[Senate Hearing 116-555]
[From the U.S. Government Publishing Office]


                                                       S. Hrg. 116-555

                       COVID-19: SAFELY GETTING BACK
                         TO WORK AND BACK TO SCHOOL

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION

                                   ON

EXAMINING COVID-19, FOCUSING ON SAFELY GETTING BACK TO WORK AND BACK TO 
                                 SCHOOL

                               __________

                              MAY 12, 2020

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                                


        Available via the World Wide Web: http://www.govinfo.gov
        
                              __________

                    U.S. GOVERNMENT PUBLISHING OFFICE                    
45-219 PDF                 WASHINGTON : 2022                     
          
-----------------------------------------------------------------------------------         
      
        
        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

                         TUESDAY, MAY 12, 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.............................................................     8
    Prepared statement...........................................     9
Redfield, Robert, M.D., Director, United States Centers for 
  Disease Control and Prevention, Atlanta, GA....................    12
    Prepared statement...........................................    13
Giroir, Brett, M.D., Admiral, Assistant Secretary for Health, 
  United States Department of Health and Human Services, 
  Washington, DC.................................................    16
    Prepared statement...........................................    18
Hahn, Stephen, M.D., Commissioner of Food and Drugs, United 
  States Food and Drug Administration, Silver Spring, MD.........    21
    Prepared statement...........................................    23

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
    Recommended Questions for the U.S. Senate Health, Education, 
      Labor, and Pensions Committee, Food & Beverage Issue 
      Alliance (FBIA)............................................    74

 
                     COVID-19: SAFELY GETTING BACK
                       TO WORK AND BACK TO SCHOOL

                              ----------                              


                         Tuesday, May 12, 2020

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:03 a.m., in 
room 106, Dirksen Senate Office Building, Hon. Lamar Alexander, 
Chairman of the Committee, presiding.
    Present: Senators Alexander [presiding], Enzi, Burr, Paul, 
Collins, Cassidy, Roberts, Murkowski, Scott, Romney, Braun, 
Loeffler, Murray, Sanders, Casey, Baldwin, Murphy, Warren, 
Kaine, Hassan, Smith, Jones, and Rosen.

                 OPENING STATEMENT OF SENATOR ALEXANDER

    The Chairman. Well, good morning. The Committee on Health, 
Education, Labor, and Pensions will please come to order.
    First, some administrative matters. Based on the advice of 
the attending physician and the Sergeant at Arms, after we 
consulted the Department of Health and Human Services and the 
Centers for Disease Control and Prevention, individuals in the 
hearing room are at least 6 feet apart. As a result, there is 
no room for the public to attend in person. Representatives of 
the press are working as a pool to relay their observations to 
colleagues.
    The hearing may be watched online. An unedited recording 
will be available on the Committee's website, 
www.help.senate.gov
    Witnesses are participating by videoconference in a one-
time exception. Some Senators, including the Chairman, are 
participating by videoconference. Senators, we have been 
advised, may remove their masks, talk into the microphone when 
they are in the hearing room as they are 6 feet apart.
    I am grateful to the Rules Committee, Sergeant at Arms, the 
Press Gallery, the Architect of the Capitol, the Capitol 
Police, Committee staff Chung Shek and Evan Griffis, all for 
their hard work to keep us safe.
    At our hearing last Thursday, I said that all roads back to 
work and back to school run through testing, and that what our 
Country has done so far on testing is impressive, but not 
nearly enough. Over the weekend, Senator Schumer, the 
Democratic leader, was nice enough to put out a Tweet quoting 
half of what I said. He left out the other half, the impressive 
part.
    Let me say again what I meant by that. When I said 
impressive, I meant that, according to the Johns Hopkins 
University study, the United States has tested over nine 
million Americans for COVID-19. That is twice as many as any 
other country. We do not know what China has done. And, it is 
more per capita than most countries, including South Korea, 
which many Members of our Committee had cited as an example of 
a country that had tested well. According to Dr. Deborah Birx, 
the United States will double testing in the month of May, 
which should get us up to about 10 million tests conducted.
    Now, here is what I mean by impressive here in Tennessee, 
where I am today. First, anyone who is sick, first responder, 
or healthcare worker, can get tested. Our Governor, Bill Lee, 
is also testing every prisoner, every resident and staff member 
in a nursing home. He has offered weekend drive-through 
testing. He has done specific outreach for testing to low-
income communities. A Tennessean can get a free test at the 
local public health department. The Governor's slogan is, ``If 
in doubt, get a test.''
    Governor Lee sent his testing goals in May to the Federal 
Government, as every state has done. The Federal Government is 
helping him make sure that he has enough supplies in case he 
has trouble getting them through the labs and the other 
commercial sources. As a result, our state has tested about 4 
percent of the population. The Governor hopes to increase that 
by 7 percent in May. That is one of the best in the country.
    This impressive level of testing is sufficient, we believe, 
to begin Phase 1 of going back to work. But, as I said last 
week, it is not nearly enough to provide confidence to 31,000 
students and faculty members that we hope will show up at the 
University of Tennessee campus in August when school starts.
    Last week, I talked with U.T. Knoxville Chancellor, Donde 
Plowman, about that. We said, what would persuade those 31,000 
students, as well as the 50 million K through 12 students in 
the country and the other 5,000 university students, what will 
persuade them to go back to campus in August?
    That is where the new Shark Tank comes in. Dr. Collins at 
the National Institutes of Health calls it RADx. We had our 
hearing about that on Thursday. It is a really remarkable 
scientific exercise to take a few early stage concepts that are 
swimming around in what we call that competitive Shark Tank to 
see if Dr. Collins and his associates can find a few new 
technologies to create millions of new tests that will scale up 
rapidly and make it more likely that students will go back to 
school in August.
    For example, the FDA authorized last week its first 
diagnostic test using saliva that a person provides at home 
instead of a nose swab or blood. It authorized its first 
antigen test--we are hearing a lot about those--like the ones 
used for flu or strep throat, which involves the swabbing of a 
nose, and you can get the result in just a few minutes.
    Another proposal not yet approved is to put in your mouth a 
sort of lollipop sponge, take a photo of that with your cell 
phone, and send that to your doctor. If it lights up, you are 
positive. Or, the university might send that saliva lollipop to 
a nearby laboratory, which could be a gene sequencing 
laboratory, which can deal with thousands of those samples 
overnight. That same process could occur at a middle school. It 
could occur at a factory.
    Of course, anyone testing negative one day can test 
positive the next. But, such widespread screening of entire 
campuses, schools, or places of work will help identify those 
who are sick, trace down those who are exposed. That, in turn, 
should help persuade the rest of us to go back to school and 
back to work.
    In addition to more testing, I expect Dr. Fauci to talk to 
us about additional treatments that will be available to reduce 
the risk of death, and the administration's plan to do 
something that our Country has never done before, which is to 
start manufacturing a vaccine before it actually has been 
proven to work in order to speed up the result in case it does 
work.
    Those vaccines, those treatments, are the ultimate 
solution. But, until we have them, all roads back to work and 
school go through testing. The more tests we conduct, the 
better we can identify those who are sick and exposed, and we 
can quarantine the sick and exposed instead of trying to 
quarantine the whole country.
    Now, in my opinion, this requires millions of new tests, 
many from new technologies. Some of these will fail, but we 
only need a few successes to get where we want to go. That is 
why I said on Thursday that what our Country had done so far in 
testing is impressive, but not nearly enough. First, squeeze 
all the tests we can out of current technologies. Next, try to 
find new technologies to help us contain the disease and 
persuade us to go back to work.
    Now, one other thing. This is a bipartisan hearing to 
examine how well we are preparing to go safely back to work and 
to school, and to determine what else we need to do in the U.S. 
Senate. Such an exercise sometimes encourages finger pointing. 
Before we spend too much time finger pointing, I would like to 
suggest that almost all of us, the United States and almost 
every country so far as I can tell, underestimated this virus; 
underestimated how contagious it would be; underestimated how 
it can travel silently in people without symptoms to infect 
other people; how it can be especially deadly for certain 
segments of our population--the elderly, those with pre-
existing conditions, minority populations.
    Let me go back to the March 3d hearing that we had in our 
Committee on coronavirus. Six weeks after the first case was 
discovered in the United States, a day when only two deaths 
were recorded in this country, I read at that hearing this 
paragraph from the New York Times two days earlier on March the 
1st.
    They reported this. ``Much about the coronavirus remains 
unclear,'' the Times reported, ``and it is far from certain''--
this is March 3rd--March 1--``that the outbreak will reach 
severe proportions in the United States or affect many regions 
at once. With its topnotch scientists, modern hospitals, and 
sprawling public health infrastructure, most experts agree, the 
United States is among the countries best prepared to prevent 
or manage such an epidemic.'' That was the New York Times on 
March 1.
    A lot of effort has gone into trying to make our Country 
well prepared. Over the last 20 years, four Presidents, several 
Congresses, in response to 9-11, bird flu, Katrina, Ebola, 
H1N1, MERS, passed nine major laws to try to help get this 
country ready for what we are going through today. These laws 
stood up the strategic national stockpile, created an Assistant 
Secretary for Preparedness. It created incentives for the 
developments of vaccines and medicines that we are using today, 
strengthened the Centers for Disease Control, created BARDA. 
Thanks to the leadership of Senator Blunt and Senator Murray 
for five straight years, we have significantly increased 
funding for the National Institutes of Health.
    All of this was part of a shared goal--Democrats, 
Republicans, four Presidents, several Congresses--to try to get 
ready for what we are going through today, whether it was 
known, like anthrax, or unknown, like COVID-19. But, despite 
all that effort, even the experts underestimated COVID-19.
    This hearing is about how we improve our response to this 
virus, as well as the next one. During the Oversight hearing, I 
also intend to focus on, as I just said, the next pandemic, 
which we know is coming.
    What can we learn from this one to be ready for the next 
one? Can we--what can we learn from the fast-tracking of 
vaccines and treatments that we are about to hear about that 
will make it even faster the next time? How can we keep 
hospitals and states from selling off protective equipment when 
their budget gets tight? How can we make sure Congress does our 
share of the funding responsibility? How do we provide enough 
extra hospital beds without canceling elective surgery or 
hurting other patients and bankrupting hospitals? Whose job 
should it be to coordinate supply lines so that protective 
equipment and supplies get where they are supposed to go when 
they are supposed to go? What is the best way to manage the 
stockpile?
    My preacher once said, I am not worried about what you do 
on Sunday; it is the rest of the week that concerns me. I am 
afraid that during the rest of the week, between pandemics, we 
relax our focus on preparedness. We become preoccupied with 
other important things. Our collective memory is short. Just 3 
months ago, this country was preoccupied with impeaching a 
President. Now that seems like ancient Roman history.
    Now, while this crisis has our full attention, I believe we 
should put into law this year whatever improvements need to be 
made to be well prepared for the next pandemic. If there is to 
be finger pointing, I hope they are pointed in that direction.
    We are fortunate today to have four distinguished witnesses 
who are at the heart of the response to the coronavirus. We are 
grateful for their service to our Country. I have asked them 
each to summarize their remarks in 5 minutes. Then we will have 
5-minute rounds of questions from each Senator. I have agreed 
we will end our hearing about 12:30, after we have a full round 
of questions. Every Senator will have a chance to have his or 
her 5 minutes. Senator Murray will then have an opportunity to 
ask the last question or to close the hearing, and I will then 
close the hearing. There will be other hearings to follow this 
hearing, like last Thursday's hearing, and Senators may submit 
their questions in writing within the next 10 days.
    Staying at home indefinitely is not the solution to this 
pandemic. There is not enough money available to help all those 
hurt by a closed economy. All roads back to work and back to 
school lead through testing, tracking, isolation, treatment, 
and vaccines. This requires widespread testing, millions more 
tests, created mostly by new technologies, to identify those 
who are sick and who have been exposed so they can be 
quarantined. And, by containing the disease in this way, give 
the rest of America enough confidence to go back to work and 
school.
    For the near term, to help make sure those 31,000 U.T. 
students and faculty members show up in August, we need 
widespread testing. Millions more tests, created mostly by new 
technologies, to identify those who are sick and who have been 
exposed so they can be quarantined. By containing the disease 
in this way, give the rest of America enough confidence to go 
back to work and back to school.
    Senator Murray.

                  OPENING STATEMENT OF SENATOR MURRAY

    Senator Murray. Well, thank you very much, Mr. Chairman. My 
thoughts are with you and your team right now as you try to 
navigate the same challenge so many in our Country are worried 
about. We all wish your staff member a speedy recovery. And, as 
everyone works to take appropriate safety precautions today, I 
would like to thank not only our witnesses for joining us 
today, but also our Committee staff for working to set up a 
safe format for Members and witnesses and the public to 
participate in this hearing remotely.
    Families across the country are counting on us for the 
truth about the COVID-19 pandemic, especially since it is clear 
they will not get it from President Trump. Truth is essential 
so people have the facts, so they can make decisions for 
themselves and their families and their communities. Lives are 
at stake. If the President is not telling the truth, we must, 
and our witnesses must, and we are counting on you today.
    Families need us to take this opportunity to dig into the 
facts about where things did go wrong so we can finally get 
them on track because the Trump administration's response to 
this public health emergency so far has been a disaster all on 
its own.
    Delays, missteps have put us way behind where we need to be 
on diagnostic tests and allowed inaccurate antibody tests to 
flood the market. Corruption and political interference have 
impeded efforts to secure desperately needed personal 
protective equipment and promoted dangerous, unproven 
treatments. And, we recently learned that after experts at the 
Centers for Disease Control and Prevention spent weeks 
developing a detailed guide to help our communities understand 
how to safely reopen when the time comes, the Trump 
administration tossed it in the trash bin for being too 
prescriptive.
    But, this is far from the first time this administration 
has silenced experts who were doing their job and putting 
public health first. The fact of the matter is, President Trump 
has been more focused on fighting against the truth than 
fighting this virus, and Americans have sadly paid the price.
    Since this Committee last heard from these witnesses on 
March 3d, we have seen over 900 deaths in my home State of 
Washington, over 80,000 deaths nationally, and the numbers 
continue to climb. Still, President Trump is trying to ignore 
the facts and ignore the experts, who have been very clear we 
are nowhere close to where we need to be to reopen safely. My 
hope today is that we can cut through this and have a serious 
discussion about what is needed to safely open, how close we 
are as a country to meeting those needs, and how we actually 
get there.
    One thing that is abundantly clear, we need dramatically 
more testing. It is unacceptable we still do not have a 
national strategic plan to make sure testing is free, fast, and 
everywhere. That is why I fought to make sure our last COVID-19 
package included an initial $25 billion testing fund and a 
requirement that the administration submit a plan by May 24th.
    When I say a plan, I do not mean a PR plan. I mean a plan 
with specific timelines and numeric goals for supply and 
funding needs; one that actually addresses the issues we are 
seeing on testing capacity and distribution and disparities and 
building out our public health system; and makes clear to 
states and tribes and employers and the American people what 
they can expect and what the administration will do to keep 
Americans safe.
    But, testing alone will not be enough to reopen our 
Country. We still need far more personal protective equipment 
than has been available for our healthcare workers on the front 
lines, and we will need far more for other workers as we 
reopen.
    We desperately need this administration to step up and get 
that equipment to states, who are doing everything in their 
power to purchase supplies but simply cannot get nearly enough. 
Because, the reality is, unlike states, the Federal Government 
has the tools to actually fix the problem, if only the 
administration would use them.
    We also need that equipment to actually work, and for the 
FDA to act promptly if it does not; not weeks later when people 
may have already been exposed.
    Just as importantly, we cannot expect people to go back to 
work or to restaurants or to confidently send their kids to 
school if there is not clear, detailed guidance about how to do 
that safely.
    Schools, from early childhood through college, need to know 
how to keep their students, their staff, and their educators 
safe. When should they wear masks? How do you run a school 
cafeteria or a school bus? And, if they cannot reopen 
classrooms, schools and families need to know we are working to 
ensure every student gets an education.
    Tools like online learning can only get us so far if we do 
not address the digital divide that--so that every student can 
access them. And, even then, there will be learning loss that 
could deepen existing educational disparities among low-income 
students, students with disabilities, English language 
learners, and other vulnerable populations if we do not make 
sure they get equal access to resources and support.
    Of course, schools are not the only workplaces we have to 
be thinking about. We need to make sure that industries across 
the country know how to safely reopen and that people know 
their workplace is safe. Secretary Scalia needs to stop 
dragging his feet and do his job and have the Department of 
Labor set forward a rule that makes clear worker safety is not 
optional.
    Mr. Chairman, I hope this Committee can hear about those 
critical issues from Secretary Scalia and Secretary DeVos, as 
well as other experts in the space in the days ahead.
    This is especially important to protect workers and 
residents at our nursing homes and other congregate care 
facilities where we have seen some of the most deadly 
outbreaks. And, as the rash of outbreaks at meatpacking plants 
shows, this is not just an issue for the healthcare industry. 
It is an issue for everyone.
    Just as we need a plan before we can start to reopen, we 
also need a plan well before we have a safe and effective 
vaccine to guarantee that we can quickly produce and distribute 
it on a global scale, and make it free and available for 
everyone. So, I will be asking about our progress on those 
issues today.
    Today, safely reopening our Country may be a ways off, and 
the administration's planning may be way behind, but there is 
still a lot that Congress needs to do. There is not time to 
spare. Some, including the White House, say we have already 
provided enough economic relief. Well, my question to them is, 
what good is a bridge that only gets you to the middle of the 
river? We do not need to wait around to see if people need more 
help. We know they do. We need to work quickly on another 
aggressive relief package, and we need to make sure our 
priorities in that bill are protecting our workers, our 
students and our families, and addressing this public health 
crisis, not bailing out corporations or protecting big business 
from accountability.
    People across the country are doing their part. They are 
washing their hands and wearing masks and social distancing and 
staying home. They need their Government to do its part, too. 
They need leadership. They need a plan. They need honesty, and 
they need it now, before we reopen, so they can rest assured 
that we are doing things safely and competently with their 
health and well-being as a top priority.
    Thank you, Mr. Chairman.
    The Chairman. This hearing, it is an important hearing, and 
I know lots of people may be watching it for the first time. If 
they are, I hope they notice that we have 23 Members of this 
Committee, I believe, one more Republican than Democrat. We 
have some very strong views, but we are able to work together 
and to express those views and respect each other and our 
witnesses, and I--and a big part of that goes to Senator Murray 
and her staff. So, thank you for that.
    Each witness will have up to 5 minutes to give his 
testimony. Thank you for making an exception and agreeing to 
testify by video because of these unusual circumstances. And, 
thank you for what you are doing for our Country.
    Our first witness is Dr. Anthony Fauci. He is director of 
the National Institutes of Allergy and Infectious Diseases at 
the National Institutes of Health. He has held that position 
since 1984, which meant he has advised six Presidents and 
worked on HIV-AIDS, influenza, malaria, Ebola, and other 
infectious diseases. He was involved in treating Ebola patients 
at NIH, and also worked on vaccine trials for Ebola.
    Next, we will hear from Dr. Robert Redfield. He is director 
of the U.S. Centers for Disease Control and Prevention, which 
has its headquarters in Atlanta. More than 30 years, he has 
been involved with clinical research related to chronic human 
viral infections and infectious diseases, especially HIV. He 
was the founding director of the Department of Retroviral 
Research within the U.S. Military's HIV Research Program. He 
spent 20 years with the U.S. Army Medical Corps.
    Third, Admiral Brett Giroir. Admiral Giroir is Assistant 
Secretary for Health at the U.S. Department of Health and Human 
Services. That puts him in charge of development of public 
health policy recommendations. He has taken on the 
responsibility for coordinating testing and focused on the 
increasing number of tests that we can do with existing 
technology. His Federal service includes a variety of 
activities with our Defense Department in advanced research, 
threat reduction, and he was part of the Blue Ribbon Panel to 
reform the U.S. Veterans Health System.
    Finally, we will hear from Dr. Stephen Hahn. He is 
Commissioner of the Food and Drug Administration. Before 
joining FDA, he was the chief medical executive of the 
University of Texas MD Anderson Cancer Center. He was chair of 
the Department of Radiation Oncology at the University of 
Pennsylvania. He was a senior investigator at the National 
Institutes of Health. He was commander of the U.S. Public 
Health Service Commissioned Corps from 89 to 95.
    Now we will ask each of our witnesses to summarize their 
remarks in 5 minutes. Following that, each Senator will have 5 
minutes for questions and answers in order of seniority.
    Dr. Fauci, let us begin with you. Welcome.

STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE 
  OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF 
                      HEALTH, BETHESDA, MD

    Dr. Fauci. Thank you very much, Mr. Chairman, Ranking 
Member Murray, and Members of the Committee. Thank you for 
giving me the opportunity to discuss with you today the role 
the National Institutes of Health has in research addressing 
COVID-19.
    The strategic plan that we have is fourfold: One, to 
improve our fundamental knowledge of the virus and the disease 
it causes; next, to develop new point-of-care diagnostics; 
next, to characterize and test therapeutics; and finally, to 
develop safe and effective vaccines.
    First, with regard to diagnostics. As you probably heard 
from Dr. Francis Collins last Thursday, the NIH has developed a 
Rapid Acceleration of Diagnostics Program, called RADx, with an 
award to that specific program up to a half a billion dollars 
to support the development of COVID-19 diagnostics. It is a 
national call for innovative technologies that will be 
evaluated in a Shark Tank-like selection process to get to 
either success or failure rapidly.
    Moving on to therapeutics. I will talk a bit about the 
Remdesivir success antiviral in a moment, but let me emphasize 
that there are a number of broad-spectrum antivirals that are 
in various stages of testing.
    In addition, we will be looking at convalescent plasma, 
which is plasma from individuals who have recovered from COVID-
19, to be used in passive transfer either in prevention or 
treatment. In addition, hyperimmune globulin, which could be 
used as a gammaglobulin shot. We will be looking at repurposed 
drugs, as well as immune-based therapies and host modifiers. 
And finally, monoclonal antibodies.
    Let me take a moment to describe the Remdesivir placebo-
controlled, randomized trial, which was done internationally 
with the power of more than a thousand individuals in sites 
throughout the world. It was in hospitalized patients with lung 
disease. The endpoint was primarily time to recovery. The 
result was statistically significant, but really modest. And, 
we must remember it was only a modest result showing that the 
drug made a 31 percent faster time for recovery. We hope to 
build on this modest success with combinations of drugs and 
better drugs.
    Moving on to vaccines. There are at least eight candidate 
COVID-19 vaccines in clinical development. The NIH has been 
collaborating with a number of pharmaceutical companies at 
various stages of development. I will describe one very 
briefly, which is not the only one, but one that we have been 
involved in heavily developing with Moderna. It is a messenger 
RNA platform.
    You might recall in this Committee that in January of this 
year, I said that it would take about one year to 18 months if 
we were successful in developing a vaccine. The NIH trial moved 
very quickly. On January 10th, the sequence was known. On 
January 11th, the Vaccine Research Center met to develop a 
plan. On the 14th of January, we officially started the vaccine 
development. Sixty-two days later, we are now in Phase 1 
clinical trial with the two doses already fully enrolled. There 
will be animal safety. The Phase 1 will directly go into Phase 
2/3 in late spring and early summer. And, if we are successful, 
we hope to know that in the late fall and early winter.
    There are some important issues, however, in COVID-19 
vaccine development. We have many candidates and hope to have 
multiple winners. In other words, it is multiple shots on goal. 
This will be important because this will be good for global 
availability if we have more than one successful candidate.
    We also, as the Chairman mentioned, will be producing 
vaccine at risk, which means we will be investing considerable 
resources in developing doses even before we know any given 
candidate or candidates work. I must warn that there is also 
the possibility of negative consequences, where certain 
vaccines can actually enhance the negative effect of the 
infection. The big unknown is efficacy. Will it be present or 
absent, and how durable will it be?
    Finally, I want to mention the NIH has launched a public-
private partnership called Accelerating COVID-19 Therapeutic 
Interventions and Vaccines. The purpose of that is to 
prioritize and accelerate clinical evaluation of therapeutic 
candidates with near-term potential.
    Hopefully, our research efforts, together with the other 
public health efforts, will get us quickly to an end to this 
terrible ordeal that we are all going through.
    Thank you very much. Happy to answer questions later.

                  Prepared Statement of Anthony Fauci

    NIH is the HHS agency leading the research response to COVID-19 and 
the novel coronavirus that causes it, 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 infectious diseases as they 
emerge, 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 improved our 
fundamental understanding of coronaviruses and provides a strong 
foundation for our accelerated efforts to address the challenge of 
COVID-19 by developing vaccines, therapeutics, and diagnostics.
          Developing Vaccines to Prevent SARS-CoV-2 Infection
    A safe and effective vaccine for SARS-CoV-2 will be essential to 
stopping the spread of infection, reducing rates of morbidity and 
mortality, and preventing future outbreaks. NIAID is supporting 
development of several SARS-CoV-2 vaccine candidates, including 
vaccines based on platform technologies that have shown promise against 
the coronaviruses that cause SARS and MERS.
    The NIAID Vaccine Research Center has collaborated with the 
biotechnology company Moderna, Inc., to develop a vaccine candidate 
using a messenger RNA (mRNA) vaccine platform expressing the SARS-CoV-2 
spike protein. On March 16, 2020, NIAID initiated a Phase 1 clinical 
trial of this experimental vaccine at the Kaiser Permanente Washington 
Health Research Institute, and later added clinical sites at Emory 
University and the NIH Clinical Center. This trial was recently 
expanded to enroll older adults to better define the safety of and 
immune response to the vaccine across various age groups. The Coalition 
for Epidemic Preparedness Innovations (CEPI) funded the manufacture of 
the vaccine candidate for the Phase 1 trial, and BARDA plans to support 
advanced development of the candidate.
    Scientists at NIAID's Rocky Mountain Laboratories (RML) are 
collaborating with University of Oxford researchers to develop a SARS-
CoV-2 chimpanzee adenovirus-vectored vaccine candidate, now in a Phase 
1/2 clinical trial supported by the University of Oxford. RML 
investigators also have partnered with University of Washington 
scientists to investigate another mRNA vaccine candidate against SARS-
CoV-2. NIAID is working with additional academic and industry partners 
to develop several other vaccine concepts.
    The rigorous clinical testing required to establish safety and 
efficacy means that it might take some time for a licensed SARS-CoV-2 
vaccine to be available to the general public. The COVID-19 response 
currently is focused on the proven public health practices of 
containment and mitigation.
               Identifying Therapeutics to Treat COVID-19
    Effective therapeutics for COVID-19 are critically needed to treat 
many patients globally who have been infected with SARS-CoV-2. On 
February 21, 2020, NIAID launched a multicenter, randomized placebo-
controlled clinical trial to evaluate the safety and efficacy of 
therapeutics for COVID-19, initially examining the antiviral drug 
Remdesivir for treatment of COVID-19 in hospitalized adults. The 
adaptive design of this trial will enable the evaluation over time of 
additional promising therapies, such as the immunosuppressive drug 
baricitinib, which was recently added to the study. An analysis of 
preliminary data from 1,063 patients enrolled in the trial indicated 
that those who received Remdesivir had a 31 percent faster time to 
recovery, 11 days compared with 15 days for those who received placebo. 
Additionally, the analysis found that Remdesivir may benefit survival, 
though the mortality data did not reach statistical significance. A 
mortality rate of 8 percent was observed for the group receiving 
Remdesivir versus 11.6 percent for placebo. NIAID is developing and 
testing other novel and repurposed therapies, including monoclonal 
antibodies (mAbs). NIAID also is planning clinical trials to evaluate 
hydroxychloroquine (HCQ) and azithromycin in patients with mild to 
moderate COVID-19, and hyperimmune intravenous immunoglobulin (IVIG) 
for treatment of COVID-19.
    On April 6, 2020, the National Heart, Lung, and Blood Institute 
(NHLBI) launched a clinical trial of HCQ in hospitalized COVID-19 
patients through its Prevention and Early Treatment of Acute Lung 
Injury (PETAL) clinical trials network. NHLBI also sponsored the 
addition of a U.S. site for a Canadian Institutes for Health Research-
funded trial of colchicine--an anti-inflammatory drug commonly used to 
treat gout--for treating COVID-19 in the outpatient setting. 
Additionally, NHLBI is leveraging the NIH-funded Strategies to Innovate 
Emergency Care Clinical Trials Network (SIREN) to study whether 
convalescent plasma, or blood plasma from individuals who have 
recovered from COVID-19, can help reduce the progression of COVID-19 in 
patients with mild symptoms.
    The National Center for Advancing Translational Sciences (NCATS) is 
leveraging the NCATS Pharmaceutical Collection, a compilation of every 
drug approved for human use by major regulatory agencies worldwide, and 
other collections of small molecules and compounds to identify 
potential SARS-CoV-2 therapeutics for further investigation. Institutes 
and Centers across NIH also are working concurrently with partners in 
academia and industry to pursue the development and testing of mAbs and 
antiviral drugs for potential treatment of COVID-19. NIAID, the 
National Cancer Institute (NCI), NHLBI, NCATS, the National Institute 
of Arthritis and Musculoskeletal and Skin Diseases, and the National 
Institute of Neurological Disorders and Stroke are all engaged in this 
critical effort.
    NIH, in collaboration with the Foundation for the NIH, recently 
launched an innovative public-private partnership to speed the 
development of COVID-19 therapeutics and vaccines. The Accelerating 
COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private 
partnership brings together stakeholders from across the U.S. 
Government, industry, and the European Medicines Agency to develop an 
international strategy for a coordinated research response to the 
COVID-19 pandemic. Other Federal partners include BARDA, the Department 
of Defense (DOD), the Department of Veterans Affairs, CDC, and FDA.
    NIH also has convened the COVID-19 Treatment Guidelines Panel, 
comprised of representatives of NIH and five other Federal agencies 
along with representatives of eight professional organizations, 
academic experts, and treating physicians including providers from high 
incidence areas. On April 21, 2020, the panel issued the first release 
of COVID-19 treatment guidelines for clinicians. The guidelines provide 
recommendations regarding specific treatments currently available and 
address considerations for special populations, including pregnant 
women and children. The guidelines will be updated regularly as new 
credible information emerges.
   Enhancing Diagnosis and Understanding the Pathogenesis of COVID-19
    NIH is supporting an HHS-wide effort to promote the development and 
commercialization of diagnostic tests to detect current SARS-CoV-2 
infection. On April 29, 2020, NIH announced the Rapid Acceleration of 
Diagnostics (RADx) initiative, which will work to identify, support, 
and make innovative strategies for COVID-19 testing widely accessible, 
in collaboration with FDA, CDC, and BARDA. RADx will leverage the 
Point-of-Care Technologies Research Network established by the National 
Institute of Biomedical Imaging and Bioengineering (NIBIB) to allow for 
potential roll out of new products by fall 2020. This initiative 
expects to award up to $500 million to support development of point-of-
care and home diagnostic devices, as well as innovations that make 
current laboratory tests faster, more efficient, and more widely 
accessible. Innovators will be matched with technical, clinical,
    regulatory, business, and manufacturing experts to increase the 
odds of success. In addition, NIAID is using CARES Act funds to support 
diverse SARS-CoV-2 diagnostic platforms including RT-PCR and enzyme-
linked immunosorbent assays, and facilitating development of sensitive, 
specific, and rapid diagnostic tests by providing critical SARS-CoV-2 
isolates and reagents to test developers. In addition, NCI is 
coordinating with FDA and NIAID to assess the sensitivity and 
specificity of marketed SARS-CoV-2 serological tests, which can detect 
antibodies indicative of a prior exposure to SARS-CoV-2.
    NIAID, NCI, NCATS, and NIBIB also are partnering on a new study to 
investigate whether adults in the U.S. without a confirmed history of 
infection with SARS-CoV-2 have antibodies to the virus, indicating 
prior infection. In addition, NIH is supporting COVID-19 natural 
history studies to understand the clinical course of infection, 
including incidents of thrombosis, strokes and 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; 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 will help to identify individuals or groups at high risk.
    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 safe and effective COVID-19 
vaccines and therapeutics, and sensitive, specific, and rapid point-of-
care diagnostic tests. These efforts will improve our response to the 
current pandemic and bolster our preparedness for the next, inevitable 
emerging disease outbreak.
                                 ______
                                 
    The Chairman. Thank you, Dr. Fauci.
    Dr. Redfield, welcome.

  STATEMENT OF ROBERT REDFIELD, M.D., DIRECTOR, UNITED STATES 
    CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA

    Dr. Redfield. Good morning, Chairman Alexander and Ranking 
Member Murray and Members of the Committee.
    Our Nation is confronting the most serious public health 
crisis in more than a century, yet we are not defenseless. We 
have powerful tools to fight this enemy. We have tried and 
true, effective public health interventions, such as early case 
identification, isolation, and contact tracing, combined with 
important mitigation strategy, including social distancing, 
frequent hand washing, and face covering. These public health 
tools have and will continue to slow the spread of COVID-19.
    I appreciate the opportunity this morning to provide a 
brief overview of some of CDC's ongoing work in response to 
COVID-19. CDC has been working 24/7 to combat the pandemic.
    CDC's Emergency Operations Center is supporting state, 
tribal, local, and territorial public health partners in 
building core capabilities, particularly workforce, laboratory, 
and data and predictive analytics.
    Epidemiologists are conducting surveillance for COVID-19, 
as well as conducting health system surveillance.
    Community mitigation teams are providing guidance on 
infection control and contact tracing, and our laboratory 
experts are performing serological testing to better define the 
extent of asymptomatic populations.
    As local leadership makes decisions to reopen, they will 
require varying degrees of Federal support. Each location will 
be different and will face unique circumstances. CDC has 
conducted a state-by-state assessment of public health testing 
capacity and contact tracing capacity, as well as surge plans.
    CDC is providing technical assistance and funding to the 
states provided through the Supplemental CARES Act and the 
Paycheck Protection Program and Healthcare Enhancement Act. We 
are working directly with the state public health leaders to 
define their needs for testing and testing devices, supplies, 
and manpower, surveillance, data collection and reporting, 
contact tracing, infection control, and outbreak investigation.
    I want to spend a moment to focus on several key elements. 
First, testing. Rapid, extensive, and widely available, timely 
testing is essential for reopening America. CDC's role in 
testing continues to support diagnosis and contact tracing, 
surveillance, and outbreak. We work with the public health 
partners to define their particular testing strategy for their 
jurisdiction. Admiral Giroir will address the testing 
components of the response in greater detail.
    Contact tracing. Increasing state, tribal, local, and 
territorial contact tracing capacity is critical. It is a 
critical part to stop the chains of transmission and prevent 
the occurrence of sustained community transmission. CDC's role 
is to provide technical training, assistance, and support for 
the states as they hire and build a workforce necessary to be 
fully prepared to effectively respond to the public health 
challenges posed by the ongoing COVID pandemic. This will be an 
expansive effort.
    Surveillance. Our Nation's surveillance program is built on 
a combination of systems, including existing syndromic 
influenza and respiratory viral disease surveillance systems, 
have been combined with commercial and research lab platforms 
in our case reporting form system. CDC is adapting these and 
optimizing it to have a surveillance system in response to 
COVID-19.
    Importantly, in light of the significant occurrence of 
asymptomatic infection, the surveillance for asymptomatic 
infection becomes an important public health tool for early 
case identification. CDC is working with each public health 
jurisdiction to develop a prospective surveillance program to 
include active surveillance among those that are most 
vulnerable, such as individuals in long-term care facilities, 
inner-city clinics, and homeless shelters.
    We need to rebuild our Nation's public health 
infrastructure, data and data analytics, public health 
laboratory resilience, and our Nation's public health 
workforce. Now is the time to put it in place for the 
generations to come, not only for the public health system that 
our Nation needs, but for the public health system that our 
Nation deserves.
    Before I close, I want to recognize the tireless commitment 
of the dedicated CDC staff, who have deployed to every corner 
of this Nation to fight COVID-19. More than 4,000 employees 
have deployed here and globally. Science and data continue, 
with technical expertise and public service, to be the backbone 
of CDC's contributions to the U.S. response.
    I extend my serious gratitude to the healthcare workers on 
the front lines, as well as their family, and the essential 
emergency personnel, as well as the American people, to say 
thank you for adhering to the stay-at-home guidelines and 
protecting the most vulnerable.
    It is important to emphasize that we are not out of the 
woods yet. The battle continues, and we must, but we are more 
prepared. We need to stay vigilant with social distancing. It 
remains an imperative. We are a resilient Nation, and I am 
confident that we will emerge from this pandemic stronger, 
together.
    Thank you.

                 Prepared Statement of Robert Redfield

    CDC is America's health protection agency, and works 24/7 to save 
lives and protect America from health, safety and security threats, 
both foreign and in the United States. Addressing infectious diseases 
like COVID-19 is fundamental to our mission and is our highest 
priority. CDC is building upon decades of experience and leadership in 
responding to prior infectious disease emergencies, including SARS, 
MERS, Ebola, Zika, and pandemic influenza to meet new challenges 
presented by COVID-19. These challenges are many, and they are 
historic. Every single American is affected by this pandemic, and CDC 
is leaning into this public health crisis with every applicable asset 
we have. CDC is drawing on its emergency response capacity and its 
relationships with State, tribal, local, and territorial (STLT), 
global, and private sector partners; and is leveraging our workforce's 
strengths in public health surveillance, and laboratory capacity, to 
address this public health emergency. CDC is developing guidance for 
healthcare professionals and the public to encourage safer practices, 
improve health outcomes, and save lives. CDC is also working with 
partners to develop guidance and decision tools to assist State and 
local officials and other stakeholders in adjusting mitigation 
strategies. Importantly, CDC is preparing the Nation's public health 
system and the private sector for a vaccine when one is available. 
Abroad, CDC is leveraging investments in global health security, 
pandemic influenza preparedness and public health infrastructures and 
capacities built through programs like the President's Emergency Plan 
for AIDS Relief to support countries in mitigating and containing 
COVID-19. The emergence and rapid spread of COVID-19 confirms that an 
infectious disease threat anywhere is a threat to Americans everywhere, 
including here at home.
    When, in late December 2019, Chinese authorities announced a 
cluster of pneumonia cases of unknown etiology centered in Wuhan, 
China, CDC began monitoring the outbreak. At the beginning of January, 
CDC began developing situation reports, which were shared with HHS, and 
reaching out to the Chinese Center for Disease Control and Prevention 
to offer CDC support. By January 7, 2020, CDC began expanding its 
incident management (IM) and response structure to facilitate staffing 
and communications. On January 21, 2020, CDC officially activated its 
Emergency Operations Center for COVID-19. Using the IM structure, CDC 
immediately set up task forces to address key needs and reached out 
frequently to our State and local partners. On March 17, 2020, CDC 
joined other HHS components and the Federal Emergency Management Agency 
(FEMA) in coordinating activities through FEMA's National Response 
Coordination Center. Addressing COVID-19 is taking an all-of-government 
effort.
    Congress has addressed the urgent need to respond to this pandemic 
at home and abroad and has allocated substantial resources for CDC's 
COVID-19 activities through the statutes mentioned above. This funding 
supports a federally guided, State managed, and locally implemented 
response to COVID-19 in the United States. With support provided by 
Congress for global disease detection and emergency response through 
COVID-19 appropriations, CDC is supporting prevention, preparedness, 
and response efforts in partnership with public health agencies, health 
ministry counterparts and multilateral and non-governmental agencies 
worldwide. Here in the United States, CDC is working with STLT partners 
to focus use of these resources to establish and enhance case 
identification; conduct contact tracing; implement appropriate 
containment and community mitigation measures; improve public health 
surveillance; enhance testing capacity; control COVID-19 in high-risk 
settings; protect vulnerable and high-risk populations; and work with 
healthcare systems to manage and monitor capacity. As of May 1, 2020, 
CDC has announced or obligated $1.627 billion in awards to 
jurisdictions across America from the funds provided by Congress.
    CDC is providing direct technical assistance and support to STLT 
partners as they consider approaches to mitigate and contain COVID-19. 
The White House, and Federal partners including CDC, have convened 
calls with all 50 states, Puerto Rico and the District of Columbia to 
identify State capacities and needs. The Federal Government has 
committed to ensuring that states can meet testing objectives for the 
month of May, as identified by each State. Through these calls and 
other outreach efforts, CDC has worked with jurisdictions to identify 
needs and develop plans to enhance testing capacity, State 
surveillance, contact tracing, and surge staffing. These discussions 
and plans for action will emphasize the need to serve vulnerable 
populations and include focused efforts for long-term care facilities, 
federally qualified health centers, and Tribal Nations, among others.
    In addition, CDC has launched a multifaceted approach to enhance 
and complement STLT efforts and expand support to communities during 
the current public health emergency. The COVID Response Corps is a new, 
nationwide community-focused initiative to identify surge staffing and 
resources to STLT health departments on the frontlines of the fight 
against COVID-19. Response Corps members will augment health department 
teams and engage in core public health functions including contact 
tracing, testing, infection prevention and control, call center 
activities, COVID-19 education, and public health surveillance.
    CDC relies on timely and accurate public health surveillance data 
to guide public health action and inform the nationwide response to 
COVID-19. This crisis has highlighted the need to continue efforts to 
modernize the public health data systems that CDC and states rely on 
for accurate data. Public health data surveillance and analytical 
infrastructure modernization efforts started in fiscal year 2020 using 
funds provided by Congress, which have been augmented by $500 million 
provided for these efforts under the CARES Act. Timely and accurate 
data are essential as CDC and the Nation work to understand the impact 
of COVID-19 on all Americans, particularly for populations at greater 
risk for severe illness, such as older Americans, those with chronic 
medical conditions, and some racial and ethnic minorities. CDC is also 
working to understand the impact of COVID-19 on healthcare workers, 
first responders, and other essential workers. Accurate data are 
critical as we continue to assess the burden placed on the American 
healthcare system to inform reopening. CDC is capitalizing on multiple 
existing surveillance systems run in collaboration with STLT partners, 
including influenza and viral respiratory disease systems. In 
collaboration with STLT partners, CDC is committed to making data 
available to the public, while protecting individual privacy. CDC's 
population-based COVID-NET system monitors COVID-19 associated 
hospitalizations that have a confirmed positive test in greater than 
250 acute care hospitals in 99 counties in 14 states. Data gathered are 
used to estimate age-specific hospitalization rates on a weekly basis 
and describe characteristics of persons hospitalized with COVID-19 
illness. CDC is using these data to monitor hospitalizations by race, 
ethnicity, underlying condition, age, and gender, and is now including 
this information in CDC's weekly COVIDView summary. CDC is now 
receiving more granular data on deaths by State and locality, allowing 
us to identify and address where there may be racial and ethnic 
disparities in morbidity and mortality. CDC also is augmenting the 
existing National Healthcare Safety Network to monitor and analyze the 
capacity of the healthcare system daily--including hospitals and 
nursing homes--so that Federal, State, and local officials can adjust 
their response and mitigation efforts as needed.
    Regarding laboratory support, from the outset, CDC laboratories 
have been applying sequencing technologies to SARS-CoV-2 and have made 
the data available through domestic and global data bases. CDC is 
leading the SARS-CoV-2 Sequencing for Public Health Emergency Response, 
Epidemiology and Surveillance (SPHERES), a new national genomics 
consortium to coordinate SARS-CoV-2 sequencing across the United States 
to do large-scale, rapid genomic sequencing of the virus. These 
advanced molecular detection and sequencing activities are being ramped 
up at the State and local levels to give us a clearer picture of how 
the virus outbreak is evolving and how cases are connected. CDC is 
engaged with the National Institutes of Health (NIH), the FDA, and the 
Biomedical Advanced Research and Development Authority (BARDA) to 
evaluate serology tests, and CDC is supporting serological surveys to 
help determine how laboratory testing can contribute to decisions about 
enabling Americans to return to work.
    CDC has developed a new serologic laboratory test to assist with 
efforts to determine how much of the U.S. population has been infected 
with SARS-CoV-2, the virus that causes COVID-19. The serology test 
looks for the presence of antibodies, which are specific proteins made 
in response to infections. It typically takes one to 3 weeks after 
someone becomes sick with COVID-19 for their body to make antibodies; 
some people may take longer to develop antibodies. The antibodies 
detected by this test indicate that a person has had an immune response 
to SARS-CoV-2, regardless of whether symptoms developed from infection 
or the infection was asymptomatic. However, it is important to point 
out that, at this point, we do not know whether the presence of 
antibodies provides immunity to the virus. Currently, CDC's serologic 
test is designed and validated exclusively for broad-based surveillance 
and research that is giving us information needed to guide the response 
to the pandemic and protect the public's health.
    During the week of March 30, CDC and public health partners began 
the first stage of studies of community transmission of SARS-CoV-2. 
These initial studies use serum samples collected in the State of 
Washington and New York City. In April, the second stage expanded to 
include serologic testing in more areas with high numbers of people 
with diagnosed infections. It also includes studies of households in 
some states. By using seroprevalence surveys, CDC can learn about 
people who have been infected, including those infections that might 
have been missed due to lack of symptoms or testing not being performed 
for other reasons. These surveys can also track how infections progress 
through the population over time. This is done by taking ``snap shots'' 
of the percentage of people from the same area who have antibodies 
against SARS-CoV-2 (also called the seroprevalence) at different time 
points.
    On April 27, 2020, CDC updated testing prioritization and focused 
testing guidelines for those who may have or who are at risk for active 
SARS-CoV-2 infection. Clinicians considering testing of persons with 
possible COVID-19 should continue to work with their local and State 
health departments to coordinate testing through public health 
laboratories or use clinical laboratory viral tests for COVID-19 that 
has been issued an Emergency Use Authorization (EUA) by FDA or are 
being offered as outlined in FDA's policy regarding COVID-19 tests. 
Increasing testing capacity will allow clinicians to consider the 
medical necessity of COVID 0919 testing for a wider group of 
symptomatic patients and persons without symptoms in certain 
situations. CDC recommends that clinicians should use their judgment to 
determine if a patient has signs and symptoms compatible with COVID-19 
and whether the patient should be tested. Most patients with confirmed 
COVID-19 have developed fever and/or symptoms of acute respiratory 
illness (e.g., cough, difficulty breathing) but some people may present 
with other symptoms as well. Other considerations that may guide 
testing are epidemiologic factors such as the occurrence of local 
community transmission of COVID-19 infections in a jurisdiction.
    The American people, communities, public health professionals, 
medical providers, businesses, and schools look to CDC for trusted 
guidance on responding to COVID-19. CDC develops and disseminates 
guidance for individuals and communities. These recommendations include 
actions that every American should take, such as following good 
personal hygiene practices, staying at home when sick, and practicing 
social distancing to lower the risk of disease spread. CDC guidance is 
available here https://www.cdc.gov/coronavirus/2019-ncov/prevent-
getting-sick-prevention.html.
    First responder and healthcare guidance documents cover a range of 
topics--from addressing potential work-related exposures, implementing 
infection prevention and control measures in health facilities, and 
optimizing the supply of personal protective equipment to clinical 
evaluation, testing, and clinical care. CDC is providing these 
recommendations to support communities' efforts, while recognizing that 
each sector and community is unique and will need to consider these in 
the context of their community-level data and circumstances. CDC teams 
on the ground and those aiding from Atlanta are and will continue 
working with State and local officials to integrate these 
recommendations into COVID-19 plans.
    Mitigation and containment of COVID-19 are the key to public health 
strategies and CDC is committed to using our expertise and partnering 
with others on the frontlines. While surveillance, testing, contact 
tracing, and community mitigation interventions are the best tools we 
have right now, looking to the future, CDC continues to work to prepare 
our Nation's public and private health systems to deliver effectively a 
COVID-19 vaccine once it is available. This includes working with CDC's 
64 immunization awardees to help ensure that the U.S. immunization 
system can mount an effective vaccine delivery program, including 
vaccine distribution and tracking. CDC remains committed to supporting 
the COVID-19 response with all available resources.
                                 ______
                                 
    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. I am here to provide you with an update on 
the Nation's progress in testing for COVID-19.
    On March 12th, Secretary Azar requested that I lead the 
COVID-19 testing efforts within HHS, including oversight and 
coordination of the FDA and CDC with regard to testing. Since 
then, the Nation has performed more than nine million COVID-19 
tests, a number far greater than any other country, and double 
the per capita tests performed to date in South Korea. To reach 
this point, we implemented a phased approach to meet testing 
needs during mitigation, and now during Phase 1 reopening of 
America.
    Beginning March 20th, we pioneered 41 community-based, 
drive-through testing sites in locations prioritized by the 
CDC. These sites have been a profound success, testing over 
167,000 high-risk individuals and demonstrating a prototype 
that is being duplicated multifold in nearly every state.
    Next, the administration leveraged trusted retailers, 
including CVS, Rite Aid, Walgreens, Walmart, Kroger, and Health 
Mart, who are now providing testing at 240 locations in 33 
states, 69 percent of which are in communities with moderate to 
high social vulnerability.
    To meet the need for collection supplies, like swabs and 
media tubes, we first secured the global supply chain through a 
military air bridge. We worked directly with manufacturers to 
increase domestic production. We collaborated with the private 
sector and the FDA to validate multiple swab and media types 
that vastly expanded supplies, while minimizing the need for 
PPE.
    Finally, we used Title III of the Defense Production Act to 
further invest in domestic manufacturing to prepare us for 
reopening.
    To support the need for surveillance testing during 
reopening, on April 27th, we issued a new testing framework 
that also prioritized testing for persons without symptoms, who 
are prioritized by health departments or clinicians for any 
reason, including screening of asymptomatic individuals, 
according to state and local plans.
    Next, our Federal multidisciplinary team conducted multiple 
calls with leadership from each state to set state-specific 
testing objectives. Collectively, states and territories 
established an overall goal to perform 12.9 million tests over 
the next 4 weeks. The Federal Government is able to, and will, 
support the achievement of this goal. Specifically, the Federal 
Government is shipping to states 12.9 million swabs and over 
9.7 million tubes of media in May alone.
    Last month, we also detailed the location and capacity of 
every lab machine in every state that could potentially run 
COVID-19 assays, and our team has worked with test suppliers to 
match reagents to these machines.
    Looking forward, between now and the end of 2020, the 
Federal Government will procure over 135 million swabs and 132 
million tubes of media and distribute these to states, as 
requested, to supplement the now robust commercial supply.
    We anticipate marked increases in current tests, as well as 
a dramatic expansion of new point-of-care tests, like the first 
in class Quidel antigen test, authorized by the FDA just last 
Friday. Quidel anticipates being able to distribute 300,000 
tests per day within just a few weeks.
    By September, taking every aspect of development, 
authorization, manufacturing, and supply chain into 
consideration, we project that our Nation will be capable of 
performing at least 40 to 50 million tests per month if needed 
at that time. And, if new technologies are authorized, like 
whole genome sequencing approaches or any novel solutions 
uncovered by NIH's new diagnostics initiative, that number will 
be much higher.
    Finally, I want to acknowledge and express my heartfelt 
gratitude to the officers of the U.S. Public Health Service 
Commission Corps, the uniformed service I am honored to lead. 
Three thousand, four hundred and seventy-one men and women have 
deployed in support of this pandemic; on the cruise ship in 
Japan; to our military bases, repatriating Americans; to our 
community-based testing sites and international airports; to 
FEMA and our task forces; to nursing facilities, including King 
County Washington; and to field hospitals in hard-hit 
communities across our Nation. I thank each and every one of 
these officers and their families. And, on their behalf, I 
thank the Members of this Committee for supporting our training 
needs and the establishment of a ready reserve to supplement 
our ranks in future national emergencies.
    Thank you for the opportunity to provide these remarks.

                   Prepared Statement of Brett Giroir

                        Diagnostics and Testing
    Testing for the presence of SARS-CoV-2 is an essential component of 
our Nation's response to the COVID-19 pandemic; its importance will be 
further magnified as states enter Phase-1 of reopening. The indications 
for viral testing depend heavily on the stage of the pandemic and the 
extent of mitigation employed. In general, testing may be indicated for 
diagnosis of those who are symptomatic, tracing of those in contact 
with those who are infected, and surveillance testing of those who are 
asymptomatic or mildly symptomatic to achieve infection control and/or 
other public health objectives.
    The focus of this testimony is on testing for the presence of the 
virus, in contrast to testing for the presence of antibody to the 
virus. The former determines whether the individual is actively 
infected, and presumably infectious. The latter determines whether the 
individual has been infected, has developed an immune response, and may 
be protected from subsequent SARS-CoV-2 infections.
    It is useful to understand the overall testing strategy in terms of 
its chronology and sequential objectives, and to understand that this 
virus was a new human pathogen for which no diagnostic tests had 
previously been developed. In addition, the predominant type of test 
relies on sophisticated RNA amplification technology that can only be 
done in a laboratory certified to perform moderate or high complexity 
testing. New point-of-care (POC) tests are an exception in that they 
are low complexity; however, this class of test still represents a 
minority of available testing capability and has limited utility 
because of its low throughput. Finally, the pandemic caused an 
unprecedented demand for all supplies and materials, such that overall 
demand in a single month approximated total annual demand of some 
components. This reality represented substantial challenges, but 
Federal leadership has guided efforts to combat these challenges in 
close collaboration with states, local jurisdictions, and the private 
sector. Our overall strategy for testing includes:

        Y  Assuring that those who need testing, receive testing
        Y  Prioritizing testing to meet the stage of the pandemic
        Y  Increasing the number and diversity of tests
        Y  Enhancing states' ability to collect specimens through novel 
        ``front ends'' like drive-through sites
        Y  Organizing and galvanizing the industry on an unprecedented 
        scale
        Y  Enhancing testing to underserved communities
        Y  Providing surge testing capacity during local outbreaks
        Y  Supporting critical infrastructure and national security 
        needs
        Y  Enhancing reimbursement for tests to stimulate the private 
        sector, and providing additional incentives for testing in 
        nursing homes and vulnerable communities

    The overall testing strategy is outlined chronologically as we met 
the needs of each evolving stage of the pandemic.
    Stage 1: Launch: Engaging the Emerging Crisis
    In the beginning stages of the COVID-19 pandemic, CDC was engaged 
in building the foundation for diagnostic testing in the United States. 
On January 10, 2020, Chinese researchers deposited the 2019-nCoV genome 
sequence to GenBank and CDC began development of the CDC 2019-nCoV 
Real-Time PCR Diagnostic Panel. On January 24th, CDC publicly posted 
its assay for the CDC's newly developed diagnostic panel, allowing the 
global community to develop their own assays using the CDC design. On 
February 3d, CDC submitted an EUA request, and the FDA issued an EUA on 
February 4th, enabling use of the CDC's COVID-19 diagnostic Panel.
    Understanding the importance of increased testing, the FDA moved 
swiftly to engage with more than 470 test developers that indicated 
their intent to submit requests for EUAs. In mid-January, BARDA 
convened a meeting of leading diagnostic companies from across America 
to encourage development of COVID-19 tests. In the ensuing months, 
multiple funding opportunities for the development of COVID-19 
diagnostic tests were announced and NIH provided COVID-19 RNA to 
diagnostic companies to expedite private-sector test development. With 
a desire to ensure high quality diagnostic testing but also ensure 
rapid development and dissemination of COVID-19 tests, the FDA has 
provided EUA templates for laboratories and manufacturers in an effort 
to streamline the entire process, and works with developers who wish to 
use alternate approaches to the templates. FDA has issued a record 
number of EUAs for COVID-19 tests. This has contributed greatly to the 
dramatic increases in testing the Nation has seen in the past months. 
The amount and expediency in which EUAs were issued for COVID-19 tests 
far exceed past viral outbreaks. For example, in response to the 2016 
Zika Virus outbreak, FDA issued 20 test EUAs; in response to the 2009 
H1N1 outbreak, FDA issued 17 test EUAs. Currently, FDA has issued more 
than 70 COVID-19 test EUAs. The timeliness and number of EUAs issued by 
FDA for COVID-19 tests is unprecedented and has been critical to 
improving the testing scale and capacity in our Country.
    Throughout the COVID-19 outbreak, the Administration has encouraged 
diagnostic test manufacturers, commercial laboratories, and 
professional societies to expand capacity and scale for existing 
nucleic acid testing platforms. Through the efforts of the 
Administration, the United States has developed a multilayered, 
multifaceted approach to testing that is capable of providing the right 
test to the right person at the right time. This approach includes 
contributions from State public health labs, high-throughput commercial 
labs, academic and hospital labs, labs at CDC, the Indian Health 
Service, the Department of Defense, and the Department of Veterans 
Affairs. In addition, the ecosystem now includes POC testing that can 
be done in rural areas at high risk without sophisticated supporting 
infrastructure, or as a tool to investigate outbreaks in nursing homes 
or other confined settings.
    As of the beginning of May, our Nation is performing more than 
200,000 tests per day, and this number will continue to increase. 
Commercial laboratories are working more efficiently, processing tests 
in rapid succession, which ensures patients receive their results, on 
average, within 3 days. Hospital and academic laboratories typically 
provide results within 2 days, and often much sooner. POC tests provide 
results within 15 minutes.
    Concurrent to the Federal Government's efforts to expand capacity 
and scale of laboratories testing capabilities across the country, the 
Administration also worked with State and local partners to establish 
Community Based Testing Sites (CBTS). At the inception of this effort, 
the 41 federally supported sites were developed and established by the 
U.S. Public Health Service Commissioned Corps (Corps), in CDC-
prioritized locations across the country and 14 sites remain open with 
Federal support. These sites are located in Colorado, Texas, Illinois, 
New Jersey, and Pennsylvania. The Corps had unique expertise in COVID-
19 testing, since many officers had deployed to Japan and elsewhere to 
assist in infection control, diagnosis, and eventual repatriation of 
American citizens. The initial objectives of CBTS were to screen and 
test healthcare facility workers and first responders, as prioritized 
by local jurisdiction. The CBTS model has been a success, having tested 
over 140,000 individuals, and with an overall COVID-19 test positive 
rate of approximately 17 percent, meaning that the CBTS are testing the 
right individuals at the right time. This effort has also supported and 
co-evolved with technological advances such as the validation of nasal 
self-swabbing, which minimizes the need for trained health 
professionals and personal protective equipment. The CBTS initiative 
was an early example to states and localities on how to conduct 
community based COVID-19 testing, and this model has been replicated 
throughout the country to screen and test hundreds of thousands more 
Americans.
    From the onset in January, and continuing to the present, the 
President, Vice President, and senior Administration officials have 
held numerous briefings with Governors and their State leadership. Many 
of these briefings have focused on joint Federal-State efforts to 
expand testing throughout the country. In addition to these calls with 
the Nation's Governors, the White House and senior Administration 
officials have organized numerous calls to enhance State, local, 
territorial and tribal testing coordination efforts. The constant 
communication between the Administration and State leadership has 
helped provide guidance to states on how to best utilize testing 
capacity in their own states. Another product that was produced by the 
Administration to assist the states to leverage the full testing 
capacity at their disposal was a data base of nationwide lab locations 
and capacity, including the specific testing platforms at each 
laboratory.
    Stage 2: Scaling and Technological Innovation
    The identification and expansion of public and private sector 
testing infrastructure has been, and continues to be, a priority. One 
example of expanding testing infrastructure through public-private 
partnerships is the engagement of the Administration with well-known 
retailers that have a regional or nationwide footprint. As of May 5 and 
with the assistance of the Federal Government, United States retailers 
have opened and are operating 102 testing sites in 31 states. In an 
effort to expand testing further, the Federal Government is building 
upon the public-private partnerships to increase the number of testing 
sites offered at commercial locations across the country. The public-
private partnerships with these retailers are being expanded to support 
many more testing sites that will be opened and operating in the coming 
weeks. These commercial testing locations are also uniquely situated to 
meet the testing needs of communities with moderate to high social 
vulnerability, which was the focus of the original sites. Going 
forward, retailers have indicated their intent to open hundreds more of 
these sites depending on local needs.
    Another effort of the Administration to further support and expand 
the testing infrastructure in the United States has been strengthening 
the testing supply chain. The Administration has massively increased 
the availability of laboratory and testing supplies by engaging 
directly with distributors and manufacturers to increase production 
capacity through direct procurement, application of the Defense 
Production Act, formation of various public-private partnerships, and 
improved allocation criteria that ultimately help ensure that supplies 
meet the state's needs and reach the locations where the supplies are 
needed most. In addition, validation of additional supply types has led 
to a dramatic broadening of available supplies and reagents.
    As of April 30, the Federal Government had directly procured 6.7 
million swabs, 3.3 million vials of transport media, 15 million 
lancets, and 15 million alcohol pads. As of March 27th, the Federal 
Government had also facilitated the nationwide delivery of 175.2 
million masks, 14.7 million gowns, and 793.8 million gloves. Through 
the mechanisms mentioned above, we are unlocking the full potential of 
laboratories in the United States and this is allowing testing capacity 
to expand consistently.
    Stage 3: Support Opening Up America Again
    Current efforts are focused on further scaling up testing 
capabilities to guarantee that each State has the testing supplies and 
capabilities they need to reopen according to their own individual 
State plans. For example, the Federal Government is procuring over 21 
million swabs and 13 million collection tubes with transport media (or 
saline) in May. These supplies will be shipping out to states over the 
course of the month. ThermoFisher, which has more than 3,000 lab 
machines across the country, will be producing more than 10 million 
extraction and PCR kits in May, enabling states to complete millions of 
additional tests in May. In mid-March, the FDA issued an EUA for 
Hologic's Panther COVID-19 test, which runs on more than 600 lab 
machines across the United States. Hologic will be shipping several 
million test kits to labs across the Nation starting in early May.
    The Administration will continue to work hand in hand with 
Governors to support testing plans and rapid response programs. The 
Opening Up America Again guidelines, provided by the Administration, 
describes roles and responsibilities as well as elements of the robust 
testing plans and rapid response programs called for in the President's 
Guidelines.
    The Laboratory Testing Task Force is providing technical assistance 
to all 50 states, tribes and territories through calls with every State 
public health team to discuss their testing goals and the best 
mechanisms to achieve them. The Federal Government is assisting states 
to develop testing plans, supplying resources to help meet these 
testing plans, and deploying teams to states that need additional 
subject matter expertise.
    Because of the Administration's success in rapidly scaling up of 
the testing ecosystem, states will be fully equipped to conduct more 
COVID-19 tests per capita each month than most countries have tested 
cumulatively to this date.
    The Federal Government will continue to support Americans by 
providing expedited regulatory approvals for tests and equipment as 
necessary and appropriate, updating guidance for administering 
diagnostic testing, and catalyzing technological and scientific 
innovation. The process of reopening the United States will be one that 
is federally supported, state-led and locally executed.
    We recognize that vulnerable populations in many underserved 
communities are among the highest risk of suffering devastating health 
and economic impacts of COVID-19. We issued a Notice of Funding 
Opportunity on May 1. The 3-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 minority 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.
         United States Public Health Service Commissioned Corps
    Since the early stages of the COVID-19 outbreak, the Corps has been 
an indispensable asset leveraged to address the public health needs of 
the Nation in response to this crisis. The Corps is one of the eight 
uniformed services of the U.S. and the only uniformed service committed 
to protecting, promoting, and advancing the health and safety of the 
Nation. Corps officers serve throughout the Nation in communities that 
are most in need by providing essential healthcare services to 
underserved and vulnerable populations.
    In January, the Corps deployed officers to provide expert outbreak 
response in direct support of CDC. Deployment expanded rapidly from 38 
officers on February 1, 2020 to more than 3,200 officers today with 
many of them undertaking multiple or consecutive deployments. Corps 
officers have been deployed across our Country and internationally to 
assist with the outbreak response, to support the return of American 
citizens, to assist in the management of hospitalized United States 
citizens with COVID-19 abroad, and to support clinical trials related 
to COVID-19. Corps officers provided critical assistance to community-
based testing sites throughout the Nation and their contributions to 
this effort are immeasurable. In response to the escalating crisis, the 
Corps established COVID-19 Clinical Strike Teams, which include 
officers from the variety of disciplines needed on the frontlines. This 
kind of ready-made unit allows the Corps to deploy a ``cavalry'' to 
support healthcare systems under stress in states across the country. 
COVID-19 Clinical Strike Teams have deployed to a long-term care 
facility in Kirkland, Washington, to the Javits Center in New York 
City; and to the TCF Center in Detroit. The Corps is also preparing to 
send teams to the Navajo Nation to provide care amidst a surge of 
COVID-19 cases.
    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.
                                 ______
                                 
    The Chairman. Thank you, Admiral Giroir.
    Now Dr. Stephen Hahn, our fourth and final witness.

   STATEMENT OF STEPHEN HAHN, M.D., COMMISSIONER OF FOOD AND 
   DRUGS, UNITED STATES FOOD AND DRUG ADMINISTRATION, SILVER 
                           SPRING, MD

    Dr. Hahn. Chairman Alexander, Ranking Member Murray, and 
Members of the Committee, thank you for inviting me to 
participate in this hearing today.
    I first want to start by thanking the American people for 
their incredible efforts at mitigation and extend my 
condolences to those who have lost loved ones.
    From day one of this pandemic, the 18,000 FDA employees, 
who are just incredible scientists, doctors, and nurses, have 
taken an active role in the all-of-government response to this 
pandemic.
    FDA has worked to facilitate the development of medical 
countermeasures to diagnose, treat, and prevent COVID-19. We 
have worked closely with laboratories, manufacturers, academia, 
product developers, our Federal partners, and companies--
companies that don't even make medical products but want to 
pitch in, for example, by making hand sanitizer, personal 
protective equipment, and ventilators.
    Every decision we have made has been driven by data, with 
the goal of protecting the health of the American people. In a 
public health emergency, however, our responses balance the 
urgent need to make medical products available with the 
provision of a level of oversight that helps ensure the safety 
and effectiveness of those medical products.
    I would like to take a few minutes to tell you what FDA is 
doing to help the country at this point, in which, Americans 
safe to return to work and to school.
    It starts with testing, as others have mentioned. FDA has 
worked with more than 500 developers who have, or said they 
will be submitting, Emergency Use Authorization requests for 
COVID-19 tests. This includes some newer technologies that 
not--that heretofore have not been used as part of diagnostic 
tests in response to a pandemic.
    We have issued 92 individual Emergency Use Authorizations 
for test kit manufacturers and laboratories, and we have been 
informed by more than 250 laboratories they have begun testing 
under the regulatory flexibilities we outlined in March.
    We are conducting rolling reviews of EUA submissions so 
that we can quickly authorize tests which the data support. In 
a public health emergency, the accuracy of diagnostic tests is 
important, not only for the individual patient, but for the 
patient at large, republic at large. FDA is helping to ensure 
the availability of tests that are providing accurate answers.
    We are also monitoring the market base for fraudulent tests 
and are taking appropriate action to protect the public health, 
and we are working to provide more clarity about which tests 
have been reviewed and authorized by FDA and which have not.
    Serologic tests will play a role in our recovery. Unlike 
diagnostic tests, which detect the presence of the virus, 
serologic tests measure the amount of antibodies or protein 
present in the blood when the body is responding to an 
infection like COVID-19. These tests can help identify 
individuals who can overcome an infection and who have 
developed an immune response. We will continue working with 
labs, manufacturers, and across the Government to find a 
balance between the assurance that an antibody test is 
accurate, and timely access to such tests.
    Of course, the way we will eventually beat this virus is 
with a vaccine, and FDA is working closely with our Federal 
partners, including the NIH, test--I mean, vaccine developers, 
manufacturers, and experts across the globe. We intend to use 
our regulatory flexibility to help ensure the most efficient 
development of a safe and effective vaccine to prevent COVID-
19.
    Until a preventative vaccine is approved, however, we need 
medical products to bridge the gap. FDA has been working for 
several months to facilitate the development and availability 
of therapeutics as expeditiously as possible, and we have 
created an emergency program for this acceleration called the 
Coronavirus Treatment Acceleration Program, or CTAP. We have 
reassigned staff to work with urgency to review requests from 
companies, scientists, doctors, who are developing therapies, 
and we are using every available authority and regulatory 
flexibility that is appropriate to facilitate the development 
of safe and effective products to treat COVID-19.
    A variety of therapeutic areas are being evaluated, as 
mentioned by Dr. Fauci and others, including antiviral drugs 
and immunotherapies, as well as convalescent plasma, 
hyperimmune globulin, and monoclonal antibodies.
    As Dr. Fauci also mentioned, we recently announced the 
positive results of the NIAID trial of Remdesivir and issued an 
EUA for the treatment of hospitalized patients with COVID-19. 
Two other promising treatments that I mentioned are the 
antibody-rich products, convalescent plasma and hyperimmune 
globulin, and I am certainly willing to go into more detail if 
Members of this Committee have questions about this.
    But, we are working very aggressively and closely with 
stakeholders to facilitate the development of monoclonal 
antibodies, which, if shown to be safe and effective, could act 
as a bridge therapy to the development of a vaccine. We 
recognize that developing vaccines and therapies need to go 
hand in hand with ensuring that there will be sufficient 
supplies for our companies--for our Country, so we are also 
working with manufacturers to make sure that this supply chain 
is robust.
    Mr. Chairman, Ranking Member, and Members of the Committee, 
please know that in FDA you have a dedicated team of some of 
the Nation's finest scientists, healthcare providers, and 
public health professionals. We are guided by science and data, 
and we will not let up until we facilitate the development of 
products that our Nation needs to get back to work. I look 
forward to your questions.

                   Prepared statement of Stephen Hahn

    From day one of this emerging 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. Long before the first domestic case 
was reported, FDA stood up an internal cross-agency group that 
continues to ensure we are doing all we can to protect the American 
public, helps ensure the safety and quality of FDA-regulated products 
and provides the industries we regulate the tools and flexibility to do 
the same. Work has focused on facilitating medical countermeasures to 
diagnose, treat and prevent the disease, and surveilling the medical 
product and food supply chains for potential shortages or disruptions 
and helping to mitigate such impacts, as necessary to protect the 
health of Americans. 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
    In an emergency, FDA oversees the validity of tests developed by 
others through the Emergency Use Authorization (EUA) process. Every 
action FDA has taken during this public health emergency to address the 
COVID-19 pandemic has balanced the urgent need to make tests available 
with providing a level of oversight that helps to ensure accurate tests 
are being deployed.
    COVID-19 has created a demand for new tests that is unprecedented 
in both volume and urgency. As with other emergencies, FDA has been 
extremely proactive and supportive of diagnostic test development by 
all comers--laboratories, and large and small commercial manufacturers. 
Even prior to any U.S. cases of COVID-19, FDA proactively reached out 
to developers to encourage the development of tests and to see what the 
Agency could do to facilitate development. In its COVID-19 Testing 
Guidance, FDA has provided flexibility to encourage innovation and help 
speed development of COVID-19 tests. FDA is engaging in rolling reviews 
of EUA submissions and is quickly authorizing tests that the science 
and data support. As outlined in the guidance, certain laboratories and 
commercial manufacturers are developing their own diagnostic tests and, 
once validated, are beginning to use them while they prepare an EUA 
submission for FDA review. In addition, under our policies, states that 
have the capacity and expertise to do so have been authorizing tests 
for use within a laboratory in that state.
    In a public health emergency, getting an accurate test is important 
not only for the individual patient, but for the public at large. All 
tests should be validated before use because it is critical that these 
tests work. FDA's policies do not change that. False positive and false 
negative results can contribute to the spread of COVID-19. As with 
medical treatments, we want tests to be safe and, in the case of 
diagnostics, accurate. FDA plays an important role helping to ensure we 
are getting accurate answers. We are monitoring the market for 
fraudulent and harmful tests. FDA has and will continue to take 
appropriate action against firms that place the public health at risk 
and follow-up with bad actors. There are several cases where developers 
of tests have updated or changed claims at FDA's urging.
    FDA is working on several fronts to provide more clarity about 
which tests have been reviewed and authorized by FDA and which have 
not. FDA has been posting on its website the tests for which it has 
received a notification as outlined in its COVID-19 testing policies.
    FDA has been working around the clock to 1) encourage and support 
test development for the U.S. market, working with over 470 developers 
since January; 2) issue EUAs for diagnostic tests, including those for 
home self-collections; 3) research and mitigate shortages of test 
components, including identifying and sharing scientifically acceptable 
alternatives for components on FDA's website; 4) arrange with the 
Department of Defense weekly airlifts of swabs to the United States; 5) 
engage nontraditional device manufacturers to support use of new swabs 
and other supplies that are needed in the United States; 6) offer 
support to all developers through a 24-hour hotline and key resources, 
including FAQs, that it updates regularly as it serves as a 
clearinghouse for scientific information that helps everyone increase 
testing capacity.
                          Serological Testing
    Serological tests measure the amount of antibodies or proteins 
present in the blood when the body is responding to a specific 
infection, like the virus that causes COVID-19. Such a test detects the 
body's immune response to an infection. These tests do not diagnose 
COVID-19; however, we believe these tests can play a critical role in 
the fight against COVID-19 by helping healthcare professionals to 
identify individuals who may have overcome an infection in the past and 
have developed an immune response. These tests may also aid in 
identifying individuals with antibodies to the virus that causes COVID-
19 so they may donate convalescent plasma as a possible treatment, 
which requires more data and research to determine if this is a safe 
and effective treatment for COVID-19, but may help those who are 
seriously ill from COVID-19.
    In March, FDA issued a policy providing regulatory flexibility for 
developers of certain serological tests that begin to market or use 
their tests once they have performed the appropriate evaluation to 
determine that their tests are accurate and reliable, without FDA 
authorization, and as further outlined in the policy. The policy is 
intended to allow for early patient access and flexibility for 
developers, with appropriate transparency regarding the limitations of 
these tests. On May 4th , FDA took important steps to build on this 
policy by updating it to outline key expectations for antibody test 
developers: 1) commercial manufacturers will submit EUA requests, with 
their validation data, within 10 business days from the date they 
notified FDA of their validation testing or from the publication date 
of this policy, whichever is later, and 2) FDA has provided specific 
performance threshold recommendations for all serology test developers. 
The policy for laboratories certified under the Clinical Laboratory 
Improvement Amendments (CLIA) to perform high-complexity testing, 
regarding their developing and performing their own serology tests, has 
not changed. They continue to perform their own validation and provide 
notification to FDA, and should follow the other recommendations with 
respect to labeling as described in the policy. In addition to these 
updates, we are introducing a more streamlined process to support EUA 
submissions and review. Two voluntary EUA templates for antibody tests 
have been made available--one for commercial manufacturers and one for 
CLIA certified high-complexity labs who decide to seek FDA 
authorization. These templates will facilitate the preparation and 
submission of an EUA request and can be used by an interested 
developer. And as we do for diagnostic tests, we are happy to work with 
developers of serology tests on other approaches if they do not want to 
use one of the templates.
    In addition, FDA issued an umbrella EUA for certain antibody tests 
that undergo a validation evaluation at NCI, or another government 
agency designated by FDA. Tests that FDA confirms meet the performance 
and labeling criteria outlined in the EUA may be added under the 
umbrella EUA, streamlining the submission and review of these important 
tests.
    We are continuing to provide updated information and educational 
materials to states and health care partners. If particular commercial 
manufacturers that are currently marketing serology tests under the 
policy fail to submit an EUA within 10 business days of notification or 
policy publication (whichever is later), we intend to share this 
information publicly and take appropriate action as needed. We will 
also keep up our work to stop illicit tests from entering the U.S., and 
to keep fraudulent products off the market.
    FDA will continue to take steps to balance assurances appropriately 
that an antibody test is accurate and reliable with timely access to 
such tests as the continually evolving circumstances and public health 
needs warrant. To date, FDA has issued numerous EUAs for serological 
tests, issued an ``umbrella'' EUA for certain serological tests, and is 
working with hundreds of developers on pre-EUAs.
    Importantly, we are working with developers and other partners to 
evaluate the validity of serological tests, and are working to 
authorize even more of these tests under EUAs. I continue to work 
closely with my fellow Coronavirus Task Force members in examining the 
role testing will play as we look to reopen our Country's schools, 
businesses, and public services.
            Vaccine Development and Treatment Interventions
    At this time there is no FDA-approved vaccine to prevent being 
infected with COVID-19. FDA is working closely with Federal partners, 
vaccine developers, researchers, manufacturers, and experts across the 
globe to help expedite the development and availability of vaccines and 
drugs to prevent or treat COVID-19 infections. FDA intends to use 
regulatory flexibility to help ensure the most efficient and timely 
development of safe and effective vaccines to prevent COVID-19.
    FDA is partnering with the NIH in their efforts to develop a 
national strategy for a coordinated research response to the pandemic. 
The Accelerating COVID-19 Therapeutic Interventions and Vaccines, or 
ACTIV, partnership is developing a framework for prioritizing vaccine 
and drug candidates, streamlining related clinical trials, coordinating 
regulatory processes, and leveraging assets among all partners to 
rapidly respond to COVID-19 and future pandemics.
                        Therapeutic Development
    At this time there are no FDA-approved drug products to treat 
COVID-19. Since the beginning of the COVID-19 pandemic, FDA has been 
working tirelessly to facilitate the development and availability of 
therapeutics for use by patients, physicians, and health systems as 
expeditiously and safely as possible. FDA recently announced 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 been supporting the program by reassigning 
staff and working day and night 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.
    There are a variety of therapeutic areas being evaluated, including 
antiviral drugs and immunotherapies, that may be helpful in reducing 
lung inflammation and improving lung function in COVID-19 patients. All 
this work is beginning to pay off, and we have recently announced the 
positive results of the recent NIAID trial of Remdesivir in patients 
with severe COVID-19. On May 1, FDA issued an EUA for Remdesivir for 
the treatment of suspected or laboratory-confirmed COVID-19 in adults 
and children hospitalized with severe disease.
    Another promising approach for treatment is the use of antibody-
rich products such as convalescent plasma and hyperimmune globulin. 
These blood products are manufactured from plasma donated by people who 
have recovered from the virus and such products are being studied to 
determine if they could shorten the length, or lessen the severity, of 
the illness. It is important that we evaluate convalescent plasma in 
the context of clinical trials as well as facilitate emergency access 
for individual patients, as appropriate. As this work moves forward, 
the key to ensuring the availability of convalescent plasma to those in 
greatest need, as well as to support clinical development of 
convalescent plasma and hyperimmune globulin, is getting fully 
recovered COVID-19 patients to donate plasma if they meet FDA's donor 
eligibility criteria. To that end, FDA is working with blood collectors 
to facilitate the collection of convalescent plasma, and working with 
developers of these therapies to move forward with clinical 
evaluations.
                         Medical Product Supply
    FDA has been monitoring and proactively adjusting 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 and biological product 
manufacturing in a timely manner. In addition to our usual 
communication with drug manufacturers, we are working closely with 
healthcare and pharmacy systems, hospitals, providers, and others on 
the frontlines of COVID-19 patient care to identify current or emerging 
regional shortages of critical care drugs used to treat COVID-19.
    We issued temporary policies under which outsourcing facilities 
registered with FDA and pharmacists in state-licensed pharmacies or 
Federal facilities can compound certain drugs used to treat patients 
with COVID-19 under particular conditions explained in FDA guidance. 
FDA understands the significant impact shortages can have on patient 
care and is doing everything within its authority to help prevent and 
alleviate this impact. 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.
    We are working to increase the supply of personal protective 
equipment (PPE) and other critical devices that patients and those on 
the front lines of the U.S. response rely upon. FDA has issued three 
EUAs to help make more respirators available to health care personnel 
and help ease burdens on the health care system. These allow for the 
emergency use of NIOSH-approved respirators in health care settings for 
healthcare personnel and the importation of non-NIOSH approved 
respirators that meet certain specified criteria, as set forth in the 
various EUAs. FDA has also issued several guidances to provide 
flexibility for those manufacturing PPE for the COVID-19 response, and 
we have published conservation strategies for gloves, gowns, and masks. 
To support these efforts further, FDA has issued several EUAs for 
devices used to decontaminate respirators for reuse by health care 
workers in hospital settings.
    FDA has also issued guidances for several other critical devices 
including ventilators, clinical electronic thermometers, and imaging 
systems, as well as remote digital pathology and remote monitoring 
devices intended to help facilitate remote care that puts patients and 
health care providers at less risk for exposure to COVID-19.
    Taken together, FDA's policies and engagement have helped to 
accelerate patient access to critical devices. FDA appreciates Congress 
including provisions in the CARES Act for additional device shortages 
authority during or in advance of a declared public health emergency, 
and looks forward to continuing to work with Members of Congress to 
expand further these authorities, consistent with the fiscal year 2021 
Budget so that we can address shortages in other situations as well.
                              Food Supply
    FDA is working with our Federal, State, and local partners as well 
as industry to help ensure a safe and adequate food supply for both 
people and animals. I want to reassure you there is no evidence of food 
or food packaging being associated with transmission of COVID-19. 
Although food product 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.
    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 workers, 
industry, and consumers on how to stay safe, keep food safe, and ensure 
the continuity of operations in the food and agriculture critical 
infrastructure sector during the pandemic.
    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 such as listeria, 
salmonella and E. coli. FDA's Coordinated Outbreak Response and 
Evaluation team has remained at work during the pandemic, is fully 
staffed, and on-the-job looking for signs of foodborne illness 
outbreaks.
                          Fraudulent Products
    FDA is exercising its regulatory authority to protect consumers 
from firms selling unproven products with false or misleading claims, 
including by issuing warning letters and pursing enforcement actions 
such as injunctions, against firms and individuals that violate the 
law. For example, we are actively monitoring for firms selling 
fraudulent and unproven products with claims to prevent, treat, 
mitigate, diagnose, or cure COVID-19.
    In addition, FDA investigators remain on the front lines at ports 
of entry, quickly examining and reviewing import entries, and refusing 
admission where appropriate. We are in close communication with our 
partners at U.S. Customs and Border Protection to proactively identify 
and mitigate any potential backlogs. FDA participates in FEMA Supply 
Chain Task Force meetings, providing regulatory support and subject 
matter expertise to respond to questions concerning medical products 
identified by FEMA, to facilitate the lawful entry and use of imported 
medical products coordinated through FEMA, and to inform medical 
product supply chain discussions.
                               Conclusion
    Thank you for the opportunity to be here to provide an update on 
the activities of HHS in responding to COVID-19 and to answer any 
questions.
                                 ______
                                 
    The Chairman. Thank you, Dr. Hahn. And, thanks to all four 
of you for your expertise, for your dedication to our Country, 
and your hard work.
    We will now begin a round of 5-minute questions from each 
Senator on the Committee, alternating between Republicans and 
Democrats. Each Senator has--if you are on videoconference, you 
have a little time clock at the bottom, and I would ask you to 
try to stay within 5 minutes for your questions and answers.
    I will start. I have a question for Dr. Fauci and then 
Admiral Giroir.
    Doctor, let us look down the road 3 months. There will be 
about 5,000 campuses across the country trying to welcome 20 
million college students, 100,000 public schools welcoming 50 
million students. What would you say to the chancellor of the 
University of Tennessee Knoxville or the president--or the 
principal of a public school about how to persuade parents and 
students to return to school in August? Let us start with 
treatments and vaccines first, Dr. Fauci. And if you could save 
about half of my 5 minutes for Admiral Giroir for testing, I 
would appreciate it.
    Dr. Fauci. Thank you very much, Mr. Chairman. Well, I would 
be very realistic with the chancellor and tell him that what we 
are thinking in terms----
    The Chairman. It is a her in this case, sir.
    Dr. Fauci. Oh, Okay. I would tell her--I am sorry, sir--
that in this case, that the idea of having treatments 
available, or a vaccine, to facilitate the reentry of students 
into the fall term would be something that would be a bit of a 
bridge too far.
    As I mentioned, the drug that has shown some degree of 
efficacy was modest, and it was in hospitalized patients; not 
yet, or maybe ever, to be used either yet as prophylaxis or 
treatment. So, if the issue is that the young individuals who 
would be going back to school would like to have some comfort 
in that there is a treatment, probably the thing that would be 
closest to utilization then would likely be passive transfer of 
convalescent serum.
    But, we are really not talking about necessarily treating a 
student who gets ill, but how the student will feel safe in 
going back to school. If this were a situation where we had a 
vaccine, that would really be the end of that issue in a 
positive way. But, as I mentioned in my opening remarks, even 
at the top speed we are going, we don't see a vaccine playing 
in the ability of individuals to get back to school this term. 
What they really want is to know if they are safe, and that is 
the question that has to do with what we discussed earlier 
about testing.
    I am about halfway through the remarks. I would like to 
just pass the baton to Admiral Giroir, who would address the 
question of the availability of testing and what role that 
might play in returning to school. Thank you, sir.
    The Chairman. Well, thank you, Doctor. Thank you, Dr. 
Fauci.
    Admiral Giroir, you said that while we are doing about 10 
million tests this month that we might be as high as 40 or 50 
million by September, in a month, which is a significant 
increase. So, if I am chancellor of the University of 
Tennessee, could I develop a strategy where I would say to all 
of my students, we have, for example, an antigen test, which is 
quick and easy? We want everybody on campus to come by and take 
it once before you begin school? That will at least let 
everybody know that on that day, we have isolated anybody who 
is positive, and then we can continue to monitor. Is that 
strategy possible in August and September?
    Admiral Giroir. Thank you, Mr. Chairman, and I may reserve 
20 seconds for Dr. Redfield, as well.
    The strategy that is going to be employed really depends 
heavily on what is the community spread at that time. If there 
is almost no community spread, your strategy will be different. 
If there is high community spread, it will also be different.
    But yes, technically, we will have the ability and your 
chancellor will have the ability. We expect there to be 25 to 
30 million point-of-care tests per month available. It is 
certainly possible to test all of the students.
    Or, it is much more likely that there would be a 
surveillance strategy done where you may test some of the 
students at different times to give an assurance that there is 
no circulation. That would be done in conjunction with the CDC 
and the local health department.
    There is also strategies that are still needing to be 
validated, but of pooling samples. We know in some experimental 
labs, as many as 10 or 20 samples can be pooled, so essentially 
one test could test 20 students.
    Finally, there are some experimental approaches that look 
interesting, if not promising, that, for example, waste water 
from an entire dorm or an entire segment of a campus could be 
tested to determine whether there is coronavirus in that 
sewage, the waste water. So, there are other strategies being 
developed.
    I would like to at least give 20 seconds to Dr. Redfield, 
who really will be working on the strategy of how to employ the 
tests given different community spread.
    The Chairman. Dr. Redfield.
    Dr. Redfield. Yes, just some quick comments, sir. I mean, 
first, I think it is really important to evaluate critically 
the role of changes in social distancing on college campuses 
and schools in the situation, not to forget the importance of 
what we have learned.
    Clearly, also developing a progressive program for wellness 
education, making sure people understand when they are 
symptomatic, they need to seek evaluation.
    I think that you are going to have to look at the role of 
testing. I think there is going to be an important role of 
testing in these circumstances, and I think it will be 
individualized based on where these different schools are, 
where they--how much infection is in an area.
    The Chairman. I am going to wrap it up there so I can set a 
good example for the other Senators with their 5 minutes.
    Senator Murray.
    Senator Murray. Thank you very much, Mr. Chairman, and 
thank you to all of our witnesses.
    Dr. Fauci, you have warned of needless suffering and death 
if we push to reopen too soon, but the President has actually 
been sending the opposite message. I want to ask you today, 
what is the most important message you have for communities and 
states that are reopening, even as our public health experts 
make it clear it is too soon? Tell us what the consequences 
are.
    Dr. Fauci. Thank you very much for that question, Senator 
Murray. As I have said many times publicly, what we have worked 
out is a guideline framework of how we safely open America 
again. And, there are several checkpoints in that, with a 
gateway first of showing, depending on the dynamics of an 
outbreak in a particular region, state, city, or area, that 
would really determine the speed and the pace with which one 
does reenter or reopen.
    My word has been, and I have been very consistent in this, 
that I get concerned if you have a situation with the dynamics 
of an outbreak in an area of such that you are not seeing that 
gradual, over 14-day decrease that would allow you to go to 
Phase 1. And then, if you pass the checkpoints of Phase 1, go 
to Phase 2 and Phase 3.
    What I have expressed then, and again, is my concern that 
if some areas, cities, states, or what have you, jump over 
those various checkpoints and prematurely open up without 
having the capability of being able to respond effectively and 
efficiently, my concern is that we will start to see little 
spikes that might turn into outbreaks. So, therefore, I have 
been being very clear in my message to try to the best extent 
possible to go by the guidelines, which have been very well 
thought out and very well delineated.
    Senator Murray. If a community or a state or a region does 
not go by those guidelines and reopens, the consequences could 
be pretty dire, correct?
    Dr. Fauci. The consequences could be really serious, 
particularly--and this is something that I think we also should 
pay attention to, that states, even if they are doing it at an 
appropriate pace, which many of them are and will, namely a 
pace that is commensurate with the dynamics of the outbreak, 
that they have in place already the capability that, when there 
will be cases, there is no doubt, even under the best of 
circumstances, when you pull back on mitigation, you will see 
some cases appear. It is the ability and the capability of 
responding to those cases with good identification, isolation, 
and contact tracing will determine whether you can continue to 
go forward as you try to reopen America.
    It is not only doing it at the appropriate time with the 
appropriate constraints, but having in place the capability of 
responding when the inevitable return of infections occur.
    Senator Murray. Well, thank you for that. And, it is very 
clear, in order to do that, we need knowledge, which is about 
testing. And, for months, this administration's approach to 
testing has really been plagued by unrealized goals and 
disregard for systemic problems within that supply chain. And, 
last week, an average of just 250,000 tests per day were 
performed in the United States. That is a small fraction of 
what we need. And yesterday, President Trump had the gall to 
declare the U.S. had ``prevailed'' on testing in a press 
conference that was filled with misinformation and distortions.
    Dr. Giroir, public health experts do not think the U.S. has 
prevailed. I am glad you finally committed that states, 
including my home State of Washington, will receive enough 
tests to meet their goals for May and June, but this 
administration has had a record of giving us broken promises 
that more tests and supplies are coming and they don't. And we 
know, by the way, that testing is going to--needs will persist 
long past June, long past.
    I wanted to ask you today, will the administration's 
forthcoming strategic plan that is now required under the COVID 
package that was just passed and signed into law, will that 
strategic plan on testing include specific numeric targets for 
testing capacity, supply chain capacity, and projection of 
shortages?
    Admiral Giroir. Thank you for that question and statement, 
Senator Murray. Yes, we are--as I have stated, we continue to 
have a work in progress as we build the testing capacity. We 
have established the targets with the states of over 12 million 
tests over the next 4 weeks. We think those targets are going 
to be good in May and June. But, as Dr. Fauci said, we really 
have to be evidence based. We expect those targets to go up as 
we progressively open, as communities go through Phase 1 and 
then into Phase 2. And, certainly those numbers will need to go 
up significantly again in the fall when we potentially have 
influenza circulating with COVID.
    Yes, there will be targets. The targets will need to change 
based on the evidence that we see, but we are highly committed 
to securing the supply chain. We have worked daily with every 
manufacturer, and I am just pleased we are in May and June able 
to get ahead of the states so that we can supply them what they 
need so they have those assurances.
    Senator Murray. Well, so my----
    Admiral Giroir. There is not going to be any doubts about 
that.
    Senator Murray. My question to you is, when you put out 
that specific plan that you are required to do, we will see 
numbers that you are going to tell us that you will reach, 
targeted for testing and supply chain capacity and projections, 
and so forth? Instead of just saying we hope to have a million 
this week, next week, so you will give us the specific targets, 
correct?
    Admiral Giroir. We know specifically--I will say yes, 
ma'am, we know the specific--we know the specific amounts of 
tests we have. Over the summer, we are I think----
    Senator Murray. Not have; how many we need.
    Admiral Giroir. Yes, ma'am. We develop the needs statements 
by working with the states individually, with epidemiologists, 
with the CDC, so that overall, in May, we will be testing about 
3.9 percent of the overall U.S. population.
    Senator Murray. Okay. But what I am telling you----
    The Chairman. Well over time, Senator Murray.
    Senator Murray [continuing]. Not how many we have, but how 
many we will need. Not just for May, but in the coming months 
so that we can be prepared to have them.
    Admiral Giroir. Yes, ma'am. And, not to be repetitive, but 
we need to be evidence and data driven because what we may see 
in May or June will drive differences in the amount of test 
goals we have. So, we really just need to be very humble about 
this. We need to look at the data. We know that the testing 
needs will go up over May and June as we progressively open, 
and we will do our best to predict that. But, you have to 
understand, we have to see what the data and the evidence show 
at that time.
    Senator Murray. Okay. I appreciate that. Mr. Chairman, 
again, what our strategic plan requires is what is the goal; 
not how many we have, but how many we need, and that is what we 
will be looking for. Thank you.
    The Chairman. Thank you, Senator Murray.
    Senator Enzi.
    Senator Enzi. Thank you, Mr. Chairman, and I particularly 
appreciated your opening statement where you had a very 
succinct list of preparations we need to learn from this 
pandemic for the next one. Not only should we be working on 
this and preparing, but we need to look at the future, too. And 
I think we have learned a lot. We are fighting a virus at the 
same time that scientists are learning about it.
    We need to be nimble. We also need to be sure that we are 
prepared for a second wave of outbreaks that could coincide 
with the start of the flu season, potentially stressing our 
healthcare system even more than it already has been.
    Admiral Giroir, I thank you for your comments. I think they 
have been comforting, about what has been done and what can be 
done. I agree with Senator Murray that we need to have some 
specific goals. As an accountant, that is always one of the 
things that I am looking for.
    For questions, Dr. Hahn, our understanding of the clinical 
picture of COVID-19 continues to evolve. What first looked like 
a respiratory illness now seems much more comprehensive, 
potentially affecting the heart, the brain, the kidneys, and 
other organs. How does this evolving picture impact the ability 
to evaluate the appropriate clinical or surrogate endpoints for 
review of vaccines and treatment?
    Dr. Hahn. Thank you, Senator, for that question. The 
evolving clinical picture, and obviously the way this is 
manifesting around the country clinically, does in fact inform 
the endpoints that we will work with developers of therapies on 
so that we can get the absolute, most efficient, but also the 
most accurate information and appropriate endpoints to make the 
necessary authorizations and approvals.
    We have set up this program called the Coronavirus 
Treatment Acceleration Program where our top scientists and 
clinicians have been at the table consulting with our 
colleagues at NIH and CDC to actually address those questions--
what are the appropriate endpoints?
    I will give you an example. We do know that in some 
circumstances, patients who have had severe COVID disease have 
developed thrombotic or clotting-type episodes, and so we 
prioritize review of agents that we think might be beneficial. 
And, obviously, the clinical endpoints for those trials will be 
different than an agent that is an antiviral, like Remdesivir, 
where, as Dr. Fauci mentioned, we are looking at time to 
recovery.
    We want to adapt it to the clinical circumstance, as well 
as to the type of therapy that is put before us.
    Senator Enzi. Thank you. Another question to Dr. Hahn. We 
have made a lot of progress in vaccine development already. 
BARDA has identified that domestic manufacturing of needles and 
syringes, there is a significant gap in pandemic preparedness. 
What has HHS done in advance of a potential national 
vaccination campaign to ensure that we have sufficient capacity 
to administer a vaccine?
    Dr. Hahn. Senator Enzi, thank you for that question. This 
is a really important point because, as you mentioned, it is 
not just about the vaccine, or hopefully vaccines, that are 
developed. It is all about--it is also about the supplies that 
are needed, as well as an operational plan for administering 
the vaccine.
    This is an all-of-government approach. There is a program 
that has been set up called Operation Warp Speed that includes 
Dr. Collins, Dr. Fauci, his colleagues at NIH, the Department 
of Defense, as well as other members of HHS and FDA. Dr. Peter 
Marks from our Center for Biological Evaluation and Research 
has been helping coordinate that and is working very closely 
with Dr. Fauci and his team.
    We have created what is called a Gantt chart to look 
forward, what are the necessary supply chain issues, syringes, 
needles, et cetera, depending on the various vaccines that are 
being developed, how many times they have to administer it, and 
the route of administration. So, we have been leaning in on 
this supply chain to ensure that when a vaccine is ready to go, 
we will have the necessary supplies to actually administer it 
and operationalize the vaccination.
    Senator Enzi. Thank you. I have a couple more questions. 
But again, the clock is not visible there, so I suspect I have 
used up my time. I will submit those in writing.
    The Chairman. Thank you, Senator Enzi.
    Senator Sanders.
    Senator Sanders. Thank you very much, Mr. Chairman, and let 
me thank all of the panelists for the hard work they are doing 
and for being with us today.
    It is sad to say that we have a President of the United 
States, the leader of our Country, who, from day one, 
downplayed the dangers facing this country from the pandemic; 
who told us that the crisis would be over in a few months; that 
we did not have to worry; who fired those members of the 
government who wanted to act aggressively; and, among other 
things, at a time when we need international cooperation, cut 
funding for the World Health Organization.
    Let me also say that I think we understand that facts are 
terribly important. Not everybody--that we don't fully 
understand all of the ramifications of the COVID-19 epidemic. 
But, let me ask Dr. Fauci a few questions, if I might.
    First off, the official statistic, Dr. Fauci, is that 
80,000 Americans have died from the pandemic. There are some 
epidemiologists who suggest the number may be 50 percent higher 
than that. What do you think?
    Dr. Fauci. I am not sure, Senator Sanders, if it is going 
to be 50 percent higher. But, most of us feel that the number 
of deaths are likely higher than that number because, given the 
situation, particularly in New York City when they were really 
strapped with a very serious challenge to their healthcare 
system, that there may have been people who died at home who 
did have COVID, who were not counted as COVID, because they 
never really got to the hospital.
    A direct answer to your question, I think you are correct 
that the number is likely higher. I don't know exactly what----
    Senator Sanders. Right.
    Dr. Fauci [continuing]. Percent higher, but almost 
certainly, it is higher.
    Senator Sanders. Dr. Fauci, let me ask you this. In the 
terrible pandemic of 1918, the virus exploded in the fall. It 
came back with a vengeance. Are we fearful that if we don't get 
our act together, as bad as the situation is now, it could 
become worse in the fall or winter?
    Dr. Fauci. Senator, thank you for that question. It is a 
frequently asked question, and I think that a possibility does 
exist. However--and the reason I say that is that when you talk 
about will this virus just disappear--and as I have said 
publicly many times, that is just not going to happen because 
it is such a highly transmissible virus. And, even if we get 
better control over the summer months, it is likely that there 
will be virus somewhere in this--on this planet that will 
eventually get back to us.
    My approach toward the possibility of a rebound and a 
second wave in the fall is that, A, it is entirely conceivable 
and possible that it would happen. But, B, I would hope that 
between now and then, given the capability of doing the testing 
that you have heard from Admiral Giroir, and the ability of us 
to stock up on personal protective equipment, and the workforce 
that the CDC under Dr. Redfield will be putting forth to be 
able to identify, isolate, and contact trace, I hope that if we 
do have the threat of a second wave, we will be able to deal 
with it very effectively to prevent it from becoming an 
outbreak not only worse than now, but much, much less.
    Senator Sanders. Okay. Let me ask--we have heard a lot of 
this question about vaccines. Obviously, everybody in Congress 
and in this country wants a vaccine. We want it as quickly as 
possible, as effective as possible. Let me ask the honorable 
FDA commissioner.
    Sir, if, God willing, a vaccine is developed and if we are 
able to produce it as quickly as we all hope we can, I would 
imagine that vaccine would be distributed to all people free of 
charge; or make sure at least that everybody in America who 
needs that vaccine will get it, regardless of their income. Is 
that a fair assumption?
    Dr. Hahn. Senator, I certainly hope so. FDA is very 
committed to making sure that all populations in the United 
States, including those most vulnerable, are included in the 
clinical trials, and very much----
    Senator Sanders. That is not what I am asking. What I am 
asking is, if and when the vaccine comes, it won't do somebody 
any good if they don't get it. And, if they have to pay a sum 
of money for it in order to profit the drug companies, that 
will not be helpful. Are you guaranteeing the American people 
today that vaccine will be available to all people regardless 
of their income?
    Dr. Hahn. Sir, the payment of vaccines is a not a 
responsibility of FDA, but I am glad to take this back to the 
task force. I share your concern that this needs to be made 
available to every American.
    Senator Sanders. Does anybody else want to comment on that?
    Mr. Giroir, do you think we should make that vaccine, when 
hopefully it is created, available to all, regardless of 
income? Or, do you think that poor people and working people 
should be last in line for the vaccine?
    Admiral Giroir. I am sorry, Senator. Were you asking me----
    Senator Sanders. Yes, I was, sir. Yes, I was.
    Admiral Giroir. No. I--my office is one of the offices 
committed to serving the underserved, and we need to be 
absolutely certain that if a vaccine or an effective 
therapeutic or preventative is available, that it reaches all 
segments of society, regardless of their ability to pay, or any 
other social determinants of health that there may be.
    Senator Sanders. Good. So, what you are telling the 
American people today, that regardless of income, every 
American will be able to gain access to that vaccine when it 
comes?
    Admiral Giroir. They should gain access to it. I don't 
control----
    Senator Sanders. Well, you represent--you represent an 
administration that makes that decision.
    Admiral Giroir. I will certainly advocate that everyone is 
able to receive the vaccine, regardless of income or any other 
circumstance.
    Senator Sanders. Let me just----
    The Chairman. Senator Sanders.
    Senator Sanders. I am sorry. Alright. Thank you, Mr. 
Chairman.
    The Chairman. Those are important questions. I don't want 
to cut Senators off, but--and it is hard to see the time clock. 
But if we could stay as close as possible to 5 minutes, then 
all Senators can get their questions in. Thank you Senator 
Sanders.
    Senator Burr.
    Senator Burr. Thank you, Mr. Chairman, and thank our 
witnesses today for what you have done for the people in this 
country and their safety, and people around the globe.
    Let me ask you, Dr. Fauci, because you have been in the 
task force and at a majority of the press conferences. Has 
anybody in this administration ever asked you or any member to 
take the foot off the gas in trying to find a cure or any type 
of countermeasure?
    Dr. Fauci. No, Senator, not at all. As a matter of fact, we 
at NIH, as you know, have been right from the very beginning, 
put our foot right on that accelerator in every aspect, 
including the development of vaccines and therapeutics. And as 
I described in my opening statement, we actually started that 
in January, literally days after the virus was known and its 
sequence was published. So, no, I have never been told by 
anyone to hold back on the development of any countermeasure or 
any basic, including the research project that we have been 
involved in.
    Senator Burr. Thank you, Dr. Fauci.
    This question is for Dr. Redfield. Dr. Redfield, we have 
authorized in this Committee and appropriated out of Congress 
multiple times over the last few decades money for 
biosurveillance, and you talked about it. In the past 4 years, 
from Fiscal Year 2016 to Fiscal Year 2020, it has been $23 
million a year, and with the CARES Act, it is over $1 billion 
in biosurveillance. We have seen the private sector go out and 
use data available to track the progress and spread of 
coronavirus around the world. Why has CDC not contracted with 
private sector technology companies to try to use their tools 
for biosurveillance?
    Dr. Redfield. Senator, thank you for the question. This is 
a critical issue, as you know, and also comes into one of the 
core capabilities I talked about, data analytics and data 
modernization, which we are appreciative of the additional 
funding Congress has given.
    I can tell you that this is under critical review now, and 
we do have contracts with some of the private sector groups now 
to try to make the type of availability of data that we have 
seen with Florida available in all of our jurisdictions across 
the country and in the process of making that happen.
    Senator Burr. Dr. Redfield, in April of last year--June of 
last year, we reauthorized the Pandemic and All-Hazards 
legislation, which authorized at that time 30 new billets, 30 
new employees, at CDC, specifically in surveillance. Now, I 
asked Dr. Schuchat in March how many of those 30 had been 
filled. She said zero. As of mid-April, zero of those 30 
billets had been filled. How many of those 30 employees that 
this Committee authorized CDC to bring on for biosurveillance 
have been filled today?
    Dr. Redfield. Sir, again, thank you for the question. I 
know our staffs have been in discussion since Dr. Schuchat's 
testimony, and I know we are in the process of continuing to 
try to figure out how to move that forward, sir. I can get back 
to you on it as I discuss what progress has been made since we 
had that discussion post her hearing with you when you brought 
that to light.
    Senator Burr. Well, I brought it to light the 1st of March, 
and now we are in mid-May. So, I am hopeful that we won't just 
talk about surveillance; we will actually execute it and will 
focus the unbelievable amounts of money that we have provided 
for you, that they will show some benefit to the American 
people.
    Dr. Fauci, let me come back to you. This is one of the 
fastest development timelines we have ever seen for vaccines, 
and the American people, and hopefully people around the world, 
will be the beneficiary of what you find and the eventual 
licensure of that product. What are the biggest unknowns with 
this particular virus that can affect the development process? 
And, Dr. Hahn, if you have anything to add after that to this, 
please do.
    Dr. Fauci.
    Dr. Fauci. Thank you very much, Senator Burr. Well, there 
are a couple of things that I think are inherent in all vaccine 
development.
    First of all, there is no guarantee that the vaccine is 
actually going to be effective. As you well know, because we 
have discussed this many times in the past, that you can have 
everything you think that is in place and you don't induce the 
kind of immune response that turns out to be protective and 
durably protective. So, one--the big unknown is, it will be 
effective. Given the way the body responds to viruses of this 
type, I am cautiously optimistic that we will, with one of the 
candidates, get an efficacy signal.
    The other thing that is an unknown that is of concern, but 
we will be able to get around that by doing the tests properly, 
is that, do you get an enhancement effect? Namely, there have 
been a number of vaccines, two in particular, Dengue and 
respiratory syncytial virus, when the vaccine induces a 
suboptimal response, and when a person gets exposed, they 
actually have an enhanced pathogenesis of the disease, which is 
always worrisome. So, we want to make sure that does not 
happen.
    Those are the two major unknowns. Putting all those things 
together, Senator Burr, I still feel cautiously optimistic that 
we will have a candidate that will give some degree of 
efficacy, hopefully a percentage enough that will induce the 
kind of herd immunity that would give a protection to the 
population at whole.
    Senator Burr. Dr. Hahn, anything to add to that?
    Dr. Hahn. Yes, sir. Thank you for the question. The 
obstacles from a regulatory point of view I think are being met 
by the approaches being taken out of HHS and led by Peter 
Marks. That is, a common, preclinical development pathway so 
that we can appropriately assess one vaccine against the other, 
and then a master protocol that allows for a common control 
group and an assessment of very common endpoints. That will let 
us be as efficient as possible for the development of vaccine.
    We will evaluate approximately 10 candidates pre-clinically 
and then in the Phase 1 and Phase 2 studies, and then take four 
to five into Phase 3 studies in this HHS effort.
    I think those are the obstacles that can be broken down to 
speed the development, but also allow us to ensure safety and 
effectiveness.
    Senator Burr. Mr. Chairman, yesterday, the State of North 
Carolina started to publicize the recovered numbers, those 
individuals who had coronavirus but have recovered. It is my 
hope that nationally, we will start reporting the recovered 
numbers. I think that is important for the American people to 
hear. I yield back.
    The Chairman. Thank you, Senator Burr.
    Senator Casey.
    Senator Casey. Mr. Chairman, thank you for the hearing, as 
well as Ranking Member Murray.
    Mr. Chairman, I wanted to start today with a question 
regarding nursing homes. In particular, across the state like 
ours, we have had, as you might know, a high number of cases in 
Pennsylvania. At last count, over 57,000 cases. The number of 
deaths have gone above 3,700 and, of course, a lot of those 
deaths are in nursing homes. We are told that nationally, more 
than one-third, as high as 35 percent, of all deaths, have been 
in nursing homes, either the death of a resident of a nursing 
home or a worker. So, I want to start today with a question for 
Dr. Redfield.
    Doctor, when we consider this challenge in our long-term 
care facilities, when we look at the number of deaths in 
nursing homes, I think a lot of families want basic 
transparency. That is one of the reasons why Senator Wyden and 
I sent you a letter dated April the 2d. It was directed to you, 
as well as the administrator of the Centers for Medicare and 
Medicaid Services, Seema Verma.
    In that letter, we asked for basic information about what 
the administration was doing to track the outbreaks in nursing 
homes, to provide information, basic information, to families 
and residents, the families of residents in nursing homes, 
certainly to the workers, as well as to the community and 
public health professionals.
    Now, it took you over--about a month to respond to that. 
But, in your response, you didn't give us any information about 
the timeline. These families need this information. And, now we 
are told by the CMS administrator, after pressing her as 
Senator Wyden and I did, that this information may not be 
available until the end of May.
    I need to hear from you today, why has there been a delay, 
a 3-month delay, in basic information that families and people 
within a community need about the outbreaks in nursing homes, 
the number of cases, what is happening in nursing homes? Tell 
us when we are going to see that information.
    Dr. Redfield. Well, thank you very much, Senator, and you 
have highlighted one of the great tragedies that we have all 
experienced together. Clearly, the long-term care facilities 
have been particularly hard hit by this pandemic.
    Several things. I know that, again, the CMS, who has 
oversight, several things have been done, and I can get back to 
you in terms of where they are at in terms of activation. But, 
clearly, all nursing homes now are required to report cases in 
either their individuals that are patients there or staff to 
the CDC.
    Second, I know that Dr. Verma and I have put a policy in 
place at all nursing homes that required that they notify the 
members of that nursing home of the existence of COVID in that 
nursing home, including family members. In--verify in terms of 
when that is, if that is operational as of today or last week, 
but I will get back to you with that.
    One of the most important--we have decided, as we talk 
about key in reopening, as Tony mentioned, we need--symptomatic 
cases. We need to be able to do the contact tracing.
    But, the other thing that we really need to do is to do 
surveillance because this virus does appear to have a high 
propensity for asymptomatic infection, which means the 
traditional ways of identifying cases is going to be blunted. 
And, so, we are developing a national surveillance system, and 
first and most important in that is to do comprehensive 
surveillance in all the nursing homes in the United States. CDC 
will be doing that in partnership with the state and local and 
territorial health departments. I think HRSA is going to have 
the responsibility to do it within the inner city clinics that 
are selected, and the Indian Health Service for the Indian 
Health Service clinics.
    But, this is critical, that we get in front of this and do 
comprehensive surveillance of everybody in these nursing homes.
    We have also done, aggressive outreach in all of them in 
enhancing infection control procedures, et cetera. CDC has been 
out to help these nursing homes with that and to the guidance, 
along with the--but, I will get back to you in terms of the 
time. I am pretty confident they are already--it is already 
operational, but I need to double check just to make sure 
because I know Seema has announced it. They are all reporting 
to the CDC now any infection in workers or patients, and that 
they are required now to notify other members in the nursing 
home, as well as family members, when COVID is one of those 
places.
    Senator Casey. Mr. Chairman, I just have one question for 
Dr. Fauci.
    Doctor, I wanted to ask you, in your testimony earlier in 
response to a question by Senator Murray, you outlined a basic 
concern you have with regard to states reopening. Can you 
restate that for us?
    Dr. Fauci. Yes. Thank you, Senator Casey. Yes. My concern 
is that if states or cities or regions, in their attempt, 
understandable, to get back to some form of normality, 
disregard to a greater or lesser degree the checkpoints that we 
put in our guidelines about when it is safe to proceed in 
pulling back on mitigation. Because I feel if that occurs, 
there is a real risk that you will trigger an outbreak that you 
might not be able to control, which, in fact, paradoxically, 
will set you back, not only leading to some suffering and death 
that could be avoided, but could even set you back on the road 
to trying to get economic recovery because it would almost turn 
the clock back rather than going forward. That is my major 
concern, Senator.
    Senator Casey. Thank you, Doctor. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Casey.
    Senator Paul.
    Senator Paul. Dr. Fauci, scientists have shown that rhesus 
monkeys that are infected with COVID-19 cannot be re-infected.
    Several studies have also shown that plasma from recently 
infected coronavirus patients neutralizes the virus in lab 
experiments. In addition, infusion of convalescent plasma is 
based on the idea that recovering coronavirus patients are 
developing immunity and that it can be beneficial as donating.
    Studies show that the recovering COVID-19 patients from the 
asymptomatic to the very sick are showing significant antibody 
response.
    Studies show that SARS and MERS, also coronaviruses, induce 
immunity for at least 2 to 3 years, and yet the media continues 
to report that we have no evidence that patients who survive 
coronavirus have immunity. I think actually the truth is the 
opposite. We have no evidence that survivors of coronavirus 
don't have immunity, and a great deal of evidence to suggest 
that they do.
    The question of immunity is linked to health policy and 
that workers who have gained immunity can be a strong part of 
our economic recovery. The silver lining to so many infections 
in the meat processing industry is that a large portion of 
these workers now have immunity. Those workers should be 
reassured that they likely won't get it again instead of being 
alarmed by media reports that there is no evidence of immunity.
    You have stated publicly that you would bet it all that 
survivors of coronavirus have some form of immunity. Can you 
help set the record straight that the scientific record as it 
is being accumulated is supportive that infection with 
coronavirus likely leads to some form of immunity?
    Dr. Fauci.
    Dr. Fauci. Thank you for the question, Senator Paul. Yes, 
you are correct that I have said that, given what we know about 
the recovery from viruses, such as coronaviruses in general, or 
even any infectious disease with very few exceptions, that when 
you have antibody present, it very likely indicates a degree of 
protection.
    I think it is in the semantics of how this is expressed. 
When you say, has it been formally proven by long-term, natural 
history studies, which is the only way that you can prove, one, 
is it protective--which I said and would repeat is likely that 
it is--but also, what is the degree or titer of antibody that 
gives you that critical level of protection, and what is the 
durability?
    As I have often said, and I again repeat, you can make a 
reasonable assumption that it would be protective, but natural 
history studies over a period of months to years would then 
tell you definitively if that is the case.
    Senator Paul. I think that is important because--in all 
likelihood is a good way of putting it. The vast majority of 
these people have immunity, instead of saying there is no 
evidence. You know, the WHO kind of fed into this by saying no 
evidence of immunity. And, in reality, there is every evidence 
stacking up. In fact, a lot of the different studies have shown 
that it is very unlikely that you get it again in the short 
term.
    With regard to going back to school, one thing that was 
left out of that discussion is mortality. I mean, shouldn't we 
at least be discussing what the mortality of children is? This 
is for Dr. Fauci, as well.
    You know, the mortality between zero and 18 in the New York 
data approaches zero. It is not going to be absolutely zero, 
but it almost approaches zero.
    Between 18 and 45, the mortality in New York was 10 out of 
100,000.
    Really, we do need to be thinking about that. We need to 
observe with an open mind what went on in Sweden where the kids 
kept going to school. The mortality per capita in Sweden is 
actually less than France, less than Italy, less than Spain, 
less than Belgium, less than the Netherlands, about the same as 
Switzerland.
    But, basically, I don't think there is anybody arguing that 
what happened in Sweden is an unacceptable result. I think 
people are intrigued by it, and we should be. I don't think any 
of us are certain when we do all of these modelings. There have 
been more people wrong with modeling than right. We are opening 
up a lot of economies around the U.S., and I hope that people 
who are predicting doom and gloom and saying, oh, we can't do 
this, there is going to be a surge, will admit that they were 
wrong if there is not a surge because I think that is what is 
going to happen.
    In rural states--we never really reached any sort of 
pandemic levels in Kentucky and other states. We have less 
deaths in Kentucky than we have in an average flu season. That 
is not to say this is not deadly. But really, outside of New 
England, we have had a relatively benign course for this virus 
nationwide.
    I think the one-size-fits-all that we are going have a 
national strategy and nobody is going to go to school is kind 
of ridiculous. We really ought to be doing it school district 
by school district, and the power needs to be disbursed because 
people make wrong predictions. And really, the history of this 
when we look back will be of wrong prediction after wrong 
prediction after wrong prediction, starting with Ferguson in 
England.
    I think we ought to have a little bit of humility in our 
belief that we know what is best for the economy. And, as much 
as I respect you, Dr. Fauci, I don't think you are the end-all. 
I don't think you are the one person that gets to make a 
decision. We can listen to your advice, but there are people on 
the other side saying there is not going to be surge and that 
we can safely open the economy.
    The facts will bear this out, that if we keep kids out of 
school for another year, what is going to happen is the poor 
and underprivileged kids who don't have a parent that is able 
to teach them at home are not going to learn for a full year.
    I think we ought to look at the Swedish model, and we ought 
to look at letting our kids get back to school. I think it is a 
huge mistake if we don't open the schools in the fall. Thank 
you.
    Dr. Fauci. Mr. Chairman, could I respond to that even 
though there are only 32 seconds left?
    The Chairman. Yes. And you might make it clear whether or 
not you suggested that we shouldn't go back to school in the 
fall.
    Dr. Fauci. Well, first of all, Senator Paul, thank you for 
your comments. I have never made myself out to be the end-all 
and only voice in this. I am a scientist, a physician, and 
public health official. I give advice according to the best 
scientific evidence. There are a number of other people who 
come into that and give advice that are more related to the 
things that you spoke about, about the need to get the country 
back open again and economically. I don't give advice about 
economic things. I don't give advice about anything other than 
public health. So, I wanted to respond to that.
    The second thing is that you used the word 'we should be 
humble' about what we don't know. I think that falls under the 
fact that we don't know everything about this virus and we 
really better be very careful, particularly when it comes to 
children. Because the more and more we learn, we are seeing 
things about what this virus can do that we didn't see from the 
studies in China or in Europe. For example, right now, children 
presenting with COVID-16--with COVID-19 who actually have a 
very strange inflammatory syndrome, very similar to Kawasaki 
Syndrome. I think we better be careful if we are not cavalier 
in thinking that children are completely immune of the 
deleterious effects.
    Again, you are right in the numbers that children, in 
general, do much, much better than adults and the elderly and 
particularly those with underlying conditions. But, I am very 
careful, and hopefully humble, in knowing that I don't know 
everything about this disease, and that is why I am very 
reserved in making broad predictions. Thank you.
    The Chairman. Thank you, Senator Paul.
    Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman and Ranking Member 
Murray and our witnesses.
    I want to try to cover a lot of territory in my 5 minutes, 
so I would certainly be appreciative of concise answers.
    But, I want to start with Dr. Redfield. Dr. Redfield, do 
you think that the current testing protocols at the White House 
presents a model for other essential workplaces?
    Dr. Redfield. I am sorry, Senator. You broke up at the 
beginning of your question. If you could just say it again. I 
am sorry.
    Senator Baldwin. Yes. Dr. Redfield, do you think that the 
testing protocols currently in place in the White House present 
a model for other essential workplaces?
    Dr. Redfield. Well, I think--thank you for the question. I 
think one of the important things you bring up is the essential 
worker guidance that CDC put out. And I think it was originally 
modeled, obviously, on healthcare workers where there were 
significant healthcare shortages and individuals that were 
exposed----
    Senator Baldwin [continuing]. Workplaces. I am asking you 
if you think that the White House protocols for testing are a 
model for other essential workplaces.
    Dr. Redfield. I would just say that I think each workplace 
has to define their own approach as to how to operationalize 
our----
    Senator Baldwin. You already had some considerable comment 
on the fact that OSHA has not stood up an enforceable, 
mandatory emergency temporary standard for workers in all sorts 
of work settings. But that aside, would you say that the PPE 
rules and protocols in effect right now in the White House are 
a model for other essential workplaces?
    Dr. Redfield. We would--my own view would go back to the 
guidelines that CDC has put out about essential workplaces for 
people. If they are an essential workforce, that they go in 
public, they maintain 6 feet distancing and they wear face 
coverings.
    Senator Baldwin. Okay. Admiral Giroir, you have testified 
about how far you have come with regard to testing assessments. 
I want to ask you if you believe that we already have a 
national testing strategy today that spans from the nationwide 
testing needs assessment to the nationwide testing supply 
assessment, and a strategy to fill that gap to procure 
domestically what we need in terms of bridging that gap with 
testing platforms, swabs, specimen collection media and 
reagents, and the PPE needed to conduct those tests.
    Admiral Giroir. Thank you for that. We do have a strategy 
that spans us at least to the fall and beyond. As I mentioned, 
we are working individually with every state, and I think 
Senator Paul is correct that Kentucky, Wyoming or New Jersey, 
Rhode Island are different. There are vastly different testing 
needs. The East Coast will have multiples of testing versus 
other states, and we are working those individually.
    Senator Baldwin. So----
    Admiral Giroir. Yes.
    Senator Baldwin. I know you testified earlier that not only 
are you working with the states, but you are working with every 
lab in every state----
    Admiral Giroir. Correct.
    Senator Baldwin [continuing]. Trying to increase capacity. 
What about working with those who would be the--those who would 
need testing to, say, reopen their school, their university, 
their business? Each of them have identified what they think 
are their testing needs based on, guidance, not mandatory, 
enforceable rules. But, are you in contact at that level? Does 
your dashboard have visibility at that lowest level, or are you 
mostly in contact with the states and with the labs?
    Admiral Giroir. Over the last few months, we have done a 
lot of the individual work at nursing homes, at meat packing 
plants, and other--I mean, really down to the very granular 
level.
    Senator Baldwin. Okay.
    Admiral Giroir. Where we are right now, however, is we are 
really working with the state leadership, with the public 
health lab, the state epidemiologist, the SHOs, the state 
health officials, because they really need to understand what 
their sum is going to be in their state.
    Senator Baldwin. Okay. Thank you.
    Admiral Giroir. Then the funding, we are asking very 
specifically, in the CDC funding, for specific plans for 
schools, nursing homes, underserved, et cetera.
    Senator Baldwin. Thank you. I have two more points that I 
am going to make. I don't have time for questions.
    One is about the transparency of that needs assessment. Can 
the public see it? Can the states see it? Can the HELP 
Committee Members see it? Is it publicly available?
    Second, the delivery of this supply is a critical issue, 
and it seems to me that the logistics for getting this out, 
whether it is PPE, testing, or medical equipment, is still 
extremely fragmented, leading to price gouging and many other 
inefficiencies. We need to stand up the full power of the 
Defense Production Act.
    Admiral Giroir. Would you like me to comment on that, 
ma'am? I am sorry.
    Senator Baldwin. I am happy to have you comment with the 
indulgence of the Chairman. We have gone over time and----
    The Chairman. Why don't you try to give a succinct answer 
to the Senator, please, Admiral Giroir.
    Admiral Giroir. Yes, ma'am, and yes, sir. Particularly for 
things like swabs and media, there is still a very, I would 
say, non-mature industry within the country, and that is why we 
have made the decision to procure that all centrally through 
December and then distribute that to the states. Because there 
are just too many small companies, too many--too many variables 
to control without a really heavy Federal hand. That is just an 
example of where we really moved into that and used the DPA for 
swabs to help support American industry.
    In more mature aspects of the industry, like some of the 
large test producers, we feel that by helping direct them to 
make sure that the states get what they need in the right 
distribution, that we are not procuring them directly by us. 
But again, we are going to be very evidence and data driven as 
we move on.
    Thank you, sir.
    The Chairman. Thank you very much, Senator Baldwin.
    Senator Collins.
    Senator Collins. Thank you, Mr. Chairman.
    Let me begin by first thanking each of our witnesses today 
for their expertise, their dedication, and their hard work.
    Dr. Redfield, I want to start with you. I am hearing from 
dentists all over the State of Maine that the fact that they 
cannot practice in our state, despite following very strict 
infection control protocols, is causing growing health 
problems.
    Dentists tell me that teeth with cavities that could have 
been filled are now going to need root canals. Teeth that could 
have been treated with root canals are now going to require 
extractions. People with oral cancers cannot get the treatment, 
the cleanings, that they need before beginning their treatment.
    Dental health is clearly so important, and Maine State 
officials, as well as our dentists, are seeking assistance in 
reaching the right decisions. Forty-seven other states either 
have reopened dental practices or have a day set for them to 
reopen.
    My question to you is this. If dentists are following the 
American Dental Association guidelines, if they are instituting 
strict protective measures for their patients, their staffs, 
their hygienists, themselves, and if they are closely examining 
and seeing a decline in the number of COVID-19 infections in 
their county, are these reasonable factors for states to 
consider in reopening the practice of dentistry?
    Dr. Redfield. Yes, Senator. Thank you for the question. You 
know, we have been interacting and talking with dentists and 
working with the state and local public health officials to 
update our guidelines on reopening a variety of medical 
services, as you know. And I think you raise a very important 
point, and I would not disagree with what you said about 
looking at the American Dental Association, as well as the 
reality of the outbreak in the area. But, we are in the process 
of updating those guidelines, and they will include direct 
guidelines for dental practices.
    Senator Collins. Thank you very much, Doctor.
    Dr. Giroir and Dr. Hahn, recently there has been a 
significant demand for Remdesivir, I may be mispronouncing it, 
which transitioned to receiving an Emergency Use Authorization.
    Last week, Maine's two largest hospital systems contacted 
me with questions about how this therapeutic will be allocated 
going forward. HHS finally released a statement on Saturday 
about allocations going to states; interestingly, not directly 
to hospitals. But, once again, the decision making behind these 
allocations is very unclear.
    HHS and the Assistant Secretary for Preparedness and 
Response say that each state is expected to receive an 
allocation, but no timetable has been provided. Beyond those 
who are being treated with this drug at Maine Medical Center 
through a clinical trial, I am concerned that hospitalized 
patients in Maine will have little or no ability to be treated 
with this promising therapeutic for the foreseeable future.
    As this and more therapeutics, and ultimately a vaccine, 
come onto the marketplace, how can these allocation and 
distribution issues be resolved so that patient care is not 
delayed and so that it does not depend on which state you live 
in whether or not you are going to get access to these 
treatments and ultimately a vaccine?
    Dr. Hahn. Senator Collins, this--oh, go ahead, Admiral 
Giroir.
    Admiral Giroir. Go ahead. Go ahead, Commissioner.
    Dr. Hahn. Senator Collins, I think we completely agree with 
you that this has to be an evidence based approach getting the 
medical therapeutics, vaccines, Remdesivir, whichever it 
happens to be, to the people in need. I think we can all agree 
upon the fact that we learned a lot of lessons from the 
Remdesivir situation. And, of course, as you mentioned, that is 
being led by HHS and ASPR.
    What you see in the most recent announcement is that what 
the task force did was provide guidance to HHS regarding where 
the most significant outbreak of hospitalizations, outbreak 
occurred and where those hospitalized patients were. This 
represented about one-quarter of the supply of drug that we 
have, and more will be allocated according to methodology that 
gets the drug to where those hospitalized patients are.
    I think valuable lessons can be learned and will be learned 
with respect to other therapies, and to vaccines in particular, 
and we must incorporate those into our operational plans moving 
forward.
    Senator Collins. Thank you, Doctor.
    Admiral, do you have anything to add? I am over time. 
Sorry. Thank you. If you have anything to add, if you would do 
so for the record.
    Admiral Giroir. No, ma'am. No, ma'am. I agree with the 
commissioner. It is absolutely critical that it is evidence 
based, based on the people who could benefit from it, and also 
fair and just throughout our Country.
    Senator Collins. Thank you.
    The Chairman. Thank you, Senator Collins.
    Senator Murphy.
    Senator Murphy. Thank you very much, Mr. Chairman. Thank 
you to you and Senator Murray for convening this. Thank you to 
all the witnesses for your service.
    This is obviously an exceptional hearing today in that 
three of our witnesses are in quarantine. So, I just want to 
start by asking a pretty simple yes or no question that I think 
I know the answer to.
    Dr. Fauci, Dr. Hahn, and Dr. Redfield, I am correct that 
all of you are drawing a salary, as you should, during your 
period of quarantine. Is that correct?
    Dr. Fauci. Senator, let me start off. I think we better be 
careful about the issue of quarantine. We are essential workers 
as part of the essential infrastructure, and we are, when 
needed, which is often, do our duties in our respective places 
at the White House. I was at the White House yesterday, and I 
will likely even--perhaps even be there today, and in my office 
at the NIH. So, it is not really strictly speaking a quarantine 
as we know it, but it is performing our duties as critical 
workers. And I would be happy to have my colleagues also 
respond to that.
    Dr. Hahn. Senator Murphy, this is Steve Hahn. I agree with 
Dr. Fauci. And yes, I am drawing a salary, and I have continued 
to work during my quarantine. And, as an essential worker, will 
participate in meetings face to face when that attendance is 
considered critical.
    Senator Murphy. My point here--listen, you all should draw 
a salary while you are taking precautionary steps because of 
the contacts you have made. My point is that quarantine is 
relatively easy for people like you and me. We can still work 
and get paid. We can telework.
    But, there are millions of other Americans who work jobs 
that cannot be performed from home, or are paid by the hour. 
And, it is just remarkable to me that this administration has 
not yet developed a mechanism for states to implement and pay 
for a quarantine system that will work for all Americans. Your 
plan to reopen America requires states develop that plan, and 
yet my state has no clue how to implement and pay for that 
system without help from the Federal Government, which leads me 
to my second question.
    Dr. Fauci and Dr. Redfield, you have made news today by 
warning us appropriately of the dangers of states opening too 
early. But, as Senator Murray mentioned, this is infuriating to 
many of us because it comes hours after the President declared 
that we have prevailed over coronavirus, which I am just going 
to tell you is going to make it much harder on state leaders to 
keep social distancing restrictions in place. It comes days 
after the President called on citizens to liberate their states 
from social distancing orders.
    I think you are all noble public servants, but I worry that 
you are trying to have it both ways. You say the states 
shouldn't open too early, but then you don't give us the 
resources to succeed. You work for a President who is, frankly, 
undermining our efforts to comply with the guidance that you 
have given us, and then the guidance that you have provided is 
criminally vague.
    I want to ask my last question on this topic. Obviously, 
the plan to reopen America was meant to be followed by more 
detailed, nuanced guidance. Right? What does a downward 
trajectory mean? What happens if the trajectory is downward in 
some settings but upward in others? What happens if you reopen 
and then there is a spike in one location or another setting? 
And, of course, you knew this because you developed this 
guidance, this additional guidance, that is site-specific, 
that, frankly, is helpful. Some of this is on the CDC website, 
but some of it is not, and we need it. My state needs it. We 
don't have all of the experts that you have, and so we rely on 
you.
    Reporting suggests, Dr. Redfield, that this guidance that 
was developed by you and other experts was shelved by the 
administration, that it was withheld from states and the public 
because of a decision made by the White House. So, my specific 
question is, why didn't this plan get released? And, if it is 
just being reviewed, when is it going to be released? Because 
states are reopening right now, and we need this additional 
guidance to make those decisions.
    Dr. Redfield. Senator, I appreciate your question. Clearly, 
we have generated a series of guidances, as you know. And, as 
this outbreak response has evolved from a CDC to an all-of-
government response, as we work through the guidances, a number 
of them go for interagency review and interagency input to make 
sure that these guidances are more broadly applicable for 
different parts of our society.
    The guidances that you have talked about have gone through 
that interagency review. There are comments that have come back 
to CDC, and I anticipate they will go back up into the task 
force for final review.
    Senator Murphy. But we are reopening in Connecticut in 5 
days, in 10 days. I mean, this guidance isn't going to be 
useful to us in 2 weeks. So, is it this week? Is it next week? 
When are we going to get this expertise from the Federal 
Government?
    Dr. Redfield. The other thing I will just say is that the 
CDC stands by to be of technical assistance to your state and 
any state upon any request. I do anticipate this broader 
guidance, though, to be posted on the CDC website soon.
    Senator Murphy. Soon.
    Dr. Redfield. I can't tell you soon, but I can tell you 
your state can reach out to CDC and we will give guidance 
directly to anyone in your state on any circumstance that your 
state desires guidance from.
    Senator Murphy. Soon isn't terribly helpful.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murphy.
    Senator Cassidy.
    Senator Cassidy. Okay. Gentlemen, thank you very much for 
your service, and I will have a set of questions. So, if your 
questions can be brief, I appreciate your answers to be brief.
    Dr. Hahn, in your testimony, you mentioned that the testing 
for the populations in the vaccine trials now includes older 
Americans. I guess my question, though, is what about children? 
Does it include children? Does it also include the obese, the 
diabetic, the immunocompromised, those who are at risk of 
having a less--a non-response or a mitigated response to 
vaccination? Can you comment on that, please?
    Dr. Hahn. Yes, sir. Thank you, Senator Cassidy. When the 
Phase 2, Phase 3 trials are in place, they will include our 
most vulnerable populations, including the individuals that you 
describe. We are working very closely----
    Senator Cassidy. If I can interrupt. Phase 2----
    Dr. Hahn. Yes, sir.
    Senator Cassidy [continuing]. Would normally check for 
safety. You would not have to do a separate Phase 2 in the 
patient who was younger? Do you follow what I'm saying? Or can 
you just assume the safety data from the adults applies to that 
of the children?
    Dr. Hahn. Sir, no, we would also want to assess safety, 
sir, as well, in children.
    Senator Cassidy. The current Phase 2 trials, do they 
include children?
    Dr. Hahn. They are in Phase 1 studies right now, sir.
    Senator Cassidy. Well, I thought Dr. Fauci said we had a 
Phase 2 going on.
    Dr. Hahn. Well, I think it is about to start for the 
Moderna vaccine.
    Dr. Fauci. No.
    Dr. Hahn. Perhaps, Dr. Fauci, you can answer that.
    Dr. Fauci. Yes. I--no, Senator Cassidy. No. I did not say a 
Phase 2. As I said, we are in a second dose of the Phase 1, and 
we will proceed when we finish the Phase 1 to go into Phase 2.
    Senator Cassidy. If this--so, I think I am hearing that 
children will be included Phase 2 trials?
    Dr. Hahn. That is a--so, that is under discussion between 
FDA and NIH at this time, sir, because we do realize that it is 
important----
    Senator Cassidy. Sounds right.
    Dr. Hahn [continuing]. For us to understand what this is in 
children.
    Dr. Redfield, to build back upon what Senator Murphy said, 
the published guidelines for schools, school opening, 
obviously, you are about to modify. But, I notice as I read 
through them, there is nothing about testing. So, we speak 
about testing, targeted testing and how we use testing, but the 
guidelines for the school systems has nothing about how to 
integrate testing. Will these be in those guidelines that are 
being released?
    Dr. Redfield. Senator, thanks for the question. Clearly, 
there is going to need to be, as has already been stated, an 
integration of a testing strategy. That is going to be 
different for different school settings, as well as different 
jurisdictions, where there is--setting, and that is going to 
have to be integrated into each of those. There is general 
overarching guidelines. And, then, as I say, I do think the 
testing strategy, which is important, is--including the 
surveillance strategy, needs to be an individualized----
    Senator Cassidy. Now, let me comment on that, Dr. Redfield.
    Dr. Redfield [continuing]. Guidelines.
    Senator Cassidy. Dr. Redfield, in all due respect, I think 
children, whether you are rural, frontier, suburban, or urban, 
is the one setting in which there is a remarkable commonality. 
And I will echo what Senator Murphy said. The resources that 
the Federal Government has greatly exceeds all but the most 
sophisticated, the populous, wealthy state. And even then, it 
exceeds it by some extent.
    I do think it would be good to have, okay, in a primary 
school setting, this is best practices, or these are three 
options and choose between one of these three. To say to each 
school district or each private or parochial or independent 
school, work with your state board of health, figure it out, 
seems a wasted effort. I say that because children play such a 
role in both protection of disease, the spread of disease, et 
cetera.
    Your thoughts on that? Because it really seems that is the 
one setting where you can have, not cookie cutter, but 
certainly a pattern which can be followed.
    Dr. Redfield. Senator, I must have been misunderstood. When 
I was talking about differences, I was thinking of the 
difference between an elementary school, a high school, a 
college in terms of how we--a trade school. There may be 
differences in how you integrate a testing strategy. But, I do 
think having a testing strategy with different options for 
people to evaluate based on different principles will be 
important in terms of guidance.
    Senator Cassidy. Dr. Fauci, you persuasively argue that the 
risk of reopening prematurely is great. But, I think the 
frustration, if I think of children in particular, the risk-
benefit ratio of a child being at home, potentially away from 
enhanced nutrition, without the parent able to work because the 
school provides daycare, without the monitoring that sometimes 
occurs for incidences such as child abuse, but perhaps most 
importantly for all children, the opportunity cost of a brain, 
which is forming, not having access to the information that 
will help that brain form optimally.
    Now, has there been any sort of kind of risk-benefit ratio 
for the child? Yes, they are at risk for Kawasaki's, but there 
are particular risks for missing out on a year of education, 
particularly for those from less than rich backgrounds.
    I guess I am very concerned about that tension. What are 
your thoughts on that?
    Dr. Fauci. No. You make a very good point, Senator Cassidy. 
There are obviously very difficult of the unintended 
consequences of trying to do something that broadly is 
important for the public health and the risk of having a return 
or a resurgence of an outbreak, and the unintended, deleterious 
consequences of having children out of school. We fully 
appreciate that. I don't have an easy answer to that. I just 
don't. We just have to see on a step-by-step basis as we get 
into the period of time of the fall about reopening the schools 
exactly where we will be at the dynamics of the outbreak.
    I might point out something that I think has been alluded 
to throughout some of the questions. We have a very large 
country, and the dynamics of the outbreak are different in 
different regions of the country. So, I would imagine that 
situations regarding school would be very different in one 
region versus another, so that it is not going to be 
universally or homogenous. And I don't have a good explanation 
or solution for the problem of what happens when you close 
schools and it triggers a cascade of events and could have some 
complicated circumstances.
    Senator Cassidy. Mr. Chairman, I will close by asking the 
permission of the Chairman to submit for the record an article 
that just came out in the Journal of Pediatric Nursing, 
Children are at Risk from COVID-19.
    The Chairman. It is so ordered and it will be included. 
Thank you, Senator Cassidy.
    [The information referred to was not submitted for the 
Record.]
    The Chairman. Senator Warren.
    Senator Warren. Thank you, Mr. Chairman, and thank you to 
our witnesses for being here today. I hope everybody is staying 
safe and healthy.
    In the past 16 weeks, over 1.3 million Americans have been 
infected with coronavirus. We now know that about 80,000 people 
have died, and 33 million people are out of work.
    Dr. Fauci, you have advised six presidents. You have 
battled deadly viruses for your entire career. So, I would just 
like to hear your honest opinion. Do we have the coronavirus 
contained?
    Dr. Fauci. Senator, thank you for the question. Right now, 
it depends on what you mean by containment. If you think that 
we have it completely under control, we don't. I mean, if you 
look at the dynamics of the outbreak, we are seeing a 
diminution of hospitalizations and infections in some places, 
such as in New York City, which has plateaued and started to 
come down, New Orleans, but in other parts of the country, we 
are seeing spikes.
    When you look at the dynamics of new cases, even though 
some are coming down, the curve looks flat with some slight 
coming down. So, I think we are going in the right direction, 
but the right direction does not mean we have, by any means, 
total control of this outbreak.
    Senator Warren. Right direction. As I understand it, we 
have about 25,000 new infections a day and over 2,000 deaths a 
day. I think those are the right numbers. And some are 
estimating we could be at 200,000 new cases a day by June. Is 
that right, Dr. Fauci?
    Dr. Fauci. I don't--I don't foresee that as 200,000 new 
cases by June. I am hoping, in looking at the dynamics of 
things starting to flatten off and come down, that we will be 
much, much better than that, Senator. I mean, I think----
    Senator Warren. Just so I understand, we are right now at 
2,000 new infections a day and--25,000 new infections a day and 
2,000 deaths a day.
    Dr. Fauci. Right.
    Senator Warren. That is where we are right now?
    Dr. Fauci. Right.
    Senator Warren. Is that----
    Dr. Fauci. Yes.
    Senator Warren. Let me just ask. We know that it is 
possible to get this virus under better control. Other 
countries have done it, like South Korea. But, we are now 3 
months into this pandemic and basically we have continued to 
set records for the number of people who are diagnosed and the 
number of people who die.
    Dr. Fauci, you recently said that a second wave of 
coronavirus in the fall was ``inevitable,'' but that if America 
``puts in place all of the countermeasures that you need to 
address this, we should do reasonably well.'' And the 
countermeasures you identified were things like continued 
social distancing, significantly more testing, widespread 
contact tracing. You also said that if America doesn't do what 
it takes, and this is your quote, ``We could be in for a bad 
fall and a bad winter.''
    Right now we are about 16 weeks away from Labor Day. That 
is about the same length of time since the virus was first 
detected here in the U.S. Do we have enough robust 
countermeasures in place that we don't have to worry about a 
bad fall and winter?
    Dr. Fauci. Right now, the projection, as you have heard 
from Admiral Giroir, with regard to testing and other elements 
that will be needed to respond, the projection is that by the 
time we get to the end of the summer and early fall, that we 
will have that in place. That is the projection that I get 
from----
    Senator Warren. We don't have it in place now, but we are 
projecting that we will have it in place.
    Let me just ask the other side of this. If we don't do 
better on testing, on contact tracing, and on social 
distancing, will deaths from coronavirus necessarily increase?
    Dr. Fauci. Of course. If you do not do an adequate 
response, we will have the deleterious consequence of more 
infections and more deaths, and that is the reason why--you 
quoted me, Senator, quite correctly, everything you said, and I 
will stand by that.
    If we do not respond in an adequate way, when the fall 
comes, given that it is without a doubt that there will be 
infections that will be in the community, then we run the risk 
of having a resurgence. I would hope by that point in time in 
the fall that we have more than enough to respond adequately. 
But, if we don't, there will be problems.
    Senator Warren. I appreciate your hope, and I wish we could 
tell the American people that the Federal Government has this 
pandemic under control, but we can't. In fact, you have said 
that the virus is not under control in the U.S. We haven't yet 
taken the measures necessary to prevent a second wave of death. 
And, we all know that the people who are going to be most 
affected are going to be seniors, essential workers, the people 
who are out on the front lines.
    The President needs to stop pretending that if he just 
ignores bad news, it will go away. It won't. The time for 
magical thinking is over here. President Trump must acknowledge 
that the Federal response has been insufficient and that more 
people are dying as a result. We are running out of time to 
save lives, and we need to act now.
    Thank you, Dr. Fauci, for all you are doing. We appreciate 
it, but the urgency of the moment could not be clearer.
    Thank you.
    The Chairman. Thank you, Senator Warren.
    Senator Roberts.
    Senator Roberts. Thank you very much, Mr. Chairman, and 
thanks to all the witnesses. You all are like the Fab 4. I 
guess there it a Fab 5 back in the day. But, we are shining the 
light of truth into darkness, with individual flashlights, for 
sure. Thank you, Mr. Chairman, for emphasizing that we have to 
be bipartisan in this approach or we are not going to get 
anywhere, and that obviously is in the eyes of the beholder.
    I am happy to say that we have a great relationship with 
Governor Kelly, who happens to be a Democrat and obviously I am 
a Republican, and her emergency management team is spot on. Dr. 
Lee Norman is doing an outstanding job. This morning I talked 
to Lee. The situation in Kansas is not very good. I am reading 
here, ``Kansas Receives 7,000 New COVID Tests for Counties With 
Food Processing Facilities.''
    You see this mural behind me. That is a stagecoach coming 
into Dodge and opposed to getting out of Dodge. That city is my 
hometown, and we are the hot spot in regards to Kansas, mainly 
because of two packing plants. We have five. That is 26 percent 
of the cattle market. At any rate, Kansas is going through a 
tough time, and it--we shouldn't be worrying about the safety 
of the food, but the food supply chain, I think nationwide, is 
under a great deal of stress. We see that in dairy. We see that 
in poultry. We see that in pork. They are euthanizing pigs, and 
obviously the livestock industry.
    Sonny Perdue at the Department of Agriculture has stepped 
up, so has the President, declaring that these packing plants 
are a national asset. We have progress--Dodge City, when we 
first started out, had five tests. Five. That is between four 
and six. Five. It is not 50 million as we hoped to receive that 
has been said by one of the witnesses.
    The reason I am really harping on all of the problems we 
are having in agriculture, on top of the fact that the 
relationship with China is such that even the first 
breakthrough with regards to trade to China seems to be on hold 
now, and that is another price depressant. And this is going on 
5 or 6 years where our prices have been below the cost of 
production.
    End result, our consumers are really figuring out that food 
doesn't come from grocery stores, and I am very worried that 
the harm to the food value chain is very real, not to mention 
the financial situation that our farmers, ranchers, and our 
growers all face.
    Now, having said all that, I want to ask. Admiral Giroir, 
you have spoken about the importance of having diversity in 
kinds of tests that are available. Of the five packing plants 
we have in Kansas, if we could get a rapid test and we could 
get it as we hopefully ask for it because of the hot spots that 
are developing not only in Kansas, but also doing great harm 
for the food value chain, that would be absolutely wonderful. 
Would you speak to that, sir?
    Admiral Giroir. Yes. Thank you, Senator. Both Dr. Redfield 
and I have been very actively involved in getting strategies 
for the industry, particularly in Kansas. We are supplying very 
heavily the public health labs with rapid diagnostics, as well 
as surging them to areas like that. The one tradeoff, however, 
is that the rapid--the ``rapid'' point-of-care diagnostics are 
very slow. So, each machine can only do four per hour, and that 
is very, very slow.
    It is a mix of testing that you need at these kinds of 
situations. On sort of the high-throughput tests that are 
available at a major lab, a Quest lab right there in Kansas, as 
well as a mix of the rapid testing, and that is what we are 
supplying in order to provide a comprehensive, holistic 
solution. And, I believe CDC is on the ground, as well, in 
Kansas supporting that.
    Senator Roberts. I appreciate that. If you are only doing 
four an hour, that is not a rapid test. Maybe it is a rapid, 
slow test. I am not quite sure how you define that.
    But, I, for one, think that, as we reopen--and by the way, 
Governor Kelly started the opening process the 1st of this 
month. Then it is May 18, and then we go to June, and then the 
hope is we open up.
    But, we do have contingency plans that, if that doesn't 
work as aptly described by Dr. Fauci, I think we will be 
alright. But, this is going to be a tough go. I have to tell 
you that, in terms of agriculture, we are not in good shape.
    I appreciate everybody and the job that you are doing. I 
will stand beside you when you are taking the boos and behind 
you when you are taking bows.
    The Chairman. Thank you, Senator Roberts.
    Senator Kaine.
    Senator Kaine. Thank you, Mr. Chairman, to the Committee 
leadership, and witnesses for calling this important hearing.
    The last time Dr. Fauci and Hahn were before us was March 
3. I have a slide that I want to put up that shows what has 
happened in America since then.
    The chart, which is here, compares the experience of the 
United States and South Korea on three dates.
    On January 21, both nations experienced their first case of 
COVID-19. At that time, the unemployment rates in both 
countries were essentially identical.
    On March 3, when the witnesses were last here, South Korea 
had experienced 28 COVID-19 deaths and the U.S. had experienced 
9. Again, the economies of both nations as measured by the 
unemployment rates were nearly identical.
    But, now the story changes. As of yesterday, more than 
81,000 Americans have died, and the U.S. economy has 
experienced job losses not seen since the Great Depression. 
Meanwhile, the economy of South Korea has not changed 
dramatically at all, and the death toll is now at 256.
    South Korea is smaller than the United States, one-sixth of 
our population. But, even if you bulk up the death toll to 
reflect the difference, the per capita death toll in the U.S. 
is more than 45 times the rate in South Korea. And, healthcare 
carnage here is causing a near depression, while South Korea 
has protected its economy by managing correctly.
    I could have done this chart with other nations. The U.S. 
has the seventh highest per capita death rate in the world. Our 
death rate is off the charts higher than that in India, 
Australia, New Zealand, Japan, and Mexico. It is nearly three 
times the death rate in Germany; twice as high as Canada's 
rate.
    The question is, Why? If we want to open up our economy and 
schools, we have to learn the lessons of nations that have 
managed this well.
    Here are some things that don't explain the difference:
    Our hospitals are as good or better than those in South 
Korea.
    Our healthcare providers, heroes, are as good or better 
than those in South Korea.
    Our research capacity is as good or better than that in 
South Korea.
    We have more resources than South Korea. Our GDP is 12 
times South Korea's, and our per capita income is 50 percent 
higher.
    To Dr. Fauci, the death roll in the United States, the 
death rate in the United States, especially when compared with 
other nations, is unacceptable, isn't it?
    Dr. Fauci. Sorry, sir. Yes, of course. I mean, a death rate 
that high is something that in any manner or form in my mind is 
unacceptable.
    Senator Kaine. Dr. Fauci, the experience of other nations 
shows that the U.S. death rate is not only unacceptable, but it 
is unnecessary. Isn't that correct?
    Dr. Fauci. I don't know if we can say that, Senator.
    Senator Kaine. But would you say that the U.S. has to do 
better?
    Dr. Fauci. Of course. You always have to do better. I mean, 
as a physician and----
    Senator Kaine. The experience of South Korea shows that how 
a nation manages the healthcare crisis has a huge impact also 
on its economic condition. Isn't that the case?
    Dr. Fauci. That is the case, sir. I understand where you 
are going with this, but I have to tell you, there is a big 
difference between South Korea and the United States----
    Senator Kaine. Let--and----
    Dr. Fauci [continuing]. In the outbreak.
    Senator Kaine. Let me get to that. I want to get to factors 
that do explain the difference since we know it is not 
resources or our health providers.
    First is testing. South Korea began aggressive testing much 
earlier than the U.S. Now, in the fifth month of the pandemic, 
we have surpassed South Korea in per capita testing, but in the 
critical month of March, South Korea was testing its population 
at a rate of 40 times the testing in the U.S.
    Admiral Giroir, Dr. Giroir, has set out the standard for 
us. When we get to September, he says the United States needs 
to do 40 to 50 million tests a month to be safe. That equates 
to about 1.3 million to 1.7 million tests a day. Yesterday, we 
did 395,000 tests. We have a long way to go.
    A second factor is contract--contact tracing. South Korea 
embraced a rigorous contact tracing program right from the 
beginning. The United States still has not engaged in a 
national contact tracing program. Isn't that right? Would that 
be Dr. Fauci or Dr. Redfield?
    Dr. Fauci. I think that question would best be directed to 
the CDC and not the NIH.
    Dr. Redfield. When the outbreak started, sir, we had an 
aggressive contact tracing program, but unfortunately, as cases 
rose, it went beyond the capacity and then we went to 
mitigation. So, we lost the containment edge clearly before 
that.
    Senator Kaine. That was key to the economy, as well, 
because South Korea did testing, contact tracing, protect, 
serve, isolate the sick, and then they didn't have to do the 
shutdowns, which helped their economy.
    Social distancing is a third factor. We have talked about 
it.
    But finally, the last one, healthcare systems. Would you 
agree with me that it helps keep people safer, even from 
serious conditions or death from COVID-19, if they have access 
to healthcare?
    Dr. Fauci. Yes, of course.
    Senator Kaine. Of course that is the case. In South Korea, 
97 percent of the population have health insurance. In the 
United States before COVID-19, millions did not have it and 
lacked access to healthcare. The massive job losses in the last 
months threaten to take health insurance away from millions 
more. And, President Trump is doing all he can to dismantle the 
Affordable Care Act, which would take health insurance away 
from tens of millions more. Let us learn the lessons from those 
who are doing this right.
    Thank you, Mr. Chairman. I yield back.
    The Chairman. Thank you.
    Admiral Giroir. Can I make a clarification, please, Mr. 
Chairman? This is Brett Giroir.
    I just wanted to clarify that I did project that we will 
have the ability to perform 40 to 50 million tests per month in 
that timeframe, but I said if needed at that time. I am not 
making a proclamation. We have to really understand what--where 
the epidemic is, what the community spread is, before we can 
estimate the number of tests that are needed. I was simply 
stating the fact that our combination of testing capabilities 
will be at that level even barring new input from the NIH.
    The Chairman. Thank you very much, Senator Kaine.
    Senator Murkowski.
    Senator Murkowski. Thank you, Mr. Chairman. And, gentlemen, 
thank you for being here this morning virtually, but also for 
all you have been doing for these many, many months.
    Alaska is doing okay right now from a numbers perspective, 
and quite honestly, we want to keep it that way because we know 
we have exceptionally vulnerable populations. We know we have a 
geography that is challenging. We know that we have facilities 
that are very limited.
    Last hearing, we had an opportunity to hear from Dr. 
Collins, and he shared where they are with the RADx, and also 
spoke to RADx-UP, which was very interesting, about what we can 
be doing in rural areas, but focusing on hot spots. And, as I 
reminded him, we don't want to be a hot spot in Alaska, so 
every effort that we make to keep the virus out of Alaska is--
are lives that are saved.
    I educated him on the community of Cordova, that it is just 
getting ready to open its Copper River salmon fishery in 2 
days, and was able to share that they had one worker tested 
positive as he was coming in from the Lower 48 to come to work. 
The good news on that is that all of the protocols that we had 
put in place seemed to be working: the quarantine, the 
isolation, not only for that individual, but for others that he 
had come in contact, were secured.
    I want to recognize the assistance that we have received 
from the administration. Dr. Eastman is in the state at this 
moment, the chief medical officer for the Department of 
Homeland Security, going out to rural communities to really 
better understand our vulnerabilities, going to some of our 
fishing communities to, again, understand how we can 
successfully prosecute our fisheries when you have to bring 
workers in from the outside. We thank you for the assistance 
with regards to additional testing capacity.
    I have been in contact with our chief medical officer of 
the state this morning, and the mayor of Cordova, just better 
understanding, again, do we have the tests that we need? What 
do we need on the ground? And, one of the things that I would 
like to have clarified, and this is probably to you, Dr. 
Giroir, because you have been so helpful in kind of shining the 
light on what we need to be doing in these rural areas.
    But so much of the focus has been on hot spots and 
responding to the hot spots, but how do you keep those rural, 
remote, small communities from becoming the hot spots in the 
first place? Are we doing enough? And, right now, the strategy 
has been we just lock it off. The travel restrictions that are 
in place are apparently working, but they are also devastating 
our economy, whether it is tourism, whether it is our resource 
industries, or whether it is the potential for our fisheries.
    Admiral, if you might speak to that aspect of it, and then 
I have a very important question as it relates to contract--
contact tracing that I would like to direct to either Admiral 
Giroir or Dr. Redfield.
    Admiral Giroir. Thank you, Senator. And, as you know, you 
have an outstanding state health officer in Dr. Anne Zink.
    Senator Murkowski. We do.
    Admiral Giroir. I have had the privilege of working with 
her, and you have a very good protocol in trying to keep Alaska 
safe by isolation over a period of time when you come in.
    As you know, we also work with the state to meet your very 
challenging testing requirements because you can't really, send 
labs out a thousand miles away. So, we put a real customized 
mix of point-of-care and also the Cepheid machines--I think we 
sent nine or 10 new to Alaska--and about 50,000 tests, which is 
about four times than you have done to date collectively in 
order to provide that support. So, again, I do think there is a 
comprehensive strategy that you do have.
    But, again, the mitigation, to the degree that you can 
given the circumstances: the face masks, the hand washing, the 
hygiene. We understand fully the challenges, particularly in 
the fishing environment and the remote. But all of these have 
to come together--the testing, the tracing, the mitigation, the 
hygiene factors--to try to keep your community safe.
    We really understand culturally that many of your 
communities were almost annihilated in the 1918 influenza 
pandemic, so--and that memory is still very sharp and very 
hurtful to many of the citizens, so we want to do our best to 
assure them that we are giving them all the protection we can.
    Senator Murkowski. Admiral, let me turn to Dr. Redfield 
because this relates to contact tracing.
    I think this is a very, very key part of how we move 
forward into getting people back to work, getting people back 
to school. Right now, we have about 100 people that are 
involved in contact tracing in Alaska. That is clearly not 
sufficient. There has been talk about a national strategy, but 
I think we recognize that we have teams in place, whether it is 
AmeriCorps or whether it is Peace Corps or whether it is our 
Public Health Corps.
    What more do we need to be doing to make sure that once you 
have been tested positive, then what happens after that? Who 
else needs to be brought into this? And I am not convinced that 
we are focusing enough on that aspect of how we move to 
reopening if we have not done the contact tracing.
    Dr. Redfield. Thank you very much, Senator. I want to just 
re-emphasize what you said. I think contact tracing 
capabilities is critical. It is going to be the difference from 
succeeding in containing this outbreak from once again causing 
wide-scale community transmission, or not. We are positioned, 
as you know, to deploy, redeploy, the number of CDC--over 500 
CDC individuals. We have another over--about 650 that we are 
trying to put in through our foundation.
    But most importantly, we are trying to work with your 
health department. With the resources that we have been able to 
give because of Congress. Also, as you mentioned, with these 
other agencies, with Lab Corp--I mean with AmeriCorps, with the 
Census Bureau, to work together and have the state develop 
their contact tracing capacity. Some states have reallocated 
state workers. Some states have reallocated National Guard 
while they begin to do this.
    But, I agree with you, and I said it is going to be a 
significant effort to build the contact tracing capacity that 
we need in this Nation. It will be state by state, but it is 
going to need to be augmented. Probably in your state, from 
what you just said, and increase five to tenfold, and we are 
there to work with the states to help them get that 
accomplished. That needs to get in place before September.
    The Chairman. We need to move on to the next question.
    Senator Murkowski. Thank you.
    The Chairman. Thank you, Senator Murkowski. I don't want to 
cut any Senator off, but we have eight more Senators who have 
5-minute rounds and it is 12:30, so I would like to request 
that the Senators and the witnesses, succinct questions and try 
to stay within 5 minutes would be appreciated.
    Senator Hassan.
    Senator Hassan. Well, thank you, Mr. Chairman. Thank you 
and the Ranking Member for having this hearing, and thank you 
to our witnesses today. And, please pass our thanks along to 
all of the hardworking women and men in your agencies, who I 
know have been working virtually around the clock to try to 
improve our response and keep Americans safe. And, Mr. 
Chairman, I hope you and all the witnesses are healthy and safe 
today, as is everybody on your team.
    I wanted to start by echoing the comments my colleagues 
have made about needing leadership from the CDC and our public 
health experts on how we are going to use facts and evidence as 
guidance so that our schools and our daycares and our 
businesses have the information they need to create safe and 
sustainable plans to reopen. And, of course, that means, too, 
that our testing capacity not only has to be enough, but it has 
to be flexible enough to meet our needs.
    The key distinction between South Korea and the United 
States is not how many tests per capita over a certain amount 
of time we have done, but the fact that at the onset of this 
pandemic, South Korea was much more able to do a lot more tests 
per capita than we were. And then, follow that with all the 
other measures you have talked about. So, that--we continue to 
need to identify the need, and then build our capacity toward 
the need, not the other way around.
    I wanted to start with a question to you, Dr. Fauci. First 
of all, thank you for your work and your expertise. I wanted to 
talk about nursing homes for a minute. In New Hampshire and 
across the country, a huge number of the deaths from COVID-19 
that we are seeing have been in nursing homes. We all know 
people who have lost a friend or a family member in nursing 
homes, and the grief compounded by the fact that people 
couldn't be at their loved ones' bedside if they died.
    Yesterday, Dr. Birx said that all one million nursing home 
residents should be tested within the next two weeks, as well 
as all nursing home staff.
    Dr. Fauci, as a short-term goal, that makes sense to me, 
but after that, what will the ongoing Federal recommendations 
look like? How frequently do we need to test patients and staff 
on a continuing basis, and what other measures will be 
necessary to keep our loved ones in these facilities safe?
    Dr. Fauci. Thank you for that question, Senator Hassan. The 
general plan, as you mentioned, that was recommended by Dr. 
Birx, is a sound plan, as you said, in the immediate. The 
question is in the long range. We will have to have infection 
control capabilities in nursing homes that are really pristine 
and really unassailable. We have to do the kinds of 
surveillances and have to have the capability of when you 
identify someone, you get them out of that particular 
environment so that they don't spread the infection throughout.
    General testing for all I think is a good start. But, when 
you look where you are going to go in the future, there has to 
be a considerable degree of surveillance capability.
    Senator Hassan. Thank you, Doctor. The White House is now 
requiring all staff to wear masks, and anyone in regular 
contact with the President to be tested daily. Do you think 
nursing homes should implement those same measures to help make 
sure that our seniors can get the same level of protection?
    Dr. Fauci. I think there should be a certain--a system in 
place for the optimal protection of people in nursing homes, 
and that would be not necessarily testing every person, every 
day. That is one approach that might not be practical when you 
think of all the nursing homes in the country. But very strict 
regulations and guidelines about who is allowed to go into the 
nursing home. And the staff, I believe, needs to be monitored 
very carefully with intermittent testing to make sure that we 
don't have introduction into the nursing home of infected 
individuals. I am not sure you can practically do testing every 
day. That, I don't think would be feasible. But something that 
is much more aggressive than has been done in the past, I 
believe, should be done.
    Senator Hassan. Well, thank you. I have one last question 
for Dr. Fauci and Dr. Redfield. I would also just say that if 
we are able to get masks to everybody in the White House, I 
hope we can get masks to every nursing home employee who needs 
it.
    Dr. Fauci and Dr. Redfield, the U.S. needs to be preparing 
now to ensure that we have capacity to manufacture and 
administer vaccines, something you have both touched on, both 
for an eventual COVID-19 vaccine, as well as other illnesses, 
such as the flu. The failure to ramp up production of testing 
and personal protective equipment early on during this crisis 
made things worse here. Those mistakes cannot be repeated when 
it comes to vaccine production and distribution. We are already 
seeing reports that some children are not receiving routine 
immunizations as it becomes more difficult to access in-person 
care.
    Dr. Fauci, what steps should we take now to ensure that we 
have sufficient manufacturing and distribution capacity for a 
COVID-19 vaccine without putting at risk our capacity to 
manufacture and distribute other important products, such as 
the flu or measles vaccine? And my follow-up question to Dr. 
Redfield would be, What efforts are underway at CDC to ensure 
that all routine vaccines are accessible during the COVID-19 
public health emergency?
    Dr. Fauci. Yes. Thank you for that question, Senator 
Hassan. I will answer it as quickly as possible.
    I alluded to this in my introductory remarks when I was 
talking about vaccines for COVID-19. And, what we said, that as 
we do the testing on these vaccines, we are going to make 
production at risk, which means we will start putting hundreds 
of millions of dollars of Federal Government money into the 
development and production of vaccine doses before we even know 
it works so that when we do--and I hope we will and I have 
cautious optimism that we will--ultimately get an effective and 
safe vaccine, that we will have doses available to everybody 
who needs it in the United States, and even contribute to the--
what is the needs globally because we are partnering with a 
number of other countries.
    The other part of your question about making sure that when 
we get into a situation like the so-called shutdown that we 
might be in now that we make sure that children get the 
vaccinations that they need. That would be an unintended 
consequence of shutting down, as we are right now. It is a very 
good point, and we want to make sure we don't fall behind on 
that, also. Thank you.
    Senator Hassan. Thank you very much. And I will take my 
answer from Dr. Redfield offline. Thank you so much for 
allowing me to go, Mr. Chairman.
    The Chairman. Thank you, Senator Hassan.
    Senator Scott.
    Senator Scott. Thank you, Mr. Chairman, and to the panel. 
Thank you all for being here virtually. Without any question, 
we find ourselves in a situation that we wish we were not. And 
I am very thankful for folks like Dr. Birx, Dr. Fauci, and many 
others for your dedication 24/7. Without any question, our 
Nation is safer because of your hard work.
    I am going to direct my questions toward Dr. Fauci. Really 
one specific question, Dr. Fauci. I am thinking about the 
reopening of America, and specifically the reopening of South 
Carolina.
    I am taking into consideration the fact that South 
Carolina, I think, overall, our cases are moving in the right 
direction. We have a little less than 8,000 cases; 
unfortunately, 350 deaths. Our hospital capacity is actually 
better now than it was when the pandemic started. Our ability 
to isolate hot spots and mitigate the spread of the virus is, I 
think, where it needs to be.
    With that in mind, I flew into Washington from South 
Carolina yesterday. We had plans to test additionally 220,000 
more residents by the end of this month, focusing on at-risk 
populations. By the end of this month, we will have tested 100 
percent, 100 percent, of nursing home residents and the staff 
that takes care of them.
    And, after increasing our contact tracing workforce 20 fold 
in a matter of weeks, our state's health department announced 
yesterday that we are going to increase it by an additional 
1,400 contact tracers.
    We have built, and we continue to build, the tools 
necessary to better detect and isolate cases, to map their 
exposure, and to prevent substantial spikes moving forward. 
Most importantly, our healthcare system, thanks in part to 
flexibilities from this administration, has the beds and the 
equipment necessary to address the most serious cases when they 
arise.
    Now, with these tools in hand, we have begun to reopen. To 
be clear, we continue to scale up testing and to make--to take 
measures to protect the most vulnerable, and the data points 
are increasingly clear. For older Americans and for those with 
chronic conditions, like diabetes and high blood pressure, this 
virus remains a threat--a dangerous threat.
    A recent report suggests that in New York, roughly 90 
percent of the fatalities had underlying issues. Two-thirds of 
fatalities were 70 years or older; 95 percent over the age of 
50.
    In South Carolina, the median age of patients who have died 
from the virus, 76.5. Nearly two-thirds of fatalities have been 
patients older than 71; and nearly 90 percent were over the age 
of 60; and roughly 98 percent in South Carolina are over the 
age of 50. Contrast that with those age 20 and younger where we 
have seen no deaths. Fewer than 1 percent of deaths in my state 
have been under the age of 40. Every single death is a tragedy, 
every single one, and we mourn with our family members who have 
lost their loved ones. We are taking every measure to protect 
our older South Carolinians, as well as those with underlying 
conditions.
    When we set out to flatten the curve by taking aggressive, 
unprecedented measures, like staying-at-home orders and mass 
small business closures, we did not set out with the goal of 
preventing 100 percent of fatalities. That would be 
unrealistic. It is impossible. And we did not set out to keep 
quarantines in place until we found a safe and effective 
vaccine. That would take too long.
    Dr. Redfield, your agency put out a helpful graphic showing 
two curves. One, which spiked quickly and peaked high, 
reflected daily cases without protective measures. The other, 
flatter curve, show cases with those measures in place. And the 
whole point, which the graphic illustrated, was to make sure 
that we did not exceed hospital capacity. So, while I respect 
the need for caution, we are too often presented with a false 
dichotomy: either saving our economy or saving lives.
    We have seen the goalposts around flattening the curve 
move, and I think that is unfortunate. Because at the same time 
we are doing that, businesses have collapsed, mental and 
physical health have declined, deaths and despair escalate, 
educational outcomes nosedive, as we wait in our living rooms, 
praying for some good news around therapies and around 
vaccines. We set out to flatten the curve, and I think we have 
done a pretty good job with that. We need to do better and we 
will do better.
    My question, Dr. Fauci, is, as we start the process of 
moving toward reopening South Carolina, what else would you 
suggest that we could do to protect our most vulnerable 
populations?
    Dr. Fauci. Thank you, Senator Scott. You gave a really very 
eloquent description of what I think is one of--would be a 
model way, the way you approach this. I mean, you have put 
things in place that I think would optimize your capability of 
reopening. And as--I was thinking as you were speaking, I 
almost want to clone that and make sure other people hear about 
that and see what you have been doing.
    The issue of your direct question to me about the 
vulnerable populations is that, as we have said in our 
guidelines--and it looks like you were ready to progress 
carefully because you have put into place a very good system--
that the vulnerables, the elderly and those with underlying 
conditions, should be those who at the very last lifting of 
mitigations, should be those who are left in a situation where 
they might be in danger of getting infected. In other words, 
protect them right up until the very end of the relaxation of 
your mitigation.
    Because, as you said very correctly, those are the 
individuals that are the most vulnerable for the morbidity and 
the mortality. So, those individuals, particularly I might say, 
sir, those in the minority group, the African American and 
Hispanics, who, for a variety of situations that are the social 
determinants of health, have a greater likelihood of not only 
getting infected, but of also having the underlying conditions 
that would make their risk for a higher degree of morbidity and 
mortality higher.
    It looks like you are doing things very, very well, and I 
would encourage you to continue and to follow the guidelines as 
you get closer to normalizing your state.
    Thank you.
    Senator Scott. Thank you, Dr. Fauci, and I will just simply 
close with this since I am out of time. Thank you for the many 
conversations that you and I have had about those vulnerable 
populations to include minorities, as well as our senior 
citizens. I will say that, without any question, when you look 
at nursing homes, that it is typically African Americans, 
Hispanics, are the certified nursing assistants who are 
providing care for the elderly population. So, your focus on 
those two very vulnerable groups is much appreciated, and thank 
you for your expertise.
    The Chairman. Thank you, Senator Scott.
    Senator Smith.
    Senator Smith. Thank you so much, Chairman Alexander and 
Ranking Member Murray. And thanks to all of you for being here 
today and for your service.
    Dr. Fauci, I have to say, you are in the unenviable 
position of being a person that so many Americans and 
Minnesotans trust to give us the straight scoop and tell us 
what is really happening. You are about the facts and not about 
the politics, and that is a really good thing.
    I have to start by asking you a question that I think a lot 
of Americans want to know, which is, how are you doing? How are 
you holding up? You have--it has been an unbelievable effort.
    Dr. Fauci. I am doing fine, Senator. Thank you very much 
for asking. This is such an important problem. It transcends 
all of us individually and has to be working as a team, and I 
enjoy very much working with your Senators and the Governors 
because it is at the local level that we are going to make this 
thing work. So, I am fine. I appreciate your concern.
    Senator Smith. Well, a lot of people are thinking about you 
and are grateful for your service, as we are for all of you.
    We are gathered today to think about what we need to do to 
reopen our economy, and I think first about what is happening 
in my home State of Minnesota, where agriculture is such an 
important part of how our state works. It is a part of our 
history and our culture.
    Pork processors right now are looking at the reality of 
euthanizing thousands of hogs a day because there is no place 
to process them because of what is happening in the processing 
plants. The working people, who do the hard work in those 
processing plants, are getting sick.
    Here is one story. This is one worker--the Star Tribune 
wrote about this--named Jomari de Jesus. She is an asylum 
seeker and a mom who works for a contractor that does the 
cleaning in the processing plants, and she works for $14 an 
hour, 7 hours a day, 5 days a week, and her job is to sanitize 
the machines that process the meat into ground meat.
    She started feeling sick on April 11th, but she kept going 
to work. And, on April 21st, when one of her coworkers fainted, 
she told her supervisor that she felt sick. And, so, she was 
told to go home, but that if she didn't show any signs of 
illness, she should come back.
    She went to the doctor and she paid $115 to get a test and 
found out a few days later that she was COVID positive, and she 
is still at home. She is still--she is not getting paid, and 
she doesn't have health insurance.
    Nearly 2 weeks ago, President Trump deployed the Defense 
Production Act to keep these processing plants open, but the 
USDA gave really limited guidance about what would be safe for 
those workers. It said, for example, in response to testing, 
which has been such a big part of what we have been talking 
about today, they said--this is a quote. ``Facilities should 
consider the appropriate role of testing and workplace contact 
tracing of COVID-19 positive workers in a worksite risk 
assessment.''
    Dr. Fauci, as we think about how we move forward, we all 
want to open up the economy, what guidance would you give us in 
a situation like this here in Minnesota?
    Dr. Fauci. Well, I can give you my commonsense guidance, 
although this is not the area of my expertise. It is more in 
others.
    But, it would seem that if you want to keep things like 
packing plants open, that you have really got to provide the 
optimum degree of protection for the workers involved, the 
ability to allow them to go to work safely; and if and when 
individuals get infected, to immediately be able to get them 
out and give them the proper care.
    I would think when you are calling upon people to perform 
essential services, you really have almost a moral 
responsibility to make sure they are well taken care of and 
well protected. And again, that is not an official 
proclamation. That is just me speaking as a physician and as a 
human being.
    Senator Smith. Well, thank you, Dr. Fauci. And I think that 
you speak as a human being, but you also speak as the chief 
epidemiologist of our Country and the person that we all trust.
    This is the point that I want to make and drive home with 
everybody, which is this is the kind of guidance that we should 
be getting and following. And then, this is the kind of--these 
are the tools that we have got to have in our Country if we are 
going to reopen our economy, as we all want to do. And, this--
we move forward with reopening our economy, and yet we still 
have circumstances like we have in these processing plants and 
in other places around the state. We are going to be--we are 
going to be right back where we started, and--except even in a 
worse place, as I think you have pointed out, Dr. Fauci.
    Dr. Fauci. Thank you, Senator. And again, it really does 
relate to one of the questions that one of your colleague 
Senators asked me before and one of the things that I keep 
emphasizing. And I will just repeat it again because it is 
important, that when you are in the process of opening up and 
pulling back on mitigation, you really must have in place the 
capability of responding when you do have the inevitable 
upticks in cases. That will absolutely occur. It is how we deal 
with it and how successful we are in putting the clamps on it 
that will prevent us from getting the kind of rebound that, not 
only from the standpoint of illness and death would be 
something that is unacceptable, but it would set us back in our 
progress toward reopening the country.
    Senator Smith. Thank you.
    The Chairman. Thank you very much, Senator Smith.
    Senator Romney.
    Senator Romney [continuing]. this hearing and the 
participants in it.
    Admiral Giroir, I am going to take off where Senator Hassan 
spoke. I understand that politicians are going to frame data in 
a way that is most positive politically. Of course, they don't 
expect that from admirals. But, yesterday you celebrated that 
we had done more tests and more tests per capita even than 
South Korea, but you ignored the fact that they accomplished 
theirs at the beginning of the outbreak, while we treaded water 
during February and March. And, as a result, by March 6th, the 
U.S. had completed just 2,000 tests, whereas South Korea had 
conducted more than 140,000 tests. So, partially as a result of 
that, they have 256 deaths, and we have almost 80,000 deaths.
    I find our testing record nothing to celebrate whatsoever. 
The fact is, their test numbers are going down, down, down, 
down now because they don't have the kind of outbreak we have. 
Ours are going up, up, up as they have to. I think that is an 
important lesson for us as we think about the future.
    On a separate topic, my impression is that, with regards to 
vaccines, that--where I am critical of what we have done on 
testing, on vaccines, we have done a pretty darn good job of 
moving ahead pretty aggressively. And yet, the President said 
the other day that President Obama is responsible for our lack 
of a vaccine.
    Dr. Fauci, is President Obama, or by extension, President 
Trump, did they do something that made the likelihood of 
creating a vaccine less likely? Are either President Trump or 
President Obama responsible for the fact that we don't have a 
vaccine now, or in delaying it in some way?
    Dr. Fauci. No. No, Senator, not at all. Certainly President 
Obama, nor President Trump, are responsible for our not having 
a vaccine. We moved, as you said--because I described it in my 
opening statement--rather rapidly. No one has ever gone from 
knowing what the virus was to a Phase 1 trial as fast as we 
have done. So, I don't think that is something that one should 
say anybody is responsible for doing anything wrong on that. I 
think that is right. That is the correct way to do it.
    Senator Romney. Thank you. That was my impression. I was 
surprised by the comment, but that was my impression.
    Dr. Redfield, Senator Sinema and I wrote a letter to you 
expressing our dismay at the lack of real-time data at the CDC. 
I am talking about granular, demographic, hospitalization, 
treatment data. How is it possible in this day and age that the 
CDC has never established such a real-time system with accurate 
data? And what can Congress do to rectify that so we never have 
to look at something like this again?
    Dr. Redfield. There we go. I am sorry. Senator, thanks for 
the question. I think you hit one of the--important they are. 
The first one I focus on is data modernization, data analytics, 
and predictive data analysis.
    Clearly, Congress has come forward in providing funding for 
data modernization, and we are in the process of implementing 
it. The reality is there is an archaic system, a non-integrated 
public health system. Each public health department has their 
own systems. The Nation needs a modern, highly capable data 
analytics system that can do predictive analysis. I think it is 
one of the many shortcomings that had been identified as we 
went through this outbreak, and I couldn't agree with you more. 
It is time to get that corrected.
    Senator Romney. Thank you. Please help guide us as to what 
we need to do to make sure that happens. And I presume it is 
not build it ourselves, but work with companies that have that 
capacity and use that capacity in our favor.
    Dr. Fauci, one last thing, which relates to the virus, and 
I know I am asking you the impossible question. But, we are all 
hoping for a vaccine, obviously. It is the objective of our 
administration to get it as soon as they can. And, from what I 
can tell, they are pulling out all the stops to do exactly 
that.
    Given our history with vaccine creation for other 
coronaviruses, how likely is it? I mean, is it extremely likely 
we are going to get a vaccine within a year or two? Is it just 
more likely than not? Or, is it kind of a long shot?
    Dr. Fauci. It is definitely not a long shot, Senator 
Romney. I would think that it is more likely than not that we 
will because this is a virus that induces an immune response, 
that people recover. The overwhelming majority of people 
recover from this virus, although there is good morbidity and 
mortality at a level in certain populations. The very fact that 
the body is capable of spontaneously clearing the virus tells 
me that, at least from a conceptual standpoint, we can 
stimulate the body with a vaccine that would induce a similar 
response. So, although there is no guarantee, I think it 
clearly, much more likely than not, that somewhere within that 
timeframe, we will get a vaccine for this virus.
    Senator Romney. Thank you. Mr. Chairman, I yield.
    The Chairman. Thank you, Senator Romney.
    I want to thank the witnesses for their patience. We have 
four more Senators, and we would like to give them a chance to 
ask their questions.
    Senator Jones.
    Senator Jones. Thank you very, very much, Mr. Chairman, and 
thanks to all our witnesses for your being here virtually, and 
also for your incredible service during this time.
    I want to follow-up real quick with an additional statistic 
that Senator Romney talked about with regard to South Korea, 
and that is the fact that we are a Nation that has about six 
times the population of South Korea, but yet we have about 310 
times the number of deaths from this pandemic. So, I think we 
have to be very careful in making comparisons around the world, 
comparing the United States to other countries.
    Dr. Redfield, I want to follow-up just a little bit with 
what Senator Murkowski and I think Senator Kaine talked a 
little bit about, contact tracing and where we are going. I 
understand that you are working with states to try to develop 
plans for reopening. The testing is important. The contact 
tracing is important. But, using that data, as well, is also 
going to be important in terms of the quarantine plans that 
Senator Murphy talked about. Childcare facilities to have--
allow people to put their kids in a facility while they are 
still--go back to work. All of those issues, including maybe 
even facilities like vacant hotels or motels that may be used 
for self-isolation.
    How is this plan being developed within the CDC? Are those 
plans going to be individualized by state? Will we, as a Member 
of Congress, be--have access to those plans? And how are states 
going to pay for these? I say that because my state is already 
using the money that we have already given them as a wish list. 
I mean, they are talking about building a few hundred million 
dollar statehouse as opposed to developing the test and doing 
the contact tracing.
    I would like for you just to drill down a little bit on how 
these plans are going to develop, what access we will have to 
have those plans and be able to see them.
    Dr. Redfield. Thank you very much, Senator. This is 
obviously, as I said before, this is a critical component of us 
taking this time now to get prepared for next fall and winter 
and building that comprehensive contact tracing capacity. We 
are working individually with the leadership of the state 
health departments, the local health departments, territorial 
and tribal, to try to let them get us to understand what they 
think their capacity needs are. And, those discussions have 
already happened. As Admiral Giroir said, there has been a 
variety of Federal agencies together on testing and contact 
tracing.
    CDC is in position that we have reprogrammed our 
individuals that we have across the country, over 500, begin to 
help each of these states. We have augmented that with some 
additional personnel that we are bringing onboard state by 
state through our foundation. We have put about $106 billion of 
the money that Congress has appropriated into the states so 
they can begin to start thinking about whether they want to 
hire--contact tracing capability. And, then, of course, it was 
mentioned that we are--well, other government programs, like 
AmeriCorps, Peace Corps so that each group is going to 
construct their contact tracing piece to what they think their 
needs are. And I do think it is going to be similar to what we 
heard from the Senator from South Carolina. These are 
significant increases. He said he increased 20 fold, and then 
they are going to increase again.
    But the point you brought up is also critically important. 
And we found that as we already struggled through the 
repatriation of different Americans from around the country, 
where we had to put many of these in quarantine, as you know, 
ended up using military bases because many of the state and 
local health departments really have not developed that system. 
Where do they put somebody who should be in isolation who is 
homeless? How do you develop those systems? So, this has to be 
part of it, too. Is it--there a certain capacity that is 
intrinsic? Or, is it hotels, as you mentioned?
    I think the point that was made by one of the other 
Senators is so important about individuals that--particularly 
like the meatpacking individual that has to go home and self-
isolate, but maybe they don't have the ability to go home and 
self-isolate because they live in a multi-generation house with 
about 12 other people.
    There needs to be mechanisms to be brought in to have an 
effective way to identify cases, identify contacts, and then do 
the appropriate public health measure, and that these have to 
be comprehensive. It is going to be developed one jurisdiction 
at a time.
    I see no reason why these are not transparent documents as 
they get completed. And, it really is a tribute to what the 
congressional support that you all have given so far. As I 
said, $1.6 billion got into the states for them to begin to do 
this, in addition of the resources that we have gotten.
    But, it is fundamental. People underestimate how important 
it is that we have a highly functional, comprehensive, 
aggressive contact tracing programs so that the next--for this 
outbreak, we still contain them. We don't have to switch to 
mitigation.
    Senator Jones. Alright. Thank you, Dr. Redfield. I 
appreciate it. It sounds to me like we have still got a lot of 
work to do. So, thank you.
    The Chairman. Thank you very much, Senator Jones.
    Senator Braun.
    Senator Braun. Thank you, Chairman. There has been so much 
discussion about testing in general. Listening to Senator 
Romney earlier; I think Senator Kaine mentioned it; everybody 
has.
    Dr. Hahn, if you remember when we first met, I said, Is the 
FDA going to be more entrepreneurial? Is the FDA going to kind 
of not be as stodgy? Talking then about how we fix the 
healthcare system in general. Now this has brought it into 
clear focus.
    I have a timeline that I am going to submit for the record 
that shows from January 24th through March 5th. And I want to 
emphasize what Senator Burr asked earlier, has the 
administration ever put an impediment in front of trying to get 
to testing?
    And, Dr. Hahn, this will end up in a question in a moment. 
But, there was a span of time, from January 24th through March 
5th, that I hope the American public looks at. It gets back to 
what is wrong with our healthcare system in general. Early 
testing, from what I am seeing, was created by the fact that 
the CDC said it was going to do its own test. The South Korean 
test that gets cited so often was not going to be looked at; we 
had to do our own. I know the FDA worked with the CDC.
    But the long and short of all of this is that for nearly a 
month, this was in that bureaucratic swirl. The FDA prevented 
private and academic development of tests for weeks. The CDC 
denied access to functioning tests, as I cited, in South Korea. 
This created, through all the red tape and bureaucracy, to 
where we had to come up with a one-size-fits all approach due 
to the uncertainty of the virus, and we are stuck with that 
now. I don't want to dwell on that necessarily because I think 
those are mistakes that we have made. I am tired of having it 
heard that it is the administration's fault.
    Dr. Hahn, I would like to ask you this question in that 
spirit of what we talked about during your nomination process. 
Here going forward, will we shed some of that stodginess? Will 
we look to get therapeutics and vaccines through the system in 
a quicker method? Because I fear if we don't, and if we treat 
through bureaucracy how we did the early period of testing, we 
can belabor this into the distant future. And, at that point, 
there is going to be not only the carnage from the disease 
itself, but from the economy to deal with.
    I would like your comment on that 1-month stretch, what 
accountability the FDA and the CDC have, and then whether it 
looks better in terms of moving more quickly into the future.
    Dr. Hahn. Thank you, Senator Braun, for the question. Our 
timeline of that period demonstrates that we began working with 
test developers beyond CDC on January 24th and had double digit 
number of test developers working with us. One of the issues 
that we identified was in fact availability of the virus and 
other supplies to actually get that test development done in a 
timely fashion.
    Senator, I completely agree with you that this is an 
opportunity for us to take a look and determine how we can do 
things better, and I think that is a really important thing for 
all of us to do, and certainly the FDA, I can promise you, will 
do that.
    Looking forward, sir, I can commit to you that we will look 
at every one of our regulatory authorities. We have done so 
during this outbreak. We have provided significant flexibility 
and have tried to provide the right balance between regulatory 
flexibility and enabling of the great test developers and 
therapeutic developers in this country with the need to ensure 
that our gold standard of safety and efficacy is in place.
    We have leaned in with manufacturers. We have learned a lot 
from them, as well as the other stakeholders, and we will 
continue to learn. And we will, I commit to you, sir, implement 
the changes that are necessary to make sure that we can act in 
a more nimble way but still protect the safety and efficacy of 
medical products.
    Senator Braun. Thank you.
    Dr. Fauci, taking a page from your anti-AIDs playbook that 
implemented a formal, clearly defined treatment review pathway, 
can we do that for COVID-19 in a similar parallel track that 
you put into place back then in the 1990's? In fact, I have a 
bill called the Promising Pathways Act that is based upon that 
protocol you put into place. Can we do that to more quickly get 
through to therapeutics and vaccines here with COVID-19?
    Dr. Fauci. Well, it is a different story, but some 
similarities if you are referring to the parallel track that I 
put into place back in the late 1980's, which was when there 
was no availability of drugs at all for HIV. And when we were 
testing drugs within a protocol, that we would make it 
available outside of the protocol in what has ultimately turned 
out to be compassionate use.
    What we did is we didn't want to interfere with the 
integrity of the protocol to determine in a controlled way what 
was safe and what was effective, but there was a dire need for 
some sort of accessibility to those drugs outside of a clinical 
trial for those who might even have some chance of having it. 
And, in fact, that was really in many respects the birth of the 
really firm concept of compassionate use.
    And, in fact, there is a version of that, which I will hand 
over to Commissioner Hahn, that is, when you have expanded 
access and Emergency Use Authorizations for drugs that have not 
yet been fully proven in a clinical trial. So, there is 
somewhat of an analogy and similarity between what I did in the 
1980's and what is actually being done by the FDA now.
    Steve, if you might want to comment on that?
    Dr. Hahn. I think that is right, Dr. Fauci. The Emergency 
Use Authorization process by statute allows us to have 
flexibility and assess the risk-benefit ratio in a public 
health emergency, and we have done that on the therapeutic side 
in three separate occasions and continue to look at those 
requests as they come in.
    The Chairman. Thank you very much.
    Senator Braun. Thank you.
    The Chairman. Thank you, Senator Braun.
    Senator Rosen.
    Senator Rosen. Here I am. Thank you, Mr. Chairman, for 
bringing this hearing. And I want to thank the dedicated 
doctors today for their lifetime of work and study and passion. 
We are a grateful Nation for all of your lifelong commitment in 
fighting disease. And not just the United States, but around 
the world.
    As I talk to Nevadans about safely reopening the economy, 
one question that frequently comes up is, so, when are we going 
to have a vaccine like everyone has talked about? In Nevada, 
travel and tourism, of course, the lifeblood for us, and the 
jobs associated with those industries, can only fully come back 
if we know it is safe to travel and visit or work in our 
hotels, casinos, restaurants, and attractions.
    Ultimately, to make this happen, we have to build 
confidence in our visitors that it is safe. We need a vaccine, 
and that research is extremely important. However, 
understanding that this takes time to develop and ensure both 
safety and efficacy, I would like to hear more about what 
research is happening regarding preventative medication 
research that could be helpful in the timeframe before a 
vaccine, and especially before one is widely available. So, I 
would like to ask if this could be part of a path in helping us 
begin to reopen our economy safely and bring visitors not only 
back to Nevada, but across our Country.
    Dr. Fauci, what research is currently happening to identify 
potential monoclonal antibody preventative treatments or other 
therapeutics? If the right antibody is identified or can be 
identified, could this be used as a preventative medication to 
block COVID-19 virus from latching onto those host cells, much 
like the treatments for rheumatoid arthritis, severe asthma, or 
other diseases? And second, would preventative medication 
options like this help complement the effectiveness of a 
vaccine once it is available?
    Dr. Fauci. Yes. So, thank you for that question, Senator 
Rosen. That is an excellent question. And, in all of the 
therapeutic interventions that we are developing, and you 
mentioned several of them, they could be direct antivirals 
along the line of Remdesivir, but that is just one of a number 
of possibilities since there are several viral targets in a 
replication cycle.
    Using convalescent plasma in a preventive modality, as well 
as monoclonal antibodies in a preventive modality, are in fact 
all feasible and will be pursued in parallel with the 
development of a vaccine. The model of using drugs and other 
interventions that are effective for treatment is really a 
great success story in the issue with HIV-AIDS because many of 
the interventions that were developed for the full treatment of 
an infected person are exquisitely effective in preventing 
infection of HIV.
    That is the kind of model that we work out in parallel with 
treatment for disease. It is using treatment as prevention. I 
believe that will be a part of our effort at the same time as 
we are putting a full court press on trying to get a vaccine. 
So, it is an excellent question. Very relevant.
    Senator Rosen. I know I have a short time left, so I am 
just going to kind of abbreviate this.
    The second most important question that I get, not just 
from our first responders and people worried about work, but 
generally, what does the next generation of PPE need to look 
like for all of us as we go about our lives? Not just as 
workers. Depending on your work, you may need something 
stronger, more specific, but as all of us--as we want to go out 
and shop or out to eat or whatever those things are, get on an 
airplane. Should masks be made of a certain material? Gloves? 
Are handkerchiefs effective? Can you talk about PPE for the 
general public?
    Dr. Fauci. Well, the best PPE for the general public, if 
possible, right now is to maintain the physical and social 
distancing. But, as we have said, and I think all of us would 
agree, there are certain circumstances in which it is beyond 
your control when you need to do necessary things, like go to 
the drug store and get your medication, go to the grocery store 
and get your food, that in fact you need some supplementation 
to just physical distancing.
    That is the reason why some time ago, the recommendation 
was made--I believe it was Dr. Redfield at the CDC who first 
said that--about getting some sort of a covering. We don't want 
to call it a mask because back then we were concerned we would 
be taking masks away from the healthcare providers. But, some 
sort of mask-like facial covering, I think for the time being, 
should be a very regular part of how we prevent the spread of 
infection. And, in fact, the more and more as you go outside 
right here where I am sitting in Washington, DC, you can see 
many people out there with masks on, which gives me some degree 
of comfort that people are taking this very seriously.
    Senator Rosen. Thank you.
    The Chairman. Thank you, Senator Rosen.
    Senator Loeffler.
    Senator Loeffler. Thank you all for being here and for your 
service.
    Admiral Giroir, before I start my questions, I want to 
recognize your new role as the U.S. Representative to the World 
Health Organization. Mitigating a resurgence of this pandemic 
will take global cooperation. In order to do that, we need 
accountability and transparency at the WHO. This organization 
was established to ensure the timely flow of accurate, unbiased 
information on global health emergencies, just as this. Reforms 
must be made in order to restore the trust that we need here. I 
hope you will work with our allies to push for these reforms.
    This question--I have two questions. The first one is for 
Dr. Redfield. And, Dr. Redfield, Georgians are wondering how we 
got here today. Fourteen hundred deaths, one-third of Georgia's 
workforce out of work. I am incredibly concerned about the 
cover-up and the misinformation coming from China and their 
efforts to suppress lifesaving information at the outset of 
this outbreak.
    As we can sit--as we continue to reopen our economy safely, 
we have to take steps to ensure that another outbreak cannot 
take hold of the world in this way. I understand CDC has worked 
with the Chinese CDC on global health security for decades. Can 
you comment on the level and the timing of the information that 
you received and relied upon from your Chinese counterparts as 
this virus emerged?
    Dr. Redfield. Well, thank you very much, Senator, and I 
want to echo how important global health security is as a 
national security priority for this Nation. We are going to 
need to be able to be able to respond to that as long as we are 
a Nation.
    CDC has had relationships with different countries from 
around the world. We have offices in over 45 countries right 
now, people in over 60, and one of those happens to be China, 
where we have a U.S. CDC that is with the Chinese CDC. And we 
have worked together for decades, particularly on influenza and 
emergent infectious diseases, and that has been a very 
productive, collaborative, scientific interaction.
    When this original outbreak of pneumonia of unknown 
etiology came from the original seafood market, there were 
obviously discussions with U.S. personnel in Beijing, with the 
Chinese CDC. I personally had discussions as early--I think CDC 
did as early as January 2d, and myself, January 3d with my 
counterpart to discuss this. So, at a scientific level, we had 
very good interactions. I think, that is different than the 
broader Chinese government level.
    Senator Loeffler. Thank you, Dr. Redfield. I have a final 
question for each of our great witnesses today, and it is one 
that my constituents often ask me.
    The mainstream media, and indeed some of my colleagues in 
the Senate, seem to want to paint each of your relationships 
with our President during this wartime effort as 
confrontational and lacking consensus. Can you categorically 
say here to the American people today whether this is true or 
untrue?
    From your testimony today, I have seen a very coordinated 
effort to address this with the administration to combat this 
pandemic. Can you give me a sense of whether this 
characterization--what the characterization is--whether it is 
true or untrue? Thank you. And I ask Dr. Fauci to answer that 
first.
    Dr. Fauci. Yes. No, there is certainly not a 
confrontational relationship between me and the President. As I 
mentioned many times, I give advice and opinion based on 
evidence-based scientific information. He hears that. He 
respects it. He gets opinions from a variety of other people. 
But, in no way in my experience over the last several months 
has there been any confrontational relationship between us.
    Senator Loeffler. Thank you. Dr. Redfield, Dr. Hahn.
    Dr. Redfield. Again, I would echo what Dr. Fauci said, that 
we are there to give our best public health advice, and that is 
what we do, and it is grounded in data and science. And I have 
always felt free to give the best public health advice that I 
think needs to be given at the time, and it has always been 
done in a very professional----
    Dr. Hahn. Senator Loeffler, this is Steve Hahn. I do not 
have a confrontational relationship, have not had a 
confrontational relationship with the President. He asks 
questions. I have given him my honest answers rooted in data 
and science, and he has listened respectfully to those, 
incorporating that into his decision making.
    Admiral Giroir. I have nothing else but to echo my 
colleagues. We work very closely together, all the scientists, 
all the physicians, of course Ambassador Birx, other scientists 
within our group. We have a very productive working 
relationship with each other and also with the President and 
Vice President. It would not be confrontational, and I 
certainly feel that we have the ability to honestly state our 
opinions and recommendations, and that has been that way since 
the beginning.
    The Chairman. Thank you, Senator Loeffler.
    Senator Murray, do you have closing comments?
    Senator Murray. I do, and if it is alright, I have a couple 
of--two quick questions.
    The Chairman. Sure.
    Senator Murray. Well, thank you.
    You know, Dr. Fauci, while President Trump claimed 
otherwise, there is no question that an essential part of 
reopening our economy safely is successfully developing and 
distributing a vaccine for COVID-19. We need to plan now to 
deploy a vaccine once it is proven safe and effective, but it 
is absolutely crucial this planning process, from the clinical 
trial to distribution and administration, recognizes and 
addresses racial and ethnic disparities in our healthcare 
system that, as we all know, for too long have been overlooked 
and unacknowledged in this country. And we have to ensure 
equitable access to this vaccine for everyone.
    Dr. Fauci, let me start with you. What steps is NIH taking 
to make sure that clinical trials for COVID-19 vaccines and 
therapeutics account for racial and ethnic disparities?
    Dr. Fauci. Yes. Thank you very much. That is a very 
relevant question, Senator Murray. And, in fact, the design of 
our clinical trials and the sites that we have chosen in our 
clinical trial network is going to be very representative of 
being able to get minority populations and populations at most 
risk to be part of the trial so that we know during the trial 
what the relative efficacy, as well as potential adverse 
events. It is something we started back in the days of HIV when 
we tried to get good demographic representation, and we are 
going to do that with these trials. Thank you.
    Senator Murray. Thank you. And Dr. Hahn, tell me what steps 
the FDA is taking now to make sure the United States is 
prepared to produce a sufficient number of vaccines, including 
the necessary manufacture and supply chain capacity, for 
supplies like vials and stoppers and syringes.
    Dr. Hahn. Thank you, Senator. This is an effort that 
started as a partnership with the vaccine developers and the 
NIH in their efforts.
    One of the most important things, ma'am, has been the data 
transparency, sharing of data, both with the agency, NIH, and 
with the manufacturers so we can understand what the capacities 
are; what the needs are from the supply chain; and then how to 
actually share that so that if one manufacturer's vaccine does 
not go forward, we can use the capacity of that manufacturer 
for another manufacturer's vaccine.
    I am very happy to report that the work of Dr. Marks and 
Dr. Fauci has led to that sort of effort. We have developed, as 
I mentioned before, this Gantt chart that describes all the 
steps that go forward with vaccination, including those 
supplies you described. It is somewhat complicated, ma'am, in 
that we may very well have hopefully five to seven different 
candidate vaccines that may need different supplies associated 
with them. But, we have been up front identifying those 
supplies, where they are available, and then working with the 
manufacturers to make sure that they are available.
    Senator Murray. Okay. Thank you. Thank you very much. And, 
Mr. Chairman, thank you, and thank you to all of our witnesses 
for joining us today.
    It is really clear to me that we have more work to do 
before we can safely get back to work and school and some 
semblance of normal life in our Country.
    We still need testing to be fast, free, and everywhere. And 
we need the White House to lay out a detailed, national plan to 
make that happen.
    We still need adequate personal protective equipment, both 
for our healthcare workers and for workers at our businesses 
and at schools when the time comes.
    We still need guidance from our experts so our communities 
have the information that they need to reopen schools and 
businesses safely, confidentially--confidently, and complete--
competently; and so public health workers and healthcare 
providers have the information they need to keep their patients 
and communities safe.
    While experts have been clear that the day we can safely 
reopen may be a ways off, there is plenty for us to do in the 
meantime, both to plan ahead--for example, to make sure that 
once we have a safe and effective vaccine, we can produce and 
distribute it to everyone quickly, equitably, and at no cost.
    To address the immediate challenges. For example, making 
sure there are appropriate mental health resources for everyone 
who is coping with the challenges that are prevented--presented 
by this virus. From the stress of physical isolation, loss of 
income, to the trauma and anxiety of patients and workers who 
have been on the front lines.
    I am going to keep pressing Congress and the White House to 
provide the action and the leadership that our communities 
need.
    And, I hope, Mr. Chairman, that we will continue to have 
the opportunities like this to hear directly from the experts 
and ask pressing questions about how to get our Country through 
this crisis. It has clearly got a lot further to go, a lot more 
to do.
    And, so, I hope that as our efforts continue, we will be 
able to bring any of you back, our witnesses, for another 
hearing soon.
    Again, thank you to all of you for joining us today.
    The Chairman. Thank you, Senator Murray.
    I have a clarification question and a couple of quick 
comments, and then we will thank the witnesses and wind up our 
hearing.
    My clarification is, I want to make sure I did not create 
some confusion by the way I asked the question about going back 
to school. I asked Dr. Fauci first about treatments and 
vaccines, and doctor--and Admiral Giroir second about testing.
    What I thought I heard was that Dr. Fauci said that 
vaccines are coming as fast as they ever have, but it will be 
later in the year at least--at the earliest before we see that; 
but there are some treatments that have--that are modest, but 
are promising--there could be more; but that doesn't mean you 
should not go back to school. That would be more for a testing 
strategy. Am I right, Dr. Fauci? You didn't say you shouldn't 
go back to school because we won't have----
    Dr. Fauci. No.
    The Chairman [continuing]. a vaccine by the fall?
    Dr. Fauci. No. Absolutely not, Mr. Chairman. What I was 
referring to is that going back to school would be more in the 
realm of knowing the landscape of infection with regard to 
testing. And, as Admiral Giroir said, it would depend on the 
dynamics of the outbreak in the region where the school is. But 
I did not mean to imply at all any relationship between the 
availability of a vaccine and treatment and our ability to go 
back to school. You are quite correct.
    The Chairman. Thank you. And what I heard from Admiral 
Giroir was that you are ramping up current technologies. You 
are hopeful for Dr. Collins' Shark Tank and the National 
Institutes of Health. But, in any event, you would expect to 
have the capacity in the fall of 40 to 50 million tests a 
month, and that ought to be adequate for the principal of a 
middle school, or even the chancellor of a campus, to design a 
testing strategy that could provide, for example, an antigen 
quick test to screen all the students in the school if 
necessary. Is that correct?
    Admiral Giroir. Yes, sir, Mr. Chairman. And again, we want 
to make as many tests available as absolutely possible. What I 
said is, what I feel comfortable with, knowing the production 
schedules, being in the position of being able to work with the 
FDA and CDC, that we should have 40 to 50--we will have 40 to 
50 million tests available per month that need to be deployed 
in a smart, strategic way, depending on the dynamics, in that 
area and in that region.
    Still, having testing even widely does not nullify the need 
that we are going to have to change our practices in terms of 
sanitation, personal cleanliness, distancing, face masks, 
things like that, given what the dynamics could be.
    The Chairman. Well, thank you for those comments, because 
given the--given that number of tests that will be available 
in, say, 3 months, or as we ramp up to that number 3 months 
from now, that should give every principal, every chancellor of 
every college campus--and again, we have about 5,000 campuses 
and 100,000 schools--some reassurance that testing, as well as 
the commonsense hygiene practices you talked about, could be 
used to develop a strategy for reopening school for school in 
August.
    And, then, two quick comments. One is, Senator Murray 
talked about the national plan, which was in the legislation 
that we all voted for. There is a little bit of a push and tug 
between what is national and what is Federal, what Washington 
should do and what the states should do.
    I have always thought it is a mistake to say Federal equals 
national. In other words, COVID-19 is clearly a national 
problem, but that does not mean the Federal Government is 
supposed to do everything.
    For example, in testing. The law actually requires states 
to tell you, Admiral Giroir, what their plans are, what their 
needs are. And, then, you said that during the month of May, 
you had a series of state plans that identified 12.5 million 
tests, and you thought you could help meet that.
    On the other hand, you have also noticed inefficiency in 
the marketplace for some supplies, so the Federal Government is 
buying those and allocating them to the states.
    We don't want to get in a situation where Admiral Giroir is 
telling all the states what to do. Governor Lee in Tennessee 
does not really want you to tell him what to do. He wants to 
tell you what he is doing and let you comment on it. I don't 
think Governor Cuomo wants President Trump telling him what to 
do. So, a push and tug between what Washington does and what 
the states do.
    I think we have a testing, contact tracing, isolating 
national strategy and plan led by the Governors, designed by 
the Federal Government, as a national effort. And then the 
national effort, clearly, is to do the research for the 
treatments and the vaccines, and what we have heard today is 
that is coming along on a faster track than we have ever seen 
before.
    Finally, I want to reiterate, I thought this was a very 
helpful hearing. I thank the Senators for their questions. I 
think anybody who took the time to watch would be impressed by 
the diversity of opinion and the honest answers we got from 
four really remarkable experts who are in the midst of this 
every day.
    I want to reemphasize what I said earlier, that I intend to 
make sure that we focus. Senator Murray suggested we need to 
have more hearings. I agree with her.
    And, as we deal with this pandemic, we need to make sure we 
are ready for the next one. What can we learn about faster 
treatments and vaccines for the next one? What can we learn 
about the stockpile, what ought to be in it, who ought to 
manage it for the next one? Or, what can we learn? Can we learn 
anything about having hospital beds so we don't have to shut 
down hospitals and bankrupt them and push patients out in order 
to create beds for sick people from the pandemic? What about 
states and hospitals that sell off their PPE in between 
pandemics?
    How do we keep our focus in between pandemics when we are--
have so many important things to be worried about in this 
country? How do we make sure that we, in Congress, sustain and 
fund all the things that we need to do? And, I want to make 
sure that we do that this year. I mean, our collective memory 
is short. So, while we are all worried about this, we need to 
not only deal with this crisis, but get ready for the next one.
    I thank the witnesses for their extra time. I hope they get 
a sense that our job, we see, is to create an environment in 
which you can succeed. Because if you succeed, our Country 
succeeds, which is what we desperately want.
    The hearing record will remain open for 10 days. Members 
may submit additional information for the record within that 
time if they would like. Thanks to everyone for being here 
today.
    The hearing is adjourned.

                          ADDITIONAL MATERIAL

                     food & beverage issue alliance
  Hearing on COVID-19: Safely Getting Back to Work and Back to School
    The Food and Beverage Issue Alliance (FBIA) represents fifty-eight 
allied U.S. based Food and Beverage Trade Associations. FBIA, through 
collaboration with regulatory authorities, ensures that any regulations 
and guidance are justified by verifiable, peer reviewed, published 
science that is accessible through an open and transparent process and 
enhance consumer understanding. In addition, FBIA works to ensure 
regulation implementation timelines are reasonable, achievable and 
economically feasible for both small and large food and beverage 
manufacturers. Find out more about FBIA and its members at 
www.feedingUS.org.
               Critical Infrastructure Access to Testing
    In March, the food and agriculture, consumer packaged goods (CPG) 
and retail industries respectfully requested that--as testing 
capabilities expand--the food and agriculture, CPG manufacturing and 
retail operations have prioritized access to testing in those 
situations where it helps protect workers. The current inconsistencies 
in testing approaches from State to State and between localities have 
resulted in the need to downscale or shut down operations altogether.
    Since their initial request, the number of food operations that 
have closed due to illness within their worker communities has 
increased, and at the same time, testing has become more accessible. 
Now more than ever, it is critical to keep the Food and Agriculture 
sector, CPG and retail industries operations functional to feed 
American families. What work is the agency doing to prioritize the 
testing resources for these sectors directly behind healthcare and 
first responders?
            State and Local Re-opening Testing Requirements
    State and local health officials throughout the country are asking 
for 100 percent testing prior to allowing businesses to reopen. While 
testing has become more accessible, but is still not readily available, 
do you believe that this is an appropriate request?
                Access to Personal Protective Equipment
    In March, the Food and Agriculture industries, including retailers, 
requested prioritization for PPE directly behind the healthcare sector 
and first responders. It is vitally important to protect these 
essential workers as businesses strive to stay operational, produce 
food and to keep grocery store shelves stocked for American families. 
What is being done to assist these sectors in securing needed supplies?
    Thank you for considering our questions. If you need any additional 
information, please contact me at [email protected].
                                 ______
                                 

    [Whereupon, at 1:30 p.m., the hearing was adjourned.]

                                   [all]