[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
                                
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                               __________

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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\
---------------------------------------------------------------------------
    \2\ Reagan-Udall Foundation COVID-19 Vaccine Confidence Project: 
https://www.fda.gov/media/142838/download.
---------------------------------------------------------------------------
                              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-
---------------------------------------------------------------------------
        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 
---------------------------------------------------------------------------
        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\
---------------------------------------------------------------------------
    \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. 
\8\
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    \8\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/enhancing-diversity-clinical-trial-populations-eligibility-
criteria-enrollment-practices-and-trial.
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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]