    [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.........
                                                                          1

      Fiscal Year 2022 Budget Request for
    the Center for Disease Control and
    Prevention..............................
                                                                        203

      U.S. Role in Global Covid-19 Vaccine
    Equity..................................
                                                                        259
    [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

                                   __________

                        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.
        [The information follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        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:
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

                                                 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:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        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:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        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.
        [The information follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        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:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        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.
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                                       [all]