[Senate Hearing 116-523]
[From the U.S. Government Publishing Office]


                                                      S. Hrg. 116-523

                      COVID-19: UPDATE ON PROGRESS
                       TOWARD SAFELY GETTING BACK
                       TO WORK AND BACK TO SCHOOL

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION

                                   ON

  EXAMINING COVID-19, FOCUSING ON AN UPDATE ON PROGRESS TOWARD SAFELY 
                GETTING BACK TO WORK AND BACK TO SCHOOL

                               __________

                             JUNE 30, 2020

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
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        Available via the World Wide Web: http://www.govinfo.gov
        
                               __________

                    U.S. GOVERNMENT PUBLISHING OFFICE                    
45-224 PDF                 WASHINGTON : 2022                     
          
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming		PATTY MURRAY, Washington
RICHARD BURR, North Carolina		BERNARD SANDERS (I), Vermont
RAND Paul, Kentucky			ROBERT P. CASEY, JR., Pennsylvania
SUSAN M. COLLINS, Maine			TAMMY BALDWIN, Wisconsin
BILL CASSIDY, M.D., Louisiana		CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas		        ELIZABETH WARREN, Massachusetts
LISA MURKOWSKI, Alaska			TIM KAINE, Virginia
TIM SCOTT, South Carolina		MARGARET WOOD HASSAN, New Hampshire
MITT ROMNEY, Utah		        TINA SMITH, Minnesota
MIKE BRAUN, Indiana			DOUG JONES, Alabama
KELLY Loeffler, Georgia			JACKY ROSEN, Nevada

                                     
               David P. Cleary, Republican Staff Director
         Lindsey Ward Seidman, Republican Deputy Staff Director
                  Evan Schatz, Minority Staff Director
              John Righter, Minority Deputy Staff Director

                          
                           
                           C O N T E N T S

                              ----------                              

                               STATEMENTS

                         TUESDAY, JUNE 30, 2020

                                                                   Page

                           Committee Members

Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, Opening statement.........................     1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State 
  of Washington, Opening statement...............................     6

                               Witnesses

Fauci, Anthony, M.D., Director, National Institute of Allergy and 
  Infectious Diseases, National Institutes of Health, Bethesda, 
  MD.............................................................     9
    Prepared statement of Doctors Fauci, Redfield, Giroir, and 
      Hahn.......................................................    10
Redfield, Robert, M.D., Director, United States Centers for 
  Disease Control and Prevention, Atlanta, GA....................    27
Giroir, Brett, Admiral, M.D., Assistant Secretary for Health, 
  United States Department of Health and Human Services, 
  Washington, DC.................................................    29
Hahn, Stephen, M.D., Commissioner of Food and Drugs, United 
  States Food and Drug Administration, Silver Spring, MD.........    30

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
Senator Sanders:
    Testimony of Dr. Joycelyn Elders.............................    75

 
                      COVID-19: UPDATE ON PROGRESS
                       TOWARD SAFELY GETTING BACK
                       TO WORK AND BACK TO SCHOOL

                              ----------                              


                         Tuesday, June 30, 2020

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:05 a.m., in 
room G-50, Dirksen Senate Office Building, Hon. Lamar 
Alexander, Chairman of the Committee, presiding.
    Present: Senators Alexander [presiding], Burr, Paul, 
Collins, Cassidy, Murkowski, Scott, Romney, Braun, Loeffler, 
Murray, Sanders, Casey, Baldwin, Murphy, Warren, Kaine, Hassan, 
Smith, Jones, and Rosen.

                 OPENING STATEMENT OF SENATOR ALEXANDER

    The Chairman. The Committee on Health, Education, Labor, 
and Pensions will please come to order.
    First, some administrative matters. Based on the advice of 
the attending physician and the Sergeant at Arms, after 
consulting with the Department of Health and Human Services and 
the Centers for Disease Control, individuals in the hearing 
room are seated 6 feet apart. As a result, there is no room for 
the public to attend in person.
    Representatives of the press are working as a pool.
    The hearing may be watched online. An unedited recording 
will be available on our website, www.help.senate.gov.
    All of our witnesses today are participating in person. We 
thank you for that. Some Senators are participating by 
videoconference.
    Before I make my opening statement, I would like to say a 
word about masks. The Office of Attending Physician has advised 
us that we may remove our masks and talk into the microphone as 
long as we are 6 feet apart. So, that is why my mask is off 
right now, because I am 6 feet away from everybody else. But, 
like many other Senators, when I am walking the hallways or on 
the Senate floor, I am wearing a mask.
    People wear masks because CDC has said, ``Simple cloth 
coverings slow the spread of the virus and help people who may 
have the virus and do not know it from transmitting it to 
others.''
    Unfortunately, this simple lifesaving practice has become 
part of the political debate. It says this: If you are for 
Trump, you do not wear a mask. If you are against Trump, you 
do. That is why I have suggested that the President 
occasionally wear a mask, even though in most cases it is not 
necessary for him to do so. The President has plenty of 
admirers. They would follow his lead. It would help end this 
political debate. The stakes are too high for this political 
debate about pro-Trump, anti-Trump masks to continue.
    Around here, Senators and staff wear masks because we do 
not want to make each other sick. For example, I was exposed to 
COVID-19 by a pre-symptomatic staff member on my way to Dulles 
Airport and, as a result, had to self-quarantine for 2 weeks. 
The Senate physician told me that one reason I did not become 
infected was because the staff member was wearing a mask, and 
that, in the physician's word, greatly reduced the chances of 
an exposure.
    It is also a pretty good way to make a statement. I like to 
wear my plaid mask. Dr. Fauci uses his mask to demonstrate his 
loyalty to the Washington Nationals. Senator Kaine is either a 
cowboy or a bandit. I am never sure which.
    If you want college football to return this fall, here is 
what Coach Phillip Fulmer, our athletic director at the 
University of Tennessee says: ``If you really, really want to 
see some football this fall, wear a mask.'' That might have 
more influence than anybody else in Tennessee.
    The United States is in the midst of a very concerning rise 
in COVID-19 cases and hospitalizations in many states. The 
experts in front of us have told us that washing our hands, 
staying apart, and wearing a mask are three of the most 
important ways to contain the disease and slow the spread of 
the virus.
    I am grateful to the Rules Committee, the Sergeant at Arms, 
the Press Gallery, the Architect of the Capitol, the Capitol 
Police, our Committee staff, both Democratic and Republican, 
Chung Shek and Evan Griffis, and all for their hard work to 
keep us safe.
    Now, Senator Murray and I will each have an opening 
statement, and then we will turn to our witnesses, who we thank 
for being with us today. Each will have 5 minutes. We would ask 
you to summarize your testimony in 5 minutes, and then the 
Senators will have a chance to ask 5-minute round of questions. 
We have full participation today, it looks like. It should be 
an interesting morning.
    Among the casualties of this dangerous and very sneaky 
COVID-19 virus are the 75 million students who were sent home 
from school and college in March. Add to the casualties the 
teachers who were not prepared to teach remotely and the 
working parents who suddenly had children at home and who were 
not prepared to home school. Add the lost sports seasons and 
the once-in-a-lifetime graduation opportunities. Then there 
were unprecedented dilemmas for administrators and inadequate 
school budgets.
    Being sent home from school does not rank with the sickness 
and the death that the virus has caused. The United States has 
over 2.5 million cases of the virus and over 125,000 deaths, 
according to Johns Hopkins. While states and communities 
continue to take action to keep people safe, nothing, though, 
was more disruptive to American life, and nothing would head it 
back toward normalcy more rapidly than for those 135,000 public 
and private schools and 6,000 colleges to reopen this fall.
    Earlier this month, this Committee heard from college 
presidents and school leaders about their plans for safely 
reopening this fall. This hearing is an opportunity for an 
update and to hear from the Nation's top health experts on how 
headmasters, principals, superintendents, chancellors, and 
college presidents can open their schools safely just a few 
weeks from now.
    This Committee last heard from today's four witnesses on 
May the 12th, when three of the four were quarantined and most 
of the Senators were participating virtually. That was one of 
the first virtual Senate hearings in history, and surely the 
best watched. Every network carried the two-and-one-half hours 
of statements and questions and answers from Senators.
    The question before the country today is not whether to go 
back to school or college, or childcare or work, but how to do 
it safely. Even though COVID-19 does not, in general, hurt 
young children and college age students nearly as much as older 
and more vulnerable Americans, there is some health risk. But, 
in my view, the greater risk is not going back to school.
    Guidance for reopening schools from the American Academy of 
Pediatricians tells school administrators the following: ``Our 
academy strongly believes that all policy considerations for 
the coming school year should start with a goal of having 
students physically present in school.''
    The Academy continues, ``The importance of in-person 
learning is well documented.''
    There is already evidence of negative impacts on children 
because of school closures in the spring of 2020. Lengthy time 
away from school and associated interruption of supportive 
services often results in social isolation, making it difficult 
for schools to identify and address important learning 
deficits, as well as child and adolescent physical or sexual 
abuse, substance use, depression, and suicidal ideation. This, 
in turn, places children and adolescents at considerable risk 
of morbidity, and in some cases, mortality.
    Beyond the educational impact and social impact of school 
closures, there has been substantial impact on food security 
and physical activity for children and families, says the 
American Academy of Pediatricians.
    Dr. Lloyd Fisher, the incoming president of the 
Massachusetts Chapter of that Academy of Pediatricians, told 
reporters, ``While for most children COVID-19 has not had the 
devastating and life-threatening physical health effects that 
have occurred in adults, the negative impact on their 
education, mental health, and social development has been 
substantial.'' Nothing can take the place of the daily face-to-
face interaction our children experience when attending school 
in person, Dr. Fisher said.
    Many American colleges, overall considered the best in the 
world, will be permanently damaged or even closed if they 
remain, in Brown University President Christina Paxson's words, 
ghost towns.
    Mitch Daniels, the President of Purdue, wrote in a 
Washington Post op-ed, ``Failure to take on the job of 
reopening would not only be anti-scientific, but also an 
unacceptable breach of duty.''
    Today, in addition to hearing more about the concerning 
rise in cases and hospitalizations in some states, I would like 
to ask our witnesses in their statements and answers to 
questions to put yourselves in the place of one of America's 
approximately 14,000 superintendents of school districts, or 
the principal or headmaster of one of 135,000 schools, or as 
president or chancellor of one of 6,000 colleges, and help them 
answer the question of how to reopen schools and colleges 
safely.
    Dr. Fauci, I hope that in your opening statement or answers 
to questions, you will suggest steps a superintendent might 
take to open schools safely. And, not only how to keep children 
safe, but to keep safe the adults--teachers, parents, 
grandparents--with whom they come in contact.
    Dr. Hahn, will there be treatments or medicines this fall 
that will help speed the recovery from COVID-19 or reduce the 
possibility of death? I believe the fear of going back to 
school, or going anywhere these days, is in large part because 
of the fear of severe illness or even death. If that risk can 
be lessened by new treatments, it should increase confidence in 
going back to school.
    I would also like to commend Dr. Hahn and the work the FDA 
did to get tests on the market quickly as possible to help 
understand the spread of the virus. Since then, FDA has worked 
out which tests have not worked as well as they should and 
taken steps to remove them from the market. That is what is 
supposed to happen in the urgency of a pandemic.
    Admiral Giroir, at our last hearing, you said you expected 
there to be 40 to 50 million diagnostic tests available each 
month by September. Is that still true? And exactly how does a 
school district go about making sure it gets those tests and 
who pays for them? What are the prospects from the shark tank 
at the National Institutes of Health that there will be new, 
reliable, and inexpensive tests so we can have even more 
widespread testing?
    Dr. Redfield, you are continuing to work on updated 
guidelines about going back to school and college safely. Are 
CDC employees going to be available in our states to help work 
with school districts to develop their plans? And what advice 
do you have about the arrival of the flu season this fall at 
the same time as COVID-19?
    This is a lot to discuss, but there will be time during the 
next 2.5 hours to answer most of those questions.
    Let me quickly highlight three areas that have come up in 
our four earlier hearings this month that I think need 
clarification.
    First, on contact tracing. No doubt, contact tracing is 
crucially important. It identifies the people who might have 
been exposed so that people who do not--so that they do not in 
turn expose someone else.
    According to an NPR report on June 18, states have already 
hired at least 37,000 contact tracers. State officials and 
Johns Hopkins Center for Health Security issued a report 
estimating the need for as many as 100,000 contact tracers.
    Several reports suggested Congress appropriate money to pay 
for those tracers. The reality is Congress already has. On 
April 24th, Congress appropriated $11 billion, which has been 
sent to states and tribes for the expenses of testing. That 
legislation explicitly said the money could be used for contact 
tracing. This is in addition to $755 million from the first 
emergency appropriations legislation on March 6th that could be 
used for contact tracing, and that is in addition to the March 
27 legislation in which Congress appropriated $150 billion--I 
mean $1.5 billion in the CARES Act for states, territories, and 
tribes to use for COVID preparedness and response.
    The CARES Act also included the $150 billion to states, but 
a significant amount of that $150 billion has not been spent, 
even though it is all designated for expenses related to COVID-
19, which include contact tracing.
    For example, Tennessee's Governor has told me he is 
reserving as much as $1 billion of that so that he can 
determine what flexibility he has in spending the money.
    Washington State has not spent as much as $1.2 billion. 
Missouri State Treasury says they have not spent about $1 
billion.
    According to the report by state health officials and Johns 
Hopkins, an average salary for a contact tracer would be a 
little more than $35,000. This adds up to about $3.5 billion 
for 100,000 contact tracers. So, the point is, Congress has 
already sent to states plenty of money to hire all the contact 
tracers that are needed.
    Second, who pays for the testing? In the CARES Act, 
Congress voted to make all COVID-19 tests available to patients 
at no cost. This meant insurers would cover diagnostic tests, 
which detect whether a person is currently infected with the 
virus, and also antibody tests, which indicate whether a person 
has had COVID-19 in the past and now may have some protection 
in the future.
    Guidance from the Labor Department, Treasury Department, 
and Centers for Medicare and Medicaid Services said last week 
that insurers are only required to pay for tests without 
patient cost sharing if a doctor orders it. I agree with that. 
But, given that the CDC specifically recommends doctors order 
tests in two situations--when a person has signs or symptoms of 
COVID-19 or recently had contact with someone known or 
suspected to have COVID-19--who pays for the testing at other 
times? I believe Congress will need to take action to further 
clarify who pays for the testing at other times.
    For example, a school may want to do random testing. 
Perhaps it should make an arrangement with the state to pay for 
that. Or, perhaps Congress needs to provide more money to pay 
for that.
    If an automaker wants to test all of its employees at the 
plant every 2 weeks, perhaps the automakers should pay for 
that. Or, perhaps the state would want to pay for that. That 
needs to be clarified.
    Finally, flu shots. CDC has said more people need to get 
flu shots this fall so healthcare workers can better 
distinguish between COVID-19 and the flu. CDC says a priority 
is for all children over the age of 6 months to be vaccinated 
for the flu so they do not become sick and pass it to more 
vulnerable populations, who can have more severe consequences.
    On January 24th, Senator Murray and I hosted our first 
bipartisan briefing on coronavirus at a time when there were 
only four cases in the United States. Since then, this 
Committee has had four more briefings. Today is our eighth 
hearing on coronavirus and U.S. preparedness.
    Last week's hearing was about steps to take this year while 
our eye is on the ball to better prepare for the next pandemic. 
I have issued a white paper outlining five recommendations for 
Congress to prepare Americans for the next pandemic, and that 
paper has received more than 350 substantive comments that are 
available to all Members of the Committee.
    After all Senators have had a chance to ask their 
questions, I will conclude the hearing by asking our witnesses 
if they have two or three suggestions about steps Congress 
should take this year to deal with the next pandemic, most of 
which will also help with this one.
    But, this hearing is about what happens now as 
administrators prepare to reopen schools and colleges. Experts 
underestimated this dangerous and sneaky virus, and there is 
still much we do not know about it.
    But, we do know the basic steps to take to reopen schools 
and colleges in 2020, before there is a vaccine, and those are 
these: social distance, wear a mask, wash your hands, test, 
contact trace, and isolate those exposed or sick. And, 
hopefully, by the fall, there will be treatments to make the 
consequences of the disease less severe.
    I look forward to hearing from our distinguished witnesses 
how school leaders and college presidents can safely reopen 
135,000 schools and 6,000 colleges, and also learning the 
latest developments on testing and treatments that we can 
expect during the year 2020 before vaccines arrive.
    Senator Murray.

                  OPENING STATEMENT OF SENATOR MURRAY

    Senator Murray. Well, thank you very much, Mr. Chairman. 
Thank you to all of our witnesses for joining us here today. 
And, of course, thank you to our staff for setting up the 
technology so we can hold this hearing safely.
    I want to get to the point quickly, and I am going to be 
blunt about it. The COVID-19 response in our Country is still a 
disaster. One hundred and twenty-six thousand lives lost was 
once considered an estimate on the high end of the spectrum, 
but the year is just half way over and it is now a grim 
reality. We have lost more Americans to COVID-19 than we lose 
to the flu each year, than we lost to the opioid crisis last 
year, and more lives than we have lost in every American war 
except the Civil War and World War II.
    Despite what President Trump claims, this pandemic is not 
fading. Far from it. Several states are seeing rapid, record-
setting increases, and the Country just saw its largest single-
day increase to date.
    While this public health crisis rages across the Country, 
we have seen a leadership crisis raging in the White House. As 
the President proves time after time, he cares less about how 
this pandemic is impacting families and communities and more 
about how it makes him look.
    Just consider his appalling, continued failure on testing. 
President Trump said anyone that wants a test can get a test. 
They still can't.
    He said testing was overrated. It is not.
    He said we prevailed on testing. We have not.
    Now he is saying we should be doing fewer tests, and 
testing makes us look bad. Well, it clearly does not, and we 
clearly need to be doing more.
    The most honest thing he has said about testing is that he 
does not take responsibility at all, and that is exactly the 
problem. It is why Congress actually took bipartisan action in 
the last COVID-19 response bill to require the Trump 
administration to submit a comprehensive, national testing 
plan. That is why I am still pushing for this Administration to 
include more details in that plan and take more steps to ramp 
up testing. Because we are still nowhere close to the testing 
and tracing capacity we need to safely reopen our Country, and 
ending support for Federal testing sites, while sitting on 
billions in testing funds Congress provided, is not going to 
get us there.
    The ongoing struggle to get President Trump to take testing 
seriously should be a stark warning to Congress that, when it 
comes to vaccines, we cannot just leave this Administration to 
its own devices. We have to hold it accountable.
    We know this pandemic will not end until we have a vaccine 
that is safe and effective, that can be widely produced and 
equitably distributed, and that is free and accessible to 
everyone, which is why we need a comprehensive, national 
vaccine plan from the Trump administration as soon as possible. 
Given the testing plan, which Congress only received after 
forcing the Administration's hand, was too little, too late, we 
need to take the opportunity we have right now to get a vaccine 
plan much earlier and avoid the missteps we have seen with 
testing.
    I hope Republicans will work with me in a bipartisan way 
once again to require this Administration to put forward a 
plan. We need the Trump administration to show us how they will 
ensure a vaccine is safe and is effective. I am as eager as 
anyone for a vaccine. But this is not just about doing 
something fast; it is about doing it right. That is why we need 
to know the process for developing a vaccine is rigorous, it is 
inclusive, it is transparent, and it is science-driven.
    But, in light of the hydroxychloroquine debacle and the 
removal of Dr. Bright from BARDA for questioning the 
Administration's efforts to promote that unproven treatment, we 
cannot take for granted this process will be free of political 
influence. We have to demand serious oversight.
    In order to give the public full confidence that a vaccine 
is safe and effective, the Administration needs to commit now 
to being fully transparent about the standards a vaccine will 
be expected to meet and releasing the clinical trial data that 
FDA uses to evaluate safety and effectiveness.
    We also need a plan detailing how to produce and distribute 
vaccines nationwide and make sure everyone can actually get 
them. We saw with testing how avoidable bottlenecks create 
damaging delays when the Federal Government refuses to step in 
and lead like it needs to do in a time of crisis. And, 
unfortunately, we saw how existing health disparities are 
exacerbated without a plan to overcome them as even the 
incomplete data we currently have shows Black, Latino, and 
Tribal communities have significantly less access to testing 
than White communities. This is an injustice that we must not 
repeat when it comes to vaccines.
    We also need a plan to guarantee vaccines are free so that 
cost is not a barrier for patients. And, it is worth noting, we 
still need to act to make COVID-19 treatment available at no 
cost, too. And the plan must address barriers, like vaccine 
hesitancy and misinformation, especially when one of the most 
prominent sources of misinformation so far has been the 
President of the United States.
    While the discovery of an eventual vaccine may still be far 
off, these are issues we need the Administration to answer now. 
So, I hope Republicans will work with me to require the 
Administration to submit a comprehensive vaccine plan and 
address many of the other urgent issues stemming from this 
pandemic.
    Our businesses, our workers, teachers, students, and 
families do not have what they need to safely return to work or 
school, period.
    Our medical system, doctors, nurses, frontline workers 
continue to face unimaginable risk, stress, and fatigue. They 
need Congress to step up to help them continue to save lives.
    Families need us to continue to ensure they have basic 
services and can keep food on their tables.
    The House passed the HEROES Act 46 days ago to get more 
relief to frontline workers, to families, and businesses. It is 
well past time for Leader McConnell and Senate Republicans to 
sit down with fellow Democrats and get to work. There is no 
question our Country is still in crisis, and every day the 
Senate fails to take action is a day we allow it to get worse.
    I also hope, Mr. Chairman, that we will be able to have 
another hearing on this crisis soon with Administration 
officials, whose testimony is long overdue--Secretary Azar, 
Secretary DeVos, and Secretary Scalia.
    Thank you, Mr. Chairman. I look forward to our witnesses 
today, and testimony, and the questions that we have for them.
    The Chairman. Thank you, Senator Murray.
    We would ask each witness now to summarize his testimony in 
5 minutes. I am pleased to welcome our witnesses. Each of you 
are making significant contributions to our Government's 
response to COVID-19, helping us go safely back to school, back 
to work. We are grateful for your service to our Country.
    Our first witness is Dr. Anthony Fauci. He is director of 
the National Institute of Allergy and Infectious Diseases at 
the National Institute of Health. He has held this position 
since 1984. He has led the Agency's research related to HIV-
AIDS, influenza, malaria, Ebola, and other infectious diseases. 
He has advised six presidents on domestic and global health 
issues. He is one of the principal architects of the Emergency 
Plan for AIDS Relief. In 2014, he was involved in treating 
Ebola patients at NIH and worked on vaccine trials for Ebola.
    Next, Dr. Robert Redfield, director of the U.S. Center for 
Disease Control and Prevention, CDC. For more than 30 years, he 
has been involved with clinical research related to chronic 
human viral infections and infectious diseases, especially HIV. 
He was founding director of the Department of Retroviral 
Research within the U.S. Military's HIV Research Program and 
retired after 20 years of service with the U.S. Army Medical 
Corps.
    Third, Admiral Brett Giroir. Admiral Giroir is the 
Assistant Secretary for Health at the U.S. Department of Health 
and Human Services. He oversees the development of the 
Department's public health policy recommendations. Specific to 
COVID-19 response, Admiral Giroir has taken on testing and 
focused on increasing the number of tests we can do with 
existing technology. His Federal service includes directing the 
Defense Sciences Office of the Defense Advanced Research 
Projects Agency and a variety of other important 
responsibilities.
    Finally, we will hear from Dr. Stephen Hahn. Dr. Hahn is 
commissioner of the U.S. Food and Drug Administration, the FDA. 
Before joining FDA, he held leadership positions as chief 
medical executive at the University of Texas MD Anderson Cancer 
Center and as chair of the Department of Radiation Oncology at 
the University of Pennsylvania. Early in his career, he was 
senior investigator at the National Cancer Institute at the 
National Institutes of Health. He has been commander of the 
U.S. Public Health Service Commission Corps in 2005.
    We welcome our witnesses.
    Dr. Fauci, welcome. Let us begin with you.

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

    Dr. Fauci. Thank you very much, Mr. Chairman, Ranking 
Member Murray, Members of the Committee. Thank you for giving 
me the opportunity to discuss briefly with you today the role 
of the National Institutes of Health in research addressing 
COVID-19. And, as you indicated, Mr. Chairman, I will, during 
the question period and alluding to in the presentation, 
address some of the issues regarding schools.
    The NIAID NIH Strategic Plan for COVID Research involves 
four major components. The first is to improve the fundamental 
knowledge of understanding the biology of the virus and the 
immune response to the virus in order to better inform us in 
the development of diagnostics, therapeutics, and vaccines. 
Some of the work that has come out of that program right now 
informs very greatly how we will address vaccine development, 
particularly understanding the confirmation of the components 
of the virus that induce an appropriate immune response.
    In addition, we will develop and are developing animal 
models. Apropos of what you mentioned about children in school, 
we have a program called HEROS, which is Human Epidemiology and 
Response to SARS coronavirus, which is determining the 
incidence and transmissibility among children--a very important 
issue when you talk about opening schools and the impact that 
might have. In addition, the development of diagnostics, point-
of-care sensitive and specific diagnostics under the RADx 
Program, including the RADx-UP for underserved populations.
    Third, to characterize and test therapeutics. You mentioned 
the importance of this as we open up schools. There are a 
number of programs very active that have already shown efficacy 
or not in some drugs, as well as a number of clinical trials 
that are ongoing. One in particular was the first randomized 
placebo-controlled trial showing that the drug Remdesivir 
diminishes by about 32 percent the time it takes to get to 
recovery in people with advanced disease, pulmonary 
involvement. In addition, we have another study combining this 
with an anti-inflammatory agent.
    Next, we have vaccines. As several have mentioned, it is 
extremely important to have safe and effective vaccines 
available for everyone in this Country, as well as globally. In 
that regard, we put together, myself and some of my colleagues, 
and published in Science Magazine a few weeks ago what we call 
a Strategic Approach to Coronoavirus-19 Vaccine Research and 
Development. It is not a comprehensive plan about every aspect 
of vaccine, but it is a strong plan regarding the research and 
development pathway. And, what we have done in this is that we 
have what is called a harmonized effect because we know there 
are many vaccines that are in trial now at various stages.
    What we did, and the Federal Government, thanks to the 
generosity of the Congress, has put a considerable amount of 
money in order to harmonize the trials of multiple candidates 
from different companies so that we have common endpoints, 
common data and safety monitoring board, and common 
immunological parameters that are being funded and are being 
pursued.
    In addition, there are a number of different platforms that 
are being pursued so that we do not have all our eggs in one 
basket. As you know, one of those is right now getting ready as 
we approach next month of going into Phase 3 trials, and others 
will be staggered along the way in the middle of the summer, 
end of the summer, early on.
    There is no guarantee, and anyone who has been involved in 
vaccinology will tell you, that we will have a safe and 
effective vaccine, but we are cautiously optimistic looking at 
animal data and the early preliminary data that we will at 
least know the extent of efficacy sometime in the winter and 
early part of next year. Again, working with the companies and 
the investment made by this Congress, hopefully there will be 
doses available by the beginning of next year.
    These are the things that we feel aspirationally hopeful 
about, and we will continue to pursue this.
    I will stop there, Mr. Chairman, and be happy to answer 
questions later.
    Thank you.
    [The prepared statement of Doctors Fauci, Redfield, Giroir, 
and Hahn follow:]
      prepared statement of doctors fauci, redfield, giroir, hahn
                              Introduction
    Chairman Alexander, Ranking Member Murray and distinguished Members 
of this Committee. It is an honor to appear before you today to discuss 
the Department of Health and Human Services' ongoing response to the 
COVID-19 pandemic. We are grateful for this opportunity to address how 
each of our agencies and office are harnessing innovation to prevent, 
diagnose, and treat the novel coronavirus SARs-CoV-2.

    COVID-19 is a new disease, caused by a novel (or new) coronavirus 
that has not previously been seen in humans. This new disease, 
officially named Coronavirus Disease 2019 (COVID-19) by the World 
Health Organization (WHO), is caused by the SARS-CoV-2 virus. There are 
many types of human coronaviruses including some that commonly cause 
mild upper-respiratory tract illnesses. Coronaviruses are a large 
family of viruses. Some cause illness in people, and others, such as 
canine and feline coronaviruses, only infect animals. Rarely, 
coronaviruses that infect animals have emerged to infect people and can 
spread between people. This is suspected to have occurred for the virus 
that causes COVID-19. Middle East Respiratory Syndrome (MERS) and 
Severe Acute Respiratory Syndrome (SARS) are two other examples of 
coronaviruses that originated in animals and then spread to people.

    The Department of Health and Human Services (HHS) is working 
closely with all of our government partners in this response. We thank 
Congress for supporting our efforts through the passage of the 
Coronavirus Preparedness and Response Supplemental Appropriations Act, 
2020; the Families First Coronavirus Response Act; the Coronavirus Aid, 
Relief, and Economic Security (CARES) Act; and the Paycheck Protection 
Program and Health Care Enhancement Act. These laws have provided 
additional resources, authorities, and flexibility. Within HHS, the 
Centers for Disease Control and Prevention (CDC), the National 
Institute of Allergy and Infectious Diseases (NIAID), the Assistant 
Secretary for Health, and the Food and Drug Administration (FDA), along 
with additional components not represented today, play critical roles 
in the response to this public health emergency as discussed below.
               Centers for Disease Control and Prevention
    CDC is America's health protection agency, and works 24/7 to save 
lives and protect America from health, safety and security threats, 
both abroad and in the United States. CDC has a key role in 
preparedness and response, and addressing infectious diseases like 
COVID-19 is central to our mission. CDC is building upon decades of 
experience and leadership in responding to prior infectious disease 
emergencies, including SARS, MERS, Ebola, Zika, and the H1N1 pandemic 
influenza, to meet new challenges presented by COVID-19. These 
challenges are many, and they are historic. Every single American is 
affected by this pandemic, and CDC is leaning into this public health 
crisis with every applicable asset we have. CDC is drawing on its 
emergency response capacity and its relationships with state, tribal, 
local, and territorial (STLT), global, and private sector partners; and 
is leveraging our workforce's strengths in public health surveillance, 
prevention, and laboratory capacity, to develop and provide the Nation 
with the science-backed information and analysis needed to address this 
public health emergency. CDC has developed and continues to update 
guidance for healthcare professionals and the public to encourage safer 
practices, improve health outcomes, and save lives. CDC is also working 
with partners to develop guidance and decision tools to assist state 
and local officials and other stakeholders in adjusting mitigation 
strategies. Importantly, CDC is collaborating to prepare the Nation's 
public health system and the private sector to disseminate rapidly a 
vaccine to the American people when one is available. Abroad, CDC is 
leveraging investments in global health security, pandemic influenza 
preparedness and public health infrastructures and capacities built 
through Presidential initiatives, including the President's Emergency 
Plan for AIDS Relief to support countries in mitigating and containing 
COVID-19. In addition, CDC has staff in over 60 countries, who work 
very closely with host governments. Since the beginning of the 
outbreak, they have been providing technical assistance, and now 
programmatic funding, to help countries mitigate the effects of COVID-
19 and stop the disease from spreading. The emergence and rapid spread 
of COVID-19 confirms that an infectious disease threat anywhere is a 
threat to Americans everywhere, including here at home.

    When, in late December 2019, Chinese authorities announced a 
cluster of pneumonia cases of unknown etiology centered in Wuhan, 
China, CDC began monitoring the outbreak. At the beginning of January, 
CDC began developing regular situation reports, including input from 
our respiratory disease experts in the CDC Country Office in China, 
which were shared with HHS, and reaching out to the Chinese Center for 
Disease Control and Prevention to offer CDC support. By January 7, 
2020, CDC began expanding its incident management (IM) and response 
structure to facilitate staffing and communications. On January 21, 
2020, CDC officially activated its Emergency Operations Center for 
COVID-19. Using the IM structure, CDC immediately set up task forces to 
address key needs, reach out to our state and local partners, and 
deploy staff where needed to support state and local screening and 
investigation efforts. CDC is an integral part of the COVID-19 response 
and coordinates with other agencies through the Joint Coordination 
Center (JCC) led by Secretary Azar. Addressing COVID-19 is an all-of-
government effort.

    Congress has addressed the urgent need to respond to this pandemic 
at home and abroad and has allocated substantial resources for CDC's 
COVID-19 activities through the statutes mentioned above. This funding 
supports a federally guided, state managed, and locally implemented 
response to COVID-19 in the United States. With support provided by 
Congress for global disease detection and emergency response through 
COVID-19 appropriations, CDC is supporting prevention, preparedness, 
and response efforts in partnership with public health agencies, health 
ministry counterparts, and multilateral and non-governmental agencies 
worldwide. Here in the United States, CDC is working with STLT partners 
to focus use of these resources to establish and enhance case 
identification; conduct contact tracing; implement appropriate 
containment and community mitigation measures; improve public health 
surveillance; enhance testing capacity; control COVID-19 in high-risk 
settings; protect vulnerable and high-risk populations; and work with 
healthcare systems to manage and monitor capacity. As of June 22, 2020, 
CDC has announced or obligated $12.1 billion in direct awards to 
jurisdictions across America from the funds provided by Congress, 
including $10.25 billion from the Paycheck Protection Program and 
Health Care Enhancement Act.

    CDC is providing direct technical assistance and support to STLT 
partners as they consider approaches to mitigate and contain COVID-19. 
CDC has deployed 149 teams at the request of state, tribal, local, and 
territorial partners to provide infection prevention and control 
consultation and epidemiological expertise in support of those on the 
front lines of this battle. The White House, and Federal partners 
including CDC, have convened calls with all 50 states, Puerto Rico and 
the District of Columbia to identify state capacities and needs. The 
Federal Government has committed to ensuring that states can meet 
testing objectives for the month of June, as identified by each state. 
Through these calls and other outreach efforts, CDC has worked with 
jurisdictions to identify needs and develop plans to enhance testing 
capacity, state surveillance, contact tracing, and surge staffing. 
These discussions and plans for action will emphasize the need to serve 
vulnerable populations and include focused efforts for long-term care 
facilities, federally qualified health centers, and Tribal Nations, 
among others.

    In addition, CDC has launched a multifaceted approach to enhance 
and complement STLT efforts and expand support to communities during 
the current public health emergency, including deploying over 1,500 
individuals to over 100 locations across the United States. These 
support staff will augment health department teams and engage in core 
public health functions including contact tracing, testing, infection 
prevention and control, call center activities, COVID-19 education, and 
public health surveillance.

    CDC relies on timely and accurate public health surveillance data 
to guide public health action and inform the nationwide response to 
COVID-19. This crisis has highlighted the need to continue efforts to 
modernize the public health data systems that CDC and states rely on 
for accurate data. Public health data surveillance and analytical 
infrastructure modernization efforts started in fiscal year 2020 using 
funds provided by Congress, which have been augmented by $500 million 
provided for these efforts under the CARES Act. Timely and accurate 
data are essential as CDC and the Nation work to understand the impact 
of COVID-19 on all Americans, particularly for populations at greater 
risk for severe illness, such as older Americans, those with chronic 
medical conditions, and some racial and ethnic minorities.

    CDC is working with and providing support to STLT partners as they 
develop plans to conduct contact tracing. Contact tracing is a core 
disease control strategy that involves case and contact investigation 
followed by the implementation of an intervention (for example, 
isolation and quarantine) that interrupts disease transmission. Case 
investigation and contact tracer staff have been employed as local and 
state health department personnel for decades to address other 
infectious diseases, and contact tracing is a key strategy for 
preventing further spread of COVID-19 as well as a key component of 
state plans to reopen. As of June 5, 2020, CDC has posted 12 different 
guidance documents including case investigation guidelines, checklists 
for developing a case investigation and contact tracing plan, digital 
contact tracing tools, and a Contact Tracing Communications Toolkit for 
Health Departments.

    CDC is also working to understand the impact of COVID-19 on 
healthcare workers, first responders, and other essential workers. 
Accurate data are critical as we continue to assess the burden placed 
on the American healthcare system to inform reopening. CDC is 
capitalizing on multiple existing surveillance systems run in 
collaboration with STLT partners, including influenza and viral 
respiratory disease systems. In collaboration with STLT partners, CDC 
is committed to making data available to the public, while protecting 
individual privacy. CDC's population-based COVID-NET system monitors 
COVID-19 associated hospitalizations that have a confirmed positive 
test in greater than 250 acute care hospitals in 99 counties in 14 
states. Data gathered are used to estimate age-specific hospitalization 
rates on a weekly basis and describe characteristics of persons 
hospitalized with COVID-19 illness. CDC also is augmenting the existing 
National Healthcare Safety Network to monitor and analyze the capacity 
of the healthcare system daily--including hospitals and nursing homes--
so that Federal, state, and local officials can adjust their response 
and mitigation efforts as needed.

    CDC is using these data to monitor hospitalizations by race, 
ethnicity, underlying condition, age, and gender, and is now including 
this information in CDC's weekly COVIDView summary. CDC is now 
receiving more granular data on deaths by state and locality, allowing 
us to identify and work with individual jurisdictions to address where 
there may be racial and ethnic disparities in morbidity and mortality. 
CDC is leveraging all available surveillance systems to monitor COVID-
19 and protect vulnerable communities. CDC is using diverse systems to 
define a more complete picture of the outbreak, including race/
ethnicity data and is working with communities of color to protect 
communities at risk. CDC has recently updated the COVID-19 Case Report 
Form (CRF) to allow for better collection of data on populations that 
have previously been under-represented in reporting. The initial CRF 
included questions for sex, age, race and ethnicity and whether the 
case is part of a recognized outbreak. The revised form includes 
additional variables for populations that may be at higher risk for 
severe illness (e.g., tribes) and risk factors (e.g. homelessness, 
disabilities, and other factors). States have improved the completeness 
of their CRF reporting in the past two months; in particular, the 
percentage of reports that include race/ethnicity data has increased 
from 18 percent in April to 43 percent in early June. While progress 
has been made, CDC will continue to work with states to improve 
completeness of the data. Additionally, new reporting requirements that 
accompanied more than $10 billion in funding for states from the 
Paycheck Protection Program and Healthcare Enhancement Act require 
states to report race, ethnicity and other important demographic 
information with test results providing information on those impacted. 
Furthermore, race and ethnicity data for hospitalizations captured in 
CDC's COVIDNET has increased to more than 80 percent providing a much 
stronger picture of the different levels hospitalizations from COVID.

    Regarding laboratory support, from the outset, CDC laboratories 
have been applying sequencing technologies to SARS-CoV-2 and have made 
the data available through domestic and global data bases. CDC is 
leading the SARS-CoV-2 Sequencing for Public Health Emergency Response, 
Epidemiology and Surveillance (SPHERES), a new national genomics 
consortium to coordinate SARS-CoV-2 sequencing across the United States 
to do large-scale, rapid genomic sequencing of the virus. These 
advanced molecular detection and sequencing activities are being ramped 
up at the state and local levels to give us a clearer picture of how 
the virus outbreak is evolving and how cases are connected. CDC is 
engaged with the National Institutes of Health (NIH), the FDA, and the 
Biomedical Advanced Research and Development Authority (BARDA) to 
evaluate serology tests, and CDC is supporting serological surveys to 
help determine how laboratory testing can contribute to decisions about 
enabling Americans to return to work.

    CDC has developed a new serologic laboratory test to assist with 
efforts to determine how much of the U.S. population has been infected 
with SARS-CoV-2, the virus that causes COVID-19. The serology test 
looks for the presence of antibodies, which are specific proteins made 
in response to infections. It typically takes one to three weeks after 
someone becomes sick with COVID-19 for their body to make antibodies; 
some people may take longer to develop antibodies. The antibodies 
detected by this test indicate that a person has had an immune response 
to SARS-CoV-2, regardless of whether symptoms developed from infection 
or the infection was asymptomatic. However, it is important to point 
out that, at this point, we do not know whether the presence of 
antibodies provides immunity to the virus. Currently, CDC's serologic 
test is designed and validated exclusively for broad-based surveillance 
and research that is giving us information needed to guide the response 
to the pandemic and protect the public's health. The test is currently 
not designed to test individuals who want to know if they have been 
previously infected with COVID-19.

    During the week of March 30, CDC and public health partners began 
the first stage of antibody studies of community transmission of SARS-
CoV-2. These initial studies use serum samples collected in the State 
of Washington and New York City. In April, the second stage expanded to 
include serologic testing in more areas with high numbers of people 
with diagnosed infections. It also includes studies of households in 
some states. By using seroprevalence surveys, CDC can learn about 
people who have been infected, including those infections that might 
have been missed due to lack of symptoms or testing not being performed 
for other reasons. These surveys can also track how infections progress 
through the population over time. This is done by taking ``snap shots'' 
of the percentage of people from the same area who have antibodies 
against SARS-CoV-2 (also called the seroprevalence) at different time 
points.

    On April 27, 2020, CDC updated testing prioritization and focused 
testing guidelines for those who may have or who are at risk for active 
SARS-CoV-2 infection. Clinicians considering testing of persons with 
possible COVID-19 should use commercial or hospital clinical laboratory 
viral tests for COVID-19 that have been issued an Emergency Use 
Authorization (EUA) by FDA or are being offered as outlined in FDA's 
policy regarding COVID-19 tests or continue to coordinate testing 
through public health laboratories and work with their local and state 
health departments. Increasing testing capacity will allow clinicians 
to consider the medical necessity of COVID-19 testing for a wider group 
of symptomatic patients and persons without symptoms in certain 
situations. CDC recommends that clinicians should use their judgment to 
determine if a patient has signs and symptoms compatible with COVID-19 
and whether the patient should be tested. Other considerations that may 
guide testing are epidemiologic factors such as known exposure to an 
individual who has tested positive for SARS-CoV-2, and the occurrence 
of local community transmission or transmission within a specific 
setting/facility (e.g., nursing homes) of COVID-19. People with COVID-
19 have had a wide range of symptoms reported, ranging from mild 
symptoms to severe illness. Most patients with confirmed COVID-19 have 
developed fever and/or symptoms of acute respiratory illness (e.g., 
cough, difficulty breathing) but some people may present with other 
symptoms as well.

    CDC has developed a new laboratory test that checks for three 
viruses at the same time, two types of influenza viruses (A and B) and 
SARS-CoV-2, the virus that causes COVID-19. Testing for all three 
viruses simultaneously will allow public health laboratories to 
continue surveillance for influenza while testing for COVID-19. This 
will save public health laboratories both time and resources, including 
testing materials that are in short supply. Another benefit of the new 
test is that laboratories will be better able to find co-infections of 
influenza and SARS-COV-2, which is important for doctors to diagnose 
and treat people properly. CDC requested emergency use authorization 
(EUA) for this combined laboratory test from the U.S. Food and Drug 
Administration (FDA) on June 18, 2020. CDC expects that private sector 
laboratory test developers may be creating similar multiplex assays to 
meet clinician needs during influenza season. The American people, 
communities, public health professionals, medical providers, 
businesses, and schools look to CDC for trusted guidance on responding 
to COVID-19. CDC develops and disseminates guidance for a range of 
audiences, individuals and communities, including business, schools, 
and healthcare professionals. These recommendations include actions 
that every American should take, such as following good personal 
hygiene practices, staying at home when sick, and practicing social 
distancing to lower the risk of disease spread. CDC guidance is 
available here https://www.cdc.gov/coronavirus/2019-ncov/prevent-
getting-sick-prevention.html.

    CDC released consideration documents to help businesses and 
community organizations operate as safely as possible during the COVID-
19 pandemic, including K-12 schools and universities. These documents 
complement other CDC resources, including interim guidance documents 
that are posted online and the decision tools that help communities 
make decisions about resuming and gradually scaling up operations. 
These decision tree tools quickly walk through some key questions that 
should be answered in preparation for phased opening of schools, 
businesses, mass transit, and other settings. These suggestions are 
updated as we learn more about COVID-19 and as state and local leaders 
continue to decide how to adjust mitigation strategies in their 
communities. School administrators and officials can consult with state 
and local health officials to determine how to put these considerations 
into place. In addition, schools may need to make adjustments to meet 
their unique needs and circumstances.

    First responder and healthcare guidance documents cover a range of 
topics--from addressing potential work-related exposures, implementing 
infection prevention and control measures in health facilities, and 
optimizing the supply of personal protective equipment to clinical 
evaluation, testing, and clinical care. CDC is providing these 
recommendations to support communities' efforts, while recognizing that 
each sector and community is unique and will need to consider these in 
the context of their community-level data and circumstances. CDC teams 
on the ground and those aiding from Atlanta are and will continue 
working with state and local officials to integrate these 
recommendations into COVID-19 plans. CDC offers a framework for 
providing non-COVID-19 clinical care that outlines key considerations 
for healthcare systems and health care providers. Key considerations 
include monitoring trends in local cases and deaths, consulting with 
state or local health departments for region-specific information and 
recommendations, following recommended infection control practices, 
screening all patients for COVID-19 symptoms and expanding services 
gradually.

    Mitigation and containment of COVID-19 are the key to public health 
strategies, and CDC is committed to using our expertise and partnering 
with others on the frontlines. While surveillance, testing, contact 
tracing, and community mitigation interventions are the best tools we 
have right now, looking to the future, CDC continues to work to prepare 
our Nation's public and private health systems to deliver effectively a 
COVID-19 vaccine once it is available. This includes working with CDC's 
64 immunization grant recipients to help ensure that the U.S. 
immunization system can mount an effective vaccine delivery program, 
including vaccine distribution and tracking.

    While it remains unclear how long the pandemic will last, COVID-19 
activity will likely continue for some time. It is also unclear what 
impact the ongoing COVID-19 pandemic will have on health care and 
public health systems during the upcoming influenza season. If there is 
COVID-19 and flu activity at the same time, this could place a 
tremendous burden on the health care system related to bed occupancy, 
laboratory testing needs, personal protective equipment and health care 
worker safety. In the context of likely ongoing COVID-19 activity, 
getting a flu vaccine is more important now than ever. Getting a flu 
vaccine will help keep you and your loved ones out of a doctor's 
offices and hospitals and help conserve scarce medical resources to 
care for COVID-19 patients.

    CDC works with public health and clinical partners each year to 
increase the number of people who get the flu vaccine and eliminate 
barriers to vaccination. Ongoing COVID-19 activity may affect where and 
how flu vaccines are given. CDC is working with manufacturers to 
maximize flu vaccine supply and with providers and health departments 
to develop contingency plans so that people can be vaccinated in a safe 
environment.

    In addition, on June 4, CDC awarded $140 million to 64 
jurisdictions through CDC's existing immunization cooperative agreement 
to enable state health departments to launch an initial scale up for 
influenza season, given the increased risk of COVID-19. Funds will, 
among other activities, begin to support staffing and preparedness 
early this summer and focus on ensuring flu coverage for these 
vulnerable populations. Due to the risk of COVID-19, the goal is to 
increase flu coverage for vulnerable populations during the 2020-21 flu 
season, ensure Americans are aware of the importance of getting 
vaccinated this flu season, and increase access to flu vaccines for 
uninsured, high-risk adults.

    COVID-19 is the most significant public health challenge to face 
our Nation in more than a century. CDC is providing the American public 
with the information and assistance it needs to address COVID-19 head 
on. As we work together to fight COVID-19 and end this pandemic, CDC is 
committed to its mission to protect all Americans from disease threats 
and to save lives.
         National Institute of Allergy and Infectious Diseases
    NIH is the HHS agency leading the research response to COVID-19 and 
the novel coronavirus that causes the disease, SARS-CoV-2. Within NIH, 
NIAID is responsible for conducting and supporting research on emerging 
and re-emerging infectious diseases, including COVID-19.

    NIAID responds rapidly to threats of emerging infectious diseases, 
by accelerating fundamental basic research efforts, engaging a domestic 
and international basic and clinical research infrastructure that can 
be quickly mobilized, and leveraging collaborative and highly 
productive partnerships with industry. NIAID also provides preclinical 
research resources to scientists in academia and private industry 
throughout the world to advance translational research on emerging and 
re-emerging infectious diseases. These research resources help bridge 
gaps in the product development pipeline, thereby lowering the 
scientific, technical, and financial risks incurred by product 
developers and incentivizing companies to partner with us in developing 
safe and effective countermeasures including vaccines, therapeutics, 
and diagnostics.

    NIAID has a longstanding commitment to coronavirus research, 
including extensive efforts to combat two other serious diseases caused 
by coronaviruses: SARS and MERS. This research has enhanced our 
fundamental understanding of coronaviruses in general and provides a 
strong foundation for our accelerated efforts to address the specific 
challenge of COVID-19 by developing vaccines, therapeutics, and 
diagnostics.

    Developing Vaccines to Prevent SARS-CoV-2 Infection

    A safe and effective vaccine for SARS-CoV-2 will be essential to 
stopping the spread of infection, reducing rates of morbidity and 
mortality, and preventing future outbreaks. NIAID is supporting 
development of several SARS-CoV-2 vaccine candidates, including 
vaccines based on platform technologies that have shown promise against 
the coronaviruses that cause SARS and MERS.

    As part of a longstanding collaboration, the NIAID Vaccine Research 
Center worked with the biotechnology company Moderna, Inc., to develop 
a vaccine candidate using a messenger RNA (mRNA) vaccine platform 
expressing the SARS-CoV-2 spike protein. On March 16, 2020, NIAID 
initiated a Phase 1 clinical trial of this experimental vaccine at the 
Kaiser Permanente Washington Health Research Institute, and later added 
clinical sites at Emory University and the NIH Clinical Center. This 
trial was recently expanded to enroll older adults to better define the 
safety of and immune response to the vaccine across various age groups. 
On May 18, 2020, Moderna announced encouraging interim findings from 
the Phase 1 clinical trial and, on May 29, 2020, a Phase 2 clinical 
trial was initiated to further study safety and the immune response to 
the experimental mRNA vaccine. NIAID and BARDA are working with Moderna 
to launch a Phase 3 clinical trial as early as July 2020, pending 
positive results from this Phase 2 trial. The Coalition for Epidemic 
Preparedness Innovations (CEPI) funded the manufacture of the vaccine 
candidate for the Phase 1 trial, and BARDA is supporting advanced 
development of the candidate.

    Scientists at NIAID's Rocky Mountain Laboratories (RML) in 
Hamilton, Montana, are collaborating with University of Oxford 
researchers to develop a SARS-CoV-2 chimpanzee adenovirus-vectored 
vaccine candidate AZD1222, formerly known as ChAdOx1, now in a Phase 2/
3 clinical trial supported by the University of Oxford. BARDA recently 
announced plans to support advanced development and production of 
AZD1222. RML investigators also have partnered with University of 
Washington scientists to investigate another mRNA vaccine candidate 
against SARS-CoV-2. NIAID is working with additional academic and 
industry partners to develop several other vaccine concepts.

    The rigorous clinical testing required to establish vaccine safety 
and efficacy means that it might take some time for a licensed SARS-
CoV-2 vaccine to be available to the general public. The COVID-19 
response currently is focused on the proven public health practices of 
containment and mitigation.

    Identifying Therapeutics to Treat COVID-19

    Effective therapeutics for COVID-19 are critically needed to treat 
patients who have been infected with SARS-CoV-2. On February 21, 2020, 
NIAID launched a multicenter, randomized placebo-controlled clinical 
trial, the Adaptive COVID-19 Treatment Trial (ACTT), to evaluate the 
safety and efficacy of therapeutics for COVID-19, initially examining 
the antiviral drug remdesivir for treatment of severe COVID-19 in 
hospitalized adults (ACTT-1). The adaptive design of this trial will 
enable the evaluation over time of additional promising therapies, such 
as the anti-inflammatory drug baricitinib, which was recently added to 
the next iteration of the study (ACTT-2). An analysis of preliminary 
data from 1,063 patients enrolled in the ACTT-1 indicated that those 
who received remdesivir had a 32 percent faster time to recovery, a 
median of 11 days compared with 15 days for those who received placebo. 
Additionally, the analysis found that remdesivir may benefit survival, 
although the mortality data did not reach statistical significance. A 
mortality rate of 7.1 percent was observed for the group receiving 
remdesivir versus 11.9 percent for placebo. These initial findings were 
published on May 22, 2020, in the New England Journal of Medicine. 
NIAID is developing and testing other novel and repurposed therapies. A 
study to evaluate monoclonal antibodies (mAbs) in outpatients with 
mild-to-moderate COVID-19 is planned for launch in early July. NIAID 
also is planning separate clinical trials to assess hyperimmune 
intravenous immunoglobulin (IVIG) and mAbs for treatment of COVID-19 in 
hospitalized adults.

    On April 6, 2020, the National Heart, Lung, and Blood Institute 
(NHLBI) launched a clinical trial of HCQ in hospitalized COVID-19 
patients through its Prevention and Early Treatment of Acute Lung 
Injury (PETAL) clinical trials network. NHLBI also sponsored the 
addition of a U.S. site for a Canadian Institutes for Health Research-
funded trial of colchicine--an anti-inflammatory drug commonly used to 
treat gout--for treating COVID-19 in the outpatient setting. 
Additionally, NHLBI is leveraging the NIH-funded Strategies to Innovate 
Emergency Care Clinical Trials Network (SIREN) to study whether 
convalescent plasma, or blood plasma from individuals who have 
recovered from COVID-19, can help reduce the progression of COVID-19 in 
patients with mild symptoms.

    The National Center for Advancing Translational Sciences (NCATS) is 
leveraging the NCATS Pharmaceutical Collection, a compilation of every 
drug approved for human use by major regulatory agencies worldwide, and 
other collections of small molecules and compounds to identify 
potential SARS-CoV-2 therapeutics for further investigation. Other 
Institutes and Centers across NIH also are working concurrently with 
partners in academia and industry to pursue the development and testing 
of mAbs, antiviral, and anti-thrombotic drugs for potential treatment 
of COVID-19. NIAID, NCI, NHLBI, NCATS, the National Institute of 
Arthritis and Musculoskeletal and Skin Diseases, and the National 
Institute of Neurological Disorders and Stroke (NINDS) are all engaged 
in this critical effort.

    NIH, in collaboration with the Foundation for the NIH, recently 
launched an innovative public-private partnership to speed the 
development of COVID-19 therapeutics and vaccines. The Accelerating 
COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private 
partnership brings together stakeholders from across the U.S. 
Government, industry, and the European Medicines Agency to develop an 
international strategy for a coordinated research response to the 
COVID-19 pandemic. Other Federal partners include BARDA, DOD, the 
Department of Veterans Affairs, CDC, and FDA. NIAID has been asked to 
lead the effort of U.S. government-supported clinical trials for 
certain vaccine candidates and some therapeutic interventions that have 
been considered by ACTIV.

    NIH also has convened the COVID-19 Treatment Guidelines Panel, 
comprised of representatives of NIH and five other Federal agencies 
along with representatives of eight professional organizations, 
academic experts, and treating physicians including providers from high 
COVID-19 incidence areas. On April 21, 2020, the panel issued the first 
release of COVID-19 treatment guidelines for clinicians. The guidelines 
provide recommendations regarding specific treatments currently 
available and address considerations for special populations, including 
pregnant women and children. On May 12, 2020, in response to the 
preliminary analysis of ACTT-1, the Panel updated these treatment 
guidelines to recommend remdesivir for the treatment of COVID-19 in 
hospitalized patients with severe disease requiring supplemental 
oxygen, mechanical ventilation, or extracorporeal membrane oxygenation. 
The guidelines are updated regularly as new evidence-based information 
emerges.

    Enhancing Diagnosis and Understanding the Pathogenesis of COVID-19

    NIH is supporting an HHS-wide effort to promote the development and 
commercialization of diagnostic tests to detect current SARS-CoV-2 
infection. On April 29, 2020, NIH announced the Rapid Acceleration of 
Diagnostics (RADx) initiative, which is working to identify, support, 
and make innovative strategies for COVID-19 testing widely accessible, 
in collaboration with FDA, CDC, and BARDA. RADx is leveraging the 
Point-of-Care Technologies Research Network established by the National 
Institute of Biomedical Imaging and Bioengineering (NIBIB) to allow for 
the potential roll out of new products by fall 2020. This initiative 
expects to award up to $500 million to support development of point-of-
care and home-based diagnostic devices, as well as innovations that 
make current laboratory tests faster, more efficient, and more widely 
accessible. Innovators will be matched with technical, clinical, 
regulatory, business, and manufacturing experts to increase the odds of 
success. In addition, NIAID is using CARES Act funds to support diverse 
SARS-CoV-2 diagnostic platforms including RT-PCR and enzyme-linked 
immunosorbent assays, and facilitating development of sensitive, 
specific, and rapid diagnostic tests by providing critical SARS-CoV-2 
isolates and reagents to the developers of tests.

    NCI is coordinating with FDA and NIAID to assess the sensitivity 
and specificity of certain SARS-CoV-2 serological tests, which can 
detect antibodies indicative of a prior exposure to SARS-CoV-2. NCI and 
NIAID also are working to establish a collaborative national network to 
increase national capacity for high-quality serological testing with 
return-of-results to subjects. In addition, they will conduct research 
to increase the understanding and application of those results and 
support related clinical efforts, including clinical trials of 
convalescent serum and the creation of registries of tested subjects 
for sero-protection studies.

    NIAID, NCI, NCATS, and NIBIB also are partnering on a new study to 
investigate whether adults in the United States without a confirmed 
history of infection with SARS-CoV-2 have antibodies to the virus, 
indicating prior infection. In addition, NIH is supporting COVID-19 
natural history studies to understand the incidence of infection in 
specific populations, including children and their household contacts, 
and aspects of the clinical course of infection, including incidents of 
thrombosis, strokes, heart attacks, and other sequelae of infection. 
Some of these studies will examine the quality and durability of the 
immune response to SARS-CoV-2 and evaluate whether unique immune 
responses may be associated with clinical disease trajectories; this 
information may be leveraged to develop SARS-CoV-2 therapeutics or 
vaccines. Natural history studies also will inform our understanding of 
COVID-19 pathogenesis, including factors that may predict disease 
progression and help to identify individuals or groups at high risk.

    In order to improve understanding of neurological consequences of 
SARS-CoV-2 and inform potential treatment strategies, NINDS is 
supporting development of a data base that would collect data on the 
prevalence and spectrum of neurological symptoms observed in patients 
with SARS-CoV-2 infection. NHLBI and the Eunice Kennedy Shriver 
National Institute of Child Health and Human Development are leading a 
trans-NIH effort, with participation from NIAID, to coordinate research 
into the multisystem inflammatory syndrome in children (MIS-C), an 
extremely serious inflammatory condition that has been associated with 
SARS-CoV-2 infection in children and adolescents.

    NIH continues to expand efforts to elucidate the viral biology and 
pathogenesis of SARS-CoV-2 and employ this knowledge to develop the 
tools needed to diagnose, treat, and prevent disease caused by this 
virus. NIH is focused on developing and evaluating safe and effective 
COVID-19 vaccines and therapeutics, and sensitive, specific, and rapid 
point-of-care molecular diagnostic and serological tests. These efforts 
will improve our response to the current pandemic and bolster our 
preparedness for the next, inevitable emerging disease outbreak.
              Office of the Assistant Secretary for Health
    Diagnostics and Testing

    Testing for the presence of SARS-CoV-2 is an essential component of 
our Nation's response to the COVID-19 pandemic; its importance is now 
further magnified as states continue in their various stages of 
reopening. The indications for viral testing depend heavily on the 
stage of the pandemic and the extent of mitigation employed. In 
general, testing may be indicated for diagnosis of those who are 
symptomatic, tracing of those in contact with those who are infected, 
and surveillance testing of those who are asymptomatic or mildly 
symptomatic to achieve infection control and/or other public health 
objectives.

    The Administration has produced numerous documents that establish 
the strategy and specific tactics for testing in America. These 
include:

          White House: Testing Blueprint Opening Up America 
        Again

          White House: Addendum to the Testing Blueprint

          HHS: Report to Congress COVID-19 Strategic Testing 
        Plan

          CDC: Priorities for Testing Patients with Suspected 
        COVID-19 Infection

          CMS: Long Term Care Facilities (Skilled Nursing 
        Facilities and/or Nursing Facilities): CMS Flexibilities to 
        Fight COVID-19

          CMS: Nursing Home Reopening Recommendations for State 
        and Local Officials

    These will be followed soon with a number of additional guidance 
documents that apply the strategic principles to specific situations. 
In addition, the Administration is now reviewing testing plans from 
each state, territory, and major city public health unit, as a 
requirement of $10.25 billion in cooperative agreement funding 
distributed by the CDC.

    Currently, there are tests for the presence of the virus and tests 
for the presence of antibody to the virus. The former determines 
whether the individual is actively infected, and presumably infectious. 
The latter determines whether the individual has been infected, has 
developed an immune response, and may be protected from subsequent 
SARS-CoV-2 infections; however, research is ongoing in determining if 
past infection confers immunity. Today I will focus mostly on 
widespread testing for the presence of the virus, which has represented 
the primary challenge the Nation has faced since the onset of the 
pandemic.

    It is useful to understand the overall testing strategy in terms of 
its chronology and sequential objectives, and to understand that this 
virus was a new human pathogen for which no diagnostic tests had 
previously been developed. In addition, the predominant type of test 
relies on sophisticated RNA amplification technology that can only be 
done in a laboratory certified to perform moderate or high complexity 
testing. Point-of-care (POC) tests are an exception in that they are 
low complexity; however, this class of test still represents a minority 
of available testing capability and has a defined role because of its 
low throughput and relatively limited sensitivity especially early or 
late in the infection. Finally, the pandemic caused an unprecedented 
demand for all supplies and materials, such that overall demand in a 
single month approximated total annual demand of some essential 
supplies and materials. This reality represented substantial 
challenges, but Federal leadership has guided efforts to combat these 
challenges in close collaboration with states, local jurisdictions, and 
the private sector. Our overall strategy for testing includes:

          Assuring that those who need testing, receive 
        testing;

          Prioritizing testing to meet the stage of the 
        pandemic;

          Increasing the number, diversity, and quality of 
        tests;

          Enhancing states' ability to collect specimens 
        through novel ``front ends'' like drive-through community-based 
        testing sites;

          Organizing and galvanizing the industry on an 
        unprecedented scale;

          Enhancing testing to underserved communities;

          Providing surge testing capacity during local 
        outbreaks;

          Supporting critical infrastructure and national 
        security needs; and

          Enhancing reimbursement for tests to stimulate the 
        private sector, and providing additional incentives for testing 
        in nursing homes and vulnerable communities

    Stage 1: Launch: Engaging the Emerging Crisis

    In the early stages of the COVID-19 pandemic, the Centers for 
Disease Control and Prevention (CDC) was engaged in building the 
foundation for diagnostic testing in the United States. On January 10, 
2020, Chinese researchers deposited the 2019-nCoV genome sequence to 
GenBank and CDC began development of the CDC 2019-nCoV Real-Time PCR 
Diagnostic Panel. On January 24, CDC publicly posted its assay for the 
CDC's newly developed diagnostic panel, allowing the global community 
to develop their own assays using the CDC design. On February 3, CDC 
submitted an emergency use authorization (EUA) request, and the Food 
and Drug Administration (FDA) issued an EUA on February 4, just 24 
hours after receiving the complete package, enabling use of the CDC's 
COVID-19 diagnostic panel.

    Understanding the importance of increased testing, the FDA engaged 
test developers from the beginning of the pandemic. Any developer, 
including labs, could introduce tests through the EUA process, as they 
had during previous emergencies; and FDA encouraged labs and commercial 
manufacturers to do so swiftly, engaging with more than 550 test 
developers since January who indicated their intent to submit requests 
for EUAs. In mid-January, the Biomedical Advanced Research and 
Development Authority (BARDA) within ASPR convened a meeting of leading 
diagnostic companies from across America to encourage development of 
COVID-19 tests. In the ensuing months, multiple funding opportunities 
for the development of COVID-19 diagnostic tests were announced and the 
NIH provided COVID-19 RNA to diagnostic companies to expedite private-
sector test development. With a desire to ensure high quality 
diagnostic testing but also ensure rapid development and dissemination 
of COVID-19 tests, the FDA has provided voluntary EUA templates for 
laboratories and manufacturers in an effort to streamline the entire 
process, and works with developers who wish to use alternate approaches 
to the templates. FDA has issued a record number of EUAs for COVID-19 
tests. This has contributed greatly to the dramatic increases in 
testing the Nation has seen in the past months. The amount and 
expediency in which EUAs were issued for COVID-19 tests far exceed past 
viral outbreaks. For example, in response to the 2016 Zika Virus 
outbreak, FDA issued 20 test EUAs; in response to the 2009 H1N1 
outbreak, FDA issued 17 test EUAs. As of June 25, 2020, FDA has issued 
more than 150 COVID-19 test EUAs. The timeliness and number of EUAs 
issued by FDA for COVID-19 tests is unprecedented and has been critical 
to improving the testing scale and capacity in our country, while 
providing enough oversight to assure patients can depend on the results 
of these tests.

    Throughout the COVID-19 outbreak, the Administration has encouraged 
and worked collaboratively with diagnostic test manufacturers, 
commercial laboratories, public health laboratories, and professional 
societies to expand capacity and scale for existing nucleic acid 
testing platforms. Through the efforts of the Administration, the 
United States has developed a multilayered, multifaceted approach to 
testing that can provide the right test to the right person at the 
right time. This approach includes contributions from state public 
health labs, high-throughput commercial labs, academic and hospital 
labs, labs at CDC, the Indian Health Service, the Department of 
Defense, and the Department of Veterans Affairs. In addition, the 
ecosystem now includes POC testing that can be done in rural areas at 
high risk without sophisticated supporting infrastructure, or as a tool 
to investigate outbreaks in nursing homes or other confined settings.

    As of June 25th, our Nation has performed over 30 million tests, 
and now at a rate of between 400,000 and 500,000 tests per day; and 
this number will continue to increase. Commercial laboratories are 
working more efficiently, processing tests in rapid succession, which 
ensures patients receive their results, on average, within 3 days. 
Hospital and academic laboratories typically provide results within 2 
days, and often much sooner. POC tests provide results within 15 
minutes.

    To expand capacity and scale without impinging on the traditional 
health care system like emergency rooms and urgent care clinics, HHS 
worked closely with FEMA, interagency, and state and local partners to 
establish Community Based Testing Sites (CBTS). At the inception of 
this effort, the 41 federally supported sites were developed and 
established by the U.S. Public Health Service Commissioned Corps 
(Corps), in CDC-prioritized locations across the country. The Corps had 
unique expertise in COVID-19 testing, since many officers had deployed 
to Japan and elsewhere to assist in infection control, diagnosis, and 
eventual repatriation of American citizens. The initial objectives of 
CBTS were to screen and test healthcare facility workers and first 
responders, as prioritized by local jurisdiction. The CBTS model has 
been a success, having tested over 318,000 individuals, and with an 
overall COVID-19 test positive rate of approximately 13.5 percent, 
meaning that the CBTS are testing the right individuals at the right 
time. This effort has also supported and co-evolved with technological 
advances such as the validation of the FDA authorized use of nasal 
self-swabbing, which minimizes the need for trained health 
professionals and personal protective equipment. The CBTS initiative 
was an early example to states and localities on how to conduct 
community based COVID-19 testing, and this model has been replicated 
throughout the country to screen and test hundreds of thousands more 
Americans. Majority of the federally supported community based testing 
sites have been transitioned to be state led efforts and the few 
remaining sites will be transitioned in the weeks to come.

    From the onset in January, and continuing to the present, the 
President, Vice President, and senior Administration officials have 
held numerous briefings with Governors and their state leadership. Many 
of these briefings have focused on joint Federal-state efforts to 
expand testing throughout the country. In addition to these calls with 
the Nation's Governors, the White House and senior Administration 
officials have organized numerous calls to enhance state, local, 
territorial and tribal testing coordination efforts. The constant 
communication between the Administration and state leadership has 
helped provide guidance to states on how to best utilize testing 
capacity in their own states. Another product that was produced by the 
Administration to assist the states to leverage the full testing 
capacity at their disposal was a data base of nationwide lab locations 
and capacity, including the specific testing platforms at each 
laboratory.

    Stage 2: Scaling and Technological Innovation

    The identification and expansion of public and private sector 
testing infrastructure has been, and continues to be, a priority. One 
example of expanding testing infrastructure through public-private 
partnerships is the engagement of the Administration with well-known 
retailers that have a regional or nationwide footprint. As of June 26, 
and with the assistance of the Federal Government, U.S. retailers have 
opened and are operating 624 testing sites in 48 states and the 
District of Columbia, and they have tested over 774,000 individuals. 
The Federal Government built public-private partnerships to increase 
the number of testing sites offered at commercial locations across the 
country. The public-private partnerships with these retailers are being 
expanded to support many more testing sites that will be opened and 
operating in the coming weeks. These commercial testing locations are 
uniquely situated to meet the testing needs of communities with 
moderate to high social vulnerability, which was the focus of the 
original sites. Going forward, retailers have indicated their intent to 
open at least one thousand more of these sites depending on local 
needs.

    Another effort of the Administration to further support and expand 
the testing infrastructure in the United States has been strengthening 
the testing supply chain. The Administration has massively increased 
the availability of laboratory and testing supplies by engaging 
directly with distributors and manufacturers to increase production 
capacity through direct procurement, application of the Defense 
Production Act, formation of various public-private partnerships, and 
improved allocation criteria that ultimately help ensure that supplies 
meet the state's needs and reach the locations where the supplies are 
needed most. In addition, validation of additional supply types has led 
to a dramatic broadening of available supplies and reagents.

    In May alone, working collaboratively with FEMA and utilizing their 
logistics, the Federal Government has procured and began to distribute 
to states--according to their needs and plans--over 12.8 million 
specimen collection swabs and more than 8.9 million tubes of transport 
media. To meet state needs, this procurement and distribution will 
continue in June and the following months, as necessary.

    Stage 3: Support Opening Up America Again

    Current efforts are focused on further scaling up testing 
capabilities to guarantee that each state has the testing supplies and 
capabilities they need to reopen according to their own individual 
state plans. For example, the Federal Government procured over 20 
million swabs and tubes of transport media (or saline) in June. These 
supplies will be shipped out to states over the course of the next few 
months. ThermoFisher, which has more than 3,000 lab machines across the 
country, will be producing more than 10 million laboratory testing 
extraction and PCR kits per month, enabling states to complete millions 
of additional tests starting in May. In mid-March, the FDA issued an 
EUA for Hologic's Panther COVID-19 test, which runs on more than 600 
lab machines across the United States. Beginning in early May, Hologic 
began shipping several million test kits per month to labs across the 
Nation.

    The Administration will continue to work hand in hand with 
Governors to support testing plans and rapid response programs. The 
Opening Up America Again guidelines, provided by the Administration, 
describe roles and responsibilities as well as elements of the robust 
testing plans and rapid response programs called for in the President's 
Guidelines.

    The Laboratory Testing Task Force is providing technical assistance 
to all 50 states, tribes, and territories through calls with every 
state public health team to discuss their testing goals and the best 
mechanisms to achieve them. The Federal Government is assisting states 
to develop testing plans, supplying resources to help meet these 
testing plans, and deploying teams to states that need additional 
subject matter expertise.

    On May 24th, HHS delivered a COVID-19 strategic testing plan to 
Congress. This Plan is a direct outgrowth of the work done by the 
Laboratory Testing Task Force and Community Based Testing Task Force, 
both under the leadership of HHS and supported by FEMA personnel within 
the NRCC. It outlines how HHS increased domestic testing capacity 
across the United States and provides additional guidance and 
information about diagnostic technologies, platforms and inventory that 
states, territories and tribes can utilize to develop flexible, 
adaptable, and robust COVID-19 testing plans. This report fulfills a 
requirement of the Paycheck Protection Program and Health Care 
Enhancement Act, signed into law on April 24th. Furthermore, HHS 
recently distributed $11 billion in support to states, territories, and 
tribes to support implementation of jurisdictional testing goals as 
well as a broad array of activities associated with testing, as 
indicated in the Paycheck Protection Program and Health Care 
Enhancement Act.

    Because of the Administration's success in rapidly scaling up of 
the testing ecosystem, states will be fully equipped to conduct more 
COVID-19 tests per capita each month than most countries have tested 
cumulatively to this date.

    The Federal Government will continue to support Americans by 
providing expedited regulatory approvals for tests and equipment as 
necessary and appropriate, updating guidance for administering 
diagnostic testing, and catalyzing technological and scientific 
innovation. The process of reopening the United States will be one that 
is federally supported, state-led and locally executed.

    We recognize that vulnerable populations in many underserved 
communities are among the highest risk of suffering devastating health 
and economic impacts of COVID-19. The Office of Minority Health issued 
a Notice of Funding Opportunity on May 1. On June 23rd, the HHS Office 
of Minority Health (OMH) announced the selection of the Morehouse 
School of Medicine as the awardee for a new $40 million initiative to 
fight COVID-19 in racial and ethnic minority, rural and socially 
vulnerable communities. The Morehouse School of Medicine will enter 
into cooperative agreement with OMH to lead the initiative to 
coordinate a strategic network of national, state, territorial, tribal 
and local organizations to deliver COVID-19-related information to 
communities hardest hit by the pandemic. The three-year initiative will 
include the development and coordination of a strategic and structured 
network of national, state, territorial, and local public and community 
based organizations that will help mitigate the impact of COVID-19 on 
racial and ethnic minorities as well as rural and socially vulnerable 
communities across the Nation. The initiative also includes a national 
multi-media outreach and education effort. One of the primary goals of 
these information dissemination efforts is to provide additional 
education and community-level information on resources to help fight 
the pandemic to those who need it most.

    On June 4th, using authorities provided to the Secretary under the 
CARES Act, HHS released new mandatory laboratory data reporting 
guidance for COVID-19 testing. This guidance standardizes reporting to 
ensure that public health officials have access to comprehensive and 
nearly real-time data to inform COVID-19 response efforts, including 
data on demographic information such as race, ethnicity, age and 
gender. This will help ensure that all groups have equitable access to 
testing, and will equip public health professionals with the data to 
determine accurately the burden of infection on vulnerable groups.

    To further support testing efforts in underserved communities, in 
May the Health Resources and Services Administration (HRSA) awarded 
$583 million to 1,385 health centers to support COVID-19 testing 
efforts. Health centers serve over 28 million patients in 12,000 
service delivery sites across the Nation and in the territories. They 
provide care to 1 in 5 of those uninsured, 1 in 5 rural Americans, 1 in 
3 individuals below the poverty line, more than 1.4 million homeless 
individuals, and nearly 1 million migrant agricultural workers. Health 
centers are uniquely situated in communities to serve those that are 
most vulnerable and 93 percent of these centers offer COVID-19 testing. 
As of June 26, health centers have reported testing nearly 1.3 million 
individuals in total and racial and/or ethnic minority patients 
represent 55 percent of those tested in the past week.

    United States Public Health Service Commissioned Corps

    Since the early stages of the COVID-19 outbreak, the Corps has been 
an indispensable asset leveraged to address the public health needs of 
the Nation in response to this crisis. The Corps is one of the eight 
uniformed services of the United States and the only uniformed service 
committed to protecting, promoting, and advancing the health and safety 
of the Nation. Corps officers serve throughout the Nation in 
communities that are most in need by providing essential healthcare 
services to underserved and vulnerable populations.

    In January, the Corps deployed officers to provide expert outbreak 
response in direct support of CDC. Deployment expanded rapidly from 38 
officers on February 1, 2020 to more than 4,532 officers as of June 24, 
2020, with many of them undertaking multiple or consecutive 
deployments. Corps officers have been deployed across our country and 
internationally to assist with the outbreak response, to support the 
return of American citizens, to assist in the management of 
hospitalized U.S. citizens with COVID-19 abroad, and to support 
clinical trials related to COVID-19. Corps officers provided critical 
assistance to community-based testing sites throughout the Nation and 
their contributions to this effort are immeasurable. In response to the 
escalating crisis, the Corps established COVID-19 Clinical Strike 
Teams, which include officers from the variety of disciplines needed on 
the frontlines. This kind of ready-made unit allows the Corps to deploy 
a ``cavalry'' to support healthcare systems under stress in states 
across the country. COVID-19 Clinical Strike Teams have deployed to a 
long-term care facility in Kirkland, Washington, to the Javits Center 
in New York City, and to the TCF Center in Detroit. At the end of 
March, the Navajo Nation requested CDC assistance to provide care 
amidst a surge of COVID-19 cases. Since that time, the Corps has 
deployed teams to support the response. The Corps has also deployed two 
teams, totaling more than 70 officers, to the Pennsylvania and the 
Florida State Health Departments to provide infection control, personal 
protective equipment (PPE) training, and consultation to long term care 
facilities.

    The United States Public Health Service Commissioned Corps stands 
ready and willing to respond to the public health needs of our country 
and to provide essential healthcare services.
                      Food and Drug Administration
    From the beginning of this public health emergency, FDA has taken 
an active leadership role in the all-of-government response to the 
COVID-19 pandemic, inspired by the resiliency of the American people 
and our great innovators. FDA stood up an internal cross-agency group 
that continues to ensure we are doing everything possible to protect 
the American public, helps ensure the safety and quality of FDA-
regulated products, and provides the industries we regulate the tools 
and flexibility to do the same. Work has focused on facilitating the 
development and availability of medical countermeasures to diagnose, 
treat, and prevent COVID-19, surveilling the medical product and food 
supply chains for potential shortages or disruptions and helping to 
mitigate such impacts, as necessary to protect the health. This work is 
a key component of the Federal Government's efforts to address this 
pandemic and reopen the economy so Americans can get back to work and 
school.

    Diagnostic Testing

    An important part of FDA's role concerns determining whether the 
tests developed for clinical use in the United States provide accurate 
and reliable results and to help provide timely access to such tests. 
In general, during an emergency, including this pandemic, FDA oversees 
the validity of tests developed by others through the Emergency Use 
Authorization (EUA) process. Every action FDA has taken regarding 
testing during this public health emergency to address the COVID-19 
pandemic has balanced the urgent need to make tests available with a 
level of oversight to help ensure accurate tests are being deployed.

    COVID-19 has created a demand for new tests that is unprecedented 
in both volume and urgency. FDA has been extremely proactive and 
supportive of diagnostic test development by all comers, laboratories, 
and large and small commercial manufacturers. Even prior to any 
diagnosed U.S. cases of COVID-19, FDA proactively reached out to 
developers to encourage the development of tests and to offer 
assistance from the Agency to help facilitate development. To balance 
the urgent need to increase diagnostic testing capacity in the U.S. 
with the need to provide adequate oversight to help ensure that 
patients can depend on the results of these tests, FDA has announced 
several policies to facilitate oversight. These include engaging in 
rolling reviews of EUA submissions, and authorizing tests that have the 
necessary data to support that the criteria for issuance are met. To 
date, we have authorized more than 150 EUAs for COVID-19 tests. States 
that have the capacity and expertise to do so have been authorizing 
tests for use within a laboratory in that state.

    In a public health emergency, getting an accurate test is important 
not only for the individual patient, but for the public at large. False 
positive or false negative results can contribute to the spread of 
COVID-19, so all tests used for COVID-19 should be validated before 
use. FDA's public health emergency policies do not change that. As with 
medical treatments, we want tests to be safe and, accurate. FDA is 
monitoring imported test kit products and where appropriate detaining 
and examining them at the ports and border and is engaging in outreach 
when we become aware that test developers are making false or 
misleading claims about their tests. We are monitoring the market for 
fraudulent tests and are not issuing EUAs for tests that do not meet 
the EUA standards. FDA has and will continue to take appropriate action 
against firms and individuals that place the public health at risk. FDA 
updates its website continually to make clear which tests have been 
authorized by the Agency, and which tests have not.

    FDA has been working around the clock to (1) encourage and support 
test development for the U.S. market, working with over 500 developers 
since January; (2) issue EUAs for diagnostic tests, including those for 
home self-collections; (3) research and mitigate shortages of test 
components, including identifying and sharing scientifically acceptable 
alternatives for components on FDA's website; (4) arrange with the 
Department of Defense weekly airlifts of swabs to the United States; 
(5) engage nontraditional device manufacturers to support use of new 
swabs and other supplies that are needed in the United States; and (6) 
offer support to developers through a hotline and key resources, 
including FAQs that are updated regularly and serve as a clearinghouse 
for scientific information that helps everyone increase testing 
capacity.

    Serological Testing

    Serological tests measure the amount of antibodies or proteins 
present in the blood when the body is responding to a specific 
infection, like the virus that causes COVID-19. Such a test detects the 
body's immune response to an infection. These tests do not diagnose a 
current COVID-19 infection; however, they can play a critical role in 
the fight against COVID-19 by helping healthcare professionals identify 
individuals who may have overcome an infection in the past and may have 
developed an immune response. These tests may also aid in identifying 
individuals with antibodies to the virus that causes COVID-19 so they 
may donate convalescent plasma as a possible treatment for severely ill 
COVID-19 patients, which is a potential treatment currently being 
researched.

    In March, FDA issued a policy providing regulatory flexibility for 
developers of certain serological tests to market or use their tests 
once they have performed the appropriate evaluation to determine that 
their tests are accurate and reliable, without FDA authorization and as 
further recommended in the policy. The policy was intended to allow for 
early patient access and flexibility for developers, with appropriate 
transparency regarding the limitations of these tests. At the time FDA 
issued this policy, flexibility was important to allow for early use of 
antibody tests to begin to answer some of the critical population-level 
questions about the prevalence of COVID-19 infections in different 
communities, whether the presence of antibodies conveys immunity and, 
if so, for how long, while also encouraging test developers to seek an 
EUA, as many did. Answering these questions is critical for informing 
how best to use these tests, but we could not answer these questions 
without tests being available.

    Once FDA had authorized more serology tests, we built on this 
policy by updating it on May 4th and again on May 11th to outline key 
expectations for antibody test developers, including that commercial 
manufacturers would submit EUA requests, with their validation data, 
within 10 business days from the date they notified FDA of their 
validation testing or from the publication date of the policy, 
whichever was later. FDA also provided specific performance 
recommendations for serology test developers. The policy for 
laboratories certified under the Clinical Laboratory Improvement 
Amendments (CLIA) to perform high-complexity testing regarding their 
developing and performing their own serology tests was not changed. 
Such laboratories perform their own validation and provided 
notification to FDA while following other recommendations with respect 
to labeling as described in the policy.

    FDA has also introduced a more streamlined process to support EUA 
submissions and review. Two voluntary EUA templates for antibody tests 
have been made available--one for commercial manufacturers and one for 
CLIA certified high-complexity labs that decide to seek FDA 
authorization. These templates can help facilitate the preparation and 
submission of an EUA request and can be used by interested developers. 
Also, as we do for diagnostic tests, we are happy to work with 
developers of serology tests on other approaches if they do not want to 
use one of the templates.

    We are continuing to provide updated information and educational 
materials to states and health care partners. When particular 
commercial manufacturers that are currently marketing serology tests 
under the May 4th and May 11th policy fail to submit an EUA within 10 
business days of notification or policy publication (whichever is 
later), we have been removing those tests from our website notification 
list and are sharing this information publicly. We will also keep up 
our work to stop illicit tests from entering the U.S. and to keep 
fraudulent products off the market.

    In addition, FDA issued an umbrella EUA for certain antibody tests 
that undergo a validation evaluation at NCI or another government 
agency designated by FDA. Tests that FDA confirms meet the performance 
and labeling criteria, among other conditions outlined in the umbrella 
EUA, can be authorized under this umbrella EUA, streamlining the 
submission and review of these important tests.

    FDA will continue to appropriately balance assurances that an 
antibody test is accurate and reliable with timely access to such tests 
as the continually evolving circumstances and public health needs 
warrant. Importantly, we continue to work with developers of 
serological tests and are reviewing submitted EUA requests to authorize 
even more of these tests. I continue to work closely with my fellow 
Coronavirus Task Force members in examining the role testing will play 
as we look to reopen our country's schools, businesses, and public 
services.

    Vaccine and Therapeutic Development

    At this time, there is no FDA-approved vaccine to prevent being 
infected with COVID-19, nor are there any FDA-approved drug products to 
treat COVID-19. FDA is working closely with Federal partners, vaccine 
developers, researchers, manufacturers, and experts across the globe to 
help expedite the development and availability of vaccines and drugs to 
prevent or treat COVID-19 infections. FDA intends to use regulatory 
flexibility to help ensure the most efficient and timely development of 
safe and effective vaccines to prevent COVID-19.

    Since the beginning of the COVID-19 pandemic, FDA has been working 
tirelessly to facilitate the development and availability of 
therapeutics for use by patients, physicians, and health systems as 
expeditiously and safely as possible. FDA announced on March 31, 2020 
the creation of an emergency review and development program for 
possible therapies for COVID-19: the Coronavirus Treatment Acceleration 
Program, or ``CTAP''. The Agency is supporting the program by 
reassigning staff and working continuously to review requests from 
companies, scientists, and doctors who are working to develop 
therapies. Under CTAP, FDA is using every available authority and 
regulatory flexibility to facilitate the development of safe and 
effective products to treat patients with COVID-19.

    Further, FDA is partnering with the NIH in its efforts to develop a 
national strategy for a coordinated research response to the pandemic. 
The Accelerating COVID-19 Therapeutic Interventions and Vaccines, or 
ACTIV, partnership is developing a framework for prioritizing vaccine 
and drug candidates, streamlining related clinical trials, coordinating 
regulatory processes, and leveraging assets among all partners to 
rapidly respond to COVID-19 and future pandemics.

    There are a variety of therapeutic products being evaluated, 
including antiviral drugs and immunotherapies, that may be helpful in 
reducing lung inflammation and improving lung function in COVID-19 
patients. All this work is beginning to pay off, and we have announced 
the positive results of the NIAID trial of remdesivir in patients with 
severe COVID-19. On May 1, FDA issued an EUA for remdesivir for the 
treatment of suspected or laboratory-confirmed COVID-19 in adults and 
children hospitalized with severe disease.

    Another potential approach for treatment is the use of antibody-
rich products such as convalescent plasma and hyperimmune globulin. 
These blood products are manufactured from plasma donated by people who 
have recovered from the virus and such products are being studied to 
determine if they could shorten the length, or lessen the severity, of 
the illness. We are evaluating convalescent plasma in the context of 
clinical trials and facilitating a national expanded access program and 
emergency access for individual patients, as appropriate. A key to 
ensuring the availability of convalescent plasma to those in greatest 
need, as well as to supporting clinical development of convalescent 
plasma and hyperimmune globulin, has been by persuading fully recovered 
COVID-19 patients to donate plasma if they meet FDA's donor eligibility 
criteria. To that end, FDA continues to work with blood collectors to 
facilitate the collection of convalescent plasma, and to work with 
developers of these therapies to move forward with clinical 
evaluations. Thousands of COVID-19 patients have received 
investigational COVID-19 convalescent plasma under FDA's pathways for 
use of investigational products, including expanded access and clinical 
trials.

    Medical Product Supply

    FDA monitors and proactively adjusts to the worldwide demand and 
supply chain disruptions for medical products caused by the COVID-19 
pandemic. We are working closely with manufacturers to help ensure they 
continue to notify the Agency of any permanent discontinuance or 
interruption of drug, biological product, and device manufacturing in a 
timely manner. In addition to our usual communication with drug 
manufacturers, we are working closely with healthcare and pharmacy 
systems, hospitals, providers, and others on the frontlines of COVID-19 
patient care to identify current or emerging regional shortages of 
critical care drugs used to treat COVID-19.

    FDA understands the significant impact shortages can have on 
patient care and is doing everything within our authorities to help 
prevent and alleviate this impact. For example, we issued temporary 
policies under which outsourcing facilities registered with FDA and 
pharmacists in state-licensed pharmacies or Federal facilities can 
compound certain drugs used to treat patients with COVID-19 under 
particular conditions explained in FDA guidance.

    In addition, when we identify a shortage, we react swiftly to 
mitigate the impact to U.S. patients and health care professionals, and 
quickly share that information with the public. For example, the Agency 
quickly identified the need for making hand sanitizers available as 
demand spiked. FDA has published and updated three guidances to 
facilitate the production of alcohol-based hand sanitizer in non-
traditional settings such as pharmacies or distilleries. As another 
example, the Agency granted an EUA to authorize use of propofol 
approved in the European Union, thus alleviating a shortage of this 
critical drug for COVID-19 patients who need to be on a ventilator.

    We are working to increase the supply of personal protective 
equipment (PPE) and other critical devices that patients and those on 
the front lines of the U.S. response rely upon. FDA has reached out to 
over 1000 manufacturers since January and has helped facilitate an 
increase of the availability of PPE while taking steps to ensure that 
patients and our health care workers on the front lines can depend upon 
these products to protect them. FDA has issued several EUAs to help 
make more respirators available to health care personnel and ease 
burdens on the health care system. These allow for the emergency use of 
NIOSH-approved respirators in health care settings for healthcare 
personnel and the importation of non-NIOSH approved respirators that 
meet certain specified criteria, as set forth in the various EUAs. FDA 
has also issued several guidances to provide flexibility for those 
manufacturing PPE for the COVID-19 response, and we have published 
conservation strategies for gloves and masks and gowns. To support 
these efforts further, FDA has issued several EUAs for devices used to 
decontaminate respirators for reuse by health care workers in hospital 
settings, where appropriate.

    FDA has also issued guidances for several other critical devices 
including ventilators, clinical electronic thermometers, and imaging 
systems, as well as remote digital pathology and remote monitoring 
devices intended to help facilitate remote care that puts patients and 
health care providers at less risk for exposure to COVID-19.

    FDA has worked steadily to support those manufacturing PPE, as well 
as those who are dealing with limited supplies and shortages, to 
provide alternatives when there are no other options available. This 
includes initiating biweekly virtual town hall meetings for those 
seeking and manufacturing respirators to ask questions and discuss 
challenges they are facing.

    FDA's policies and active engagement with the medical product and 
healthcare community have helped to accelerate patient access to 
critical devices. FDA appreciates Congress including provisions in the 
CARES Act for additional device shortages authority during or in 
advance of a declared public health emergency and looks forward to 
continuing to work with Members of Congress to expand further these 
authorities, consistent with the fiscal year 2021 Budget so that we can 
address shortages in other situations as well.

    Food Supply

    FDA is working with our Federal, state, and local partners as well 
as industry to help ensure a safe and adequate food supply for both 
people and animals. I want to reassure you there is no evidence of food 
or food packaging being associated with transmission of COVID-19.

    Although food production and manufacturing in the United States 
remains strong, resilient, and is for the most part dispersed 
throughout the United States, some components are under stress. We are 
monitoring these situations closely and identifying mitigation 
strategies.

    There has been a significant shift in where consumers are buying 
food, because of the pandemic. We have taken steps to provide temporary 
guidance to provide flexibility in packaging and labeling requirements 
to help industry divert products manufactured for food service and 
institutional use to retail grocery stores.

    FDA recognizes that the food supply chain is dependent on the 
safety of the Nation's food and agricultural workforce. Along with our 
Federal partners, we have provided best practices for food and 
agricultural workers, industry, and consumers on how to stay safe, and 
help ensure the continuity of operations in the food and agriculture 
critical infrastructure sector during the pandemic and as retail 
establishments begin to reopen. FDA's Coordinated Outbreak Response and 
Evaluation team has been working throughout the pandemic, is fully 
staffed, and on-the-job looking for signs of foodborne illness 
outbreaks. FDA continues to monitor closely the overall safety of the 
Nation's food supply. Importantly, we continue to work with CDC, the 
U.S. Department of Agriculture, and our state and local partners to 
protect consumers from foods contaminated with pathogens. For example, 
in March, FDA found and detained Salmonella-contaminated tahini 
products at the port of entry; products that were already in U.S. 
distribution were recalled. Earlier this month FDA started 
investigating a multistate outbreak of Cyclospora illnesses potentially 
linked to store brand garden salads; three retailers have recalled the 
product.

    Fraudulent Products

    FDA exercises its regulatory authority to protect consumers from 
firms and individuals selling unproven products with false or 
misleading claims to prevent, treat, mitigate, diagnose, or cure COVID-
19, including by issuing warning letters and pursuing civil and 
criminal enforcement actions, where appropriate. For example, FDA has 
sent hundreds of abuse complaints to domain name registrars and 
internet marketplaces, which in most instances have voluntarily removed 
listings for products that fraudulently claim to diagnose, cure, 
mitigate, treat, or prevent COVID-19. The Agency also has sent more 
than 50 warning letters to sellers of such fraudulent products. Working 
with the Department of Justice, FDA has sought and obtained several 
preliminary injunctions that require defendants to halt the sale of 
fraudulent products claiming to treat or prevent COVID-19, including 
one product that, when used as directed, is equivalent to industrial 
bleach.

    In addition, FDA investigators remain on the front lines at ports 
of entry, quickly examining, reviewing, and sampling import entries, 
and refusing admission where appropriate. We protect the supply chain 
in two equally critical ways: first, we help ensure safe products are 
coming in and second, that illegal, dangerous and fraudulent products 
do not get into the country. As FDA import staff screen medical 
products entering our country, we also find and block the entry of 
fraudulent products that falsely claim to prevent, treat, mitigate, 
diagnose, or cure COVID-19. For example, in March, at the border, FDA 
intercepted fraudulent COVID-19 ``treatment kits'' that were falsely 
declared as ``water treatment.'' Import examination of these shipments 
found misbranded ``kits'' intended to treat SARS-CoV-2. This joint 
investigation, which included FDA's Office of Criminal Investigations, 
led to an arrest in the UK by law enforcement partners there. In 
addition, in April, FDA intercepted a bulk shipment of 
hydroxychloroquine coming from China going to a physician in 
California. The physician was charged with smuggling hydroxychloroquine 
from China to make his own pills and concealed the shipment from CBP by 
misdeclaring it as yam extract. In May, FDA worked with U.S. Customs 
and Border Protection (CBP) to intercept several shipments of 
counterfeit facemasks, with the result that they were refused and 
destroyed before getting into U.S. commerce.

    We are in close communication with our partners at U.S. CBP to 
proactively identify and mitigate any potential backlogs. FDA 
participates in FEMA Supply Chain Task Force meetings, providing 
regulatory support and subject matter expertise to respond to questions 
concerning medical products identified by FEMA, to facilitate the 
lawful entry and use of imported medical products coordinated through 
FEMA, and to inform medical product supply chain discussions.
                               Conclusion
    HHS appreciates the support and interest of Congress in our work 
related to COVID-19. We look forward to continuing to work together as 
the Country continues to open safely again. Thank you for the 
invitation to testify today and we look forward to answering your 
questions.
                                 ______
                                 
    The Chairman. Thank you, Dr. Fauci.
    Dr. Redfield, welcome.

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

    Dr. Redfield. Good morning, Chairman Alexander, Ranking 
Member Murray, and distinguished Members of the Committee. I 
want to thank you for the opportunity to testify before you 
today with my HHS colleagues.
    The COVID-19 pandemic is the most significant global public 
health challenge that we have faced as a Nation in more than a 
century. In the United States, daily cases are increasing after 
an extended decline. We are seeing significant increases in the 
southeast and southwest regions of this Nation. The number of 
jurisdictions in upward trajectory has continued to increase. 
Now 29 of 55 jurisdictions fall into this category.
    The evidence tells us that these cases are driven by many 
factors, to include increased testing, community transmission, 
and outbreaks in the settings, such as nursing homes and 
occupational settings. Hospitalizations now are going up in 12 
states. And, as of this weekend, daily death now has increased 
in the State of Arizona.
    CDC is closely monitoring these increases and have 48 teams 
with more than 140 staff currently deployed in 20 states and 
two territories. CDC is providing technical expertise to the 
health departments in epidemiology, contact tracing, infection 
prevention and control, and communication.
    Beyond providing this critical boots on the ground, CDC is 
working with your states and community in other ways. CDC is 
speaking with the states, tribal, local, and territorial health 
departments on a daily basis to develop strategies to stop 
COVID while reopening businesses and schools. The initial 
guidance for institutes of higher learning was shared in March, 
and the K through 12 setting was shared in February. Both these 
guidances have been updated since and over the past several 
months. As more information becomes available, we will continue 
to disseminate that more broadly.
    CDC released consolidated recommendations for COVID 
testing, including interim testing guidelines for nursing 
homes, as well as testing options for high-density, critical 
infrastructure workplaces after a COVID case is identified.
    Testing guidance for higher education and K through 12: the 
higher education should be posted today, and K through 12 later 
this week. These recommendations are consistent with previously 
published testing guidelines and are meant to supplement, not 
replace, the guidance of local jurisdictions.
    CDC continues to advance science around the COVID-19 impact 
in certain populations and those who are at heightened risk for 
severe outcomes. Our most recent analysis of the United States 
case data from the pandemic, hospitalizations were six times 
higher and death 12 times higher among those with reportedly 
underlying conditions compared to those who did not have these 
conditions.
    We have expanded the list of underlying conditions where 
the evidence is clear that they put people at higher risk of 
severe illness. These conditions include chronic kidney 
disease, COPD, having a weakened immune system from a solid 
organ transplant, obesity, serious heart disease, sickle cell 
disease, and Type 2 diabetes.
    Our analysis also provides further evidence that racial and 
ethnic populations are disproportionately affected by this 
epidemic.
    While data is the backbone of this response, containing the 
outbreak depends on four core interventions: readily available 
testing, comprehensive contact tracing, timely isolation of 
known cases, and quarantine to break the transmission.
    We are not defenseless against this disease. We have 
powerful tools at our disposal--social distancing, wear a face 
cover in public, and be disciplined about the frequent hand 
washing.
    It is critical that we all take the personal responsibility 
to slow the transmission of COVID-19 and embrace the universal 
use of face coverings. Specifically, I am addressing the 
younger members of our society, the Millennials, and the 
Generation Zs. I ask those that are listening to spread the 
word.
    Before I close, I would like to speak briefly about how CDC 
is assisting the frontlines of our health departments to fight 
COVID. With your support, CDC has awarded $12 billion to 64 
jurisdictions. Data modernization is underway. Public health 
laboratories are building resilience. Number of contact tracers 
have grown 345 percent.
    The disease impacts us all, and it is going to take all of 
us working together to stop it. Together, I believe we can 
achieve the possible.
    Thank you, and I look forward to your questions.
    The Chairman. Thank you, Dr. Redfield.
    Admiral Giroir, welcome.

 STATEMENT OF ADMIRAL BRETT GIROIR, M.D., ASSISTANT SECRETARY 
   FOR HEALTH, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN 
                    SERVICES, WASHINGTON, DC

    Admiral Giroir. Chairman Alexander, Ranking Member Murray, 
and distinguished Members of the Committee, it is good to see 
all of you again.
    First, I want to clarify my current role. On March 12th, 
Secretary Azar requested that I lead the coordination of COVID-
19 testing efforts within the Department. To be clear, although 
I am assuming some of my traditional duties as the assistant 
secretary, I am maintaining my role of coordinating testing, 
including now the NIH RADx Diagnostics Program, along with Dr. 
Collins, to assure that innovations are immediately translated 
into practice.
    In order to get back safely to work and school, the 
overarching, most critical, and essential action we must first 
accomplish is to control the virus, meaning rapidly 
extinguishing any outbreaks and minimizing community 
transmission. All of us are concerned about recent data from 
several states, indicating rising infections, and now an uptick 
in hospitalizations and deaths even as other states and the 
majority of counties are maintaining a low infection burden.
    Knowing what we know now about asymptomatic transmission, 
and the fact that we are in a much better position today in 
terms of our mitigation strategies, PPE, and testing, we can 
reverse these concerning trends if we work together.
    First, we must take personal responsibility and be 
disciplined about our own behavior. Maintain physical 
distancing. Wear a face covering whenever you cannot physically 
distance. Wash your hands. Stay at home if you feel sick. If 
you have been in close contact with someone infected or at a 
gathering without appropriate precautions, get tested. Shield 
the elderly and the vulnerable of any age. And, follow the 
guidelines for opening up America again. The criteria are very 
specific and are as relevant today as when we released them.
    In addition, this week we are initiating surge testing in 
multiple communities of highest concern in coordination with 
state and local officials.
    Now, back to schools and businesses. As Dr. Redfield 
stated, the CDC will release recommendations on K through 12, 
institutions of higher education, and general business 
reopening. These will include considerations for integrating 
testing, especially surveillance testing, into a comprehensive 
strategy.
    As you asked me, Mr. Chairman, if you are a superintendent 
of a school system or a president of a university, No. 1, apply 
the CDC guidelines in consultation with your state and local 
public health officials so that testing is a part of your 
comprehensive plan, which should also include prevention and 
clear mechanisms to isolate positive students.
    No. 2, assure your testing needs are incorporated into your 
state testing plans. As we outlined in the national testing 
strategy, each state has developed and will continue to build 
upon a customized-to-state testing plan developed in full 
coordination with the Federal Government.
    The next iteration, covering July to December, is due on 
July 10th. These state plans drive the allocation of certain 
scarce resources. For example, in May and June, the Federal 
Government has distributed nearly 26 million collection swabs 
and over 19 million tubes of transport media.
    HHS also prioritizes allocation of certain key laboratory 
tests, like point-of-care tests, according to state-specific 
needs.
    There are also strategies particularly relevant to 
surveillance testing, especially in universities and 
businesses. For example, pooling of samples, meaning combining 
two or more samples, and possibly up to 10, into a single test 
makes sense where the prevalence of infection is low, and such 
pooled surveillance testing can be conducted in a university 
research lab outside of a CLIA environment. But, if a pooled 
sample is positive for COVID, every individual in that pool 
would need to be tested through a health system.
    I would like to close by recognizing my fellow officers in 
the United States Public Health Service Commission Corps, the 
uniformed service that I lead. Four thousand, five hundred, and 
thirty-six officers have deployed to support the pandemic 
response, exemplifying the care and compassion that all of us 
feel for those who have suffered during this pandemic. I thank 
each and every one of these officers and their families. And, 
on their behalf, sincerely thank all of you in Congress for 
supporting our training needs in establishment of a ready 
reserve corps to supplement our rank during inevitable future 
national emergencies.
    Thank you for the opportunity to provide these remarks.
    The Chairman. Thank you, Admiral Giroir.
    Welcome, Dr. Hahn.

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

    Dr. Hahn. Thank you, Chairman Alexander, Ranking Member 
Murray, and Members of the HELP Committee. I appreciate very 
much the support that you all have provided for our efforts 
during this time of COVID-19.
    FDA has a vital role in the Federal Government's response 
to the pandemic. One of our core missions is to advance the 
public health by helping to speed medical products that are 
safe and effective. We have provided appropriate regulatory 
flexibilities to assure that the American public has access to 
critical medical products and safe food, and confidence that 
our decisions are based on medicine and science.
    Since the public health emergency was declared, FDA has 
issued more than 100 Emergency Use Authorizations for 
diagnostic tests, personal protective equipment, ventilators, 
other devices, and drug products. And, we have issued more than 
50 guidance documents to ensure the continuity of healthcare in 
the food supply.
    I am pleased to announce that today, FDA is taking action 
to aid the timely development of a safe and effective vaccine 
to prevent COVID-19 by providing guidance for developers with 
recommendations on the data needed to facilitate manufacturing, 
clinical development, and approval. We recognize the urgent 
need to develop a safe and effective vaccine to prevent COVID-
19, and we want to work collaboratively with industry, 
researchers, and other partners to accelerate these efforts.
    While the FDA is committed to help expedite this work, we 
will not cut corners in our decisionmaking. And, we are making 
clear in our guidance what are the data that we need that 
should be submitted to meet our regulatory standards of 
approval. This is particularly important as we know that some 
people are skeptical of vaccine development efforts.
    The FDA strongly encourages the inclusion of all--of 
diverse populations in all phases of clinical development, 
including populations most affected by COVID-19, and 
specifically racial and ethnic minorities, as well as adequate 
representation in late-phase trials of elderly individuals and 
those with medical comorbidities. We also have information in 
this guidance about including women who are pregnant, as well 
as for pediatric assessments of safety and effectiveness.
    The American people should know that we have not lost sight 
of our responsibility to maintain our regulatory independence 
and ensure that our decisions related to all medical products, 
including COVID-19 vaccines, are based on sound science and the 
available data. This is a commitment that the American public 
can have confidence in and that I will continue to uphold 
personally.
    While vaccine research is ongoing, rapid testing and 
therapeutic development can aid in the safe return to school, 
college, and the workplace. FDA is constantly evaluating new 
data we receive on testing so that we can promote the 
development of new and better tests, and remove tests that are 
not reliable from the market.
    We have put into place an initiative to accelerate the 
development of treatments called the Coronavirus Treatment 
Acceleration Program, or CTAP. We have seen some of the 
consequences of that program, such as the authorization of 
Remdesivir and the recent information regarding other 
therapeutics that might be of benefit to patients with COVID-
19.
    We are working day and night to provide guidance to and 
review proposals from companies, scientists, and researchers, 
who are developing therapies for COVID-19.
    We are now preparing for the next phase of addressing this 
evolving crisis. It is mission-critical that the Agency 
constantly evaluate whether our processes are maximal to 
promote and protect the public health, and therefore, we are 
beginning a comprehensive real time review and assessment of 
our actions to date to address the COVID-19 pandemic, and I am 
glad to answer questions about that review.
    I want to thank the more than 17,000 FDA employees, who 
have been working night and day to help expedite medical 
products, but also to provide the necessary oversight with the 
appropriate science and data. We know that the virus remains 
with us. FDA is committed to doing the critical work that will 
get the Country to the point at which Americans judge it safe 
to return to work and school as quickly as possible. I am 
incredibly proud of the dedicated women and men of the FDA, 
whose commitment to defeating this pandemic has been 
unwavering.
    I can assure you the FDA will continue to provide 
leadership, expertise, guidance, and information as we continue 
to address this unprecedented challenge and fulfill our mission 
to protect and promote public health.
    Thank you, and appreciate and look forward to your 
questions.
    The Chairman. Thank you, Dr. Hahn. And thanks to each of 
our witnesses.
    We will now begin a round of 5-minute questions. All the 
Senators are participating today--almost all--and so I would 
ask the Senators and the witnesses to try to keep each segment 
within 5 minutes.
    Dr. Fauci, assume I am superintendent of one of 14,000 
school districts. In our community, we understand that there 
are health risks for children going back to school, but we have 
concluded that the risks of--to their education, mental health, 
and social development is a greater risk if they don't go back 
to school.
    What would your advice be to a school superintendent about 
what he or she should be thinking about as children go back to 
school in a few weeks to keep it safe?
    Dr. Fauci. Thank you for that question, Mr. Chairman. It is 
an important question, but I think we need to point out that it 
really will depend on the dynamics of the outbreak in the 
particular location where the school is. And one of the things 
we want to emphasize, and have been emphasizing, is to take a 
look at where you are in the particular area of the so-called 
opening America again. Are you at the gateway? Phase 1? Phase 
2? Phase 3? The CDC has guidelines about the opening of schools 
at various stages of those checkpoints.
    The basic, fundamental goal would be, as you possibly can, 
to get the children back to school and to use the public health 
efforts as a tool to help get children back to school.
    Let me explain what I mean. In other words, if we adhere to 
guidelines of what we have heard in many of these presentations 
you just heard about--the physical distancing in the community, 
the use of masks, things like that--that will help to keep the 
level of infection in the community down, which will then make 
it easier to get the children back to school.
    If you are in an area where you have a certain amount of 
infection dynamics, there are things that can creatively be 
done about modifying things like the school schedule--alternate 
days, morning versus evening, allowing under certain 
circumstances online, virtual lessons. Those are the kind of 
things that we need to consider.
    But, also importantly, always make the goal that it is very 
important to get the children back to school for the 
unintended, negative consequences that occur when we keep them 
out of school.
    The Chairman. Thank you, Dr. Fauci.
    Dr. Redfield, one of the concerns would be that children, 
who have--who, generally speaking, have not been damaged nearly 
as much as adults, particularly elderly adults, by this virus 
might carry the virus to their teachers, administrators, or 
parents or grandparents at home.
    It seems to me that the availability of treatments this 
fall, medicine for the environments that reduce the risk of 
sickness and death, could be very important in increasing 
confidence in going back to school. You mentioned some of those 
in your testimony. Are there others? What would the 
availability of treatments be this fall? And, specifically, 
what about so-called antibody cocktails of the kind that were 
developed for Ebola and approved by the FDA?
    Dr. Redfield. Well, I think that would be a great question 
also for Dr. Fauci. I am going to make a small statement. He 
may want to add to it.
    Clearly, we do have Remdesivir, as you mentioned. We have 
now evidence that steroids can improve therapy. And, as you 
mentioned, we have convalescent plasma, that Steve Hahn could 
comment on, that is using the antibodies from individuals that 
have gotten better from COVID, that are currently under 
evaluation and potentially be available.
    The Chairman. I have just a minute, Dr. Redfield. Let me go 
to Dr. Hahn and let him answer that question, too. Thank you.
    Dr. Hahn. As I mentioned, Remdesivir has been authorized 
based on its reduction in hospitalization days. The steroids 
were mentioned. Convalescent plasma, we have evaluated the 
safety through a large, expanded access program at the Mayo 
Clinic and it has been found to be safe in over 20,000 patients 
administered it. We are waiting for the safety data, and we 
will be passing those data along to BARDA, who is the sponsor 
of that program.
    I think that antibody data will help us in terms of the 
development of monoclonal antibodies. We have a number of 
sponsors who have come in for monoclonal antibody studies. We 
are already well into that treatment. Monoclonal antibodies are 
synthetic antibodies that will provide--that the theory is will 
provide protection against the infection of the virus. And, we 
are hopeful that those studies by the late summer, early fall 
will provide us information about their effectiveness and 
safety. And as you----
    The Chairman. You are optimistic that there will be more 
than one treatment available this fall for teachers, 
administrators, older adults?
    Dr. Hahn. Yes, sir, I am optimistic.
    The Chairman. Thank you very much.
    Senator Murray.
    Senator Murray. Thank you very much to all of our 
witnesses. We all very much appreciate your service and your 
work.
    Dr. Fauci, last time you testified before this Committee, 
you warned us of needless suffering and death if states begin 
reopening too early. And just over a month later now, we are 
seeing a record number of cases. We do not have enough tests 
and we do not have enough contact tracers. And just yesterday, 
CDC's Dr. Schuchat said we have too much virus to control in 
the U.S., arguing, and I quote, ``This is really the 
beginning.''
    Our strategy has not worked. I wanted to ask you, what do 
the Federal Government and the more than 30 states with rising 
case numbers need to do to reverse this trend?
    Dr. Fauci. Thank you very much for that question, Senator 
Murray. I am also quite concerned about what we are seeing 
evolve right now in several of the states. As you know, in four 
of the states--in Florida, Texas, California, and Arizona--more 
than 50 percent of the new infections are in the those areas 
where we are seeing surges.
    The things we need to do I think you alluded to in your 
question to me. We have to make sure that when states start to 
try and open again, they need to follow the guidelines that 
have been very carefully laid out with regard to checkpoints. 
What we have seen in several states are different iterations of 
that. Perhaps maybe in some, going too quickly and skipping 
over some of the checkpoints.
    But, even in states in which the leadership in the form of 
the Governors and the mayors did it right with the right 
recommendations, what we saw visually in clips and in 
photographs of individuals in the community doing an all-or-
none phenomenon, which is dangerous. And by all-or-none, I mean 
either be locked down or open up in a way where you see people 
at bars, not wearing masks, not avoiding crowds, not paying 
attention to physical distancing.
    I think we need to emphasize the responsibility that we 
have both as individuals and as part of a societal effort to 
end the epidemic, that we all have to play a part in that.
    I think if you look at the visuals, what we saw were a lot 
of people who maybe felt that because they think they are 
invulnerable--and we know many young people are not because 
they are getting serious disease--that therefore, their getting 
infected has nothing at all to do with anyone else when, in 
fact, it does. Because if a person gets infected, they may not 
be symptomatic, but they could pass it someone else, who passes 
it someone else, who then makes someone's grandmother or 
grandfather, sick uncle, or a leukemic child on chemotherapy 
get sick and die.
    We have got to get that message out, that we are all in 
this together. And if we are going to contain this, we have to 
contain it together.
    Senator Murray. Well, I assume that would mean that elected 
and community leaders need to model good public health behavior 
and wear a mask.
    Dr. Fauci. We recommend masks for everyone on the outside, 
anyone who comes into contact in a crowded area. You should 
avoid crowds where possible. And when you are outside and not 
have the capability of maintaining distance, you should wear a 
mask at all times.
    Senator Murray. Thank you.
    Dr. Redfield, last week Dr. Julie Gerberding, who served as 
the CDC director under President George W. Bush, testified to 
our Committee that if she were in charge, one of her top 
priorities would be the creation of a national vaccine plan 
that addresses the science, development, allocation, uptake, 
and monitoring of a vaccine, saying, ``We know this is in our 
future, and we are not ready for it.''
    I could not agree more. And that plan has to detail how the 
Federal Government will scale up manufacturing, coordinate the 
supply chain so we avoid the missteps we saw with testing. It 
needs to combat misinformation and vaccine hesitancy, and make 
sure that vaccine distribution addresses health disparities, 
and a lot more.
    Dr. Redfield, do you agree a plan like that is needed?
    Dr. Redfield. Senator, I think it is very important that we 
have an integrated plan for this vaccine.
    Senator Murray. When can we expect to see one?
    Dr. Redfield. Well, I am going to ask Dr. Hahn if he would 
like to comment. I know recently they had a vaccine plan for--
at least for the FDA's perspective. CDC is working on the 
issues that you said that I think are so important in building 
vaccine confidence----
    Senator Murray. Well, can you tell me----
    Dr. Redfield [continuing]. In this Country.
    Senator Murray [continuing]. When the CDC will be giving us 
their plan since CDC would be writing the comprehensive plan?
    Dr. Redfield. We are developing a plan as we speak. And 
again, depending--building on the efforts that we have to 
rebuild what I call vaccine confidence in this Country, which 
is really critical. And then on top of that, there will be a 
very defined plan for distribution of this vaccine, 
prioritization of this vaccine----
    Senator Murray. But you cannot tell----
    Dr. Redfield [continuing]. Monitoring for safety of this 
vaccine.
    Senator Murray [continuing]. Us if it will be a couple 
weeks? A couple months? The end of the year? Do you have any 
estimate on when we will see that plan?
    Dr. Redfield. Well, it is currently in development within 
the group, and, I would anticipate that we will see that plan 
in the near weeks ahead, Senator.
    Senator Murray. Weeks, not days or months?
    Dr. Redfield. In the weeks ahead. It is a collective effort 
that we are doing together within the concept of Operation Warp 
Speed. But, CDC has been working on this plan literally for 
probably the last 10 to 12 weeks.
    Senator Murray. Well, Mr. Chairman, I would just say we 
need to see that plan. We need to know what it is. The American 
public needs to know what that is. Communities need to know 
what that is. So, I hope that we urge that plan to be public as 
soon as possible so we all know what to expect.
    Dr. Redfield. Thank you, Senator.
    The Chairman. Thank you, Senator Murray.
    Senator Burr.
    Senator Burr. Thank you, Mr. Chairman.
    After working on pandemic policy now for 17 years, I am 
reminded this morning, Tony Fauci has been doing it twice as 
long as I have, and most of you at the dais have been doing 
that, as well.
    I urge my colleagues, pay attention to what each of these 
individuals say. Because some things are predictable up here. 
Congress is a full-fledged partner and funds things when there 
is an urgent need, a threat that is out there. And I know, 
Tony, you have seen over the years when there is not that 
threat out there, things get shelved, like platforms, that we 
could have developed and had better countermeasures today, 
platforms that then could address vaccines at a much faster 
pace than maybe what we are doing. But, we spend more time with 
the blame game than we do with focuses on how the future should 
look.
    While all of us, Members of Congress and people within 
Government, wish that we could get back to normalcy, your 
agencies and Members of Congress are also charged with making 
sure that we map the future so the future generations have 
better protections than what we have, and that is why I applaud 
the Chairman for his white paper. And I would encourage every 
member of that dais to be brutally honest with us about where 
changes need to be made and where they don't need to be made.
    Dr. Redfield, I think you would agree with me that testing 
and surveillance on this has not been the best performance by 
CDC. I do not want to dwell on where we have come up short. 
Share with these Members and myself, what can we expect over 
the next several months from CDC that will be different than 
what the past has looked like?
    Dr. Redfield. Well, thank you, Senator, for your question. 
I think CDC will continue to work with the state, local, 
tribal, territory health departments to build their capacity.
    I think we all know that for decades, there has been 
consistent underinvestment in public health in this Nation and 
the core capabilities to do that job. Data, data modernization, 
predictive data analysis, laboratory resilience, workforce--
very appreciative for the emergency response fund that Congress 
provided--these are critical infrastructure issues that the 
reality are have been underinvested.
    CDC is right now probably providing 50 to 70 percent of all 
public health funding to each state. We need to have a much 
more robust investment in these core capabilities.
    What you are going to see, because of the Congress acting, 
CDC has provided now $12 billion to the local, state, 
territorial, tribal health departments to begin to build that 
core capability that we would have liked to build over the last 
several decades so that there is enhanced testing.
    It has been mentioned, it is complicated here because this 
virus is so asymptomatic for so many, so the traditional 
methods of diagnosis, contact tracing, isolation are going to 
be inhibited for many individuals, and that is going to require 
broader community-based surveillance strategies.
    Those plans, as was mentioned by the Admiral, are--we have 
received them for June and July. We are working with the local 
jurisdictions. They are going to have them in middle July for 
the plans for the rest of the year. And we are going to be 
working side by side with them to continue to augment the 
public health capacity to respond to the COVID virus with 
basically enhanced surveillance and enhanced early diagnosis, 
contact tracing, isolation to begin to bring this outbreak 
under control.
    Senator Burr. I hope some of that money will be used to 
upgrade the systems at CDC that are antiquated.
    Dr. Redfield. Sir, I agree with you there. I mean, I think, 
as those of you know, when I was given the opportunity to do 
this job, very early on, within a month, I recognized that the 
core capabilities of our public health infrastructure is not 
there, particularly the one that I know you have been very 
supportive of--data, data modernization, predictive data 
analysis--and that is in progress. It cannot happen too soon.
    We are appreciative of the support that Congress has given. 
And I do think it is fundamentally critical to bring our data 
system, and, as you know, the data personnel that we have, and 
we thank you for your efforts there. And as we need to hire 
those individuals strategically, we will continue to do that to 
make sure that the premier public health agency in this Country 
has the personnel and data systems that it does need.
    But, I will say, the other big issue we have to correct is 
to make sure our public health--state, local, territorial and 
tribal--have that integrated health system of data.
    Senator Burr. Dr. Hahn, I think you have used your 
authorities under PAHPRA at FDA in a very effective way, and 
the FDA has risen to the challenge during the public health 
emergency, cutting red tape and maintaining the Agency's gold 
standard for review of lifesaving medical products. You have 
specifically mentioned innovative trial--clinical trial designs 
and the use of real-world data as areas where the FDA has 
gained ground during the response to COVID. How do you plan to 
ensure that this progress is maintained long after the 
coronavirus response is over?
    Dr. Hahn. Thank you, Senator Burr. Critical issues that you 
bring up. In addition, some of the things that we are doing on 
the review side to actually expedite review and work with 
innovators and developers, we will continue. Part of our review 
of our actions to date, so a mid-action review, will inform how 
we move forward.
    No question, the fact that real-world evidence and 
modernization of our data systems are needed, particularly 
around supply chain and demand for medical products, but also 
on the review cycle and the innovative clinical design trials, 
as you just--as you mention.
    Senator Burr. Thank you for that.
    Mr. Chairman, I do hope that you or another member will 
allow Dr. Fauci at some point today to make any comments on the 
reports that there is a new swine flu that the Chinese have 
apparently identified and how that might affect us in the 
future in this Country.
    The Chairman. Well, Dr. Fauci, why don't you do that now if 
you have anything to say about a swine flu.
    Dr. Fauci. The Chinese, over the last week or two, have 
identified a virus in the environment. It is not yet shown to 
be infecting humans, but it is exhibiting what we call re-
assortment capabilities. In other words, when you get a brand 
new virus that turns out to be a pandemic virus, it is either 
due to mutations and/or the re-assortment or exchanges of 
genes.
    They are seeing virus in swine, in pigs, now that have 
characteristics of the 2009 H1N1, of the original 1918, which 
many of our flu viruses have remnants of that in it, as well as 
segments from other hosts like swine. When they all mix up 
together and they contain some of the elements that might make 
them susceptible to being transmitted to humans, you always 
have the possibility that you might have another swine flu-type 
outbreak as we had in 2009.
    It is something that still is in the stage of examination. 
It is not so-called an immediate threat where you are seeing 
infections, but it is something we need to keep our eye on, 
just the way we did in 2009 with the emergence of the swine 
flu. It is called G4, is the name of it.
    The Chairman. Thank you.
    Senator Sanders.
    Senator Sanders. Thank you very much, Mr. Chairman. And let 
me thank all of our panelists for being here and for the great 
work that they are doing on this pandemic.
    Let me ask a question that has just bothered me lately. All 
of you, and I think most Americans, understand how important 
social distancing is. We are told over and over again, and the 
Chairman told us at the beginning of this meeting, stay apart, 
at least 6 feet apart, if you can.
    Just the other day, however, American Airlines announced 
that they were going to fill up all of their planes, and other 
airlines have done the same. So, you are going to have people 
going from New York to California, 5, 6 hours, sitting inches 
apart from each other. And then you have buses all over America 
where people are kind of packed in like sardines.
    But, my question is, why hasn't the Government, whether it 
is the CDC or the Department of Transportation, issued 
guidelines prohibiting those violations of what we all know to 
be commonsense?
    Who wants to--Dr. Fauci, you want to start on that one or--
--
    Dr. Fauci. Thank you, Senator. Well, I am not the CDC, but 
I would be happy to make a comment on that, and maybe Bob 
would, also. I mean, obviously, that is something that is of 
concern. I am not sure exactly what went into that 
decisionmaking. I would hope there would be something to 
mitigate against that because I know, as we have said and I 
continue to repeat it, that avoiding crowds, staying distant, 
and when in a situation like that, wear a mask. I think in the 
confines of an airplane, that becomes even more problematic.
    Senator Sanders. But generally, I agree--I understand the 
mask thing, but doesn't it sound a little bit silly and little 
bit in violation of everything you guys have been talking about 
to have people sitting next to each other for 5 or 6 hours in 
an airplane or crowded into a bus? And my question is, why 
hasn't, the President issues a lot of executive orders. Why 
haven't we stopped that type of activity and told the airlines 
and bus companies that is unhealthy?
    Dr. Redfield. Senator, I appreciate your question, and I 
think it is a critical area. I can tell you that when they 
announced that the other day, obviously there was substantial 
disappointment with American Airlines. A number of the airlines 
had decided to keep the middle seat thing. I cannot say this is 
under critical review right now by us at CDC. We do not think 
it is the right message, as you pointed out. Again, we think it 
is really important in individuals that are in whether it is a 
bus or a train or a plane are social distancing to the degree 
that it is feasible and at least have a reliable face covering. 
So----
    Senator Sanders. Okay. Well, thank you, and I--I just hope 
very much that the CDC or the appropriate agency basically 
tells these companies that is unacceptable behavior. They are 
endangering the lives of the American people.
    Let me go to another question. And I just have a few more 
questions and not a lot of time, so I would appreciate brief 
answers.
    At the University of Washington, the Institute of Health 
there indicated that if 95 percent of the American people were 
to wear masks, we could save some 30,000 lives. A number of 
countries, including South Korea, France, Turkey, and Austria, 
have provided low-cost or free masks to all of their people--
something that I believe in. Would you support an effort to 
greatly increase the production of high-quality masks in this 
Country and distribute them free of charge to every household 
in America?
    Dr. Fauci. Yes.
    Senator Sanders. Dr. Fauci, or anybody else wants to jump 
in on that?
    Dr. Fauci. Yes, of course. I think masks is--are extremely 
important, and we keep hammering home. And I think what you 
just mentioned is as important. There is no doubt that wearing 
masks protects you and gets you to be protected. So, it is 
people protecting each other. Anything that furthers the use of 
masks, whether it is giving out free masks or any other 
mechanism, I am thoroughly in favor of.
    Dr. Redfield. I just want to echo that, Senator. In my 
opening statement, again, I called on an environment that we 
have universal masks. I think it is fundamentally----
    Senator Sanders. Good.
    Dr. Redfield [continuing]. The most important thing we can 
do.
    Senator Sanders. That is great. But when you refer to 
``universal masks,'' which I agree with you on, would you be 
supporting the increased production of high-quality masks and 
basically distributing free of charge to every household in 
America? Because I think that is going to save tens of 
thousands of lives. Would you agree?
    Admiral Giroir. Senator Sanders, this is Brett Giroir. Yes, 
sir. I agree that is very important because we need to support 
mask wearing.
    I would also point out that Dr. Kadlec, the ASPR, has 
contracted for hundreds of millions of cloth face coverings 
to--that could be distributed around the Country, and those 
kinds of processes are being thought of. When I am not in 
uniform, I wear them. They are white. They work very 
effectively, and I think they are a great investment for the 
American people.
    Senator Sanders. Good. Thank you.
    My very last question. It is an issue I have raised now for 
the last couple of months. All of us hope to God that a good, 
safe vaccine will be developed as soon as possible, but that 
vaccine may not mean anything to a lower income person who 
might not be able to afford it. I happen to believe that we 
should make these vaccines--and by the way, as you all know, 
Federal Government, our tax dollars, are going to the tune of 
billions of dollars into drug companies to help develop this 
vaccine. That is okay. But don't you--do you--would you agree 
with me that after that kind of investment, we should make sure 
that every American, every person in this Country, can get a 
vaccine regardless of their income?
    Dr. Fauci. Yes.
    Senator Sanders. Okay. Anybody else want to comment on 
that?
    Admiral Giroir. Yes, Senator. Agreed.
    Dr. Redfield. Yes, Senator.
    Dr. Hahn. Yes, Senator.
    Senator Sanders. Well, good. Thank you all very much.
    The Chairman. Thank you, Senator Sanders.
    Senator Paul.
    Senator Paul. Thank you.
    Fatal Conceit is the concept that central planning with 
decisionmaking concentrated in a few hands can never fully 
grasp the millions of complex, individual interactions 
occurring simultaneously in the marketplace.
    It is a fatal conceit to believe any one person or small 
group of people has the knowledge necessary to direct an 
economy or dictate public health behavior. I think Government 
health experts during this pandemic need to show caution in 
their prognostications.
    It is important to realize that if society meekly submits 
to an expert and that expert is wrong, a great deal of harm may 
occur when we allow one man's policy or one group of small men 
and women to be foisted on an entire nation. Take, for example, 
Government experts who continue to call for schools and daycare 
to stay closed, or that recommend restrictions that make it 
impossible for a school to function. For a time, there may not 
have been enough information about coronavirus in children, but 
now there is. There are examples from all across the United 
States and the world that show that young children rarely 
spread the virus.
    Let's start in Europe. Twenty-two countries have reopened 
their schools and have seen no discernible increases in cases. 
These graphs behind me show no surge when schools open. The red 
line is where the schools opened. There is data from Austria, 
Belgium, Denmark, France, Germany, Netherlands. No spike when 
schools are opened.
    Contact tracing studies in China, Iceland, Britain, and the 
Netherlands failed to find a single case of child-to-adult 
infection.
    Here at home, childcare for essential workers continued to 
be available in some states throughout the pandemic. Brown 
University researchers collected data on daycares that remained 
open during the pandemic. Over 25,000 kids in their study, 
found that only .16 percent got COVID. And when you look at the 
confirmed cases for staff, there was about 1 percent of more 
than 9,000 staff.
    The YMCA also has put forward statistics. Forty thousand 
kids at 1,100 sites, there were no reports of coronavirus 
outbreaks or clusters.
    Dr. Joshua Sharfstein of Johns Hopkins writes, ``There is 
converging evidence that the coronavirus doesn't transmit among 
children like the flu,'' that it is a lower risk.
    Just yesterday, the American Academy of Pediatrics says we 
have to get kids back in school. We want them physically 
present in school. They even cite mounting evidence that 
children are less likely to contract the virus.
    Ultimately, this all comes down to the fatal conceit that 
central planners have enough knowledge somehow to tell a nation 
of 330 million people what they can and cannot do.
    Perhaps our planners might think twice before they weigh in 
on every subject.
    Perhaps our Government experts might hold their tongue 
before expressing the opinion whether we can play NFL football 
or major league baseball, not in October.
    Perhaps our experts might think twice before telling the 
whole world that a COVID vaccine likely won't provide herd 
immunity.
    We don't know. Why weigh in with these opinions that we 
have no knowledge of? These are forecasts that may well be 
wrong.
    Perhaps our experts might consider the undue fear they are 
instilling in teachers who are now afraid to go back to work.
    No one knows the answers to these questions. We should not 
presume that a group of experts somehow knows what is best for 
everyone.
    Hayek had it right. Only decentralized power and 
decisionmaking based on millions of individualized situations 
can arrive at what risks and behaviors each individual should 
choose. That is what America was founded on, not a herd with a 
couple of people in Washington all telling us what to do and 
we, like sheep, blindly follow.
    This all begs the question, when are we going to tell the 
people the truth, that it is okay to take their kids back to 
school?
    Dr. Fauci, every day, virtually every day, we seem to hear 
from you things we cannot do, but when you are asked can we go 
back to school, I don't hear much certitude at all. I hear, 
well, maybe, it depends.
    All of this body of evidence about schools around the world 
shows there is no surge. All of the evidence shows that it is 
rare. I mean, we have so politicized this and made it 
politically correct that the WHO releases that it is rare. And 
you have a scientist up there honestly giving her opinion. What 
happens to her? She is blackballed and her report that she 
refers to is taken off the website. When you go to that 
scientist's speech and you try to click on the link, the WHO 
has now streamed it from us because it said something that is 
not politically correct; that guess what, it is rare for kids 
to transmit this.
    But, I hear nothing of that coming from you. All I hear, 
Dr. Fauci, is we can't do this, we can't do that, we can't play 
baseball. Well, even that is not based on the science. I mean, 
flu season peaks in February. We don't know that COVID is going 
to be like the flu season. It might, but we don't know that. 
But we wouldn't ban school in October. You might close some 
schools when they get the flu. We need to not be so 
presumptuous that we know everything.
    But, my question to you is, can't you give us a little bit 
more on schools, that we can get back to school? That there is 
a great deal of evidence and that it is actually good--good 
evidence that kids are not transmitting this? It is rare and 
that kids are staying healthy and that yes, we can open our 
schools?
    Dr. Fauci. Mr. Chairman, do I have a little bit of time 
to----
    The Chairman. I will give you a little. That was well over 
5 minutes, but we will----
    Dr. Fauci. Thank you, Senator.
    The Chairman. Go ahead and answer the--please answer the 
question.
    Dr. Fauci. Yes. So, very quickly, Senator Paul. I agree 
with a lot of what you say about, this idea about people having 
to put their opinions out without data. And sometimes, you have 
to make extrapolations because you are in a position where you 
need to at least give some sort of recommendation.
    But if you were listening, and I think you were, to my 
opening statement and my response to one of the questions, I 
feel very strongly we need to do whatever we can to get the 
children back to school. So, I think we are in lock agreement 
with that.
    The other thing that I would like to clarify very briefly 
is that I--when things get into press of what I supposedly 
said, I didn't say. I never said we can't play a certain sport. 
What happens is that people in the sport industry--they could 
either be people from players association, owners, people 
involved in the health of the players--ask me opinions 
regarding certain facts about the spread of the virus, what the 
dynamics are. I give it, and then it gets interpreted that I am 
saying you can't play this sport or you can't play that sport.
    I agree with you. I am completely unqualified to tell you 
whether you can play a sport or not.
    The only thing that I can do is, to the best of my ability, 
give you the facts and the evidence associated with what I know 
about this outbreak.
    Thank you.
    Senator Paul. Thank you. We----
    The Chairman. Senator Paul----
    Senator Paul [continuing]. Just need more optimism. There--
--
    The Chairman. Thank you, Senator Paul.
    Senator Paul [continuing]. Is good news out there. We are--
--
    The Chairman. We will now go to Senator Casey.
    Senator Paul [continuing]. Not getting it.
    Senator Casey. Mr. Chairman, thank you very much for the 
hearing, and I want to thank our witnesses for their public 
service.
    Mr. Chairman, let me start with Dr. Hahn. Then I will move 
to Admiral Giroir.
    Dr. Hahn, I wanted to ask you about vaccines. And as your 
testimony indicates, and as we have been discussing over time, 
as researchers work to develop vaccines to protect against 
COVID-19, it is important that the final FDA-approved products 
have the full confidence of the American people. A vaccine 
doesn't help if people don't choose to in fact be vaccinated.
    My first question is, given that we have seen very high 
rates of both vaccine refusal, as well as skepticism, what role 
can the FDA play in the coming months to earn the public's 
trust that the COVID-19 vaccines are safe and effective? That 
is question No. 1, what role the FDA can play.
    Then the second question is, what steps can you take as FDA 
commissioner to bolster public confidence?
    Dr. Hahn. Thank you, Senator, for that question. I could 
not agree more that public confidence in vaccines is so 
important.
    To your first question, we have an obligation to use all of 
our scientific knowledge, our regulatory framework, to ensure 
that any vaccine that comes before us, whether for 
authorization or approval, meets our stringent standards for 
safety and effectiveness.
    One of the reasons that we issued that guidance that I 
mentioned in my opening statement was to provide regulatory 
clarity around what FDA expects with respect to those data. We 
want to see certain parts of those data so that we can 
demonstrate to the world, to the Nation, to the American 
people, that we are following our rigorous standards with 
respect to safety and efficacy.
    The other thing that we have done is draw a very bright 
line between FDA and our regulatory independence and all the 
sponsors who are putting forth vaccine applications to us, and 
that includes Operation Warp Speed. So, we are providing 
technical assistance to those sponsors, but we are not part of 
the decisionmaking process, and we will maintain our regulatory 
independence. I will not prejudge. The Agency will not prejudge 
any decision with respect to this. We will use the science and 
the data.
    With respect to what I can do personally, Senator, I commit 
to you that I will continue to be a voice emphasizing the 
regulatory independence. We have a number of communications in 
progress to communicate to the American people that the 
standards we are going to uphold are firm, they are rooted in 
science and data, and that they will ensure that we meet the 
usual high standards of FDA with respect to safety and 
efficacy.
    Senator Casey. Thanks very much, Doctor. I might submit a 
question for the record to Dr. Redfield, as well, but just so I 
can get my second question in to the Admiral.
    Admiral, I want to ask you about testing and insurance 
coverage. Testing, as you know and as we have emphasized in 
these hearings, is so fundamental in order to prevent the 
spread of COVID-19. Congress, I think, acted upon that 
knowledge by mandating total coverage of COVID-19 diagnostic 
and antibody testing, both in the Families First bill, as well 
as the CARES Act. We made it clear that Americans should not 
have to pay a dime for COVID-19 testing, but we are hearing 
alarming reports of people not being tested often for one of 
two reasons: because they are under the impression they will 
have to pay for testing, and patients who have been tested are 
receiving surprise medical bills.
    The Administration has issued guidance that appears to be 
in conflict with congressional intent and public health 
guidance, and so we have some confusion here. I would ask you, 
Admiral, can you assure the American people that the Department 
of Health and Human Services will fulfill the intent of both 
the Families First bill and the CARES Act and ensure that the 
American people will be provided wide access to COVID-19 tests 
without cost or limitation?
    Admiral Giroir. Thank you, Senator. And I want to thank all 
of you for emphasizing the importance of testing and 
eliminating any barriers that there could be.
    I cannot speak for the Department. I certainly speak as the 
assistant secretary and as the testing person that we firmly 
believe and support the concept of no-cost testing. There 
should not be a disincentive in any single way to get the 
diagnostic test that you need to get tested during screening or 
the serology test as Congress intended. So, thank you for that. 
We do need to keep getting that message out. It is a very 
important one to have.
    Senator Casey. Thank you, Admiral. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Casey.
    Senator Collins.
    Senator Collins. Thank you very much, Mr. Chairman. And I 
want to thank all of our witnesses today for your dedication 
and hard work. It has really been important.
    The Chairman raised a very important question about who 
pays for the testing when a person has no symptoms and no known 
exposure to the virus. And I would add another key question, 
and that is how are such tests even accessed?
    These are critical questions for the reopening of schools 
and for the thousands of jobs in the tourism industry, upon 
which Maine's economy depends. In Maine, for a tourist to come 
and visit, that out-of-state visitor, one option is to show a 
recent negative COVID test. The problem is that when hotel 
owners in Maine surveyed testing sites in 10 states, they found 
that 90 percent of requests for a test for travel purposes were 
denied.
    Now, this lack of access to tests is devastating for 
reopening Maine's tourism businesses. One innkeeper told me 
that last year in the month of June, she had an occupancy rate 
of 94 percent. This year, it was 6 percent, so you can imagine 
the impact on employment at that inn.
    Given the impact on reopening schools and on jobs in the 
tourism and other industries, how is the Federal Government 
working with states to better match demand for testing with 
supply and to overcome these geographic variations? Admiral, I 
would direct that question to you.
    Admiral Giroir. Thank you, ma'am. I will try to be brief 
and not to take much of your time. But, we were very careful in 
our prioritization that we do prioritize persons without 
symptoms who are prioritized by health departments or 
clinicians for any reason, including public health monitoring, 
surveillance, or screening of other asymptomatic individuals 
according to state and local plans. So, that is a priority that 
if it is important for the state, those asymptomatic 
individuals can be screened.
    The second issue, just again to be brief, is we work--we 
have worked individually with every single state to determine 
what their state testing needs are, how are they organizing in 
the context of the CDC, and we are supplying them with the 
supplies they need to meet that. So, every week, shipments of 
the basic supplies go to every single state according to their 
state testing plans. And we keep a little bit in reserve, 
right, because when there is an outbreak somewhere that we need 
to surge, we do have that. So, for example, the state testing 
goals for July are somewhere--across the Country are about 13.9 
million tests is their first-line goals, and we will match 
those state by state.
    Senator Collins. I hope that you will help us get that word 
out to testing sites in states from which--a lot of tourists 
usually come to Maine. That would be very helpful to us.
    Dr. Fauci, let me turn to you. Earlier this month, higher 
education leaders in Maine issued a framework for safely 
returning to campuses this fall that recognizes the importance 
of testing and the need to include financially struggling 
institutions in partnerships in order to make sufficient 
testing protocols possible.
    You, last week, spoke about the possibility of the 
development of pool testing strategies. And, as I understand 
this, this would allow more people to be tested using fewer 
resources.
    The medical director of Stanford's clinical virology lab 
suggests that this makes particular sense in areas with low 
rates of COVID-19 where you would expect the large majority of 
tests to be negative. Could you expand on the possibility of 
expanding pool testing and tell us more about that?
    Dr. Fauci. Yes. Thank you for the question, Senator. What 
that really is, if you want to get a feel for the penetrance of 
infection in a community, rather than testing multiple, each 
individual person, which takes resources and time, what you 
do--and you can do a statistical analysis of--not losing 
sensitivity by pooling let us say 10 or 15 or five together.
    You put all the tests together and you do one test. If that 
test is negative, then those 10 people are all negative. So, 
instead of utilizing 10 tests, you have utilized one test.
    Then you get another batch of we will say 10 or so. And if 
you then find one is positive, then you go backtrack and figure 
out who that person is. And if you do the mathematical 
calculation, you can save a lot of time, a lot of resources, 
and use the testing for a variety of other things that you 
would need.
    It is a really good tool. It can be used in any of a number 
of circumstances at the community level, or even in school if 
you wanted to do that. So, apropos of what you started your 
comment off with, it clearly can be extrapolated to that.
    Senator Collins. Thank you so much. That sounds like an 
excellent technique for our schools to use.
    The Chairman. Thank you, Senator Collins.
    Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman. I want to thank 
all of our witnesses today for joining us.
    Like so many Members of this Committee, I am concerned 
about new outbreaks and increasing cases. Certainly, I have 
seen them in my home State of Wisconsin, and I know we are 
seeing that nationally.
    Now, CDC and OSHA have issued recommended safety guidance 
for businesses, but this guidance is not enforceable. Many 
businesses are truly trying to do the right thing in protecting 
workers and customers and the public that interacts with those 
businesses.
    We also had a previous discussion. I think Senator Sanders 
raised the issue of American Airlines filling up their planes, 
versus others that are still not trying to push to do so 
because of safety concerns.
    We also had--I think it was Admiral Giroir pulled up the--
what he called critical guidance. Please follow this critical 
guidance.
    Dr. Redfield, should we be supporting businesses that have 
taken the steps to protect their workers and customers by fully 
implementing CDC's and OSHA's recommended safety guidance? Yes 
or no.
    Dr. Redfield. Yes. We should be supporting those 
businesses.
    Senator Baldwin. Now, can you confirm, yes or no, that all 
businesses have adopted and implemented this guidance as they 
have opened up?
    Dr. Redfield. I think, Senator, you know that, 
unfortunately, that has not been the case.
    Senator Baldwin. It is an uneven playing field, and it 
hurts businesses that are trying to do the right thing by 
voluntarily adopting CDC and OSHA safety guidelines because 
their competitors don't have to incur the same safety and 
health costs. And, if you believe that we should be supporting 
the good actors, then shouldn't we create a level playing field 
by issuing an emergency, temporary standard to require all 
business to adopt and comply with enforceable safety standards?
    Dr. Redfield. I make two comments, Senator. First one, it 
is so important that we have tried to say is that this is a 
time that everyone in our Nation accept the responsibility that 
Dr. Fauci and I spoke about to recognize they have the 
fundamental responsibility not just to protect themselves, to 
protect others, by the social distance, face mask, and hand 
washing.
    Second, again, is we look at the local jurisdictions, 
again, to see where, in fact, that enforceability would be, 
whether it is in the local health department, the state health 
department, or the Federal Health Department. I think, again, 
we see that the community can get behind that responsibility. 
Those businesses that support that responsibility may find, in 
fact, their business is better than those businesses that 
don't.
    I can tell you that----
    Senator Baldwin. I want to interrupt you. I apologize, Dr. 
Redfield, but my time is limited. The panel right now is 
composed of people representing public health and public health 
institutions. OSHA is our lead Federal agency for protecting 
workers' safety and health. Have you had communication with the 
Department of Labor and OSHA about issuing mandatory, 
enforceable standards rather than this voluntary guidance?
    Dr. Redfield. Secretary Scalia is a member of the task 
force, and he is in the discussions with us that the Vice 
President chairs. That specific topic----
    Senator Baldwin. The answer is yes?
    Dr. Redfield [continuing]. We have not had a discussion 
directly, but we have had discussions in review of the guidance 
that we put to businesses, both critical infrastructure and 
non-critical infrastructure businesses, with OSHA.
    Senator Baldwin. I have limited time left, but I do want to 
say that the University of Wisconsin announced that they will 
be reopening for classes in the fall. They have released a plan 
called start--Smart Restart. It calls for about 2,000 tests per 
week on campus. They will need supplies to do this, including 
PPE, reagents, and swabs. At every hearing on COVID-19, we have 
heard about shortages of these supplies, and it is why I 
introduced the Medical Supply Transparency and Delivery Act to 
unlock the full authority of the Defense Production Act to 
increase production of critical supplies, the things that are 
needed to conduct widespread testing.
    Admiral Giroir, can you describe how you are working to 
make sure that universities and others will have access to 
these supplies needed to conduct this testing in the fall?
    Admiral Giroir. Thank you so much, Senator. And I want to 
communicate this, and I am happy to work with any university. 
We coordinate what we give to the states through the state 
plan, so it is very important that universities coordinate 
through the states. And we supply those materials directly to a 
single point of contact in the state, who distributes them.
    We have been through a lot, but we have a lot of swabs now, 
partially because of increased domestic production using the 
DPA. We are distributing about 20 million swabs per month. We 
are going to do a lot more than that.
    Senator Baldwin. What about reagents?
    Admiral Giroir. Reagents, we do not purchase centrally 
because the market is a little bit more mature, so we can trust 
with an allocation strategy that we allocate--we support the 
allocation to different states depending on their needs.
    We have mapped every single machine in every single state, 
every single county, every single city, and unfortunately, 
there is not enough of one thing that everybody if they want 
that can get it. So, we really do a matching game to understand 
specific state needs. For example, in Alaska, it is very rural 
and there is varied limitations to what they have, so we need 
to make sure they get what they absolutely need, versus other 
states that can be a little bit more flexible. So, we do have 
this control----
    Senator Baldwin. With respect----
    The Chairman. Senator Baldwin, I am afraid we are----
    Admiral Giroir. I am so sorry.
    The Chairman [continuing]. Well over time. We have a large 
number of Senators who want to ask questions, so I would renew 
my----
    Senator Baldwin. Thank you, Mr. Chairman.
    The Chairman [continuing]. Request that Senators and 
witnesses try to keep the questions and answers within 5 
minutes.
    Senator Cassidy.
    Senator Cassidy. Thank you, gentlemen, for all that you are 
doing.
    I have a couple slides. Can you--can I ask for the staff to 
show the first two slides?
    [Slides shown.]
    Senator Cassidy. Here it shows that we are doing poorly 
relative to the countries that are doing it best. And you can 
argue that Taiwan is much smaller than we, but Taipei is a very 
congested city. So, consider our cities just a collection of 
Taipeis, for example, than our Seoul, South Koreas. It would 
suggest that what we are currently doing is less robust and 
less whatever adjective you want to use than the countries that 
are doing it best.
    Could I have the next slide, please?
    [Slide shown.]
    Senator Cassidy. This is developed out of a group by 
Harvard. And, just so I can put a plug in it, they will be 
speaking at a roundtable we have Thursday morning, and you can 
get details from my office if you wish.
    But, kind of that interplay between collecting--doing the 
testing, tracing those, compiling your data, knowing where your 
hotspots are, and then tracing. And everyone on this panel 
knows this is how it is done.
    You mention that you are going to have a strategy that is 
coming out later on. It does beg the question, why has it been 
so long? And I am not accusing. I am just curious. But this has 
been developed----
    You can take the slide down, please.
    Knowing that you are going to develop this strategy, and 
kind of building upon what Senator Burr mentioned, what is the 
goal of the strategy? Is the goal of the strategy to achieve 
suppression? That is No. 1.
    No. 2, what metrics will you use?
    Knowing that CDC is the one who really gives guidance to 
state and local governments--I am hoping, Dr. Redfield, since I 
will direct this to you, that it won't be up to the states and 
locals to put this plan together; it will be the considerable 
intellectual fire power of the CDC that gives a pretty 
detailed--if you have this kind of community, this is what you 
do. If you have that kind of community, that is what you do. 
Because that is the kind of role that CDC is expected to play.
    Dr. Redfield, any thoughts on this?
    Dr. Redfield. Thank you very much, Senator. A very 
important question.
    First--on your first slide, just as a quick comment, and I 
will try to be quick. I think it is really important because it 
does illustrate back to the comment that we tried to make of 
the importance of personal responsibility, to really practice 
the social distancing and----
    Senator Cassidy. That is a given, Dr. Redfield. I want to 
ask you just to go quickly because I have limited time. That is 
a given. But there has to be a testing aspect of this because 
people don't--you awaken people to their responsibility if they 
know they have been exposed. If they don't know they have been 
exposed, they tend to be more complacent. So, please focus upon 
the testing data and tracking aspect.
    Dr. Redfield. Yes, Senator. Initially, obviously, the--it 
was early case identification, contact tracing, isolation. 
Obviously, testing and contact tracing without isolation has 
little value. The challenge has been when we learned in March 
that this virus is significantly asymptomatically 
transmissible, and then, therefore, requiring alternative 
strategies.
    The strategy that we are evaluating now is more of a 
community-led testing strategy where you go into a broader 
community and you actually test a wide number of individuals as 
opposed to----
    Senator Cassidy. But do you have--what metrics are you 
following? And is there a specific strategy that is going to be 
given to state and locals as to how to implement this? That is 
very high level. What we need is granularity. That is my 
question.
    Dr. Redfield. Yes. We did the initial strategy, and as I 
said, we are currently evaluating this community test-led 
strategy in a number of communities now.
    The metrics are simple. It is the percent cases that are 
positive. We were doing well there for a while. You know----
    Senator Cassidy. But now--again, sorry to interrupt. But, 
of course, if you take the entire city of New Orleans or 
Shreveport, you are going to have some that are hot spots and 
some that are really fairly safe. And, so, I guess I am 
pointing to the granularity. Should it be a census track? 
Should it be a hot spot--a building with multifamily housing, 
et cetera? So, I----
    Dr. Redfield. You are exact----
    Senator Cassidy [continuing]. Guess I am just frustrated 
because when I speak to my state and locals, they are not 
getting that granularity from CDC. That seems to be where we 
get to where Seoul, South Korea is, and I have not yet heard 
that is kind of what we are doing.
    Dr. Redfield. We are sharing right now at the county level 
the exact kinetics. We have about 130 counties in this Country 
out of the more than 5,000--more than 3,000 are having trouble. 
And, continuing to get that granularity--I think you have said 
it, Senator. It is critical. It has got to be a very local, 
focal response at the granular level. We are trying----
    Senator Cassidy. But, Dr. Redfield, do we have that 
granularity? We have been at this for 3 months. We have all 
these data systems. We know where the people live who are 
tested. You know, we have a federated system, which you alluded 
to earlier. Is the plan coming out tonight, this afternoon, 
going to implement that granularity?
    I am over time, but if you would allow, Mr. Chairman, for 
an answer, then I will cease. I apologize for going over.
    Dr. Redfield. My comment would be that is where we are 
going with that granularity. We appreciate some of the changes 
in reporting to CDC in terms of testing that Congress recently 
did. We are now looking at the granular level. We don't 
disagree with the premise behind you. It is that granular 
response to control those mini outbreaks, which is going to be 
fundamental to get this under control.
    The Chairman. Thank you----
    Senator Cassidy. Thank you.
    The Chairman [continuing]. Senator Cassidy.
    Senator Murphy.
    Senator Murphy. Thank you very much, Mr. Chairman.
    Mr. Chairman, if this were the policy of the United States 
of America, the recommendations and guidelines being given by 
our panelists today, we would likely not be in the situation we 
are with a virus back on the march, spreading at rapid rates 
throughout big parts of the Country.
    The problem is our four panelists do not set the policy of 
the United States of America. The President of the United 
States does. And, so, while our panelists tell us about the 
importance of wearing masks, the President of the United States 
is re-Tweeting articles, for example, entitled ``Mandatory 
Masks Aren't About Safety, They're About Social Control.'' He 
re-Tweets people that are criticizing how folks look when they 
wear masks.
    Though our panelists today are telling us about the 
effectiveness of social distancing, the President of the United 
States is holding rallies all across the Country, in which he 
deliberately prevents people from distancing. His staff ripped 
signs off of chairs encouraging people to separate from each 
other.
    The President's allies are out there on TV every day saying 
that wearing masks are dehumanizing. Somebody said the other 
day, a Member of the House, that viruses do what viruses do; 
the only way you are going to get immunity is to get exposed. 
These are the President's allies trying to curry favor with 
him.
    We have these two parallel messaging operations, and I just 
think it is worth stipulating that everything we are hearing 
today is responsible. It is based on evidence.
    But, the agencies represented here today have social media 
followings of about five million people. The President of the 
United States has a social media following of 82 million. And, 
so, you can understand why folks are confused out there. They 
hear the recommendations from Dr. Fauci and Dr. Redfield, but 
then they hear the President of the United States criticizing a 
reporter for wearing a mask because that reporter is being 
social--is being politically correct.
    That is why we are in the position we are in today where 
you see large numbers of people not complying with 
recommendations because they are hearing something very 
different from the Chief Executive, and they are watching him 
behave in a manner and encourage behavior that is directly 
contrary to what we are being told today. And it just probably 
requires saying that out loud at this hearing.
    Let me ask a few questions, Mr. Chairman, if I can, about 
global public health because we have not covered that here 
today.
    Dr. Fauci, this virus got here really quickly, and what we 
learned is that while travel restrictions can help or give you 
time, they cannot fully prevent a disease from arriving here. 
And, so, even if we do turn the corner in the United States in 
a meaningful way, so long as this virus exists in large 
quantities outside of the United States, we are still 
vulnerable. Is that right?
    Dr. Fauci. That is correct, sir.
    Senator Murphy. Dr. Redfield, what is your understanding of 
why the United States has not joined the global vaccine effort? 
Why are we not in something like CEPI, an organization that is 
working with other nations to try to coordinate not only the 
development of the vaccine, but also the distribution of the 
vaccine?
    Dr. Redfield. Well, I think the U.S. has obviously 
developed an aggressive, comprehensive program, but, Senator, 
it would not preclude being part of these international 
organizations, also, from my perspective.
    Senator Murphy. We have legislation pending right now 
before the Foreign Relations Committee that would put the 
United States into these global vaccine efforts. It just 
doesn't make a lot of sense to many of us on both sides of the 
aisle as to why the Trump administration has not joined.
    Finally, Admiral, just maybe help us understand what our 
relationship with the WHO is today. Right around the time that 
the President declared that we were pulling out of the WHO--not 
just that we were not going to fund it, but his announcement 
was actually we were going to sever our relationship with the 
WHO--you were confirmed to a seat on the executive board. And, 
so, have you been recalled from the WHO? Are you attending 
meetings? Are you participating? What are the details 
surrounding our withdrawal from the WHO? Which, by the way, is 
maybe one of the most dangerous things in my opinion that the 
Administration has done in the middle of a global pandemic. 
What is our status and what is your status as a confirmed 
member of that board?
    Admiral Giroir. Thank you, Senator, and I really do 
appreciate the confirmation.
    I was confirmed on May 7th, and I did attend the executive 
board on May 22d. The executive board, it was virtual. I did 
participate and support our multilateral commitments. I have 
not been recalled. I have not been given any direction to 
recall myself in any way. There would be another executive 
board meeting probably in October.
    I believe all of us on our public health standards still 
work with the WHO as a WHO partner. For example, we 
participated with the WHO on a global sickle cell meeting just 
2 days ago.
    We work--we certainly work from the public health aspects 
direction on the official--whether we are going to be a member 
or whether I am not going to go to the executive board, I have 
not gotten that direction yet.
    Senator Murphy. Okay. Thank you. The announcement was that 
we are terminating our relationship with the WHO, so probably 
some additional clarification would be helpful.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murphy.
    Senator Murkowski.
    Senator Murkowski. Thank you, Mr. Chairman. And, gentlemen, 
thank you for not only your testimony today, but all that you 
have been doing.
    I think I have had conversations with each one of you about 
the Alaska-specific issues, most notably with regards to our 
seafood processing. This is the time of year where we typically 
welcome a million plus tourists, as well as many thousands that 
come up from the Lower 48 and other places to help with our 
seafood processing.
    It has been a very anxious time, I think, for all of us in 
Alaska as we see outsiders coming in. We have seen obviously 
elevated cases of confirmed COVID. Our numbers, I think, are 
enviable when other states look at us to know that we are 
working about 500 active cases right now. About double that in 
terms of what we have seen throughout this whole pandemic.
    But, again, we know, and you have stated, that we don't 
have resources that we can look to, to neighboring states. We 
are kind of on our own island there in terms of resourcing. So, 
what you have done to help facilitate, whether it is the plans 
with the seafood processors, the guidance, the ability to come 
in on an as-needed, if the situation so demands, we appreciate 
that.
    We have seen the benefit of how these very rigorous plans 
have worked. An individual who comes up to work in a seafood 
processing facility is tested before they come to the state. 
They are tested when they get to the state. They are put in a 
14-day quarantine. We have seen positive cases once people have 
arrived, but we have been able to do what the plan calls for, 
which is that contact tracing and then isolation and keeping 
things to a minimum. So, I think it does demonstrate that these 
tough plans really can work.
    They are expensive, though. If you are bringing in several 
hundred or perhaps a thousand workers and you have to put them 
up in a hotel for 14 days, with pay, when you have to provide 
for the health protocols, this is costly. I would ask for your 
input, and probably a question for the record, just in terms of 
which agencies can best help facilitate these seafood 
processors with not only implementation of this specific 
guidance, but how we can be dealing with the cost. We do 
receive some benefit from the discretionary funds provided to 
the states.
    But, I think we would all recognize, like the meatpacking 
facilities, our seafood processors are an important and a 
critical industry, not only to Alaska, but to the Country, so 
we want to work to address that.
    I do want to speak very quickly, though, to the public 
health infrastructure. I am told that in Alaska, as we are 
doing our contact tracing, it is still a paper copy Excel 
spreadsheet faxed to the epidemiology labs. This is how we are 
doing our tracing. I thought, well, maybe that is just Alaska, 
and I am told by Dr. Zink, who you have all had conversations 
with, that, well, this is actually going on in California, as 
well.
    That, to me, is not a contact tracing system that works and 
is sufficient. So, I want to ask about not only your view of 
the sufficiency of contact tracing--and this is probably to 
you, Dr. Redfield.
    But, then, Dr. Fauci, I want to ask you about the concern 
that we have with certain parts of the Country where you have 
public mistrust of vaccines in general. My fear is that we may 
get to the place where--we will get to that place where we have 
that successful vaccine, but we still have the concern from 
many, and a mistrust. And whether it is vaccine hesitation or 
vaccine confidence--I don't know what the buzz word is, but I 
am worried that we don't have a plan for how to deal with that.
    First, contact tracing, and then the vaccine.
    Dr. Redfield. Thank you very much, Senator. I think it is 
really important just to highlight what you said about the 
current state of data systems for public health in the United 
States, that they really are in need of aggressive 
modernization. And, again, thank Congress for the funding 
there. But, it is a substantial investment that needs to take 
place. There are a number of counties that are still doing this 
pen and pencil, as you commented, and we need to have a 
comprehensive, integrated public health data system that is not 
only able to do something that is in real time, but actually 
can be predictive. And it would be one of the great, I think, 
investments of our time to make that happen once and for all.
    Senator Murkowski. Agreed.
    Dr. Redfield. That is really fundamental to be able to 
operationalize contact tracing, et cetera.
    Contact tracing in this case, and I will be very quick, 
really does not have any value unless you can do it in real 
time. It doesn't help, like I just did with the airlines, where 
we had the people that were flying infected from Afghanistan 
and we didn't get the information until Day 14, Day 15, Day 16. 
It is irrelevant.
    Again, we love the partnership to get an integrated public 
health data system, not just for CDC, but for all of our 
jurisdictions across the Nation, into one timely, integrated 
system.
    Dr. Fauci. Senator, thank you for the question about----
    The Chairman. If you could be succinct, we are----
    Dr. Fauci. Yes.
    The Chairman [continuing]. Well over time.
    Dr. Fauci. We will be quick. We have a community engagement 
program that is embedded within the sites where the vaccine 
trials will be done because we are thoroughly aware of what you 
are concerned about. And it is a reality--a lack of trust of 
authority, a lack of trust in Government, and a concern about 
vaccines in general.
    We need to engage the community by boots on the ground and 
getting community--particularly those populations that have not 
always been treated fairly by the Government--minority 
populations, African Americans, Latinx, and Native Americans. 
And we have a program that is already operable right now to do 
that.
    Thank you.
    Senator Murkowski. Thank you.
    The Chairman. Thank you, Senator Murkowski.
    Senator Warren.
    Senator Warren. Thank you very much, Mr. Chairman.
    Dr. Fauci, you came before the HELP Committee 7 weeks ago 
to discuss the Country's response to the COVID-19. And at the 
time, you told me that the U.S. did not ``by any means have 
total control over this outbreak.'' But, you also told me that 
we were ``going in the right direction.''
    Now, on the day you testified before the Committee--that 
was May 12th, 2020--there were about 21,000 new cases of 
coronavirus. Yesterday, there were about 40,000 new cases of 
coronavirus.
    Dr. Fauci, do these numbers show that the Country is still 
moving ``in the right direction'' and that the coronavirus 
pandemic is under control?
    Dr. Fauci. Well, I think the numbers speak for themselves. 
Although we do have a number of parts of the Country that are 
doing well, I am very concerned about what is going on right 
now, particularly in the four states that are accounting for 
about 50 percent of the new infections, but the other 
vulnerable states.
    I would have to say the numbers speak for themselves. I am 
very concerned and I am not satisfied with what is going on 
because we are going in the wrong direction if you look at the 
curves of the new cases. So, we have really got to do something 
about that, and we need to do it quickly. Short answer to----
    Senator Warren. So----
    Dr. Fauci [continuing]. Your question is that clearly we 
are not in total control right now.
    Senator Warren. Thank you. Thank you very much. You know, 
our case numbers are getting worse, and our death rates are 
going to get worse soon.
    During this same period of time, some other countries 
around the world have controlled the virus. They are reporting 
fewer cases each day, and they are able to provide targeted 
testing and to keep it up so that they can tell what is 
happening and follow-up if there is an outbreak. In other 
words, controlling the coronavirus can be done. But because of 
bad Federal leadership, we have not been able to do this here 
in the United States.
    Dr. Fauci, the last time you were before this Committee, 
you told me that if the U.S. did not have ``an adequate 
response'' that the Country would ``have the deleterious 
consequences of more infections and more deaths.'' Now, I know 
that we have made some progress, but half measures won't save 
lives.
    Dr. Fauci, I am asking you to be very direct with all of us 
on this. If we don't fully implement the widespread testing, 
contact tracing programs, and social distancing practices that 
everyone seems to agree that we need, can we expect these 
spikes in infection to keep happening in different places 
around the Country?
    Dr. Fauci. Thank you, Senator. I am always direct with you. 
And I will tell you in direct answer to your question that, if 
you look at what is going on and just look at some of the film 
clips that you have seen of people congregating, often without 
masks, of being in crowds and jumping over and avoiding and not 
paying attention to the guidelines that we very carefully put 
out, we are going to continue to be in a lot of trouble, and 
there is going to be a lot of hurt if that does not stop. And 
that gets back----
    Senator Warren. Okay. If----
    Dr. Fauci. No. I was----
    Senator Warren. If we don't get our act together, more and 
more communities around the Country are going to see these 
dangerous surges----
    Dr. Fauci. Right.
    Senator Warren [continuing]. Of COVID-19. Dr. Fauci, back 
in March, you also said, ``Looking at what we are seeing now,'' 
you expected there to be between 100,000 and 200,000 
coronavirus deaths and millions of infections in the U.S. So, 
let's flash forward to late June. Here we are, at the end of 
June. We have already seen 126,000 deaths with infection rates 
rising rapidly.
    Dr. Fauci, based on what you are seeing now, how many 
COVID-19 deaths and infections should America expect before 
this is all over?
    Dr. Fauci. I cannot make an accurate prediction, but it is 
going to be very disturbing--I will guarantee you that--because 
when you have an outbreak in one part of the Country, even 
though in other parts of the Country they are doing well, they 
are vulnerable. I made that point very clearly last week at a 
press conference. We cannot just focus on those areas that are 
having the surge. It puts the entire Country at risk.
    We are now having 40-plus thousand new cases a day. I would 
not be surprised if we go up to 100,000 a day if this does not 
turn around, and, so, I am very concerned.
    Senator Warren. Can you make any kind of estimate on what 
we are looking at overall on the number of deaths before this 
is over? You made an estimate back in March, between 100,000 
and 200,000----
    Dr. Fauci. Right.
    Senator Warren [continuing]. But we have a lot more 
information now, and we are already at 126,000 deaths.
    Dr. Fauci. Right. I can't make an estimation because that 
would have to be modeled out. Because when models are done--and 
that is where those original numbers came from, Senator. As I 
have said very often, models are as good as the assumptions 
that you put into the model, and those assumptions often 
change, depending upon what your response is. So, I would 
really be hesitant to give a number that will come back and 
either be contradicted and overblown or underblown.
    But, I think it is important to tell you and the American 
public that I am very concerned because it could get very bad.
    Senator Warren. Alright. I appreciate that, Dr. Fauci.
    The Chairman. Okay. We are----
    Senator Warren. We all want our economy----
    The Chairman. We are well over time, Senator Warren.
    Senator Warren [continuing]. To recover.
    I would just like the same time that my Republican 
colleagues got. Because I want to say----
    The Chairman. Alright. Then your----
    Senator Warren [continuing]. That we want our economy----
    The Chairman. Then your time is up. Senator Warren.
    Senator Warren [continuing]. To recover.
    The Chairman. Senator Warren.
    Senator Warren. But we can't keep pretending----
    The Chairman. Senator Warren, now, I am being just as----
    Senator Warren. I need to get the----
    The Chairman [continuing]. Fair to you as I was----
    Senator Warren. Our Republican----
    The Chairman [continuing]. To Senator Sanders and the 
others.
    Senator Warren [continuing]. Colleagues got a lot more 
time.
    The Chairman. Senator Warren.
    Senator Warren. Mr. Chairman.
    The Chairman. I always treat you fairly, and I would 
appreciate your respecting the Chairman's rules. If you would 
like to make a closing statement, go ahead and do it, but I 
don't appreciate your----
    Senator Warren. Thank you.
    The Chairman [continuing]. Questioning my fairness in----
    Senator Warren. I appreciate that, Mr. Chairman.
    The Chairman [continuing]. Presiding over the hearing.
    Senator Warren. I just was under the understanding----
    The Chairman. Because I have been scrupulously fair.
    Senator Warren [continuing]. Based on what others had done 
that you were allowing more time since we had such important 
witnesses.
    The Chairman. Well, when----
    Senator Warren. I appreciate--time.
    The Chairman [continuing]. Are chairman, you can make 
that--you can make those decisions.
    Senator Warren. Thank you.
    You know, I just want to make the point that we can't keep 
pretending this virus is getting better when it isn't. That is 
how we end up with messes like the situation in Texas. Racing 
to reopen too soon; then scrambling to close down before the 
hospitals get completely overwhelmed.
    If we don't get our act together, this is our future, see-
sawing back and forth between too few restrictions and then 
exploding cases and repeated shutdowns.
    In this future, thousands more Americans will die and our 
economy will be brought to its knees. We have got to have a 
national strategy that makes testing available to every school, 
every business, every hospital, every church, anywhere that 
Americans come together.
    We need to expand contact tracing, and we need leaders, 
starting with President Trump, who have enough backbone to face 
reality, distribute our resources, set our standards, and stick 
to them. Because if we don't, the result is going to be more 
economic wreckage and more death.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Warren.
    What I have tried to do in this hearing is to ask Senators 
to stay within 5 minutes and the answers within 5 minutes. And, 
if the answers go beyond that, I have tried to be respectful of 
that. But to--but I would ask Senators not to ask their 
questions into well past 5 minutes and then expect to make a 
speech at the end.
    Senator Scott.
    Senator Scott. Thank you, Mr. Chairman, and I will 
certainly respect your time limits. I think we all should do 
that.
    Frankly, as we were asking Dr. Fauci for an estimate of how 
many lives may be lost, I recall the first estimates were 
between one and 2.4 million lives, so I am certainly glad that 
we are not there.
    Perhaps one of the reasons why we should be thankful for 
where we are now and force ourselves to have a serious 
conversation about continuing to flatten the curve is because 
the all-hands-on-deck approach is effective. We just need as 
much cooperation from as many people as conceivably possible in 
every state around the Country in order for us to see these 
numbers continue to make a dive in the right direction as 
opposed to spike in the wrong direction.
    I think about the Operation Warp Speed, along with the 
crucial support from BARDA and other Federal agencies, public-
private partnerships, and accelerating groundbreaking 
technologies that could eradicate COVID-19 and revolutionize, 
frankly, the vaccine development landscape. Because of these 
efforts by industry, academia, and Government working in 
concert, we could see a viable candidate or candidates in a 
matter of months for a vaccine.
    Because of the growing number of large-scale manufacturing 
agreements with companies like Moderna, Pfizer, and J&J 
producing hundreds of millions of doses at risk, which means in 
advance, we are already working to address issues of access. 
And this is critical, especially for our most distressed 
communities.
    That said, effective development and widespread access, 
while essential, are only part of the equation. If and when--
and I feel optimistic that it is when and not if--we get a 
viable vaccine, we need to encourage folks to choose to get 
vaccinated.
    I was really concerned when I saw a recent AP survey that 
showed that only 49 percent of American adults plan to get 
vaccinated once the COVID-19 vaccine came to market. A full 20 
percent said that they did not plan to get vaccinated, and one-
third of Americans were not sure.
    Given the public's recent and vital focus on health 
disparities, it is worth noting that among certain groups, 
these figures are even more alarming. Just 25 percent of Black 
Americans, 37 percent of Hispanic Americans plan to get 
vaccinated against the coronavirus.
    My question to the full panel, what steps can we take at 
every level of Government and in the private sector with 
healthcare providers to ensure a proactive education campaign 
and outreach strategy on the importance of getting vaccinated, 
both for COVID-19 and, frankly, even more broadly?
    Dr. Fauci. I will take a shot at it first, Senator. As I 
mentioned in response to another question, that we have a 
community engagement program that actually operates out of 
Operation Warp Speed, the vaccine development program component 
of that.
    Also, there needs to be engagement of people who the 
community trusts, particularly individuals who are noted sports 
figures or whomever. When we were involved, and continue to be 
involved, in community engagement with HIV, we used people in 
the community, boots on the ground, to go out who looked and 
lived and are like the people they are trying to engage. It is 
very critical, because I share with you the concern that we get 
to the hoop and we get through it of getting a safe and 
effective vaccine only to find that a substantial proportion of 
the population do not want to get vaccinated.
    Of particular concern is that it is that proportion of the 
population that generally are the most vulnerable in the sense 
of the minority communities--African Americans, Latinx, Native 
Americans, who, in fact, because of underlying conditions, make 
it more likely that if they do get infected, they would have a 
poor outcome. So, it is extremely important to engage them at 
the local level.
    Thank you.
    Senator Scott. Thank you very much for your answer, Dr. 
Fauci.
    Let me just close with my 40 seconds that I have left and 
respecting the time, and I hope that we continue to do so.
    The pandemic has triggered a drop of 60 to 80 percent of 
immunization rates among children. And even now that states are 
reopening, we are not seeing the rebound in these rates as--
that are necessary. This creates a real risk of secondary 
infections and disease outbreaks that are not on the general 
public's radar as we reckon with the chief crisis at hand.
    I think it is incredibly important that we follow your 
strategy, Dr. Fauci, as it relates to engaging community 
leaders and perhaps people with notoriety to challenge us to 
get involved in taking the vaccines.
    Thank you, Mr. Chairman. I apologize for being 4 seconds 
over my time.
    The Chairman. Thank you, Senator Scott, for respecting the 
time. We have eight Senators remaining who have questions, and 
we should have time for all of them to have a chance to ask 
their questions.
    Senator Kaine.
    Senator Kaine. Thank you, Mr. Chairman, and thank you to 
the witnesses.
    Dr. Fauci, I saw an interview with you last week where you 
talked about a concern that there is too sizable a percentage 
of our population that sort of doesn't like science and 
scientists and advice from scientists. And I hear real emotion 
in your voice as you express concern about people gathering in 
large groups and without masks, and I gather that is the kind 
of anti-science concern that you were worrying about when you 
had that interview last week.
    Dr. Fauci. Yes. That is part of it, Senator, yes, because a 
disregard of recommendations that come from authorities only 
because it is a recommendation. I think the attitude of pushing 
back from authority and pushing back on scientific data is very 
concerning. We are in the middle of a catastrophic outbreak, 
and we really do need to be guided by scientific principles.
    Senator Kaine. This could cause problems down the road if 
we get to a vaccine, but people don't want to get the vaccine, 
so we all have to message this pretty strongly.
    Dr. Redfield, I want to thank you. I was going to ask you a 
question today that I have been asking over and over again: Why 
does the CDC's guidance for institutions of higher education 
not even mention the word testing?
    But as soon as your testimony was done this morning, the 
CDC website changed and there are now guidelines for the 
institutes of higher education with fairly extensive 
recommendations and guidance, not mandates, about testing. I 
didn't have a chance to read them, but I saw them popped up on 
the CDC website, and I wanted to thank you for that.
    Your testimony, Dr. Redfield, today in some of the written 
testimony talks about the fact that the public health system 
relies on timely and accurate data systems, but that we have 
underinvested in them and the crisis has ``highlighted the need 
to continue efforts to modernize the public health systems.''
    Last year, I introduced a bill called the Saving Lives 
Through Better Data Act. It was with Senator Isakson and 
Senator King, and colleagues were helpful in this. We were able 
to get $50 million in December in the appropriations deal, and 
then another $500 million in the CARES Act. But, I would urge 
my colleagues to do even more because the request from our 
public health communities is significantly more sizable. I hope 
we might be able to get that into the next COVID package.
    Dr. Fauci, this is a challenging question, challenging how 
to figure it out. The CDC last week said that a new group that 
we have to consider at risk is pregnant women and lactating 
women. The NIAID's Remdesivir testing and vaccine testing often 
does not include pregnant women, I think for some safety 
reasons. But, we would want to make sure that pregnant and 
lactating women have access to treatments and access to 
vaccines. So, how will we be trying to do research and testing 
so that women can safely access these----
    Dr. Fauci. Yes.
    Senator Kaine [continuing]. Treatments or vaccines?
    Dr. Fauci. Yes. That is a great question. It applies also 
to children. So, what we are doing with the vaccine is you do a 
Phase 1 trial in normal, healthy adults--not pregnant, not 
children--and you show initial safety. Then when you move into 
the Phase 2 and 3 studies, if you get even the slightest 
glimpse of efficacy and safety in that population, you go back 
and do a Phase 1 in pregnant and lactating women, as well as in 
children. And, if that is safe there, you bridge the data so 
that you could use the efficacy data that you already started 
to apply back to pregnant women.
    Senator Kaine. I see.
    Dr. Fauci. That is how you do it.
    Senator Kaine. Let me ask you this. At this point, is the 
Nation's goal with respect to coronavirus to mitigate it or 
suppress it?
    Dr. Fauci. Vaccines right now--are you talking about 
vaccines, sir?
    Senator Kaine. No. I am just talking about what is our 
goal? Are we----
    Dr. Fauci. Yes.
    Senator Kaine [continuing]. Trying to mitigate or are we 
trying to suppress?
    Dr. Fauci. It depends on where you are. There is 
containment and mitigation. So, if you have a level of virus 
that is low enough that you can adequately contain by the 
standard way of identification, isolation, contact tracing, 
particularly if you make sure you link the identification with 
isolation--because if you just do contact tracing without 
isolation, it is not going to work. When you get into a 
situation----
    Senator Kaine. If I could, Dr. Fauci, because I don't want 
to go over time. I want to say just one thing about testing 
real quick.
    Admiral Giroir, when you were here last, you said we would 
have capacity to do 40 to 50 million tests a month in 
September. That is about 1.3 to 1.7 million a day. On May 12th, 
we had done about 310,000. Yesterday, we did 560,000. Are we 
going to get to 1.3 to 1.7 million tests a day by September?
    Admiral Giroir. Thank you for asking that. We will 
absolutely have the capacity to do that. It is depending on the 
need. And, again, as you might expect, a few weeks ago, the 
need for testing was much less than it is now.
    We had a good system that--it was actually very good that 
we were able to identify an increase in positivity very early. 
But, obviously, with the outbreaks we are having now, we need 
to massively surge testing in those areas.
    We will have that capability across the board. Yes, we will 
have that, and that is assuming no pooling. When we start 
pooling these together, three, four tests, then you do the 
math. So, I am never going to be happy until we have more 
tests, that we never have to say the word test again, but we 
are going to be in reasonably good shape given those 
parameters.
    Senator Kaine. Thanks, Mr. Chairman.
    The Chairman. Thank you, Senator Kaine.
    Senator Romney.
    Senator Romney. Thank you, Mr. Chairman, and thank you to 
each of the panelists for the sacrifice and the effort that you 
have been making over these past several years--past several 
months, as well as years.
    As you know, because we didn't know a great deal about this 
virus when it first came on the scene in America, we asked the 
American people to basically shut down their lives. Cut back on 
flying, family reunions, funerals, church services, 
restaurants, bars, theaters. Everything got shut down.
    Well, now it is end of June, and hopefully we have learned 
something about how this disease actually spreads, and the 
American people need to go back out. They are going to go back 
out, and they are going back out. We saw, for instance, at the 
Lake of the Ozarks, all these people and we said, oh, my 
goodness, this is going to be a major problem. But, my 
impression was because people were outside or who knows what 
other reason, it wasn't a major problem.
    My question is this: Where is the risk greatest? How is it 
that it is spreading? Is it spreading indoors? Is it spreading 
more in restaurants and bars? Is it okay to be outdoors and 
perhaps not socially distance? Are family reunions okay?
    Could you give us some guidance based on what hopefully we 
know as to where the risks are greatest? I know you keep saying 
social distance and masks, but, people are getting in 
airplanes, they are going to restaurants. Where is the risk 
greatest and where are we relatively safe? Can you help us 
through that? Family reunions? Can we get together with family 
reunions, outdoors? Is it safer outdoors than indoors?
    Give us some guidance. Can you do that, Dr. Fauci and Dr. 
Redfield?
    Dr. Redfield. Thank you, Senator. I think first and 
foremost, the most important thing in that assessment is 
knowing at the granular level what the kinetics of transmission 
are in that community. As I mentioned, we have 130 counties 
right now in the United States where we consider them ``hot 
spots.'' We have many other areas where there is very limited 
transmission. So, first and foremost, it is knowing the--if you 
are in that area of active transmission.
    Then second, it is knowing what you do when you are in that 
area of active transmission and what precautions one takes. I 
think these----
    Senator Romney. Got to be brief. You got to be brief, 
Doctor. I have only got 5 minutes.
    Dr. Redfield. Alright. Well, I think those are the two 
things. I will say that there is just more and more data 
showing that the use of face coverings and masks are an 
effective way to prevent transmission in these gatherings. And 
I think we are just going to come back and tell you the most 
important thing, if you are within a community with limited 
transmission and you are wearing face masks, or if there is 
significant transmission and you are wearing face masks, and 
you practice the social distance and hand washing, that is the 
best thing, best recommendations, I can tell you.
    Dr. Fauci. Yes. In addition, Senator, outdoor better than 
indoor. Bars, really not good. Really not good. Congregation at 
a bar inside is bad news. We have really got to stop that right 
now when you have areas that are surging like we see right now.
    But in answer to your question a little bit more granular, 
outdoor is always better than indoor. If you are outdoor, 
distance, as Bob said. Wear a mask if you can. But you can have 
some social interaction.
    The one point I want to make very briefly is that we should 
not look at the public health endeavors as being an obstruction 
to opening up. We should look at it as a vehicle to opening up 
so that you don't want to just restrict everything because 
people are not going to tolerate that.
    You can get outdoors. You can interact. Wear a mask. Try to 
avoid the close congregation of people. Wash your hands often. 
But don't just make it all or none. We have got to be able to 
get people to get out and enjoy themselves within the safe 
guidelines that we have. So, make public health work for you as 
opposed to against you.
    Senator Romney. I very much appreciate those responses. I 
think it would be extraordinarily helpful for all of us, as we 
are going about our lives, if there was data that indicated 
where people are getting infected. Were they in a bar? Were 
they in a restaurant? Were they outdoors at a pool?
    I have heard reports that virtually nobody has been 
infected if they are outdoors. Is that true or not true?
    We--given how long we have been at this, we have got to 
have more granular data so people know where there is greater 
risk. How many people, for instance, have been infected as a 
result of flying on airplanes? We have to know that. If we 
could publish that information for the American people, they 
will know where they can be safe and go back. Of course, 
continuing social distancing and wearing masks, but we need 
that data.
    Finally, I will just ask one--an answer. Who is responsible 
for distributing the vaccine? What person or what agency 
determines how the vaccine, when it is available, will be 
distributed?
    Dr. Redfield. Well, since--thank you, Senator. This is a 
central function of CDC where we really help with vaccine 
distribution throughout the Nation. Childhood vaccines----
    Senator Romney. That is--so that is the CDC. That is on 
your shoulders. Thank you.
    Mr. Chairman, back to you.
    The Chairman. Thank you very much, Senator Romney.
    Senator Hassan.
    Senator Hassan. Well, thank you, Mr. Chairman, and thank 
you to all the witnesses for being here and for the teams you 
lead. I know how hard everybody is working.
    Dr. Redfield, I want to start with a question to you. 
Forty-three percent of the deaths in this Country have been in 
nursing homes or long-term care facilities. In my State of New 
Hampshire, 80 percent of our deaths are attributed to residents 
of nursing homes and long-term care facilities.
    In mid-May, the White House urged states to complete COVID-
19 testing on every nursing home worker and resident within 14 
days. A month and a half later, that still has not happened.
    CDC has since put out different guidance on nursing home 
testing, calling for a baseline test for residents and weekly 
testing for nursing home workers.
    Given the widespread outbreaks within nursing homes and 
unique risks posed to residents, what is CDC doing to ensure 
that states carry out the recommendations for nursing home 
testing issued by CDC on June 13th? And, how many states have 
met these guidelines so far?
    Dr. Redfield. Thank you, Senator. We are working in close 
contact with CMS on that issue. As you say, we are not an 
enforcement agency. We make recommendations.
    Senator Hassan. But I am asking, and my time is short. I am 
asking what you are doing to keep track of compliance with 
guidelines. Forty-three percent death rate nationwide is huge, 
and people are looking to you all for granular guidance here. 
So, what are you doing to find out who is in compliance and who 
is not?
    Dr. Redfield. I was trying to emphasize that we are working 
in partnership with CMS, which has that regulatory oversight. 
We are there to continue to reinforce the guidances you 
mentioned, which we think is critical. And we think we do have 
to get everyone screened in these nursing homes, and the 
employees every week.
    Unfortunately, we still think that we need to keep visitors 
isolated from the homes right now, particularly in areas with 
high jurisdictions. But, the regulatory function of this is 
CMS, but we are really meeting with them daily to see what more 
we can do to try to ensure that there is greater compliance.
    Senator Hassan. I thank you for that. People are looking to 
the CDC for not only very clear and granular guidelines--and 
you have heard that all throughout the questioning--but 
particularly with nursing homes and long-term care facilities. 
There is a lot more work to be done, and we are still hearing 
that they are not getting usable personal protective equipment 
all the time, either.
    Let me go to another question. And, Dr. Fauci, I will start 
with you. We have heard discussion already today about the 
difference in the effectiveness of measures taken, for 
instance, in Europe and the United States. This is a graph that 
shows the disparities between new confirmed cases per million 
residents over the previous 7 days to the United States, 
Europe, Canada, and Japan. The disparity is eye-popping.
    [Slides shown.]
    Senator Hassan. Surveys suggest that mask-wearing in the 
United States occurs less frequently than in Europe. You and 
our witnesses have been very clear on the importance of mask-
wearing in public places. Do you attribute the improvements in 
Europe to more widespread use of masks? Or are there also other 
specific Government policies or individual behavioral 
differences that you believe should be incorporated into our 
national strategy?
    Dr. Fauci. It certainly--masks play a role, but there are a 
number of other multifaceted things in each of those very 
disturbing graphs that you show.
    Senator Hassan. Yes.
    Dr. Fauci. One of the things that became clear, when we 
shut down as a Nation, in reality, only about 50 percent of the 
Nation shut down with regard to other things that were allowed.
    In many of the European countries, 90, 95 percent of all 
activities were shut down. So, that is one of the reasons why 
you saw, particularly in Italy, which shut down to a much 
greater extent than we did, the cases came way down in a sharp 
curve downward and then stayed.
    It is not only masks. It is the fact that the countries in 
Europe and the other countries you have there had a much more 
uniform response. We are a very heterogeneous Country, and we 
had a heterogeneous response, depending whether you are in the 
northeast, southern, west, or what have you.
    There is a number of other factors, probably some that we 
still don't even understand.
    Senator Hassan. Well, thank you.
    I am going to move onto just one other issue, and it is 
really just to urge Dr. Redfield and the CDC to issue 
additional guidance for schools, in particular on reopening. I 
understand that you are continuing to do that.
    I appreciate that the CDC has released FAQ--frequently 
asked questions--documents on things like youth sports, which 
provide more concrete, useful information for families. And, I 
am hoping that you will do the same kind of FAQ documents for 
parents and teachers that directly address practical questions 
and concerns about school reopening plans. Simply like, what 
happens? What should a school do specifically if one or two 
positive cases come up in a classroom or in a teacher? What 
should parents and teachers expect school administrations to 
do?
    We can follow-up with that. I appreciate the Chairman's 
indulgence.
    The Chairman. Thank you, Senator Hassan.
    Senator Braun.
    Senator Braun. Thank you, Mr. Chairman.
    I have two sets of questions and would like for Dr. Fauci 
and Redfield to give about a minute each to the first.
    I want to get the broad numbers. I think, Dr. Redfield, you 
might have been on record that you think there is 10 times as 
many cases out there as--and I know that is a guess. I would 
like to know because, if that is the case, all the sudden, the 
fatality rate goes from 5 percent down to five-tenths a 
percent; 20 times as many cases, of course, 2.5 down to .25.
    What is your--start with you Dr. Redfield. How many cases 
do you think we actually have out there? And then, how many 
vaccinations in our herd immunity combinations, as a percentage 
of our total population, do we need to get to for this thing to 
be in the rearview mirror? So, we have a few big numbers to 
kind of relate to the journey ahead.
    Dr. Redfield. Thank you very much, Senator. Quickly, we now 
know that this virus began to really spread in the United 
States in March. And between March and the end of May, we have 
been able to do antibody testing, and that is what allowed us 
to understand how many people were really infected. So, during 
that period, it was our best estimate about 10 to one, so we 
are probably talking over 20 million, 22 million Americans have 
been infected.
    I don't want people to assume that is the same ratio now in 
June and July going forward because there is----
    Senator Braun. You think it is more than that or less than 
that?
    Dr. Redfield. No. I think it is going to be less because we 
are doing more and more testing. Okay? But, clearly, it gives 
us a good idea the extent of infection was more in March, 
April, and May. Not two million individuals, but more closer to 
20 million individuals.
    Senator Braun. What is your opinion of how many individuals 
we need vaccinated and/or having herd immunity before this 
thing goes into the rearview mirror?
    Dr. Redfield. Yes. Tony may comment on that, too. It has 
really got to be over 70 percent of the population----
    Senator Braun. Okay.
    Dr. Redfield [continuing]. Has got to be immune before we 
even see any impact of herd immunity.
    Senator Braun. Dr. Fauci.
    Dr. Fauci. Yes. I totally agree. Given the 
transmissibility, which is highly efficient, you are going to 
need somewhere between 70 and 85 percent. I would say 70 at the 
lowest.
    Senator Braun. Okay. Second set of questions would be on 
the issue of herd immunity. Because, of course, we have the--we 
don't know how long it is going to take to have an effective 
vaccine. And, I am guessing when you are talking about herd 
immunity, it has to actually confer immunity if you get it, and 
there might be some uncertain--let's assume you do get the 
immunity.
    What is the--how do we go about--the approaches that we 
have used to this point, is herd immunity going to be something 
that you think will march through if we take the strategy of 
having a different approach for younger people that seem to 
have lower hospitalization rates and less significant 
consequences? Because I think--that is another thing we need to 
know because I think that is already going to be done by each 
individual in a way as they seize up their own personal risk. 
So, how much can we count on herd immunity?
    Dr. Redfield. I can answer quickly and then turn it to 
Tony.
    I think it is important to realize even now, we are 
probably looking at somewhere between five and 8 percent of the 
American public has experienced this virus. So, for me, herd 
immunity as a basic strategy, you are talking about a multi-
year strategy. This is why it is so important that the 
alternative strategy is a biological countermeasure in the 
development of a vaccine.
    Dr. Fauci. One of the issues that might be complicating--I 
don't think it is going to be something that is going to be any 
kind of a show-stopper, but we have got to realize and, as 
Senator Paul said, we have to be humble and know there is a lot 
we don't know.
    What we don't know is what the durability is. In other 
words, so, if you wound up getting herd immunity to 75, 80 
percent, what we need to learn, and only time will teach us 
this, is how long this immunity lasts. Is it a year? Two? 
Three? Four? Or is it even less? Is it months? We don't know.
    When we find out, then that will inform us as to whether or 
not if you get a vaccine, how often you need to boost it. So, 
we have to realize, we don't really know the answer to your 
question in any definitive way.
    Senator Braun. At least that gives some clarity, some 
parameters to live within.
    Senator Hassan stressed the point of protecting the most 
vulnerable. Because, to me, the one thing it looks like we 
could certainly do is to take that highest-risk group from the 
data we have already got and build, in essence, an iron dome 
around them. That is the one thing that would seem to be the 
most important thing to do where you get certain results. And I 
think that has to be in place as we--the uncertainty of herd 
immunity, and when we get an effective vaccine, actually 
converge.
    Dr. Fauci. I might add, just--we always think about herd 
immunity with regard to natural infection and/or vaccination. 
But, when you want to talk about protecting the vulnerable, we 
want to see if some of the other programs that are more 
prophylactic treatment programs, like passive transfer of 
plasma, or monoclonal antibodies, or hyperimmune globulin. 
Those are some of the things that you can do to protect the 
vulnerable until we do get an effective vaccine.
    Senator Braun. Thank you.
    The Chairman. Thank you, Senator Braun.
    Senator Smith.
    Senator Smith. Thank you, Chairman Alexander, Ranking 
Member Murray. It is good to see all of you today. And thank 
you again to our panelists.
    We need robust surveillance and occupational testing if we 
are going to safely reopen our economy and our schools, our 
nursing homes and our group homes, to make sure that they are 
not a conduit for infection. And we are seeing this. A good 
example of this is in New York State, where employees in 
nursing homes are required to get a COVID-19 test twice a week.
    Here is the problem if you are a worker. Who pays for that 
test? Is it my employer? Is it my private insurance, if I have 
insurance? Or, do I have to pay for it out of my pocket? So, I 
am thinking about that low-wage worker working in childcare or 
food processing or maybe a security, worker, or a janitor. And, 
the average cost of a test is somewhere in the neighborhood of 
75 to $150, though there are reports of people being charged 
over $6,000 to be tested, assuming you can find a test.
    This is my first question. Last week, Federal agencies 
posted guidance on this question, and the guidance said that 
health plans are not required to cover the full cost of tests 
for surveillance or occupational reasons. And, the Federal 
testing plan, which talks about the value of surveillance 
testing and occupational testing, is silent on this.
    Let me ask you, Dr. Fauci, do you agree that we are going 
to be better able to contain the spread of COVID-19 and save 
lives if we have surveillance testing?
    Dr. Fauci. No doubt surveillance testing is going to be a 
very important part of the program to understand not only the 
current penetrance of the virus to society, but where it is 
going.
    Short answer to your question is it is going to be very 
important in our public health measure.
    Senator Smith. Would not also the price of these tests or 
the ability to pay for these tests be a pretty significant 
barrier to having that surveillance happen?
    Dr. Fauci. I think common sense tells you that if people 
cannot pay for it, they are not going to do it. That is one of 
the reasons we have got to figure out how we can do it without 
having the stress of people who cannot afford it to be part of 
that process.
    Senator Smith. Of course, the worry, of course, is that 
this ability to pay for these surveillance tests or this kind 
of surveillance testing, that could really tend to exacerbate 
underlying inequities since a lot of frontline workers and 
essential workers, who don't have the privilege of working from 
home, are much more likely to be Black and Brown and indigenous 
people, people of color. Is that not right?
    Dr. Fauci. As in all cases that people who are economically 
not able to engage in some of the things that benefit others, 
they always, in general, get a short end of the stick on that, 
and that is what we have to be concerned about.
    Senator Smith. Right. Well, colleagues, I think this is a 
really important place where we have the potential to work 
together to make sure that, as we expand surveillance testing 
and occupational testing, as we look at our schools, our higher 
institutions of higher education coming back, that we have the 
ability to do this and that the ability to pay for that test is 
not a barrier.
    I appreciate--Chairman Alexander, you mentioned this at the 
beginning, others of my colleagues have mentioned this, and I 
think this is a place where we could work together in a 
constructive way.
    I want to ask a question specifically related to vaccines 
because there has been a lot of discussion about this, a lot of 
discussion about how we can make sure that people trust these 
vaccines, that they are safe, that they work, and that the 
long-term consequences, potential negative side effects, we 
understand those.
    Let me just ask--maybe I will ask you again, Dr. Fauci. How 
do we trust a vaccine that has only had a short number of 
months potentially being tested in a human body?
    Dr. Fauci. There are a couple of ways to overcome that. 
First is that you have a large number of people in the trial. 
The trials that we are talking about now are going to have 
30,000 people in the trial, and maybe even more in some of 
them. You can get a considerable amount of safety data.
    But, then there is a process, after a vaccine maybe would 
show efficacy to do further studies following licensure, 
availability. I will let Dr. Hahn maybe comment on that more 
because that becomes something very much involved with the 
FDA's authority in making sure we do have safe vaccines. So, 
Steve?
    Senator Smith. Let me just--if I could maybe put a finer 
point on this question for you, Dr. Hahn. I mean, what if a 
manufacturer were to say that they could get a vaccine to 
market in January, but only if they were released from 
liability? What is the FDA policy on that? How would you 
resolve that question?
    Dr. Hahn. Thank you, Senator. So, we would not get into the 
issue of liability for an individual sponsor. And, what we 
would do, and that is why we released the guidance this 
morning, is we would ensure that our normal regulatory approach 
and our standards for safety and efficacy are met. So, while we 
are all----
    Senator Smith. You would not release that manufacturer from 
liability?
    Dr. Hahn. That is not an FDA authority that----
    Senator Smith. Okay.
    Dr. Hahn [continuing]. We would use.
    Senator Smith. How do you guard against----
    The Chairman. Senator Smith, we are running----
    Senator Smith [continuing]. The possibility----
    The Chairman. We are running a little late. Go ahead with 
your question, but let's--the witnesses have to----
    Senator Smith. This should be--hopefully this will be an 
easy one. I mean, what I am worried about is that there is some 
sort of October surprise and that there is pressure put on the 
decisionmakers here to announce the vaccine in October 2020.
    Dr. Hahn, can you just tell us how we can have transparency 
so that people can trust that is not happening?
    Dr. Hahn. Senator Smith, a very good question and really 
important and leads to the issue of public confidence. It is 
why we released our guidance today. We want to be clear about 
what the standards and the data that we will need to make a 
decision and what factors go into this decision. I want the 
American people to hear me when I say we will use the science 
and data from those trials, and we will ensure that our high 
levels of standards for safety and efficacy are met.
    The Chairman. Thank you, Senator Smith.
    Senator Smith. Thank you, Mr. Chairman.
    The Chairman. Senator Loeffler.
    Senator Loeffler. Good morning. Thank you all for being 
here. Sorry I cannot be there in person.
    I wanted to ask, Dr. Redfield, can you outline what steps 
the CDC is taking to, look at, as we prepare for handling both 
the flu and COVID-19 season simultaneously this fall? I know 
the CDC recently developed a test that diagnoses both COVID-19 
and the flu, but what other activities is the Agency engaged 
in? And, are there any novel approaches that you see in terms 
of implementing this? I would love to hear about the Agency's 
process for approaching the season this fall and your thoughts 
there.
    Dr. Redfield. Thank you very much, Senator. I think it is 
really important to recognize that it is going to be difficult 
with the flu and COVID this fall.
    First and foremost is to try to increase the American 
public's acceptance of flu vaccine. As you know, less than 50 
percent accept it. We are working hard to begin to reach out, 
particularly to groups that have been under-represented, to try 
to build that confidence in vaccination.
    We have worked with the manufacturers to see if they could 
boost the amount of vaccine that would be available. They have 
now increased their commitment to almost 189 million doses. CDC 
bought another 7.1 million doses. Normally, we buy about 
500,000 to be able to be available to the states and local 
health departments for uninsured adults. We have--we increased 
that to 7.1 million doses.
    We have augmented our commitment to the children's vaccine 
program, anticipating that there is going to be more children 
that will qualify in light of the unemployment.
    Those are some of the areas that we have begun to prepare 
for.
    Senator Loeffler. Thank you. And this question is for Dr. 
Hahn.
    The pandemic has exposed our vulnerabilities in the medical 
supply chain, and obviously we have a reliance on imports from 
countries like China that can quickly pose a national security 
risk in the face of an outbreak of infectious disease. We need 
to come up with a strategy to boost our production here of 
pharmaceuticals and supplies.
    I have introduced some legislation entitled the BEAT CHINA 
Act to offer incentives to companies that bring manufacturing 
back to the United States, but would like to hear from you, 
what additional steps can policymakers take to boost our 
capability to produce these supplies and pharmaceuticals 
domestically?
    Dr. Hahn. Thank you, Senator Loeffler, and thank you for 
your leadership on this. I think one issue that we can all 
agree upon is the lack of redundancy in the supply chain and 
the dependency that we have seen during the COVID-19 pandemic 
has been a problem.
    The Agency's primary focus has been on instilling 
redundancy in the supply chain, particularly of 
pharmaceuticals, by diversifying that supply chain and really 
looking for opportunities to encourage domestic manufacturing.
    We, of course, on the regulatory side provide guidance, as 
well as regulations, around the manufacturing specifications to 
ensure quality of pharmaceuticals and other medical products. 
We will continue to do that, particularly in the advanced 
manufacturing space, in order to encourage domestic 
manufacturing.
    We look forward very much to working with you and other 
Members of Congress to see how we can create the proper 
incentives to have that redundancy, and particularly to have as 
much domestic manufacturing as possible.
    Senator Loeffler. Thank you, Dr. Hahn.
    No further questions. I yield my time.
    The Chairman. Thank you, Senator Loeffler.
    Senator Jones.
    Senator Jones. Thank you, Mr. Chairman. Thank you all for 
being here today. I really appreciate your testimony, your 
consistency over the last few months. It has got to be somewhat 
discouraging to all of you, as it is to us, to see these 
numbers.
    I want to kind of focus a little bit on schools as we will 
start opening schools up in Alabama in August. And, let me give 
you a little chronology here.
    The State of Alabama kind of began to open up its economy 
more in May, a little bit more toward the end of May, and then 
in--for Memorial Day, we saw the photographs and videos that 
Dr. Fauci referred to with everybody just having a big time 
over the Memorial Day holiday.
    Now, at the end of June, we are at our highest levels. The 
last 14 days have shown over 10,000 cases, which is 28 percent 
of the cases that we have seen have occurred just in the last 
14 days.
    At the end of this week, we have the July 4th holiday 
coming up. And, we are going to see a delay in hospitalizations 
from right now. If we do the same thing on July 4th, we are 
going to have a huge problem at the end of July and early 
August when we start opening schools up.
    Our state school superintendent this week said that it 
would cost about $1.8 million for the average school system to 
do those things necessary to try to protect kids and the 
faculty. But, I heard Senator Paul in his comments and 
discussing a number of things to where you would get the 
impression that we could just open schools back up without 
spending any of that money.
    My question, primarily to Dr. Fauci and Dr. Redfield, could 
you comment on some of the statistics and some things that you 
heard about children transmitting this disease and whether or 
not we need to spend some extra, additional moneys for our 
schools to do things like have extra PPE? To do things like 
hiring--potentially hiring additional health officers, 
temperature screenings, those kind of things? Are those going 
to be necessary, based on what I have heard from Senator Paul 
and what happened on his charts in other countries?
    Dr. Fauci and Dr. Redfield?
    Dr. Fauci. I will quickly give it a shot and then hand it 
over to Dr. Redfield.
    We don't know precisely. I think the data that was very 
interesting that Senator Paul showed about school openings and 
not seeing any real obvious surge in cases is important, but we 
don't really know exactly what the efficiency of spread is.
    First of all, how many children get infected. That was the 
reason why in my opening statement I mentioned the study that 
we are doing at the NIH of 6,000 families, looking at children, 
what is the rate of their infection and how often did they 
infect their families. Because if it is true that the rate is 
down, we would know that they don't get seriously ill with 
hospitalizations when they get infected. But, if the rate of 
infection is down and they don't readily transmit to their 
parents and family members, that is going to be very important 
in the decisionmaking process of opening schools. Hopefully, we 
are going to find that out reasonably soon by this study that 
we are doing.
    Bob.
    Dr. Redfield. I would echo what Dr. Fauci said. CDC has a 
number of what we call household studies going on to try to get 
a better understanding of how does the virus get into a 
household, who brings it in, what happens with--when it is in 
the household, how does transmission vary depending on how the 
household responds in terms of social distancing, et cetera. 
So, there is information that we are gathering. I think--we 
don't know the impact that children have yet on the 
transmission cycle, so I think we should just acknowledge that.
    The greater threat, obviously, is, again, the children to 
the vulnerable, but I think one can actually have social 
behavior that can prevent that. So, I think that would be just 
to emphasize. I think it is really important.
    It has been said already that we move forward and work to 
reopening schools in a safe way. I think it is of note that CDC 
never really recommended closing schools. It sort of just 
happened, as you know. We can do targeted school closings if we 
have to in a particular region like we have done for other 
viral diseases.
    But, I think we really need to move forward now and work to 
how to reopen these schools safely.
    Senator Jones. Thank you. Admiral Giroir, just--I want to 
make sure you are--we are tuned in, and we have talked about it 
a little, about are we going to be able to make sure that we 
get vaccines distributed in the most vulnerable of communities? 
Because that seems to be where so much is happening right now, 
in the rural south. And, are you making specific plans to make 
sure that we get that into the rural areas?
    Admiral Giroir. Thank you very much. So, we all work on 
parts of this problem, right? So, the CDC actually controls the 
distribution. But, what my office does, running the national 
vaccine program, does things like the Morehouse Grant that--the 
cooperative agreement that we announced last week. That really 
reaches into the rural, into the Hispanic, into African 
American, to really have the community, the people who are in 
that community, not only linked to services like testing, but 
to lay the groundwork for vaccine acceptance. Because we know 
that the burden of disease is fundamentally burdened on these 
individuals. So, these are the people, assuming the science 
works out, that we want to get vaccinated first.
    Senator Jones. Alright. Great. Thank you.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Jones.
    We know the witnesses need to leave about 1. We are going 
to try to respect that.
    Senator Rosen.
    Senator Rosen. Hold on. Can you hear me?
    The Chairman. Yes, we can.
    Senator Rosen. Well, good morning. I will try to be as 
quick as I can, talking about antibodies this morning. Thank 
you Chairman Alexander, Ranking Member Murray, all of our 
witnesses, for being here today.
    As our communities focus on how to safely get back to work 
and school, just like we are all talking about, we know we have 
to follow the science and adapt to new information to be sure 
that we are making timely, targeted, and thoughtful decisions 
to protect both lives and livelihoods.
    Dr. Fauci, the last time you were here, we talked about the 
monoclonal antibody treatments, and I would just like to 
follow-up on that conversation if we could.
    As we have learned more about the virus, how it functions, 
how it is different from other respiratory illnesses, what 
updates can you tell us about the development of preventative 
treatments that block the virus from attaching to the cells 
that it is targeting?
    Dr. Fauci. Thank you for the question, Senator. You 
mentioned monoclonal antibodies. Monoclonal antibodies are 
going into trials right now in a number of trials sponsored by 
a number of groups. Hopefully, within a reasonable period of 
time, we will get information as to whether or not that is 
effective both in the prevention, as well as in the treatment. 
Those antibodies are directed against a component of the virus 
that is--what is called the spike protein, and that protein is 
the one that binds to the now well-established receptor in your 
body for the virus, and that is the receptor called ACE2.
    There are a number of other studies that are not 
necessarily antibody studies, but studies that have an effect 
on the virus itself and its initial replication.
    In answer to a question that the Chairman mentioned just a 
bit ago is that there will be therapies that we will be giving 
some for treatment early on and others for prophylaxis. And, 
as--we hope, as we get into the fall and winter, we will have 
everything from small molecule treatments and prophylaxis to 
the kinds of antibodies that you are talking about.
    There is a lot of activity going on to do that early in 
disease, both for prevention and for the treatment of early 
disease.
    Senator Rosen. I know that you have been doing a lot of 
serology testing and that individuals are presenting with 
antibodies. So, out of the five types of antibodies that people 
are most likely to have, which ones do most recovered 
patients--which ones do they show? And, if one of these 
specific antibodies are present, does that make a difference in 
if the patient can be re-infected or not? Are they effectively 
immune at least for some period of time? What kind of answers 
does this give us if you do have the presence of certain 
antibodies?
    Dr. Fauci. I am--I would like--I would love to give you a 
really precise, scientifically based answer, but the fact is, 
we don't know. Standard wise, when you get an acute infection, 
you get an IgM antibody. As you go off in time and develop a 
more mature immune response, it becomes an IgG. There are 
subclasses of IgGs, some more protective than others.
    The thing we don't know, Senator, that we--we will know in 
time, but it is going to take time to know it, is what the 
relationship between the neutralizing antibody and binding 
antibodies that don't neutralize, what is the relationship 
between the titer and degree of protection, and what is the 
durability of protection.
    We have seen some puzzling things. We have seen people 
recover from COVID infection and find out they don't have very 
high numbers of antibody. Could it be a cell mediated response 
that got them through the illness? And, some other individuals 
have very high levels, and we don't know how long those levels 
last.
    We are getting there with regard to our knowledge, but it 
is going to take several more months to a year to really be 
able to definitively answer your question about the role of 
antibodies in protection following natural infection.
    Senator Rosen. Well, building upon that, I would like to 
ask this question then. We know that this virus affects--it is 
multi organ. It can affect your kidneys, your lungs, your 
heart, producing strokes, all kinds of things, your digestive 
system, your sense of smell. So, on the science that you are 
talking about and the antibodies, is the science of stopping 
the virus from causing harm the same regardless of which organ 
it attacks? And how do we help direct funding for the kind of 
research that you are going to need to look at this multi organ 
attack of this virus, if you will?
    Dr. Fauci. This is a very perplexing virus because it is a 
respiratory virus and it gets in through the respiratory tract. 
If the virus stays in the respiratory tract and doesn't go 
systemic to involve other organs, that is good news because you 
don't get very sick.
    The other side of the coin is your antibody response is not 
as potent because when you get systemic involvement, 
invariably, you will have a more potent and robust immune 
response. So, many people, and probably the people who are the 
asymptomatic carriers, they have a reasonable titer of virus in 
their nasopharynx, but the virus doesn't go any other place in 
their body.
    People who get multi system disease that get triggered by 
the virus, those are the ones that, unfortunately, get more 
sick, but also the ones that make a more potent immune 
response.
    Senator Rosen. Thank you so much. I appreciate you all 
being here today.
    The Chairman. Thank you, Senator Rosen. Very interesting 
questions.
    Senator Murray, do you have closing remarks?
    Senator Murray. I have one additional question, if I might, 
and then some closing remarks. I wanted to ask Admiral Giroir 
one question.
    Admiral Giroir. Yes, ma'am.
    Senator Murray. Thank you. Despite some of the limited 
data, we do know that COVID-19 is infecting and killing Black, 
Latino, and Native American people at a much higher rate than 
White people. I wanted to ask you how HHS is going to adjust 
its response to reduce cases and deaths in communities of 
color. And, specifically, can you commit to redirect some of 
the $14 billion that is in unspent funds Congress provided to 
address those disparities?
    Admiral Giroir. Let me answer the two parts of the 
question. First, as you know, and we really appreciate your 
support, we have tried to focus our testing into high social 
vulnerability communities. So, 70 percent of our over 600 
pharmacy sites are in high SVI communities. That means racial 
and ethnic minorities, language disparities, socioeconomic.
    FQHCs: We have made a major push that the federally 
qualified health centers that take care of one out of three of 
those in poverty, over 1,300 of those are now offering testing.
    Of course, we are super excited about the award to 
Morehouse School of Medicine last week that has a large 
coalition to create a national infrastructure to reach 
minorities and underserved.
    That is what we are really doing. And, my office, this is 
what we do on a daily basis, but even without a pandemic.
    Your second question is, I don't commit the money. So, I 
certainly think we need continued investment in this area, 
continued significant investment in this area, that the $40 
million is a down payment on how we could best reach the 
underserved community, but you are going to have to talk to OMB 
about how the money is spent.
    Senator Murray. Well, actually, HHS oversees that, so we 
will ask them. But, I think that is an important question. I 
will keep following up and tracking that.
    Admiral Giroir. Yes, ma'am.
    Senator Murray. Thank you, Mr. Chairman.
    I appreciate all of our witnesses taking the time to join 
us today to update our Committee on the course of this pandemic 
and all of our efforts to respond to it.
    I hope we will continue to have an opportunity to hear from 
all of you, as well as other key Administration officials, 
about this because the absolute worst thing we could do right 
now is to pretend this crisis is over when it is painfully 
obvious that is not true. The reality is that the losses in 
this pandemic so far are nearly unthinkable, and any further 
delays in our response is really unacceptable. We need to 
take--this President to take this crisis seriously and lead, 
and we need Congress to act.
    I hope we can all get back to work as soon as possible. We 
need to support our families, our frontline workers, our 
businesses, our schools, our communities. We need to get 
testing where it needs to be. We need to make sure we are 
making progress toward a safe, effective, widely available 
vaccine, and we need to strengthen our ties with the global 
community rather than cut them.
    There is a lot left to do, Mr. Chairman. I look forward to 
working with you on this.
    The Chairman. Thank you, Senator Murray.
    I know our witnesses have a meeting they need to go to, so 
I will abbreviate my remarks. But, one thing I want to ask 
you--perhaps you can each do it in a minute or less.
    I put out a white paper in recognition of what some of you 
have said, which is that in between pandemics, we have found it 
difficult to do some of the things we need to do to prepare for 
the next pandemic. So, if there were one or two things that you 
thought we should try to do now in order to be prepared for the 
next pandemic, what would those one or two things be? Dr. 
Fauci?
    Dr. Fauci. One of the things that I would like to see is an 
appreciation on the part of our entire Nation of the importance 
of responding as a Nation as a whole and not have a situation 
where, when you have a challenge such as we have right now, we 
have very disparate responses. We have got to do it in a 
coordinated way because we are all in this together.
    The other thing I would like to do now is to cement in our 
minds as we bridge to the future the fact that we cannot forget 
that what was thought to be unimaginable turned out to be the 
reality that we are facing right now. So, it relates to the 
kind of appreciation that outbreaks happen, and you have to 
deal with them in a very aggressive, proactive way.
    The Chairman. Dr. Redfield.
    Dr. Redfield. Thank you, Mr. Chairman. I think the most 
important thing that I could say is that when it comes to 
public health threats, our Nation needs to be over-prepared, 
not under-prepared.
    As I mentioned before, decades of under-investment in the 
core capabilities of public health, data modernization, 
laboratory resilience, workforce, emergency response, I think 
is fundamental. We have really been hit with this simple virus, 
and I think at the end of the day, it is going to cost our 
Nation trillions of dollars.
    I think that we have a moment in time where I think people 
are attuned, and I would say now is the time to make the 
necessary investment in our public health at the local, 
territorial, tribal, state, and Federal level so that this 
Nation finally has the public health system not only that it 
needs, but that it deserves.
    The Chairman. Admiral Giroir.
    Admiral Giroir. Of course, I agree completely with my 
colleagues and we are all singing from the same hymnal here.
    I will say three things. No. 1, data infrastructure is 
really important. When we came into this, we didn't know how 
many ventilators were in use, how many tests were out there, 
were the tests positive or negative, who was being tested. I 
mean, the complete soup to nuts infrastructure that we need to 
make decisions. You need those data to make decisions and to 
allocate resources. And now that--we have built this on the 
fly, but we absolutely have to invest in that.
    Second, I would say resiliency of the healthcare system. 
Yes, we need to attack COVID, but what happens to everything 
else? We have seen cancer screenings go down by 80 percent. 
Childhood immunizations plummet. Just about every other thing 
in the healthcare system was sacrificed for our COVID response. 
So, it is not just the pandemic response, but it is everything 
else we need to do.
    The third thing I would say is we continue to have to focus 
on health disparities. If everyone was healthier in the 
Country, if we invested into those--to hypertension, diabetes, 
obesity, all the things that could bring the general health up, 
you would not see as horrible of outcomes as we have in any 
pandemic. So, working on health disparities that have been here 
for decades is, I think, critical to raise our general health 
and prepare us for whatever is going to hit us.
    The Chairman. Dr. Hahn, you can have the last word.
    Dr. Hahn. Thank you, Mr. Chairman. First of all, thank you 
for your leadership and your white paper. I think that is 
really important to put this conversation forward.
    There are two things I want to emphasize. One is the data 
modernization, but from an FDA perspective. It is a very manual 
process to, No. 1, collect data on demand, and also, the supply 
chain. We need a very robust system to understand that.
    We also need a robust, real world evidence approach so that 
when we make decisions in real time during an emergency--
doctors do that all the time, agencies do that, particularly 
during public health emergencies--we have the appropriate data 
infrastructure to collect real world evidence and feedback into 
our decisions, and then revise those decisions as needed. 
Critically important for the Agency.
    The second thing is linked, and that is to my previous 
comments that Senator Loeffler asked about. We absolutely need 
redundancy in the supply chain. We need redundancy in 
manufacturing. And, we need to emphasize the importance of 
domestic manufacturing.
    Thank you.
    The Chairman. Thank you, Dr. Hahn.
    Well, the one thing this sneaky, dangerous virus has 
reminded us is that there will be another sneaky, dangerous 
virus one day. And, we know from experience that it may be 
easier to take the steps you have just described while our eye 
is on the ball rather than between pandemics because we get 
interested in other issues.
    I am grateful to the witnesses for your time. I thank the 
Senators on both sides of the aisle for really careful, 
insightful, and courteous questioning.
    The hearing record will remain open for 10 days. Members 
may submit additional information within that time if they 
would like. Thank you for being here. The Committee will stand 
adjourned.

                          ADDITIONAL MATERIAL

                    testimony of dr. joycelyn elders
                       15th U.S. Surgeon General
               Co-Chair African American Health Alliance
    Good morning Chairman Alexander, Ranking Member Murray and Members 
of the Senate Committee on Health, Education, Labor, and Pensions. I am 
Dr. Joycelyn Elders the 15th Surgeon General of the United States. I am 
also co-chair of the African American Health Alliance a nonprofit 
organization working to help eliminate racial and ethnic health 
disparities and the social determinants thereof. We thank you for 
convening this special hearing on COVID-19 Update on Progress Toward 
Safely Getting Back to Work and Back to School as well as the hearing 
on COVID-19 lessons learned to Prepare for the Next Pandemic, along 
with the many other coronavirus hearings held by this Committee.

    COVID-19 continues to take its deadly toll, especially across the 
Black community and other vulnerable populations. As the United States 
seeks to send workers back to work and children back to school, among 
the major missing factors to date remains: safe and effective treatment 
and vaccines, and an overall safe, effective and sustained public 
health response that includes ongoing robust reliable testing, contact 
tracing, care and treatment, and isolating. This is just basic 
responsible operating requirements for opening the workplace and 
schools.

    In a whirlwind of disasters, Americans remain barraged by a 
worldwide pandemic of a new virus and medical unpreparedness; shortages 
of PPE, hospital space and medical personnel; government 
unpreparedness, economic recession and unemployment; huge numbers of 
hungry and homeless people; police brutality and systemic racism.

    Our Nation's underbelly has been exposed in COVID-19, brutal 
policing, racism and income insecurity. People are taking to the 
world's streets to demand peace with justice and an end of racism. The 
world has awakened to discover that huge numbers of people are 
dissatisfied with disparities that are obvious in all areas of 
economics, social justice, education, housing, medicine and more. Black 
lives do matter.

    It is crystal clear that the events of the past few weeks and 
months have revealed the awful truth about the impact made by racial, 
health and economic disparities in our country. Standing there naked in 
view of the world, we are humbled. However, being humble is not enough. 
We can see clearly how unfavorably we compare to other countries in the 
world, and they can see it, too. The people of the United States have 
not fared as well as other developed countries. Our nation's responses 
to the coronavirus pandemic including its disease rates are higher and 
our ability to mobilize resources, identify the presence of the virus, 
isolate and support people while they do, is miserably deficient.

    Our Nation's infection rates and death numbers are higher than many 
other industrialized countries. While our Nation offers hope of a 
vaccine that remains out there on the horizon the immediate need is for 
safe, effective, lifesaving treatments that are accessible to all that 
need it. This must be coupled with an effective ``Test-Trace-Treat-
Isolate-Repeat'' package. People across the Nation and around the world 
are asking how, when, where, why, and what went wrong in United State, 
that America has been bent so low? Especially with regard to 
coronavirus, it seems ridiculous, since America has the best doctors, 
nurses, medical teams, and research laboratories in the world. However, 
being the best professionals doesn't cover all our bases in providing 
the best health care for all our people. Because, all our people do not 
have access to this remarkable world of medicine that we have built.

    Mr. Chairman, Ranking Member Murray and Members of the Committee 
surely you can understand my deep concerns regarding access to safe, 
effective and accessible treatments and vaccines to the Black community 
and other vulnerable communities. Even before COVID-19, our Nation's 
delivery system, for all its wonderful medical know-how, was and 
remains broken. And, doctors scarcely have a word in the way health is 
delivered to all our people. While doctors provide medical expertise, 
the organizational power is given over to others in the corporate and 
political world.

    At least for 30 years, we have been ``working'' on eliminating 
healthcare disparities. When Healthy People 2000 came out in 1990, 
eliminating Disparities in Health Care was an objective. Then, it was 
an objective in Healthy People 2010; then it was an objective in 
Healthy People 2020. In these 30 years, we have not made much of a dent 
in the actual disparities. The Affordable Care Act is helping and it 
must be protected and strengthened. Additionally, we must address the 
social determinants of health. Clearly, a person is only as healthy as 
the least healthy person.

    Health care must be extended to everyone for public health to be 
good. Without it, the risk to opening America including its schools--is 
too risky. It is unsafe without the appropriate tools, resources, 
medical and mental health teams, PPE, safe and effective coronavirus 
treatments as well as access to safe, effective and affordable 
medications for pre-existing health conditions and more. The unintended 
negative consequences are real and must not be ignored. Instead, we 
must ``test-trace-treat-isolate-repeat''.

    The compounding coronavirus pandemic, the economic collapse, police 
brutality and systemic racism, individually and collectively take their 
toll. Again, while these epidemics are truly humbling, being humble is 
not a solution. As a Nation, we are at a dangerous low point in society 
and humanity. Know that when there is a vacuum, someone and/or 
something will fill it good or bad. We are all in this together: 
doctors, scientists, clergy, elected officials, frontline workers, the 
public and private sectors, and we the people. Equity is important to 
the well-being of every man, woman and child and to our Nation on every 
front.

    Disparities must not only be addressed; they must be eliminated. 
COVID-19, racism, excessive policing and the economic disaster, 
continue to show us that we can no longer just re-arrange the deck 
chairs on the Titanic. We must conquer coronavirus, put an end to 
racism, reform our policing and healthcare system, and build a life 
sustaining economy for all. Among these, that includes developing a 
healthcare system that provides healthcare to all and eliminates 
disparities in health and health care.

    Now, our Nation only has a sick-care system for all, with a 
healthcare system for some. The United States cannot stop at only 
healthcare access and delivery; we must also address all the 
disparities in the social determinants of health. They are the backbone 
on which to develop the most effective response. America has not wanted 
to spend the money investing in health care for all and public health. 
Now, America is reaping the negative consequences of her reluctance to 
invest in people. The United States will continue paying until our 
Nation invests in eliminating racial and ethnic disparities.

    The compounding intersecting adverse outcomes come as no surprise. 
Either we will invest in people now or pay later. The Committee will 
recall the findings of the 2002 Institute of Medicine Report ``Unequal 
Treatment'' that urged the Nation to confront racial and ethnic 
disparities in health and healthcare. The African American Health 
Alliance strongly believes that if the recommendations of that report 
had been implemented the burden of coronavirus and other health 
disparities would not be so dire. Nevertheless, we are once again at 
the urgency of now and must effectively deal with this deadly novel 
coronavirus head-on.

    While Coronavirus has been declared a National Emergency, the void 
is clear racial and ethnic health disparities elimination and racism 
elimination have not. Surely, the deadly extent of coronavirus in the 
Black community and the impact of the virus across communities of color 
demands that racial and ethnic health disparities elimination and 
racism elimination must be declared national emergencies, and 
effectively addressed as such. To that end, from lessons learned to the 
opening of places of work, schools, entertainment and more, the African 
American Health Alliance submits recommendations via my testimony to 
this distinguished Committee to help our Nation better address the 
COVID-19 epidemic.

    It is against this collective backdrop that the African American 
Health Alliance urges implementation of the recommendations coupled 
with the accelerated development of safe, effective, accessible and 
affordable to all COVID-19 treatments and vaccines and the required 
wrap around services people need to benefit from them.

               Recommendations Details and Justification:
    The coronavirus pandemic requires a comprehensive response. Black 
lives do matter. Declare Racism a National Emergency: Declaration to 
provide for inclusion of racism elimination and prevention provisions 
in all policies, practices, and programs. This action systematically 
takes into account the adverse consequences of racism in policing and 
all social determinants impacting the quality of life. For all, the 
declaration limits and helps to prevent the harmful effects of racism 
across the lifespan. Black lives do matter.

    The elimination and prevention of racism is vital to helping to 
ensure that all persons achieve their fullest potential, freedom and 
justice. Conduct racism impact assessments, elimination efforts 
including engaging state and local and community workgroups for the 
purpose of informing decisions that promote elimination thereof as well 
as those that prevent elimination. Racism's consequences and protests 
nationwide and worldwide against racism support this declaration. 
[Within, that is AAHA's recommendation for the declaration of 
``Racism'' and the ``Elimination of Racial and Ethnic Health 
Disparities'' national emergencies.'']
             Disease Detection, Manage, Control and Monitor
    Coronavirus Testing: Provide Testing, Contact Tracing, Isolate, 
Treat, Social Distance, Repeat: Remove barriers and provide accessible, 
robust rapid accurate and timely testing with accurate rapid results: 
priority testing must be targeted especially for those African 
Americans with chronic pre-existing health conditions that place them 
at increased risk for coronavirus deaths and disease. Lack of testing 
remains a major missed opportunity to help control the spread and 
reduce coronavirus cases and deaths, and for making informed decisions 
about re-opening. This requires testing of not just those with symptoms 
but also those without.

    Provide both COVID-19 mobile testing labs along with mobile health 
units. This companion effort provides for continuity of care for pre-
existing chronic health conditions. Together, they are absolutely 
essential especially in high-risk communities, pre-existing health 
condition, hot spot breakout areas, crowded public housing and 
frontline jobs/workplaces. Additionally, re-energize the DHHS health in 
public housing program. DPA: Robust test production, testing, contact 
tracing and isolation are essential to help control this deadly 
pandemic and treat and manage pre-existing health conditions.

    Coronavirus test to also include the serology test. Negatives must 
continue precautions including social distancing and isolation. 
Effective contact tracing requires that tracers also include African 
Americans and others from communities of color. Coronavirus testing 
coupled with contact tracing, monitoring, identification, isolation, 
diagnosis and immediate coronavirus care, treatment and management 
coupled with ongoing testing and treatment for pre-existing health 
conditions is a must solution.

    State and local health departments must be supported also to help 
do the contact tracing and follow-up that is necessary to be effective. 
Directly fund each state and territory to do contact tracing and robust 
testing. The CDC's respiratory surveillance system is not adequate to 
the task. States must demonstrate a system where data is collected from 
all populations indicating the ability to provide rapid diagnostic 
services to all residents and ongoing serologic monitoring the state's 
population including unserved and underserved areas (MUAs).

    Responsible opening, care, treatment and control are them care. Do 
not open schools without testing. Without it, the approach is reckless. 
National robust testing requires releasing the full powers of the 
Defense Procurement Act; that act exists to help save lives; do it now.

    Engage/ Command / Control /Preparedness / Emergency Response / 
Resilience Expert: We strongly urge you to work with retired General 
Russell Honore to develop a comprehensive Coronavirus Resilience 
National Strategy with emphasis on public health, the supply chain, 
economic security, vulnerable populations, cyber security, broad band 
and more including a build-back-better approach. General Honore has 
tremendous expertise that is needed to help improve the coronavirus 
response.
             Extent of Need: Pre-existing Health Conditions
    Pre-existing Health Conditions: Provide Healthcare Access for Care 
and Treatment: Expand and ensure access to care and treatment: include 
Medicaid expansion; allow Medicare enrollment at age 45, allow 
``special open ACA enrollment season now'' and permit young adults to 
remain on their parents' health care plan to age 30. In addition, 
expand existing community health centers and continue to increase the 
number of new centers especially in unserved and underserved 
communities. There must also be mobile community health satellite 
centers with full or near full array of services. Coronavirus and 
chronic health conditions together require immediate, short and long-
term care, treatment and follow-up.

    Continuity of care is vital. Expansions in access to care and 
treatment with wrap around services is necessary to respond to both the 
coronavirus medical, mental health conditions and to chronic pre-
existing health conditions that the virus further complicates. Overall, 
make sure everyone has some form of affordable health care coverage 
with facilitated access to it, and that effective responds to their 
needs.

    Concern abounds about rationing: care, treatment, medications and 
testing, including that for chronic pre-existing health conditions. 
Unserved and underserved communities need reliable connectivity 
technologies to effectively accommodate and benefit from telemedicine, 
tele-health, tele-mental health, tele-dental, and tele-nutrition to 
name a few. Stable reliable internet/broad band services are essential 
for health, home schooling, higher education, training in the trades 
and more.

    These deficiencies adversely limit health, education and employment 
opportunities. In addition to care, treatment, and dire testing 
shortages, medication shortages are also on the rise. Addressing the 
overall twin conditions: coronavirus and ongoing health needs of people 
in public housing, nursing homes, prisons, assisted living, the 
homeless and similarly situated environments is paramount.
                 Data Collection Analysis and Reporting
    Extent of the Coronavirus: Provide Data Collection, Analyses, 
Monitoring and Reporting: Racial and ethnic health disparities are well 
known to Federal, national, state, local leaders, officials and 
community gate-keepers and agencies. Data must be collected and 
documented at point of medical system and testing entry. Agencies must 
collect, analyze, monitor and publically report coronavirus racial and 
ethnic demographic data. Months into the coronavirus pandemic and 
national emergency race and ethnic data are insufficient to 
appropriately inform the medical, the Nation's and community's response 
to the deadly and highly contagious coronavirus.

    The Department of Health and Human Services and its agencies must 
collect, compile, analyze, release, and report race and ethnic 
demographic data including but not limited to that on cases, deaths, 
location, zip code, outbreaks, hospitalizations, and testing. Data is 
extremely limited and seriously life-threatening-insufficient. 
National, state and local coronavirus reporting must be accurate, 
timely, complete and transparent. Additionally, data is an essential 
factor helping to identify where services and resources must be 
targeted and concentrated. Testing, care and treatment data help inform 
efforts to improve outcomes.
                               Workforce
    Provide Hazardous Pay, Worker Protections and Whistle Blower 
Protections: Provide hazardous pay to coronavirus frontline workers, 
double existing pay/salary. Months into this deadly contagious 
coronavirus the shortages of staff, personal protective equipment and 
gear continue to place workers and their family at increasing risk for 
disease and death. The frontline workforce includes nurses and doctors, 
non-medical hospital staff; home health and nursing home workers; 
grocery store, postal, transportation, medical technicians, meat 
packing plant workers; the list goes on and on. Direct OSHA to update 
issue and monitor coronavirus worker protection guidelines. Provide 
whistle blower protections.

    Coronavirus frontline and essential workers across all fields must 
be paid hazard pay, double current pay. Every day, they put their life 
on the line to serve the public . . . facing the deadly coronavirus 
head-on without hazardous pay. Months into this deadly pandemic, 
despite dire working conditions, still the full powers of the DPA have 
not been released and that deficiency has now spilled over into the 
extreme deadly shortage of coronavirus tests. Essential materials, 
equipment, test and test material remain in short supply including 
medical equipment, cleaning supplies, gowns, gloves, masks and 
medications.
                           Care and Treatment
    Establish Coronavirus Community Access Points: Because of the 
highly contagious nature of COVID-19, the fact that it may spread 
before the individual becomes symptomatic, the severity of its illness, 
and the fact that many individuals will be at risk of becoming infected 
for years to come, the health system must adopt modifications 
immediately to respond to medical, mental health, social determinant 
requirements and complications stemming from coronavirus in immediate, 
short-and long-term.

    Without national testing and within it African American priority is 
testing, the coronavirus is more deadly for all. Community Access 
Points must be developed to provide unserved and underserved 
communities with sites which will be: highly accessible loci for 
services and for the provision of information regarding COVID-19; sites 
providing immediate testing and informing of virus status; care entry 
points for those testing positive; and loci for isolating, counseling 
and contact tracing staff in the community. [Test-trace-treat-isolate-
repeat.]

    Access points must have separate waiting areas for patients and 
address (treat, manage and control) pre-existing chronic health 
conditions. These facilities must have: up to date laboratory test and 
equipment; access to the most up to date COVID-19 information provided 
by DHHS; ability to diagnose and quickly report COVID-19 status; a 
waiting room separate from non-COVID-19 patients; and ability to 
transport positive patients to an in-patient facility which serves 
symptomatic COVID-19 patients. Staffing team minimum requirements: a 
physician or nurse practitioner; nurse, technicians, counselor with 
social work training; and contact tracing staff. The unit/entity/
facility should be located on the site of an established community 
health facility and operated by that facility collaborating with local 
or state health departments.

    Establish Prison Coronavirus Systems: The Federal Bureau of Prisons 
must develop a coronavirus plan for each of its regions. Each plan must 
specify mechanisms for: identifying positive staff and inmates; 
separation of positive staff and inmates from the general population; 
isolation, contact tracing, and also ongoing identification of staff 
and inmates missed in the initial screening; and screening of all 
incoming staff and new inmates and separation of positives.

    Collaborating with state health departments for contact tracing 
purposes: each region must designate a COVID-19 coordinator, preferably 
a physician. A COVID-19 counselor must be designated within the staff 
of each prison's clinical facility. This counselor must have direct 
communication with the regional coordinator. Regions must also 
designate a clinical facility for patients who must be hospitalized and 
specific systems for transportation to the facility and management of 
the hospitalized inmates.

    State Grants: Make grants to each state to develop systems to 
manage COVID-19 within its prisons. Each plan must specify mechanisms 
for: identifying positive staff and inmates; separation of positive 
staff and inmates from the general population; contact tracing; and 
ongoing identification of staff and inmates missed in the initial 
screening; and screening of all incoming staff and new inmates and 
separation of positives. Collaborating with the state health department 
for contact tracing purposes:

    States must designate a COVID-19 coordinator, preferably a 
physician, for its prison system. A COVID-19 counselor must be 
designated within the staff of each prison's clinical facility. This 
counselor must have direct communication with the state's coordinator. 
States must also designate a clinical facility for patients who must be 
hospitalized and specify specific systems for transportation to the 
facility and management of the hospitalized inmates. Oversight of these 
state systems must be shared by the Federal Bureau of Prisons and the 
Department of Health and Human Services. [Test-trace-treat-isolate-
repeat.]
               Small Businesses and Community Investment
    Provide for Small Businesses: Continuing to struggle, African 
American businesses are among the hardest hit. Low cash and weaker 
banking connections threaten their existence as they compete for PPP 
against much larger businesses. The combination compounding crises 
income, pay checks, unemployment insurance, job instability, and others 
seriously threaten small businesses and their staff. The disadvantage 
conditions collide and escalate in the coronavirus national emergency 
requiring automatic triggers and path ways to help save families and 
businesses during this national emergency that is no fault of their 
own. They did not choose the deadly coronavirus health and financial 
crises.

    Invest in Community Development: Increase investments in jobs (with 
living wages); quality education Pre-K through 12th grade; safe 
schools; meaningful employment training; job creation and placement; 
entrepreneurial opportunities; creation of avenues for innovation; 
grocery stores and transportation; business development, growth and 
sustainability; safe affordable housing; convenient access to quality 
affordable healthcare; safe communities; and affordable quality 
daycare.

    These interlinking investments are absolutely essential for viable 
productive communities. Establish and make available to communities a 
team of Federal Government experts from Department of Justice, to 
Department of Education, DHHS to EPA, to Office of Preparedness and 
Response, to Department of Labor, SBA, DHS and others to work in 
partnership with local agencies, community leaders, business and 
others. Provide technical assistance focused on helping communities 
identify and establish linkages and partnerships with business and 
industry. Fund at such sums as necessary.

    Community Empowerment Zones: Provide community partnership grants 
to establish community empowerment zone programs in communities that 
disproportionately experience over-policing. Funding provided for Black 
communities that seek to improve economic, race relations, health, 
education, environment and policing to help reduce disparities, and 
other highly coronavirus vulnerable communities. Assist community in 
accessing Federal programs; to obtain and coordinate the efforts of 
governmental and private entities regarding the elimination of racial 
and ethnic justice disparities and over-policing crisis.

    Communities to be served by the empowerment zone program are those 
that disproportionately experience over-policing and economic 
opportunity deserts. The community establishes an empowerment zone 
coordinating committee: determine priorities, establish measurable 
outcomes, obtain technical assistance and utilize but not limited to 
community and evidence-based strategies including goals, management, 
implementation, monitoring, assessment and evaluation. Submit to the 
Congress community empowerment zone reports. Fund at such sums as 
necessary.
                         Training and Education
    Conflict Resolution Training: Include conflict resolution in the 
education curriculum Pre-K through 12. The techniques learned in 
conflict resolution training would be beneficial across the life span. 
They would be helpful in encounters with police and all other 
relationships. Fund at such sums as necessary.

    Expand Academic Opportunity and Achievement: Have school systems, 
courts and police work with the community and academic institutions to 
implement mentorship programs focused on youth including troubled youth 
to provide them with insight and opportunity to better benefit from the 
powerful value of education and training beyond high school. Tie 
college and training scholarships to these programs, and help to ensure 
that free community college becomes a real accessible opportunity. This 
investment in the individual's and America's future helps to further 
innovation, entrepreneurial development, research, business, industry 
and technology advances on all fronts in all fields. Fund at such sums 
as necessary.

    Provide Summer Enrichment and Afterschool Programs: After school 
and summers is the most unsupervised period of time facing latchkey 
children and teenagers. Effective programs must be implemented that 
provide that supervision ranging from summer jobs, to summer education 
and training, to sports and arts, to innovation and business, to 
enrichment programs and Junior Achievement. For young children, provide 
summer Pre-K. Overall, programs must also provide meals and 
transportation for those in need. Fund at such sums as necessary.

    Establish National Teaching-Learning-Tutoring Corp: [Establish, 
Provide, Conduct, Monitor and Fine-tune as necessary] Provide students 
and parents the academic assistance needed to bring students up to 
grade level and beyond. This must be a joint goal. The portfolio must 
include but is not limited to materials, computers, technologies, 
skilled supplemental personnel and other resources needed. Students and 
parents must not be penalized for the education and stress crises 
created by the Pandemic. Additionally, establish a family support 
hotline professionally staffed to address family stress, mental and 
behavioral health control and management support.

    Compile, train and provide techniques and exercises that parents 
and students need to help control and manage stress. Also, identify and 
provide parents and students the privacy tools needed to help keep 
online schooling and socializing safe. Remain mindful that our Nation's 
children and parents sudden thrust into full scale home schooling, 
online learning/educating has placed students at increased academic 
disadvantage and to successfully close the void they must be provided 
the necessary resources. Fund at such sums as necessary. Additionally, 
increased online use by the elderly also places them at increased 
online fraud. Fund at such sums as necessary.
                    Enhance Community Participation
    State and Local Offices on Community Relations: Establish Offices 
on Community Relations to help communities empower themselves: make 
available technical expertise, linkages, and resources. Create and make 
available community relations improvement resource toolkits that 
communities can tailor to fit their needs.

    Voting: The African American Health Alliance would be remiss to not 
highlight voting. Voting no matter what form or forms it takes must be 
protected, voter-friendly and facilitated, and funded at such sums as 
necessary. Voter registration and rolls must also be respectively 
facilitated and protected. Every vote counts and must be counted. Also, 
as a Nation, we can and must improve the response to all aspects of the 
coronavirus national emergency. The response deficiencies are life 
threatening especially for Blacks. Clearly, everyone must be a part of 
the solution to the Nation's emergencies racism, policing, COVID and 
the economy.

    In closing, Mr. Chairman, Ranking Member and Members of the 
Committee our collective purpose must hold us accountable to the 
reality that we are all in this together and we must do our part. As 
Dr. King's quote continues to remind us: ``We are caught in an 
inescapable network of mutuality, tied in a single garment of destiny. 
Whatever affects one directly, affects all indirectly.''_Martin Luther 
King Jr., Why We Can't Wait The coronavirus pandemic requires a 
comprehensive response. The African American Health Alliance thanks you 
for this opportunity to provide testimony and recommendations. We 
deeply appreciate your ongoing leadership and support. Black lives do 
matter.

    AAHA Board Members: Co-Chairs: M. Joycelyn Elders, MD, 15th U.S. 
Surgeon General and Lucille Perez, MD, President and CEO, The Cave 
Institute, Past President, National Medical Association; Members: Clive 
Callender, MD, Professor of Surgery, College of Medicine, Howard 
University, Howard University Hospital Transplant Center; Founder, 
National Minority Organ/Tissue Transplant Education Program; Fredette 
West, Director, African American Health Alliance; Rev. Fred Williams, 
President and CEO SYF Associates; Allan S. Noonan, MD, MPH, Founding 
Dean, School of Community Health and Policy, Morgan State University, 
Assistant Surgeon General (RET), U.S. Public Health Service Point of 
Contact: Fredette West.
                                 ______
                                 
    [Whereupon, the hearing was adjourned at 1:11 p.m.]

                                [all]