[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]


                  DEPARTMENTS OF LABOR, HEALTH AND HUMAN
                SERVICES, EDUCATION, AND RELATED AGENCIES
                         APPROPRIATIONS FOR 2022

_______________________________________________________________________

                                 HEARINGS

                                 BEFORE A

                           SUBCOMMITTEE OF THE

                       COMMITTEE ON APPROPRIATIONS

                         HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SEVENTEENTH CONGRESS

                              FIRST SESSION

                               _________
 
                SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN SERVICES, 
                        EDUCATION, AND RELATED AGENCIES

                   ROSA L. DeLAURO, Connecticut, Chair

  LUCILLE ROYBAL-ALLARD, California
  BARBARA LEE, California
  MARK POCAN, Wisconsin
  KATHERINE M. CLARK, Massachusetts
  LOIS FRANKEL, Florida
  CHERI BUSTOS, Illinois
  BONNIE WATSON COLEMAN, New Jersey
  BRENDA L. LAWRENCE, Michigan
  JOSH HARDER, California

  TOM COLE, Oklahoma
  ANDY HARRIS, Maryland
  CHUCK FLEISCHMANN, Tennessee
  JAIME HERRERA BEUTLER, Washington
  JOHN R. MOOLENAAR, Michigan
  BEN CLINE, Virginia

  NOTE: Under committee rules, Ms. DeLauro, as chair of the full 
committee, and Ms. Granger, as ranking minority member of the full 
committee, are authorized to sit as members of all subcommittees.

      Stephen Steigleder, Jennifer Cama, Jaclyn Kilroy, Jared Bass,
    Philip Tizzani, Laurie Mignone, Rebecca Salay, and Trish Castaneda
                            Subcommittee Staff
                            
                                _________


                                  PART 8

                                                                   Page
  National Institutes of Health.........                                                           
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  Fiscal Year 2022 Budget Request for 
the Center for Disease Control and 
Prevention..............................                                                                
                                                                    203
                                        

  U.S. Role in Global Covid-19 Vaccine 
Equity..................................                                                                
                                                                    259
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                    U.S. GOVERNMENT PUBLISHING OFFICE                    
46-728 PDF                 WASHINGTON : 2022                     
          
-----------------------------------------------------------------------------------                                    

                      COMMITTEE ON APPROPRIATIONS

                                ----------                              
                  ROSA L. DeLAURO, Connecticut, Chair


  MARCY KAPTUR, Ohio
  DAVID E. PRICE, North Carolina
  LUCILLE ROYBAL-ALLARD, California
  SANFORD D. BISHOP, Jr., Georgia
  BARBARA LEE, California
  BETTY McCOLLUM, Minnesota
  TIM RYAN, Ohio
  C. A. DUTCH RUPPERSBERGER, Maryland
  DEBBIE WASSERMAN SCHULTZ, Florida
  HENRY CUELLAR, Texas
  CHELLIE PINGREE, Maine
  MIKE QUIGLEY, Illinois
  DEREK KILMER, Washington
  MATT CARTWRIGHT, Pennsylvania
  GRACE MENG, New York
  MARK POCAN, Wisconsin
  KATHERINE M. CLARK, Massachusetts
  PETE AGUILAR, California
  LOIS FRANKEL, Florida
  CHERI BUSTOS, Illinois
  BONNIE WATSON COLEMAN, New Jersey
  BRENDA L. LAWRENCE, Michigan
  NORMA J. TORRES, California
  CHARLIE CRIST, Florida
  ANN KIRKPATRICK, Arizona
  ED CASE, Hawaii
  ADRIANO ESPAILLAT, New York
  JOSH HARDER, California
  JENNIFER WEXTON, Virginia
  DAVID J. TRONE, Maryland
  LAUREN UNDERWOOD, Illinois
  SUSIE LEE, Nevada

  KAY GRANGER, Texas
  HAROLD ROGERS, Kentucky
  ROBERT B. ADERHOLT, Alabama
  MICHAEL K. SIMPSON, Idaho
  JOHN R. CARTER, Texas
  KEN CALVERT, California
  TOM COLE, Oklahoma
  MARIO DIAZ-BALART, Florida
  STEVE WOMACK, Arkansas
  JEFF FORTENBERRY, Nebraska
  CHUCK FLEISCHMANN, Tennessee
  JAIME HERRERA BEUTLER, Washington
  DAVID P. JOYCE, Ohio
  ANDY HARRIS, Maryland
  MARK E. AMODEI, Nevada
  CHRIS STEWART, Utah
  STEVEN M. PALAZZO, Mississippi
  DAVID G. VALADAO, California
  DAN NEWHOUSE, Washington
  JOHN R. MOOLENAAR, Michigan
  JOHN H. RUTHERFORD, Florida
  BEN CLINE, Virginia
  GUY RESCHENTHALER, Pennsylvania
  MIKE GARCIA, California
  ASHLEY HINSON, Iowa
  TONY GONZALES, Texas

                 Robin Juliano, Clerk and Staff Director

                                   (ii)

 
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED 
                    AGENCIES APPROPRIATIONS FOR 2022

                              ----------                              

                                             Tuesday, May 25, 2021.

                     NATIONAL INSTITUTES OF HEALTH

                               WITNESSES

FRANCIS S. COLLINS, M.D., DIRECTOR, NATIONAL INSTITUTES OF HEALTH
DIANA W. BIANCHI, M.D., DIRECTOR, EUNICE KENNEDY SHRIVER NATIONAL 
    INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND 
    INFECTIOUS DISEASES
GARY H. GIBBONS, M.D., DIRECTOR, NATIONAL HEART, LUNG, AND BLOOD 
    INSTITUTE
NORMAN E. SHARPLESS, M.D., DIRECTOR, NATIONAL CANCER INSTITUTE
NORA D. VOLKOW, M.D., DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE
    The Chair. This hearing will come to order.
    As this hearing is fully virtual, we must address a few 
housekeeping matters.
    For today's meeting, the Chair or staff designated by the 
Chair may mute participants' microphones when they are not 
under recognition for the purposes of eliminating inadvertent 
background noise.
    Members are responsible for muting and unmuting themselves. 
If I notice that you have not unmuted yourself, I will ask you 
if you would like the staff to unmute you. If you indicate 
approval by nodding, staff will unmute your microphone.
    I remind all members and witnesses that the 5-minute clock 
still applies. If there is a technology issue, we will move to 
the next member until the issue is resolved, and you will 
retain the balance of your time.
    You will notice a clock on your screen that will show how 
much time is remaining. At 1 minute remaining, the clock will 
turn yellow. At 30 seconds remaining, I will gently tap the 
gavel to remind members that their time is almost expired. When 
your time has expired, the clock will turn red, and I will 
begin to recognize the next member.
    In terms of the speaking order, we will begin with the 
chair and ranking member. Then members present at the time the 
hearing is called to order will be recognized in order of their 
seniority, and finally, members not present at the time the 
hearing is called to order.
    Finally, House rules require me to remind you that we have 
set up an email address to which members can send anything they 
wish to submit in writing at any of our hearings or markups. 
That email address has been provided in advance to your staff.
    And with that, I want to acknowledge Ranking Member Cole 
and all of our colleagues for joining this morning, and I want 
to thank our witnesses for testifying.
    Good morning to Dr. Collins. Welcome back to the Labor, 
HHS, Education Appropriations Subcommittee.
    I would also like to welcome the five institute directors 
joining Dr. Collins today: Dr. Diana Bianchi, Director of the 
Eunice Kennedy Shriver National Institute of Child Health and 
Human Development; Dr. Anthony Fauci, Director of the National 
Institute of Allergy and Infectious Diseases; Dr. Gary Gibbons, 
Director of the National Heart, Lung, and Blood Institute; Dr. 
Ned Sharpless, Director of the National Cancer Institute; and 
Dr. Nora Volkow, Director of the National Institute on Drug 
Abuse.
    I want to note that I intend to invite an additional panel 
of institute and center directors to testify in front of the 
subcommittee later this year. We were not able to hold a second 
panel last year due to the pandemic, but I want to make sure 
the subcommittee hears from every institute about its promising 
research.
    The last time Dr. Collins and the IC directors were here to 
testify on the National Institutes of Health budget was March 
4, 2020. There were 128 newly reported COVID cases that day in 
the United States, which more than doubled the total number of 
cases that had been identified to date.
    Later that day, the House would pass the first COVID 
supplemental bill, which included over $800 million to support 
NIH on basic research, diagnostics, treatments, and vaccines 
for COVID-19.
    Today, over 14 months later, the Congress has provided over 
$4.8 billion to support NIH research related to COVID.
    Based in part on these investments and the partnerships 
with other agencies and the private sector, three COVID-19 
vaccines were developed in record time and are now widely 
available in the United States, and nearly 300 million vaccine 
doses have been administered, including nearly 4 million in my 
home State of Connecticut.
    In my view, this is a remarkable achievement made possible 
not only by targeted investment in COVID research, but also by 
the annual sustained investment in biomedical research made by 
this committee in recent years.
    In the 20 years before the COVID-19 pandemic, the National 
Institute of Allergy and Infectious Diseases, NIAID, invested 
over $650 million in basic research on coronavirus, and in 
particular on the spike protein that is the target of 
coronavirus vaccines. This crucial breakthrough allowed 
researchers at the NIAID Vaccine Research Center to rapidly 
generate a stabilized spike protein for use in developing the 
COVID-19 vaccines in use today.
    In addition, NIH has also made substantial investments into 
mRNA technology and its potential use in vaccines and 
therapeutics, which was essential to the rapid development of 
COVID vaccines.
    I call your attention to an article that was November of 
2020, and I will just give you the title: ``Government-Funded 
Scientists Laid the Groundwork for Billion-Dollar Vaccines.'' 
And I mention this because I think it is critical in what this 
committee is able to accomplish and also what our scientists at 
the NIH, with the funds, Federal funds, are able to accomplish.
    Quite frankly, it is such a relief to millions of Americans 
to finally have access to the COVID vaccine.
    In Connecticut a couple of weeks ago we had a FEMA mobile 
vaccination clinic open on the New Haven Green. A family with 
two teenagers was there to get their vaccines. Their father, 
Roberto, said that he wanted his daughter, Sophia, and his son, 
Diego, to get vaccinated as soon as possible to avoid the risk 
of their contracting COVID and spreading it to the youngest of 
their younger sisters, who is only 4 years old.
    After receiving her shot, Sophia, who is 16, said, and I 
quote, ``Now I am vaccinated. It means I won't be afraid to get 
COVID-19 as much as I was before,'' end quote.
    Can you imagine being a 16-year-old and fearing for your 
life and the health of your family? Thanks to the vaccine, 
Sophia and her brother can finally stop living in fear and get 
back to being normal teenagers.
    This is just one of the many stories of how the COVID 
vaccine has made such an immeasurable difference in our lives.
    None of it would have been possible without the increased 
funding that Congress has consistently provided for the NIH. 
And I am proud that we have increased NIH funding by $12.9 
billion, 42 percent, over the past 6 years. And this support 
has been bipartisan from this subcommittee. Last year, the 
Congress provided an additional $1.25 billion increase over the 
fiscal year 2020 level for the NIH.
    I am pleased to see President Biden's budget request to 
continue the momentum in fiscal year 2022. The request proposes 
an increase of about $2.5 billion to expand funding for NIH's 
core activities, such as research grants, clinical trials, and 
infrastructure support. The request also proposes to establish 
a new Advanced Research Projects Agency for Health, or ARPA-H, 
to accelerate the development of treatments and cures.
    I am especially glad to see that the budget proposes 
increased investment in research on maternal health to address 
the crisis of maternal mortality. In the U.S., maternal 
mortality is such a major problem and an issue that I have been 
working on for quite some time, as have so many of my 
colleagues.
    I also look forward to further details about how the budget 
proposal will support research on how to reduce racial and 
ethnic disparities in maternal health outcomes and improve 
maternal mental health.
    In that vein, I am grateful that this budget proposes 
increased funding for research into other health and mental 
health disparities that are disproportionately affecting 
underrepresented communities.
    As I have often said, these issues have been further 
exposed and exacerbated by the COVID-19 pandemic. And as Dr. 
Collins says so eloquently in his written testimony, it is, and 
I quote, ``forcing a recognition that our country is still 
suffering the consequences of centuries of racism.''
    I was also glad to see that the budget doubles funding for 
research on gun violence prevention at the NIH, building off 
the investments the subcommittee has made over the past 2 
years. I am interested in getting a progress report on the 
funded projects and any potential evaluation that you may have. 
I know it may be too early, but I hope you can let us know a 
little more about the status of this program.
    I might add that I am intrigued by the proposal to 
establish ARPA-H as it appears to be a novel approach to 
supporting innovation to address problems in health and medical 
research. I look forward to learning more about this proposal.
    And I want to emphasize that it is critical that we strike 
a balance between this new approach and investments in basic 
research and fundamental discovery at NIH.
    As I noted earlier, the Congress and this subcommittee have 
consistently provided funding for basic research at NIH that 
was integral in setting the stage for the rapid development of 
COVID-19 vaccines.
    As we move forward, I think it will be important to balance 
the promise of this new approach with a continued commitment to 
basic research.
    One of my priorities on a Labor-HHS bill has been to ensure 
a strong across-the-board increase for NIH research so that we 
continue to invest in all areas of research instead of limiting 
new investments to a few of the most high profile diseases.
    I am disappointed that research on amyotrophic lateral 
sclerosis, ALS, has not been mentioned as a potential area of 
focus for ARPA-H and hope to learn more about how NIH proposes 
to make decisions about how best to target ARPA-H funding.
    I am also curious to hear more about how ARPA-H would 
differ from existing NIH centers and programs that support high 
risk, high reward research, such as the National Center for 
Advancing Translational Sciences, NCATS.
    I realize that because the administration's full budget has 
not yet been released, Dr. Collins, you cannot provide all of 
the details on the NIH request today. But I believe we can have 
a good discussion on the priorities that have been announced, 
and we look forward to receiving the full NIH request in a few 
days.
    Now let me turn to my friend from Oklahoma, the ranking 
member, Congressman Cole, for any opening remarks that he may 
have.
    Mr. Cole. Well, thank you very much, Madam Chair. And I 
could probably just say ``amen'' and dispense with my remarks 
because there is essentially nothing in your opening statement 
that I don't agree with wholeheartedly.
    I have enjoyed all the hearings held by the subcommittee 
this year, and that is a compliment to you, Madam Chair. I 
think we have had a succession of really terrific hearings on a 
variety of topics.
    But, I must admit, welcoming the scientific leaders from 
the National Institutes of Health is the hearing I most look 
forward to every year.
    I am pleased to once again welcome Director Francis 
Collins. As I often say, clearly the best politician in 
Washington, DC, having been appointed by President Obama, 
President Trump, and now President Biden. I challenge anybody 
to match that record. But I think it is a clear indication of 
how much regard the Director is held in, and, frankly, the NIH 
itself.
    Each year brings new and exciting innovations in medicine 
and treatment and a glimpse into the world and the 
possibilities of our future. I am always encouraged when we 
learn about these scientific advancements.
    And I know I have said this numerous times, but it bears 
repeating: Increasing funding for the NIH is one of the best 
bipartisan accomplishments of this subcommittee, Madam Chair, 
as you noted in your opening statement.
    Let me break from my prepared statement to make a point 
that I think is important to make here.
    I have made the point repeatedly in previous hearings that 
I think the administration's budget is pretty heavy on domestic 
spending, it goes up 18 percent, pretty light on defense 
spending, which is flat and actually has an inflation adjusted 
cut. And I have said that that needs to change, that the 
defense number needs to come up and the domestic number, in my 
opinion, needs to come down, or we run the risk of a CR.
    Having said that, I want to make it crystal clear, I 
support the President's topline budget number for the NIH, and 
I would throw in the CDC and the Strategic Stockpile as well. I 
think those are areas of critical national investment that we 
can all work together on and see the benefit of.
    And I say that just to make it clear to my friends, while I 
haven't changed my view on the overall budget in this area, I 
doubt there is much daylight between the chairman and me as to 
the importance of this investment for our future. I think we 
have demonstrated that together over the last 6 years. I am 
comfortable and confident we will demonstrate that again going 
forward.
    The sustained commitment to increasing funding for the NIH 
is a vital step in preserving our status as the world's leader 
in biomedical research and to finding novel treatments and 
cures for the many diseases burdening our strained healthcare 
system.
    The funding also does far more. Several studies have shown 
funding for the NIH has a multiplier effect, contributing to 
overall U.S. economic growth.
    The investments made at NIH over the past few years, and, 
even further back, over the past decades, as our chair pointed 
out, laid the groundwork for our response to the COVID 
pandemic.
    The National Cancer Institute stepped in with advanced lab 
capacity.
    The National Institute of Allergy and Infectious Diseases 
led the way with expertise related to infectious disease.
    The Office of the Director supported efforts to make rapid 
advancements in therapeutics and diagnostics.
    And of course, last but certainly not least, with NIH 
support, Operation Warp Speed provided enough doses of vaccine 
for every adult in America.
    The NIH is a shining example of what can be achieved when 
we put our best minds together and work to accomplish bold and 
challenging goals.
    Much attention in the past year has gone to COVID and the 
associated scientific discoveries, and rightly so. But I hope 
in the coming years we can also continue our conversations and 
scientific advancements in Alzheimer's disease and cancer 
treatment.
    These two areas have seen strong congressional interest and 
represent a foundational shift in how we treat diseases 
responsible for the loss of most Americans each year.
    I also hope that the promises of precision medicine can be 
experienced by more patients and believe that the All Of Us 
Program can improve how we use genetic information in routine 
medical care.
    Dr. Collins, you have once again brought an excellent team 
representing some of the largest institutes and most promising 
frontiers of new discoveries. I look forward to hearing from 
all of you.
    I also want to recognize that the NIH is composed of 27 
institutes and centers, most of whom are not able to be with us 
today. Even though we are not able to have each director come 
before us, our offices continuously hear about the 
groundbreaking work and collaborative partnerships at all of 
the NIH components. We know that work is done across the NIH 
and that each institute or center is a contributor.
    In closing, I want to stress that each dollar invested in 
the NIH is a down payment on our future. This work has in the 
past, and will in the future, continue to improve the course of 
disease detection, treatment, and even cures in the years and 
generations to come. I know congressional commitment to 
advancing these shared objectives has been unwavering.
    And I want to thank you, Madam Chair, for holding the 
hearing. And, frankly, more importantly, thank you for your 
long record of support for the NIH and dealing with the issues 
of disease. It has been an area where you have led throughout 
your career, and you continue to lead today. And you certainly 
have all of our support on this committee in that effort.
    With that, Madam Chair, I yield back.
    The Chair. Thank you for your comments, but again, most 
importantly, the friendship, but working together on this 
issue, which is so critically important. And it has been really 
a team effort, and I am most appreciative of that.
    Before I turn to Dr. Collins, I want to ask unanimous 
consent to put into the record the article I referenced, 
``Government-Funded Scientists Laid the Groundwork for Billion-
Dollar Vaccines.''
    [The information follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    The Chair. Dr. Collins, your full testimony will be 
included in the record. You are now recognized for 5 minutes 
for your opening statement.
    Dr. Collins. Well, thank you, Chair DeLauro, Ranking Member 
Cole, and distinguished members of this subcommittee. I am 
honored to be here today with my colleagues representing the 
National Institutes of Health, the NIH.
    I could spend hours describing the exciting work that the 
President's budget is proposing for NIH, including major 
investments to address impacts of the COVID-19 pandemic, reduce 
health disparities in maternal mortality and morbidity, improve 
mental health, broaden approaches to pain and opioid addiction, 
and establish a bold new agency within NIH called ARPA-H.
    But in our brief time together it is also important to 
emphasize how the steady funding increases that you have 
provided to NIH, starting well before the pandemic, made it 
possible for the NIH to meet the challenges of the pandemic and 
to prepare for what comes next.
    You know, often at these hearings I share the story of a 
patient whose life has been saved by NIH research. But in this 
uniquely challenging year, it is hard to single out any one 
person. In fact, all of the more than 160 million Americans who 
have received COVID-19 vaccines are success stories made 
possible by the sustained investment that this committee made 
years ago to basic biomedical research.
    The road to these mRNA vaccines that Pfizer and Moderna now 
are distributing around this country and around the world 
actually started in the 1960s when the function of messenger 
RNA was first understood. These messengers carry instructions 
from the cell's DNA manual to produce the proteins that do the 
work.
    For vaccines, we knew that certain proteins, like the spike 
proteins on this coronavirus, could spur an immune response. 
But might it be safer and just as effective to use RNA to 
instruct the patient's own body to produce these proteins?
    Though it took surmounting numerous obstacles to get there, 
we are blown away by how well it works.
    In parallel, other scientists, including some in our 
Vaccine Research Center, learned that locking that spike 
protein into the right configuration could make an even better 
vaccine.
    So when COVID hit, we knew exactly what to do. As the 
seriousness of the pandemic became clear, research institutions 
and drug companies started off in multiple directions, 
competing over trial capacity, duplicating efforts, and 
flooding the FDA with disparate data.
    NIH was prepared to step in with a coordinated playbook. 
Working with other agencies and industry partners, we stood up 
something called ACTIV, A-C-T-I-V, the Accelerating Covid-19 
Therapeutic Interventions and Vaccines Partnership, and we 
stood it up in just 2 weeks. ACTIV's teams of public and 
private sector visionaries implemented objective prioritization 
of therapeutic candidates, knitted together clinical trial 
networks, and wrote master protocols to streamline approvals.
    Another vital partnership NIH was able to build on was one 
we have with underserved communities. As we pushed to enroll 
patients in phase 3 vaccine trials, NIH opened a dialogue with 
communities disproportionately affected by COVID.
    The Community Engagement Alliance, or CEAL, initiative 
built on existing long-term partnerships with trusted leaders 
in underserved communities to encourage trial participation. We 
were able to use the enrollment techniques we learned in large 
longitudinal studies, such as All of Us, that you have 
championed.
    The result is that all Americans can look at the major 
vaccine trials and see that people like them were included, and 
CEAL has now moved on to help with vaccine hesitancy in these 
same communities.
    Now the President's budget proposes a major investment to 
build on this momentum, the Advanced Research Project Agency 
for Health, or ARPA-H. This new agency within NIH will catalyze 
novel strategies to speed transformational and innovative 
ideas. Ideas like simple blood tests to detect free-floating 
DNA or protein markers that signal a cancer is growing 
somewhere in the body. Maybe a micro needle patch that delivers 
a vaccine to hard-to-reach communities in the mail. Or using an 
innovation funnel to recruit, test, and scale up new 
technologies for ambulatory blood pressure measurement with the 
potential to transform the management of hypertension.
    Those are just three of the bold ideas that ARPA-H could 
tackle. But they are not science fiction. With standard 
approaches, they might happen in a decade or two. With ARPA-H, 
it could take half that time.
    The President believes that, with your help, we can learn 
from the lessons of the pandemic and transfer this scientific 
momentum into big improvements in the health of all Americans. 
I do, too.
    My colleagues and I would be pleased to answer your 
questions.
    [The information follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    The Chair. Thank you. Thank you very much, Dr. Collins.
    I just want to say, I sometimes make reference to this 
panel when you come up, and I use the Yankee baseball team, 
talking about the power and the hitting power of Murderers Row. 
But today I just want to talk about Healers Row and really 
extraordinary work that has translated to the benefit of so 
many and have already saved so many lives. So thank you for the 
work that you do.
    I know that you can't share so many details about the 
structure of ARPA-H. That will be, I understand, in the 
President's budget. You just started to talk about some of the 
things. I have kind of three questions in this area.
    Again, share some examples of the kind of research that 
this might support and how it differs from the types of 
research typically supported by the NIH.
    How is ARPA-H different than NCATS, which was established a 
decade ago, and that was about promising medical research into 
treatments and cures that are available, and how is this 
approach different?
    And then I just wanted to ask about how ALS research could 
benefit from the high risk, high reward accelerated approach 
proposed by ARPA-H.
    Dr. Collins. Well, thank you. That is a wonderful set of 
questions. And I want to tell you that my colleagues and I are 
really excited about the potential that ARPA-H offers for us to 
move biomedical research even more nimbly and aggressively 
forward to make the kinds of discoveries that the public is 
waiting for.
    We learned a lot in the space of our experience with COVID-
19 about how it is possible when there is an urgent sense of 
the need for clinical advances to happen at unprecedented 
speed. And that happened with vaccines. That happened with 
diagnostics. That happened with setting up therapeutic trials. 
And from that, we have gathered the general sense that this 
momentum ought not to be lost.
    In talking with all of the 27 institutes and centers, the 
notion of taking the DARPA approach to biomedical research has 
gathered a lot of enthusiasm. DARPA, as you know, as part of 
DOD, has had that experience of moving things in a very bold 
and risk-taking way. And that is why we ended up with the 
internet and with GPS and with self-driving cars and a long 
list of other things.
    And we think there is a subset of biomedical research that 
would also be amenable to this kind of approach. This would 
involve program managers who are given the flexibility to 
identify in an area of opportunity ways that you could bring 
together partners who might not normally write an NIH grant--
those might be academics, they might be small businesses--and 
figure out how to create the kind of momentum with appropriate 
financial support to move things forward at unprecedented 
speed.
    You could think, for instance, taking what we have learned 
about messenger RNA for COVID-19, and speeding up the process 
of cancer vaccines, which are showing a lot of promise but 
could go faster.
    What about something such as a new approach to hearing aid 
development, which has been a little stuck in one place and 
might greatly be advanced by this kind of innovation funnel or 
``Shark Tank''?
    Such things as using the technologies we now have to learn 
ZIP Codes of all of the human cell types so that you could 
deliver drugs or gene therapies an appropriate and rapid 
fashion.
    Those are all ideas that are coming up. Every one of the 27 
institutes and centers is hitting me with lots of great ideas.
    The Chair. So tell me how this differs from NCATS.
    Dr. Collins. So I am very much proud of NCATS, having had a 
lot to do with nurturing that idea, coming up with something 
that would provide translational efforts, and they have in 
things like tissue chips, in terms of making high-throughput 
screening available.
    But it is on a modest scale. Most of NCATS is supporting 
the CTSAs, a very important part of our clinical research 
effort.
    This basically takes the NCATS model and puts it on 
steroids, takes the kinds of things that have been in the Cure 
Acceleration Network and makes it possible to do so at a much 
more rapid pace and across all diseases in a way that all the 
institutes at NIH can join in on and very much want to.
    So, yeah, I think it is building on that experience, but 
taking it to the next level.
    The Chair. I understand that, but just let me ask you this 
then. What happens with NCATS? If we are going to build on 
that, do we then fold in this? Do we then have one area that we 
are looking at here rather than two, ARPA-H and NCATS, and then 
we just create one effort?
    Dr. Collins. It is a very good question, Madam Chair. I 
don't think we have a completely clear best option at the 
present time. It might be possible, for instance, for the CTSAs 
to move into ARPA-H or potentially to stay where they are with 
NCATS. We might take the Cures Acceleration Network model and 
move that into ARPA-H.
    Those are all issues that need to be worked out. We need a 
lot more input now that we can talk more publicly about this, 
or we can in a couple of days, to get input from stakeholders.
    The Chair. It would appear to me that when you talked about 
Alzheimer's, diabetes, and cancer with regard to ARPA-H, I 
don't know where ALS fits in that and was that left out for 
some reason. And it is a devastating neurological disease, as 
you know.
    Dr. Collins. Yes.
    The Chair. And there are no current effective treatments to 
stop or even slow the progression, as I understand it, and you 
know I am not a scientist.
    Dr. Collins. So, if I may, I know the clock has run out, 
but just very quickly.
    Cancer, Alzheimer's, and diabetes were put forward as 
examples of common diseases that ARPA-H could work on. But the 
intention is for this model to be applied to all of the 
diseases that are ready for this scientifically.
    And I think ALS is a great example. Already had 
conversations with the Neurology Institute about an ARPA-H 
project specifically focused on ALS, recognizing that we are 
learning some fundamental things about what happens to the 
motor neurons in the spinal cord that could, with a crash 
program, be advanced much more quickly to understand the 
pathogenesis and ultimately new approaches to therapy using 
such things as RNA approaches.
    So I think it is a great example, Madam Chair, of what we 
could do that we currently can't quite do with this new 
mechanism.
    The Chair. Thank you. And I will have questions for Dr. 
Fauci and Dr. Gibbons.
    But with that, let me yield to the distinguished ranking 
member of the committee, Congressman Cole.
    Mr. Cole. Thank you very much, Madam Chair. And I want to 
build on your line of questioning because, as I said in my 
opening remarks, look, I am very supportive of the President's 
topline proposal here.
    As a matter of fact, I am pleased to have a President who 
set out a marker. With all due respect to the last two, this 
committee went well beyond what was proposed here.
    And so it is nice to have a partner at the other end of 
Pennsylvania Avenue who sees this, the value of this 
investment, I think the same way the chairman and I do.
    Having said that, I am wondering, I look at the $6 billion-
plus investment in ARPA-H, and as you said, Dr. Collins, we 
still have unresolved questions and procedures.
    Would it be better to start with a more modest investment--
DARPA itself is about $3.8 billion--and plow the rest of that 
money into our normal research? Again, I am not arguing for a 
reduction in total spending. I am just arguing for we are going 
a little fast here before we actually have this thing worked 
through.
    So I would love your thoughts on that, with the recognition 
that you work for the President of the United States, so your 
job is to defend his proposal.
    Dr. Collins. Thank you for pointing that out.
    Mr. Cole. May be a little bit more aggressive here, 
although I like the instinct that he is showing.
    Dr. Collins. Well, thank you, Congressman Cole, and I 
appreciate your thoughtfulness in this regard in terms of what 
is the right balance here.
    Let me point out, though, that ARPA-H is not intended to be 
a freestanding entity that is sort of over here somewhere, and 
then you have the 27 institutes and centers over there doing 
something different.
    This is an engine for discovery that is going to be tapped 
into by every one of those 27 institutes and centers, extending 
their reach beyond what they could do with their current budget 
line. So we shouldn't think of these as competitive, but rather 
as synergistic.
    Yeah, it is a big deal to start something up with a $6.5 
billion budget. Fortunately, this has been put forward by the 
President as 3-year money, which would help a lot as we are 
sort of ramping this up.
    But I believe, based upon the experience we have had with 
COVID-19--and again, thank you, Congress, for providing us 
during this crisis with, as Chairman DeLauro said a little bit 
ago, over $4 billion of additional funds to help. We had no 
difficulty figuring out how to invest those in vaccines, in 
therapeutics, and in diagnostics.
    And I believe, if funds are available, there are enough 
ideas and enough science and enough scientists out there to do 
the work that we could very well utilize what has been proposed 
by the President.
    Mr. Cole. Well, good. Well, I look forward to working with 
you on that. I still have some concerns, but we can resolve 
those in dialogue because we don't have any differences on the 
top line here.
    Let me turn to Dr. Sharpless, if I may.
    One of the more both impressive and challenging problems we 
have had is there have been so many wonderful proposals in the 
area of cancer research in recent years. And while we steadily 
pushed up the number of money at NIH, it seems to me we have 
had a hard time funding all the good proposals in front of us 
in terms of cancer. There seems to be a lower percentage of 
grants funded than in most of the other areas.
    So could you sort of bring us up to date where we are in 
funding good science and give us your thoughts as to what else 
we ought to be doing to make sure that we are not leaving good 
ideas on the table in terms of cancer research?
    Dr. Sharpless. Thank you, Representative Cole. It is a 
really important topic.
    I think the good news to start off with is that, thanks to 
the support of this Appropriations subcommittee, we have had 
the ability to increase our pay lines and success rates, these 
metrics we follow, which had gone down to very low levels 
because of the dramatic increase in applications to the 
National Cancer Institute. So applications were up 47 percent 
since 2013, and that is hard to keep up with.
    So I think our pay line, one metric we follow, nadired at 8 
percent, but is now up to 11 percent, so that is a 35 percent 
increase in the last 2 years, which I think is good progress, 
but that is still a pretty low support rate.
    I think we would like to get to a number that would be more 
like 15th percentile, which would match sort of the rest of the 
NIH a little more closely. As you know, there are a lot of 
important things we support outside of that pool that we have 
to fund as well.
    So I think that this is a good problem in some ways. It 
says there are a lot of scientists coming to NCI with ideas 
that are very, very valuable, and we need to be able to get to 
them all. And the support of this subcommittee has been very 
important in the past, but I think that is still an area where 
our pay lines are still too low.
    Mr. Cole. Well, we don't have a lot of time left, so I am 
not going to use all mine. But I want to say I am glad you are 
back at the NCI after your stint at the FDA. I know you did a 
great job there, but we really like you where you are at and 
appreciate the job that you have done.
    I have got a lot of questions, like you do, Madam Chair, 
but I will hold them for the next round, and I yield back.
    The Chair. I thank the chair, and I appreciate that 
question to Dr. Sharpless. It is a question that I had as well. 
So thank you very, very much. I say that to the ranking member.
    Now, Congresswoman Roybal-Allard.
    Ms. Roybal-Allard. Thank you, Madam Chair.
    Let me begin, Dr. Collins, first of all, by joining my 
colleagues in thanking you for the incredible work that you do. 
However, I would like to address my questions with regards to 
the ECHO program.
    It has been 6 years since the congressionally directed 
National Children's Study was prematurely canceled, despite an 
investment of approximately $1.5 billion over its 14 years of 
planning and implementation.
    At the time of its termination, without informing Congress, 
this subcommittee was guaranteed that newly developed 
environmental influence on child health outcomes, quote, 
``would make use of the existing maternal pediatric cohorts 
that were recruited through the National Children's Study.''
    We were further reassured that the ECHO program would 
attempt to answer many of the original seven critical research 
questions about the environment's influence on child 
development and health.
    We are now 6 years into what was designed to be a 7-year 
program, and it is my understanding that over 67,000 children 
are being followed in longitudinal core study factors affecting 
child health in the areas of [inaudible] Child development and 
well-being.
    Which of the original NCS study questions are being 
addressed through the ECHO program? And can you give us some 
examples of the research that is being done utilizing these 
cohorts?
    Dr. Collins. Thank you very much, Congresswoman, for the 
question. I am going to turn to Dr. Diana Bianchi, Director of 
the National Institute of Child Health and Human Development, 
who has been quite engaged as one of the advisers for the ECHO 
program, which is managed by Dr. Matthew Gillman.
    Dr. Bianchi.
    Dr. Bianchi. Thank you, Dr. Collins and Representative 
Roybal-Allard.
    As you know, the ECHO program brings together 72 different 
cohorts, and they are currently doing observational studies of 
over 50,000 children.
    One of the most impactful studies that has recently been 
completed has looked at women entering pregnancy and looking at 
the connection between a healthy weight in the mother or the 
pregnant woman and eating a healthy diet during pregnancy, and 
that has resulted in a statistically significant decrease in 
the rate of pre-term birth.
    And, interestingly, it was significant in both Black and 
White women, because Black women do have a higher incidence of 
pre-term birth. So that is quite impactful.
    In addition, NICHD is working with the ECHO program on an 
interventional study using the IDeA States Pediatric Clinical 
Trials Network, which is part of the ECHO program, and we are 
working together to provide comparative effectiveness studies 
to determine how best to treat neonatal opioid withdrawal 
syndrome.
    So these include pharmacology-free intervention, which is 
eat, sleep, and console the babies, as well as a weaning trial, 
and we have trials planned for the future to look at 
buprenorphine in infants.
    Mrs. Roybal-Allard. Okay. I have several questions 
regarding this program, but I will just go to my last question 
because time is running short.
    Is the NIH considering extending the ECHO program, given 
that the original NCS study was designed to follow children 
from birth through age 21, and the cohorts, as I understand it, 
have not yet reached the age of 21?
    Dr. Bianchi. Dr. Collins, do you want to answer that since 
the program sits in the Office of the Director?
    Dr. Collins. Sure.
    No, I think that is a very important question, and we do 
want to fully realize the potential of this very important 
cohort of over 50,000 kids. And, obviously, the time is about 
right in the course of the next year to figure out exactly what 
that future course will be.
    We have engaged internally in some deeper discussions about 
that, and we would like to get back to you, Congresswoman, 
about possible paths that we might take this forward.
    But I do want to endorse how critical we see the ECHO 
program is for answering all those questions that you and we 
are quite concerned about.
    Mrs. Roybal-Allard. Okay. Well, I hope it will continue 
because, as you know, the purpose was to evaluate the effects 
of chronic and intermittent exposures on child health and human 
development in the United States. And it would actually be the 
first study to collect this broad range of environmental 
exposure measures for a national probability sample of 100,000 
children followed from birth or before birth at age 21.
    And this is extremely important for communities such as the 
one that I represent because it looks at the disparities of 
children in rural and underserved communities which often have 
greater health issues and problems. So I am hoping that you 
will find a way to continue this program because, as you said, 
it is extremely important.
    I yield back the balance of my time.
    The Chair. Congressman Harris.
    Mr. Harris. Thank you very much.
    And thank you all for being here again this year.
    One of the things that we have to do is provide some 
oversight of the moneys that have been appropriated to NIH. For 
instance, this morning's front page story in The Wall Street 
Journal is the Wuhan lab leak debate. So this continues to be 
discussed. And I just would like, Dr. Collins, maybe just a 
couple of clarifications.
    I understand we did not directly fund the Wuhan Institute 
of Virology, but my understanding is we did send about $3.7 
million in grants to EcoHealth Alliance, of which $600,000 went 
to the Wuhan Institute of Virology to various studies there. Is 
that true?
    Dr. Collins. That is correct. I am going to ask Dr. Fauci 
also----
    Mr. Harris. No, I only have 5 minutes. I just need that is 
true, okay, because I read it. That is true.
    Do we know whether the Wuhan Institute of Virology does 
gain of function research?
    Dr. Collins. They were not approved by NIH for doing gain 
of function research. We do not--and that is the official 
governmental identification of that term, by the way. We are, 
of course, not aware of other sources of funds or other 
activities they might have undertaken outside of what our 
approved grant allowed.
    Mr. Harris. Okay. So we could have sent money through 
EcoHealth Alliance. Money could have ended up in the Wuhan 
Institute of Virology, which might be doing gain of function 
research. And, in fact, since they sent a general of the 
Communist Party Army to take over the lab in February 2020, it 
is not out of the realm of possibility they are doing that.
    So because I do know that money is somewhat fungible once 
you send money to institutes, it bothers me a little bit that 
we would send money to an institute that might be doing gain of 
function research, especially China.
    Do we send any money to any sub-agencies or sub-grantees 
that could be sending money to Russia?
    Dr. Collins. I don't know the specific answer to that. I 
think we have in the past, and I don't know whether we 
currently do or not.
    Mr. Harris. Okay. And we will submit it as a QFR, if you 
could get back to us about that.
    Now, in Nature.Com, a publication occurred in last 
September about the development of humanized mouse and rat 
models with full thickness human skin and autologous immune 
cells.
    Dr. Fauci, this was funded out of the NIAID. It involved 
scalp skin transplants from 18- to 20-week aborted fetuses.
    And what I want to know is, does the NIH ever follow up on 
how these specimens are obtained on a mid-second level--mid-
second trimester aborted fetuses for studies like this?
    Dr. Fauci. Well, Dr. Harris, that grant and that study you 
are referring to was gone through all the appropriate 
guidelines and oversight. So I am not sure exactly what you are 
asking, but all of the research that comes out of that was done 
with the appropriate oversight and guidelines that have to do 
with fetal tissue research.
    Mr. Harris. Okay. So I will--again, I will submit a QFR. 
Perhaps if you could send me what the NIH knows about how these 
tissues were obtained.
    You know, I don't know, the idea of taking 18- to 20-week 
human fetus scalps, obviously, this would have to result from 
decapitation because you have to harvest the scalp, implanting 
it on the backs of rats. I am just not sure that is something 
we should be involved with to any significant level.
    Now, one issue that has come up is the question of research 
on the immunology of COVID. And the immune response T cells, I 
think, are going to be found to be fairly important, and I 
think most people recognize they are pretty important in 
determining immune response.
    Would measuring T cells and T cell immunity, especially in 
people who have had the disease, would that be of interest? And 
if so, is the NIH urging the FDA to promote the EU, emergency 
use authorization, for T cell testing, which is not widely 
available but may be very useful in informing us about the 
immune response?
    Dr. Collins.
    Dr. Collins. I think, yes, FDA is intensely interested in 
this. I don't know that we have to particularly urge them. They 
have approved one T cell test from adaptive technologies, and I 
know they are interested in looking at others. And I agree with 
you, this is a very important part of understanding immune 
response to COVID.
    Mr. Harris. Dr. Collins, I will have to inform you that 
they are not, and they have, in fact, informed other companies 
that this is not a priority for FDA and they are not actively 
looking at further EUAs.
    But my time is up. I yield back.
    The Chair. Congresswoman Lee.
    Ms. Lee. Thank you very much. Thank you, Madam Chair and 
Ranking Member.
    Thank you to Dr. Collins and all of our directors for your 
tremendous leadership.
    And thank you, Dr. Collins and all of you, for really 
fighting so hard to crush this virus, and all of the work that 
you have done, you said for the last 30 years, in just getting 
us prepared to save lives and to address the coronavirus. So 
thank you so much.
    Let me ask you, Dr. Collins, we have talked a little bit 
about the continued commitment to address disparities of Black 
men and women in science and medicine. And I would like for you 
to share how NIH has incorporated the findings of the 
recommendations of the National Academies of Sciences' 
Roundtable on Black Men and Women in Science, Engineering, and 
Medicine to address really the--and it is a major, alarming 
underrepresentation of Black men in the medical schools and in 
the medical profession.
    That is the first question. I am going to do a couple of 
questions at one time.
    Also, just in terms of health disparities, Dr. Collins, let 
me ask you, what specifically--and I know NIH is committed to 
this--but specifically to address the health disparities 
stemming from structural racism and more research and resources 
into behavioral health, trauma-related informed mental 
healthcare, diversity in clinical trials, diversified 
workforce, all of the major issues that address African 
Americans, people of color, within the whole--within the health 
space, the National Institutes of Health, as it relates to 
dismantling structural racism and building systems which 
include equity and justice.
    Dr. Collins. Well, thank you, Congresswoman Lee. I think 
those questions actually I can fold into a synthesized 
response, because we at NIH are deeply invested in taking a 
very fresh and aggressive look at what we can do about the 
problem of structural racism in the United States, which we 
have come to recognize is something that affects all 
institutions, and that includes the biomedical research 
institutions that we support.
    And I have to recognize this is the one-year anniversary of 
the killing of George Floyd, which I think was a very 
significant event for many people who had somehow imagined that 
we were past the point where racism existed in this country. 
And we at NIH took that and other episodes like that very 
seriously and have formed together an effort called UNITE, U-N-
I-T-E.
    There are five groups in UNITE, each of which has a 
specific focus. One is on the workforce. And you specifically 
have highlighted the problem about the diminishing numbers of 
Black men going into medicine and medical research, and that is 
a concern.
    But, frankly, we have a much broader set of concerns. When 
you look at the diversity of our workforce, it does not look 
like our country.
    We have worked hard on that, Congresswoman, and we have 
made some progress, if you look at the numbers of those who are 
applying for grants and getting funded, but we are still well 
short of where we need to be.
    We aim with this UNITE initiative to make a much stronger 
push in that direction, both in terms of recruiting and 
retaining. Because it is one thing to recruit Black men into 
medical research. It is another if they find an environment 
that is not welcoming, and then they don't stay. We have to 
work on that part as well in terms of our whole culture, our 
whole environment.
    And then, when it comes to health disparities, we are aware 
of the facts that health disparities are oftentimes based upon 
deep-seated structural racism in our environment, in our 
culture. And it is not sufficient for us to categorize the 
various factors. We need to invest more in interventions to see 
how those can be changed.
    We have announced a Common Fund program of $24 million, it 
is already out there, to do transformative research on health 
disparities. And we have a joint funding announcement that now 
involves a whole bunch of institutes, led by the Minority 
Health and Health Disparities Institute, that is putting 
another $30 million into research in fiscal year 2022 on this 
very topic.
    We will be publishing in the fairly near future a broad 
description of this UNITE initiative that I think all of the 
members of the subcommittee will be interested in.
    I just want to tell you, personally, of the things that 
happened in 2020, COVID-19, well, yeah, we will all remember 
that. But I think we also had this wakeup call that we have to 
address this issue of structural racism. And my colleagues and 
I are determined to do so in a bold, energetic, and determined 
way.
    Ms. Lee. Thank you so much, Dr. Collins. And we will follow 
up on the specifics in terms of the budget.
    Very quickly, Dr. Fauci, good to see you. HIV and AIDS. We 
know you recently were addressing the COVID-19 virus, but you 
played such an important role in HIV and AIDS early on. How far 
backwards have we gone now as a result of the COVID virus, and 
will we achieve an AIDS-free generation?
    Dr. Fauci. I don't think we have gone--thank you for that 
question, Congresswoman Lee. I don't think that we have gone 
backwards. Obviously, when you shut down a society, the 
accessibility for testing and for the chain of drug 
availability can be disrupted, the way everything is disrupted 
in this very terrible time, including vaccinations for children 
and things like that.
    However, there have been a number of really important 
advances that have been under the radar screen with regard to 
HIV and AIDS. For example, the demonstration that cabotegravir, 
the long-acting injectable, can be very adequately used for 
pre-exposure prophylaxis, which I think is going to increase 
dramatically the adherence to that.
    And as I have discussed with you in the past, the PrEP, 
pre-exposure prophylaxis, is an important ingredient in our 
attempt over the 10 years from 2020 to 2030 to end the epidemic 
in the United States. And I believe, notwithstanding COVID-19, 
that we will achieve that goal as trying to implement many of 
the things that we are doing.
    So although it appears that things have been under the 
radar screen, they have, in fact, been going on I believe at a 
good pace. But thank you for that question.
    Ms. Lee. Thank you. Thank you, Dr. Fauci.
    Thank you, Madam Chair.
    The Chair. Thank you.
    Congresswoman Herrera Beutler.
    Ms. Herrera Beutler. Thank you, Madam Chair. And like 
everyone else, this is probably my favorite hearing of the 
year, just getting a chance to talk with really the world class 
experts on just about everything.
    I have a few different questions. The first one, Dr. 
Collins, I think would be for you.
    Last year I requested that NIH develop a comprehensive 
pediatric research agenda to study the impacts of COVID-19 on 
children and to report to this committee in 120 days. And I 
wanted to ask about the status of that report, and what are the 
NIH's maybe preliminary findings and plans for this research 
agenda.
    Dr. Collins. Well, it was a very appropriate assignment to 
give us, because we know that children have been affected 
significantly by COVID-19. They can get the illness. They can 
have this strange and somewhat unusual outcome of MIS-C, Multi-
System Inflammatory Syndrome of Children. They also can get 
long COVID where they don't seem to recover. And we have a big 
effort on this.
    Actually, if I may, I would like to call on Dr. Bianchi, 
our pediatrician, who can tell you a bit more about what we 
have been doing.
    Ms. Herrera Beutler. Great. And I apologize. I have a 
couple of questions I am going to fit in here, so----
    Dr. Bianchi. Okay. I will try to be brief.
    But, as you know, almost 4 million children have had 
positivity for SARS-CoV-2. The critical question is, of those 
children, most of them are going to be mildly affected, but who 
is the one in a thousand who is going to get very sick with 
Multi-System Inflammatory Syndrome in Children, requiring 
perhaps an ICU stay and perhaps serious illness and death?
    To address this through the RADx-rad program, which is 
developing radical approaches to testing, we are leading a 
program, a trans-NIH program called PreVAIL kids, which 
comprises eight different programs that are all taking a 
different piece of the pie and are looking at children who, for 
example, come into the emergency room with a fever. Do they 
have COVID? Are they going to be at risk for MIS-C?
    And all of these different programs are taking biospecimens 
and using bioinformatics to predict who is going to get sick 
with MIS-C and then possibly the long COVID.
    Ms. Herrera Beutler. Do we have that preliminary 
information? Do we have some answers on that?
    Dr. Bianchi. No. The program has started within the last 
few months.
    Ms. Herrera Beutler. Okay. Okay. I am interested to be kept 
abreast of that. Thank you, Dr. Bianchi.
    Dr. Bianchi. Absolutely.
    Ms. Herrera Beutler. You know, I read something earlier 
this week about how 16-year-olds, I think it was with Moderna's 
shot, after 4 days show an enlarged heart. I have seen other 
things about different kids and how it impacts them. And I 
cannot stress enough how important I think it is that we turn 
our attention to the children as it relates to the pandemic.
    One of the things I do have some challenges with--my 2-
year-old just hopped on my lap, and she hopped off--the mental 
health and developmental issues that these kids have been 
through in the last year.
    Like, I took my kid, my youngest, to Costco. She hadn't 
been in a big box store. It kind of flipped her out, seeing 
that many people. That is a small thing, right?
    I think about telling a 2-year-old who maybe is in daycare, 
you have to wear a mask now all day long, and all the other 
kids have masks. There is learning and speech developmental 
issues. There is interaction.
    So my 2-year-old doesn't speak very much yet. We read a ton 
to her. But so much of what we do is nonverbal. In fact, most 
communication is nonverbal anyway.
    I am really concerned that now that we have reached this 
point where you can get a vaccination if you want one, that we 
are further putting the burden on children to keep the adult 
population safe by telling young children, ``Indoors, outdoors, 
you are going to mask.''
    While everybody else is now feeling this sense of freedom, 
we are putting more of the burden on kids--who have, I believe, 
borne the disproportionate share of this, whether it is school 
and learning loss, mental health, possibly domestic violence, 
all these different things that we are not going to know for 
the next--we are going to know in the next 10 years.
    I was hoping someone could speak to that. The mask mandate 
for children that age at this point, I need to be convinced 
that that is appropriate.
    Dr. Collins. Thank you for that question and those 
observations.
    I think we are all really concerned about this. People sort 
of shrug and say, ``Well, kids are resilient.'' But, wait a 
minute, this is really an incredible, unprecedented challenge 
to their life experience.
    The National Institute of Mental Health has recently issued 
that we are asking for grant applications to look specifically 
at the mental health consequences of COVID-19 for children.
    What has it meant for them to be out of school, which is 
normally the place where a lot of socialization and education 
happens for this prolonged period.
    And what about this issue of being fearful of an illness 
that might actually affect your families, might suddenly be 
blamed on you if you were the one who happened to bring the 
illness in?
    I totally am with you here. There are a lot of unanswered 
questions. We are going to be studying that, I think, with some 
considerable intensity, and hopefully we can provide some 
better answers about how best to help.
    Ms. Herrera Beutler. Can we be kept abreast?
    Dr. Collins. Absolutely.
    Ms. Herrera Beutler. Thank you, Madam Chair.
    The Chair. Congressman Pocan.
    Mr. Pocan. Thank you very much, Madam Chair. And thanks to 
everyone for being here. I completely agree with Representative 
Herrera Beutler. This is my favorite hearing of the year as 
well. I have tremendous respect for every single one of the 
witnesses here.
    And thank you for all of the incredible work you do every 
single day for all of us. I just wish we could direct more of 
the Department of Defense funds to the defense that you are 
doing for this country and the defense that we needed to do so 
much in the last year, things like COVID-19.
    I have lots of questions, but I do want to give you a 
chance, Dr. Collins. I think you were trying to pass a question 
to Dr. Fauci about the Wuhan lab. I heard lots of things like 
``could,'' ``might,'' and ``not out of the realm of 
possibility'' is really hard evidence there. I believe there is 
some white whale narrative changing trying to occur. But if you 
wanted to have Dr. Fauci answer that briefly, because I do have 
a lot of questions, I would be glad to give some time out for 
that.
    Dr. Collins. Dr. Fauci, please.
    Dr. Fauci. So, what is the question, Congressman Pocan, 
please? What specific question do you want me to answer?
    Mr. Pocan. Well, I believe the question Dr. Harris was 
asking is did we fund COVID-19, my bad? I am paraphrasing it 
because we have 5 minutes. But that seems to be the new 
narrative that is out there that somehow, let's not worry about 
vaccinating people and getting the economy going. Let's figure 
out how to somehow say there is a different way this all 
started. And I am just kind of curious because I know you have 
had some interviews on this, but you were asked the question 
but not given the opportunity to answer.
    Dr. Fauci. Well, thank you, Congressman Pocan. Let me first 
say that I think one of the things that was perhaps was a 
subtext of Dr. Harris' question is, why do any research in 
collaboration with our Chinese colleagues? Well, the underlying 
reason for that is that we had a big scare with SARS-CoV-1 back 
in 2002, 2003, where that particular virus unquestionably went 
from a bat to an intermediate host to start an epidemic and a 
pandemic that resulted in 8,000 cases and close to 800 deaths. 
It would have been almost a dereliction of our duty if we 
didn't study this. And the only way you can study these things 
is you have got to go where the action is. So I often say 
somewhat tongue in cheek, you don't want to study bats in 
Fairfax County, Virginia, to find out what the animal/human 
interface is that might lead to a jumping of species.
    So we had a modest collaboration with very respectable 
Chinese scientists who are world experts on coronavirus, and we 
did that through a sub grant from a larger grant to EcoHealth. 
The sub grant was about $600,000 over a period of 5 years. So 
it was a modest amount. And the purpose of it was to study the 
animal/human interface to do surveillance and to determine if 
these bad viruses were even capable of transmitting infection 
to humans.
    And the question of, well, did you do gain of function 
research? And, as Dr. Collins clearly articulated, there was 
nothing in the grant application and/or granting of the purpose 
of the grant and the description of the grant that would call 
for what is referred to as gain of function, gain of function 
meaning taking the virus that could infect humans and making it 
either more transmissible and/or pathogenic to humans. That 
categorically was not done. So that is the answer to that 
question.
    Mr. Pocan. Thank you. So I have got minute and a half left, 
and I know there is going to be a second round. But in the 
minute and a half, I am very concerned about, I think, the more 
important issues of making sure we get more people vaccinated. 
Is there anything, initiatives or funding, that you might need 
from this committee to enhance vaccinations? Are you concerned 
of where we are at? Then a very specific question that I have 
had, if someone can ask--someone was concerned about spike 
proteins and the long-term consequences and their potential 
health effects on cold and flu season. So, if you can answer 
all of those, I will keep the rest of my subjects for the next 
round.
    Dr. Collins. This goes to Dr. Fauci again.
    Dr. Fauci. I am sorry, Congressman Pocan, specifically, 
your question?
    Mr. Pocan. Specifically, how are we doing on vaccinations? 
Is there anything else we need to get funding or initiatives to 
do that? And then, very specifically, a question about spike 
proteins, long-term consequences. I think there is a concern 
about potential health effects during cold and flu season. Some 
of the people who are reluctant right now that I am talking to, 
that was an issue on vaccinations.
    Dr. Fauci. Well, we are doing extremely well with 
vaccinations, as you well know. We have now more than 60 
percent of the adult population has been vaccinated. The 
toxicities adverse events are remarkably low in this when you 
look at the denominator of the literally tens if not hundreds 
of millions of vaccine doses that have been given.
    However, whenever you get adverse events, even though they 
are very, very rare, we obviously are interested in whether or 
not there is anything about the spike protein that would 
trigger something, such as an autoimmune reaction, that might 
give you a deleterious effect. Again, these things are 
extremely rare. We don't see anything that we can directly 
relate to the spike protein, but we are certainly looking for 
that. And there are immunologists who are right now looking to 
see if there is any connection there. But, again, to 
underscore, Congressman, these are really extraordinarily rare 
events.
    Mr. Pocan. Thank you very much, Madam Chair. I will be 
ready for the second round.
    The Chair. Thank you. Congressman Moolenaar.
    Mr. Moolenaar. Thank you, Madam Chair. And I want to thank 
everybody for their participation today.
    Dr. Collins, Dr. Fauci, I first of all want to congratulate 
you on Operation Warp Speed and the record timing to get this 
out, to get this working in America. I think it has been a 
tremendous success.
    Because of the nature of, you know, how quickly the 
vaccines were developed, I know there is some percentage of the 
population that has hesitancy, kind of viewing it as somewhat 
experimental, kind of seeing how it all works out. And 
especially women of childbearing age who would like to have 
children in the future, I know there have been some concerns 
about whether or not the vaccine would in any way affect them 
in a negative way. I wonder if you could talk to that and just 
mention if there is any evidence of any risk or concern to 
women who might be considering that in the future.
    Dr. Collins. I think the evidence is actually quite 
reassuring, but let me ask Dr. Fauci to give a specific answer 
to your question.
    Dr. Fauci. Yes, thank you very much, Congressman, for that 
very important question. So, if you look at--the vaccine trials 
did not include pregnant women in the trials. There are now 
trials that are looking at vaccines specifically for effects in 
pregnant women and in lactating women. Those are ongoing right 
now.
    However, if one looks at post-EUA, the number of pregnant 
women who elected to get vaccinated because of the clear 
indication that the effect of COVID-19 disease on the pregnant 
woman and the fetus is really something to be concerned about. 
So many, many women elected after the EUA to get vaccinated. 
There have been about 115,000 to 120,000 of these pregnancies, 
and there have been 5,000 to 6,000 of the births that have now 
been followed by the CDC and by the FDA. And as alluded to by 
Dr. Collins, there is no red flag signal at all that there is 
any concern about deleterious effects of the vaccine on 
pregnant women. This is really important because the one thing 
we do know for sure is that when pregnant women get infected 
with COVID-19, they can have a serious deleterious outcome.
    Mr. Moolenaar. Thank you for that. And I just, I think that 
that message is really important to get that out there, and I 
appreciate hearing that directly from you.
    I wanted to talk a little bit about the patent protection. 
And, you know, Dr. Collins, maybe you can answer this question. 
There has been some discussion, and I believe the Biden 
administration recently announced it will support waiving 
intellectual property protections for COVID-19 vaccines. I 
think everyone wants to see these vaccines readily available 
and the supply. But I am concerned about waiving the patent 
rights for these biopharmaceutical companies and how that might 
impact their willingness and their ability to partner with the 
Federal Government in the future when addressing pandemics 
because we are taking away significant protections for their 
investment in research.
    Dr. Collins. So it is a very important question, and it is 
a complicated issue that no one should just assume can be 
superficially understood. I think all of us, companies, 
government, and academics, just citizens of the world believe 
we need to do everything we can to get vaccinations made 
available to all the people who need them, and especially so in 
low- and middle-income countries, where the need is great and 
the availability in terms of the supply is low.
    But it should not be assumed that it would be possible just 
by a quick effort over the course of a couple of months to 
establish vaccine manufacturing capacity in lots of other parts 
of the world that don't have it. These are very complicated 
biochemical processes, biotechnology processes that require--if 
you start from basically no previous experience, more than just 
a few months, more like years.
    And so, while this, I think, is in the long term, what we 
need to see is this expansion of manufacturing capability, in 
the short term, we are going to depend on the companies that 
have that capacity to do as much as they can to expand their 
capabilities. And, certainly, I think all of us would agree 
that is what we need to see happen.
    So it is going to have to play out over the course of time 
to see whether this opening up of intellectual property can 
help with low- and middle-income countries. But we should not 
assume that, in the short run, that this is going to be an 
immediate solution.
    Mr. Moolenaar. Are you concerned about the long-term 
impact, though, and the message that sends to, you know, 
private sector investment and research?
    Dr. Collins. I don't think industry is terribly concerned 
about that. Stephane Bancel, the CEO of Moderna, said he didn't 
lose a minute of sleep the night after this announcement was 
made by the White House. Moderna had already announced they 
were going to make their intellectual property available to 
manufacturing capabilities in low-income countries.
    What is really more necessary than just the IP is the 
technology transfer capabilities, the skills that have to be 
transferred, the training that has to be done. And that is 
where we are going to need industry to participate, and I think 
they are ready and willing to do so.
    Mr. Moolenaar. Okay. Thank you very much.
    And I yield back, Madam Chair.
    The Chair. Thank you.
    Congresswoman Clark.
    Ms. Clark. Thank you so much, Madam Chair. And I share the 
enthusiasm over having this incredible group of panelists here 
today. And we have all witnessed the incredible benefits of R&D 
investments at the NIH, which have produced lifesaving vaccines 
during this pandemic. And I am encouraged by the President's 
vow to end cancer through proposals like ARPA-H, but I have 
heard some concerns that a new agency may diminish your base 
funding.
    I know that we are eagerly awaiting the President's budget 
this week, but, Dr. Collins, can you do anything to assure us 
that this new agency can maximize its effectiveness without 
supplanting any funding from existing budgets at NIH?
    Dr. Collins. I would very much like to reassure you about 
that. And, again, there will be more details available in a 
couple of days. The proposal, though, is for ARPA-H to provide 
an opportunity for all of the institutes to be able to take on 
this DARPA-like approach to the projects that could move much 
more swiftly with the kind of flexibility and nimbleness and 
risk-taking that ARPA-H will provide. So it augments the 
capabilities of the rest of what NIH is about. It is not 
detracting from the base; it is adding a layer of translation 
of clinical application that can now go faster.
    I would also say the way the President's budget rolls out, 
it proposes a $2,500,000,000 increase for all of the rest of 
NIH, which is a pretty reasonable number as well. So when you 
put that together, I think for cancer, diabetes, heart disease, 
and everything else, including ALS, Chair DeLauro, we are going 
to have an opportunity, through all of these mechanisms, to do 
more. And the proposal of this total of an increment of 
$9,000,000,000 is going to open up all kind of vistas of 
opportunity.
    Ms. Clark. Thank you. And to Dr. Sharpless, we have also 
heard reports that grant funding has gone down [inaudible].
    Dr. Sharpless. Uh-oh. I think I lost Representative Clark.
    The Chair. Let's try to find out if we can get Congressman 
Clark. Can anybody tell me anything? Well, maybe what we will 
do is to--we will come back to Congresswoman Clark.
    Congressman Cline.
    Mr. Cline. Thank you, Madam Chair, and I want to thank our 
witnesses for being here and for their diligent work in 
developing the vaccine for COVID and for working with its 
distribution.
    I want to first start by quoting from a 2011 opinion piece 
that Dr. Fauci and Dr. Collins wrote for The Washington Post, 
``A flu virus risk worth taking,'' where it includes that--you 
conclude: Along with support for this research comes a 
responsibility to ensure that the information is used for good. 
Safeguarding against the potential accidental release or 
deliberate misuse of laboratory pathogens is imperative. The 
engineered virus developed in the ferret experiments--in your 
column--are maintained in high-security laboratories. The 
scientists, journal editors, and funding agencies involved are 
working together to ensure that access to specific information 
that could be used to create dangerous pathogens is limited to 
those with an established and legitimate need to know.
    So, when I am looking at a letter that Congressman Mike 
Gallagher sent to you back in early May, it says that funding 
for the--sorry, let me find this here--that funding was about 
$17,000,000 was directed to EcoHealth Alliance, and rather than 
$600,000, much of that was sent to the Wuhan lab.
    Can you account for the $17,000,000 that was allocated to 
Eco lab, and speak to the disparity and the amounts that you 
are discussing, Dr. Fauci.
    Dr. Fauci. Yeah, Congressman Cline, it is absolutely 
correct that about $600,000, about $800,000 was allocated, and 
about $600,000 was spent over a 5-year period, no more than 
that. That comes through between $125,000 and $150,000 per year 
that went to collaboration with Wuhan. So the number of 
hundreds of thousands, as opposed to millions, is correct. The 
millions number is incorrect. EcoHealth had several millions. I 
don't know the exact amount that went to EcoHealth, but would 
be happy to get you that precise number.
    Mr. Cline. I see it now: 13.7 that was allocated to 
EcoHealth; 17 projects sponsored by NIAID, providing over 
$7,900,000 in Federal rewards for the research of viral 
emergence from bats in Southeast Asia. EcoHealth Alliance 
passed some of its funding to WIV, the Wuhan lab. And in 2020, 
NIH made efforts to obtain information from EcoHealth Alliance 
about Wuhan lab related to concerns about the origins of COVID-
19.
    It says that in your letter to EcoHealth: It is our 
understanding that one of the sub recipients is Wuhan lab. It 
is our understanding that WIV studies the interaction of 
coronavirus in bats. And there are now allegations that the 
current crisis was precipitated by the release of--from WIV of 
the coronavirus responsible for COVID-19. Given these concerns, 
we are pursuing suspension of WIV from participation in Federal 
programs. It is in the public interest that the NIH ensure that 
a subrecipient has taken all appropriate precautions to prevent 
the release of pathogens that it is studying.
    Would you say it has come to your conclusion that the Wuhan 
lab was not engaged in a safe--ensuring the safety of its 
facility, as you wrote back in 2011? Is that your conclusion?
    Dr. Fauci. I didn't--I am sorry, Congressman Cline. I am 
not sure what you are reading from. I didn't write anything in, 
I don't believe, in 2011. You are reading from something that I 
don't have in front of me. Was that something that I signed?
    Mr. Cline. This is an April 2020 NIH letter to EcoHealth 
Alliance.
    Dr. Fauci. I think that was from Building One perhaps, but 
that is not from me.
    Mr. Cline. Okay. Let me just go ahead and ask real quick, 
have you responded to the letter to Congressman Gallagher, 
dated May 25, Dr. Collins?
    Dr. Collins. There is a draft of that letter that is in the 
process of going through appropriate clearance and should be 
received by Congressman Gallagher fairly soon.
    Mr. Cline. Have you responded to the letter from House 
Commerce Ranking Committee Member Cathy McMorris Rodgers? She 
has written two, one dated March 18, one dated May 6. Have you 
responded to either of those?
    Dr. Collins. Again, those responses are in the works. Those 
were very detailed with some 29 questions of 11 pages and 40 
footnotes. So it is taking us a little while.
    Mr. Cline. All right. And you have a May 20th letter from 
several Senators that is waiting for an answer as well?
    Dr. Collins. We do indeed on similar topics from Senator 
Johnson and others, and that is also in the works.
    Mr. Cline. All right. Thank you.
    The Chair. Let me ask, is Congresswoman Clark back on yet?
    Okay.
    Congresswoman Frankel.
    Ms. Frankel. Good morning. Thank you, Madam Chair.
    And thank you to the panel for your great work, for saving 
so many lives.
    I am going to start with two questions, somewhat personal. 
I am the grandmother of a newborn nursing grandson. I would 
like to know where we are in terms of implementing any findings 
that will include pregnant and lactating women in clinical 
trials?
    Dr. Collins. Dr. Bianchi.
    Dr. Bianchi. Thank you, Congresswoman Frankel, and 
congratulations on the birth of your grandson.
    As you know, one of the goals of the PRGLAC Task Force was 
to create recommendations and then create a plan as to how to 
implement them. And we have already shown a big effect in our 
institute's priorities because we have established a maternal 
and pediatric precision therapeutics hub that is going to take 
the recommendations to the next level and create a center for 
knowledge around medications that lactating women can take 
safely and what are the effects on the newborn. So that is 
coming up. But also the PRGLAC recommendations influence our 
institute's strategic Plan, where we have a whole team 
dedicated to safe therapeutics and devices for pregnant women, 
lactating women, children, and people with disabilities.
    Ms. Frankel. Thank you very much. If you can keep us posted 
on that.
    Dr. Bianchi. Absolutely.
    Ms. Frankel. Then, of course, I have another personal 
question because I had a really lousy night's sleep like a lot 
of Americans. And, you know, I read--I have read many times 
that a lack of sleep is related to all kinds of health 
problems, cognitive impairment. And I am just curious--and that 
most Americans are not getting the recommended amount to sleep. 
I am just curious, what kind of research is being done in order 
to help us sleep better?
    Dr. Collins. It is a great question, Congresswoman. As one 
of those who is not getting enough sleep, I resonate with your 
question very personally. And I bet a lot of the other people I 
am looking at on this screen are in the same boat trying to 
wrestle with all of our responsibilities, especially with 
COVID-19.
    Yeah, we have a whole program on sleep research. It is part 
of the National Heart, Lung, and Blood Institutes. And Dr. 
Gibbons, as the director of that institute, might want to take 
a quick shot at your question about sleep research.
    Dr. Gibbons. Sure.
    Thank you, Congresswoman Frankel. And as you say, it is a 
common challenge we all face, but it is clear that sleep and 
its restorative power are really important to our 
functionality. And, indeed, disturbances of sleep appear to 
affect almost every organ in the body. The body has its own 
natural rhythm. It affects your blood pressure, and your body's 
temperature. In fact, every cell in your body has a clock that 
has a rhythm that aligns with the clock. And when it is 
perturbed, it can promote diseases; a number of them related to 
obesity, diabetes, heart disease. When you have a heart attack, 
it is all influenced by sleep and circadian rhythms.
    In fact, one of the studies we have been doing in 
collaboration with NIH's child health institute relates to, 
again, women in pregnancy. And what we have learned is that 
many women develop a sleep disturbance during pregnancy. That 
is surprising to men, well-known by women. And, indeed, those 
sleep disturbances in which you stop breathing can impair and 
have an influence on the course of the pregnancy and on the 
child. In fact, we are doing an intervention study after making 
that observation to see whether interventions that reduce sleep 
apnea, which is stopped breathing during sleep, can actually 
improve outcomes of both mom and child.
    Ms. Frankel. Dr. Gibbons, sorry to interrupt, but now you 
are really getting me nervous about this. But what is the cure 
for us that are--for people who are not sleeping? What are you 
suggesting, or what are you researching?
    Dr. Gibbons. There are simple things that you can do. As it 
turns out, a lot of them are probably what your grandmother 
told you is, when you get good exercise, you tend to have a 
better sleep. When you have a healthy diet and when you watch 
your screen time, particularly at night, and when you avoid all 
those distracting noises or eating late and you actually rest 
and start to cool down before you go to sleep, all those sleep 
hygiene habits are nonpharmacologic and can help you get a 
better sleep.
    Ms. Herrera Beutler. So, basically, we are all toast. Like 
none of that is going to happen. We are all toast. Excuse my 
language.
    Ms. Frankel. I just want to know if there is a pill.
    Dr. Gibbons. Well, our hope, is that, in fact, lifestyle 
and even nonpharmacologic things as well as medication can 
help. Certainly, in the disease context, we are looking at 
sleep medications that can be nonaddictive. A key part of it is 
in the NIH common fund where we are looking at, how can we 
figure out biomarkers of sleepiness as well as understand the 
restorative, refreshing parts of sleep in ways that might be 
manipulated therapeutically?
    Ms. Frankel. Thank you. I am going to follow up with you.
    And I will share the research, folks.
    I yield back.
    The Chair. Thank you very much, Lois, for opening up the 
Pandora's box here for all of us here.
    I understand that Congresswoman Clark is back on. So let me 
yield to Congresswoman Clark.
    Ms. Clark. Well, thank you, Madam Chair. I hope this is a 
more successful outing.
    I had a brief question for Dr. Sharpless about NCI. I just 
wanted see if he can review for us why the National Cancer 
Institute needs more funding while we are seeing a decline in 
grants being awarded at the same time?
    Dr. Sharpless. Sure. So, Congresswoman Clark, our grant 
applications are up 47 percent. So we have got this massive 
influx of new ideas to the NCI. What has gone down is our 
ability to fund a large percentage of them because with that 
many coming in, it is hard to--the pay lines and success rates 
are on the decline.
    So, you know, they nadired at about 8 percent 2 years ago, 
which the success rates are a little higher than that. But that 
is an important metric. They have now come up to 11 percent, 
which is progress, but it is still too low. You know, this is 
one of the things that is keeping me up at night, frankly, is 
the idea that there is this great investigator-initiated 
science and these pools of grants that we are not able to get 
to. So, for example, that pool of money has funded things like 
checkpoint inhibitors to cure melanoma, the CAR-T cells to cure 
the leukemia and drugs, problems like that, and then, you know, 
things like PROTACs, this new invention to do medicinal 
chemistry that is all the rage in the pharmaceutical industry 
presently. All of this came out of this pool of moneys. So it 
really drives progress in cancer research. And if 89 percent of 
them are not getting funded, that makes me very anxious.
    So I think that that is our problem is that we need further 
support to reach these great ideas because there may be a cure 
for pancreatic cancer in there. And that is why we really need 
to support them.
    Ms. Clark. Well, thank you. Thank you for that explanation. 
And Doctors Volkow and Fauci, I want to talk a little bit about 
COVID survivors who have long-term symptoms. It has come to my 
attention that patients that have different symptoms, fatigue, 
depression, brain fog, also can have significant muscle and 
bone pain. And we are seeing [inaudible].
    The Chair. We will get back for a final question.
    Congresswoman Bustos.
    Mrs. Bustos Thank you, Madam Chair.
    And, obviously, if Katherine comes back on, I am happy to 
either yield time to her or----
    The Chair. Sure.
    Mrs. Bustos [continuing]. I can start all over as well.
    Dr. Fauci, I would like to talk to you a little bit about 
vaccine hesitancy. We have seen the polls out there, the 
research out there that talks about the top reasons why people 
aren't taking the vaccine. They want more evidence that it is 
safe. They don't think COVID will seriously impact them. They 
already had COVID and have antibodies. I think those are the 
top three reasons that we are hearing about. This is more 
prevalent in rural America, much like the congressional 
district that I serve, very, very rural.
    I saw also a poll that found that it is 21 percent of rural 
residents are saying now that they definitely would not get a 
vaccine as compared with about 10 percent of those who live in 
more of our bigger cities.
    So what we are seeing on the ground here in the State of 
Illinois, we have 102 counties altogether. So we have got of 
the 15 least populated counties, 8 of them are overall the 
least vaccinated counties. And then, of the most populated 
counties, we have got 11 of those 15 that are doing the best. 
So, again, we are seeing this divide on the ground. We are 
certainly seeing it in the district that I serve.
    I am wondering, Dr. Fauci, as a trusted voice in all of 
this, what do you have to say to the folks who are holding off 
getting vaccinated for the reasons that I just listed?
    Dr. Fauci. Well, thank you for that question, Congresswoman 
Bustos. The answer is the first thing we have got to do is make 
sure we don't point fingers at them to do that and make them 
feel guilty about that. But you try to explain to them each and 
every one of the potential reasons why they feel they don't 
want to get vaccinated. One of the most common is that ``this 
was done so quickly that I am not sure that it is safe. And 
that you have got to get trusted messengers out there to 
interact with them. And when I say ``trusted messengers,'' what 
we put together is a COVID-19 community corps where there have 
been thousands of trusted messengers. They could be sports 
figures, celebrities in the entertainment business, clergymen, 
we find and women, we find are having an important role in 
getting out and extending themselves to address each and every 
one of the reasons because if you just take the time to examine 
those reasons, there is a really logical firm scientifically 
sound counter to each of those concerns, including the safety, 
including the quickness that it was done, et cetera.
    The other thing that we have found interesting that if you 
make the capability of getting vaccines to the hesitant people 
as easy as you possibly can, that mitigates some of the 
concern. For example, right now, in 40,000 pharmacies, 
including pharmacies that are located in areas that are the 
rural areas that you are talking about, that anyone can get to 
a pharmacy within 5 miles of where they are no matter where 
they live, that you can go now, walk into a pharmacy, you don't 
need a computer, you don't need an appointment, you don't need 
anything, you just go in and get vaccinated. The same things 
for mobile units to going into the rural areas when people 
don't have the transportation capability to get to a place. So 
there are a lot of things that we are doing.
    Obviously, we are concerned about vaccine hesitancy because 
we want to get as many people vaccinated as quickly as we 
possibly can. But there are many things going on now to try to 
address that, particularly in those areas that you correctly 
indicated are more likely to not want to get vaccinated.
    Mrs. Bustos. Dr. Fauci, in addition to--I am thinking of, 
we have got one county in this congressional district that I 
represent, which is pretty much the entire northwestern corner 
of the State of Illinois, we have one county where the entire 
population of the county is a little more than 6,000 people. 
The vaccination as of this morning--I get a daily report on 
this--is 19 percent. And so I appreciate--here was part of the 
problem too. They have one phone line to sign up to get the 
vaccine. That grown now to two. The high-speed internet is a 
problem in a very, very rural county; this is along the 
Mississippi River. Is there--I don't know. I am just trying 
to--I want to do everything that I can to help get those 
numbers up. But you have got pharmacies. You have got 
validators. Anything else when you think about a very rural 
part of the country that we might be able to help as Members of 
Congress, or any other ideas you have in a county like I just 
spelled out.
    Dr. Fauci. Yeah, I think mobile units would likely be one 
of the most important things to do because you are describing 
people who don't have real ready access to the kinds of things 
that would make it really easy.
    Let me get back to the medical unit at the White House and 
see if there is anything that could be done. Because I believe 
mobile units to bring the vaccines to those rural areas are 
probably the best way to do that.
    Mrs. Bustos. Okay. All right. Well, we would welcome any of 
that. I am out of time. I am sorry. But I can't ask my second 
question that I was going to ask Dr. Collins about Down 
syndrome. Maybe we will revisit that another time.
    Thank you very much, Dr. Fauci.
    And, again, Dr. Collins, to you and your entire time, thank 
you for all you are doing to help people.
    With that, Madam Chair, I yield back.
    The Chair. We will have a second round, Congresswoman 
Bustos. So, if you can stay, you know, I would be happy to get 
your question on Down syndrome.
    I am going to ask again if Congresswoman Clark is----
    Ms. Clark. I am here. Can you hear me?
    The Chair. Yes, go for the last bit here with your second--
and then we are going to have another round, Katherine.
    Ms. Clark. Okay. Super quick, I am concerned about the rise 
in prescriptions for COVID long-haulers to address some of the 
bone pain and other medical pain they are experiencing. I 
wonder if this concern is shared by Dr. Fauci and Dr. Volkow, 
and if we are looking at nonopioid treatments for the 
neurological effects.
    Dr. Collins. Dr. Volkow.
    Dr. Volkow. Opioids are quite addictive, and this 
highlights actually why it is so important that we continue 
training on the proper use of opioid medications but also on 
the proper management of pain many instances not requiring 
opioids, which of course triggered that whole opioid crisis. 
But this is also why one of the priorities of the HEAL 
Initiative for which we got specific funds by Congress 
allocated to address the challenges of the opioid crisis. One 
of the main initiatives is to accelerate the development of 
effective pain medications that are nonaddictive.
    Ms. Clark. Thank you. And thank you for your patience, 
Madam Chair.
    The Chair. Thank you.
    Congresswoman Watson Coleman.
    Mrs. Watson Coleman. Thank you, Madam Chair.
    And thank you Dr. Collins and to all of your colleagues, 
this has been so helpful, and it is so good to talk to you 
scientists about the value of science.
    Dr. Fauci, I have a quick question for you. I am like Lois; 
I have got a personal issue here. I have got an 8-year-old 
granddaughter that I don't want to go back to school until she 
is vaccinated. How close are we to getting children vaccinated 
from that age?
    Dr. Fauci. Yeah, you know, unfortunately, Congresswoman, I 
don't believe that they are going to be able to be vaccinated 
by the time the fall term comes. We certainly will get high 
school adolescent individuals vaccinated then. But the age de-
escalation studies that we are doing to get to an 8-year-old 
would likely not be available towards the end of this calendar 
year, but at the latest the first quarter of 2022. I would 
imagine late fall, early winter.
    Mrs. Watson Coleman. So does that concern you about sending 
your granddaughter back to school under those conditions? 
Should we be seeking virtual, continue virtual educating?
    Dr. Fauci. Well, what the CDC and other organizations, but 
certainly the CDC is trying to do is, given the number of and 
the percentage of teachers that will be vaccinated that are 
already vaccinated, that there should be no reason not to get 
children of any age back to in-person school by the time we get 
to the fall term. I myself would likely, would not be--I don't 
have children that young, but I would not be concerned when we 
get to the fall.
    The reason I say that, Congresswoman, because if you look 
at the rate of vaccinations now, what is an important factor in 
the safety of the children is the degree of infection that is 
ongoing in the community. And if you look at the last few 
weeks, the number of infections per day have gone down in a 
very steady encouraging manner, from 60,000 a day to 50 to 40 
to now we are well into lower than 30.
    If we get to the President's goal of getting 70 percent of 
adults vaccinated with at least one dose by July 4, I believe 
by the time we get to the fall, that even though young children 
might not be vaccinated, it will be really rather safe in 
school. I do believe that.
    Mrs. Watson Coleman. I pray so. I pray so. And I thank you 
for being such a stand-up person throughout all of this.
    Dr. Collins, I am very interested in NIH as it relates to 
all of the space that it could improve in terms of diversity, 
whether it is the researchers, the clinical participants, 
whether it is the individuals or the groups of or the work 
groups that review these grants. I am interested in all of 
that. And in last year's funding bill, I added the language 
that I would ask the NIH to develop a strategic plan and 
establish the working group to address the lack of diversity 
among researchers and staff and among those who are reviewing 
the grants. And I realize that you had initiated the UNITE 
Program since March. But I really would like to know some of 
the specific strategies that you all are employing to get at 
and overcome these barriers. And I would like to know what have 
you been actually focusing on in these initiatives, and what is 
your intention with regard to continued reporting back to us on 
the progress which is made? I am really interested in some of 
the strategies that you are employing to this extent.
    Dr. Collins. Congresswoman, those are great questions, and 
we appreciate your asking us for the strategic plan. I 
appreciate Congress also giving us a little bit more time 
because we are in the midst of this groundbreaking UNITE 
initiative, which touches on all the areas you have just 
mentioned.
    Time is short, but I will give you one example of how we 
are seeking to really improve the diversity of our workforce. 
Most of our workforce, of course, is out there in our grantee 
institutions; 85 percent of our money goes to those academic 
institutions where the science gets done. And yet their 
workforce is not as diverse as it could be. And when they go to 
try to recruit individuals of diverse backgrounds, oftentimes 
they are not successful. If they are successful, individuals 
are recruited, but they are not retained.
    A new model where we would encourage them, and this is now 
possible to do with an additional common-fund program to 
recruit not just single individuals from underrepresented 
groups but a cohort, and to bring them on board collectively 
together. Something that we have piloted in our intramural 
program with considerable success. And then they are not like 
the only person of color in their community of researchers. 
They have this kind of opportunity to arrive together to be 
mentored, to be encouraged. This is a program called FIRST, F-
I-R-S-T. And I think we are going to watch closely to see what 
this does in terms of the expanding the capabilities of our 
workforce to be more diverse. And this is not just something we 
are doing because it is a nice idea. We know that diversity 
equals productivity, and we want to be sure we are not missing 
out on that productivity by the lack of our diversity in many 
of our institutions. We are going to work really hard on that.
    Mrs. Watson Coleman. And I thank you. I am going to want to 
hear about the use of HBCUs in this. And I am also going to 
want to understand the sort of contractual relationship you 
have with the grantees that are expected to bring on this 
diversity and whether or not their mechanism success is 
connected to the stability of these diverse researchers and 
professionals. So those are some of the areas I am very 
interested in.
    I have run out of time unfortunately, but I yield back, and 
I thank you very much.
    Dr. Collins. Thank you.
    The Chair. Thank you.
    Congressman Harder.
    Mr. Harder. Thank you so much, Chair DeLauro, for hosting 
this.
    And thank you so much to all of our witnesses for taking 
the time to be here and sharing their testimonies.
    I want to take this in a little bit of a different 
direction than what we have been doing so far and talk about 
asthma and air quality, which are two interconnected issues in 
our district. Many of the cities in the California Central 
Valley are classified as the most polluted cities in the U.S. 
for both particulate matter and ozone pollution that have a lot 
of the direct impacts on the health of folks in our 
communities, especially for kids. One in six children in the 
San Joaquin Valley have asthma, the highest in the State, and I 
believe among the highest in the country. And asthma prevalence 
across the valley has reached as high as 20 percent in school-
aged kids.
    I had childhood asthma as a kid. My brother had it. It is 
incredibly and heartbreakingly common in our area. We, of 
course, have seen that in the health data even afterwards. We 
have among the highest emergency room visits for asthma in 
California. And add in the devastating wildfires in California, 
as well as the respiratory impacts of COVID-19, and it really 
creates a lot of impact for our healthcare system, and some of 
the costs are high. And yet it seems like we haven't 
necessarily made major breakthroughs in asthma research in 
recent decades. And many Americans are resistant to current 
asthma therapies.
    Dr. Gibbons, I would love to hear from you as the director 
of the National Heart, Lung, and Blood Institute, what can you 
tell us about the use of Federal funds to research and develop 
programming to address childhood asthma? And is there more that 
this committee can be doing to assist in this program?
    Dr. Gibbons. Thank you for that important question, 
Congressman Harder. As you point out, asthma is one of the 
leading chronic conditions of children, in general. It 
certainly affects certain communities disproportionately. You 
recognize the rural health challenges. In addition, we are 
seeing similar patterns in communities of color, inner city, 
underserved communities where, again, these exposures can be 
concentrated. Indeed, that is an area of research in part 
related to the ECHO Program. It is a children's study where we 
have been assessing that.
    We have learned through those studies that exposure to air 
pollution, particularly early in life, actually, has influence 
on lung development. We have learned that lung development 
actually continues all through childhood, even into early 
adulthood. It is driving the overall reserve and structure of 
the lungs over time. And that is why it is so important, as you 
indicate, to mitigate those exposures that are happening both 
in these rural communities and some of the inner city 
communities that also occur in these hot spots or pockets of 
high air pollution.
    We also are making progress in further defining the 
mechanisms of the disease, to advance therapeutics beyond the 
drugs that currently exist and have been used for the last 
decade or so. Indeed, we have been engaged in a program called 
TOPMed in precision medicine in which we have gathered together 
cohorts of children and adults with asthma in a large 
sequencing study to identify new mediators of asthma as a part 
or means of developing new targets and new therapeutics.
    Similarly, we have developed a platform in which we are 
starting to engage in precision medicine for asthma. We call it 
PrecISE, where we are recognizing asthma as kind of a catch-all 
and recognizing that there are certain subsets of patients that 
may respond to particular interventions that have a certain 
biological impact.
    Mr. Harder. That research, I am sure--I want to make sure I 
have a chance to ask a second question as well. I appreciate 
that.
    I think that is great segue to my question for Dr. Collins, 
which is: In the President's budget, there is proposed $110 
million for the Climate Change and Human Health Program. Can 
you describe some of the research projects that you expect to 
come from that, especially any projects that focus on health 
outcomes related in poor air quality and how it impacts 
underserved communities like ours? Do you have a big piece of 
where this might then go or not?
    Dr. Collins. Absolutely. And it does tie in very nicely to 
the question you just posed to Dr. Gibbons. Climate change 
affects human health in numerous ways. People tend to think 
about it as perhaps it is more in the area of infectious 
disease. And there is a lot to be concerned about there as well 
as climate makes different opportunities for different 
pathogens to find their way into the human population.
    But it also affects, as you have just pointed out, air 
quality, the issues that are going to relate to such things as 
asthma, as well as heart disease, as well as cancer. All of 
those are wrapped up in what we think is now an appropriate 
moment for an enhanced and expanded effort to understand the 
health consequences of climate change.
    Our National Institute of Environmental Health Sciences, 
NIEHS, will be taking the lead on this. But already they have 
reached out to numerous other institutes at NIH so that we can 
come forward with a really exciting, very broad holistic 
approach to how we could tackle this issue of environmental 
science related to health and the effects of the climate. So I 
am glad you highlighted it. We are excited about the 
opportunity here.
    Mr. Harder. Thank you. Thank you, Dr. Collins.
    I yield back, Madam Chair.
    The Chair. Congresswoman Lawrence.
    Mrs. Lawrence. Good morning. Thank you, Chairman DeLauro. I 
represent a majority-minority district in Michigan, and the 
past year has exposed the alarming disparities for communities 
of color. I believe it is absolutely critical that we act on 
these disparities to develop a plan for research.
    Dr. Collins, it was heartbreaking when I saw the 
disproportionate number of African Americans being hospitalized 
and dying from this past pandemic. And it is almost as if in 
unison the response was, well, it is expected because they have 
underlying conditions.
    When are we going to start planning? And what is the plan 
to address these underlying conditions in the Black community, 
which I know are multiple? We have--access to healthcare is an 
issue, food deserts, lack of proper nutrition, obesity. We were 
the highest in heart disease, in cancer. And so I want us as a 
country to move from ``Yes, this is the problem'' to ``This is 
what we are going to do.'' So can you please talk to me how the 
Minority Health and Health Disparities Institute, when will we 
start see a plan and results of that?
    Dr. Collins. Well, your question is incredibly well-
articulated. And it certainly resonates with myself and my 
colleagues, as we really have to look at what has happened with 
COVID-19 as another example of just how devastating health 
disparities are in the United States and that those same 
populations that have suffered from disparities, like obesity, 
diabetes, hypertension, got hit extremely harder by COVID-19. 
And nobody can look at that and not say, ``We have got a 
serious issue here.''
    If your ZIP Code is a stronger predictor of your longevity 
than your DNA code--and it certainly is--there is something 
serious awry here in terms of the way in which structural 
racism, which undergirds so much of what is happening 
institutionally and across the country, has played out in terms 
of health effects.
    We at NIH have been studying minority health and health 
disparities intensively over the course of many years. I think 
we are energized by these observations and again by this UNITE 
initiative that I have mentioned already to go deeper, to 
really understand not just what are the causes of health 
disparities--some people have cynically called that admiring 
the problem--but actually to intervene and to come up with 
studies that would involve those kind of interventions to see 
if they work.
    We can't fix the healthcare system in the United States. As 
the NIH, we are a research organization, but we can understand 
studies to see what would happen if you changed certain 
approaches to health and other aspects that are contributing to 
this. And we aim to do that with a new common fund program that 
is more progressive than what has been possible before. So we 
are right with you.
    Mrs. Lawrence. Thank you, and I am on executive board of 
Black Caucus, and I am also co-chair of Women's Caucus. And so 
my philosophy in life is that you can't tell me what the 
problem is more than once because once you can identify it, 
then let's get about fixing it.
    My next question is about mental health. The other thing 
that COVID ripped the scab off during this pandemic is the 
critical need for mental healthcare and especially in our 
children.
    Dr. Collins, realizing the alarming rates of mental 
illness, how will the National Institute of Mental Health 
leverage the partnerships to ensure that the grant recipients 
receive the cutting-edge discoveries in this field, and how do 
we move mental health to the top of the--to the front of the 
line?
    Dr. Collins. Well, you are quite right that this is another 
crisis, and COVID-19 has accentuated it. We can see that both 
the disease itself, which is capable of inspiring various 
mental health issues to depression and sometimes even frank 
psychosis, which is frankly the whole experience that our 
country has had where mental health services have oftentimes 
been injured by a lack of access because of the concerns about 
being in the physical space together.
    But one bright light in all of this, Congresswoman, is the 
way in which, because of COVID, we have seen telemedicine 
finding its way into the mental health arena in ways that it 
previously hadn't. And we have a number of research studies 
underway right now that are looking pretty promising in terms 
of showing that that actually works really well. If there is a 
silver lining here, it might be that we learn how to use mental 
health services remotely by telemedicine in a way that benefits 
people who otherwise just don't have access to those services. 
That is just one example.
    There are many other things that we need to do. We have big 
programs now trying to come up with new approaches to treat 
depression, for instance, in ways that would not be the 
traditional methods with the traditional drugs but other 
approaches that might be more successful. It is a huge broad 
portfolio in that particular part of NIH that I would love to 
tell you more about if we had more time.
    Mrs. Lawrence. Thank you, Doctor.
    Thank you all.
    The Chair. Thank you.
    What I would like to do now is I think we can move to a 
second round. And we will make it a 3-minute round so that--and 
try to please hold to the 3 minutes so we give everyone a 
chance to ask additional questions of our panelists.
    And, with that, let me let me start off. Dr. Fauci, this 
was about universal flu. I am going to ask three--I have got 
two questions. And I want to get Dr. Gibbons in as well. With 
regard to the universal flu, does the mRNA technology show the 
promise for use in vaccines for other diseases, such as flu? Is 
there a hope that mRNA technology could be used to develop a 
universal flu vaccine? What other progress has been made in the 
past unit towards developing a universal flu vaccine?
    Dr. Fauci. Thank you for those important questions, Madam 
Chair. The answer to your first question is that the mRNA 
technology, which as you know is spectacularly successful in 
developing a COVID-19, is now being used in a number of other 
attempts of vaccines, including a universal influenza vaccine, 
including vaccines against HIV, and including in cancer 
immunotherapy. So mRNA is now very exciting.
    It is very interesting that you asked that question about 
where we are with other areas of universal flu vaccine. Just 
today, just today, we started a phase 1 trial on the 
nanoparticle, using a mosaic where we have multiple different 
hemagglutinins--these are the different colors--that are now 
very, very promising because we have at least four or five 
different hemagglutinins to cover the waterfront of the 
troublesome influenza components that we are dealing with. And, 
literally, it just started today, a phase 1 trial of simply 
what is called a nanoparticle mosaic approach towards universal 
flu vaccine. So thank you for asking that question. This is 
what it looks like.
    The Chair. This is fabulous. It looks like something I 
would have in my office as well, Dr. Fauci. So thank you. Thank 
you.
    Dr. Gibbons, this is about cardiovascular disease in women. 
In 2017, 300,000 women died as a result of heart disease. And 
heart disease and stroke is the leading cause of death of women 
in the United States. Critical, research in heart disease. 
Quick update, NHLBI-supported research and yeah--let me go 
there, and I don't think that there is--we need to have more 
information out about women and heart disease and what we are 
doing on that research. Dr. Gibbons.
    Dr. Gibbons. Yeah, thank you for that. Yes, we need to 
continue to beat the drum of awareness and ensure that all 
women recognize that it is the number one killer. We have 
actually--polls and surveys suggesting that we may even be 
moving backwards in that regard, particularly in communities of 
color.
    The Chair. How much time and money are we spending on heart 
research for women.
    Dr. Gibbons. Well, we can give you that exact number. But 
is certainly one of our highest priorities. A couple of 
examples include leveraging the Women's Health Initiative, 
where we found out about physical activity in elderly women. 
And we are now doing an intervention study to demonstrate that 
it is both safe to engage in that exercise and indeed still 
improve cardiovascular health in elderly women.
    The Chair. Dr. Gibbons, what I am going do is ask because 
my time is out. I would like to follow up with you and get 
information, chapter and verse, about what we are doing on 
heart disease in women, and how much research, how many 
research dollars are being appropriated to do that? And so 
thank you.
    And, with that, Congressman Cole, let me yield to you.
    Mr. Cole. Delighted. Thank you. As the chair, you are never 
out of time, number one. Number two, when you held the--when 
Dr. Fauci held that thing up, I thought that should be in 
Rosa's office. So we think exactly the same way.
    Let me first go to Dr. Collins. A couple of my colleagues 
have raised, and I think very appropriately, concerns about 
China. But, look, we know China is sort of a bad actor. They 
will steal anything that is not nailed down. And we have plenty 
of evidence of them trying to penetrate our research within the 
biomedical sphere in particular.
    So I would like you to take a moment and tell us what you 
are doing in response to that? What are the things that, you 
know, are underway at the NIH to make sure that our 
intellectual property is safe and, frankly, that science is 
used in an appropriate way, which I think our people at the NIH 
do? I am not sure what the Chinese counterparts always do as 
well. I don't mean that individually. I mean that in a regime 
way.
    Dr. Collins. Well, I appreciate the question. This is a 
very serious issue and one where we, the NIH, are out in front 
of all the science agencies in trying to be sure that our 
resources are not being misused and intellectual property being 
appropriated inappropriately to another country.
    First of all, let me say that we depend for the success of 
the American scientific enterprise on a broad diversity of 
folks who come to our country from other places and contribute 
wonderfully to progress, including winning Nobel Prizes. And I 
want to be really clear that the vast majority of those 
foreign-born scientists are wonderful additions to our 
community that we greatly value.
    But there are some bad actors. We have been very aggressive 
in seeking those out, finding examples of individuals. And, 
yes, most of them are from China, who have been supported 
through something called the Thousand Talents program or 
similar programs like that from China where they basically have 
deceived us in terms of the support they have for their work 
from the Chinese Government and, in some instances, have in 
fact been diverting intellectual property as a result.
    We have acted on that. We have worked with the FBI. There 
have been at least 80 instances of individuals who have quickly 
resigned or been terminated, and there are criminal actions 
that have been undertaken in some instances. So I think we are 
taking this with a grain of seriousness in watching for other 
examples. I think nobody at this point would imagine that we 
are looking the other way. We are looking really carefully to 
try to identify if there are people who are misusing the 
resources that we provide them and that we will not allow that 
to continue.
    Mr. Cole. Well, I very much appreciate that and commend you 
for your diligence and urge you to double down on that.
    Now, Dr. Fauci, if I could turn to you very quickly, I am 
very interested in the efforts on tick-borne research. One of 
our best supporters who is not on this committee is our good 
friend from New Jersey, Chris Smith. That has been an interest 
of his, and, honestly, I appreciate his advocacy for this 
program. So I want to give you a chance to update us on that.
    Dr. Fauci. Yeah. Thank you very much for that question, 
Congressman Cole. We actually, as you probably know, the HHS 
has a Tick-Borne Disease Working Group, which we are now 
coordinating work not only at the NIH but also with the CDC and 
other agencies to address tick-borne disease.
    Particularly, one that is particularly problematic, as you 
well know, is Lyme disease. We still have what I believe is not 
yet an adequate vaccine to be able to be used. We had one 
vaccine early on that was not used probably because of, I 
think, some ill-advised concern that was not really justified 
about the toxicity of the vaccine, which it really was not. So 
we are going to be starting all over again to try and do that.
    There are a number of other things also looking at how you 
can block transmission by inhibiting proteins in the ticks that 
actually transmit it. So there are four or five other things 
that are going on right now. So we are taking that very 
seriously because, as we all know, tick-borne disease, 
particularly Lyme disease, is of concern as you get into the 
post-Lyme syndrome, which is something that is bothersome not 
only to individuals but actually to communities as a whole 
where you have a lot of Lyme disease in a community.
    Mr. Cole. Thank you very much.
    Dr. Fauci. So we are on it.
    Mr. Cole. I Appreciate that. Madam Chair, thanks for the 
indulgence on the time. I yield back.
    The Chair. Thank you.
    Congresswoman Roybal-Allard.
    Ms. Roybal-Allard. Dr. Collins, according to a 2019 Survey 
USA nationwide poll, 80 percent of voters said that medical 
researchers seeking funding for animal tests should first be 
required to show that an alternative is not available. 
Unfortunately, this is not always the case. The OIG reports 
have repeatedly found that failure to search for alternatives 
to pain procedures and to document the availability of 
alternatives in research proposals is common, and scientists 
who have served on laboratory oversight committees have echoed 
this concern.
    I am going to ask all three questions in the hope that I 
can get to Dr. Volkow. What role has NIH played in educating 
the research community about non-animal research methods? What 
steps is NIH taking to incentivize researchers to utilize 
existing human non-animal approaches? And have you offered any 
training grants or any stage investigator or warrants or 
supplementary grant funding to give researchers the resources 
and confidence needed to switch from an animal-based to animal-
free research method?
    Dr. Collins. Well, very quickly, because I know you want to 
ask another question, we are very much interested in trying to 
be sure that every experiment that involves animals is done 
appropriately with rigor and reproducibility and that the 
animal model is, in fact, one that is going to give valuable 
information for human health. In many instances, there really 
are no alternatives to the animal model to be able to get those 
answers, and so we need to support that to be sure we are doing 
it, though, with great responsibility.
    In terms of grants to others, yes, we are supporting 
vigorously such things as tissue chips, which allow you to look 
at the effect of a drug or some other intervention in a chip. 
And it is basically made up of human cells, maybe closer to 
humans, but that doesn't work for lots of other applications. 
So we still are going to need animals. But we are looking at 
this as vigorously as we can, looking forward to a time where 
we have more substitutions.
    I think, though, to be honest, for the foreseeable future, 
if we are going to make advances in things like cancer, 
diabetes, heart disease, rare diseases, we are still going to 
need to depend for a lot of that effort on animal research.
    Ms. Roybal-Allard. Well, I look forward to working with you 
on this issue. I will be introducing a bill, which I would like 
to talk to you about later.
    Dr. Volkow, the last time we met, you were starting to do 
some research on marijuana. Can you give us an update on the 
research that you are doing and the impact of marijuana on the 
brain, especially the developing brain?
    Dr. Collins. We are not hearing.
    Dr. Volkow. Research on marijuana, and one of the most 
prominent ones is [inaudible] targeted towards understanding in 
a longitudinal study in a large sample size of children how 
exposure to marijuana may influence the development of the 
brain, how it may influence cognition and behaviors, and how 
ultimately it may affect their performance at school. That 
study is ongoing and already has resulted in publications that, 
for example, show that the use of marijuana during pregnancy 
was associated with delayed development of the newborn brain.
    But this is not the only project that we are doing. We are 
actually very interested also on establishing better ways of 
standardizing the metrics of consumption so that when people 
look at whether it is for medical purposes or to understand 
negative consequences, what are the doses that people are being 
exposed to? So, yes, we have not neglected at all this area of 
research. It is extremely important.
    Ms. Roybal-Allard. I see my time is up. Thank you so much.
    The Chair. Congressman Harris.
    Mr. Harris. Thank you very much. And, first, I just want 
to--just to correct the record. I think Mr. Pocan paraphrased 
what my question was about the Wuhan Institute. It did not have 
to do with globally not funding overseas research. It had to do 
with through the indirect costs that are associated with grants 
actually sending money to the Wuhan Institute of Virology when 
we don't know if they are doing gain of function research.
    Now, Dr. Collins, although you do mention that Moderna 
might not have had a problem with the transfer of IP to other 
countries regarding vaccines, I will tell you that the CEO of 
Pfizer certainly had a different opinion, and the CEO of BIO, 
the Biotechnology Innovation Organization, certainly has a 
different opinion about that effect. And I would ask unanimous 
consent to enter their statements into the record that oppose 
the transfer of intellectual property to other countries.
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    Mr. Harris. I am also concerned, Dr. Collins, because you 
are, you know, the researcher general of the country, that you 
would--I hope that you will take the position on the effect of 
H.R. 3, if it should become law, on the negative impact it 
would have on research. And I would ask unanimous consent to 
enter into the record a report from Vital Transformations, a 
group that would report on the devastating effect it would have 
on biotechnology research going forward since so much of our 
biotechnology research is funded by private companies, not by 
the NIH.
    Madam Chair, I ask unanimous consent that they be entered 
into the record.
    The Chair. So ordered. Sorry. So ordered.
    Mr. Harris. Thank you. Now, two other--just two very quick 
things. One is, is that I do worry about therapeutics. And, you 
know, we seemed to have solved the vaccine problem, but 
therapeutics are an issue because if variants become prevalent 
and our vaccines don't work against the new variants, 
therapeutics will be important.
    And I was a little concerned that BARDA has suddenly 
suspended their broad agency announcement. Of course, you know, 
the NIH is not BARDA, but there was no public explanation why, 
and some unofficial discussions indicated that the funding was 
being channeled to NIH. So I would hope that NIH and, Dr. 
Collins, that you share my concern for the vital importance of 
the private sector in funding our biotechnology research.
    And just a final question for Dr. Volkow. Just put plainly, 
is recreational use of marijuana in youth with a still 
developing brain a good idea?
    Dr. Volkow. No.
    Mr. Harris. Okay. So there is no new research that shows 
somehow because there is an acceleration among States of 
legalizing recreational marijuana, but there is no research 
that would indicate, new research, that it is actually not a 
bad thing. Is that right? There is no new research indicating 
that it is good for developing brains, for instance.
    Dr. Volkow. There is no research indicating that it is 
benign in young people, but there is increasing research 
indicating that it has deleterious effects.
    Mr. Harris. Okay. Thank you very much, and I yield back the 
few remaining seconds I have, Madam Chairman.
    The Chair. Okay. Yes.
    Congresswoman Lee.
    Ms. Lee. Chairman, this has been such an informative 
hearing, but, also, it gives me a lot of hope. It is truly life 
affirming, all of the work that you do.
    And I wanted to follow up with Dr. Gibbons on so many of 
the issues that we have been working with over the years 
because it relates to diseases that I have personal knowledge 
of that NIH has been so helpful in putting on the radar and 
conducting research. One is our COPD action plan. You all know 
my late mother died from complications of COPD, and I would 
like to know where we are with our COPD plan.
    Secondly, with the issue of multiple sclerosis, again, the 
research, where we are on MS in terms of a cure. And, of 
course, many of you know my sister has MS, and I have worked on 
this issue for many, many years.
    Finally, Dr. Gibbons, the whole issue around sickle cell 
disease, where we are in terms of a cure, and have we figured 
out how to address the sickle cell trait as it relates to HIV--
excuse me--as it relates to diabetes and how to identify those 
most, you know, prone to sickle cell trait and the A1C test.
    Dr. Gibbons. Well, thank you, Congresswoman.
    Again, I appreciate your leadership in this area. And, 
again, in the spirit of your mom, we are making continued 
advances in COPD. Our Top Med program of precision medicine 
where we have sequenced over 150,000 individuals has been a key 
driver, and where we are starting to identify pathways that may 
be driving COPD. We hope that will usher in a new generation of 
therapeutics.
    With regard to sickle cell, we are very excited about the 
opportunities. It is on the horizon to cure sickle cell 
disease. And we have made substantial progress in a number of 
trials now that are testing various curative genetic therapies 
that offer a lot of promise and have very encouraging 
preliminary results to suggest that we may be very much on the 
brink of a transformative kind of therapy to advance the lives 
of those living with sickle cell disease.
    Critical to your point about sickle cell trait, that if, 
indeed, we have a curative therapy, it will be critical that 
there be genetic counseling to identify early on who is at most 
risk and, eventually could be cured from this disease. Thank 
you.
    Ms. Lee. Thank you again.
    Thank you, Madam Chair, very much.
    Thank you all for this hearing.
    The Chair. Thank you.
    Ms. Lee. I yield back my time.
    The Chair. Congresswoman Herrera Beutler.
    Ms. Herrera Beutler. Thank you, Madam Chair.
    And, Dr. Volkow, just following up on what Dr. Harris was 
mentioning where you said you do see deleterious effects on the 
developing brain. To what age are brains developing, just so 
that I have an end point on that?
    Dr. Volkow. Our brain does not stop developing until our 
mid-20s.
    Ms. Herrera Beutler. Okay. So people who are legally 
allowed to purchase recreational marijuana are still possibly 
developing, and it can have a deleterious effect on their 
brains.
    Dr. Volkow. That is correct, and we are doing the studies 
to actually document how it negatively affects the brain.
    Ms. Herrera Beutler. Thank you. I wanted to ask, switching 
gears a little bit, in one of your blogs about the--and I am 
speaking fast to get it all in--monitoring our future survey 
for 2020, you--basically I wanted to see when we can expect to 
see results from the supplemental funds NIDA issued to research 
the impact of the pandemic on adolescence risk of substance 
use.
    Dr. Volkow. We already are getting some of the results 
back. For example, one of the questions that we had was the 
extent to which the COVID pandemic was going to negatively 
influence vaping, which has been taken up so rapidly by 
teenagers. And what the data seems to show is in some 
instances, when the parents are there at home, this has 
resulted in a decrease in vaping among teenagers overall. So 
that is one example.
    But on the other hand, we are seeing negative effects, for 
example, of alcohol drinking or smoking in those families where 
the parents actually themselves take these drugs, or they are 
not at home to observe the behavior of these teenagers.
    Ms. Herrera Beutler. Got it. Thank you.
    Dr. Volkow. We will get more data.
    Ms. Herrera Beutler. Thank you. I look forward to that.
    I am going to switch over, I think over to Dr. Gibbons. 
Yes. So acute and chronic kidney disease in children are 
often--well, maybe--maybe, which doctor--in children often 
differs from that in adults, both in its underlying causes and 
its treatments. There are not enough pediatric nephrologists, 
not enough pediatric researchers. And we continue to struggle 
to obtain funding for research proposals, or at least the ones 
that are out there do. Without this funding, children with 
kidney disease are not able to benefit from the resources that 
Congress allocates to NIH and NIDDK.
    So what is NIH doing to ensure that study sections have 
access to pediatric subspecialist reviewers who have the unique 
expertise required to review pediatric research proposals? And 
what other steps are you all taking to ensure research meets 
the needs of children with kidney disease?
    Dr. Bianchi.
    Dr. Collins. Dr. Bianchi is probably better positioned--
    Dr. Bianchi. Yes. So we have formed, actually, a trans-NIH 
Pediatric Research Consortium or N-PeRC, and that group meets 
every other month to discuss areas of shared interest. We 
happen to have a pediatric nephrologist on that committee. We 
also have a representative from the Center for Scientific 
Review. So the CSR knows that we are very interested in getting 
more pediatric reviewers onto the study sections. And by having 
a representative there, that person can hear what we are 
discussing. And we are particularly interested in adolescence, 
which is a gap area across NIH, and also the transition of 
adolescence to adulthood in terms of transferring their medical 
care. We have recently had a workshop on that whole issue. So 
it is a very active area of research.
    Ms. Herrera Beutler. Thank you. I yield back.
    The Chair. Thank you.
    Congressman Pocan.
    Mr. Pocan. Thank you very much, Madam Chair.
    Dr. Volkow, I have a question for you. In the last 
appropriations bill that we did, we added some language that 
said that the committee encourages NIDA to expand research on 
all health aspects of kratom. Specifically, we talked about 
people who may be abusing opioids, how it can help. We also 
directed some funds to the Agency for Healthcare Research and 
Quality, $500,000 to do such, and we have had some promising 
results come back on that.
    Just in the last month, the FDA did a major raid on a 
company in Florida on kratom using some old rhetoric that the 
FDA used to use in this area. I know there is no new guidance, 
there is no new head of FDA, but have you had any conversations 
with them? And there is also a letter that we just recently got 
access to from 2018 sent from the Secretary of HHS to DEA about 
kratom saying: Back off our early guidance. We were wrong. We 
need research on this.
    Have you had any conversations with the FDA or anything we 
can do because I do think there is some really strong results 
for people who are getting addicted to opioids that can be help 
by kratom, and now we are seeing the opposite actions happening 
again under the FDA?
    Dr. Volkow. We have not had discussions with the FDA during 
the COVID pandemic, but we did have them beforehand. We are 
very interested on the products, the chemicals that are within 
kratom, the most notable Mitragynine, which it has many 
interesting properties that could be of value potentially as 
medication for pain, but, also interestingly, it could also 
hold value as treatments for addiction. At the same time, we 
are aware that kratom can produce an addiciton in some 
instances and that it can have toxicity. Therefore, highlights 
why this is important to actually do research on the substance 
that people are taking. They are taking it for multiple things.
    Mr. Pocan. No. I appreciate that. If it would be possible, 
since the FDA doesn't have a technical head right now, to maybe 
reach out to them and let them know some of this because we 
really appreciate that great research work that you are 
advocating for right now. Thank you.
    Dr. Collins, isn't it true, I believe you updated the 
report in the last year that in the last now, I believe it was, 
decade every single drug approved by the FDA had NIH research 
support. Is that correct?
    Dr. Collins. That is correct. That was 100 percent of those 
drugs, and that was a study done by Dr. Fred Ledley and 
published in the Proceedings of the National Academy.
    Mr. Pocan. Yeah. I have got that document, and, Madam 
Chair, without objection, I would like to enter that into the 
record as well.
    [The information follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Pocan. And then, finally, very quickly, Dr. Collins. If 
you had 10, 20, 70 billion dollars more, literally, what would 
that mean as far as research, and what new areas would we be 
going to, in a very quick amount of time?
    Dr. Collins. What a lovely question. You know, a lot of it 
would be basically that we could provide for this amazing 
research workforce that is out there the opportunity to pursue 
all kinds of ideas that we currently can't quite get to. We are 
still only funding about one grant application out of five, and 
I know we are leaving really good science on the table when 
that happens. To be healthy, really, to take advantage of all 
that creativity, it ought to be at least one out of three.
    So that would be a big part of what I would do, and I would 
particularly focus on those early stage investigators. They are 
our future. They are the ones that are most vulnerable when 
things seem a little tight, and we would want to be sure that 
they felt this experience to be something that was going to be 
sustainable and, particularly, if they come from diverse 
backgrounds where we have this need, as we have been talking 
about in this whole hearing, to enhance the ability of all 
those different voices to come and join us, to make their 
careers out of biomedical research and for us to sustain them. 
That is what I would want to do is just make sure the whole 
landscape is advantaged by this kind of opportunity.
    Mr. Pocan. Thank you very much. And working towards that 
with DOD, but we will get back to you on it. And I yield back, 
Madam Chair.
    The Chair. Thank you.
    Congresswoman Cline.
    Mr. Cline. Thank you, Madam Chair.
    Let me start with a question for Director Collins. There 
was an NIH OIG report from January of last year that found that 
NIH resolved 262 of the 487 audit recommendations that were 
outstanding during fiscal year 2015 and 2016. However, it did 
not resolve about 63 percent or 166 out of the 262 
recommendations within the 6-month resolution period required. 
In addition, as of September 30 of 2016, NIH had not resolved 
225 audit recommendations that were past due for resolutions. 
Are you familiar with this report, Director Collins?
    Dr. Collins. This is a report about our IT systems and 
cybersecurity
    Mr. Cline. It is several different audit recommendations, 
but the OIG report, yes.
    Dr. Collins. So, yes, I am very familiar. And we have 
worked hard working with IG to respond to those. And I think 
actually a lot of work got done that doesn't necessarily get 
reflected in that report in that we inspired actions across the 
board. And the actual numbers now of responses would be 
considerably better than what you have seen there.
    So, yes. I think all organizations are struggling a bit 
with this. Many of us have had government agencies that have 
been around a long time, and the new era of cyber security is 
challenging us, and we are going to need more resources for 
that as well in order to try to be sure we are doing everything 
we can to keep the bad actors out of our systems.
    Mr. Cline. Well, I was pleased to find that a March 2020 
OIG report found that NIH successfully checks all applications 
to identify instances of duplicate grant funding. As funding 
levels are increased and new grants are established, the 
Federal Government does continue to grow. This dramatic 
increase in Federal spending is of great concern, and I am 
reminded of a quote by Milton Freedom, who said, nothing so 
permanent as a temporary government program. Can you answer 
what safeguards you are putting in place that work to eliminate 
duplicative funding for NIH?
    Dr. Collins. We have worked hard on that, Congressman, 
because we are in agreement. Every dollar that the taxpayer is 
providing, that you, the Congress, gives to us needs to be 
considered as something that we hold a great deal of 
responsibility for. We are able, through our now very much far 
advanced portfolio analysis system, to see exactly what is in 
our portfolio, what we are funding. And we can compare what is 
in our grant portfolio with other agencies, like the National 
Science Foundation, like ARC, like Department of Defense, 
identifying if there are instances where somebody is basically 
trying to double dip. And if we find those, obviously, we are 
going to take appropriate action. So I think I can reassure you 
that we are on top of that using a lot of the latest tools for 
doing text mining to discover things like that.
    Mr. Cline. All right. Thank you, Madam Chair. I yield back.
    The Chair. Thank you.
    Congresswoman Frankel.
    Ms. Frankel. Hello. Thank you again. I have a couple of 
questions.
    First, I think this would go to Dr. Sharpless. 
Gynecological cancers are impacting millions of women each 
year, yet I am told that we are experiencing declining NCI 
funding levels and that there is a very huge disproportionate 
amount between what is funded for, for example, prostate cancer 
versus ovarian, cervical, and uterine cancer. It is almost 
like--I will just give one example. Not that I want less for 
prostate cancer. That is not the point here. But $1.8 million 
per person, a year's life lost for prostate; ovarian, $97,000. 
So I guess really the question is, do we need more money for 
research for women's gynecological cancers?
    Dr. Sharpless. Thank you for raising the issue, and this is 
something we have looked at carefully. I share your concerns 
about, you know, funding major diseases like endometrial 
cancer, ovarian cancer, and cervical cancer. I think, you know, 
if you look at our GYN portfolio, there are some really strong 
areas of progress but also some areas where we need to see more 
attention. I would say endometrial in particular is an area 
that we have spoken to the community about and heard a lot 
about where I think we can do more.
    We have seen some really remarkable progress in these 
areas, you know. Our networks enrolled something like 675 women 
on GYN oncology trials. We have these specialized programs of 
research excellence, these large grants. And I think we have 
seven of those now dedicated to gynecological malignancies, 
including five in ovarian cancer. So I think that, you know, we 
have to take the opportunity to fund where the scientific 
availability is, but, you know, it is certainly an area that we 
are watching closely.
    Ms. Frankel. I hate to interrupt, but do you need more 
funding for that kind of research? That is the question.
    Dr. Sharpless. Well, you know, I think as I answered 
earlier, we have a lot of grants that we can't get to, you 
know, and we certainly have a lot of great gynecological 
malignancy grants in that pool of moneys that we are unable to 
get to. So, yes, I think more funding for gynecological 
malignancy research would be very much appreciated.
    Ms. Frankel. Okay. So, if you could just follow up with, 
like, an amount, that would be helpful.
    Dr. Sharpless. Sure.
    Ms. Frankel. I did have another question, Madam Chair, but 
I guess I don't really have time for it. There are only 32 
seconds. Okay. You are going to let me ask it. Well, here is 
the thing. No. I guess you are not going to let me ask it.
    The Chair. I am not going to let you ask it. I thought you 
were waiting for an answer from Dr. Sharpless.
    Ms. Frankel. Dr. Sharpless, do you want to answer that 
question? How much more do you need?
    Dr. Sharpless. Well, we will provide that to you, that 
number to you? Let us give it thought.
    Ms. Frankel. Okay. Thank you so much.
    Now I yield back, Madam Chair.
    The Chair. Thank you very much.
    Congresswoman Watson Coleman.
    Mrs. Watson Coleman. Thank you, Madam Chair.
    Tackling onto what Lois just said, I agree. I support 
additional resources in this area, particularly concerned about 
issues of the disparity in outcomes in health as it relates to 
some of these issues like uterine cancer, like cervical cancer, 
and its disparate impact on Black women; like sickle cell 
anemia, when are we going to be able to really be able to 
tackle this disease; and also maternal and infant mortality and 
morbidity. I just kind of want to lay them on the table. I know 
they are of concern. Some of them have been mentioned. I just 
need to know that they are a part of the priorities, even with 
all the competing needs and requests, that these issues of 
disparity in healthcare and in outcomes to minorities in 
particular are your top--are one of your top priorities.
    And, Dr. Collins, you can just answer for everybody.
    Dr. Collins. I can speak for everybody. Absolutely, yes, 
and you will see when the President's budget is fully fleshed 
out in a couple of days that health disparity research is going 
to be one of the most highly prominently featured areas that we 
want to do more.
    Let me just quickly ask Dr. Bianchi to say something about 
maternal mortality because we haven't talked about it at this 
hearing, and we have this program she can tell you about called 
INCLUDE, which I think is really important.
    Dr. Bianchi. No. IMPROVE, not INCLUDE.
    Dr. Collins. Yeah. That is right. I got the wrong acronym.
    Dr. Bianchi. Maternal Health and Pregnancy Outcomes Vision 
for Everyone, and this was in response to the meeting we had 
prepandemic with the Black Maternal Health Caucus, where we 
were challenged to do something, and, indeed, we did. And last 
time when I came to this committee in early March of 2020, we 
introduced it. But since then, we have funded over $7 million 
in grants addressing disparities in maternal morbidity and 
mortality, and we as an institute are very committed to this. 
We are the largest funder in maternal health research.
    And just as an example, in California, research that we 
funded implemented a quality improvement to address obstetric 
hemorrhage, which was an area of major disparity between Black 
women and White women. And by implementing 17 recommendations, 
the rate of severe morbidity in Black women went down by 9 
percent. So it had----
    Mrs. Watson Coleman. I know that there is a lot being done. 
I want you to know I need to give New Jersey a shoutout. Our 
first lady, Tammy Murphy, and our Governor, they have made this 
a priority in New Jersey. And I am sure they are looking for 
the funding, but they are also looking to be a model. Thank you 
so much, and I yield back.
    The Chair. With that, let me yield to the ranking member 
for any closing remarks as he would like to make.
    Mr. Cole. I am sorry, Madam Chair. It took a minute to 
unmute. You came to me faster than I anticipated. I am very 
happy to have the opportunity.
    First, I want to begin by thanking you for this hearing. It 
is wonderful to hear how many members on both sides of the 
aisle say, ``This is my favorite hearing of the year.'' And 
more profoundly, I want to thank you for your partnership over 
6 years in the majority and the minority in working to increase 
the resources available to the NIH.
    And I think your questions and some of the responses we 
got, certainly from Dr. Collins and others, showed what a 
difference this subcommittee has made by prioritizing this 
particular investment for the American people. It has saved a 
lot of lives, you know, in a variety of ways, but certainly in 
the pandemic that we have been going through.
    I am really proud of what this committee did, and I am very 
proud of what the NIH, more profoundly, accomplished in this 
year, not only for us but for all of humanity. Everybody in the 
world benefited from this investment. So I am pleased and proud 
about that.
    I also want to do something that is probably a little 
unusual. I want to associate myself with the remarks of Mr. 
Pocan. We don't agree on everything; we agree on this. If we 
could do additional resources here, that would be wonderful. 
Although, again, I really want to point out, I am very pleased 
with what the administration has proposed as a top line. I have 
some questions about how we should distribute those funds and 
whether ARPA-H should get, you know, exactly the amount we are 
talking about or we should put that to more traditional things 
and let this initiative grow, but those are matters of 
discussion and debate. They are not matters of disagreement. 
And so I certainly will be working hard with you to see that we 
reach these top lines because I think they are really important 
for the American people.
    I will disagree with my friend from Wisconsin on one thing. 
It shouldn't come at the expense of defense. And I just say 
this as an old historian. Look. The cost of great power rivalry 
in history is very high, and we should not underestimate the 
kind of world we live in today with China and Russia. It is a 
dangerous world.
    So we can debate, and we will in another forum, what is 
appropriate for defense. I don't think that investment there, 
whether it is as high as I would like or lower as others might 
prefer, should interfere with this investment because I think 
this investment is as important for the health and security of 
the American people as any other that we make.
    So I am going to be working with my friend, the Chairwoman, 
to try and get the maximum number here and certainly working 
with the administration where I have some disagreements, as I 
have expressed in other areas, but we don't disagree here. And 
I am very pleased to see the President actually, you know, 
frankly stepping up to Congress.
    My friend, the Chair, and I have talked about this before. 
Congress has been the leader in this area for, not a few years, 
but for generations. It has been Congress that has made these 
investments. I always tell people I think it is because we are 
at townhall meetings, and we interact more with people that 
tell us about their challenges in their family with cancer, 
their challenges with Alzheimer's or what they have seen a 
friend at church or at work or at their civic clubs go through 
in terms of chronic illness. And I think we feel that 
collectively, Republican and Democrat, very deeply, and I think 
that is why this committee has done what it is done over many, 
many years.
    And, particularly, though, I am proud of my association 
with you, Madam Chair, over what we have done in the last 6 
years. So I would just say, number one, thank you for the 
hearing. It is always a great hearing. Much more importantly, 
thank you for your commitment in this area. It is well known 
and widely appreciated on both sides of the aisle.
    And I want to thank Dr. Collins and his associates at the 
NIH. We really appreciate the work that you and your colleagues 
do. We really appreciate not just the immediate science but the 
thoughtfulness about what it takes to create an infrastructure 
of science, if you will, where we are attracting young 
researchers, where we are, you know, presenting people with the 
opportunities to good science.
    I think about what our good friend, Dr. Sharpless, said 
about cancer in particular. You know, it is a great thing to go 
from 8 to 11 percent, I guess, funding the proposals, but it is 
11 percent. None of us should be excited about that. I can 
assure you not every one of the proposals we didn't fund is 
good science, but a lot of them are, and we lose over 600,000 
people a year, 650,000, as I recall, to cancer. That is as much 
as COVID, you know. That is on an annual basis, and that is 
with a 65-percent recovery, rate which is something this 
committee in particular can be proud of when it is done, but we 
need to do more.
    So let me just end with this: What a great hearing. I want 
to thank all the members, you know. Their participation was 
great on both sides of the aisle. I want to thank you, Madam 
Chairwoman, for holding it. I particularly want to thank Dr. 
Collins and his colleagues at the NIH. I think most Americans 
probably don't realize what an extraordinary thing we saw in 
the last year. The idea that we could create in this country in 
less than a year multiple vaccines for a pandemic is an 
extraordinary achievement. NIH wasn't the only player in that, 
but they were the quarterback in the big game, and they were a 
major player all the way through. I particularly appreciate Dr. 
Collins pointing out how the previous investments of this 
committee over multiple years and multiple iterations of who 
was in control have really made a difference for the American 
people. This is something, and we have talked about this many 
times, Madam Chair, where we need sustained, annual, above-
inflation increases. We have achieved that all 6 years you and 
I have worked together. It is very much my hope we will achieve 
that again as we go forward. I think it is really in the 
interest of the American people, and, frankly, in this case, in 
the interest of all humanity because the engine of the NIH does 
a lot more than just help us here in this country. I think the 
best thing we can do, you know, diplomatically in terms of our 
geopolitical situation is just help people around the world. It 
is a wise investment, whether it is in foreign assistance, 
whether it is the science that is made available here. I do 
associate myself with my friends who are worrying about the 
decision to, you know, willy-nilly give away intellectual 
property. I personally think that is a mistake, but I think the 
instinct behind helping people beyond our own borders is 
something that we should be proud of and something an asset for 
our country.
    So, with that, Madam Chair, again, thank you for a great 
hearing. I am sorry I won't be with you tomorrow, believe me, 
in multiple ways, but I appreciate very much again this 
hearing. Not only this hearing, the sequence of hearings you 
have put together. They have been spectacular for this 
committee. And, with that, I yield back to my friend.
    The Chair. Thank you very, very, very much, and I will miss 
you tomorrow. I will miss you. And I thank you. I think you 
have, you know, laid out both how we sustain what is happening, 
how we really, in effect, utilize this opportunity to build 
that architecture for the future, you know, that we need 
because this is about the noble mission of saving lives. That 
is where we--you know, there isn't a greater goal or a mission 
of anything that we do at the Federal level as what is really 
accomplished through the NIH.
    I do believe that Congresswoman Lawrence is still here, and 
she didn't get a chance. If you had a quick question or a quick 
comment, Congresswoman Lawrence, because we need to wrap up.
    Mrs. Lawrence. Yes. I wish that the system hadn't gone 
down.
    I just want to express this concern, that I was so 
impressed at the response and all hands on deck when it came to 
fighting this virus. But as you have heard from multiple 
members, there is, for me, the impression that it is just 
business as usual with some very chronic diseases like cancer, 
hypertension, and other diseases that we know is what they call 
the underlying conditions. Where is it--is it more money 
needed? Is it the direction of leadership that we can keep this 
overall--Dr. Fauci, I mean, you led the way of not allowing any 
stone unturned, and I feel that our science in some of these 
critical diseases, dementia and others, we are not getting the 
same amount of a sense of urgency. Can you address that? Is it 
money? Is it--what is it that we need to do?
    Dr. Collins. So let me take a first stab at that, but Tony 
may want to add. I think you put your finger on exactly the 
reason why we think at NIH, there are two major things we need 
to push harder in this coming year: health disparities research 
being one, and mechanisms to be able to do that more 
aggressively, more nimbly, more in a different way of actually 
trying to achieve results. And that is where this ARPA-H model 
actually fits in. And I don't think I have said it until now, 
and I should have. ARPA-H also offers opportunities to pursue 
problems like the ones you are mentioning, the chronic 
illnesses, diabetes, hypertension, that cause health 
disparities, and we would aim to use that engine for that 
purpose as well. I have had many ideas already brought to me 
about what we might be able to do with that mechanism that our 
traditional method of grant giving can't quite achieve at the 
same timetable.
    Tony, I don't know if you want to add something because I 
think she really addressed the question to you.
    Dr. Fauci. Well, you know, Congresswoman Lawrence, it goes 
well beyond the NIH. So not to pass the buck to others, but I 
think it is important, what you point out, that the COVID-19 
pandemic has shown a bright light on these kinds of disparities 
which are really due to literally decades-long social 
determinants of health that start from birth. As you mentioned 
in a very articulate way in your presentation, from diets that 
are not available to people to not getting your hypertension 
diagnosed when you are young and to present when you have 
already scars of hypertension and renal disease and heart 
disease.
    There are things that we can do at the NIH, but I hope that 
the rest of the world and the rest of the country specifically 
realizes that this is a decades-long commitment to remove those 
social determinants that are really part, as Dr. Collins said 
in his opening remarks, part of the racism that has existed in 
this country for such a long period of time.
    Mrs. Lawrence. Thank you. I just want to say that we really 
need all hands on deck on this, and thank you for everything 
you have done with COVID. Thank you.
    I yield back.
    The Chair. Thank you. And let me just--I am just--I will 
wrap up, but I want to just say to my friend, the ranking 
member, Congressman Cole, I think about how blessed we are that 
we are serving in the United States House of Representatives, 
that we are part of an effort, and particularly with this 
subcommittee, where we have come together over the last several 
years and increased NIH funding by $12.9 billion, 42 percent 
over the last 6 years. We did it in a collaborative way. And it 
is not just to give lip service to being bipartisan, but it is 
genuinely understanding the value of the research that is done 
at the NIH.
    And, you know, we often think about we are in these 
positions, you know, and it is what you do with a position, 
that you come to understand why you come to serve. And I know 
why Congressman Cole has come to serve, and that is to make the 
institution work for the benefit of people that he represents, 
but for the entire country, and yes, in this context, for 
humanity.
    So it is really an honor and a pleasure to be able to work 
with him on these issues because there is such a commonality of 
purpose and, you know, a sense of a moral responsibility to be 
able to get these--to be able to get things done and to provide 
the resources that this committee has to be able to get these 
efforts underway and to fruition.
    I want to say a thank you. I would just say to you, Dr. 
Sharpless, I know that your sleepiness, you are staying up at 
night, I think it could be resolved and remedied by resources. 
So I think that that is what, you know, I picked up during the 
course of your exchanges with our colleagues today.
    But to all of our witnesses here today, it is exhilarating. 
I don't know how best to say it. It is exhilarating. And my 
hope and yours is that we are together next year in person. I 
believe that we will. And one of the reasons why this is the 
most important hearing, in my view, that we have is because 
what we do is we learn of the discoveries to cure that you are 
engaged in and what you are doing. What is it that we learn? 
What your future research will result in, what it can do. And 
we know that the resources that we provide for a specific area 
can, in fact, lead to the discovery in so many other areas. And 
it is all with the goal of saving lives. And as I said a few 
moments ago, there isn't any more important mission.
    I always say, you know, I represent, you know, a State that 
deals with helicopters. We deal with roads. We deal with 
bridges. We deal with all kinds of issues. But nothing is more 
important than the content of what is the subject matter of 
today's hearing. I will again repeat: The tremendous success of 
COVID-19, the mRNA technology. Listen. This is the biomedical 
research that you have been working on, and you never know. You 
can tell us better than we can tell you because we are not 
scientists. You never know where the years and the decades of 
basic research are going to take you, where the breakthroughs 
are going to be made. And in that context, I reiterate the 
importance of continuing to support sustained increases in 
funding for basic research at NIH. None of the successes that 
we have discussed today would be possible without that basic 
research.
    So, you know, I am excited about the administration's 
proposal to create ARPA-H. It is so promising. You know I have 
questions about how we avoid duplicating the efforts of 
existing NIH activities, how we balance investments with ARPA-
H, investments in basic research, and how the NIH will make the 
decisions about what the research is that we pursue. And we 
want you to make those decisions. You know that this has been a 
subcommittee that has tried very, very hard not to earmark, if 
you will, areas of research. That is not our jurisdiction. It 
really isn't. That is yours.
    So excited about the proposals that we know are going 
forward, and those proposals that are going to look at the 
health disparities which have been mentioned today, the 
maternal issues, and so many other critical areas. So I thank 
the witnesses not just being here today but for the commitment 
that you have made in your professional careers to focus on how 
we, in fact, yes, use your talent, your ability, use the NIH to 
save people's lives. Thank you.
    And, with that, I bring this hearing to a close. Thank you.
    Material submitted for inclusion in the record follows:
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                                             Tuesday, May 26, 2021.

FISCAL YEAR 2022 BUDGET REQUEST FOR THE CENTERS FOR DISEASE CONTROL AND 
                               PREVENTION

                               WITNESSES

ROCHELLE WALENSKY, M.D., DIRECTOR, CENTERS FOR DISEASE CONTROL AND 
    PREVENTION
ANNE SCHUCHAT, M.D., PRINCIPAL DEPUTY DIRECTOR, CENTERS FOR DISEASE 
    CONTROL AND PREVENTION
    The Chair. This hearing will come to order.
    As this hearing is fully virtual, we must address a few 
housekeeping matters.
    For today's meeting, the chair or staff designated by the 
chair may mute participants' microphone when they are not under 
recognition, for the purposes of eliminating inadvertent 
background noise.
    Members are responsible for muting and unmuting themselves. 
If I notice that you have not unmuted yourself, I will ask you 
if you would like the staff to unmute you. If you indicate 
approval by nodding, staff will unmute your microphone.
    I remind all members and witnesses that the 5-minute clock 
still applies. If there is a technology issue, we will move to 
the next member until the issue is resolved, and you will 
retain the balance of your time.
    You will notice a clock on your screen that will show how 
much time is remaining. At 1 minute remaining, the clock will 
turn yellow. At 30 seconds remaining, I will gently tap the 
gavel to remind members that their time has almost expired. 
When your time has expired, the clock will turn red and I will 
begin to recognize the next member.
    In terms of the speaking order, we will begin with the 
chair and ranking member. Then, members present at the time the 
hearing is called to order will be recognized in order of 
seniority; and, finally, members not present at the time the 
hearing is called to order.
    Finally, House rules require me to remind you that we have 
set up an email address to which members can send anything they 
wish to submit in writing at any of our hearings or markups. 
That email address has been provided in advance to your staff.
    With that, I would want to acknowledge Congressman Harris, 
who is serving as ranking member today for this hearing in 
Congressman Cole's absence. And I also want to thank all of our 
colleagues for joining.
    I am pleased to have the Centers for Disease Control and 
Prevention leadership back before the subcommittee to discuss 
the current state of the pandemic and our Nation's response and 
the President's budget request for fiscal year 2022 for the 
CDC.
    On February 23, this subcommittee held a roundtable session 
with CDC focused on the COVID-19 response, and, a day later, we 
held a hearing focused on public health infrastructure.
    Since that roundtable and hearing in February, our Nation's 
response to COVID-19 has made significant advancements. 
Vaccines are now widely available. One vaccine is now approved 
for those age 12 and above. Nearly 300 million vaccine doses 
have been administered, including nearly 4 million in my home 
State of Connecticut.
    Last week, we heard from the Yale New Haven Health System 
that they are now treating a, and I quote, ``staggeringly 
small'' number of COVID patients. This is a tremendous 
accomplishment. Our public health workers are finally able to 
sleep again. Our families are finally breathing a sigh of 
relief. And our workforce and our economy are beginning to 
rebound.
    But the messages from the public health infrastructure 
hearing in February were clear. COVID-19 exposed numerous 
realities in our Nation, including that our Nation's public 
health infrastructure is extremely fragile.
    Many health departments are still using fax machines or 
doing data entry by hand. Information about patients' names, 
sex, or pregnancy status are not being shared across 
departments. Health workers are leaving the field in droves, 
while others need workforce development. And our research labs 
are struggling to find the equipment, capacity, and trained 
workforce they need.
    But, now, communities are realizing that our public health 
partners are essential, not only for infectious diseases but 
for health promotion and protection to keep our communities 
healthy and functioning. Our Nation's public health system can 
no longer only get attention during a crisis. We must invest in 
the public health workforce, laboratories, and data 
modernization, not just to respond to the pandemic but every 
year.
    After this pandemic is over, our public health agencies 
cannot go back to where they were. We need to meet this moment 
and build a public health architecture to move our public 
health partners and workforce forward. Today's hearing is the 
next step in turning those recommendations into action.
    While we will not receive the details of the President's 
budget until later this week, we know from the budget blueprint 
that the administration is requesting $8,700,000,000, an 
increase of $1,600,000,000 over 2021 enacted, for the CDC. The 
administration has described this request as, and I quote, 
``the largest increase in budget authority for CDC in nearly 
two decades.''
    But, while this is a very welcome increase, I think in 
general we need to consider increasing investments for the CDC 
not just this year but every year. As I have said many times, 
one-time investments do not ensure the CDC and our public 
health departments are ready to address chronic challenges.
    And we need to ensure our public health infrastructure is 
ready to address the challenges or pandemics of the future. 
This COVID-19 pandemic has only further underscored the need to 
view public health infrastructure as a fundamental service, not 
just something we fund when the need arises. The tide has 
turned. We need to start providing funding to address core 
public health activities.
    While I look forward to receiving detailed requests for 
CDC, the programs highlighted to receive increases in the 
summary released in April are very welcome: maternal mortality 
prevention, firearm injury and mortality prevention research, 
climate and health, social determinants of health, and the 
establishment of a new community-based violence intervention 
program.
    In terms of gun violence research, I am particularly 
interested in getting a progress report. I know it may be too 
early, but I hope that you can let us know a little more about 
the status of gun violence research and what we have learned.
    In terms of maternal mortality prevention, I also want to 
say that I am pleased to see increased investments in research 
on maternal health to address the crisis of maternal mortality 
in the U.S. We absolutely need to make this a nationwide 
effort. Not one more mother should die just for participating 
in the miracle of birth.
    I also think the increased funding for research on how to 
reduce racial and ethnic disparities in maternal health 
outcomes and improving maternal mental health is particularly 
crucial.
    I might add that, 2 weeks ago, the CDC made a significant 
update to its guidance: that fully vaccinated people no longer 
need to wear a mask or physically distance in most situations.
    Dr. Walensky committed to leading the CDC with science, and 
I know that we will have a lot of questions about the current 
scientific evidence that led to this updated guidance and the 
subsequent guidance that we are all awaiting to be updated by 
CDC.
    I know that many people I have spoken to are still 
uncomfortable with this change and are not confident that being 
around people who are unmasked is safe. There is still a lot of 
uncertainty about the nuances that may be implied in such 
guidance.
    Throughout this pandemic, CDC has been in the unenviable 
position of making black and white recommendations in a world 
of gray areas. So I think it will be helpful to drill down on 
what this guidance means and how we can continue to restore 
public confidence in such guidelines. That is why I greatly 
look forward to today's discussion.
    Now, let me turn to my colleague, Congressman Harris, for 
any opening remarks that he may have.
    Mr. Harris. Thank you very much, Madam Chair.
    And good morning, Dr. Walensky. Thank you for coming before 
the subcommittee this morning.
    Before I begin, I want to recognize the outstanding work 
and careers of Drs. Anne Schuchat and Nancy Messonnier, two 
longtime CDC physicians who have both recently announced their 
departures. I want to thank both of these remarkable scientists 
for their public service, dedication, and commitment to public 
health, especially during the COVID pandemic. You will both be 
missed.
    Just over 14 months since the COVID pandemic began, it is 
finally winding down in America. I think it is worth 
recognizing once again the stunning success that rapidly 
bringing a COVID-19 vaccine to market has had on the trajectory 
of this disease in America.
    The COVID-19 vaccines are the most quickly developed 
vaccines in history, thanks not only to the skill of 
researchers at Pfizer, Moderna, and other manufacturers but 
also due to the work of Operation Warp Speed under the previous 
administration. Operation Warp Speed set our country up for the 
outstanding results of our current vaccination efforts.
    It has been a pleasure for me personally to lend a hand to 
help get Marylanders vaccinated, and I continue to encourage to 
get everyone vaccinated as soon as they can. The vaccines are 
relatively safe and effective and are enabling us to resume our 
normal lives quickly.
    On that note, I was glad to see that the CDC finally began 
to follow the science and recognize that vaccinated individuals 
can safely resume activities. Studies have shown for months 
that vaccines are effective and that outdoor transmission is 
almost nonexistent.
    I continue to question why the CDC resisted making these 
statements for so long, why many of our schools continue to be 
closed, why the mask mandate continues in the House of 
Representatives, and why children at outdoor camps this summer 
need to wear a mask.
    One wonders whether pressure from teachers' unions and the 
need to distract from other difficulties facing our Nation, 
such as growing inflation, spiking gasoline prices, renewed 
conflict in the Middle East, have influenced this public health 
guidance on schools. I certainly hope this is not the case, but 
the timing and information about the influence that teachers' 
unions had on CDC guidance are troubling.
    A key part of our transition back to normalcy will rely on 
fully reopening our schools. Census data shows that 50,000,000 
working Americans have children who are school-age or younger. 
For many of these individuals, schools are the primary form of 
childcare. As such, it is imperative that all schools fully 
reopen immediately, not only so parents are not forced to 
choose between working and caring for their children but also 
so that the children can continue learning in the best 
educational environment.
    Children with disabilities and those without as many 
resources at home have been robbed of over a year of academic, 
social, and emotional growth during this pandemic. But the 
science is clear: We need to bring these children back into the 
classroom now.
    These are important issues to discuss, and I am sure there 
will be questions about them this morning, but let me briefly 
touch on the fiscal year 2022 budget request before I conclude 
my remarks.
    The fiscal year 2022 request contains the largest budget 
authority increase in CDC in nearly 20 years. You are asking 
for funding to enhance State and local public health 
infrastructure as well as to build international capacity to 
detect and respond to emerging global biological threats.
    I support many of these efforts. As an obstetric 
anesthesiologist, for instance, I especially support the focus 
on reducing maternal mortality and morbidity. But I do question 
the magnitude of these increase in a single year, especially 
when overlaid on top of the billions of dollars provided in 
emergency COVID relief bills last year.
    I also question whether some of the funding items 
highlighted in your request are outside of CDC's core mission. 
For example, the budget will request double the amount of 
funding for firearm prevention research.
    You are also asking for $110,000,000 for CDC's Climate and 
Health Program, a 1,000-percent increase, to, quote, ``identify 
potential health effects associated with climate change and 
implement health adaptation plans.''
    Are these kind of activities in the same priority category 
as combating COVID or other chronic diseases that threaten our 
most vulnerable populations or reducing antibiotic resistance? 
I would argue that they are not and that we should focus our 
CDC resources on communicable and chronic diseases rather than 
on controversial, politically charged activities.
    I look forward to the hearing this morning, and I yield 
back the balance of my time.
    The Chair. With that, we would like to again welcome and 
introduce our witnesses: Dr. Rochelle Walensky, Director, 
Centers for Disease Control and Prevention.
    Good morning and welcome, Dr. Walensky. And many, many, 
many thanks for the outstanding work that you have been doing 
and really using science as your guide, particularly with 
regard to COVID and the manner in which we should proceed. And 
we are grateful for that guidance and, really, returning the 
CDC to, really, its former past in being drivers of science and 
letting the CDC, and not politics, engage in the direction that 
we take a pandemic or any other illness.
    Dr. Anne Schuchat, Principal Deputy Director, Centers for 
Disease Control and Prevention.
    And as my colleague has mentioned, you recently announced 
your plans to retire, Dr. Schuchat, after 33 years at the CDC. 
I say thank you to you for your dedication, for your public 
service. We have been many times--whether it was Ebola or 
whether it was the lead poisoning of our children in Michigan 
and other areas, you have had a stellar career. And we are 
delighted to have you once again before this subcommittee.
    And, Dr. Walensky, your full written testimony will be 
included in the record. You are now recognized for 5 minutes 
for your opening statement.
    Dr. Walensky. Good morning. Thank you very much. Good 
morning, Chairwoman DeLauro, Dr. Harris, and distinguished 
members of the committee. Thank you for your support of CDC.
    I am here today, as you note, with Dr. Anne Schuchat, CDC's 
Principal Deputy Director. I have enormous gratitude for Dr. 
Schuchat's leadership and contributions over three decades as 
well as during this very challenging time for our country and 
for her rock-solid support of me in my transition into this 
role.
    Anne embodies selfless public service, the pinnacle of 
scientific and intellectual standards, and has given her heart 
to our agency and to the public health community. I will be 
forever grateful that I had the opportunity to work with Anne, 
even if just during this brief period of time.
    The COVID-19 pandemic threw the United States and the world 
into a health, economic, and humanitarian crisis. As the crisis 
unfolded, it put a spotlight on the fragility of our public 
health infrastructure. It illuminated great disparities in 
health outcomes by race and ethnicity, reminding us that, thus 
far, we have failed to address the systemic racism that results 
in poorer health for people of color in the United States.
    I am committed to working with you, the administration, and 
our public health partners to ensure that every lesson from 
this horrible crisis is used to build a better, stronger, 
healthier America. I also commit to using our public health 
expertise and experience, in partnership with the global 
community, to move the world into a safer, healthier future.
    CDC's fiscal year 2022 discretionary budget request of 
$8,700,000,000 is an increase, as noted, of $1,600,000,000 over 
fiscal year 2021, the largest increase CDC has received in 
nearly 20 years.
    The increase is focused on four critical areas: building 
public health infrastructure, reducing health disparities, 
using public health approaches to reduce violence, and 
defeating diseases and epidemics. These increases build on the 
investments made in the COVID-19 supplements and are an 
important first step in addressing deficits in the public 
health infrastructure.
    COVID-19 not only exposed the vulnerability within the 
United States' public health infrastructure but also how 
underlying chronic conditions and lack of access to healthcare 
put too many Americans at great risk. Across the globe, we see 
billions of people without access to vaccines and medical care, 
which means that SARS-COVID-2, its variants, and other 
infectious disease threats will continue to threaten us all.
    Experts had warned for years that a pandemic of this scale 
was coming, and we must expect additional diseases to emerge. 
We need to ask ourselves, are we ready? We must have a strong 
infrastructure that can identify and detect outbreaks at their 
source and take quick action before they take hold.
    Over the last 12 years, the United States has faced four 
significant emerging infectious diseases threats: the H1N1 
influenza pandemic, Ebola, Zika, and now COVID-19. We are also 
confronting an overdose epidemic, a drug overdose epidemic, 
with nearly 500,000 people dying from an opioid-related 
overdose between 1999 and 2019. The increase continued in 2020 
and appears to have accelerated during the COVID-19 pandemic.
    These experiences show that public health emergencies are 
here to stay. Each of these threats demanded a rapid and unique 
response, but none resulted in the sustained public health 
improvements we need.
    Long-term investments in public health infrastructure, 
flexible infrastructure, will save lives and avert economic 
losses caused by public health emergencies and chronic public 
health problems.
    The fiscal year 2022 request makes initial investments to 
continue public health data modernization, build the public 
health workforce, enhance global health security, and 
strengthen our immunization infrastructure.
    In addition, we are requesting funds to help States and 
communities be climate-ready and prepared to confront new 
health risks, such as those associated with vector-borne 
diseases.
    The fiscal year 2022 request also makes specific 
investments in programs that work to improve health equity, 
such as maternal mortality review committees.
    With new resources outlined in this request, CDC will also 
significantly expand efforts to address the social determinants 
of health. Proposed increases will address public health 
problems that have been exacerbated by the pandemic, such as 
opioid, injuries and violence, HIV, and sexually transmitted 
infections.
    We at CDC are grateful for your support and look forward to 
working together to build a sustainable, resilient public 
health system that can respond effectively to emerging threats 
and meet the public health needs of every American. We will 
work tirelessly to ensure the health of this Nation and the 
world.
    Thank you. Dr. Schuchat and I very much look forward to 
your questions.
    [The information follows:]
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    The Chair. Thank you very much, Dr. Walensky.
    I also might add, before I get to my question, that when 
you spoke about the work done by CDC with the vaccine, et 
cetera, I also want to mention--because yesterday we had the 
NIH appear before the committee for their budget hearing. And 
it was remarkable that the achievements that you have made 
were--you know, this was possible not only by targeted 
investments in COVID research but, I believe, also--and I think 
that the subcommittee agreed yesterday on a bipartisan basis--
also by the annual and the sustained investments in biomedical 
research made by this committee over the years, which was over 
$650,000,000 in basic research on coronavirus that helped us to 
be able to move as rapidly as we were able to. And, again, 
thank you for your outstanding work in this area.
    I have a question for you, Dr. Walensky, and I will also 
ask Dr. Schuchat to respond to it.
    It is clear to me that our Nation's public health agencies 
cannot go from crisis to complacency to crisis. We can't think 
about public health agencies just during the crisis, about 
thinking about the infrastructure of our public health system.
    In your opinion, what COVID-related lessons and response 
efforts need to be sustained post-pandemic that public health 
agencies, including CDC, as well as State and local health 
agencies, are better positioned every day to support the health 
of our communities?
    When we did our hearing, our health partners testified 
about core needs--public health data, workforce, laboratory--
that are not specific to one disease or activity. Do you agree?
    Dr. Walensky. Thank you, Chairwoman DeLauro.
    First, let me say congratulations to you and the State of 
Connecticut for all of your extraordinary work----
    The Chair. Thank you. Thank you.
    Dr. Walensky [continuing]. On getting the vaccine rolled 
out. You have been a beacon example. Thank you to you and the 
State. That has been extraordinary.
    Maybe I will just jump off of where you started with this, 
which is the NIH, and just comment that what we are looking for 
in the CDC budget is something very similar to what has 
occurred with NIH, and that is long-term, longitudinal, 
sustainable increases.
    And maybe I will just highlight that there is evidence 
that, once a scientific study has been published, that by the 
time it gets to the community, the core community, in the rural 
South, in the urban settings, that it can take up to 17 years 
before it gets from the scientific data to a guidance, to 
training doctors, to reaching people in hospitals, to then 
reaching people in the core community. It can take that long. 
And that is the work of what public health can do. And that is 
why we need the sustainable resources.
    I think the buckets that you have just described are 
exactly where we need to be on what we have learned where we 
were fragile in the COVID-19 pandemic.
    Our workforce. We need an upskilled, trained workforce that 
is diverse both in discipline and in background coming from the 
communities that they are going to serve. We know that, over 
the last decade, when we have had all of these infectious 
threats, that we have lost over 60,000 public health jobs. We 
also know that about a quarter of our public health workforce 
is eligible to retire. So we now need a data-savvy, skilled 
workforce that works at State health departments, local health 
departments, and, in the communities, community health workers 
to reach the people that they serve.
    We need to bolster our public health labs. When we started 
in this administration, we were doing less than 3,000 samples 
of genomic sequencing a week. We are now up to 35,000 samples a 
week. We didn't have the infrastructure in the lab to be able 
to bolster that.
    And then, finally, as you note, the data modernization and 
the need--you mentioned the faxes, the personal data entry, the 
need to bolster our data to make sure it is interoperable 
across different health departments, across different States, 
and up to the CDC.
    The Chair. Okay.
    Dr. Schuchat, would you like to please comment? Thank you.
    Dr. Schuchat. Thank you so much. And thank you for your 
kind remarks.
    Just to, of course, agree with Dr. Walensky about the 
priorities, I would just add that we live in a global world and 
that COVID has taught us that a threat anywhere is a threat 
everywhere.
    We were not as prepared as we thought we were here. And we 
know that every Nation needs that capacity to prevent, detect, 
and respond adequately. And we need systems that can surge 
rapidly. And we need to work together on that.
    I regret that I will be 33 years at CDC, leaving with a 
public health infrastructure that is not stronger than when I 
got here. When I look at the NIH and the enormous improvements 
in biomedical research capacity that we have seen, I wish that 
we have seen the same kind of strengthening of our public 
health capacity.
    Because I think we have all seen that, regardless of the 
fantastic scientific breakthroughs, if we don't have that 
frontline workforce and we don't have a nimble and resilient 
system, if we don't have data systems that surge and are faster 
than the threats we are facing, that we are all vulnerable.
    So I hope that the incredible investments in COVID will be 
extended for the other threats that are out there.
    The Chair. Just a quick followup. We included in the 
emergency supplemental last year expediting the modernization, 
the data modernization initiative. Just very quickly, can you 
give us, you know, any kind of a progress update on the 
multiyear initiative?
    Go ahead. Dr. Walensky.
    Dr. Walensky. Sure.
    You know, this has been something that we knew we needed to 
address early on. And we are now working across--so, for 
example, the electronic health records that we were able to do 
in COVID, we were able to bridge test results with electronic 
health records from Cerner and Epic to be able to gather more 
date in a HIPAA-compliant way.
    So all of these systems have been bolstered very much. We 
have had to move quickly through the COVID-19 pandemic. But we 
really do need to work with our health centers, our public 
health workforce, bioinformatics and information through the 
private sector. And all of that work is actively ongoing.
    The Chair. Thank you.
    My time has expired. So, Congressman Harris, please. Sorry 
I went over time. Go for it, Dr. Harris.
    Mr. Harris. Thank you very much.
    And, you know, one thing that is important is that the 
public have trust that science is behind decisions made by CDC 
and public officials.
    So the first question I want to get out of the way quickly 
is that--Dr. Walensky, are you and Dr. Schuchat in the same 
room?
    Dr. Walensky. We are.
    Mr. Harris. You are. And neither of you have masks on.
    So what I am going to ask you is--you know, if we were 
conducting this hearing in a House committee room, we would all 
have to wear masks, whether we were vaccinated or not, because 
that is the ruling of the Speaker. In fact, in the House 
Chamber, we have to wear masks.
    I have a very simple question. Did the Speaker or the 
Attending Physician of the House consult with you or anyone 
else at CDC before coming up with that policy--a policy that, 
by the way, results in a fine of up to $2,500 for someone who 
is not wearing a mask who has been vaccinated.
    Did they consult with you?
    Dr. Walensky. We put our mask on till about 2 weeks ago 
to--that spoke to the science about individual risks, and, in 
fact, those decisions have to be made locally. So our guidance 
was data-informed, scientific----
    Mr. Harris. Did they consult with you before coming up with 
the House policy?
    Dr. Walensky. We have been in contact with both the Capitol 
Physician as well as the Speaker's office.
    Mr. Harris. So they consulted with you about this policy?
    Dr. Walensky. There has been--we have been in dialogue----
    Mr. Harris. That is a simple question. Before they came up 
with the policy, which is a new policy now, that 100 percent of 
people have to be vaccinated before anybody takes a mask off, 
did they consult with you about science behind that policy?
    Dr. Walensky. The science that we put in our guidance is 
related to the science of individual risk. And then the 
decisions have to be made at the local level with data that we 
do not have access to.
    Mr. Harris. Dr. Walensky, that is not responsive. And, you 
know, I am actually puzzled by why you are not--it is a simple 
``yes'' or ``no'' answer. Did they consult with you?
    This is why America doesn't trust public health officials. 
This is why America doesn't trust elected officials. Because I 
can't get a straight answer about whether the Speaker of the 
House and Attending Physician consulted about the latest change 
in policy, which is that 100 percent of Members and staff have 
to be vaccinated before anyone takes their mask off.
    Let me turn to the problem with schools. Is it true that 
the teachers' unions helped drive the CDC policy on reopening 
schools?
    Dr. Walensky. As a matter of practice within the CDC, we 
engage with many partner organizations related to any guidance 
that we have put out. So it----
    Mr. Harris. Okay. So it is just coincidence that the 
wording of the guidance pretty closely mirrors some of the 
discovered communications between the teachers' union and CDC?
    Dr. Walensky. We engage with many partners. I spoke to 
teachers, I spoke to parents, I spoke to many people before 
that guidance came out. And what became clear in some of those 
discussions is that there was a piece missing.
    The teachers were asking for, what happens if we have a 
teacher who is immunosuppressed? How do we act if we have a 
teacher who is immunosuppressed or a family member of that 
teacher who is immunosuppressed?
    That piece was missing from our original document. With the 
feedback, we were able to include science-based 
recommendations.
    Mr. Harris. Okay.
    Now, the other thing that--and, again, I appreciate we 
discussed at some length yesterday on the telephone the need 
for people who have had prior infections to be vaccinated with 
two vaccines, if they are receiving Pfizer or Moderna, despite 
the evidence that there is a--first of all, that there is a 
good T-cell response following natural infection, whether 
symptomatic or asymptomatic. That information has been out 
there for months. And a recent study by the Penn Institute of 
Immunology indicated that there is a very robust response after 
only one additional vaccine.
    So, given that these are still experimental vaccines, these 
are under emergency-use authorization, would it be reasonable 
to begin looking at saying that people who have had disease 
should either have tests for antibodies or T cells or should 
only get one vaccine if they are in a two-vaccine regimen?
    Dr. Walensky. Dr. Harris, I think you bring up one of the 
things that is going to be the Holy Grail of this, and that is, 
what are the correlates of protection, both in the T cells as 
well as the B cells?
    As we had the pleasure of discussing the other day, we 
don't have great correlates of protection in either of these. 
And, in fact, we can easily measure antibody response. We don't 
even have a good measurement of T-cell response right now.
    When we get those measurements that we can use in a large-
scale public health sort of way----
    Mr. Harris. So the Oxford--and I only have a few seconds 
left. The Oxford Immunotec test, which, unfortunately, FDA has 
put on the back shelf for evaluating for EUA but is licensed in 
England, is not a good test?
    Dr. Walensky. I am saying it is not applicable that we can 
use now in a public health way to make a decision about whether 
somebody who is sitting in front of us should get vaccinated or 
not.
    Mr. Harris. Sure.
    Thank you. I yield back.
    The Chair. Thank you.
    I would just like to make a comment. I am looking at a 
document that is dated May 13, 2021, and this was a major 
speech made by the American Federation of Teachers president, 
Randi Weingarten, where she says, ``There is no doubt: Schools 
must be open, in person, 5 days a week, with the space and 
facilities to do so. We know that is how kids learn best and 
that prolonged isolation is harmful. Educators have yearned to 
be back in school with their students. They only ask for two 
things: a safe workplace during this pandemic and the resources 
they and their students need to succeed.''
    With that, I am going to recognize Congresswoman Lee. But I 
am going to step away for a moment to pose a couple of 
questions to Secretary Mayorkas in the Homeland Security 
hearing, and Congresswoman Lee will take over the gavel while I 
am gone. I should be back in short order.
    So, Congresswoman Lee, you are recognized.
    Ms. Lee. Thank you very much, Madam Chair.
    And thank you to Dr. Walensky for your testimony and also 
for your leadership in declaring that racism is a public health 
threat.
    And also to Dr. Schuchat, thank you so much for your 30 
years of service and your commitment to public health. We are 
going to miss you, but you have really made your mark. So thank 
you so much.
    Let me ask Dr. Walensky, with regard to the whole issue of 
structural racism and public health--it is undeniable, so, 
again, thank you for the declaration.
    We have to work together to ensure that our healthcare 
systems work to confront and dismantle the racist systems and 
practices that perpetuate racial disparities. And so 
Congresswoman Ayanna Pressley, Senator Warren, and myself, we 
introduced the Anti-Racism and Public Health Act, which calls 
for the development of a national center for anti-racism at the 
Centers for Disease Control and Prevention and also a law 
enforcement violence prevention within the National Center for 
Injury Prevention and Control at the CDC in coordination with 
the Department of Justice.
    Now, the President has included $100,000,000 for CDC to 
start a new community-based violence prevention--or violence 
intervention initiative. And so in what other ways are you 
going to ensure the interagency and interdepartmental 
collaborations and accountability to really begin to address 
and dismantle racism in public health? And is this $100,000,000 
appropriate to use to begin to establish some of these programs 
that we have laid out in our legislation?
    Dr. Walensky. Thank you so much, Congressman Lee, and 
really to you for your extraordinary leadership in this area. 
As I think you know, I have history in my work in HIV, which is 
where this interest for me had started, and I know you share 
that interest as well.
    As you know, about a month ago, we declared here at CDC 
racism as a serious public health threat. Through COVID-19, we 
very much saw that: 0.8 years of life lost for people who are 
White, 1.7 years of life lost for people who are Hispanic, and 
2.9 years of life lost for people who are Black in this country 
due to COVID-19. Truly extraordinary years of life lost. And 
that has, you know, opened the door for us to be able to do 
that for everybody else to see what you and I have been seeing 
for years, that health is different for people of color in this 
country.
    One of the things I charged my agency with, my center 
directors with, when we made this declaration is to say, yes, 
we have documented the problem in all sorts of different kinds 
of screening mechanisms and in all sorts of different care, we 
have documented that these are disparities in care; I want to 
now do something about it.
    So I have asked each of my agency center directors to plan 
an intervention for the next year, a measurable intervention, 
that will show impact in how we can improve health in people of 
color in this country.
    And among the areas where we are going to be using these 
resources is deep in these communities. It is among the reasons 
that we need community workers, to understand the impact of 
what is happening in those communities and understand how we 
can reach them.
    And I really look forward to seeing what our center 
directors are planning and what they find.
    Ms. Lee. Thank you.
    And one thing I am working on, Dr. Walensky, is the issue 
of the lack of Black men in medicine and behavioral health 
professionals. And so anti-racism strategies have got to be 
integrated into all areas where we see shortages of people of 
color.
    And so I am wondering, as you move forward on this, how are 
you looking at putting these strategies together, across the 
board, everywhere within your authority?
    Dr. Walensky. You know, one of the things I think that is 
so important is that our workforce be diverse, both in their 
expertise as well as in their background and the communities 
they serve. They need to come from the communities they serve.
    I had the great pleasure of being in rural Georgia last 
week talking to a rural community, and I said, ``How are you 
doing at vaccination?'' And they said, ``Well, it didn't work 
when they sent in the National Guard.'' They trust the local 
firefighter, right? These communities trust the people who have 
been in the communities, from the communities.
    I have seen that in working with community health workers 
in my own HIV work back in Boston. They trust the people from 
their community. It has to be at every single level of 
expertise.
    Ms. Lee. Okay. Thank you.
    And, finally--I have a few seconds left--let me just ask 
you as it relates to sterile syringes. We know it is the most 
effective intervention to prevent the spread of infectious 
diseases. And so how are those syringe service programs 
working? And how are we encouraging organizations, healthcare 
entities, to use this program, syringe service programs?
    Dr. Walensky. You know, the opioid crisis is a real 
challenge. It had been a challenge before the pandemic. It 
continues to be a challenge, both with--and, in fact, was 
exacerbated by the pandemic, both in terms of infectious 
threats that are transmitted through injection use--and so, 
yes, we are working closely to embrace the sterile syringes 
under the context of the law and what we are able to do. And we 
are really looking forward to moving forward with you.
    Ms. Lee. Thank you very much.
    I guess our chair--I will yield back to you now, Chairwoman 
DeLauro. You made it back.
    The Chair. Congresswoman Herrera Beutler.
    Ms. Herrera Beutler. Thank you, Madam Chair.
    And thank you both for being here and for your service.
    I think my question is for you, Dr. Walensky. And I think 
part of my challenge is, it is all based around how we are 
treating children in this pandemic.
    You know, there is a large amount of discussion around 
school reopening, but I hear from parents in my parent whose 
children are being forced to quarantine for long periods of 
time beyond CDC guidance, which ultimately interrupts their 
learning.
    And, in some cases, a medical provider is not allowed to 
clear a child to return to school. And throughout your guidance 
for school reopening, the CDC has encouraged students and 
parents to talk to their healthcare providers, but it seems 
like their opinions are being overlooked, which is hugely 
disappointing.
    So, on one hand, I want to make sure that you are 
communicating, and I wanted to ask what you are doing to 
communicate down through the levels to the local level that can 
provide some of this guidance.
    But then I think the broader observation that I have is, I 
do think we are getting so many mixed messages. It is very 
difficult to have one source of information. You know, I saw a 
story in The New York Times from a week or two ago that said 
that CDC's benchmark for outdoor transmission was about 10 
percent, which, if you dig down on the science on that, it is 
really--leading doctors will say it is actually less than 1 
percent. So to say 10 percent is not inaccurate; it is just 
really imprecise.
    And so, when you have this kind of muddle of information 
flowing around, it causes some real challenges on how do we 
provide leadership in our communities with regard to what to 
do.
    That brings me to the next point, which is masking in 
children. I brought this up yesterday. I think children have 
disproportionately borne the isolation burden throughout this 
whole pandemic, whether it is learning loss through school, 
interaction with one another, especially children in the 
younger grades who are learning to talk, who are learning to 
interact, whose social and emotional interaction is really what 
is at stake.
    You know, I saw some remarks from--I am not going to say 
his last name right, so I am not going to try--a doctor from 
Stanford, but I can provide you his name--I just don't want to 
butcher it--citing studies from Sweden and the WHO, who 
recommend in The Wall Street Journal that we avoid masking kids 
up until at least age 11 because they are at low risk for 
infection and the very real hazard is stunting their 
development.
    And yet our only recommendation at this point is, kids, 
young kids, you are going to have to continue to mask. As we 
are lifting this burden on everyone else, we are going to make 
you do it. We are even going to make you do it outside, where 
there isn't a single documented, you know, infection instance 
anywhere in the world from that casual outdoor interaction.
    So I wanted you to speak to--because science, science, 
science is our base, right? That is what you said; that is what 
the chair said. I believe that. But the science doesn't show 
that children are at high risk. And a CDC study from last July 
shows that they are not at high risk for spreading it either, 
when we are talking about, you know, about 2 to 7, 8, 9, right?
    So why are we making the kids bear this burden?
    Dr. Walensky. Thank you, Congressman.
    First, maybe I will acknowledge two important things. One, 
I have three kids myself. One has been home all year. I 
understand the challenge. I deeply understand the challenge.
    And maybe the second is the complexity of managing guidance 
and information and providing it to the public when it is 
changing and when it is evolving and when we are learning so 
much so quickly, and how we are able to evolve our guidance in 
the context of that.
    And I think you are highlighting something that is really 
important. This is complex. And as we change things, things 
that we knew a year ago are different now because we have much 
more information and they continue to evolve.
    I have always said schools should be the last place to 
close and the first place to open. And I very much still agree 
with that. I very much want those to be safe places. My own 
kids were home from camp last summer, and I want camps to be 
open this summer.
    All of our guidance has highlighted it is better to be 
outside than inside. And what I really want in our camp 
guidance--and we are working through revising that guidance in 
the context of vaccination for 12- to 15-year-olds. My whole 
goal is to make sure that camps can remain open and that 
outbreaks don't occur.
    Ms. Herrera Beutler. But can I jump in on there, just 
because my time is running low? And I appreciate that.
    Based on the science, children 0 to 4 are less than, I 
think it is, 1 percent or 1.3 percent of all infections. And so 
I guess part of me is saying--I get it, 12 and up, you can get 
a vaccination, but you can't vaccinate the younger kids. Yet 
they are at low risk for getting it. They are at even lower 
risk for hospitalization. They are at low risk for spreading 
it. So why are we making them mask? Because the science doesn't 
support that.
    Dr. Walensky. There are still transmissions associated with 
young children. They have been vectors of transmission for 
older people. And----
    Ms. Herrera Beutler. What studies--that is the thing I need 
to know. Maybe you can provide that, because my time is up.
    Dr. Walensky. I would be happy to do that.
    Ms. Herrera Beutler. Can you provide the studies for that? 
Because that is not readily available.
    Dr. Walensky. Absolutely.
    Ms. Herrera Beutler. Thank you.
    The Chair. Congressman Pocan.
    Mr. Pocan. Thank you very much, Madam Chair.
    And thank you both for being with us.
    First, I just want to say, you know, I am very happy with 
the increase that you have. You have outlined many ways you are 
going to spend it. I guess my only regret, and this might be 
Barbara Lee's as well, is that the Pentagon increased budget 
alone is more than 50 percent than your total budget. For 
perspective, I think that is important for people to 
understand, given the biggest threat to this Nation in the last 
year was COVID-19.
    Having said that, let me ask a couple questions, first 
about contact tracing. Is this a good time to really be very 
specific in our contact tracing efforts?
    I know it was hard at moments last year to keep up. I think 
at one point we were doing one out of every five people is the 
best we could do in the State of Wisconsin. But now that you 
have far fewer people, is this something worth intensifying the 
efforts on to really help further eradicate its spread?
    Dr. Walensky. Thank you, Congressman.
    Contact tracing has always been a strategy for containment. 
We have used it in measles when we have fewer cases. And, in 
fact, it is hard to do contact tracing when you are in a 
mitigation strategy with hundreds of thousands of cases, as you 
exactly note. So, yes, I think now is a good time. With fewer 
cases, we are able to do so, we are able to isolate.
    But I think one of the bigger things to mention is, who are 
those contact tracers? They are the community health workers. 
They are the people who are on the ground, the infrastructure 
we never had, that we couldn't deploy to do the contact tracing 
to begin with.
    And that is what a sustainable public health infrastructure 
will be able to do. They will be able to be in the community, 
working on hypertension, childhood vaccinations, diabetes 
control, and then pivot quickly when you have an emerging 
threat.
    So I believe our contact tracers should not only serve as 
contact tracers now but as vaccine navigators--they know their 
community--and, really, to promote both quarantine of people 
who are potential contacts but then vaccination.
    Mr. Pocan. I don't want to put words into your mouth, but I 
would like to be able to pass on this information. So this 
would be a good time to make sure that we are thoroughly doing 
contact tracing with the limited cases that we now have?
    Dr. Walensky. And I would emphasize, contact tracing with 
vaccination.
    Mr. Pocan. Yes.
    Dr. Walensky. Because those who have to quarantine are 
likely those who are not vaccinated.
    Mr. Pocan. Gotcha. Thank you very much.
    Second question is--I know that, you know, when you put out 
the new guidelines, it was a lot of new guidelines, ones for 
everybody.
    And, last night, Secretary Walsh was in town, so I was out 
doing a few things in the community. And, based on your 
guidelines, I haven't been doing many things--I wasn't supposed 
to--in my district that previously I have.
    But it seems like the change has been very--a lot of people 
are doing a behavior without masks and things, which is in many 
ways okay.
    Are there things that, if you are vaccinated, that we 
should still not be doing right now, and if you are in a mixed 
crowd, that we should not be doing right now?
    Dr. Walensky. Thank you.
    You know, the guidelines that we put out for fully 
vaccinated people was really intended at the individual level. 
And I think what we really need to understand is that the 
policies have to be locally driven.
    What we know is that there are counties that still have 
less than 20 percent of people vaccinated and still greater 
than 100 per 100,000 cases of disease every 7 days.
    And so this was the start, because, in fact, we needed 
people to recognize that this was important information, 
science-based information, to make those local policies. But 
the heterogeneity of both vaccine rollout and cases, I think, 
really needs to be taken into account here.
    Mr. Pocan. So, for example, indoor situation but mixed. If 
you know at least a quarter of the people aren't vaccinated and 
you are within 2 feet of people in the size of the room, should 
you be wearing a mask?
    Dr. Walensky. I would defer to the local policy. But I 
would say, if you need to make that decision yourself and you 
are vaccinated and you are not immunocompromised, it is not you 
that is at risk; it is the unvaccinated cohort.
    Mr. Pocan. Gotcha.
    And then a last question in the minutes left about sending 
vaccines abroad. You mentioned in your initial comments--I 
personally am trying not to do any international travel this 
year, just because I think, you know, the rest of the world is 
not as far as we are in vaccines.
    But what should the U.S. be doing more to make sure--
because we are never really going to be in the place we want to 
until we get people vaccinated across the world. What more 
should we be doing?
    Dr. Walensky. I think, as Dr. Schuchat already noted, 
disease anywhere now is a threat to us here. And so we need to 
be assisting.
    We have already put $4,000,000,000 into COVAX--
$2,000,000,000 that has already been given and another 
$2,000,000,000 that is going to be--80,000,000 doses of vaccine 
that we are hoping to get out before the end of June.
    And we at CDC are going to be providing global support, 
technical support, how we do massive immunization campaigns, 
how we do vaccine safety. And we will be providing all that 
support.
    Mr. Pocan. Great.
    And just in the remaining 9 seconds, thank you. I know you 
have all put a lot of extra time in. It has been a pretty 
tremendous time in our history. I just want to say thank you.
    And I yield back, Madam Chair.
    Dr. Walensky. Thank you so much.
    The Chair. Congressman Cline.
    Mr. Cline. Thank you, Madam Chair. I appreciate you having 
this hearing today.
    I want to thank our witnesses and ask Director Walensky, in 
encouraging vaccinations--and I encourage people to get 
vaccinated--you mentioned that we need to be specific for each 
locality, each individual.
    But suffice it to say that your recommendations include the 
idea that, if you are vaccinated, not only do you run a reduced 
risk of contracting COVID but you have a reduced risk of 
transmitting COVID. Is that accurate?
    Dr. Walensky. That is what emerging science is telling us, 
yes.
    Mr. Cline. Okay.
    So, circling back to the ranking member's questioning, were 
you in contact with the Attending Physician, Dr. Monahan, as he 
developed this most recent policy announced by the Speaker, 
where 100-percent vaccination was encouraged? Were you in 
contact with the Attending Physician?
    Dr. Walensky. We have been a resource for the Capitol 
Physician throughout this pandemic. I know our offices have 
been in contact with him. I can't tell you exactly the timing 
of that, in terms of when the last discussion was versus when 
the guidelines for the House came forward.
    Mr. Cline. Okay.
    Were you in contact with his office as he developed 
recommendations for the Senate? Because the Physician also 
provided a recommendation to the Senators as well. Were you 
aware of that?
    Dr. Walensky. Congressman, my reply to that would be the 
same. I know our office has been in contact, but I just 
couldn't tell you when our office was directly in contact with 
him and when his decisions for either the House or Senate 
occurred.
    Mr. Cline. And would it surprise you to learn that the 
Attending Physician issued a recommendation to the Senate that 
was substantially different than the recommendation to the 
House, in that the Senate was encouraged to proceed with normal 
business without masks being required, social distancing 
respected, but that 100-percent vaccination was not required in 
recommendations from the Attending Physician's Office to the 
Senate, but in the House it is somehow being mandated? Does 
that surprise you?
    Dr. Walensky. Congressman, one of the things we have just 
mentioned is how complex these decisions are. In the case of 
evolving science, of course the Capitol Physician has much more 
information than I do about both the vaccination rates in each, 
the House and the Senate, as well as the medical records of 
people, as well as the average age and immunity durability. So 
I think he would be best equipped to make those decisions.
    Mr. Cline. Well, the Senators, on average, are older. The 
average age of the Senators is higher. And the science of the 
virus is not different in the Senate Chamber than it is in the 
House Chamber, correct?
    Dr. Walensky. I just don't know the immunization rates of 
each of the House and Senate. And he would be equipped with 
that information that I don't have.
    Mr. Cline. Is it your opinion that American society should 
be 100-percent vaccinated before we open back up?
    Dr. Walensky. As I mentioned, I think that these have to be 
locally driven, both based on vaccination as well as based on 
background rate of disease. So----
    Mr. Cline. But that is a pretty good softball for you. Do 
you have to be 100-percent vaccinated to open back up and stop 
wearing masks?
    Dr. Walensky. No, I don't believe so.
    Mr. Cline. Okay. Thank you.
    Let me ask you about the business community. The 
livelihoods of many businesses in my district have been 
threatened over the last year as they worked to adjust to the 
changing environment during COVID. As more has been discovered 
over the last year, guidance has changed as well. A Federal 
Reserve study found that the pandemic resulted in the permanent 
closure of roughly 200,000 U.S. businesses.
    What will you do to empower States to determine how best to 
govern so that overly burdensome recommendations and 
regulations from the Federal Government do not cause further 
harm?
    Dr. Walensky. We have been putting forward--first of all, 
we are working to get people vaccinated. Because I think, as we 
have seen, when people get vaccinated, disease rates in their 
local areas come down, and that is the ticket out of this, in 
my mind, when people get vaccinated.
    We are working really hard with all jurisdictions, with all 
communities, at the State, the local level, to get people 
vaccinated to ensure confidence, to provide the best 
information possible so that people feel empowered to make 
these decisions, that they are the right decisions coming from 
trusted messengers in those communities.
    And so we are working to do that at the public health 
level. And then we are providing the guidance that can lead to 
informed decisions in communities with local jurisdictions, 
with Governors--I spoke to the Governors yesterday--to make 
sure that our guidance is applied in a safe manner at the local 
level.
    Mr. Cline. Thank you.
    I yield back.
    The Chair. I would like to recognize Congresswoman Clark. 
But, for one moment, I am going to again hand the gavel to 
Congresswoman Lee so I can just--see, it did not work the last 
time, of getting to Homeland Security, and I will get there and 
get right back.
    So, Congresswoman Clark, you are recognized.
    Congresswoman Lee, take the gavel.
    Ms. Clark. Thank you so much, Chairwomen.
    And thank you both for joining us. And just the deep 
gratitude of a Nation for the work of the CDC and the response 
to this pandemic.
    Dr. Walensky, you and I have talked about the value of 
public service, the importance of treating public health jobs 
as we would a career at DOJ or Defense. Are there programs or 
incentives that the CDC would like this committee to prioritize 
that would address the needs of our public health workforce?
    And, in particular, how can we work with the CDC and State 
and local level to build a more diverse public health 
workforce?
    Dr. Walensky. Thank you very much, Congressman Clark.
    I think one of the things that is really important here is 
to make sure that the compensation is competitive with the 
private sector in our public health jobs. As I talked to the 
State health officials, they would tell me they can't hire an 
M.D. In a State public health--the compensation wasn't 
competitive. Somebody who came out of medical training and 
medical school with, on average, $200,000 worth of debt was not 
going to enter the public health workforce, because they didn't 
have salaries that are competitive.
    As we are working on expanding our ``disease detective'' 
EIS program, one of the things we are really looking forward to 
is hoping to do loan repayment programs.
    And across our workforce, of our training, loan repayment 
programs would really go a long way so that people could enter 
into public health, which obviously pays less than the private 
sector. Many of the training programs that we would put forward 
to be tuition-free, to be accessible to people who have had 
less resources.
    Ms. Clark. Great. Thank you for that.
    And anything specific around your plans and strategies for 
increasing diversity in your workforce?
    Dr. Walensky. We are reaching people where they are. We are 
working to, you know, go to historically Black universities. We 
are working in communities to try and bolster people within the 
communities.
    We have the potential now, as we are scaling up our 
workforce within public health that we have had to do by 
necessity through this pandemic, to retain them. These are 
people who are interested in public health. They have 
demonstrated, they have volunteered to help. And now is the 
time to scale them up, to retain them, and to make sure that 
they can continue the important work they have been doing, to 
continue the outreach that they have already made, to maintain 
that network. And that, I think, is really going to be key for 
our next step forward.
    Ms. Clark. And just really quickly, if an employer made a 
decision around masks based on two different groups, one that 
had a 96-percent vaccine rate, one that had a 77-percent 
vaccination rate, would you think that was a fair way and 
aligned with the science to make a decision around masks at the 
workplace?
    Dr. Walensky. Most definitely. Almost every morning, I look 
at a map of vaccination rates across this country by county.
    Ms. Clark. Thank you.
    Dr. Schuchat, I was wondering if you could tell me a little 
bit about the gun violence research that was first funding in 
20 years in the fiscal year 2020 budget. And I wondered if you 
can tell me what you are learning in our research on firearm 
injury and mortality prevention.
    And we just so appreciate you treating this as the public 
health crisis that it is. And any updates and strategies and 
interventions that have emerged from the research that you can 
share?
    Dr. Schuchat. Thanks so much for that question, 
Congresswoman Clark, and for the congressional resources that 
we first got in 2020. Our call for proposals for firearm safety 
opened a flood of applications, and we were really pleased to 
be able fund several that were focused on the gaps that the 
National Academy of Medicine had identified.
    The scientific research that we are supporting is helping 
us understand firearm-related injury across different types of 
incidents, different types of populations, and different 
settings.
    We had 18 funded sites in that research. They are looking 
at firearm behaviors and co-occurring mental health and 
behavioral risks among youth. They are looking at individual- 
and neighborhood-level risks for firearm-related violence so 
that communities can design tailored interventions. And they 
are setting a clinical screening tool to assess youth risk for 
future firearm violence.
    These are really important projects that span the Nation. 
But I can say, we had so many more applications than we were 
able to fund. So the ability to scale it up is going to be 
precious.
    The other aspect of the resources that we received helped 
us strengthen the data gathering on the surveillance, just so 
we would know who was getting injured by firearms and where 
these events were occurring, when they were occurring, so that 
we could understand trends and risk factors.
    So I think it is a really important, precious area for us 
to continue.
    Ms. Clark. Thank you so much.
    I see my time has expired. I yield back, Chairwoman Lee.
    Ms. Lee [presiding]. Thank you very much.
    Now I will yield to Representative Frankel.
    Ms. Frankel. Good morning. And thank you both, Doctors, for 
all your good work.
    And not to monotonize this discussion on Members wearing 
masks, but, Madam Chair, I just would respectfully suggest that 
our colleagues who do not want to wear masks, whom we have 
heard from today, ask their colleagues who have not gotten 
vaccinated to get the vaccine.
    Because, you know, I think I speak for most Americans who 
have been vaccinated. And we don't want to wear masks, but we 
do not want to be sitting in small areas with people who are 
refusing--who know better, who are refusing to get vaccinated.
    So my next question, Doctor--either of you can answer 
this--is, what is expected for when we are going to need 
boosters for our vaccinations?
    Dr. Walensky. Thank you for that question, Congresswoman. 
And congratulations on your grandbaby, who I think was pending 
as we last spoke.
    Ms. Frankel. Yes, he is here, thank goodness. Something 
good came out of the pandemic.
    Dr. Walensky. That is right.
    On the topic of boosters, I think that it is really 
important for us to understand several things.
    First, if you have received two doses of vaccine or you are 
completed vaccinated, right now you don't need a booster. You 
are protected. Or, at least, the data that we understand now 
for the general population implies that you do not need a 
booster right now.
    I think all of us recognize that we don't want to be back 
to where we were again. And so we would like to study this. We 
are studying when we might need a booster.
    And, in fact, that gets back to the, what are the true 
correlates of protection? We do know that antibody levels, over 
time, we have seen they wane. And so the question is, when they 
wane, are these people still protected? What do these 
quantitative numbers mean with regard to protection?
    We also know, importantly, that we vaccinated first our 
most vulnerable. We vaccinated people who are in long-term-care 
facilities, we vaccinated our elderly, we vaccinated people who 
might not have had the most robust immune response to start.
    And so we are looking at the timing of when boosters might 
be needed. Will it be 6 to 9 months, will it be 9 to 12, or 1 
to 2 years? We have seen data from SARS, the SARS-1, that has 
demonstrated reinfections after 2 or 3 years. That is after 
natural infection.
    And so I think the most important thing is, we certainly 
want to be ready. And so that is where we are right now.
    Ms. Frankel. That is good.
    And do you expect, though, that with the next shots, we are 
going to be able to get them like with the flu shots, you know, 
not having to go to mass sites and things like that?
    Dr. Walensky. I think one of the things that is really 
important to recognize here is, we don't have an adult 
immunization structure in this country. We haven't. We have a 
childhood immunization structure in this country, but we do not 
have one for adults. We don't have a mechanism to do this right 
now.
    And among the reasons for the funding is to develop and 
bolster an adult immunization structure in this country, for 
flu shots, for COVID vaccines if we need them again. That would 
be the vision for Shingrix, for all the other--for, you know, 
tetanus when we need tetanus updates, for all of the things. We 
don't have that mechanism right now.
    Ms. Frankel. Well, thank you. That is a good idea. Because 
our rollout in Florida of the vaccines was chaotic. I said it 
was like ``The Hunger Games'' here. So, I mean, it was really--
it was frightening.
    You know, I think one part of our population that really 
suffered were the elderly, and I am just interested in whether 
you are doing any work to address, you know, how we handle 
these kinds of situations with our elderly population. There 
was so much isolation and depression.
    Dr. Walensky. I think--you are noting the elderly 
specifically, and I totally agree, the isolation here had been 
so challenging, and in long-term-care facilities, so 
devastating to watch. But I think you are raising a larger 
issue too, which is, the mental health of this Nation has 
suffered.
    And so we are doing a lot of work in collaboration with 
SAMHSA, to evaluate mental-health-related issues, to look at 
issues related to suicide, to do more surveillance, and to do 
outreach with interventions that are data-driven, that have 
toolkits provided by the CDC for how we can do outreach in 
these communities with community workers to really do evidence-
based science in mental health across the age spectrum.
    Ms. Frankel. And real quick, talking about toolkits, how 
about in terms of ideas for communities on how to increase 
vaccination rates? Is there a place that our health departments 
can go to get different ideas or strategies?
    Dr. Walensky. Yeah. Thank you for that. We have an 
extraordinary number of resources.
    We have vaccine confidence consults. You can call the CDC 
and get a vaccine confidence consult.
    We have, through HHS, the We Can Do This campaign. It is 
5,000 community corps. So if you have a group that NASCAR 
speaks to, you can go get your vaccine and then take a ride 
around the Talladega track. So there are lots of different ways 
to engage with this community corps through the 
wecandothis.gov.
    I would really encourage your State departments to engage 
these community corps organizations, be it NASCAR, NFL, country 
music, or Infectious Disease Society of America. Faith-based 
organizations can really help do the outreach so that people 
are talking to people they trust.
    Ms. Frankel. Thank you very much.
    I yield back, Madam Chair.
    The Chair [presiding]. Let me thank my colleague, 
Congresswoman Lee. Mission accomplished.
    And, with that, let me recognize Congresswoman Bustos.
    Mrs. Bustos. All right. Thank you, Madam Chair.
    And, Dr. Walensky, thank you so much for taking time 
earlier in the week to chat. I am going to talk with you a 
little bit as an extension to what you just shared with 
Congresswoman Frankel about new ways and innovative ways to 
reach out to people, specific, in this case, to rural America.
    I talked with Dr. Fauci about this yesterday at our 
hearing. He was going to take the questions that I was asking 
about reaching rural residents and try to come up with some new 
ideas.
    But I want to talk specifically about the disparity between 
those who live in rural counties compared with those who live 
in more urban counties. We know by the numbers that CDC has 
released that it is less than 40 percent of residents in rural 
counties who have received at least one dose, compared with 
just about 46 percent in urban counties.
    And so I want to hear your thoughts about vaccine 
hesitancy, other issues that are specific to rural counties.
    If I may throw out an example, in the congressional 
district that I serve here in northwestern Illinois, we have 
one county, which is a couple counties south of where I am 
talking to you right now, it is along the Mississippi River. 
The entire county has 6,700 residents. And early in the--for 
people to sign up for the vaccine, they just had a couple phone 
lines. Broadband is spotty at best. Their volunteer corps, as 
far as getting people out to help, were very, very senior 
themselves and were concerned about getting COVID themselves, 
so that was all brought to a halt. They were registering 
people. There was no online portal to register. It was all 
handwriting, you know, paper and pencil.
    And so, now, with the announcement that just came out 
earlier today, where we have half of the adult population that 
is vaccinated, in this county only 19 percent overall is 
vaccinated. And so, just these great big disparities.
    So I am just wondering, Dr. Walensky, on top of what you 
just talked about, I am very curious, like, can I get a Chicago 
Bears player to come to Henderson County? I mean, I am just 
wondering how that might work.
    But what steps is the CDC taking to increase these 
vaccination rates in rural areas? And, specifically, also, how 
we can address vaccine hesitancy. And maybe even really talk 
through, like, these celebrities, because maybe that would be a 
way to have this work. I am wondering if we could get some 
folks in my neck of the woods to help out.
    Dr. Walensky. Thank you for that question and for 
highlighting data that we have discussed about these 
discrepancies in vaccine rates really through the end of April.
    Another piece you didn't actually raise is the 
discrepancies in telehealth, right? In rural counties, it would 
be so helpful to have telehealth. And yet we saw in a previous 
MMWR that telehealth wasn't reaching, for exactly the comments 
you said--broadband, telephone, you know, decreased access.
    I think it speaks to the fact that we don't have community 
workers in these communities that have had a long-term public 
health infrastructure in these communities to do the work of 
public health. We don't have a public health department that is 
sustained, that has been viable, that has been well tended to, 
that has competitive salaries, respected positions, and 
community workers in those communities to do the work that you 
are talking about.
    And that is exactly what--we have had resources that have 
gone out that are specifically line-itemed for rural areas 
because we recognized that deficit through the context of 
COVID. We have had community-based organizations specifically 
outlined for rural areas through the context of COVID. And what 
we are asking for, not just to have it for the context of 
COVID, but now you are going to find them, you are going to 
find these people who are devoted to this community work.
    We need to make sure that they are trained. We need to 
scale them up. They need to be able to interact with the data 
systems. You don't have data systems there for people. You are 
doing it by hand, by paper and pencil. That is not a way to do 
public health in this country in 2021, never mind for what we 
need to reach for in 2030.
    In terms of what we are doing now, you and I discussed, you 
know, I was in rural Georgia, and it was really incredible to 
talk to the people who are doing this work, who are going door 
to door, the elderly people, as you note, and who are hearing, 
``The National Guard didn't work.'' What did we need to do? We 
needed to be at the change of shift at 4:00 a.m. And have 
people trip over us and say, ``Can you get your vaccine now?'' 
That is the kind of grassroots efforts that we are moving 
forward with now.
    We have these confidence consults, that people can call the 
community corps. I am a Patriots fan, I am sorry to say, but I 
bet the Bears might be something to facilitate. You know, I do 
think when you call these--wecandothis.gov, you will get a 
wealth of resources. These people want to help.
    Mrs. Bustos. Good to know.
    Dr. Walensky, again, thank you to you and your team for all 
you are doing to help our country get past this pandemic. 
Grateful to you.
    With that, Madam Chair, I yield back.
    Ms. Clark. I don't think you need to apologize for being a 
Patriots fan, though.
    The Chair. Now we get to the real core of the issues here. 
But my hope is that you are a Yankees fan so there doesn't have 
to be a Red Sox fan here.
    Right, Katherine? Anyway.
    Congressman Harder.
    Mr. Harder. I don't know if I want to get myself in the 
middle of this. But thank you so much, Chair DeLauro, for 
hosting this hearing.
    And thank you so much to the witnesses for taking their 
time. And a special thanks to Dr. Schuchat for your decades of 
service.
    One of the things that I really wanted to focus on is how 
this pandemic has highlighted some of the gaps in our public 
health system. And I think one of things that has become 
abundantly clear to me is just how critical a strong, well-
funded public health workforce is to care for folks across the 
country, especially in rural districts like mine, where 
capacity, especially healthcare capacity, is already thin.
    I have seen the beginning of some grant announcements out 
of the CDC that are going to help fund some of the programs 
outlined in the American Rescue Plan, specifically the 
$7,000,000 investment to hire and train public health workers.
    Dr. Walensky, could you describe the rollout of the public 
health hiring and training programs and especially how the CDC 
will support these positions on an ongoing basis after the 
rescue funds expire?
    Dr. Walensky. Thank you for that, Congressman.
    You know, we just put out the first tranche of 
$7,400,000,000. Really, $4,400,000,000 is intended to help 
scale up where we are now to get us out of this pandemic, to do 
the hard work of continuing testing, continuing disease 
diagnostics, continuing workforce for lab and genomic 
surveillance, and to make sure that we are--and vaccine 
distribution and community workers for that vaccine 
distribution.
    The other piece of it, the $3,000,000,000, is an investment 
in the future, to be able to take that infrastructure and to 
invest in the workforce that will be moving forward.
    But I think the most important thing you highlight is that 
these are not one-time investments. One-time investments will 
not fix the problem that led to this pandemic of COVID-19 and 
our inability to handle it. They need to be sustainable. They 
need to be longstanding. They need to be keeping the pace with 
inflation. They need to be keeping the pace with technological 
advancements. And so this is an investment now, but it needs to 
be a sustained investment over time.
    Mr. Harder. How will it be a sustained investment over 
time? Do you expect that to be--I haven't necessarily seen that 
investment in the budget document. How do you expect that to 
manifest itself in the discussions we are having today?
    Dr. Walensky. I think this is going to be a continued 
conversation. I think I am going to probably see you here this 
time next year to demonstrate all the hard work that we have 
been able to do with the resources that we have had and what we 
still need to do in the years ahead.
    Mr. Harder. Well, I look forward to working with you on 
that and especially, I think, making sure that rural areas that 
are especially strained in some of the public health capacity, 
like our district in the California Central Valley, have some 
of the opportunities to get some of these grants, because I 
think it is very much needed.
    My second question is, you know, just a little bit more 
broad, and to you, Dr. Schuchat. I think we have a tendency to 
only invest in public health during times of crisis, and I 
think we need to be doing a lot more to improve the capacity of 
State and local public health departments, not even for the 
pandemic we are dealing with now but to prevent others in the 
future.
    What else can we be doing to consistently and sustainably 
equip public health departments for future public health 
emergencies and especially for the special considerations we 
may need for rural districts?
    Dr. Schuchat. Yeah. Every aspect of an emergency response 
is improved by the work that is done beforehand, the 
relationships that have been built, the data systems that are 
in place, the skill level of the staff, and the familiarity 
that they have with the communities and the other organizations 
nearby.
    We were not ready for this pandemic. Our data systems were 
very far behind, and our public health workforce was gone, 
basically, you know, the 60,000-some jobs that were no longer 
filled. And so, you know, looking back on what has happened 
over the past year and over the past few decades, I think we 
can see that we just need to do better going forward.
    I want to say a few words about the public health data 
modernization, because I think that left us lead-footed at the 
beginning of this response, with not really knowing what was 
going on and not being able to keep up.
    And so we know--you know, I have talked to healthcare 
executives who have described investments in a single hospital 
of $700,000,000 versus, you know, what our initial resources 
were, $50,000,000 for the entire public health data 
modernization effort.
    I think, going forward, we really need to take data and its 
complexity and the full ecosystem seriously, both with data 
scientists and with interoperable systems, migrating our 
systems to the cloud, strengthening what public health local 
and State capacity is and also what the CDC's is.
    So that is a really big, complex job. And it also relates 
to what Dr. Walensky was describing, where it is tough for 
public health at any level to be competitive with the private 
sector. And so we have to figure out how to attract quality 
individuals to work with us and have strong public-private 
partnerships to go even further.
    So I see data hand-in-hand with workforce in getting us out 
of the state of preparedness that we were in.
    Mr. Harder. Excellent. Yeah, you can't fight what you can't 
find. Well, thank you so much.
    And, with that, I yield back, Chair DeLauro.
    The Chair. Congresswoman Watson Coleman.
    Mrs. Watson Coleman. Thank you, Madam Chair.
    Dr. Walensky, thank you for all the work that the CDC has 
been doing, not only in this space as it relates to getting us 
through COVID and having an after-COVID experience, but all the 
other work that you all do at the same time.
    And, Dr. Schuchat, thank you so much for your 30-some 
years. God bless you. You have been enormously important to all 
of us and our well-being, and we wish you the very best.
    Dr. Walensky, I am sorry that we didn't get a chance to 
talk beforehand, because I have, really, a lot of questions. I 
am just going to raise some of them, but hopefully we will talk 
about them a little bit further down the road.
    I want to talk about the gun violence issue. I appreciate 
the fact that we funded research for the first time in, I 
guess, a very, very long time, and that is being used valuably 
by you all.
    I am wondering, with the President's new initiative where 
he is talking about more local interventions, what that means. 
How do you see that rolling out? What are the kind of 
interventions that will have an impact on the kind of violence 
and death by guns that we see in our communities now, 
particularly our inner-city and low-income communities?
    Dr. Walensky. Thank you so much for that question, 
Congresswoman.
    We are really looking forward to seeing how the investment 
of the initial funds from fiscal year 2020 and 2021, and as 
those data mature, what we learn, and then really looking 
forward, using the template of the information that we need 
from the National Academy of Medicine to inform the kinds of 
research that is being done.
    Of course, that research, as you note, has to be at the 
local level. It has to be related to behavioral health and 
mental health, but, importantly, it has to be at the 
neighborhood level and at the level--and because, you know, not 
every neighborhood is going to be the same.
    So the science that we are going to do is going to be about 
the who, the how, the why of firearm injury prevention. And we 
are going to move forward, and I really look forward to seeing 
how that science matures.
    Mrs. Watson Coleman. So do you think we are at the 
beginning of that? And how long will we see the actual 
implementation of effort evidenced by the research that was 
being done? Because we are in a very urgent, crisis situation 
with gun violence in our communities.
    Dr. Walensky. I would agree with you. I will say, we will 
need to, sort of, see what the science demonstrates, and then 
we are going to implement at an actionable level within those 
communities. We need to understand what the science says before 
we can act. And we are really looking forward to seeing how 
that evolves.
    And maybe Dr. Schuchat?
    Dr. Schuchat. Yeah. Just to expand a little bit, you know, 
we had that first investment of the $3,000,000 in this work, 
but the proposed expansion--excuse me--the proposed community 
violence work is a larger scale.
    And the idea there is to take what we have shown to work 
through the technical packages that we have issued on violence, 
including on youth violence for instance, and to scale those 
up, to have communities take on the ability to implement proven 
methods.
    They may involve, you know, strengthening connectedness 
between kids and schools and adult mentors in the community. It 
will really vary community to community. But we are hoping to 
fund a large number of communities to really take those to 
scale.
    Mrs. Watson Coleman. And, Dr. Schuchat, I am really 
interested in hearing some of the specifics that are going to 
be employed under this effort.
    The President also said in his skinny budget he wanted to 
end the HIV/AIDS crisis. And one of those things I think is 
very important in this is the bill that I sponsored with regard 
to PrEP.
    And so what I am wondering is--two things. Number one is, 
what do you say about the trend in HIV/AIDS right now? Is it 
still going down? Do we see an upshot because of the pandemic 
or whatever?
    And what do you think of how the resources should be 
applied? How are we going to ensure that they are applied 
across the board to all races and communities?
    Dr. Walensky. Thank you for that question. As you know, 
prior to my coming here, my career was in HIV disease and 
prevention. I am an HIV doc by training.
    Yes, I think, you know, right now, the Ending the HIV 
Epidemic initiative has been invested in 57 jurisdictions with 
the highest rates of HIV. I think that, as with many diseases 
that were pre-occurring before this pandemic, they have been 
exacerbated by social isolation, by inaccess to medical care, 
by many things. We are looking at the investments that were 
made in those 57 jurisdictions, some of the lessons learned 
there.
    As I am certain you are aware, with your interest in pre-
exposure prophylaxis, it is not getting to the communities that 
need it, necessarily, for cost reasons, for access reasons, 
behavioral health reasons, that places that have the highest 
rates of HIV actually have the lowest rates of pre-exposure 
prophylaxis use. And that mismatch is something we need to fix 
in the years ahead.
    Mrs. Watson Coleman. Thank you.
    I know my time is up, but I think that that is a crisis 
that needs to be addressed. That is what we saw with testing 
for COVID. That is what we saw with contact tracing. That is 
what we are seeing in some respects with vaccinations but not 
as much. And so that is a crisis, in and of itself, as it 
relates to poor communities or minority communities. And I want 
to know specifically at some point how we are going to get at 
those communities.
    I thank you, Madam Chair. I yield back.
    Thank you, Doctor.
    The Chair. Thank you.
    Congresswoman Lawrence.
    Mrs. Lawrence. Thank you. Good morning.
    As you know, I represent Michigan and was very involved 
with the lead crisis in Flint. And we know that lead exposure 
is unfortunately prevalent across Michigan, and that includes 
the lasting effects of the Flint water crisis. I am proud to 
work with my colleague, Congressman Kildee, to provide funding 
for the Flint Lead Exposure Registry at the CDC.
    Dr. Walensky, I am incredibly concerned with the high 
levels of lead in cities across the country, especially in the 
schools. When I talk to my colleagues, there are numerous 
schools that put the plastic bag over the drinking fountain, 
with no research of how long the children drank from that water 
fountain before we put that plastic bag over it, the lasting 
effect.
    Can you speak to how the CDC will utilize the Childhood 
Lead Poisoning Prevention Program with more targeted 
initiatives like the Flint Registry to combat lead poisoning in 
our communities, especially the impact it has on children and 
their developing brains?
    Dr. Walensky. Thank you very much, Congresswoman.
    And one thing I think we learned from this pandemic--and 
this was reported in the MMWR as well--is the decrease in lead 
poisoning surveillance that happened because of the pandemic or 
lack of access to care.
    I think one of the things that we will really understand as 
we invest in our public health infrastructure is different 
communities need different things. We heard in rural 
communities they need broadband, but in other communities we 
need investments in our community workers to do surveillance of 
lead.
    We are doing active surveillance, and maybe I will ask Dr. 
Schuchat to chime in as well.
    Dr. Schuchat. Just to thank you for your leadership around 
the Flint crisis. And, you know, the registry has been 
incredibly valuable for the community as a community-owned and 
-led response. You know, the children affected potentially 
could have long-term consequences, but with mobilizing 
wraparound services and engagement, we hope that some of that 
will be mitigated.
    We don't know how many other communities are in the same 
boat that Flint was in, and that is part of the focus of 
expanding lead surveillance through the public health systems. 
There are other departments that are really engaged in 
investments that can help reduce the exposures, the lead pipes 
and so forth that you mentioned, but we think that data is the 
first thing. We have to know what is going on to be able to 
target effective responses.
    And, ideally, those are community-owned, the way that they 
were in Flint, to not just have, you know, a distant government 
trying to figure out what was going on but having those 
community workers who could help the families that are 
affected.
    So I share your sorrow about what happened and enthusiasm 
about the registries and the ability for us to strengthen 
surveillance around the country.
    Mrs. Lawrence. I will tell you, if we had a hearing on lead 
poisoning, many members will step up and talk about the concern 
they have in our communities, urban and rural.
    The last thing I wanted to add is to add my voice to gun 
violence. We know for decades there was a refusal to establish 
or identify gun violence as a health crisis, because, for 
whatever reason, administrations did not have the wherewithal 
or the desire to do the data, as you talked about, so that--we 
knew that we could use the data from car crashes to implement 
safety belts and airbags, but we have never had the courage to 
see through the research so that we can begin a federally led 
program to address gun violence.
    And I just want to tell you why this is so critical. In 
2020, there were 327 homicides, 1,017 nonfatal shootings in 
Detroit alone, a 19- and 53-percent increase respectively. This 
problem is not getting less; it is increasing.
    And this obsession we have in America with guns, I can only 
see it getting worse. And for mayors--I am not a mayor, but for 
people in Congress who are seeing these deaths so frequently, 
this has to be a priority.
    So, with that, I want to yield back and say thank you so 
much for everything that you and the administration are doing.
    The Chair. Thank you so much.
    And we are now going to move to round two, and I think we 
have the time to do a 5-minute round. So thank you very much.
    I want to begin by, I know several of my colleagues have 
addressed the firearm injury, the mortality research. And I 
just wanted to say that I was so proud that this subcommittee 
held the first hearing in 20 years on gun violence prevention 
research. And we began funding for the NIH and for CDC, the 
ability to do this research, which can take a look at suicide, 
can take a look at gun storage, and a whole variety of other 
areas that could help bring relief to prevent this violence.
    And I am pleased that the President's budget proposes to 
double the funding to $25,000,000. My hope is that--but I just 
have a very quick question here, because I want to get to a 
couple of others.
    And I guess, Dr. Schuchat, when do you believe that you 
will have the opportunity, or CDC will have the opportunity, to 
share some results?
    Dr. Schuchat. Yeah, the research projects are in progress, 
and, you know, I hope that within a year or 2 there will be 
preliminary results from the initial investments. You know, 
they are doing extraordinary work, but, as you know, research 
can take time, and these are complex issues to fully 
investigate.
    The Chair. Right. Thank you. Thank you very, very much.
    Let me ask both Dr. Walensky and Dr. Schuchat, this is 
about cardiovascular disease in women. Heart disease, stroke 
continues to be a leading cause of death of women in the U.S. 
In 2017, nearly 300,000 women died as a result of heart 
disease.
    And the research shows that women often experience 
different symptoms of heart attack than men, leads doctors to 
misdiagnose women, results in worse treatment outcomes. 
Critical for the CDC to support an education and an awareness 
campaign in all 50 States and territories on heart disease so 
that women can receive appropriate care.
    My question is to both of you. Give us an update on CDC-
supported activities to educate women about heart disease and 
cardiovascular health, and the need to create an urgency about 
our looking at this issue to impact the research that needs to 
get done.
    Dr. Walensky. I am going to let Dr. Schuchat start with 
that one. Thank you.
    The Chair. Okay. Thank you.
    Dr. Schuchat. Sure. Thanks so much for raising this issue. 
It is so important as a leading cause of death in women and as 
an underrecognized, preventable problem.
    We know women are less likely to--they have atypical 
symptoms. You know, I was telling colleagues the story about my 
mom, you know, had neck pain playing tennis, which we thought 
was arthritic, and it turned out it was angina, and, you know, 
fortunately got surgery in time.
    But it is very common for women to have different symptoms, 
delay, to be detected later because of clinician as well as 
bias and to have bad outcomes because of that. So I think there 
can be benefit from education and communication efforts.
    You are familiar with our Million Hearts initiative, which 
is really trying to get hypertension to be well-treated, to 
prevent a million heart disease and stroke events, which takes 
public and clinician and institutional effort. And I think that 
the communication and education call that you raised can be 
done as part of that system.
    We are working together with the Center for Medicare and 
Medicaid Services in partnership on this, and education and 
communication campaigns are part of that.
    Obviously, you know the Wear Red event that I have seen 
many Congresswomen be part of, that can't just be a 1-day or a 
1-month thing. It needs to be year-round and sustained, because 
there are a lot of preventable deaths that we could attend to.
    The Chair. Uh-huh. Thank you. That is going to be one of 
the issues I would like to focus on, you know, as we move 
forward.
    I just wanted to ask this question, and this is about the 
global response to COVID. We have made significant progress 
here, but the pandemic will not be over until there is a global 
success.
    Dr. Walensky, how is CDC working with international 
partners to support the global response to COVID? How is the 
agency planning to expand surveillance, prevention, and 
response to pandemic threats around the globe?
    Dr. Walensky. Thank you very much.
    A threat anywhere is a threat everywhere, right? And so we 
do, we have a responsibility to not just take care of ourselves 
but around the world. CDC has collaborations in 60 countries, 
150 sites, and the ability to have these collaborations that 
have been longstanding have served us well.
    So, for example, we have a regional office in India that is 
20 years old. We have trusted colleagues there. They trust us. 
For the last year, we have been training up infection control 
preventionists in India, over 10,000, within these 
collaborations within country. So, when it came time and India 
was having challenges, we were able to mobilize those 
collaborations. We were able to rapidly get oxygen canisters to 
India.
    Our work at CDC is really in our technical surveillance, 
our technical advice, our technical and scaling-up capacity. 
And it really is critical to have those trusted people on the 
ground so that we are able, in times of crisis, like we also 
have done in the Congo and Guinea for Ebola just this past year 
as well, to be able to scale up in times of crisis. And so that 
is exactly what we are doing and what we are looking for 
resources to be able to continue.
    The Chair. Okay.
    I know my time is up, but I want to make this one comment. 
I was pleased that the administration and Ambassador Tai was at 
the WHO and talking about lifting the waiver on supplying 
India, South Africa, other countries with the opportunity for 
the benefit, in a temporary way, of the licensing, the patents, 
et cetera, so that they can deal with manufacturing.
    Your point earlier, it is not good enough for us to be 80, 
90 percent covered and 20 to 30 percent in other countries, 
because we are at risk if that is the case. So I look forward 
to working with you on that effort.
    Congressman Harris.
    Mr. Harris. Thank you very much, Madam Chair.
    And, again, thank you, Doctors, for coming before the 
subcommittee.
    And I would be remiss--I forgot to thank Dr. Redfield, a 
fellow Marylander, for the work he did at CDC. You know, the 
job sometimes--you have to take slings and arrows, no question 
about it. Because, if you recall, he was highly criticized for 
suggesting that the Wuhan virus came from a lab in the 
Institute of Virology, castigated in the public media. And now 
it seems we have come 180 degrees around where that is actually 
something that we actually should look at if we are to truly 
determine how this got started and where it came from.
    But let me go ahead and just ask about--and just to clear 
something up, by the way, the--because it was suggested that 
somehow Florida had kind of a bad response to COVID, I guess. I 
don't know. I think that Florida actually has among the lower 
rates of infection. And despite the possible description of a 
vaccine rollout as hectic, it seems that the public health goal 
should be to get to a good result, and I think Governor 
DeSantis did. That is just my comment. I mean--and it is 
objectively backed up by objective data, which is what we 
should be talking about, is objective data.
    So let me just ask a brief followup on gun violence, 
because, last year, in the 28 largest cities, there was a 36-
percent increase in gun violence between June and October. Very 
briefly, any ideas, what could possibly have resulted in such a 
huge increase in gun violence in our cities?
    Dr. Walensky. Thank you, Congressman. I also--or Dr. 
Harris. I also neglected in our first round to applaud you and 
thank you for all of your public service in trying to get 
people vaccinated. I did want to highlight that and thank you 
for that.
    We are actively doing research on firearm injury 
prevention, as highlighted by the priorities of the National 
Academy of Medicine, the who, what, when, and how of gun 
violence, of firearm injury. And we will look forward to those 
studies.
    Mr. Harris. Okay. No, thank you very much, because I think 
we have to get to the root of the increasing gun violence and 
then question whether or not it is because policing activities 
have decreased. Many police forces in my local jurisdiction, 
for instance, have up to a third of their positions vacant 
because you can't find someone who wants to be a law 
enforcement officer anymore.
    The other thing that I wanted to ask about is the data. As 
you look at robust data collection, I would hope two things. 
One is that you do it, obviously, across the various parts of 
the CDC and bring it into what you suggest, Doctor, should be 
the way we collect data in 2021, not on the backs of envelopes, 
and develop a robust system, because it certainly is necessary.
    But as part of that, I do hope that you look at what went 
on with nursing home deaths in New York during the COVID 
epidemic. Because I think we owe it to our seniors to 
understand what appears to have been data manipulation in New 
York, and I think we need to get to the end of it.
    Now, I will just close out the last minute and a half and 
ask you to update us on Zika, which we haven't heard about for 
a while, thank goodness. Zika and--very briefly, you in passing 
mentioned Ebola, but we know that it is still simmering in 
Africa. What are the threats of these two diseases right now to 
Americans?
    Dr. Walensky. I am going to pass that to Dr. Schuchat, but 
just sort of comment and say that, among the things that I 
think of as critically important is the investment in SET-NET, 
which is the review of mother-baby pairs, which I think helps 
us evaluate not only Zika but also COVID-19.
    But Dr. Schuchat?
    Dr. Schuchat. Yeah. I think there are a lot of lessons from 
the Zika epidemic, you know, a virus that had been recognized 
many years earlier with a mild syndrome, but a lab test that 
was developed because of that initial outbreak in Yap, and 
then, you know, the introduction into our hemisphere and the 
terrible outbreak in Brazil and then in many other countries, 
including southern U.S.
    That reminded us how important it is to have entomologists 
in public health, a discipline that had been lost, and to have 
surveillance at the local level for mosquitoes. We know there 
are a lot of threats right now in mosquitoes and ticks and 
other vectors that can be the carriers of new diseases to 
susceptible populations.
    So the result of the Zika work was strengthening that 
infrastructure that we have with some centers of excellence, 
the SET-NET that you just heard about that helps us track not 
just Zika but other threats like opioid-related harms, 
syphilis, other things that can affect mothers or babies.
    And so it really gets back to the public health 
infrastructure and the need for sustained focus. We get 
investments, and then we lose them, and then we are surprised 
when a new threat takes us without preparation.
    I can tell you from meetings with the World Health 
Organization, they were very concerned about loss of 
researchers to be able to continue to understand Zika as it hit 
newer communities that hadn't yet been through what we went 
through in the Americas.
    So I just think the emerging threats are out there and that 
we need systems that are agnostic to pathogen or agnostic to 
disease that protect all of us.
    Mr. Harris. Thank you very much.
    I yield back.
    The Chair. Congresswoman Lee.
    Ms. Lee. Thanks very much.
    For Dr. Schuchat: One lesson that we learned during COVID-
19 was the need for consistent, standardized, disaggregated, 
culturally appropriate data collection methods to really 
determine how to address and where to address targeted 
resources for medically underserved communities.
    Now, this was a heavy lift. We put this in all of our 
legislation. We asked CDC to collect the data, to work with 
States, to give us the information as it relates to language, 
and to disaggregate the database on race, ethnicity, gender, 
socioeconomic status. We never really--I don't think CDC ever 
took us seriously.
    So I am wondering now, where are we in terms of data 
collection? Because we have to know, not only for COVID, but 
also for any healthcare initiatives that disproportionately 
impact people of color.
    And then, Dr. Walensky, let me follow up. I wanted to just 
ask you, following up from Congresswoman Bonnie Watson 
Coleman's question on HIV and AIDS, you know, we have an HIV/
AIDS national strategy and plan. We went around the country 
seeking input from impacted communities to develop this plan.
    And I am wondering if we have an update of a national HIV/
AIDS strategy/plan and if we have a point person in the White 
House who is really putting all of this together and 
coordinating it.
    Dr. Schuchat.
    Dr. Schuchat. Yeah, thank you. I really appreciate the 
attention that Congress gave to race and ethnicity and 
socioeconomic variables. And it was a tragedy at the beginning 
of the epidemic, how behind we were.
    We are not done with improvements, but this has been a very 
high priority for the administration and the CDC, and we have 
made it a priority for State and local public health.
    They are somewhat hamstrung by what data they have access 
to, and so we have been trying to take a systematic approach to 
address both tracking cases, hospitalizations, deaths, as well 
as vaccinations, in a way that gives us complete, actionable 
information.
    We have been using something called the Social 
Vulnerability Index, which has really driven where we try to 
get vaccine access to be improved. And that has borne results. 
We have seen narrowing of the disparities of who is getting 
vaccinated.
    We have deployed through partners, with HRSA and FEMA, to 
get federally qualified health centers out in the areas of 
greatest need, to get the pop-up and the mobile clinics that 
FEMA is facilitating into the areas of need.
    In our pharmacy partnership, we have been reaching much 
greater percentages of individuals who reside in high Social 
Vulnerability Index areas. We have been looking at the ZIP Code 
level, not just the county level, to get those resources out.
    And I just really applaud Congress for saying this is 
important, you have to do it, and us being able to have the 
resources to try to follow up. But it----
    Ms. Lee. Thank you. And I would like--we only have a couple 
minutes left--to get a report back from CDC at some point on 
the status of what we asked for in all of the legislation, as 
it relates to data collection, if that is possible.
    Dr. Schuchat. Yes. And we have been providing a monthly 
update on the data systems, but I think a more comprehensive 
one, I am sure we are happy to follow up on.
    Ms. Lee. Thanks a million.
    Dr. Walensky, what about--and like you mentioned earlier, 
we have known each other for many, many years, as it relates to 
getting a handle on how we achieve an AIDS-free generation by 
2030.
    So have we updated our national AIDS strategy? And are we 
coordinated now with the White House in implementing one, if we 
have one?
    Dr. Walensky. I--well--so what I know is, I used to use 
that AIDS strategy as my research bible. These are where we 
needed to study, so I am very familiar with it.
    I am not familiar--I don't believe we have yet updated it 
in this administration. Of course, this administration for the 
last 4 months has been really focused on making sure that we 
can get out of COVID so that we can focus on other areas of 
health.
    But I do know that, in the months ahead, when COVID is no 
longer what we are doing most of the time, that this is a high 
priority for this administration. I will look forward to that.
    Ms. Lee. Okay. Thank you.
    Madam Chair, I will yield the balance of my time. And thank 
you again, Madam Chair. Thank you.
    The Chair. Thank you.
    Congresswoman Herrera Beutler.
    Ms. Herrera Beutler. Thank you, Madam Chair.
    I wanted to go back to maternal mortality. I know that was 
discussed a little bit earlier.
    In my district, two of my counties, Skamania and Pacific 
County, are considered maternity care deserts. And Lewis 
County, which is near there, is classified as having low access 
to maternity care. And lack of access to care stops women from 
receiving care that they need, especially those struggling with 
mental health and substance use, which I have seen a spike in 
in those counties and in that area.
    So a 2020 or 2018 report found that the rate of maternal 
mortality in the U.S. could be even higher if we consider 
suicide and accidental overdose. And, as you know, our rates 
are not good.
    I wanted to ask how the CDC is going to work to help the 
State MMRCs, our maternal mortality review committees, build 
their capacity to collect data on mental health and substance 
use issues. Obviously, they are investigating the deaths, but I 
want to make sure that we are collecting more and complete data 
to better understand that piece of substance use in mental 
health problems.
    Dr. Walensky. Thank you for that question.
    The high rates of maternal mortality in this country, to 
me, are inexcusable. This is something that we have to address.
    I think you commented on the MMRCs. Not only are we 
interested in focusing on expanding the depth of what they do, 
including mental health, but also the breadth, because they are 
not covering every area, as you note. And so we are interested 
in resources to do both, expand the breadth and expand the 
depth in mental health as well.
    I know you are aware of the Hear Her campaign, the campaign 
to make sure that people know and understand and can see the 
warning signs in the pregnancy period, in the peripartum 
period, and the postpartum period. And those are all parts of 
the efforts that we intend moving forward.
    Ms. Herrera Beutler. Awesome.
    I am going to switch gears to kidney transplant patients 
and probably others who are in a similar, you know, solid-organ 
transplant group who are immunosuppressed.
    You know, most of these folks have spent the last year in 
deep isolation to protect themselves from COVID, and the 
immunosuppressant drugs that maintain their transplant is 
making them uniquely vulnerable to severe COVID infection.
    And now, as the vaccine becomes widely available, it has 
been reported that patients on these immunosuppressants 
obviously may not be creating the antibodies anticipated after 
receiving the vaccine.
    What is the CDC planning to do for these communities who 
are following all the guidelines, getting vaccinated, but still 
may not be protected?
    Dr. Walensky. Thank you. I cared for these patients last 
year, so I am deeply aware of, following these patients, their 
worse COVID outcomes and now the challenges associated with how 
we care for them moving forward, given the vaccine may not be 
protective.
    We know this is true of a lot of vaccine-preventable 
diseases, both in the oncology world before transplant as well 
as in the transplant world as well. And there is a whole 
discipline of transplant infectious diseases for exactly this 
reason.
    And, in fact, what you are raising is not unique to kidney 
transplant. This was studied out of Hopkins; Dr. Dorry Segev 
demonstrated it is many different kinds of transplants. And it 
is not just unique to transplant. They also demonstrated that 
dialysis patients, even before they were transplanted, didn't 
have as robust an immune response.
    We continue to learn an extraordinary amount about these 
vaccines, who they protect, how long it lasts, and what we can 
do about it.
    We have very much indicated that we will continue to need--
that those patients, in order to remain protected, will 
continue to need to mask until we understand this further for 
their own health.
    Ms. Herrera Beutler. I think when it comes to the masking 
piece--you know, one of my family members is immune-
compromised, and I also have small children. So I understand 
that tension between public and the need for my younger kids to 
have that access to social/emotional development, but also want 
to protect, you know, one of my other kids, who, obviously, a 
vaccine isn't going to do it. So I understand this.
    I think the data really has to lead us. And that is a 
really easy thing to say, considering I recognize there were 
challenges with the last administration and politics. There are 
challenges with this administration and politics. That is the 
name of the game. But making sure that you, as the Director, 
the CDC Director, that it is all backed up with policies based 
on the data, I think is going to give us the best path forward.
    No one knows all the answers on this. I don't think anybody 
is expecting you to do that. But the trust, to me, is the most 
important thing, is making sure I know I can trust the data and 
the recommendations that are coming out and I can back those up 
at home with my constituents as well. So thank you for that.
    Dr. Walensky. And maybe what I will just add is, for those 
who can't get vaccinated or for those who are not going to have 
a robust immune response, the best protection we as a society 
can give them is to have everybody else around them vaccinated.
    Ms. Herrera Beutler. That is true. I had my shot.
    Thank you.
    The Chair. Thank you.
    Congresswoman Clark.
    Ms. Clark. Thank you.
    And staying on children and the pandemic for a moment, we 
know that kids are at a lower risk for severe infection, but my 
understanding is that COVID-19 has also become one of their top 
10 causes of death in this country, which is, of course, a 
cause for alarm.
    What do you see as the benefits of vaccinating our children 
and youth? And when do you expect to have enough safety data 
available to vaccinate a child of any age?
    Dr. Walensky. Thank you for that question, because I do 
think that some of the data and numbers are hard. You know, it 
is the case that a young person may be less likely to die of 
COVID-19 than an old person. But a young person is less likely 
to die of anything than an old person. And so comparing these 
are not always easily compared.
    And when you say, like, it is one of the top 10 causes of 
death among young people, that, I think, really does highlight 
the importance of protecting our children.
    And so, you know, of course I want to see what the clinical 
trials demonstrate and what the data shows on the safety, as 
they do these scaled-down trials, down from age 12 to age 9, to 
age 6, to age a year. As we look at those and we see the trial 
data that demonstrate they are both safe and effective, I think 
there is an extraordinary role for vaccinating our children to 
protect their own health, to protect their family's health, and 
to protect their community's health.
    Ms. Clark. Do you have any sense of a timeline, or is that 
just too hard to really know at this point?
    Dr. Walensky. My understanding is they are looking for a 
timeline of late fall, early 2022, is the last that I have 
heard. I don't know whether that will be the entire spectrum or 
whether that will be, like, down to age 9 or age 6.
    Some of this really--I hate to say it--it depends. You get 
outcomes in these trials when people, you know, in the placebo 
arm get infected. If there is less disease out there, you have 
less infections in the placebo arm. So, really, it does depend 
on where we are with the pandemic too.
    Ms. Clark. Okay.
    I also wanted to talk to you about, recently, the World 
Health Organization urged that wealthy countries, like the 
U.S., postpone vaccinations for children in order to donate 
more doses to COVAX, the vaccine sharing initiative.
    Is your agency concerned that vaccinating our children will 
detract from participating in being a partner and ending the 
global pandemic? And, sort of, how are you approaching this 
balancing act?
    Dr. Walensky. I think we have to do both.
    I think we were the country with the largest number of 
deaths across the world due to COVID-19. This was a ``put on 
your own face mask so that you are able to help others,'' and 
that is what we are working to do right now.
    We are actively scaling up in our efforts not only to 
provide funds to COVAX but also to provide vaccine, as I 
mentioned, the 80,000,000 doses.
    We at CDC are now working as those doses get donated and 
implemented with countries so that we can help them in 
immunization programs, help them with vaccine confidence, help 
them with adverse outcome events, surveillance, and to do all 
the work that we have been doing here in this country scaled up 
around the world.
    Ms. Clark. Great. Thank you.
    And in my brief minute left, I want to go back to talking 
about data collection. And we know extensive evidence showing 
communities of color are disproportionately impacted.
    Dr. Schuchat, I wonder if you can tell me how CDC's data 
collection has changed, and how are you working to make sure 
that we are collecting impact data on communities of color and 
disaggregating that data?
    I am sorry. There is, like, no time left, basically.
    Dr. Schuchat. That is all right. This is such an important 
issue. If we don't know where the problems are, we can't 
address them. And so the public health data modernization 
effort needs to reach every community with trust and with 
skilled systems--you know, skilled people working on skilled 
systems.
    We have made progress this past year with increased 
completeness of race/ethnicity data. We have much more timely 
mortality data now. The laboratory reporting has gotten to be 
quite speedy, but it is usually missing all the information we 
are interested in. So some of our highest-yield focus areas now 
relate to electronic health records and other data systems that 
can be linked to the public health information so that we can 
have complete, actionable, timely data.
    So a lot of progress, but a lot more to do. And we do think 
this really needs to go beyond COVID, because the next thing is 
not going to be COVID. We are not done with this, but we can't 
develop a beautiful, perfect, pristine system for one disease 
and then have everything else fall behind.
    You will recall with the EVALI lung injury problem, just a 
couple thousand cases really exhausted our data capacity. Now 
with many millions of cases of COVID, we have learned that we 
have to scale, we have to have the systems and the workforce 
that can handle them.
    Ms. Clark. Thank you.
    My time has expired. I just want to thank you again, Dr. 
Schuchat, for your remarkable service. We are very grateful.
    Thank you, Madam Chairwoman.
    The Chair. Thank you.
    Congressman Cline.
    Mr. Cline. Thank you, Madam Chair.
    I understand the need to ensure that we vaccinate as many 
as possible. And, in considering that, we also want to make 
sure that our children are kept safe. But I am concerned that, 
in the effort to keep children safe, by going beyond 
vaccinations, to continuing to keep lockdowns in place, 
continuing to keep mask requirements in place--my colleague 
from Washington spoke to it earlier--we are doing just as much 
harm as we are potentially doing good to these children.
    One thing we do need to remember is that, when we are 
talking about COVID deaths, of the 500,000 deaths in the United 
States involving COVID-19 as officially reported by CDC, 238 
have been in children 17 and younger. That equals 0.04 percent 
of all COVID-19 deaths reported in the United States.
    So we do have to make sure that, as we consider protecting 
our children, we also consider the effects of locking down too 
much, keeping them out of harm's way in excess.
    And, to that end, I would ask, do you have statistics on 
the suicide rates of children over the past year and how much 
that has risen?
    Dr. Walensky. Thank you for that question. I don't have 
them off the top of my head.
    My understanding is that there have been increase in mental 
health challenges with children, increase in emergency 
department visits. It is not yet clear, and the research will 
show in the months and years ahead, whether and how much those 
are related to lockdowns or other adverse childhood events that 
are associated with this pandemic, such as food insecurity and 
parents losing jobs and whatnot.
    One thing I do want to highlight--and I want to just make 
sure you understand we are aligned--is, I very much believe 
that all schools should be open in person, full-time, 5 days a 
week, come the fall.
    And we have put extraordinary resources and measures and 
outreach to make sure that that can be the case, through 
teacher vaccination through the month of March, which was able 
to vaccinate over 80 percent of teachers, and through testing 
initiatives in places that cannot vaccinate younger children. 
We have routine screening testing in the schools--extraordinary 
resources and efforts that are science-driven, so that we can 
make sure that our schools are not only open full-time in the 
fall but are safe to do so.
    Mr. Cline. Okay.
    I want to shift over to the study that you all are going to 
be undertaking into gun ownership. The last study you all 
undertook was in 2013, I believe.
    I am concerned about some bias within your organization 
regarding gun ownership. So I want to confirm right from the 
start that underpinning this study will be a recognition of the 
right to bear arms as a basic human right established in our 
Constitution and affirmed in D.C. v. Heller.
    Dr. Walensky. Congressman, I don't know the specifics of 
that study. That is not one that I am familiar with. I am 
certainly happy to have our staff get back in touch with you to 
discuss the details.
    Mr. Cline. Okay. Well, can you commit to me that that will 
be an underpinning in the study that your organization 
undertakes as a result?
    Dr. Walensky. You know, I would like to understand and know 
the study before I speak to it.
    Mr. Cline. Well, you all were just appropriated funds to 
study gun safety.
    Dr. Schuchat. Yeah, maybe I can clarify.
    In 2020, we received funds to be able to reinitiate 
proposals for research on firearm safety, gun violence, et 
cetera, and have the----
    Mr. Cline. And when was the last one?
    Dr. Schuchat. Yeah, you are right that this was suspended 
since the 1990s, I believe.
    Mr. Cline. 2013 was the last one that came out, I believe. 
The Obama administration issued an executive order to conduct a 
study regarding----
    Dr. Schuchat. Yeah, that I am not--I am not familiar with 
the details.
    But what I can say is that we do not do advocacy. We are 
funding evidence-based research. And the funds for research 
that we have put out have followed the research gaps that were 
identified by the National Academy of Medicine. So that is----
    Mr. Cline. Okay.
    Well, in my closing seconds, let me just urge you to speak 
to the benefits, in addition to any risks associated with gun 
ownership, that law-abiding gun ownership provides to society 
as a whole by the defensive use of guns by crime victims as a 
common occurrence.
    Although exact numbers do remain disputed, defensive gun 
usage by victims are at least as common as offensive uses by 
criminals. Estimates range from about 500,000 to more than 
3,000,000 per year, in the context of about 300,000 violent 
crimes involving firearms back in 2008.
    So there is a way to look at this issue from a balanced 
perspective, and I would urge you to do so.
    Thank you. I yield back.
    The Chair. Thank you.
    And if I may comment to my colleague, because it has been 
on my watch in which we have really held the first hearing--and 
please understand this--it is gun violence prevention research. 
And it is about the public health crisis. And the amount of 
research has been--there has been no research in the same way 
that we have dealt with automobile accidents and crashes, et 
cetera, and what that did in terms of helping to prevent the 
loss of life.
    And this is research that is--I guess it was our colleague, 
Congresswoman Lawrence, who talked about a public health crisis 
in this area. And that is what the research is focused on.
    I will give you--and we had an entire hearing, and I am 
happy to provide you with the transcript of that hearing, but 
we are not looking into--or the dollars appropriated were not 
looking at gun ownership. The issue is, how do we--there are 
more suicides than homicides. Why do we have suicides? And 
those suicides are of the highest number with our veterans. Why 
is that happening? If we can store guns, as people across the 
board from wherever position are, in a better, safer way, would 
that cut down on gun violence?
    So that is the basis of the--and we can provide, again, as 
I say to you, what is in the legislation, the language of the 
legislation which lays out what the scope and the mission of 
the resources are for the gun violence prevention research.
    And, with that, let me recognize Congresswoman Frankel.
    Ms. Frankel. Thank you, Madam Chair.
    Yeah, I mean, sadly, as we are speaking here today, there 
is a mass shooting happening right now in California, in San 
Jose.
    Madam Chair, I just want you to know that I actually live 
in Florida. I don't know if you knew that, but I do.
    The Chair. I know.
    Ms. Frankel. There have been so many questions, so, to our 
guests--thank you very much--if this has been asked, just say, 
okay, you missed it.
    This whole issue of the vaccine passports have been a 
little controversial, especially in my State where I live, 
Florida. And I would just like to get your feedback on that, on 
the use of requiring, you know, vaccine passport to go into 
certain establishments or cruises or so forth.
    Dr. Walensky. So the Federal Government has made the 
decision not to use--not to be the leader in vaccine passports 
but has said that local communities, the private sector may use 
it for their industry if they so choose.
    I can envision that there would be certain sectors where 
this would be incredibly helpful. And, for example, cruise 
ships I think would be one of those, where cruises would like 
to be able to know the status of the people who are taking the 
voyage.
    What I will say is that the most important thing is that 
people get vaccinated. And if there are a lot of people who are 
getting vaccinated, the utility of this passport--in fact, if 
everybody gets vaccinated, the utility of these passports is 
nil, right?
    So, really, the most important--the reason that we even 
have to have a discussion about passports is because people are 
not getting vaccinated. But if we can get people vaccinated, 
then the importance of these passports really diminishes 
entirely, or these verification mechanisms really diminish 
entirely. You know--yeah. I will just stop.
    Ms. Frankel. Okay. And if you could get us--maybe someone 
on the staff can get us that confidence hotline number, that 
would be helpful.
    Dr. Walensky. I would be happy to do that.
    Ms. Frankel. I am going to just switch the subject for a 
moment, and I want to talk a little bit about domestic 
violence. Because I know that you have a program; I think it is 
called DELTA. You also manage the Rape Prevention and Education 
Formula Grant. And I would like to ask you a little bit how 
that is going, what kind of progress is being made.
    Dr. Schuchat. You know, these are such difficult issues for 
the individuals involved and those who love them. You know, CDC 
has been developing technical packages, the toolkits of what we 
know works, the evidence-based, and facilitating that to be 
used by communities around the country.
    And we have funded additional programs to, sort of, scale 
up these efforts. You know, things are different in one place 
or another, and sometimes, you know, whether it is rural or an 
urban area, the nature of the challenges are complex.
    The team working on this is incredibly dedicated and 
empathetic in their carrying out the research efforts, but 
mainly what we are doing is supporting programs to implement 
evidence-based strategies.
    Ms. Frankel. Thank you.
    I will give one softball question. I know we have been 
talking a lot about COVID and AIDS and other diseases and so 
forth. What, in your opinion, are the top healthcare issues 
that face Americans today?
    Dr. Walensky. I am not even a good hitter, but I am going 
to take a swing.
    You know, we need to bolster our public health 
infrastructure--our workforce, data, our labs.
    We need to work on health equity in this country. 
Everything that we do has to be founded in health equity in 
this country.
    We obviously need to get through this COVID-19 pandemic and 
get everyone vaccinated.
    And, you know, we have a lot of work to do in opioids. We 
have a lot of work to do in HIV. We have a lot of work to do in 
mental health. We have a lot of work to do in health losses 
that we saw during this pandemic. Eleven-point-seven million 
childhood vaccinations have not been given.
    And so I look forward in leading this agency through this 
pandemic and to address all of the public health infrastructure 
of this country.
    Ms. Frankel. Thank you so much, everybody. I am going back 
to the beaches.
    Dr. Schuchat. Wear sunscreen.
    Ms. Frankel. Maybe this weekend.
    The Chair. We will get into that issue as well, Lois.
    I don't know that there are any other members with 
questions, because if there are not, what I would want to do is 
yield to Congressman Harris and recognize you for any closing 
remarks you would like to make, Dr. Harris.
    Mr. Harris. Yeah. Thank you very much, Madam Chair.
    And, as usual, you know, some of the hearings we have in 
this subcommittee are the most fascinating hearings, I think, 
in all of Congress, to be honest with you.
    And I want to thank again the doctors for being with us 
today. I want to say that the CDC, obviously--you know, look, 
the CDC plays an incredibly important role in the interface 
between science and the American public to a large extent. The 
American public looks to leadership in the CDC, grounded in 
science.
    You know, for an example, I am glad to hear that the 
Federal Government is not going to get involved in vaccine 
passports. Because we have to admit, there is no data that 
vaccine passports would contribute anything right now. There is 
just no data. Now, it might, and it might be tempting to think 
it would. But it was very tempting to think the fomite 
transmission was also very, very important at the beginning. It 
kind of made sense. Look, I used all the hand cleaner in the 
world. It turns out that is not really as important as we 
thought. But there is a big difference between making someone 
carry a vaccine passport and making someone clean their hands 
with hand sanitizer.
    And I think that this is where the difficulty lies in 
public health and, kind of, treading that fine line between 
what really will help people and recognizing that there are 
civil liberties in this country. And that is the best way I can 
explain it.
    And, again, Dr. Walensky, she said, I am more than happy to 
help staff vaccine clinics, and I have done it. But, in the 
end, it is an individual's choice to get this vaccine, because 
it is an EUA; it is not an FDA-approved vaccine. I encourage 
the vast majority of people I speak to to get it, but, in the 
end, it is their decision.
    And I think the CDC has taken a tremendous step in their 
mask mandate removal or mask guidance removal for people with 
vaccines. Because I think that that engenders a lot of 
confidence in Americans. Finally, a lot of Americans I meet 
would say, ``Wow, yeah, my common sense is, I got in line, I 
got the vaccine, now I should be able to take my mask off,'' 
and now our policies are aligned on that.
    And I think that sent a very important signal. I think that 
is why we are approaching the 70-percent mark in adults being 
vaccinated. And, of course, you know, that combined with the 
natural immunity, we should be pretty near herd immunity, and I 
think that is what the figures are beginning to show now.
    So thank you all for the work you do. It is thankless work. 
As has been pointed out in your testimony, public health 
officials are underpaid relative to their skill and training. 
This leads to some problems, there is no question about it. 
There is no easy solution. But hopefully some of the budget 
things you discuss for the fiscal year 2022 budget will get us 
on a better path into getting the public health workforce that 
we need for the 21st century.
    And, again, Madam Chair, thank you again for a fascinating 
hearing, and I yield back.
    The Chair. I want to thank Dr. Harris for his comments.
    And, I mean, I think I agree, and I--not in a self-serving 
way, but I think that this subcommittee has the best hearings. 
And I think, between yesterday and today, there really is--I 
used the word yesterday ``exhilarating.'' I mean, what we 
learn, you know, and what both the NIH and the CDC can do to 
save lives, to keep people healthy in this country is quite 
remarkable. And I think it is a hallmark of the United States, 
in terms of our healthcare system.
    I am going to just--and I am going to ask both Dr. Walensky 
and Dr. Schuchat to be absolutely, singularly, like, in a 
nanosecond: What keeps you up at night?
    Dr. Walensky. Variants and the concern that people won't 
get vaccinated and the fact that we are not serving everybody 
in the country equally.
    The Chair. Yeah. Okay.
    Dr. Schuchat.
    Dr. Schuchat. I think we have to remember the rest of the 
world, and that while it is getting better here, there are many 
places at risk. So, until we are all out of this, none of us 
are out of this.
    The Chair. Uh-huh.
    Thank you. Thank you very, very much. Really, I think we 
covered some very important topics today.
    And I just wanted to say this: You know, historically, the 
CDC has been the trusted voice in leading the response to 
public health crises. And I will say this--and, look, whether 
it was Ebola, Zika, lead poisoning, and so many others. But I 
think we saw a recent departure from that standard.
    So I want to just say a thank you, a real thank you, to 
both of you and CDC for returning the CDC to be that trusted 
voice and relying on the science and the data that is necessary 
to create the confidence in this country that we do have the 
agency that they can take a lead from. People want to know the 
truth, they need to be given the truth, and then we could look 
to how we can direct them.
    I would again add that COVID exposed a number of realities 
in this country. We need a robust public health infrastructure. 
We can't go back to where we were, and we have to go forward.
    So we look forward to receiving the comprehensive 
President's budget. That is later this week. And then the 
subcommittee has the challenging task of addressing so many 
critical issues included in your bill.
    And it is remarkable, the range of issues that you look at. 
We talked about some of them today--you know, maternal 
mortality. But you do food safety, you do so many other things, 
you know. And it is immunization and mental health and opioids 
and HIV, and doing all of that work at the same time of dealing 
with a pandemic.
    So we want to provide the resources that you need, and we 
will continue to fight for that sustainability that I think has 
come through as the thread of this hearing today. And that, for 
the CDC to do the job that we want them to do, you need to have 
the continued resources, not for just this pandemic, but for 
whatever else comes to pass for this country.
    So thank you.
    And, with that, this hearing is adjourned.

                                      Wednesday, November 17, 2021.

              U.S. ROLE IN GLOBAL COVID-19 VACCINE EQUITY

                               WITNESSES

GARY DISBROW, DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT 
    AUTHORITY, DEPARTMENT OF HEALTH AND HUMAN SERVICES
DAVID A. KESSLER, CHIEF SCIENCE OFFICER, COVID-19 RESPONSE
LOYCE PACE, DIRECTOR, OFFICE OF GLOBAL AFFAIRS, DEPARTMENT OF HEALTH 
    AND HUMAN SERVICES
    The Chair. This hearing will come to order.
    As this hearing is fully virtual, we must address a few 
housekeeping matters. For today's meeting, the chair or staff 
designated by the chair may mute participants' microphones when 
they are not under recognition for the purposes of eliminating 
inadvertent background noise.
    Members are responsible for muting and unmuting themselves. 
If I notice that you have not unmuted yourself, I will ask you 
if you would like the staff to unmute you. If you indicate 
approval by nodding, staff will unmute your microphone.
    I remind all members and witnesses that the 5-minute clock 
still applies.
    If there is a technology issue, we will move to the next 
member until the issue is resolved, and you will retain the 
balance of your time.
    You will notice a clock on your screen. That will show how 
much time is remaining. At 1 minute remaining, the clock will 
turn to yellow. At 30 seconds remaining, I will gently tap the 
gavel to remind members that their time has almost expired. 
When your time has expired, the clock will turn red, and I will 
begin to recognize the next member.
    In terms of the speaking order, we will be going with the 
chair and ranking member; then members present at the time the 
hearing is called to order will be recognized in order of 
seniority; and, finally, members not present at the time the 
hearing is called to order.
    Finally, House rules require me to remind you that we have 
set up an email address to which members can send anything they 
wish to submit in writing at any one of our hearings or 
markups. That email address has been provided in advance to 
your staff.
    And, with that, I want to acknowledge Ranking Member Cole 
and all of our colleagues for joining this morning.
    And a thank you to our witnesses--Dr. Kessler, Dr. Pace, 
Dr. Disbrow--for speaking with us on our Nation's role in 
global COVID-19 vaccine equity.
    Let me just start by saying that I am disturbed. I am 
disturbed by the general lack of urgency in ensuring that every 
person across the world has access to the COVID-19 vaccine. 
This pandemic has already sickened 250 million people and 
claimed more than 5 million lives across the globe. People are 
dying every day, and, yet, little progress has been made to 
deliver more vaccines to the countries that are being left 
behind.
    Even as many of us in the United States are receiving 
booster shots, fewer than 5 percent of people in low-income 
countries have received a single dose. By some estimates, many 
people in low-income nations will not have access to a 
vaccination until 2023 without significant increases in 
worldwide vaccine production and distribution.
    I do sincerely appreciate the work that the Biden 
administration has done. After all, this administration has 
been delivering vaccine doses abroad since June. And, so far, 
United States has donated more vaccines than all other 
countries combined.
    It is also encouraging that President Biden has pledged to 
donate at least 1.1 billion doses of vaccine by the end of next 
year while calling for 70 percent vaccination in all countries 
by fall 2022.
    I am particularly proud of the work that my friend, Dr. 
David Kessler, who joins us here today, has done both during 
this pandemic and for many years as former Commissioner of the 
Food and Drug Administration and under the leadership of three 
American Presidents. I welcome his testimony, and I applaud his 
commitment to the health and the safety of the people.
    I just might add here that I was pleased, Dr. Kessler, to 
hear the administration's announcement today of a new 
initiative to invest in domestic vaccine production to increase 
vaccine by 1 billion doses per year. That is the kind of effort 
we are looking for, but also wanting to hear is how we are 
going to accomplish that and how we are going to oversee that 
distribution as well.
    I also want to note the important role that BARDA has 
played during this pandemic, working extensively to scale up 
production of everything from PPE and at-home tests to vaccine 
and therapeutic treatments. I am also grateful that BARDA has 
used funds provided by Congress to work with COVID vaccine 
manufacturers, such as Moderna, and that it was BARDA's many 
years--BARDA's many years of support for mRNA, the platform 
technology, along with decades of basic research at the NIH 
that enabled Moderna to produce the COVID-19 vaccine.
    And I want to commend the efforts of Dr. Pace, whose Office 
of Global Health will be instrumental, along with USAID and 
CDC, in addressing vaccine equity efforts on the ground.
    But, on the other hand, it is shocking to me that we have 
not received full and unfettered cooperation from all of our 
partners in this effort, including the private companies, such 
as Moderna, making billions of dollars from U.S. taxpayers.
    The fact of the matter is every day low-income countries 
remain vulnerable to COVID-19 is another day for the virus to 
mutate and to adapt. And, if we fail to ensure their access to 
vaccines, those countries will become the breeding grounds for 
new variants, variants that may be more transmissible or, even 
worse, vaccine resistant.
    I will be blunt. I do not believe we are moving fast 
enough. Unless we take a more active role in significantly 
increasing vaccine production and accelerating distribution 
worldwide, sharing technology and expertise, and scaling up 
health system capacity, and strengthening multilateral 
institutions, we are essentially shooting ourselves in the 
foot, putting ourselves collectively at the risk of a fifth, 
sixth, or seventh wave.
    We absolutely need to accelerate the production of COVID 
vaccine by any means necessary, including by invoking any legal 
authorities at our disposal to compel these vaccine companies 
to work with partners in the U.S. and throughout the world. 
Quite frankly, it is not just our moral imperative to ensure 
the health and safety of our friends across the globe; it is in 
our own self-interest.
    While the United States, as I noted earlier, has donated 
more vaccines than all other countries combined and has become 
a powerful leader in the fight to vaccinate the world, why is 
it taking so long to manufacture the vaccine? Why are we as a 
Nation being held captive by a botched Trump administration 
contract, one that allowed Moderna to ignore the involvement of 
the NIH and benefit from millions of dollars in taxpayer funds?
    Just this week, it was announced that Moderna is close to 
making an agreement to pledge doses to low- and middle-income 
countries in 2022. This is a positive step forward, but not 
enough. For the life of me, I cannot understand why we are 
beholden to this company. People are dying. Time is of the 
essence. And, in the midst of it all, Moderna is making 
billions of dollars, controlling vaccine production and 
negotiations of a lifesaving vaccine that HHS helped them to 
create.
    This is unacceptable. NIH and BARDA must be aggressive in 
protecting and asserting legal rights to their work. This 
administration must be aggressive in pursuing every option to 
work around that botched contract and to use every tool at its 
disposal to accelerate vaccine production, including the 
Defense Production Act. And President Biden must be aggressive 
in compelling other countries to back the TRIPS waiver, which 
would allow more countries to manufacture more COVID-19 
vaccines.
    When the World Trade Organization meets later this month 
for its 12th ministerial conference, I will be watching closely 
to ensure the proposal on temporarily waiving some intellectual 
property rights rules under the TRIPS agreement is accepted.
    I know these are serious and they are complex issues that 
cannot be easily resolved, but I also know that failure is 
simply not an option. This pandemic will not be over until it 
is over around the world.
    I hope that, through this hearing, we can gain some clarity 
as to why we are not moving fast enough, why we are enabling a 
system that allows pharmaceutical companies like Moderna to 
profit off of global suffering and how exactly we plan to 
vaccinate 8 billion people as soon as humanly possible.
    With that, let me turn to my good friend from Oklahoma, the 
ranking member of the committee, Congressman Tom Cole, for any 
opening remarks that he may have.
    Mr. Cole. Thank you very much, Madam Chairman.
    And, just before my remarks, a quick housekeeping piece of 
advice to you as you preside over. I may have to leave at some 
point because of my duties in Rules, so I might not be here at 
the end, but I certainly am going to stay for as much as 
possible.
    Madam Chair, the United States' investments in biomedical 
research and medical countermeasures have paved the way for the 
fastest vaccine ever developed in our Nation's history. These 
strategic investments led by--with Federal support have also 
enabled the U.S. to lead the world in vaccine availability. As 
the President has said, anyone who wants a shot can get one. 
That is a remarkable achievement, and we are fortunate to be in 
such a position.
    I want to thank the thousands of government and private-
sector employees who worked tirelessly to make this reality. 
Operation Warp Speed, in my mind, remains one of the most 
undervalued achievements of the last administration.
    And I want to associate myself, Madam Chair, with your 
remarks about the role our country is playing in trying to help 
other less fortunately situated countries and to get the 
vaccine as rapidly as possible. I think those are important 
goals and important questions need to be raised and answered.
    And I know we are here today to discuss the United States--
what the United States Government can do to bolster global 
supply of coronavirus vaccines. But, before we delve into that 
topic, I want to spend a few minutes on a fact that I find 
deeply troubling.
    The Build Back Better legislation introduced in the House 
contains just $3,000,000,000 for pandemic preparedness. That is 
less than 0.2 percent of the total. Let's pause and think about 
that. Nearly $2,000,000,000,000 in spending, and just 1.7 
percent--that is just less than one-fifth of a percent--is 
dedicated to preparing for the next pandemic.
    Of that amount, less than half is dedicated to funding for 
public health and preparedness research, development, and 
countermeasures capacity. Such a de minimis amount dedicated to 
so critical a function should be unacceptable to everyone.
    I have said multiple times that you are far more likely to 
die from a pandemic than a terrorist attack, and, sadly, the 
results of the last 2 years have shown how devastatingly true 
that is. I would hope the majority's flagship effort to build a 
better tomorrow after a global pandemic that has shook the 
world would recognize the need to invest in a substantial way 
in biomedical and biodefense research enterprise.
    I find this omission another sign of shortsightedness that 
we see throughout the legislation with short-term extensions 
and unreasonable policies that most Americans do not support.
    I also want to acknowledge, however, that the chair's 
markup contains six times as much funding compared to the Build 
Back Better bill, and that is with nearly seven times less 
money.
    Now, while I still believe we need to invest more in 
biodefense infrastructure, I am pleased to see the levels 
proposed in the chair's fiscal year 2022 appropriations for 
this subcommittee. I know our chair strongly supports access to 
childcare, improving our Nation's schools, and paving a way to 
affordable higher education for all children.
    She also recognizes, in addition to human infrastructure 
investments, that we cannot neglect the biomedical and 
biodefense infrastructure. She supported these programs in her 
markup, and I hope she sustains that level of support going 
forward.
    We have always found these areas of agreement to serve as 
the basis for our partnership for 6 years running. I also want 
to recognize that, in her annual funding bill, she is proposing 
nearly the same amount of funding as what was put forward in 
the Build Back Better bill, which covers up to 10 years.
    I think this fact shows this subcommittee, possibly more 
than any other, understands how important these programs are. 
Underinvestment here ensures the Nation will be less prepared 
for the next outbreak.
    I led with the importance of the continuing investment in 
biomedical research and programs like BARDA because it was past 
funding that enabled the United States to be in the--be the 
current leader by far in global COVID vaccination donations. 
U.S. has donated and delivered more than 235 million doses of 
COVID vaccines to more than a hundred countries, and I am 
pleased at the even more aggressive plans that the 
administration has unveiled in recent days.
    In addition to efforts by the Federal Government, vaccine 
manufacturers have also made commitments to increase production 
and availability to ensure vaccination becomes a global 
reality. As proud as I am of our Nation leading the way, United 
States should not have the sole responsibility for vaccinating 
the global population. It is a shared problem and a shared 
responsibility.
    In addition, in my opinion, the Department of Health and 
Human Services should not be responsible for vaccinations 
abroad. I understand the agency may have a supporting role to 
the Department of State and USAID, but events over the last 18 
months have shown that we have enough challenges domestically 
for HHS to focus on, and it should not try to achieve 
objectives beyond its responsibility and capability.
    I would like to end by noting that now is the time for us 
to be looking at opportunities for the next generation of 
vaccine technology, development of new therapeutics, and more 
affordable diagnostics. I know some of those efforts are 
underway, but too much focus has been given to the continuing 
of the status quo.
    If we continue that approach, we will not achieve global 
vaccination for years to come. We need to look to new 
technologies to achieve our goal and should not be neglecting 
those investments now.
    I also think we need to expand our focus to future threats. 
Now is the best time to leverage what we have learned about 
COVID to begin research into new countermeasures and potential 
pathogens. We know the devastation that can be caused by a new 
virus.
    We need to do a better job to identify future threats on 
the horizon and work on mitigation now. Waiting for the next 
virus to strike and hoping it is far into the future is 
foolish. The more we shortchange our preparedness today, the 
less prepared we are when what may be--just for what may be 
just around the corner.
    I want to thank our witnesses for their time today, and I 
look forward very much to their testimony.
    With that, Madam Chair, I yield back my time.
    The Chair. Thank you very, very much.
    And now what I would like to do is to turn to our 
witnesses: Dr. David Kessler, who is the chief science officer 
of COVID-19--the COVID-19 response; Ms. Loyce Pace, director, 
Office of Global Affairs, the Department of Health and Human 
Services; Dr. Gary Disbrow, director, Biomedical Advanced 
Research and Development Authority, BARDA, the Department of 
Health and Human Services.
    Our first witness is Dr. David Kessler. Your full written 
testimony will be included in the record, Dr. Kessler.
    You are now recognized for 5 minutes for your opening 
statement, and welcome, welcome to the committee.
    Dr. Kessler. Thank you so much, Chair DeLauro.
    Chair DeLauro, Ranking Member Cole, distinguished members 
of the committee, I am David Kessler. I am honored to be 
serving as chief science officer for the COVID-19 response. 
Thank you for having me here today and for the opportunity to 
testify before you.
    I have the great privilege of working closely with my 
colleagues from the Department of Health and Human Services--
Director Pace, Dr. Disbrow--who are also appearing before you 
today.
    The United States, by far, is leading the effort to 
vaccinate the world. We have proudly donated more doses than 
all other countries combined. We will continue and must 
continue to donate more and more doses.
    Currently, we are donating 1.2 billion doses to the world. 
This includes the U.S. Government's groundbreaking deal to 
deliver 1 billion donated doses of Pfizer vaccine to countries 
in need through COVAX. As of today, 250 million donated doses 
have been shipped to 108 countries. For every one shot we have 
put in the arm of an American, we are donating about three 
shots globally.
    Because of what you have allowed--because of what you have 
allowed HHS and USAID to do, we are spending over 
$11,000,000,000 on global vaccine supply. And we continue to 
encourage our international partners to share more doses and 
expedite the delivery of those already committed.
    Today, we are announcing that, to meet short- and long-term 
needs both domestically and globally, the United States 
Government is seeking to enter into a historic partnership with 
one or more experienced pharmaceutical manufacturers to 
increase the mRNA vaccine U.S.-based production capacity for 
domestic and global use by at least 1 billion doses annually, 
not later than the second half of 2022. This will allow us to 
address the current COVID-19 pandemic and prepare for future 
pandemic response efforts.
    I want to be clear that I personally continue to engage 
vaccine manufacturers to increase production and availability 
of vaccines for low- and low-middle-income countries. Chair 
DeLauro, we share--we share your urgency and the passion to 
make sure that we are a leader--the leader in making available 
vaccines for low- and low-middle-income countries.
    As part of those conversations, we negotiated a deal with 
Moderna and the African Union where the United States defers 
deliveries of 33 million doses, allowing the AU to buy up to 
110 million Moderna vaccines at a reduced rate negotiated by 
the United States.
    We also broke through a logjam and brokered a deal between 
Moderna and COVAX enabling the two parties to reach an 
agreement where COVAX will purchase, to date, 56 million doses 
of Moderna vaccine.
    Moderna is also retroactively discounting doses already 
sold to COVAX, all because of the United States Government's 
intervention. We have told Moderna that we expect them to help 
fill the remaining COVAX shortfall. We expect that the number 
of doses that Moderna will make available to COVAX will 
increase in the next few weeks.
    Let me tell you about another step that we took that I 
think is a first. The United States Government brokered a 
historic deal with J&J and COVAX to facilitate the first-ever 
delivery of COVID-19 vaccines to people in conflict zones and 
other humanitarian settings that cannot be reached by 
government vaccination campaigns.
    The USG and COVAX worked with J&J to waive liability for 
doses, pioneering a novel legal approach that will allow COVAX 
to give donated doses to NGOs to administer to people in these 
conflict zones and other humanitarian settings.
    The U.S. also negotiated a path-breaking deal to make 
300,000 doses of J&J available to humanitarian workers around 
the world.
    As the Biden administration continues this critical work, 
we also need the world to do more. We need every other country 
to step up against this virus like the United States is doing.
    Thank you very much, Chair DeLauro. I am happy to answer 
your questions.
    [The information follows:]
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    The Chair. Thank you for your testimony, Dr. Kessler.
    And our next witness is Dr. Loyce Pace.
    Your full written testimony will be included in the record, 
and you are now recognized for 5 minutes for an opening 
statement.
    Ms. Pace. Well, good morning, distinguished members of the 
subcommittee.
    We see the numbers. COVID has caused more than 5 million 
deaths worldwide, more than half of these in low- and middle-
income countries. Vaccination rates in some of these countries 
are in the single digits. Less than 10 percent of the 
population of Africa is vaccinated compared to more than 50 
percent in North America and Europe. We know this is 
unacceptable.
    So I want to thank you, Chairwoman DeLauro, Ranking Member 
Cole, and your esteemed colleagues for convening us today to 
talk about global vaccine equity and the role our government 
should play in driving that.
    Now, two things I want to say upfront. One, this isn't only 
up to us. It is going to take actors from all over the world--
government officials, industry leaders, community 
organizations, philanthropists, and others--to make this 
happen. This is why the President convened those very 
stakeholders this fall and called on them to fulfill their 
promises and help close the global access gap. He issued this 
challenge not only for vaccines, but also for treatments, 
tests, and critical supplies.
    Number two, the U.S. is doing its part, playing a lead role 
and practicing what we preach. At this point, we have donated 
close to 250 million vaccines to more than 100 countries around 
the world, both directly and through partners like COVAX, 
CARICOM, and the African Union. That is millions of people 
protected from this virus, thanks to our commitments and 
action.
    We have engaged governments and companies in Asia and 
Africa to expand manufacturing in those regions, and also 
called for voluntary technology transfer to facilitate those 
efforts.
    Of course, the world needs more, which is why our work 
continues. We are not letting up. Those of us in the center of 
this work know what is at stake if we don't follow through. Not 
only could we face the constant threat of COVID, but we could 
continue to burden our health workforce, supply chains, and 
overall society with an ongoing and seemingly neverending 
pandemic.
    Not only are our efforts practical; they are personal. We 
read the same headlines you do, and we hear those accounts 
ourselves every day. Many of us have lived and worked in 
countries still lacking what they need. Some of us have friends 
and family there, managing an unsettling reality and all-too-
common stories of persistent health disparities.
    HHS staff take calls from colleagues around the world, 
partners with whom we have worked for years, describing what 
life is like without access to vaccines. Those are tough 
conversations, recognizing how great the demand is worldwide. 
But they are easier when we can offer help, and we do.
    Our staff meet with ministries of health about their 
national vaccination campaigns and how to maximize the supply 
they receive. We have engaged foreign regulators and 
researchers so that more product comes to market when and where 
it is needed. And we have worked with policymakers from Africa 
to Asia to Latin America and the Caribbean on real-time 
responses throughout this crisis, helping to establish or 
reinforce health surveillance systems and essential services 
required to succeed.
    So, when Kenya or Mexico needed vaccines, they reached out 
to us. And, when Brazil or India found themselves in crisis, it 
was the same. Whether working through country-based health 
attaches, our hundreds of international staff focused on global 
health security, or contacting the Secretary directly, 
governments around the world look to HHS for solutions to their 
public health problem. That has been as true in this pandemic 
as any other time.
    Our track record speaks for itself, built on decades of 
international relationships and programs that have been tested 
through multiple health crises, like Ebola, Zika, and HIV. We 
know how to get this right, and we can do this together. It is 
in the spirit of partnership that is critical to showing up in 
the world in a way that matters.
    From day one, the President has talked about the importance 
of international cooperation as part of our COVID response. 
Similarly, his administration is committed to using equity as 
the guiding principle for these efforts, but, while ensuring we 
address health disparities across borders, we must also do so 
within countries.
    We know from our own American experience how vital it is 
that lifesaving innovations are available to those who need 
them. Otherwise, we are all at risk. I want to be able to tell 
a different story, one that has countries not in the tenth 
percentile but meeting our global goal of 70 percent coverage 
for COVID vaccine; a world focused on getting back to life 
rather than fearing another variant or worse.
    I want us all to feel safe again and to remember this time 
as a moment when we did right by one another. We have both a 
strategic imperative and a moral one to deliver what we can 
where we can, working to end this pandemic once and for all.
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    The Chair. Thank you. Thank you very much.
    Our next witness is Dr. Gary Disbrow. Your full written 
testimony will be included in the record.
    You are now recognized for 5 minutes for your opening 
statement. Thank you.
    Mr. Disbrow. Chairwoman DeLauro, Ranking Member Cole, and 
distinguished members of the committee, thank you for your--the 
opportunity to testify today on our efforts to develop, 
manufacture, and procure safe and effective COVID-19 vaccine.
    I am grateful for the opportunity to address this committee 
and appreciate your continued support for the ongoing response 
efforts. I want to start by thanking this committee for the 
funding and support provided to BARDA over the years and during 
this pandemic, and the entire BARDA team for their tireless 
efforts for the last 21 months to develop critical medical 
countermeasures, or MCMs, to develop--address COVID-19.
    BARDA continues to play a critical role in the development 
of vaccines, therapeutics, diagnostics, and other supportive 
efforts to bring forth these lifesaving medical 
countermeasures. BARDA has invested over $49,000,000,000 to 
develop and procure products to address COVID-19, 
$33,000,000,000 in vaccines, $16,000,000,000 in therapeutics, 
and over $500,000,000 in diagnostics.
    To date, BARDA had supported the delivery of over 556 
million doses of vaccine, and over 443 million doses have been 
administered; the delivery of over 3.3 million treatment 
courses of therapeutics; and over 168 million diagnostic tests.
    BARDA has been proactive in engaging with our stakeholder 
communities since the very beginning of the pandemic, to 
include holding an industry call in January of 2020 with over 
1,500 participants. In that same month, BARDA established an 
MCM portal to act as a single point of entry for parties 
interested in working with the U.S. Government.
    To date, BARDA has received over 4,500 submissions to the 
portal, and interagency representatives have met with over 670 
companies, providing transparent feedback and guidance. BARDA 
made initial investment to jump-start the development of MCMs 
utilizing annual appropriations under advanced research and 
development and pandemic influenza funding.
    We received--we have reviewed our portfolio of partnerships 
and identified proven technologies that could quickly pivot to 
develop COVID-19 products. These initial investments and 
additional investments made once supplemental funds were 
provided laid the groundwork for the portfolio of products 
supported under Operation Warp Speed and now the Countermeasure 
Acceleration Group, or the CAG. The CAG has been able to 
support development of one licensed vaccine, two vaccines 
granted emergency use authorization, two vaccines that have 
positive phase 3 efficacy readouts, and one vaccine that is 
completing a phase 3 efficacy trial.
    Vaccines are now available for primary series, booster 
doses, third doses for immunocompromised individuals, 
adolescents, pediatrics 5 to less than 12 years of age, and 
studies are ongoing for pediatrics ages 6 months to less than 5 
years of age.
    Development was accomplished in 11 months, providing safe 
and effective vaccine, and represents the best of what the U.S. 
Government and industry can do when we work together. Moving 
forward, these unprecedented collaborations will be critical to 
better prepare the U.S. and the globe for future pandemic 
threats.
    BARDA supported the collaboration between Johnson & Johnson 
and Merck to enhance production capacity announced by the 
President. BARDA provided funding to Merck to modify one of 
their manufacturing facilities, a fill/finish facility, and a 
storage facility to expand domestic production of the J&J 
vaccine for their international effort.
    In addition to the direct support for development of 
vaccine candidates, BARDA has worked with the International 
Development Finance Corporation, providing technical expertise 
for their global investments to expand manufacturing capacity 
for vaccines.
    BARDA initiated efforts to expand domestic manufacturing 
capacity for the critical components that are necessary to 
support population-scale manufacturing of vaccines.
    BARDA has been provided $2,600,000,000 under the American 
Rescue Plan Defense Production Act to expand capacity for raw 
materials, consumables, fill/finish capacity, needles and 
syringes and vials. Expanding production of these vaccine 
components is critical to support expanded domestic and global 
vaccine production.
    As David mentioned, the administration is committed to 
donating over 1.2 million doses of vaccine. Under HHS CAG 
efforts, over 133 million doses have been already donated, and 
an additional 500 million doses are being donated under the 
USAID-JPEO contract. BARDA and JPEO are in discussions for an 
additional 500 million doses of Pfizer vaccine to be purchased 
in a not-for-profit price for donation.
    As David mentioned, we recently modified our contract with 
Moderna to support Moderna's commitment to making vaccine 
available to the African Union at a not-for-profit price.
    Thank you again for inviting me to testify before you on 
efforts within ASPR and BARDA to support the COVID-19 response. 
I look forward to answering your questions and working with my 
team at BARDA and our colleagues across HHS and DOD to end this 
COVID-19 pandemic.
    Thank you.
    [The information follows:]
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    The Chair. Thank you all very, very much for your 
testimony.
    We now will move to questions, and I will start with the 
questions, and I would just--and the questions--these are a 
question, Dr. Kessler, and a couple of followups, but all of 
which I will mention at what time and--at one time in the 
interest of time.
    I will be frank, and you know that I am. We have dealt with 
each other before. The irresponsible, monopolistic behavior of 
Moderna is infuriating. Moderna has made billions in profits 
through an arrangement gifted to the company by the prior 
administration, by the Trump administration, and the company's 
refusal to recognize NIH's role in the development of the 
vaccine.
    Further, Moderna has refused to cooperate, lend its 
expertise to partners that could increase production of its 
vaccine by hundreds of millions of doses. That is unacceptable.
    So my questions are: Why is Moderna able to limit 
production of a vaccine that U.S. taxpayers spent billions of 
dollars to develop and manufacture?
    What is the administration doing to compel the company to 
increase production as well as distribute the vaccine at a 
reduced cost to low-income countries?
    How is the administration going to guarantee that Moderna 
meets all of its commitments?
    Should NIH scientists who were involved in developing 
Moderna's vaccine be listed on the principal patent application 
as coinventors, and should NIH receive coownership interest in 
the vaccine?
    Dr. Kessler. Chair DeLauro, the government's position is 
that mRNA-1273, the Moderna vaccine, was coinvented by 
government and Moderna scientists. However, Moderna has so far 
refused to name the government scientists to the principal 
patent application. Omitting NIH inventors from the principal 
patent application deprives NIH of coownership interest in that 
application and the patent that will eventually issue from it.
    With regard to your questions about what we have asked 
Moderna to do and what we expect, we have gone to the extent of 
actually calling in and discussed this with the chair of the 
board of Moderna, members of the board, as well as the senior 
management of Moderna. Very explicitly, we have asked Moderna 
to do four things.
    One, we have asked them, in the short term, now--not wait 
quarters from now--but to provide the African Union with doses. 
To their credit, they have stepped up. And, with our colleagues 
in the African Union and through the fact that the United 
States basically deferred our doses so the doses could go to 
the African Union, that is happening.
    Number two, we have told Moderna that we expect them to 
help fill the supply gap with COVAX at not-for-profit prices 
with significant doses. We will hear, I expect, over the next 
several weeks the result of those discussions that are 
currently underway between Novavax and Moderna.
    Number three, we have commitment from Moderna to build a 
plant--to build manufacturing capacity on the African 
Continent. That is very important to us.
    Chair DeLauro, you know I chair the Elizabeth Glaser 
Pediatric AIDS Foundation. We have been with you for 30 years. 
We have worked on the continent in HIV, and I understand, if 
there is a manufacturing capacity on that continent, that 
continent will not be last in line. It is just that simple. We 
have Moderna's commitment. We will see what their followup is.
    Lastly, as we testified this morning, we have asked all 
manufacturers with experience in mRNA to help us expand that 
capacity for both global and U.S. needs, for both pandemic and 
for COVID, and we would like Moderna's assistance in there.
    A lot to be done. We are watching closely. The President is 
watching closely. These needs are absolutely essential.
    The Chair. Thank you.
    And I have just a short period of time remaining, but I 
need to ask the question: The NIH scientists, as you offered at 
the outset, that there was a coinvention. Are we going to have 
them labeled and listed as principal patent application as the 
coinventors, and thereby getting coownership interest in the 
vaccine, which, as you know, opens the door to the U.S. being 
able to deal with some of these issues?
    So just--I really want to know. If I can very, very 
quickly, what is our guarantee that that is going to happen?
    Dr. Kessler. That is the United States Government's 
position, Madam Chair.
    The Chair. Okay. I will get back. Just--and I want to be 
able to guarantee. And you said that we have a way in which we 
can talk about further of guaranteeing that Moderna meets all 
of the commitments that it has made, so thank you.
    Thank you, and let me now yield to Ranking Member Cole.
    Mr. Cole. Thank you very much, Madam Chair.
    Dr. Kessler, I just actually had some questions that are 
informational to help me and hopefully the committee get a 
better idea of the task in front of us.
    How much funding remains for the purchase of additional 
doses for the U.S. population, either booster shots for adults 
or for children?
    Dr. Kessler. Ranking Member Cole, just how much money 
remains?
    Mr. Cole. Yeah.
    Dr. Kessler. Can I just ask you to repeat your question?
    Mr. Cole. Yeah. I am just curious what we may need to do 
going forward, how quickly we need to do it?
    Dr. Kessler. So we have assured adequate supply for 
boosters for all Americans, and that is also true for 
adolescents and children. Obviously, you know, the question 
beyond that, you know, variants, I always try to stay one step 
ahead of where we are. But the good news is we really, through 
your help, right--I mean, this is--this should not be 
understated. Okay? We could not have done what we have done in 
providing primary vaccines, boosters, adolescents, now school-
age children, without this committee's help----
    Mr. Cole [continuing]. You are kind for saying that.
    Dr. Kessler. That was essential, and we have done that.
    Mr. Cole. Well, you are kind to say that. I share your 
opinion. This committee, I think, has done an exceptional job 
under our chairman in this regard.
    How about--let me ask--switch now. How much funding remains 
for the purchase of international vaccines, which I know you 
are really focused on? And, again, what do we need to look at 
going forward there to fulfill the commitments that our country 
has made?
    Dr. Kessler. Let me, if I may, Ranking Member Cole, let 
Director Pace answer that question.
    Mr. Cole. Of course.
    Ms. Pace. Well, thanks for this question.
    It is our understanding that we have the funding available 
to fulfill the President's commitment of the additional 500 
million Pfizer vaccines. Beyond that, additional funds through 
the American Rescue Plan are being utilized towards vaccine 
readiness and ensuring those shots get into arms once they are 
delivered.
    Mr. Cole. Terrific. This may be more appropriate to you, 
Dr. Pace. I will let you guys decide who is the best person to 
answer the question. I trust your judgment.
    I am curious, of what we have committed, how much has been 
distributed? And I know there is a lot of logistical problems 
involved in a distribution effort like this. So, if you would 
address that a little bit, too, because I know it is going to 
impact the speed with which you can get what you have out the 
door literally.
    Ms. Pace. Of course. I can try and address some of this, 
and then defer to my colleagues. And so, with this initial 
tranche of 500 million Pfizer doses that is being--that has 
been procured and being distributed by our partners at USAID, 
we have 100 million that has gone out. There will be some--an 
additional 100 million, we hope, by the end of this year, and 
then tracking towards finishing that tranche in the first 
quarter of next year, followed by the additional 500 million 
that the President committed at the summit back in September.
    And I defer to my colleagues for anything I might have 
missed in that regard, Congressman.
    Mr. Cole. Do either of you have additional information you 
would like to provide?
    Mr. Disbrow. Yeah. Ranking Member Cole, this is Gary 
Disbrow from BARDA.
    So, in addition to the USAID doses that Director Pace 
mentioned, for vaccine that was purchased by HHS for domestic 
use, as vaccine supply exceeded the demand, we have also 
donated over 133 million doses to over 95 countries.
    Mr. Cole. Well, I will say--I don't have a lot of time, but 
I just want to thank all of you for your efforts in this 
regard, and I would just ask you to keep the committee abreast. 
I really do worry. We are juggling a lot of balls right now on 
Capitol Hill. And, looking forward in funding, this is a stream 
where I don't think anything should ever be at risk either in 
terms of obviously taking care of our people here, but also 
fulfilling these very important international commitments. We 
want to make sure that you have the resources that you need in 
a timely fashion, particularly given some of the logistical 
problems I think are involved in, you know, dealing literally 
with a global project and conditions that very, very broadly in 
many places are very, very difficult.
    So, with that, Madam Chair, thank you very much, and I 
yield back.
    The Chair. Thank you.
    And Congresswoman Lee.
    Ms. Lee. Thank you very much, Madam Chairman. Thank you, 
Chairwoman. Thank you so much for this hearing, and to our 
ranking member, and to all of our witnesses.
    I think everyone agrees it is imperative that the United 
States lead this fight because we won't be able to end this 
pandemic and Americans will continue to be under threat unless 
we find a way to assist every country in the world to vaccinate 
their people.
    And I wanted to focus on the equity issues today. And I 
guess, Dr. Kessler, you mentioned, if there is capacity on 
the--manufacturing capacity on the continent of Africa, that 
certainly would be welcome and supported.
    But I think--and I guess maybe Dr. Disbrow, you may be able 
to answer this, in terms of the United States providing the 
support for the manufacturing of pharmaceuticals on the 
continent of Africa. I mean, we know that it is going to be--it 
is a challenge, and so how do we increase vaccine manufacturing 
on the continent of Africa using United States' leveraging and 
with the private companies, with the pharmaceuticals? I mean, 
what could be a plan, or do we have a plan? That is the first 
question.
    And then, to Director Pace, let me just ask you: Less with 
regard to CARICOM countries and the continent of Africa, last 
time I looked, it was pretty dismal in terms of the Caribbean, 
in terms of the numbers of vaccine, the percentages that had 
been distributed on the continent of Africa and in the 
Caribbean. And so I would like to find out--and this was about 
a month ago when I looked at those numbers. It was horrible.
    And so what is the problem? What is the bottleneck, and are 
we getting any better with countries where there are, quite 
frankly, the descendants of Africa, because, once again, we see 
the inequities in Black and Brown countries throughout the 
world?
    So I want to know why in the world are we seeing this when, 
in fact, we are investing so much into vaccine production and 
distribution?
    Mr. Disbrow. Congresswoman Lee, thank you for that 
question. I will address your first part of your question.
    So agreed. And, as David mentioned, ensuring that we have a 
vaccine manufacturing facility on the African Continent will 
make sure that those individuals are not last now and in the 
next pandemic.
    As you are aware, BioNTech has made a commitment to 
building a facility and supporting a facility on the African 
Continent. As Dr. Kessler mentioned, Moderna has also committed 
to supporting a facility on the African Continent. And then we 
are also working with our colleagues at CEPI and WHO and the 
Gates Foundation, as they want to establish a vaccine hub on 
the African Continent.
    And what we need to do is, even though this is not directed 
from--I am sorry--funded directly through USG efforts, the 
funds that have been provided to Moderna and Pfizer to support, 
either through vaccine manufacturing--procurement, actually has 
provided them the funds to, you know, be able to expand and 
establish these facilities in Africa.
    And I think it is important that Gates, CEPI, WHO, and the 
companies collaborate so that there is a concerted effort to 
make sure that the vaccine manufacturing facility or facilities 
that are established in Africa can be sustained in the long 
run. That is my biggest concern. You know, everybody is, you 
know, making these, you know, concerted efforts, but we need to 
make sure it is coordinated so that we can sustain this beyond 
the COVID pandemic.
    Thank you.
    Ms. Lee. Thank you.
    Director Pace.
    Ms. Pace. Yes. Congresswoman Lee, thank you for your 
question as well.
    So, with regards to the Caribbean in particular, sharing 
your concerns about where they have been in terms of their 
vaccination. We have been proud to be able to contribute the 
vaccines that we have, and now we are facing a pivot point, 
right, where they have received the vaccines, and now we are 
working closely with them and the Caribbean Public Health 
Agency and others on readiness and absorption.
    One of the challenges honestly is around demand, the same 
issue we faced in this country when it came to the distribution 
of vaccines. The availability and accessibility was there, but 
we still have to work through community engagement and our 
longstanding programs to ensure that people really lined up for 
their shots.
    Similarly, there are some logistical and operational 
challenges that we are working across the interagency to 
resolve, particularly with some of these mRNA vaccines, as you 
are well aware, and some of the cold chain capacity that is 
required on the ground.
    And then, finally, there are just workforce constraints, 
particularly as we continue to pull from existing programs, 
other immunization programs for those vaccinators, and so that 
presents a challenge as well, not only in CARICOM, but on the 
African Continent in terms of readiness.
    Ms. Lee. So we have the same challenges in the CARICOM 
countries as we have on the African Continent?
    Ms. Pace. Similar, yes, ma'am.
    Ms. Lee. We have the CDC in Africa, on the continent of 
Africa. We don't have a comparable CDC in the Caribbean. You 
would think that we would see better results on the continent 
of Africa because CDC is sited there.
    Ms. Pace. That is a fair point, Congresswoman, and I 
appreciate the work that the African CDC has done. And, yet, I 
think they require additional support from our CDC, from USAID, 
and others. And so we are working hand in glove with them and 
the Africa regional office to resolve those issues as soon as 
possible, and making progress along the way.
    Ms. Lee. Thank you very much.
    Thank you, Madam Chair.
    The Chair. Thank you. And just a quick note with regard to 
that. It really is about not just the vaccine, but it is about 
the skills development and the skills training that is required 
and the technical assistance that is required in terms of 
capacity building. Those are the critical ingredients I think 
we need to focus on.
    And I want to thank Congresswoman Lee.
    Congressman Harris.
    Mr. Harris. Thank you very much, and thanks--thank you all 
for appearing this morning.
    Dr. Kessler, I have a question. The vaccines--and, as a 
background, you know, I think what we are talking about is 
using last year's technology for this year's problems, or for 
next year's problems. So these vaccines that we are talking 
about giving to other countries, or enabling other countries to 
get, these are the leaky vaccines. Is that right?
    I mean, it is pretty clear now that this generation of 
vaccine that we are talking about sending to other countries 
are leaky vaccines? They--people who get the vaccines can get 
coronavirus. They can get--maybe it is a variant. Maybe their 
immunity wanes. Is that true? Is that clear now?
    Dr. Kessler. These vaccines, Congressman--you and I--I 
mean, over our careers, what, we have--you know, we trained 
together, I mean, at Hopkins. I think we have seen a lot of 
vaccine development. I have never seen vaccines developed in as 
short a period of time that are as effective. I mean, these are 
remarkably, remarkably effective. No----
    Mr. Harris. But they are not----
    Dr. Kessler. No new medicine, no therapy is 100 percent 
effective. You and I know that.
    Mr. Harris. Sure.
    Dr. Kessler. These are remarkably effective. To think that 
these are----
    Mr. Harris. Right, but they are not as effective as we had 
hoped they would be. I don't think anybody anticipated that we 
were going to have people get boosters at 6 months, and that, 
at 6 months--I am just telling you, you know, I talked to 
people out in the real world.
    They were kind of promised that this vaccine was going to 
be like the other vaccines they have taken. That is, you know, 
if they have had the disease, they wouldn't have to take the 
vaccine. You know, if they got the vaccine, they wouldn't have 
to get a booster in 6 months.
    I don't think there is any other vaccine we administer, is 
that correct, Dr. Kessler, where you get a booster in 6 months? 
Is that correct?
    Dr. Kessler. Go back to your immunology, your----
    Mr. Harris. But there are none.
    Dr. Kessler. Our basic immunology passage right. Remember 
those, sir?
    Mr. Harris. But there are none.
    Dr. Kessler. Many of these vaccines, if I may----
    Mr. Harris. Dr. Kessler, I have very limited time. It was a 
very simple question.
    Dr. Kessler. If I can just answer your question.
    Mr. Harris. Is there any other vaccine where you need a 
booster in 6 months?
    Dr. Kessler. There are many vaccines--in fact, majority of 
vaccines--a lot of vaccines require three doses as primary 
series, so I would ask you to think about----
    Mr. Harris. I am talking about a booster--Dr. Kessler, come 
on. I am talking about a--and this is important here because we 
not only have to get the doses to Africa. We have to get 
boosters to Africa.
    So let me move on.
    Dr. Kessler. No, no, no, but, Congressman, I think this is 
very important.
    Mr. Harris. Dr. Kessler, I am sorry. It is my--Dr. Kessler, 
I am the one who asks the questions here.
    Dr. Kessler. I understand, but, please, if I may answer the 
question.
    Mr. Harris. Well----
    Dr. Kessler. There----
    Mr. Harris. Madam Chair, could you please direct the 
witness to let me ask a question of Dr. Disbrow?
    The Chair. Well, yes. And I will allow you to do that.
    Mr. Harris. And not have it count toward my time.
    The Chair. Congressman, no. And I will provide----
    Mr. Harris. Thank you.
    The Chair [continuing]. The time. But, Dr. Kessler, answer 
your question. You will have time to ask Dr. Disbrow a question 
as well. Dr. Kessler.
    Mr. Harris. Madam Chair, it is----
    Dr. Kessler. If you will excuse me.
    Mr. Harris. I have 5 minutes. I have more questions than 
Dr. Disbrow. I was going to go back to Dr. Kessler. I need to 
keep--the witnesses cannot filibuster in this.
    Dr. Kessler. You are raising doubts about the efficacy of 
this vaccine, and that is wrong, sir.
    Mr. Harris. Oh, I am sorry, sir. Let me tell you, I am a 
scientist. You are a scientist. Science raises questions about 
everything. There may be more effective----
    Dr. Kessler. Very important. You are undermining----
    Mr. Harris. Yes, it is important.
    Dr. Kessler [continuing]. The confidence of the American 
people----
    Mr. Harris. There have been more effective vaccines----
    Dr. Kessler [continuing]. And the world in the vaccine, and 
that is wrong, sir.
    Mr. Harris. Oh, good. I am glad you have decided what is 
right and wrong.
    Dr. Disbrow, is it true that Florida did not fund the phase 
3 trials for molnupiravir, which looks like it is going to be 
the breakthrough therapeutics? Is that true?
    Mr. Disbrow. That is correct, sir.
    Mr. Harris. So, despite sending BARDA billions and billions 
of dollars, the decision was made not to fund a phase 3 trial 
of a drug that now could be made available to millions of 
people worldwide who get COVID, even maybe from a leaky vaccine 
or unvaccinated.
    So I have got to--I am going to come back to Dr. Kessler. 
What are you doing as the COVID czar to see to it that 
therapeutics are rapidly advanced as rapidly as possible 
through the FDA, things like fluvoxamine, very cheap, could be 
widely available, as a second-prong approach, we send vaccines 
and therapeutics to these other countries?
    So if you could answer about therapeutics.
    Dr. Kessler. From day one, therapeutics has been very high 
on our agenda. We invested $3,200,000,000. We are the ones, 
right, that work with Merck and work with Pfizer. NIH 
developed--wrote the protocol for the Pfizer antiviral that now 
has where we are seeing very, very important results that are 
going before the FDA. We are pushing very hard.
    I would like to work with you, Congressman, right, to make 
sure, once FDA has reviewed these data, that antivirals in 
addition to vaccines, right--complementing, not substituting 
for vaccines. Vaccines are still one, two, and three on the 
list, but I want to get a safe and effective antiviral, 
accessible to all, so we can turn this around. That is what I 
would like to work with you on, sir.
    Mr. Harris. Thank you, and I look forward to that.
    I yield back, Madam Chair.
    The Chair. Thank you.
    Congressman Pocan.
    Mr. Pocan. Thank you, Madam Chair, and to the witnesses. My 
apologies for the cult-like fervor to discredit vaccines that 
some people seem to be obsessed about that could cost American 
lives. I don't get it, but I am not a doctor. I am just a small 
business owner, so--but I still want to say apologies because 
it is rather embarrassing to watch this.
    My questions are specifically around the distribution, and 
I think these will probably be for either Director Pace or Dr. 
Disbrow. Four questions around distribution.
    One, cold chain. I had someone who knows quite a bit about 
this. I believe the country is Zambia, where they are concerned 
that, as the vaccines go to the proper cold storage, they have 
talked to some of the folks that are the insurers who put 
little thermometers in with the product and that they see 
spikes going to 45 degrees in those cold storage overnight.
    I am concerned about how closely we are watching the cold 
chain aspects and the consistent deliverable nature of power to 
these, specifically in some Third World countries like Africa.
    Two, do we--are we putting enough resources into the human 
distribution of these vaccines because that is one issue I have 
heard that could be another factor in some of these especially 
Third World countries?
    Three, are we investing in--by doing this, in some 
infrastructure so that perhaps whatever we do with this vaccine 
could turn out to have other positive health ramifications in 
these countries?
    And, finally, four, can you talk a bit about the 
demographic discrepancies? We have seen that, in many of these 
countries, far more men rather than women and other populations 
aren't getting the vaccine. What are we doing in trying to 
address that?
    So I just thought I would put the four questions out there, 
and whoever wants to answer them, but specifically I think 
Director Pace and Dr. Disbrow.
    Ms. Pace. I am happy to----
    Mr. Disbrow. Would you like to go first?
    Ms. Pace. Yes, sir. Thank you, Dr. Disbrow. I appreciate 
that. And thank you, Congressman Pocan, for those questions.
    I want to leave time for my colleague to come in. Briefly, 
I will say one of the things we are trying to do across U.S. 
Government is build on existing global health programs and 
platforms, and so we talked about even leveraging the PEPFAR 
platform. Again, not to put that under a constraint, but to 
utilize the health workforce, supply chain, and other capacity 
in place in countries to help speed up the rate of COVID 
vaccinations.
    We are also hopeful, though, to your point, that, by adding 
additional resources or support to these national vaccine 
campaigns, that they will then sort of survive into the future 
and be able to address some of these existing global health 
programs, and so it is a nice cycle, if you will.
    On the point of reaching women or other special populations 
and subgroups in particular, we know this from other 
immunization programs that that is key, and so we are focused 
on those historically marginalized or vulnerable groups 
certainly in our efforts working with WHO, Africa CDC, or other 
community-based organizations in particular.
    I will say one thing about the cold chain support, which is 
just to say we are factoring that into our readiness analysis, 
if you will, in ways that we can provide technical assistance, 
not only through CDC and HHS, but through USAID, DOD, and 
others, and so part of this package of technical assistance. 
That is part of our sort of global vaccination strategy. But it 
is also why it is critical to think about other vaccines that 
can come into the picture that don't require the same level of 
logistics.
    Dr. Disbrow, please.
    Mr. Disbrow. Yeah. Director Pace, I think you answered the 
questions very well and completely. I really don't have 
anything to add.
    Mr. Pocan. Can I just follow up, then, on the cold storage, 
though, because this was from a very, very reliable source, 
that, you know, in some of this cold storage where the 
insurance companies actually are gauging the temperatures, 
because they do for obvious reasons, they are seeing spikes go 
up to 45 degrees at night.
    So how do we know--yes, they might have the right cold 
storage, but how do we know that the vaccine is still secure at 
that level? Are we doing extra to ensure they either have 
adequate power or they are keeping the temperature so that we 
are not giving a nonuseful vaccine to people? I would just like 
to ask that again.
    Mr. Disbrow. Yeah. So I think it is critically important 
that, you know, we work with the countries that are receiving 
the vaccine to make sure that they have ample not only primary 
power but secondary power as well. We had to do this during the 
2014-2015 outbreak of Ebola in West Africa. We actually sent 
people over there to make sure that they had, you know, primary 
power and backup generators because you have to ensure that the 
cold chain is maintained to make sure that the vaccine is still 
effective.
    Mr. Pocan. All right. Thank you.
    I yield back, Madam Chair.
    The Chair. Congressman Fleischmann.
    Mr. Fleischmann. Thank you, Madam Chair.
    I would like to thank the chairwoman and all of the 
witnesses for their compelling testimony today, for taking this 
opportunity to highlight our country's role in the global 
vaccine distribution effort.
    We have heard testimony today about the great success of 
Operation Warp Speed, and I think we ought to really underline 
success. The previous administration worked diligently with 
vaccine manufacturers to develop a safe and effective vaccine, 
and we are still working to administer primary COVID-19 doses 
and booster to individuals who voluntarily wish to be 
immunized.
    While I think forced vaccine mandates are counterproductive 
and send the wrong message on immunization, I am happy to note 
that the domestic production meets current demand in this 
country, and I think that is something that all of us can be 
proud of regardless of our branch: the House, the Senate, or 
the administration.
    In regard to the global vaccine distribution, Dr. Kessler 
has stated in his written testimony to the committee that the 
United States has pledged to donate more COVID-19 doses than 
all of the other countries combined, a whopping 1.2 billion 
doses worldwide. That effort will provide much-needed relief 
for lower income countries, and I think that is a goal that 
both of us share on both sides of the aisle.
    That being said, I have heard concern from one of the 
vaccine manufacturers, Moderna, about that effort. And I think 
this point is very important to be made in defense of Moderna's 
position. Twice in 2021, the Biden administration requested 
contractual modifications requiring Moderna to accelerate and 
prioritize deliveries from its U.S. factories to the United 
States Government. These were contractual modifications that 
were made with the government and with Moderna. My question, I 
guess for Dr. Kessler, is, how could Moderna have supplied more 
doses to COVAX under these conditions, sir?
    Dr. Kessler. Moderna has the ability to supply the United 
States and COVAX, in our judgment, with doses that are needed. 
They certainly have today, Moderna has that capacity, and we 
hope that they use it.
    Mr. Fleischmann. Yes. And it appears that they are trying 
to do that. But given the contractual modifications that they 
were faced with, you would agree that that did place additional 
contractual constraints on them.
    Dr. Kessler. Early on, Congressman, you are exactly right. 
I mean, I sat there, and the President's position was that it 
was very important to get Americans the vaccine and to do that, 
and also the world.
    So we have done that. We have plenty of vaccine here. We 
are donating that. And now it is up to Moderna. And we will see 
over the next couple of weeks. We have enough vaccine in the 
United States. Moderna has significant capacity. I hope the 
deal between COVAX and Moderna gets signed, and let's see.
    Mr. Fleischmann. I appreciate your response, Doctor.
    And for everyone, I think the United States, all of us, can 
be proud of all of the manufacturers, including Moderna and the 
others, for stepping up in unprecedented times. We can look 
back now and say maybe things should have been done 
differently. But I think the United States of America came 
together, all of us, yourself included, to work towards 
combating this COVID pandemic.
    So as we go through this, Madam Chair, and to the 
committee, I think sometimes we need to laud some of the people 
and praise them as we continue to move forward. Because God 
forbid if we are ever faced with this situation again with 
another pandemic or epidemic, we want private companies to 
partner with the government to get to our end goal.
    And with that, I yield back in a great spirit of 
cooperation. Thank you.
    The Chair. I thank the gentleman.
    And I would just say with regard to that, I understand the 
cooperative relationship between the pharmaceutical companies 
and the Federal Government.
    I just think the pharmaceutical companies, and in this case 
Moderna, need to acknowledge the very serious role that the 
National Institutes of Health and the government played in 
getting its product to the market.
    In fact, they hadn't gotten a product to the market prior 
to the infusion of both capital and technology that resides 
with the National Institutes of Health, with the three NIH 
scientists who co-invented.
    And so that ought to be acknowledged in a very public way, 
and they should not--our scientists should not be frozen out of 
that process.
    And with that, let me recognize Congresswoman Watson 
Coleman.
    Mrs. Watson Coleman. Thank you, Madam Chair.
    And thank you to all of the witnesses for your testimony.
    I want a clarification on a couple of things I have heard.
    Number one, we keep referring to 2022. So are you telling 
me that we are going to be masked and vulnerable even into the 
second half of 2022? Can I get that from each of you really 
quickly, yes or no?
    I will start with you, Doctor.
    Am I being heard?
    Dr. Kessler. Yes, you are, Congresswoman.
    Can I just say, just a point of clarification, will we need 
to be masked and vulnerable in the----
    Mrs. Watson Coleman. Yeah, yeah, yeah, in the second half 
of 2022, because that is a time of the year that has been 
mentioned a couple of times in terms of having to do these 
various things to get us where we need to be. I just am trying 
to understand my future here.
    Dr. Kessler. Congresswoman, I go to bed every night, and 
before I go to bed, I mean, I look at the numbers for the day. 
One of the hardest jobs I have when I had the opportunity to 
brief the President was to be able to project out where we are 
going to be in 4 weeks, in 8 weeks, and by the end of 2022.
    Anyone who tells you they know where we are going to be in 
2022, I don't think it is going to be accurate. I think the 
most important thing is these vaccines----
    Mrs. Watson Coleman. Are vitally important.
    Dr. Kessler [continuing]. They will prevent hospitalization 
and death.
    Mrs. Watson Coleman. Thank you.
    Dr. Kessler. You do not have to worry, if you are 
vaccinated, and as long as you are not immunosuppressed, these 
are protectors. These prevent hospitalization and death from 
COVID. That is the key.
    And I hope with the antiviral, let's see what the FDA does. 
And I think we are going to have significant quantities of 
antiviral.
    Vaccines plus the antiviral, it is the first time I can sit 
here and I am beginning to see a way we can get this under 
control--not eliminate, not get rid of the virus entirely, but 
I think we can get this under control.
    I am sorry for going on, Congresswoman.
    Mrs. Watson Coleman. Thank you, Dr. Kessler. I can talk to 
you for a long time, I am sure.
    So if we can't do better on the continent of Africa and in 
the Caribbean, and even if we are doing better in terms of 
total vaccinations and boosters, how does that negatively 
impact our well-being here?
    I guess I am going to give that to Doctor--the 
representative from BARDA, Doctor--I am sorry.
    Mr. Disbrow. Congresswoman, this is Gary Disbrow. I can 
take your question.
    Mrs. Watson Coleman. Disbrow. Dr. Disbrow. I am sorry.
    Mr. Disbrow. No, that is fine.
    So, I mean, obviously, until everybody is vaccinated, I 
mean, or the vast majority, the 70 percent set by the 
administration, that goal, there are potentials for variants to 
arise.
    And so we need to maintain our vigilance, and we need to do 
everything that we can to make sure that the COVAX commitments 
are met, that we are working with countries to make sure that 
their capacity is increased, so that they----
    Mrs. Watson Coleman. Dr. Disbrow, I am sorry. I want to 
interfere because I want to ask two quick questions that can be 
answered by you or anybody.
    Number one is, how many variants are we monitoring now and 
what is happening in countries with regard to those variants 
since we are not having access to one of the three of four 
vaccines that we are talking about?
    And number two is, if we are talking about there being a 
vaccine capacity manufacturing presence on the continent of 
Africa, are we talking about 2021, 2022, 2023? What are we 
talking about?
    Those are my two questions.
    Mr. Disbrow. Sure. I can answer your second question first. 
The commitments by Moderna and BioNTech are in 2022, calendar 
year 2022.
    For your first question, there is an interagency group 
called the SARS-CoV-2 Interagency Working Group, which is made 
up of experts, subject matter experts from across the Federal 
Government who are working with WHO and GISAID to evaluate, 
then monitor different variants, variants of concern, variants 
of interest, and determining, testing those variants against 
the monoclonal antibodies that we have as well as the vaccines 
that we have.
    Mrs. Watson Coleman. How many are there, do you know, kind 
of a round number, how many variants we are tracking, 
monitoring?
    Mr. Disbrow. It varies, both as variants of concern, but I 
am happy to provide that in a written response.
    Mrs. Watson Coleman. Thank you very much.
    Thank you, Madam Chair. I yield back.
    The Chair. Congressman Cline.
    Mr. Cline. Thank you, Madam Chair.
    I want to thank our witnesses. And I want to thank the 
committee for working in a bipartisan manner with both the 
previous administration and this administration to distribute 
as many vaccines as possible, as many doses as possible through 
Operation Warp Speed. The development of the vaccine was 
critical, and its distribution is still ongoing and remains 
important.
    Dr. Kessler, Moderna is the only company to pledge not to 
enforce COVID-19 IP during the pandemic. Do you support this 
pledge?
    Dr. Kessler. Yes.
    Mr. Cline. They have also offered NIH co-ownership, 
including the ability to license IP, covering Moderna scientist 
inventions made as part of the NIH collaboration. What is the 
status of that offer?
    Dr. Kessler. I will let the lawyers at NIH and Department 
of Justice who are handling this respond. I am not part of 
those discussions.
    Mr. Cline. But it is safe to say they are ongoing?
    Dr. Kessler. Again, let me defer, if I may, to counsel on 
negotiations with regard to the patent issues.
    Mr. Cline. Okay. Counsel is not testifying today, and so if 
you could get me that information, that would be helpful.
    It is also disappointing that Moderna was not invited to 
testify today to actually defend themselves against some of the 
allegations that have been made.
    Dr. Kessler, at a recent event by Yale Law School titled 
``How to Vaccinate the World'' you stated it would likely take 
several years to build vaccine facilities in places like South 
Africa. And further, these facilities wouldn't be ready in time 
to help with this pandemic. Is that correct?
    Dr. Kessler. There is to doubt that building manufacturing 
capability will take several years. We have done that. But 
saying that, it is still very important because we have to 
prepare for future pandemics.
    That is why we are working very hard and expect Moderna to 
be able to work with COVAX to get doses now to low- and low-
middle-income countries and to the AU, as well as prepare for 
the future, sir.
    Mr. Cline. Thank you.
    Dr. Disbrow, is it true that money that was appropriated in 
previous COVID legislation for BARDA to assist with the 
development of COVID-specific vaccines was diverted to NIH for 
other purposes? I think this was referenced in an earlier 
question.
    Mr. Disbrow. Yeah. Sir, I would have to check with the 
Assistant Secretary for Finance and Resources for HHS and 
provide you that in a written response.
    BARDA is appreciative of the funds that this committee has 
provided to them and the investments that you have made.
    Mr. Cline. Okay. If you come to find that it was diverted, 
do you believe it should have been diverted if it stymies the 
ability of entrepreneurs and others in their efforts to find 
other solutions besides an injectable vaccine?
    Mr. Disbrow. So I think it is important that across the 
U.S. Government we continue to look at other technologies, 
vaccine technologies. I know there is a vaccine that is being 
developed that is an oral vaccine as well as one that is a 
nasally administered vaccine, and I think those are all 
important to be evaluated, especially as we move forward for 
pandemic preparedness for the future.
    Mr. Cline. I would agree it is important, and, in fact, 
there are significant complexities involved in manufacturing, 
storing, and transporting mRNA vaccines.
    So you would agree that rather than forcing companies to 
give up their intellectual property, we should be encouraging 
them to develop other forms, including oral and therapeutics?
    Mr. Disbrow. So, I mean, we work with companies from all 
different sectors, and we are happy to have those engagements. 
We have what is called the market portal, the MCM portal, that 
companies can submit their ideas. And we have a CoronaWatch, 
TechWatch meeting. If companies are interested in potentially 
partnering with BARDA, they can submit their ideas to us, and 
we would be happy to meet with them and have those discussions.
    Mr. Cline. And I understand the portal exists, but why is 
it that very little advanced developments for next-generation 
COVID vaccines and therapeutics have gone through BARDA in the 
past year and a half?
    Mr. Disbrow. So the funds that we have been provided to 
support the priorities under Operation Warp Speed and now the 
Countermeasures Acceleration Group for vaccines and 
therapeutics, we have made key investments to bring those 
vaccines and therapeutics forward.
    And as Dr. Kessler mentioned, we have multiple vaccines 
that are available as well as therapeutics. But we have not yet 
been provided additional resources for advanced research and 
development for earlier symptoms.
    Mr. Cline. And it seems to me that the bigger problem isn't 
that companies aren't sharing their intellectual property or 
patent, but there are many other considerations as it relates 
to making vaccines available around the world.
    And that is a troubling trend by this administration. Big 
government solutions, mandates on employers, and a complete 
disregard for property rights ultimately does more harm than 
good. So I hope that the Biden administration will reverse 
course on both of these issues and instead focus on real 
solutions for the pandemic.
    Madam Chair, I yield back.
    The Chair. Thank you.
    Is Mr. Moolenaar back? No.
    If not, we will move to a second round of questioning, a 
second round of 5-minute questioning.
    I think while we acknowledge the role of the pharmaceutical 
companies, we need to continue to really acknowledge the role 
of the National Institutes of Health and American taxpayers' 
dollars and the contribution that it makes to developing these 
vaccines.
    Let me ask about the donation of domestic excess vaccine.
    Dr. Kessler, the excess vaccines in the domestic supply, 
can they be donated, dealing with that before there are 
expiration dates involved?
    When I asked this question at an earlier time of USAID, 
they told me to deal with HHS on this and looking at the chain 
of custody issues once the vaccine has been distributed.
    What steps is HHS taking to reduce the number of vaccines 
going to waste in the United States? And what are the chain of 
custody challenges to sending the valuable vaccine where it 
will be administered both domestically and internationally?
    Dr. Kessler. Chair DeLauro, thank you very much for that 
very important question. It is something we spend a lot--both I 
and my colleagues spent a lot of time on.
    Number one, what is most important is that the United 
States will always and only distribute and donate high-quality 
vaccines. There is no difference between a vaccine that we are 
donating and a vaccine that I would put in my family's arms. So 
it is quality vaccines across the board.
    With regard to specifically, we spend a lot of time dealing 
with expirations. The good news is, in circling, we have seen 
and we have been able to work to extend the expiration date. 
And certainly no, for example, no Moderna vaccine--there is no 
expiration of any vaccine that occurs in our possession. We 
monitor expiration very carefully, and we plan accordingly.
    Now, you are right that sometimes--and we have seen this, 
and it has been enormous efforts for our State colleagues to do 
the efforts and get everyone who has wanted a vaccine as 
quickly as possible, vaccines in the arms of American citizens. 
It is a heroic effort.
    But you are right, when you distribute vaccines out in the 
field, and they keep on going to certain fields, we are limited 
by our FDA colleagues, correctly, that we can't send vaccines 
that we can't assure that chain of quality.
    So we work very carefully to make sure that the States 
don't order more than they actually need. So we are on top of 
this, I promise you, Chair DeLauro.
    The Chair. And that has to do with the international side 
of that as well as extending of vaccines that are not going to 
expire in short order, given that in some places the domestic 
capacity--the international domestic capacity--is limited. In 
some countries, it is much more limited than it is in the 
United States.
    So it is that technical assistance that I think we have to 
be really focused on as well to be able to get them distributed 
at the appropriate time so we are not wasting the vaccine.
    So thank you.
    Let me just ask one question. It has to do with our 
international partners, Dr. Kessler.
    The U.S. has donated 250 million doses, more than all other 
nations combined. Are other G7, G20 countries fulfilling their 
pledges for vaccine donations to the low- and middle-income 
countries? What is the U.S. doing to pressure other high-income 
countries to meet their pledges and with more urgency?
    Dr. Kessler. With your permission, I would ask Director 
Pace to answer that.
    The Chair. Thank you.
    Director.
    Ms. Pace. Thank you, Dr. Kessler.
    And thank you, Chair DeLauro.
    So I am really glad you asked this. We have really been 
pressing on this issue ourselves, recognizing it is going to 
take all of us.
    As you said, the G7 did make a commitment to sharing 
vaccine, half of which included U.S. commitments, but the 
others coming from those countries, and we have not fully seen 
those realized. It is one of the reasons the President convened 
those world leaders in September and at that event pushed those 
very countries to come through with their commitments.
    Following that meeting, and most recently, the Secretary of 
State, Secretary Blinken, convened foreign ministers as well 
and reiterated that call to action.
    Since then we published--or what has been published--is a 
dashboard of sorts that shows how countries are tracking toward 
their various commitments. And so it is a very transparent look 
at how not only the U.S., but these other countries, including 
the G7, are doing with their commitment to COVAX.
    So now it is online for the world to see, and we are hoping 
that that also provides some additional impetus for them to 
take action.
    The Chair. Okay. Thank you.
    Congressman Cole.
    Mr. Cole. Thank you, Madam Chair.
    And thanks again to our witnesses.
    Dr. Kessler, we have talked about lots of ways in which we 
have tried to help, and it is certainly appropriate to have 
additional vaccines sent overseas. And some of our companies 
have offered to build facilities overseas to try and distribute 
supply.
    Probably one of the more controversial things is the idea 
of intellectual property transfer. Do you have any thoughts 
about that, whether or not that is effective, whether or not 
that is wise?
    And, frankly, are other countries--because we are not the 
only vaccines in the world, obviously, there are other 
countries--are other companies considering transferring 
intellectual property?
    Dr. Kessler. I think that companies working together, joint 
strategic partnerships, the voluntary transfer, the voluntary 
tech transfer, I think we applaud and we are seeing. We are 
seeing, for example, Pfizer partner on fill/finish in South 
Africa. There are a whole host of those examples.
    The world needs these vaccines. No one company can do it. 
We need that technology shared. We have a lot to do here.
    Mr. Cole. Well, again, there is a difference between 
companies working together across international lines to meet 
what we all agree is an incredible need and us forcing 
companies, mandating them to share intellectual property.
    And I just, for the record, I would be very much opposed to 
that. I don't think that is fair to those companies, and I 
think it would discourage investment later. That is my personal 
view. Others may have a different point of view.
    So I am curious about your thoughts about that, whether or 
not that is happening. And, again, we are not the--we don't 
think they are nearly as effective.
    And, again, you may know more about it. I am sure you know 
more about it than I do. There are Chinese vaccines, there are 
Russian vaccines, there are other countries that have vaccines 
in one sort or another.
    Are they considering transferring intellectual property, to 
your knowledge? And, again, it may not be something that is in 
your purview even.
    Dr. Kessler. I can give you probably the best example that 
I think we can all applaud and should applaud. We have seen 
Merck and yesterday Pfizer agree to transfer, in essence, to 
the Medicines Patent Pool with regard to their antiviral.
    That is enormously important. If these antivirals are as 
effective as I hope they will be, they are going to be 
important not only to the United States, they are going to be 
essential to the world.
    And generic drugs--I will let my colleagues, Director Pace 
and Dr. Disbrow, add--but the generic availability of these 
drugs, it took us, Ranking Member Cole, I mean, it took us 
several decades to get this right with HIV. You will remember, 
the Chair will remember the efforts that we went through in the 
1990s, finding those drugs and then spending a good decade to 
figure out how to make these available.
    I think the antivirals that we have now, through really 
heroic efforts, that we may be able to get on the market here 
in the United States are going to need to be available around 
the world, and we are going to need to have generics available.
    So I think there are tools to do that. I will let my 
colleagues comment.
    Mr. Disbrow. So, Ranking Member Cole, to answer your 
question, I am not certain if the Chinese companies that are 
developing the vaccines, Sinovac and Sinopharm, are tech 
transferring their technologies.
    I think it is important, as Dr. Kessler mentioned, for the 
companies to tech transfer where they can to expand capacity. 
But I think it is even more important that we are supporting 
all of the critical components that are necessary to 
manufacture additional vaccines.
    We have to do more than just do tech transfers for drug 
substance and drug product. We need to make sure that we are 
expanding capacity for the raw materials, the consumables that 
are in short supply, the fill/finish capacity that was in short 
supply even before the COVID-19 pandemic hit, needles and 
syringes which are going to be necessary across the globe, as 
well as vials.
    So we are making those investments. And, again, I 
appreciate the funding that has been provided by this 
committee. We are doing that. The primary investments will be 
here domestically and to onshore those, but they will not only 
support domestic manufacturing but our global partners who also 
need those materials as well.
    Mr. Cole. Very helpful.
    One quick last question, and this is directed at you, Dr. 
Kessler, but, again, please feel free to share it around.
    I am just trying to get a clearer--and you may not be in a 
position to give it--but a clearer view of the level of funding 
we need to deal with the problem.
    So what do you anticipate HHS needing, and I mean in 
dollars, for the global COVID response for the next year? My 
friend the Chair and I will be probably dealing with this at 
some level when we are negotiating what is the appropriate 
level of funding next year. Or, I don't know, maybe it is a 
supplemental, maybe it takes time to get around it.
    We all have the same objective here. I think owing or 
having some sense of what the scope of the efforts should be is 
really important in getting it right.
    So your best judgment now, with the caveat you can revise 
it when you need to, because I am sure it is a pretty complex 
question and pretty moving target.
    Dr. Kessler. It is a very welcome question, Congressman 
Cole.
    I will take responsibility. You gave us the resources. And 
I will tell you, we have put those resources to very good use. 
You see that. That is why we have the vaccines we have today. 
That is the reason why we can get our school-age kids, it is 
because of those resources.
    But I will tell you, Congressman, I have spent those 
resources, and we are scratching. Let me let our colleagues, 
our staffs work together. But it is really because of this 
committee we got to where we got. And it is not done without 
real investment by the American people for both the United 
States and for the world.
    And we have spent a lot of dollars, and we are very 
grateful for that. And if we can work together on that 
question, I would appreciate it, sir.
    Mr. Cole. Yeah, absolutely. And, again, it is absolutely 
not a critical question, it is just an informational one to try 
and get to where we are going.
    I appreciate what has been done. I think it is an 
extraordinary effort. I think it is something the country can 
be proud of and all of humanity benefited from.
    So I think you have used the resources we have given you 
wisely and well. I am just trying to get an idea of what we 
might need going forward. So we will work on that together.
    Madam Chair, thank you very much for your indulgence on the 
time. I am very grateful. Yield back.
    The Chair. Thank you.
    Congressman Pocan.
    Mr. Pocan. Thank you, Madam Chair.
    And I am going to follow up on Ranking Member Cole's 
question, because that was exactly what I was going to ask, and 
maybe even a little more specifically, to Director Pace.
    I know from last month's SFOPs hearing USAID funding is 
soon to be finished. How much more money are you going to need 
before the end of year to accomplish our goals? And are we 
going to be seeing an additional request from the White House?
    I am just trying to get a little better idea, because I 
completely agree with our Ranking Member, what we have done 
already has been very important, but I know it is not enough, 
and you have broader goals than the funding we have given you. 
I would like to have a little better understanding of what you 
may need.
    Ms. Pace. Sorry. I was trying to get myself off mute here.
    Well, like Dr. Kessler said, we very much appreciate this 
question. And as he also said, we have fully obligated the 
funds that we have received and graciously so.
    One of the issues that we have focused on in this hearing 
has been the issue of readiness and the fact they are at this 
pivot point. And so that truly is a focus of our moving 
forward. Not to say we won't keep our foot on the pedal when it 
comes to sharing, but we still need to be focused on shots in 
arms and some of the logistical issues, demand generation, and 
other areas that you flagged for us earlier, Congressman.
    So that is one way we could use additional resources or 
might use additional resources should they be available.
    We also have a cadre of Health Attaches around the world 
who have been working tirelessly on these efforts for longer 
than I think they expected. And so sometimes we, because that 
is not what is in front of us, we don't realize how much man or 
woman power is sort of powering this engine to allow us to 
respond effectively worldwide.
    So those are just some examples of what has been working or 
where we would like to lean into our work, but obviously we 
defer to R&D (ph) to present the case more broadly.
    I suppose the last thing I will offer is the idea of 
preparedness and not forgetting that alongside our response. 
And I know the Vice President made this announcement at the 
President's summit committing $250,000,000 to a Financial 
Intermediary Fund and furthermore requesting of Congress 
another $850,000,000 toward that effort.
    And so ensuring we have a balance across response and 
preparedness will be important for us too. Thank you.
    Mr. Pocan. Thank you.
    And then one final question for Dr. Disbrow on vaccine 
access in some difficult places. I know last week the U.S. 
announced it negotiated a deal to ship additional doses of 
vaccines like Johnson & Johnson overseas to conflict zones. And 
Secretary Blinken specifically talked about the need to get 
that in some of the areas that have humanitarian concerns.
    Can you talk a little bit about what technology 
infrastructure and human resource investments are needed to 
deliver those vaccines to humanitarian settings? And can you 
talk a little bit more about that J&J deal, please?
    Mr. Disbrow. Yeah. So I apologize. I am going to defer to 
Dr. Kessler who brought it up in his earlier comments.
    Mr. Pocan. I apologize. I am getting the wrong spot. Thank 
you.
    Mr. Disbrow. David.
    Dr. Kessler. Congressman, you are exactly right. This was 
the first. It may not have been the most doses that we have 
shipped, but I will tell you, among many of us, my colleagues, 
it was some of the most meaningful doses, to be able to get 
doses to people for whom no government program has ever gone 
before.
    And I want to applaud our colleagues at J&J for working 
with us. Because we talk about donating doses, it sounds 
simple, but I can tell you the regulatory, legal, all those 
things are important because of the safety of this.
    So to those humanitarian centers, just absolutely critical 
and very important.
    Mr. Pocan. And is there anything on the actual delivery 
side you can share with us, specifically more information on 
this J&J deal? I know you said it may be smaller than we would 
like, but still extremely significant that this is happening. 
Can you just share a little more on the details?
    Dr. Kessler. No, the only reason I said smaller than we 
would like is we tend to talk in tens of millions and billions 
of doses. And here every 10,000, a hundred, is a big deal. I am 
not minimizing. I will get you the delivery schedule if I can, 
if I could submit that to you. I will get you the delivery 
schedule.
    Mr. Pocan. I would love to see that.
    I would yield back, Madam Chair. Thank you.
    The Chair. Thank you.
    Mr. Fleischmann. Congressman Fleischmann.
    Mr. Fleischmann. Thank you, again, Madam Chair.
    And to Dr. Kessler, Director Pace, and Director Disbrow, 
thank you for your testimonies today and for your very good and 
candid, informative answers to the committee's questions.
    We are all appropriators today, and our oversight questions 
are so important, not only to the committee, but to the 
Congress, but to the American people. So I thank you.
    I want to touch on a couple of issues that we have touched 
on before, but really just for clarification purposes more than 
anything.
    Dr. Kessler, do you fear that there is a lack of 
infrastructure that would safely support independent vaccine 
manufacturing and distribution in some of these other countries 
in which we want to help their citizens?
    Dr. Kessler. I will let Director Pace comment in a second.
    I do recognize, sir, that getting vaccines delivered is 
only part of the equation. I think I mentioned I spent a decade 
chairing the board of the Elizabeth Glaser Pediatric AIDS 
Foundation.
    Some of you will remember Elizabeth. That foundation was 
started in the U.S. because of her kids becoming infected. And 
we moved globally very early on to be able to get doses to low- 
and low-middle-income countries.
    That technical assistance, that capacity, that absorption, 
that uptake, I mean, again, we have more to do on supply. But I 
think your question is absolutely key with regard to that kind 
of technical assistance with regard to that uptake.
    Director Pace, please correct me.
    Ms. Pace. Thank you very much, Dr. Kessler.
    I want to draw on something Dr. Disbrow said earlier about 
the sort of spectrum of needs and technical assistance when it 
comes to manufacturing capacity in some of these countries and 
clarify our sense that it is not only building some of the 
facilities, if you will, or hubs from scratch, but there is 
some existing infrastructure there, and it is a capacity on 
which we might be able to build the various investments the 
U.S. Government is making.
    So in addition to some of the other examples that my 
colleagues have offered, our Development Finance Corporation, 
working with the Department of Health and some of our Health 
Attaches in places like India and South Africa, have identified 
those locales to sort of again build on existing capacity in a 
way that can accelerate us getting to scale.
    I am not sure if Dr. Disbrow has more to add or if you, 
Congressman, have additional questions. Thank you.
    Mr. Disbrow. In addition to that, Director Pace--and your 
question is a great question. So it is more than just the 
facilities. You also have to make sure that you have trained 
people who can work in the facilities.
    And so in some of the countries where they may have not had 
the experience of manufacturing vaccines and fill injectables, 
you really need to make sure that you have that, they become 
very--once they are trained, other companies want to take them 
away and use them because training and making sure that those 
individuals are available is very difficult.
    But it is more than just the facility, it is also making 
sure that you have the people and the infrastructure to support 
it.
    Mr. Fleischmann. I sincerely appreciate all three of your 
answers to clarify that for the committee.
    In closing, I would like to say this to everyone involved. 
It is my hope that these conversations progress in a way that 
will provide for a solution that continues our humanitarian 
work while staying sensitive to the protections and the 
liabilities of U.S. companies.
    As you know, I am a champion for the free enterprise 
system. I think all of the companies involved have done a very 
laudatory job stepping up at a time of crisis, coming together, 
working with the government to accomplish the goal of defeating 
COVID both nationally and internationally.
    So with that, I thank you, Madam Chair, and I yield back.
    The Chair. I thank the gentleman.
    And what I will do is to just--I just want to ask one 
question and then we will close. And if the gentleman would 
just bear with me because we need the two of us to continue. I 
think we are the only two left. But I will make my case here.
    I will submit for the record questions that have to do with 
vaccine equity to you, Ms. Pace.
    I would love to know about the antivirals, Dr. Disbrow, and 
I will get this question to you about how BARDA contributed to 
that development.
    And to you, Dr. Kessler, about our negotiations with Pfizer 
or others or using the Defense Production Act for us to up our 
production in order until we have 20--while we pledged 1.1 
billion doses, only 226 million doses have been shipped, 20 
percent or so, and Pfizer is producing the 1 billion. So what 
is it that we can do to accelerate the pace? And I note that 
people are working very, very hard at this.
    But I will submit those questions.
    And if I might just close, and I want to just say a thank 
you to you, Dr. Kessler, Dr. Pace, Dr. Disbrow. I think we 
covered important topics today.
    I would make one. It would be my hope that we could move on 
our appropriations bills for 2022 because locked within those 
bills at the moment are serious, very, very serious resources 
for the areas that you cover and for the issues attached to 
this discussion. That would be very, very helpful in your being 
able to further continue your work.
    A couple of points here. The virus exposed a number of our 
shortcomings in our preparedness, but also our 
interconnectedness with the world. And so COVID is not just a 
domestic challenge, it is a global challenge. And the United 
States needs to contribute to that solution, and we are working 
at that.
    But the longer COVID is allowed to spread, it becomes a 
breeding ground for new variants that may be more transmissible 
and that could evade current vaccine.
    So not enough vaccine in the world now. Limited vaccine 
needs to be better. That includes providing as much vaccine as 
quickly as possible to other countries.
    We must also support the efforts to accelerate 
manufacturing capacity, and that is a conversation with BARDA, 
to maximize vaccine access and equity as soon as possible.
    We have had the discussion about facilitating tech 
transfers sooner rather than later because in some ways the 
lack of capacity that some of these countries have. And we have 
this capacity, but they don't. And we need to help them with 
that effort.
    I would urge you to explore every avenue to continue to 
exert pressure on those companies that were supported with U.S. 
taxpayer dollars to accelerate production and distribution of 
the vaccine. I know some of the companies have been excellent 
partners. I commend them for their leadership.
    I would find it unconscionable for any company to make 
billions in profits without doing everything in its power to 
reach the most needy throughout the world. It is not just a 
moral imperative to ensure the health and safety of billions of 
people, it is in our Nation's national security interest to 
bring this pandemic to a close as rapidly as possible to save 
lives. And we have the power to do that, I might add.
    And a final note. It is my hope--and I know that this is 
not your bailiwick, I am sure you will refer me to USTR--but 
that we do have a ministerial meeting on the 30th of this month 
where the issue of the temporary transfer of intellectual 
property--and I emphasize the word temporary transfer of that 
intellectual property--will be the point of discussion.
    And I want to commend the work that the United States has 
done already in this area at the last TRIPS meeting and my 
optimism for what we will do at the ministerial on the 30th.
    I just say, all in all, it is so much within our power here 
in the U.S. to be able to deal with these issues. I thank you 
for your work, for your life's work, and for what you are doing 
for all of us now, what you are doing for our country, and what 
you are doing internationally. Thank you so much for being with 
us.
    And with that, I call this hearing to a close. Thank you 
all very much.
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