducted in nonpregnant individuals. In
this regard, FDA has published guidance for industry titled,
``Considerations for Developmental Toxicity Studies for Preventive and
Therapeutic Vaccines for Infectious Disease Indications,'' which sets
forth recommendations for assessing the developmental toxicity
potential of preventive vaccines for infectious diseases for females of
childbearing potential and pregnant women. In addition, in 2015, to
facilitate pre-licensure studies in pregnant women, FDA convened its
Vaccines and Related Biological Products Advisory Committee (VRBPAC) to
solicit the input of independent, external experts on the evaluation of
investigational vaccines intended for use during pregnancy to prevent
diseases in newborn infants. The VRBPAC's input on evaluating safety
outcomes in pregnant women and their newborns is broadly relevant to
the evaluation of preventive vaccines used during pregnancy, whether
intended to protect the mother or the infant.
It is important for developers of COVID-19 vaccines to plan for
pediatric assessments of safety and effectiveness, and to ensure
compliance with the Pediatric Research Equity Act (PREA). The
epidemiology and pathogenesis of COVID-19, and the safety and
effectiveness of COVID-19 vaccines, may be different in children
compared with adults. In order to ensure compliance with 21 CFR Part 50
Subpart D (Additional safeguards for children in clinical
investigations), vaccine developers should discuss with FDA, the
considerations on the prospect of direct benefit and acceptable risk to
support initiation of pediatric studies, and the appropriate design and
endpoints for pediatric studies, in the context of their specific
vaccine development programs.
FDA supports the appropriate inclusion of pregnant women in
clinical trials for development of therapeutics to treat emerging
infectious diseases, including COVID-19. FDA has been working with
sponsors during the COVID-19 pandemic to encourage enrollment of
pregnant women in COVID-19 treatment trials and is also working to
provide treatment to pregnant women through individual patient
emergency use investigational new drug applications (INDs) when
necessary. FDA has also recently published draft guidance, Pregnant
Women: Scientific and Ethical Considerations for Inclusion in Clinical
Trials, which describes appropriate circumstances for the enrollment of
pregnant women in clinical trials.
FDA has recently published several draft guidances related to
therapeutics development during pregnancy and lactation, including:
Post-approval Pregnancy Safety Studies, Draft Guidance for Industry;
Clinical Lactation Studies: Considerations for Study Design, Draft
Guidance for Industry; and Enhancing the Diversity of Clinical Trial
Populations--Eligibility Criteria, Enrollment Practices, and Trial
Designs, Draft Guidance for Industry.
FDA is also involved in broader efforts to increase the
availability of high-quality data to support the safe use of drugs,
biological products, and vaccines during pregnancy and lactation. FDA's
Office of Women's Health (OWH) serves as the Agency lead to the Task
Force on Research Specific to Pregnant Women and Lactating Women
(PRGLAC).
(f) What steps has the FDA taken to involve representatives of
communities of color, people with disabilities, older
Americans, and other groups at elevated risk from COVID-19 in
the review process for vaccines?
Answer 1 (f). Amongst other recommendations on developing a safe
and effective vaccine, FDA strongly encourages the inclusion of diverse
populations in all phases of vaccine clinical development, including
populations most affected by COVID-19, specifically racial and ethnic
minorities, to help to ensure that vaccines are safe and effective for
the indicated populations. Late phase clinical development in adults
should also include adequate representation of elderly individuals and
individuals with medical comorbidities to evaluate vaccine safety and
effectiveness.
In addition, FDA's Office of Minority Health and Health Equity
(OMHHE) has continued to advance racial and ethnic minority
participation in clinical trials through a variety of culturally and
linguistically competent strategies and resources, including an ongoing
campaign to raise awareness on the need for racial and ethnic minority
populations to participate in clinical trials. The campaign includes:
educational materials in multiple languages that highlight the value of
clinical trial participation; public service announcements and social
media outreach that encourage different groups to participate; a
dedicated webpage with various resources including a communications
toolkit; engaging different communities and health professionals to
raise awareness about the need for diverse participation; and
developing close collaborations across government, academia, and
industry to educate consumers about the importance of diverse
participation in clinical trials.
FDA has developed policy strategies to support diverse
participation in clinical trials, including the collection and
reporting of race and ethnicity data, through the issuance of guidance
documents, such as Collection of Race and Ethnicity Data in Clinical
Trials, Guidance for Industry and Food and Drug Administration Staff.
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Hydroxychloroquine in Nursing Homes
Question 2.
Nursing homes continue to be at the epicenter of the spread of
COVID-19 in the United States. Recent reports from state inspection
officials have revealed that in more than one such facility, residents
were treated with hydroxychloroquine without their consent or without
approval from state officials. As the agency charged with protecting
the public health by ensuring the ``safety, efficacy and security'' of
pharmaceutical products, my colleagues and I wrote to you on September
8, 2020 to request information on what the Food and Drug Administration
(FDA) is doing to track adverse events associated with the use of
hydroxychloroquine in this population:
(a) Has FDA imposed additional post market surveillance
requirements on the manufacturers of hydroxychloroquine? If so,
please describe these requirements.
Answer 2 (a). FDA has not imposed additional post-market
surveillance requirements for hydroxychloroquine (HCQ) as FDA
regulations require post-marketing surveillance and reporting for
applicants of approved drugs. Under 21 CFR 314.80, applicants are
required to promptly review all adverse experience information obtained
or otherwise received by the applicant and submit to FDA post-marketing
safety reports either as soon as possible (but no later than 15 days
after receipt) if the adverse experience is serious and unexpected or,
if not, through periodic adverse drug experience reports. Each sponsor
with an approved application must also develop written procedures for
the surveillance, receipt, evaluation, and reporting of post-marketing
adverse drug experiences to FDA. In addition, through the MedWatch
system, FDA has made it easy for healthcare professionals and patients
to report adverse events directly to the FDA.
Finally, sponsors of clinical trials using hydroxychloroquine must
also report to FDA any serious and unexpected adverse events that occur
during the clinical investigation and that might be related to the drug
within seven to 15 days, depending upon the seriousness of the event.
(b) What steps has the FDA taken to monitor the use of
hydroxychloroquine both before and since the revocation of the
EUA? Please describe the steps that have been taken, including
whether such steps include monitoring use outside of hospital
or clinical trial settings.
Answer 2 (b). As discussed above, FDA has regulations to ensure
that important safety information is reported by sponsors when using a
drug in an FDA regulated clinical investigation and in commercial use.
FDA reviewers analyze this safety information on an ongoing basis to
identify new or worsening safety issues with the product.
In addition, FDA's EUA for hydroxychloroquine sulfate and
chloroquine phosphate included requirements for tracking adverse events
through the duration of the EUA. Specifically, the letter of
authorization for hydroxychloroquine required, as a condition of the
EUA, that health care providers be informed through a Fact Sheet of
their obligation to report to FDA all serious adverse events and all
medication errors associated with the use of the authorized products.
The Fact Sheets for health care providers for hydroxychloroquine and
chloroquine outlined information on reporting adverse events to the
MedWatch system: submitting a MedWatch form on FDA's website2 or using
Form FDA 3500 (health professional) and mailing it to FDA or submitting
it by fax (1-800-FDA-0178). Additionally, the Fact Sheets for
hydroxychloroquine and chloroquine required health care providers to
provide patients, prior to treatment, information about reporting side
effects to MedWatch or FDA.
As part of its efforts to monitor the drug supply during COVID-19,
beginning in April 2020, FDA began monitoring certain medications,
including hydroxychloroquine, that were expected to see a surge in
increased utilization during COVID-19. FDA continues to measure
utilization of hydroxychloroquine and other medications potentially
used in the treatment of COVID-19 and other conditions across inpatient
and outpatient settings of care.
(c) Has FDA taken steps to track the use of hydroxychloroquine
among seniors (adults age 65 or older) for treatment or
prevention of COVID-19? If so, please describe the steps that
have been taken.
Answer 2 (c). FDA is not aware of any data source that
comprehensively tracks the use of drugs linked to specific indications
at a national level, particularly for inpatient or long-term care
settings. Indeed, even when FDA uses the Sentinel system to explore
safety information about a particular drug, it is often difficult to
determine if a drug is being used for its FDA approved indication or
for a non-approved indication at the physician's discretion;
relationship of the use of a drug and an indication are based on
temporal associations of available data. FDA does, however, continue to
monitor all safety data that is submitted pursuant to FDA's regulatory
requirements, and will take appropriate action, if necessary, to
protect the public.
As part of a comprehensive assessment of cardiovascular (CV)
adverse events reported to the Agency associated with the use of HCQ,
FDA assessed utilization patterns for HCQ in the Medicare population.
Although this analysis was not conducted to track the use of HCQ in
seniors, it was one of many analyses conducted to assess patterns of
concurrent use of HCQ and azithromycin to inform reports of CV events
associated with HCQ and azithromycin based on data from MedWatch and
other sources.
In this study, approximately 2,000 or fewer Medicare beneficiaries,
weekly, had a new HCQ prescription between January 2019 and the week
ending March 1, 2020. The weekly number of patients with a new HCQ
prescription increased to approximately 2,500 patients in the week
ending March 8, 2020, and to more than 14,000 patients during the week
ending March 15, 2020. Although this analysis did not include age-
specific strata, the Medicare population is comprised of approximately
85 percent seniors aged 65 years and older and 15 percent individuals
with a qualifying disability.
Additionally, based on data obtained from other proprietary data
bases, total weekly estimates of prescriptions dispensed for
hydroxychloroquine from U.S. outpatient pharmacies across any
indication and patient age increased from an estimated 115,000
prescriptions dispensed during the week ending February 7, 2020, to a
peak of 300,000 prescriptions dispensed in the week ending March 20,
2020. By the week ending May 29, 2020, prescriptions decreased to an
estimated 127,000 prescriptions dispensed, a 58 percent decrease from
the peak in March.
(d) How many adverse event reports has FDA received regarding
hydroxychloroquine since (a) President Trump's March 19
announcement, (b) FDA's issuance of the EUA, and (c) FDA's
revocation of the EUA? How many of those reports are associated
with seniors?
Answer 2 (d). Figure 1 below shows the number of cases reporting
adverse events with the use of hydroxychloroquine for the treatment or
prevention of COVID-19 for each requested time period. Data for each
time period is represented by two columns. The first column represents
the number of cases for all ages and the second column represents only
those cases associated with patients 65 years of age and older. Cases
in both columns are further categorized into the report source, the FDA
Adverse Event Reporting System (FAERS) data base, and other data
sources (i.e., medical literature, National Poison Data System (NPDS),
and other safety reports).
It should be noted that FAERS does not contain all adverse events
occurring with a product and does not collect information about the
total number of persons exposed to that product, therefore, FAERS data
cannot be used to quantify a risk estimate or calculate the incidence
of an adverse event. Given these limitations, it is difficult to
interpret and draw conclusions based only on changes in the number of
FAERS reports submitted to the FDA.? Accordingly, FDA does not focus
solely on the number of adverse event reports; rather, we also rely on
the quality and scope of information in these reports when assessing
adverse events.? FAERS data by themselves cannot be used to fully
characterize the safety profile of the drug or biologic. Additionally,
because FDA reviewers have conducted a hands-on analysis of each
report, they have removed duplicate reports, and in some cases,
reclassified the adverse event terms for individual cases after
reviewing the narrative details, the numbers provided in Figure 1 may
differ from the number of the reports that may be obtained from the
FAERS public dashboard.
(e) Is FDA conducting additional analysis of the adverse event
reports linked to hydroxychloroquine? If so, please describe
the analyses being conducted.
Answer 2 (e). In response to the COVID-19 pandemic, FDA has been
conducting ongoing surveillance of postmarketing safety data for drug
products--including hydroxychloroquine--used in the prevention or
treatment of COVID-19 from FAERS, as well as several other data sources
for the purpose of identifying newly emerging safety concerns.
(f) Has FDA received any complaints regarding the use of
hydroxychloroquine in nursing homes or other congregate care
facilities? If so, please provide those complaints.
Answer 2 (f). FDA has not received any complaints regarding the use
of hydroxychloroquine in nursing homes.
(g) Has FDA issued any warning letters to nursing homes or
other congregate care facilities regarding the use of
hydroxychloroquine? If so, please provide those letters.
Answer 2 (g). FDA has not issued any warning letters to nursing
homes or other congregate care centers regarding hydroxychloroquine.
However, on April 24, 2020, FDA issued a drug safety communication to
our stakeholders, including healthcare professionals, alerting the
public about reports of serious heart rhythm problems in patients with
COVID-19 being treated with HCQ and CQ, often in combination with
azithromycin. As such, FDA warned that use of these drugs to treat
COVID-19 should be limited to a clinical trial or for treating
hospitalized patients under the now revoked EUA for CQ and HCQ. FDA has
made it clear in its communications around the revocation of the EUA
for CQ and HCQ that FDA does not recommend HCQ or CQ for COVID-19
outside of a clinical trial and has described the risks associated with
the use of HCQ and CQ. FDA updated its safety communication on July 1,
2020, to provide a summary of the safety issues associated with HCQ and
CQ to treat hospitalized patients, including reports of serious heart
rhythm problems, kidney problems and liver failure.
Communication About Changes to EUAs
Question 3.
Transparency about the known and potential risks and benefits of
drugs, devices, and biological products authorized under EUAs is
critical to protecting public health. However, notification about such
risks and benefits are of little use if they are not clearly
communicated to health care practitioners and other first responders.
With supply chains continuing to experience instability and first
responders continuing to face shortages of PPE, Massachusetts health
care workers are relying on the FDA to safeguard their health. To
better understand how the FDA communicates changes to health care
practitioners and the public, I wrote to you on August 24, 2020 to
request answers to the following questions:
(a) Please describe steps the FDA takes to inform any entity
that is using a product authorized under an EUA of any
modifications or revocations of the EUA, either directly or by
imposing conditions on the product manufacturers and importers.
Answer 3 (a). If an EUA is revised or revoked, the Agency
communicates to healthcare providers, patients, and the public at large
through a variety of mechanisms, as noted above. This includes through
stakeholder calls, updates to our EUA webpage, news releases, virtual
webinars and town halls, meetings with stakeholder groups, and other
communications to help ensure those impacted are aware of these
important developments. Many examples can be found on FDA's website.
FDA makes available the most recent EUA documents for issued EUAs
(i.e., Letter of Authorization, authorized labeling) on its website.
FDA also maintains an archive of revoked EUAs for public reference on
its website.
(aa) Please describe steps the FDA takes to inform any entity
that is using a product authorized under an EUA of preliminary
data that suggests a change in the known and potential benefits
and risks associated with the use of the product that has not
yet resulted in modification or revocation of the EUA.
Answer 3 (aa). If FDA identifies an urgent safety signal that
warrants public communication before the Agency is able to update the
relevant EUA documents, FDA will communicate such information through
the various mechanisms the Agency ordinarily employs for other
products, such as safety communications, Letters to Health Care
Providers, and consumer updates.
As noted, FDA maintains strong communication with all impacted
stakeholders, including those who are using EUAs during public health
emergencies, and regularly publishes information about new data and
issues that we are seeing with EUAs, as well as communicating when we
make updates to EUAs and revoke them.
(b) Please describe how the FDA enforces compliance with
modifications or revocations of an EUA, including any
consequences for continued distribution or use after a product
is no longer authorized.
Answer 3 (b). FDA exercises its inspectional authority to monitor
manufacturing facilities and verify that required modifications are
implemented and that unauthorized modifications are not made to medical
products authorized through an EUA. FDA also monitors the marketplace.
The Agency has and will continue to exercise its authorities to address
products marketed in violation of the FD&C Act, including issuing
Warning Letters, detaining and refusing products at the border, and
asking firms to change claims or remove language that falsely indicates
that products are FDA approved or authorized, among other things.
(c) Please describe the role of health care workers and patient
advocates in collecting and evaluating information about the
safety and effectiveness of products authorized under an EUA,
and how their perspectives are considered in decisions about
whether to modify or revoke an EUA.
Answer 3 (c). Health care workers on our front lines and patient
advocates play a critical role in providing information to the Agency
about the safety and effectiveness of products authorized under EUAs.
We also rely on these stakeholders to convey information and Agency
updates broadly to their networks so that as many people as possible
are aware when FDA makes communicates about EUAs. This is particularly
critical if there are safety issues and adverse events. For this
reason, depending on the facts and circumstances of the product, FDA
publishes fact sheets for health care providers, patients, and
healthcare facilities (HCFs) regarding use of cleared, approved, and
authorized COVID-19 products (including tests, ventilators,
respirators, personal protective equipment, and therapeutics) that
outline information about the product and how to report adverse events.
FDA encourages patients and may, depending on the product, require
health care providers to report adverse events and other issues with
authorized products to the Agency. This helps inform our continued
evaluation of these products so we can take action to update or revoke
EUAs when appropriate. Information received from these voluntary or
required reports, in addition to other data sources, are important to
FDA's continued efforts to protect patients.
senator kaine
Question 1.
Dr. Hahn, I am very troubled to see that your agency still has not
updated the relevant regulations to reflect the new minimum age of sale
for tobacco products, even though bipartisan legislation I authored
required FDA to put this rule out no later than 180 days post-enactment
of our bill--by June 17th, 2020. Given that youth e-cigarette use is
still occurring at dangerously high rates, and the increased risk of
COVID-19 to youth who use e-cigarettes, can you explain why the FDA has
yet to follow through on its statutory obligation and provide a
timeline for when we can expect the final rule?
Answer 1. In December 2019, the President signed legislation
raising the Federal minimum age for sale of tobacco products from 18 to
21 years. This legislation was effective immediately upon signing. FDA
inspections to determine retailer compliance now include the use of 16-
to 20-year-olds (prior to T21, FDA used 16-and 17-year-old underage
purchasers). FDA appreciates the importance of updating its regulations
to conform with this statutory change and the rule is currently pending
with OIRA for regulatory review.
Question 2.
Dr. Hahn, if the U.S. participated in the COVAX Facility, in
addition to pursuing our own agreements with vaccine manufacturers as
we have been doing, wouldn't we be increasing our odds of getting some
of the first safe and effective doses of a COVID-19 vaccine to
Americans as soon as possible? Why wouldn't we want to do that?
Answer 2. FDA's regulatory functions and role in reviewing and
authorizing or approving vaccines are distinct from the other operating
divisions responsible for determining vaccine distribution. The
following response has been provided by other components of the
Department of Health and Human Services.
The COVID-19 pandemic has demonstrated once again that infectious
diseases do not respect borders and threaten local, regional, and
global economies. Recognizing the critical role that medical
countermeasures play in controlling and ending a public health
emergency, especially in a pandemic, the USG remains committed to
working closely with partners overseas to mitigate the impact of this
devastating pandemic. Operation Warp Speed (OWS) has prioritized the
research, rapid development, and manufacture of safe and effective,
FDA-licensed vaccines, and teamed up with multiple pharmaceutical
companies to potentially produce multiple safe and effective vaccines.
As vaccine development and approval progresses, the United States will
continue to demonstrate strong leadership in global health security and
is developing policies to address the international distribution of
surplus doses of authorized or licensed vaccines that are procured or
reserved by the United States, once our domestic needs are satisfied.
In distributing any vaccine, consideration will have to be given to the
specific characteristics of the authorized or licensed products,
including the populations for which the products are most appropriate
and product transport, storage, and administration requirements.
______
[Whereupon, at 1:03 p.m., the hearing was adjourned.]
[all]