    [House Hearing, 114 Congress]
    [From the U.S. Government Publishing Office]

                        EXAMINING THE U.S. PUBLIC HEALTH RESPONSE
                                  TO SEASONAL INFLUENZA

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

                                    HEARING

                                   BEFORE THE

                  SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                     OF THE

                        COMMITTEE ON ENERGY AND COMMERCE
                            HOUSE OF REPRESENTATIVES

                        ONE HUNDRED FOURTEENTH CONGRESS

                                 FIRST SESSION

                                   __________

                                FEBRUARY 3, 2015

                                   __________

                                Serial No. 114-6

    [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

          Printed for the use of the Committee on Energy and Commerce

                            energycommerce.house.gov

                                   _____________

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                        COMMITTEE ON ENERGY AND COMMERCE

                              FRED UPTON, Michigan
                                     Chairman

    JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
      Chairman Emeritus                    Ranking Member
    ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
    JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
    JOSEPH R. PITTS, Pennsylvania        ELIOT L. ENGEL, New York
    GREG WALDEN, Oregon                  GENE GREEN, Texas
    TIM MURPHY, Pennsylvania             DIANA DeGETTE, Colorado
    MICHAEL C. BURGESS, Texas            LOIS CAPPS, California
    MARSHA BLACKBURN, Tennessee          MICHAEL F. DOYLE, Pennsylvania
      Vice Chairman                      JANICE D. SCHAKOWSKY, Illinois
    STEVE SCALISE, Louisiana             G.K. BUTTERFIELD, North Carolina
    ROBERT E. LATTA, Ohio                DORIS O. MATSUI, California
    CATHY McMORRIS RODGERS, Washington   KATHY CASTOR, Florida
    GREGG HARPER, Mississippi            JOHN P. SARBANES, Maryland
    LEONARD LANCE, New Jersey            JERRY McNERNEY, California
    BRETT GUTHRIE, Kentucky              PETER WELCH, Vermont
    PETE OLSON, Texas                    BEN RAY LUJAN, New Mexico
    DAVID B. McKINLEY, West Virginia     PAUL TONKO, New York
    MIKE POMPEO, Kansas                  JOHN A. YARMUTH, Kentucky
    ADAM KINZINGER, Illinois             YVETTE D. CLARKE, New York
    H. MORGAN GRIFFITH, Virginia         DAVID LOEBSACK, Iowa
    GUS M. BILIRAKIS, Florida            KURT SCHRADER, Oregon
    BILL JOHNSON, Ohio                   JOSEPH P. KENNEDY, III,
    BILLY LONG, Missouri                 Massachusetts
    RENEE L. ELLMERS, North Carolina     TONY CARDENAS, California
    LARRY BUCSHON, Indiana
    BILL FLORES, Texas
    SUSAN W. BROOKS, Indiana
    MARKWAYNE MULLIN, Oklahoma
    RICHARD HUDSON, North Carolina
    CHRIS COLLINS, New York
    KEVIN CRAMER, North Dakota

                                     7_____

                  Subcommittee on Oversight and Investigations

                            TIM MURPHY, Pennsylvania
                                     Chairman
    DAVID B. McKINLEY, West Virginia     DIANA DeGETTE, Colorado
      Vice Chairman                        Ranking Member
    MICHAEL C. BURGESS, Texas            JANICE D. SCHAKOWSKY, Illinois
    MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
    H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
    LARRY BUCSHON, Indiana               JOHN A. YARMUTH, Kentucky
    BILL FLORES, Texas                   YVETTE D. CLARKE, New York
    SUSAN W. BROOKS, Indiana             JOSEPH P. KENNEDY, III,
    MARKWAYNE MULLIN, Oklahoma               Massachusetts
    RICHARD HUDSON, North Carolina       GENE GREEN, Texas
    CHRIS COLLINS, New York              PETER WELCH, Vermont
    KEVIN CRAMER, North Dakota           FRANK PALLONE, Jr., New Jersey (ex
    JOE BARTON, Texas                        officio)
    FRED UPTON, Michigan (ex officio)

                                      (ii)
                                 C O N T E N T S

                                  ----------
                                                                       Page
    Hon. Tim Murphy, a Representative in Congress from the
      Commonwealth of Pennsylvania, opening statement................     1
        Prepared statement...........................................     3
    Hon. Diana DeGette, a Representative in Congress from the State
      of Colorado, opening statement.................................     5
    Hon. Fred Upton, a Representative in Congress from the State of
      Michigan, opening statement....................................     6
        Prepared statement...........................................     7
    Hon. Frank Pallone, Jr., a Representative in Congress from the
      State of New Jersey, opening statement.........................     9

                                   Witnesses

    Anne Schuchat, M.D., Director, National Center for Immunization
      and Respiratory Diseases, Centers for Disease Control and
      Prevention, Department of Health and Human Services............    11
        Prepared statement...........................................    14
        Answers to submitted questions...............................   112
    Karen Midthun, M.D., Director, Center for Biologics Evaluation
      and Research, Food and Drug Administration, Department of
      Health and Human Services......................................    26
        Prepared statement...........................................    28
    Robin A. Robinson, Ph.D., Director, Biomedical Advanced Research
      and Development Authority, Office of the Assistant Secretary
      for Preparedness and Response, Department of Health and Human
      Services.......................................................    37
        Prepared statement...........................................    39
        Answers to submitted questions...............................   115
    Anthony S. Fauci, M.D., Director, Nationa Institute of Allergy
      and Infectious Diseases, Nationl Institutes of Health..........    51
        Prepared statement...........................................    53

                               Submitted Material

    Subcommittee memorandum..........................................    99
    Letter of February 2, 2015, from Mr. Pallone, et al., to Mr.
      Upton, et al., submitted by Ms. DeGette........................   109

        EXAMINING THE U.S. PUBLIC HEALTH RESPONSE TO SEASONAL INFLUENZA

                                  ----------

                           TUESDAY, FEBRUARY 3, 2015

                      House of Representatives,
          Subcommittee on Oversight and Investigations,
                              Committee on Energy and Commerce,
                                                        Washington, DC.
        The subcommittee met, pursuant to call, at 10:02 a.m., in
    room 2123 of the Rayburn House Office Building, Hon. Tim Murphy
    (chairman of the subcommittee) presiding.
        Members present: Representatives Murphy, McKinley, Burgess,
    Blackburn, Griffith, Bucshon, Flores, Brooks, Mullin, Hudson,
    Collins, Cramer, Upton (ex officio), DeGette, Schakowsky,
    Castor, Tonko, Clarke, Kennedy, Green, Welch, and Pallone (ex
    officio).
        Also present: Representative Ellmers.
        Staff present: Charlotte Baker, Deputy Communications
    Director; Sean Bonyun, Communications Director; Leighton Brown,
    Press Assistant; Noelle Clemente, Press Secretary; Brad Grantz,
    Policy Coordinator, Oversight and Investigations; Brittany
    Havens, Legislative Clerk; Charles Ingebretson, Chief Counsel,
    Oversight and Investigations; Emily Newman, Counsel, Oversight;
    Alan Slobodin, Deputy Chief Counsel, Oversight and
    Investigations; Peter Bodner, Democratic Counsel; Elizabeth
    Letter, Democratic Professional Staff Member; and Nick Richter,
    Democratic Staff Assistant.

       OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
             CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

        Mr. Murphy. Good morning. Today we convene the first
    meeting of this session of the Subcommittee on Oversight and
    Investigation of the 114th Congress. I welcome back Members who
    served here last session, particularly, my friend and
    colleague, Diana DeGette, the ranking member from Colorado, and
    the new members from the 114th Congress, which we hope, as we
    come up, you may introduce them today, and I will introduce
    ours on our side.
        The subcommittee is here to examine a very serious U.S.
    public health response to seasonal influenza. America is
    experiencing a severe flu season with an unstable predominant
    strain that could result in one of the deadliest and costliest
    flu seasons in recent memory. An estimated 50,000 people will
    die. Over 200,000 will be hospitalized, and most of these will
    be senior citizens.
        Last February, when public health officials needed to
    decide what strains would go into this year's seasonal flu
    vaccine, the FDA bet on the wrong predominant strain. Just a
    few weeks after the FDA's decision, doubts were already
    beginning to creep in the scientific community about the FDA's
    decision. By September, the U.S. vaccine was such a poor match
    for the dominant strain of flu that the World Health
    Organization, with consultation from the CDC, revised the
    vaccine formula, but not for the United States. It was changed
    for the Southern Hemisphere nations. In other words, the
    American people were stuck with a vaccine that wasn't going to
    work for nearly 4 out of 5 people, and for nearly 9 out of 10
    seniors. Despite a growing body of knowledge that the vaccine
    for the United States would not be effective, production went
    forward anyway for a number of reasons that we hope to discuss
    today.
        With a mismatched strain, this year's vaccine is estimated
    to be only 23 percent effective. It is even lower for the
    elderly at 12 percent. While this season's vaccine has a lower-
    than-usual effectiveness, CDC is still recommending
    vaccinations for everyone 6 months or older. In addition to
    vaccination, CDC has also recommended that all high-risk
    patients should be treated with antiviral drugs as soon as
    possible when influenza is suspected.
        So what are agencies doing to communicate with the public?
    Many are choosing not to vaccinate against the flu because they
    hear the vaccine doesn't work, so why bother. We are seeing a
    similar result with measles vaccinations but for very different
    reasons, and now we are paying the piper for more than 100
    cases have been stricken with a disease of measles that had
    once been eradicated from our shores.
        False rumors still exist that vaccines and a preservative
    for multi-dose vaccines, which once used a microscopic amount
    of mercury as a preservative to prevent bacteria growth, led to
    autism. There is no credible evidence to support that claim. In
    fact, mercury is not used as a preservative in the MMR vaccine,
    and in developing nations where vaccination rates have
    increased, autism rates have not changed. So in addition to
    understanding why this year's flu vaccine missed so badly, and
    what should be done to protect the public in future years, I
    hope we can use this platform to educate the public and advance
    vaccine development in the interest of public health.
        Now on to the flu vaccine. We must know: Did the Federal
    Government do everything it could at the right time to respond
    to the challenge of this year's flu season? As I noted, the CDC
    knew in late September that there was a significant mismatch,
    as great as 50 percent, with the U.S. vaccine, however, the CDC
    did not issue a health advisory in response to this mismatch
    until more than 2 months later. Did the CDC make the right
    public health decision to delay the health advisory, especially
    on delaying a recommendation to treat high-risk patients with
    antivirals? Could vaccine manufacturers have developed a new
    vaccine for high-risk groups? The CDC and the FDA tell us that
    the significant change in the strain could not have been
    addressed any earlier than September 2014, way too late to make
    changes in the U.S. vaccine. However, one flu expert at the
    University of Utah School of Medicine has stated on the record
    that there was a pretty good indication that the drifted strain
    by April or May 2014, that probably would have led to a
    decision to change at that time if strain selection decisions
    for manufacturing were made in May instead of February.
        In hindsight, it was a bad decision, and thousands will
    die. Surely there are lessons to be learned here to do
    something different in the future, and we want to know how we
    can partner with these agencies to come up with some solutions.
        In 2009, when there was a similar outbreak of the swine
    flu, Federal agencies declared a public health emergency and
    responded by producing a monovalent, or single strain, vaccine
    to protect the public in a very short time. In only 12 weeks,
    they had developed this new vaccine. Here, we must know, was a
    monovalent rescue vaccine targeting the drifted strain a
    possible response? Who made the decision to not go forward with
    a different vaccine? If not, was this partly because the FDA
    and other agencies lacked emergency authority to respond? Did
    they recognize the problem and ask for authority to respond
    quicker? If an astounding 50,000 deaths and 200,000-plus
    hospitalizations does not equal an emergency then what is?
    Shouldn't we be treating this problem with more urgency, and is
    there even a backup plan in the event a vaccine mismatch to a
    deadly strain exists?
        HHS has set a goal for vaccines to vaccinate 70 percent of
    their population as part of the Healthy People 2020
    initiatives, but overall vaccination rates in the U.S. have
    been around 45 to 46 percent in the last few years. CDC has not
    even met its target of 50 percent. Does the CDC have an
    effective strategy to increase vaccination rates, or is there a
    better strategy for reducing flu deaths than seeking further
    increases of vaccination rates in all subgroups?
        So we are here today to challenge some of the policies and
    decisions, but in the spirit of us all working together to make
    improvements in the public health response to seasonal flu. I
    am encouraged by the potential of ongoing research and
    innovation. We appreciate the cooperation and attendance of
    these excellent witnesses from the CDC, the FDA, NIH, and
    BARDA. We need your input to help us decide how we change this
    system for the better. I welcome our witnesses today, and thank
    them for help in this inquiry.
        [The prepared statement of Mr. Murphy follows:]

                     Prepared statement of Hon. Tim Murphy

        Today we convene the first meeting of the Subcommittee on
    Oversight and Investigations in the 114th Congress. I welcome
    back members who served here last session, particularly my
    friend and colleague, Diana DeGette, the ranking member, and
    our new members for the 114th Congress.
        The subcommittee is here to examine the U.S. public health
    response to seasonal influenza. America is experiencing a
    severe flu season with an unstable predominant strain that
    could result in one of the deadliest and costliest flu seasons
    in recent memory. An estimated 50,000 people will die. Over
    200,000 will be hospitalized, most of these will be senior
    citizens.
        Last February, when public health officials needed to
    decide what strains would go into this year's seasonal flu
    vaccine, the FDA bet on the wrong predominant strain. Just a
    few weeks after the FDA's decision, doubts already were already
    beginning to creep in the scientific community about the FDA's
    decision. By September, the US vaccine was such a poor match
    for the dominant strain of flu that the World Health
    Organization, with consultation from the CDC, revised the
    vaccine formula--But, not for the United States. It was changed
    for the Southern Hemisphere nations.
        In other words, the American people were stuck with a
    vaccine that wasn't going to work for nearly 4 out of 5 people
    and nearly 9 out of 10 seniors. Despite a growing body of
    knowledge that the vaccine for the United States would not be
    effective, production went forward anyway for a number of
    reasons we will discuss today.
        With a mismatched strain, this year's vaccine is estimated
    to be only 23 percent effective. It's even lower for the
    elderly (12 percent).
        While this season's vaccine has lower-than-usual
    effectiveness, CDC is still recommending vaccination for
    everyone 6 months or older. In addition to vaccination, CDC has
    also recommended that all high-risk patients should be treated
    with antiviral drugs as soon as possible when influenza is
    suspected. What are agencies doing to communicate to the
    public?
        Many are choosing not to vaccinate against the flu because
    they hear the vaccine doesn't work, so why bother. We're seeing
    a similar result with measles vaccinations but for very
    different reasons, and now we're paying the piper as more than
    100 have been stricken with a disease of measles that had once
    been eradicated from our shores.
        False rumors still exist that vaccines and a preservative
    for multi-dose vaccines, which once used a microscopic amount
    of mercury as a preservative to prevent bacteria growth, led to
    autism. There is no credible evidence to support that claim. In
    fact, mercury is not used as a preservative in the MMR vaccine,
    and in developing nations where vaccination rates have
    increased, autism rates have not changed.
        So in addition to understanding why this year's flu vaccine
    missed so badly--and what should be done to protect the public
    in future years--I hope we can use this platform to educate the
    public and advance vaccine development in the interest of
    public health.
        Now on the flu vaccine, we must know: Did the Federal
    Government do everything it could at the right time to respond
    to the challenge of this year's flu season?
        As I noted, the CDC knew in late September that there was a
    significant mismatch--as great as 50 percent--with the U.S.
    vaccine. However, the CDC did not issue a health advisory in
    response to this mismatch until more than two months later. Did
    the CDC make the right public-health decision to delay the
    health advisory, especially on delaying a recommendation to
    treat high-risk patients with antivirals? Could vaccine
    manufacturers have developed a new vaccine for high risk
    groups?
        The CDC and the FDA tell us that the significant change in
    the strain could not have been addressed any earlier than
    September 2014, way too late to make changes in the U.S.
    vaccine. However, one flu expert at the University of Utah
    School of Medicine has stated on the record that there was a
    pretty good indication about the drifted strain by April or May
    2014, that ``probably'' would have led to a decision to change
    at that time if strain selection decisions for manufacturing
    were made in May instead of February. In hindsight it was a bad
    decision--and thousands will die. Surely there are lessons to
    be learned here to do something different in the future.
        In 2009, when there was a similar outbreak of the swine
    flu, Federal agencies declared a public health emergency and
    responded by producing a monovalent--or single strain--vaccine
    to protect the public in a short time. In only 12 weeks they
    had developed this new vaccine. Here we must know--was a
    monovalent ``rescue'' vaccine targeting the drifted strain a
    possible response? Who made the decision not to go forward with
    a different vaccine?
        If not, was this partly because the FDA and other agencies
    lacked emergency authority to respond? Did they recognize the
    problem and ask for authority to respond quicker?
        If an astounding 50,000 deaths and 200,000-plus
    hospitalizations does not equal an emergency then what is?
    Shouldn't we be treating this problem with more urgency?
        Is there even a backup plan in the event of a vaccine
    mismatch to a deadly strain?
        HHS has set a goal for States to vaccinate 70 percent of
    their population as part of the Healthy People 2020 initiative,
    but overall vaccination rates in the U.S. have been around 45
    to 46 percent the last few years. CDC has not even met its
    target of 50 percent vaccination. Does CDC have an effective
    strategy to increase vaccination rates? Or is there a better
    strategy for reducing flu deaths than seeking further increases
    of vaccination rates in all subgroups?
        So we're meeting here today to challenge some aof the
    policies and decisions, but in the spirit of us all working
    together to make improvements in the public health response to
    seasonal flu. I am encouraged by the potential of ongoing
    research and innovation. We appreciate the cooperation and
    attendance of witnesses from CDC, FDA, NIH and BARDA. We need
    your input to help us decide how we change this system for the
    better.
        I welcome our witnesses today and thank them for their help
    in this inquiry.

        Mr. Murphy. And I recognize the ranking member for 5
    minutes.

     OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF COLORADO

        Ms. DeGette. Thank you so much, Mr. Chairman. I am really
    happy that our first hearing of this new Congress is on an area
    of bipartisan concern and interest. And I want to join you in
    welcoming our new members on both sides of the aisle to this
    committee. This is a venerable committee that has a long
    history of bipartisan investigations, and I think it is going
    to be a really important year to continue this trend.
        Flu preparedness and response is incredibly important, and
    this committee has a long history of hearings and
    investigations on this issue. What we need to do is come
    together in support of a strong public health infrastructure
    that prevents outbreaks, and responds quickly and appropriately
    when they occur.
        These past several months have been a harsh reminder that
    infectious disease is all around us. Last October and November,
    this subcommittee convened hearings on the Ebola outbreak and
    the dire situation in West Africa. We saw and, frankly,
    continue to see, the deadly consequences of a breakdown in the
    public health infrastructure there. Fortunately, we are now
    seeing the lowest number of new Ebola cases since last June,
    largely because of international efforts both to build and
    operate effective Ebola treatment centers, and also education
    of local populations on Ebola prevention and control. But, you
    know, it is interesting because as much attention as we have
    given to Ebola in this country, far more people die every month
    from influenza than they do of Ebola, and this is a continuing
    problem.
        This month, we are hearing about the measles outbreak,
    which was linked to Disneyland in California and has now spread
    to at least 14 States. Infectious disease experts at the CDC
    and the State health departments have mounted a fast and
    aggressive response to prevent this highly contagious disease
    from spreading.
        And, Mr. Chairman, I know you have received a letter from
    me and Ranking Member Pallone and Ranking Member Green asking
    this committee to hold a targeted hearing on the measles
    outbreak and the urgent public health threat. I would like to
    make a copy of that letter part of the record, Mr. Chairman.
        [The information is available at the conclusion of the
    hearing.]
        And, while that letter is pending, I want to commend you,
    Dr. Fauci. I saw you on the news last night telling all of the
    families in America to get their measles vaccine, and I really
    appreciate that. I want to add from this podium, as the mother
    of two daughters, one of whom is immunocompromised: Vaccinate
    your children against measles. There is no reason not to, and
    there is every reason that they could be a threat to themselves
    and other children if they don't get that vaccine. So I just
    want to pile onto that. It is very, very important.
        But on to the flu, which is the topic of this hearing, the
    predominant strain of flu is H3N2, which is resulting in
    increased hospitalizations, particularly for vulnerable
    populations like seniors and young children. And the CDC
    announced several weeks ago that the flu vaccine has only 23
    percent effectiveness. That is significantly lower than in
    recent years, and as the chairman mentioned, it is largely due
    to changes in the virus that have resulted in a mismatch
    between the strain of the virus used in vaccine production and
    the one actually circulating. But even with a 23 percent
    effectiveness, we still need to protect ourselves as much as we
    can. Dr. Frieden reminded us several weeks ago that even a
    vaccine with 23 percent effectiveness will still prevent
    millions of people from getting sick. And so, therefore, as the
    chairman said, people also need to get this vaccine. And it is
    not too late; flu season is still going on. We have to do
    everything we can to protect our vulnerable populations; young
    children, seniors, pregnant women, and others with compromised
    immune systems.
        So I am looking forward to hearing from our wonderful
    witnesses today about what we can do to mitigate the effects of
    this flu season, and how doctors and hospitals are prepared to
    respond. I also want to look to the future. What can we do to
    inform our prevention and response efforts in future flu
    seasons? I want to hear about the research and technological
    developments in diagnostics, antiviral treatments, and
    vaccines.
        In our last hearing on this topic in February 2013, we
    heard about FDA approval of quadrivalent vaccines and cell base
    technology. Today, I am hoping our witnesses can give us
    encouraging news about the development of a universal flu
    vaccine.
        So regardless of the particular effectiveness rate in a
    given season, the flu vaccine remains the best tool that we
    have to protect as many people as possible, and we need to have
    ongoing work on that. This flu season reminds us that it is
    almost impossible to predict what the strain will be, but it
    underscores the importance of a strong public health
    infrastructure.
        And so, Mr. Chairman, I just want to say I appreciate the
    witnesses coming today. I hope we can all work together to move
    the country toward better flu preparedness.
        Mr. Murphy. I thank the gentlelady. And now recognize the
    chairman of the full committee, Mr. Upton, for 5 minutes.

       OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF MICHIGAN

        Mr. Upton. Well, thank you, Mr. Chairman.
        This is an important issue, that is for sure, and it has
    been an especially harsh flu season, and preliminary estimates
    show that this year's vaccine is only 23 percent effective in
    preventing folks from going to the doctor for treatment, even
    lower for high-risk groups, which is often the case I know.
        Usually, the flu vaccine is about 50 to 60 percent
    effective, and I, like many folks back in Michigan and across
    the country, would like to see us do better in addressing this
    major public health threat.
        Every year, between 5 and 20 percent of Americans get the
    flu. In a severe flu season like this one, there could be more
    than 50,000 deaths, over 200,000 hospitalizations, and more
    than $10 billion spent on direct medical costs. The flu is and
    should be a top priority for all of U.S. public health.
        This year's vaccine, we know, is less effective because it
    is not a good match for the flu strain that has become
    dominant. The flu virus strain changed significantly during the
    6 months after the strain selection decision for the U.S. was
    made. The World Health Organization, in September, recommended
    changing the flu vaccine for the Southern Hemisphere to use in
    their upcoming flu season that starts in April but by the time
    the change in virus was evident, it was too late to change the
    U.S. vaccine.
        Now, it is worth pointing out that the CDC continues to
    recommend vaccinations in the U.S., even with a lower
    effectiveness, and that high-risk patients should be treated as
    soon as possible with all antiviral drugs.
        When we learned that there was a shift in the virus, what
    options were available to respond to the mismatch in viruses?
    Was there a way to deploy a rescue vaccine targeting just the
    changed virus? Was there a way to improve the effectiveness of
    this year's vaccine by adding substances to boost the immune
    response? Those are some of the questions that we need to have
    answered as we proceed with this hearing.
        And I appreciate the folks that are testifying today and
    yield to Dr. Burgess and then to Marsha Blackburn.
        [The prepared statement of Mr. Upton follows:]

                     Prepared statement of Hon. Fred Upton

        Thank you, Mr. Chairman, for convening this hearing on the
    U.S. public health response to seasonal influenza. We remain in
    the midst of a particularly harsh flu season and preliminary
    estimates show that this year's vaccine is only 23 percent
    effective in preventing folks from going to the doctor for
    treatment, even lower for high-risk groups. Usually, the flu
    vaccine is about 50-60 percent effective. I, like many folks
    back in Michigan and across the country, believe we can do
    better in addressing this major public healththreat.
        Every year between 5 percent and 20 percent of Americans
    get the flu virus. In a severe flu season like this one, there
    could be up to 50,000 deaths, over 200,000 hospitalizations,
    and more than $10 billion spent on direct medical costs. The
    flu is, and should be, a top priority for U.S. public health.
        We understand that the reason this year's vaccine has lower
    effectiveness is because it is no longer a good match for the
    flu strain that has become dominant. The flu virus strain
    changed significantly during the six months after the strain
    selection decision for the U.S. vaccine was made, and we have
    been told it was too late to change the vaccine for the U.S. As
    a result of the evidence of change in the virus, the World
    Health Organization in September 2014 recommended changing the
    flu vaccine for the Southern hemisphere to use in their
    upcoming flu season that starts in April. The CDC continues to
    recommend vaccination in the United States, even with the lower
    effectiveness, and that high-risk patients be treated as soon
    as possible with anti-viral drugs.
        While it is difficult to know when or how seasonal flu
    viruses are likely to change, leading to a need to change the
    vaccine for that year, we have made significant improvements in
    the past 10 years and it seems like we should be able to do
    better. There were known weaknesses in the surveillance system.
    In 2011, the World Health Organization conference found that a
    key test used to check for flu virus changes was not very
    effective in detecting evidence of changes in the deadliest flu
    strain. Our understanding is that this same test is still used.
    What tests were used as an alternative to the inadequate test?
        And when we learned that there was a shift in the virus,
    what other options were available to respond to the mismatch in
    viruses? Was there a way to deploy a rescue vaccine targeting
    just the changed virus? Was there a way to improve the
    effectiveness of this season's vaccine by adding substances
    that boost the immune response?
        Improving our response to a severe flu season with a
    mismatched vaccine could mean saving thousands of lives. My
    concerns and questions do not diminish my admiration and
    support for the dedication of the U.S. public health agencies
    working on flu preparedness. It is because of their talent and
    hard work that I believe improvement is really possible. We can
    work together to make that happen. I am also eager to learn
    about the latest research and innovation, and how we can better
    support and leverage these advances to improve our response to
    seasonal influenza.
        I welcome all our witnesses, and look forward to their
    testimony.

        Mr. Burgess. I thank the chairman for yielding. And, Mr.
    Chairman, thank you for holding the hearing today.
        In fiscal year 2014, the estimated Federal investment in
    seasonal flu preparedness exceeded $850 million. The public-
    private partnership driving research and development has had
    successes, but we must do better.
        First, communication between agencies and with the public
    must improve. If there is a mismatch in the vaccine, which
    became apparent in May or even as late as September, it is
    unacceptable that advisories were not issued until December.
    Second, there must be transparency and consistency in the
    regulatory pathways for innovation in vaccines. Experts have
    recognized the promise of adjuvanted flu vaccines for over a
    decade, yet not one is licensed in the United States, and no
    guidance has been issued. Third, greater emphasis must be
    placed on modernizing the development and manufacture of flu
    vaccines. I would add my acknowledgement to the ranking member
    of the subcommittee, I too at one time was promised a universal
    flu vaccine, I think in this committee at a hearing just like
    this. That was probably in 2004 or 2005. We are still waiting.
    We want to see it.
        So I appreciate the opportunity to be able to speak on
    this. I look forward to hearing from our witnesses.
        And I will yield the balance of the time to Mrs. Blackburn,
    Vice Chair of the full committee.
        Mrs. Blackburn. Thank you, Mr. Chairman. And I want to
    continue our conversation about vaccinations. And, yes, we are
    talking about flu today, but there is another issue out there
    and Ms. DeGette mentioned this. Vaccine politics injected into
    2016, measles outbreak infects politics and debate.
        Now, this is far too serious an issue to be treated as a
    political football. People still die from measles. And the CDC
    Web site tells us it was eliminated from the U.S. in 2000, but
    yet we are seeing this outbreak. And I have to tell you, it is
    of tremendous concern to me as a mother and a grandmother. I am
    hearing so much about this from my constituents, and they want
    to know some answers, they want to know how you all are
    addressing this. And I will tell you, when I hear about
    counties in California that have lower immunization rates than
    the Sudan and Chad, this is something that is of concern to me.
        I am a Rotarian. We have invested decades into eliminating
    and wiping out polio, and then to hear this about the U.S., I
    am concerned.
        We know the measles outbreak started in California. It has
    affected over 100 people in 14 States, and that most of those
    people were not vaccinated. So we do want to veer off and ask
    you some questions in this realm today.
        And I yield back.
        Mr. Murphy. The gentlelady yields back. I now recognize Mr.
    Pallone for 5 minutes.
        Mr. Pallone. Thank you, Mr. Chairman, and thanks for
    holding this hearing today.
        I have to tell Ms. DeGette that this is actually the first
    time that I have been a member of the O&I Subcommittee, so I am
    very happy.
        Ms. DeGette. And we are happy to have you, Mr. Pallone.
        Mr. Pallone. Thank you.
        Mr. Murphy. Welcome aboard. It is the best subcommittee in
    Congress.

    OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
                IN CONGRESS FROM THE STATE OF NEW JERSEY

        Mr. Pallone. Thank you. So this year, we are seeing a
    severe flu season. Across the country, hospitalization rates
    are higher, especially for seniors over age 65, and for young
    children, and public health experts predict these flu activity
    levels will continue and even increase in the next few weeks.
        The Centers for Disease Control and Prevention continues to
    recommend that we all get the flu vaccine. Initial estimates
    show that this year's flu vaccine is 23 percent effective,
    meaning that 23 percent of those vaccinated for the flu will
    still have to visit a doctor because of the flu. But despite
    being less effective this year than the recent past, flu shots
    will still protect against and decrease the severity of flu-
    related illnesses. Moreover, flu shots don't only protect the
    vaccinated, they also protect those who have not been
    vaccinated from getting sick, and as members of Congress, I
    think we all have to play a role to ensure that message gets
    out and it is not too late to get your flu vaccine.
        This hearing is also a good opportunity to talk about how
    we can improve vaccination rates. We took important steps in
    the ACA to provide coverage for preventative services like
    immunizations. Since the law went into effect, nearly 76
    million Americans have received no-cost coverage for
    preventative services, and as millions more receive coverage
    through the ACA, we hope to see the vaccination rate improve so
    that we can realize the benefits of a better-protected
    population. However, we still must improve public awareness,
    and continue to improve access to these preventative services.
    This is especially of concern as we hear reports of the measles
    outbreak that began at Disneyland, and is now spreading
    throughout the country. Just yesterday, the President urged all
    parents to get their children vaccinated against measles, and I
    would certainly echo his comments.
        Dr. Tom Frieden, who heads the CDC, is warning that the
    U.S. could see a large outbreak of measles. There are now over
    100 cases in 14 States, and measles is extremely contagious, 90
    percent of those exposed to the disease will be infected unless
    they have been vaccinated. According to Dr. Frieden, there has
    been growing evidence that more parents are not vaccinating
    their children against measles, and that these lower
    vaccination rates have led to the latest increase in measles
    cases. The CDC is further assuring families, and parents
    especially, that the measles vaccine is safe and effective, and
    we were able to eliminate measles in the U.S. in 2000, largely
    because of a highly effective vaccination program. So it is
    important to reiterate that measles is a preventable disease
    for which there are safe, effective and available vaccines.
        So I look forward to hearing from our public health
    officials today about how we can improve vaccination rates for
    the flu, but we also need to learn how we can improve
    vaccination rates for the future for other infectious diseases,
    including measles.
        I know that Ms. DeGette mentioned that both herself and Mr.
    Green and myself sent a letter yesterday asking for a hearing
    with regard to the measles public health emergency, and I hope
    that we can actually see that occur. I think it would be very
    important. And I just want to thank everyone.
        And I would now yield the balance of my time to
    Representative Castor.
        Ms. Castor. Well, thank you for yielding the time, and good
    morning. Thank you, Mr. Chairman and Ranking Member DeGette,
    for holding this important hearing to better understand the flu
    and the flu vaccine.
        Vaccines are incredibly valuable tools to protect and
    improve the health of all of our neighbors. And as we have seen
    with the recent and surprising measles outbreak, vaccines
    protect lives. According to reports, there have been 102 cases
    of measles reported across 14 States, and those who do not
    vaccinate their children are putting them at risk, and they are
    putting others at risk. Vaccines are safe and effective.
        I want to give particular thanks to Dr. Schuchat from the
    Centers for Disease Control for traveling to the Tampa Bay area
    a few months back to raise awareness with another important
    vaccine, the anti-cancer vaccine of HPV. Thank you for meeting
    with our public health students, and anti-cancer advocates to
    explain. See, Florida had one of the lowest rates of HPV
    vaccines, and we can save lives and prevent cancer if people
    will understand the importance of the HPV vaccine. Your visit
    was a great boost to our efforts to prevent cancer through the
    HPV vaccine, so thank you again for the work you do to educate
    the public on vaccinations.
        You know, we are so fortunate to live in America where we
    have studied and investigated and tested all of these vaccines
    to ensure that they are safe and effective. So thank you to all
    the panelists for all the work you do, and I look forward to
    your testimony.
        I yield back.
        Mr. Murphy. Thank you.
        I would now like to introduce the witnesses on the panel
    for today's hearing. First is Dr. Anne Schuchat. Did I
    pronounce that correctly? The director of the National Center
    for Immunization and Respiratory Diseases at the Center for
    Disease Control and Prevention. Dr. Karen Midthun is the
    director for the Center for Biologics Evaluation and Research
    at the U.S. Food and Drug Administration. Dr. Robin Robinson,
    the director of Biomedical Advanced Research and Development
    Authority, otherwise known as BARDA, within the Office of the
    Assistant Secretary for Preparedness and Response. And Dr.
    Anthony Fauci is the director of the National Institute of
    Allergy and Infectious Diseases at the National Institutes of
    Health. I welcome you all here and we look forward to your
    testimony.
        I will now swear in the witnesses.
        You are aware that this committee is holding an
    investigative hearing, and when doing so, has the practice of
    taking testimony under oath. Do any of you have any objections
    to testifying under oath? Seeing no objections, the Chair then
    advises you that under the rules of the House and the rules of
    the committee, you are entitled to be advised by counsel. Do
    any of you desire to be advised by counsel during your
    testimony today? Everybody has said no. In that case, if you
    would please rise and raise your right hand, I will swear you
    in.
        [Witnesses sworn.]
        Mr. Murphy. Thank you. You are now under oath, and subject
    to penalties set forth in Title XVIII, section 1001 of the
    United States Code. You may each now give a 5-minute summary of
    your written statement. Make sure you pull the microphone close
    to you, and watch that red light.
        Dr. Schuchat, you can begin.

     STATEMENTS OF ANNE SCHUCHAT, M.D., DIRECTOR, NATIONAL CENTER
    FOR IMMUNIZATION AND RESPIRATORY DISEASES, CENTERS FOR DISEASE
        CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN
     SERVICES; KAREN MIDTHUN, M.D., DIRECTOR, CENTER FOR BIOLOGICS
        EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION,
      DEPARTMENT OF HEALTH AND HUMAN SERVICES; ROBIN A. ROBINSON,
     PH.D., DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
     AUTHORITY, OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS
      AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND
    ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY
         AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH

                       STATEMENT OF ANNE SCHUCHAT

        Dr. Schuchat. Good morning, Mr. Chairman, and members of
    committee. I am Dr. Anne Schuchat, Director of the National
    Center for Immunization and Respiratory Diseases at the Centers
    for Disease Control and Prevention.
        Influenza virus is a formidable adversary. Influenza's
    propensity to change presents unique challenges. New flu
    vaccines must be developed each year based on the predictions
    of which viruses are likely to be most common during the next
    season. Vaccine development is complex and time-consuming,
    typically requiring vaccine candidates that grow well in eggs
    and provide immunity in humans. And while we tackle seasonal
    flu, we must conduct constant global surveillance and prepare
    for the emergence of dramatically changed or shifted influenza
    virus that could trigger the next pandemic.
        Over the past decade, we have made significant improvements
    in our ability to detect, prevent, and respond to influenza,
    yet, despite our improvements, the current severe influenza
    season has been difficult. My colleagues and I represent
    agencies that work together to respond to seasonal and pandemic
    flu. The NIH supports research on vaccines, diagnostic tools,
    and antiviral drugs for seasonal and pandemic influenza. The
    Food and Drug Administration regulates influenza vaccines,
    convening public health and influenza disease experts to
    recommend which influenza virus strains should be included in
    FDA-licensed vaccines.
        The Biomedical Advanced Research and Development Authority,
    BARDA, supports advanced research, development, and procurement
    of innovative medical countermeasures to address manmade and
    emerging infectious diseases, including influenza pandemics.
    And at CDC, we support surveillance and diagnostic capacity to
    rapidly detect, prevent, and respond to annual influenza
    epidemics, and novel and pandemic influenza threats.
        Our CDC systems provide the scientific basis for global
    vaccine virus selection for seasonal flu, vaccine as well as
    for pandemic vaccine stockpiling. We monitor for genetic
    changes in the flu virus, and identify how these changes affect
    disease transmission and severity. We build public awareness
    and provide our knowledge about prevention and early treatment,
    and support public sector delivery of routine and emergency
    immunizations.
        The 2014/15 influenza season has proven a particularly bad
    season. The virus that is predominant, H3N2, is associated with
    more severe disease. The vaccine we are using is not well
    matched to circulating H3N2 strains. Antivirals can be
    important aids in some patients, but clinicians are
    underutilizing them.
        How do we find ourselves with vaccine that isn't well
    matched to the circulating H3N2 viruses? When the 2014/15 flu
    vaccine strains were selected last February, the drifted virus
    we are seeing now was not yet detected. A small number of these
    drifted viruses were first detected in March 2014, and CDC
    continued to monitor them throughout the summer, looking for
    genetic patterns and geographic spread.
        In September 2014, when we began promoting seasonal
    vaccination, about \1/2\ of the H3N2 viruses circulating were
    like the vaccine component. When the influenza season took off
    at the end of November, only \1/3\ of the H3N2 viruses CDC
    detected were like the vaccine component. Our early vaccine
    effectiveness estimate found people vaccinated had about 23
    percent lower risk of influenza infection requiring a medical
    visit. While this is lower than we usually see, the vaccine is
    providing some protection.
        Influenza viruses follow their own schedules, not ours. New
    strains can emerge at any time. Some appear and die out, and
    others persist and spread. Our actions are proportional to
    risks. We work year-round to detect and characterize viruses of
    concern that circulate globally, monitor their emergence and
    geographic spread, and develop viable vaccine candidates for
    drift viruses as they occur. When we detected relatively small
    numbers of the drifted H3N2 strain late last spring, CDC began
    preparing candidate vaccine virus strains.
        As the Nation's public health agency, we are committed to
    provide the information people need to protect their patients'
    and families' health, and to be transparent in our assessments
    and the evidence base that supports our recommendations.
        As a physician and a public health professional, I too wish
    we could guarantee better protection each year, yet, we have
    made significant advances on several fronts. Our surveillance
    network is characterizing more viruses with improved methods.
    Significantly more Americans get flu vaccine each year, and
    information on viruses, disease, and vaccination is released
    more rapidly.
        In closing, this flu season has caused more suffering and
    serious disease than many previous years, and there will be
    more challenging seasons ahead, but collaboration across the
    agencies, and with our public and private partners, holds
    promise for the future, including progress toward development
    of universal influenza vaccines, since better, broader, and
    long-lasting protection could transform our approach to this
    challenging virus.
        [The prepared statement of Dr. Schuchat follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you.
        Dr. Midthun, you are recognized for 5 minutes. Thank you.
    Make sure the microphone is turned on and it is close to you.
    Thank you. You still have to turn it on. Press the--there you
    go.

                       STATEMENT OF KAREN MIDTHUN

        Dr. Midthun. Thank you. Mr. Chairman and members of the
    subcommittee, I am Dr. Karen Midthun, Director of the Center
    for Biologics Evaluation and Research, the center within FDA
    that is responsible for regulating vaccines. Thank you for the
    opportunity to be here today to discuss our role in a highly
    collaborative, multi-partnered effort in preventing influenza
    through vaccination in the U.S.
        Influenza viruses continually undergo changes in their
    genetic makeup, and the resulting proteins that interact with
    the immune system. Due to these continuous changes, the
    composition of influenza vaccines must be periodically updated
    so that they are effective against what are anticipated to be
    the predominant circulating viruses in the upcoming influenza
    season.
        The strains of virus in the vaccine include 2 distinct
    subtypes of influenza A, H1N1, and H3N2, and 1 or 2 influenza B
    strains, depending upon whether the vaccine is trivalent or
    quadrivalent. To identify virus strains likely to cause illness
    during the upcoming season, the World Health Organization
    convenes influenza and public health experts to study recently
    circulating influenza viruses from around the world, and recent
    global disease patterns. After careful evaluation of the
    assessment, WHO makes recommendations on the composition of the
    influenza vaccines, usually in late February for the upcoming
    season in the Northern Hemisphere, and in September for the
    upcoming season in the Southern Hemisphere. The recommendations
    must be made months in advance because of the time required for
    manufacturing, testing, lot release, and distribution of a very
    large number of vaccine doses.
        Each year, following the WHO recommendations, FDA convenes
    its vaccines and related biological products advisory
    committee, typically in late February or early March. The
    committee considers the WHO recommendations and reviews
    information regarding viruses that caused illness in the
    previous year, how these viruses are changing, and disease
    trends. Based on the data available at the time of the meeting,
    the committee makes recommendation for the composition of the
    influenza vaccines licensed by FDA for the upcoming season in
    the U.S. Once the strains are selected, candidate influenza
    viruses that are adapted for high growth are generated and
    accepted by WHO collaborating centers, and are provided to
    manufacturers who generate the seed viruses for manufacturing
    vaccines. The manufacturing demands are tremendous and the
    timelines are tight. No other vaccine is produced, FDA approved
    and distributed every year across the U.S. within a six-month
    time frame.
        This season, more than 150 million doses were manufactured.
    Given the yearly need for a new vaccine, there is limited
    flexibility in the timelines of vaccine manufacturing and
    availability. And parallel with vaccine manufacturing, FDA
    develops and calibrates reagents which are used by both FDA and
    the manufacturers to test vaccines for potency and identity
    before FDA approves the new formulation for distribution.
    Manufacturers submit their vaccine testing results, along with
    samples from each lot, to FDA for lot release. As FDA releases
    lots, the manufacturers can make these lots commercially
    available throughout the U.S.
        In February 2014, when the strain selection recommendation
    for the current influenza season was made, it reflected the
    circulating viruses. The drifted H3N2 viruses were first
    detected in March 2014 and were uncommon. Over the ensuing
    months, the drifted strains gradually increased. By late
    September, when WHO made its recommendations for the 2015
    Southern Hemisphere influenza vaccine, the drifted H3N2 strains
    were common, prompting a recommended change in the upcoming
    Southern Hemisphere vaccine composition. Because of the
    manufacturing time required, there was not enough time to make
    a similar change for the current Northern Hemisphere influenza
    season. The drifted strains have caused the majority of
    influenza cases this season, however, vaccination is still
    important to prevent disease and minimize the public health
    burden of influenza. Influenza vaccines contain three or four
    influenza viruses, so even when there is a less than ideal
    match or lower effectiveness against one virus, the vaccine may
    protect against the other viruses.
        FDA has made progress in our preparedness efforts and
    collaboration with BARDA, CDC, NIH, manufacturers, and other
    stakeholders, and we thank Congress for your support of these
    efforts. New influenza vaccines have been licensed, including
    cell-based, recombinant protein vaccines and quadrivalent
    vaccines. To enhance pandemic preparedness, FDA licensed an
    adjuvanted H5N1 avian influenza vaccine, and has worked with
    U.S. Government partners and manufacturers to facilitate the
    development of candidate vaccines directed at H7N9 avian
    influenza. Surveillance efforts are more extensive than ever
    before, and offer the potential for early detection of emerging
    viruses. The number of candidate vaccine virus strains
    available to manufacturers has greatly increased over the last
    few years, providing them with more options to increase vaccine
    yields. We continue efforts with our Government partners to
    develop high-yield candidate vaccine strains, as well as more
    modern, faster testing methods for vaccine potency and
    sterility. To further address the challenges presented by the
    constantly changing nature of influenza viruses, scientists and
    Government laboratories, academic institutions, vaccine
    manufacturers, are all working to develop new generation
    vaccines that might provide longer-lasting and broader
    protection against influenza viruses, including drifted
    strains. Although these development efforts are still in early
    stages, some may have the potential to increase and broaden
    protection against influenza.
        FDA will continue to work with its Government partners,
    manufacturers, and other stakeholders to facilitate development
    of new vaccines, and identify methods that have the potential
    to speed the manufacturing process for existing vaccines. Our
    goal is to better protect the American public against
    influenza.
        Thank you.
        [The prepared statement of Dr. Midthun follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you.
        Now, Dr. Robinson, you are recognized for 5 minutes.

                     STATEMENT OF ROBIN A. ROBINSON

        Dr. Robinson. Good morning, Chairman Murphy, Ranking Member
    DeGette, and distinguished members of the subcommittee. Thank
    you for the opportunity to speak with you today. I am Dr. Robin
    Robinson, Director of the Biomedical Advanced Research and
    Development Authority, and Deputy Assistant Secretary for
    Preparedness and Response, as well as a former developer of
    influenza vaccines in industry.
        BARDA is the Federal Government agency mandated to support
    advanced research and development, and procurement of novel and
    innovative medical countermeasures such as vaccines,
    therapeutics, diagnostics, and medical devices for the entire
    Nation to address the medical consequences of manmade and
    naturally occurring threats like the H1N1 pandemic, the 2013
    H7N9 influenza outbreak, and the current Ebola epidemic.
        Pandemic influenza is one of our primary concerns. We
    understand that preparedness for pandemic influenza is directly
    tied to seasonal influenza. Medical countermeasures for
    seasonal influenza underpin the vaccines, antivirals, and
    diagnostics used for pandemic influenza. BARDA has invested in
    the advanced development of medical countermeasures that have
    utility for both seasonal and pandemic influenza preparedness.
        BARDA transitions medical countermeasures from early
    research and development at NIH, into advanced development
    toward FDA approval and potential procurement. BARDA has funded
    and successfully managed the advanced development of more than
    60 medical countermeasures for pandemic influenza. More than 20
    of these medical countermeasures for influenza have been FDA
    approved, with 6 receiving approval in the last 3 years, as Dr.
    Midthun indicated. Additionally, BARDA developed and procured
    vaccines and antivirals used in the 2009 H1N1 pandemic, and
    stockpiled vaccines for preparedness against H5N1 and H7N9
    viruses. BARDA, through partnerships with NIH, CDC, FDA,
    industry, and academia, has met and overcome many but not all
    of the challenges inherent to making medical countermeasures
    associated with seasonal and pandemic influenza. Specifically,
    BARDA, with our partners, has made major progress in the
    following pandemic areas.
        First, modernization of influenza vaccine manufacturing
    through the development and licensure of new cell- and
    recombinant-based influenza vaccines, and antigen-sparing
    pandemic vaccines with adjuvants towards meeting our strategic
    goal of more and better influenza vaccines sooner. These new
    vaccines were part of our successful H7N9 response in 2013.
        Second, shortening influenza vaccine manufacturing time by
    weeks, effected through the Influenza Vaccine Manufacturing
    Improvement initiative, as recommended by PCAST, to optimize
    the generation of high-yielding vaccine seed strains, and
    alternative potency and sterility assays. Many of these
    improvements, such as biosynthetic technology, were employed
    during the H7N9 vaccine response in 2013, which was the fastest
    on record.
        Third, establishment and maintenance of pre-pandemic
    influenza vaccine stockpiles for H5 and H7N9 viruses that may
    be used to immunize tens of millions of persons at the onset of
    an influenza pandemic with these viruses.
        Fourth, and last, multi-fold expansion of domestic pandemic
    influenza vaccine production capacity, afforded by retrofitting
    of older manufacturing plants, building new state-of-the-art
    manufacturing facilities for making 21st century influenza
    vaccine, and establishing three centers for innovation and
    advanced development and manufacturing, with rapid, nimble, and
    flexible manufacturing capabilities through public-private
    partnerships with industry.
        The new national infrastructure responded in 2013 to the
    H7N9 outbreaks, and today, in the Ebola epidemic. Despite these
    significant accomplishments, our pandemic preparedness work is
    not over. Making a more effective influenza vaccine remains a
    significant scientific challenge. Indeed, progress towards more
    effective influenza vaccines has been noted in recent years,
    but much more is needed.
        Going forward, there is reason for hope that more effective
    influenza vaccines may be within our grasp. The discovery of
    new influenza viral targets within the last 4 years has renewed
    interests and efforts to develop new universal influenza
    vaccine candidates.
        Developing more effective pandemic influenza vaccines is
    one of our top priorities, and BARDA will support new methods
    based on evolutionary biology that may help forecasting and
    selection of new seasonal and pandemic influenza vaccine
    strains.
        In parallel, we are launching this month an initiative to
    support advanced development of new, more effective influenza
    vaccine candidates that may elicit greater, broader, longer
    immunity in all populations against divergent influenza virus
    variants, and that may serve as primers for pandemic influenza
    vaccines.
        In conclusion, influenza viruses with pandemic potential
    continue to evolve and change, infect animals and man, and pose
    significant threats to global and domestic public health. This
    year's limited seasonal influenza vaccine effectiveness, and
    the arrival of the first human case of H7N9 virus in North
    America underscore our urgent need to complete this mission. To
    be better prepared, our Nation must continue to invest in
    domestic pandemic preparedness, and work with key global
    partners.
        I thank you for this opportunity to discuss how we can be
    better prepared for seasonal and pandemic influenza, and I look
    forward to your questions.
        [The prepared statement of Dr. Robinson follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you, Dr. Robinson.
        Dr. Fauci, you are recognized for 5 minutes.

                     STATEMENT OF ANTHONY S. FAUCI

        Dr. Fauci. Mr. Chairman, Ranking Member DeGette, members of
    the committee, I appreciate the opportunity to discuss with you
    today very briefly the role of the National Institute of
    Allergy and Infectious Diseases in research addressing both
    seasonal and pandemic influenza.
        [Slide shown.]
        As shown on this slide, the NIH research agenda is really
    based on the traditional approach that the NIH has taken with
    all diseases; namely, fundamental basic research, clinical
    research, and field research, the provision of research
    resources both to the academic community, as well as to the
    biotech and pharmaceutical companies. The endgame is to
    ultimately produce interventions in the form of diagnostics,
    therapeutics, and vaccines. You have heard about the
    diagnostics and therapeutics. We can talk about them a little
    bit later. I want to focus the remainder of my remarks on a
    subject of obvious importance; namely, the development of
    influenza vaccines.
        [Slide shown.]
        Traditionally, the classic what we call platforms, or the
    way you develop the vaccine, have been based on growing the
    virus itself either in eggs, which is somewhat cumbersome, or
    more recently using it in cell lines, which are a bit more
    predictable. You either have a live attenuated vaccine or an
    inactivated vaccine, and that has been the traditional approach
    towards vaccines. It is cumbersome, it takes a long period of
    time because you have to grow the virus.
        [Slide shown.]
        Our researchers, both at the NIH and our grantees and
    contractors, over the last several years have been attempting,
    with some success, to make a conversion to what we call a
    recombinant DNA technology, molecular-based approach that would
    obviate the need to actually continue to grow the virus to make
    a vaccine. Several of these are illustrated on this slide. We
    don't have time to go into each and every one of them, but they
    are particularly suited to develop a vaccine that we are all
    hoping for, and that Dr. Burgess mentioned in his 5-minute
    remarks, and that is a universal influenza vaccine.
        [Slide shown.]
        This is the cover of a Nature Medicine article that I wrote
    with my colleague, Dr. Gary Nabel, the former director of the
    Vaccine Research Center, namely, how we can induce what I
    called unnatural immunity; namely, immunity that a normal
    vaccine induction or the virus itself doesn't induce, and that
    is broad protection against subsequent exposures to different
    types of influenzas that have a tendency to drift over a period
    of years, and sometimes to even shift, which gives us a
    pandemic.
        [Slide shown.]
        Now, the reason we can do this, and I just want to point
    out on this slide, on the lower right is a blown-up schematic
    of the influenza virus. The proteins that coat the outside are
    referred to as hemagglutinin, and that is where we get the H
    for H3, H2, or H1. It is a designation of a major protein. The
    other one is N for neuraminidase. But notice how those proteins
    are clustered on the surface of the virus, so that what the
    immune system sees generally is just the top, what we refer to
    as the head or the bulb of that protein.
        [Slide shown.]
        If you look at this slide, that head is where most of the
    antibodies that protect you and me against influenza are made.
    That is the good news. The sobering news is that is a variable
    region, which tends to change as influenzas drift from season
    to season and change an awful lot when it goes to a pandemic.
        If you look at the little stem, the thin part of that
    protein, that the immune system doesn't see very well,
    interestingly, we found out several years ago that that is the
    part--that is what we called highly conserved. It doesn't
    change from necessarily a Texas H3N2 to a different type, a
    Singapore or a variety of others. They stay the same, which
    means that if you can induce an immune response against that
    unchangeable one, you might be able to get what we call a
    broader reactivity.
        [Slide shown.]
        And over the last several years, we have made considerable
    progress as shown on this slide here, where a number of
    candidates have used molecular techniques to essentially show
    the body predominantly the part of that protein that doesn't
    change. And there are a number of ways of doing that. Instead
    of giving the body the entire virus, either killed or
    attenuated, by molecular techniques, you show the body only the
    part that you want it to respond to, unencumbered by the
    physical structures that don't allow the body to see it. And we
    now have done this in several candidates--in mice, in ferrets,
    and what we call phase one studies in humans--which means we
    know it is safe, we know it can induce the kind of response
    that is more broad. In collaboration with BARDA, we are now
    starting to produce that to go into larger trials. And as Dr.
    Burgess said, we are not there yet, but we are clearly many
    steps further than what we were the last time I testified
    before this committee.
        So I will stop there and be happy to answer any questions.
        [The prepared statement of Dr. Fauci follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Murphy. Thank you.
        I will now recognize myself for opening questions for 5
    minutes.
        But let me just start off, and I know that a lot of
    concerns about vaccines and autism. As a psychologist, I have
    seen many a child with autism. It is a deeply concerning
    problem with the families. Past publications have been
    discredited, and data was deemed fraudulent. Multiple studies
    said there is no link between developmental disorders such as
    autism and vaccines.
        I want to ask each of you, do you agree, Dr. Schuchat? Dr.
    Midthun, do you agree? Dr. Robinson, do you agree? Dr. Fauci,
    do you agree? And--yes, you can say this verbally. Should
    parents have their children vaccinated? Dr. Schuchat?
        Dr. Schuchat. Vaccines save lives and are the best way for
    parents to protect their children----
        Mr. Murphy. Yes, right.
        Dr. Schuchat [continuing]. From vaccine-preventable
    diseases.
        Mr. Murphy. Dr. Midthun, yes or no? Yes?
        Dr. Midthun. Yes. I have three children, and they were all
    vaccinated on time with all the recommended vaccines.
        Mr. Murphy. Dr. Robinson?
        Dr. Robinson. Absolutely.
        Mr. Murphy. Dr. Fauci?
        Dr. Fauci. Definitely.
        Mr. Murphy. OK. Dr. Schuchat, flu expert Dr. Andrew Pavia
    at the University of Utah School of Medicine said, ``By April
    or May, there was good evidence of the drifted A/Switzerland
    strain. It wasn't clear it was going to be a dominant strain,
    but there was a pretty good hint, we probably would have chosen
    the vaccine differently.'' Dr. Schuchat, do you agree that
    there was good evidence of the drifted strain by, say, April or
    May of this last year?
        Dr. Schuchat. We were certainly keeping a close eye on this
    drifted strain last May, and that is when the CDC began to
    develop a candidate vaccine virus, but as you know, it can be
    very challenging to develop candidate vaccine viruses, and to
    take it from a candidate to all the way to production of
    vaccine, all the way to production of hundreds of millions of
    doses of vaccine.
        Mr. Murphy. But by May, there was evidence of a 17 percent
    mismatch. Do you think that 17 percent mismatch was a concern
    at that point, and were there any discussions about that at
    CDC?
        Dr. Schuchat. Yes, there were. In fact, in March, we
    started to reach out to the global community, the international
    WHO collaborating centers, when we saw the first handful of
    this drifted strain to ask others were they seeing it.
        I think it is important to realize that strains emerge and
    can disappear, and in the spring, it is very difficult to know
    which ones will still be around in the summer or fall. We
    actually respond to these new drifted strains by working on
    candidate vaccine viruses, but it is very difficult with
    influenza to predict what strains will dominate, whether it is
    going to be an H3N2 year or a H1N1 year. And so we continue to
    go through the routine seasonal flu work while we are also
    developing the candidate vaccine virus----
        Mr. Murphy. Well, let me ask about this pattern. We have
    here, I am looking at the mismatch notes, by March there is
    about a 10 percent mismatch drift, by May, 17 percent. We
    understand by September it was already up to 50 percent. Do we
    know in these gaps of April or June or July or August what
    those drift rates were? Was there a problem by those times that
    was being seen?
        Dr. Schuchat. Yes, we have information for the summer. It
    is important to remember that there is very limited influenza
    circulating here in the U.S. in the summer, and it takes off in
    the fall. That is one of the reasons we do global worldwide
    surveillance----
        Mr. Murphy. Sure, but right here----
        Dr. Schuchat [continuing]. And we have greatly increased
    the numbers there.
        Mr. Murphy. But here in September, a decision was made for
    the World Health Organization to change this for the Southern
    Hemisphere. And so I am wondering, because there are big gaps
    here, were there discussions between all your agencies that we
    ought to be doing something differently other than telling
    people to have some kind of an antiviral medicine?
        Dr. Schuchat. Thanks. I think it is important--Dr. Fauci
    talked about the idea of drift and the idea of shift, and I
    think the members remember in 2009 where, in the spring of
    2009, we did decide it was important to go forward with a
    monovalent vaccine----
        Mr. Murphy. Right.
        Dr. Schuchat [continuing]. Against a pandemic. We think of
    pandemics as having catastrophic risk because they generally
    are defined by a new strain that the population has no
    protection against at all. It is so differing from----
        Mr. Murphy. But you could do that fairly quickly during
    that--the issue of the Swine--from 2009. Once it reached this
    level where we are now only 23 percent effectiveness, and about
    12 percent for senior citizens, a high-risk group for death,
    for mortality and morbidity, why not move forward at this point
    with at least a monovalent strain for high-risk groups and
    high-risk geographical areas?
        Dr. Schuchat. The time between developing a candidate
    vaccine virus, which we started working on in May, and the
    ability to have a lot of doses is about 6 months. So it really
    wouldn't be available----
        Mr. Murphy. But you did it in 12 weeks in 2009.
        Dr. Schuchat. The large amounts of vaccine were only
    available in November in 2009, after having really started in
    May.
        Mr. Murphy. But you did it in a much shorter time, but not
    the 6 months. My point is, when you identify something that is
    going to have that level of mortality and morbidity, and it can
    be done in a short period of time, were your agencies talking
    with each other and saying--clearly, a decision was made in
    September, hey, for the Southern Hemisphere, we need to change
    that, but for the Northern Hemisphere it says let us keep going
    with what we have, recognizing that it is only effective for 1
    out of 5 people and 1 out of 10 seniors. It seems to me that
    you need a different decision-making process.
        Dr. Schuchat. Thanks. I think another point that is
    important to make is the difference between the laboratory
    mismatch and the clinical protection. In 2003/04, we had a
    laboratory mismatch. It turned out that when we measured
    clinical protection, protection was about 50 to 60 percent in
    different populations. So seeing that in the lab in that
    hemagglutinin inhibition testing that there is drift or that
    there is a difference between the strain and the vaccine, and
    the strains that are circulating, doesn't perfectly predict how
    the vaccines will work in practice. So I think it is very
    important to differentiate that decision to make a monovalent
    vaccine against a pandemic where we know there is not going to
    be the widespread protection because people haven't seen the
    strain before, and where it is a race against time in terms of
    the--although it is challenging with current technology, the
    value of trying to make a vaccine is worth it.
        Mr. Murphy. I am way over time. I need to----
        Dr. Schuchat. By which--OK.
        Mr. Murphy [continuing]. Pursue other members.
        I recognize Diana DeGette for 5 minutes.
        Ms. DeGette. Thank you very much, Mr. Chairman.
        Well, following up on the chairman's question, Dr.
    Schuchat, would it be fair to say, and really yes or no would
    work here, would it be fair to say that the way we are going to
    be able to substantially reduce the time between when we
    identify a strain and developing the vaccine will be what Dr.
    Fauci is talking about, which is development of new platforms
    and ways to get the vaccine?
        Dr. Schuchat. Absolutely.
        Ms. DeGette. Now, Dr. Fauci, I want to turn to you because,
    over the years, you have come and talked about the development
    of these vaccines. I remember when we had a hearing in this
    committee when we were trying to move from the egg to the cell
    vaccine. And now you say you have the cell techniques, but you
    also say that you are getting ready to go into larger clinical
    trials on these new platforms, is that correct?
        Dr. Fauci. That is correct, Ms. DeGette. The important
    point is that we really think that anything that needs to grow
    the virus----
        Ms. DeGette. Right.
        Dr. Fauci [continuing]. And produce it just is a time sink.
    So that is the point that I made on the----
        Ms. DeGette. Right.
        Dr. Fauci [continuing]. Slide.
        Ms. DeGette. No, and we actually, even those of us who only
    took high school biology, understood that point.
        Dr. Fauci. Yes.
        Ms. DeGette. So----
        Dr. Fauci. Yes.
        Ms. DeGette [continuing]. Good work again. But what I want
    to know is now that you have done your phase 1 trials, and you
    are trying to move beyond that, what is your time frame for
    that?
        Dr. Fauci. Well, you know, it is going to really depend on,
    first of all, testing it in a season to show that even though
    you don't specifically have it against this particular strain,
    that it is covering that strain. So when you are trying to
    prove universality, you want to test it in a season in which it
    is a broader response. One of----
        Ms. DeGette. Right.
        Dr. Fauci. Yes. One of----
        Ms. DeGette. So would that be like next season----
        Dr. Fauci. Well, we----
        Ms. DeGette [continuing]. Do you think?
        Dr. Fauci [continuing]. Actually are going to try now, in
    collaboration with BARDA, to make enough of that new concept to
    be able to test it----
        Ms. DeGette. Test it in this season.
        Dr. Fauci [continuing]. In the following season.
        Ms. DeGette. Dr. Robinson, you are----
        Dr. Fauci. Following season.
        Ms. DeGette [continuing]. You are nodding your head, yes.
    Is----
        Dr. Robinson. Yes, the following season.
        Ms. DeGette. OK. So what can Congress do to help you with
    that? Do you need additional resources? What do you need to be
    able to start to expedite that research?
        Dr. Fauci. Well, I mean, obviously, you ask a scientist if
    they need resources, the answer is an automatic knee-jerk----
        Ms. DeGette. Well----
        Dr. Fauci [continuing]. Of course we can do better with
    more resources, but we actually need your continued support to
    keep the focus on the need for this, because when we do these
    tests, remember, we don't have control over the companies that
    make the contracts with the various----
        Ms. DeGette. Right.
        Dr. Fauci [continuing]. Health organizations that
    distribute this, but I think the focus that this committee has
    continually put on this has been very helpful to us.
        Ms. DeGette. Now, in your written testimony, you talk about
    the difference between seasonal flu and pandemic flu. Can you
    briefly explain that to us?
        Dr. Fauci. So I mentioned in my oral testimony a few
    moments ago that influenza viruses tend to change slightly. We
    call that a drift.
        Ms. DeGette. Right.
        Dr. Fauci. Right.
        Ms. DeGette. Every season.
        Dr. Fauci. That is a little bit. Now, if it changes
    slightly, even if you don't get the vaccine match right, there
    is enough background immunity in the community against similar
    viruses that the vast majority of the population are not going
    to have a catastrophic outbreak where people would be
    completely unprotected.
        Ms. DeGette. Right.
        Dr. Fauci. When you have an influenza that has what we call
    a shift, not a drift, that means major changes, so when you
    look at the general population, the overwhelming----
        Ms. DeGette. Right. They don't have that.
        Dr. Fauci [continuing]. Majority don't have any background
    protection. So it is almost as if you are totally naive to this
    new----
        Ms. DeGette. And that is what happened in----
        Dr. Fauci [continuing]. Virus.
        Ms. DeGette [continuing]. 2009 and 2010.
        Dr. Fauci. Indeed. The bad news, it happened in 2009. The
    somewhat comforting news is that it wasn't a particularly
    virulent----
        Ms. DeGette. Right. Exactly. And that is what we----
        Dr. Fauci [continuing]. Virus. So we----
        Ms. DeGette [continuing]. Were worried about.
        Dr. Fauci [continuing]. Were lucky.
        Ms. DeGette. So, Dr. Robinson, now, you said in your
    testimony that there remains significant technical challenges
    before a substantially better influenza vaccine is available,
    and I would assume that the biggest concern for both of you
    gentlemen, well, for all four of our witnesses, would be that
    if we don't develop that significantly better vaccine system,
    and we get a virulent pandemic flu, is that right, Dr.
    Robinson?
        Dr. Robinson. That is right. I mean, as Dr. Fauci pointed
    out, we actually have new ways to actually make these vaccines
    by looking at a different portion of one protein. We normally
    make the vaccines against the hemagglutinin and our immunities
    to that, the head of that, and now we can actually look at the
    stalk which we are making these candidates. We may be able,
    that way, to protect against many different drifted strains and
    serve as a primer for a pandemic so that you have one dose of
    this, so you only need one dose of pandemic vaccines instead of
    maybe two.
        Ms. DeGette. Yes, and so what we are concerned about, or
    what I am concerned about, what keeps me awake at night, is if
    we don't do enough, both Congress and also our research
    institutions, to be able to have that vaccine available if we
    get a virulent pandemic flu. Dr. Fauci?
        Dr. Fauci. So another important point besides the fact that
    all of the issues, the advantages of this universal flu
    vaccine, namely, molecular biology rather than growing----
        Ms. DeGette. Right.
        Dr. Fauci [continuing]. The critical issue is if you--if we
    get it right, you could actually stockpile it.
        Ms. DeGette. Right.
        Dr. Fauci. So we wouldn't have to worry about the chart
    that the chairman put up about it changing and trying to keep
    up with it----
        Ms. DeGette. Right.
        Dr. Fauci [continuing]. Because if you stockpile it, you
    could stockpile it the same way you stockpile polio vaccine,
    measles vaccine, et cetera. That is really the endgame.
        Ms. DeGette. Thank you. Thank you very much, Mr. Chairman.
        Mr. Murphy. Thank you.
        Now recognize Mrs. Blackburn, vice chair of the full
    committee, for 5 minutes.
        Mrs. Blackburn. Thank you, Mr. Chairman. And as I said
    earlier, I want to focus on measles because we are hearing so
    much about this. And bear in mind, I have a daughter who has
    two children. They are in kindergarten and pre-K, and I can
    tell you, and I am sure you all and your teams, are fully aware
    that a lot of the mommy blogs are focused on this issue right
    now. And it is a big issue with our constituents.
        And, Dr. Schuchat, let me come to you first. I just want to
    be sure what the known knowns are about the measles virus. If
    you would elaborate for just a second. We are hearing 102
    cases, that out of these only five had a vaccination against
    measles. Do you know what the rate is how they are affecting
    elderly as well as children? If you will give us just 1 minute
    on this.
        Dr. Schuchat. Yes, so far, there have been 102 people from
    14 States that have developed measles in 2015. There are
    another 11 cases of measles from the end of 2014 that were
    linked to the Disneyland outbreak. Not all of the 102 cases
    this year are linked with Disneyland, but the majority are.
        The majority of people in these outbreaks so far have not
    been vaccinated. Only a small number are known to have been
    vaccinated. Important to remember that there are about 20
    million measles cases around the world each year, and so
    measles is literally a plane ride away. When it gets into
    communities like the United States now, in certain pockets
    where a lot of people are unimmunized, it has a chance to
    spread. And so that is why California is really working day and
    night to follow every lead and put an end to it there. And that
    is why the health departments in every State are really on
    alert right now.
        Mrs. Blackburn. OK. Let me ask you this. As a physician,
    and a representative of our Nation's public health agency, if
    you are talking to a parent, should they be more fearful of the
    disease, measles, or the measles vaccine?
        Dr. Schuchat. Every parent wants their child to be healthy
    and safe, and I absolutely respect that. As a physician and as
    a public health expert, I can tell you the measles, mumps,
    rubella, or MMR, vaccine is very effective and very safe.
        Measles can be serious, and I would hate for a parent to
    think that everything will be fine, and have a bad outcome with
    their child. So I strongly recommend people talk with their
    physicians and get the right information, but personally, I
    would definitely have my child vaccinated.
        Mrs. Blackburn. Thank you.
        Dr. Fauci, same question to you.
        Dr. Fauci. Same answer from Dr. Schuchat. There is no
    doubt, if you do a risk/benefit of the vaccine versus the
    disease, I think it is very, very clear that you have one of
    the most highly effective vaccines against any virus, and you
    have a highly contagious disease, measles, that can have
    serious complications, so to me it is really a slam dunk what
    the decision would be.
        Mrs. Blackburn. So if it were your child or grandchild, you
    would say vaccinate?
        Dr. Fauci. Without a doubt, and I have done that with my
    three children.
        Mrs. Blackburn. Excellent. Thank you, sir.
        Dr. Robinson, I am going to let you off the hook today. I
    usually have quite a group of questions for you. And I do, I
    have some questions on Tamiflu and on the stockpile and the
    shortage, but as one of my researchers from Vanderbilt told me
    this weekend, we don't always get the flu right and had a way
    of terming how we go about looking at this. I am going to, in
    the interest of time, submit these and would love a response
    from you.
        And I yield back.
        Mr. Murphy. Thank you. The gentlelady yields back.
        Now Mr. Pallone is recognized. Thank you.
        Mr. Pallone. Thank you, Mr. Chairman. I wanted to start out
    with Dr. Midthun. I am concerned about the low flu vaccine rate
    for children. By November 2014, only 42 percent of children
    between the ages of 6 months and 17 years have been vaccinated
    for the flu, and I think we need to change this. And, of
    course, the measles outbreak raises more concerns about
    childhood vaccination. Yesterday, we mentioned that Ms.
    DeGette, Mr. Green, and myself called for a separate hearing on
    the outbreak, and the importance of vaccination to prevent the
    spread of measles.
        I am sorry, actually, my question is of Dr. Schuchat. What
    can we do to increase childhood vaccination rates, both for the
    flu and for other infectious diseases?
        Dr. Schuchat. You know, I think that parents' decisions to
    vaccinate their kids are often related to their sense of the
    threat and their sense of the value of the intervention. And we
    are so fortunate in this country that our disease rates have
    been quite low, that many parents don't realize these diseases
    are still out there, and that if their children aren't
    vaccinated, they will come back. So with the measles outbreak,
    I think most parents who weren't vaccinating didn't realize
    measles was still around and could be dangerous.
        In terms of the value of the intervention, it is important
    for parents to have all the information they need about the
    safety, the effectiveness, the risks, and benefits. It is
    important to me that parents know that the immunization system
    is deeply committed to transparency, to monitoring vaccine
    safety, to sharing information about risks when we determine
    them, and to updating our recommendations whenever there is new
    data. Right now, we know that the vaccines we are giving are
    saving lives and saving money. For each dollar we put in, we
    get about $10 back for the childhood immunization series.
        So what we do to try to support and promote immunization is
    a strong public-private partnership between healthcare
    professionals, doctors and nurses, and pharmacists, and
    community groups and consumer groups, to get information where
    it is needed, when it is needed, in many different formats. We
    know that most people trust their doctors and nurses more than
    they trust me or other public figures, and so we really try to
    support the doctors, nurses, pharmacists, that are that
    frontline.
        Mr. Pallone. Well, thank you. Let me continue with you. I
    know that the flu activity began in early December, and
    continued to increase through the end of 2014. Has the flu
    activity peaked for this year, and what data do you evaluate to
    make that determination?
        Dr. Schuchat. We are well along in the season, but it is
    difficult to say whether there will be a long tail or not. In
    many areas it is flattening off but not deeply declining yet.
    And sometimes later in the season, we see another strain
    increase. We have had many seasons where one of the H1N1 or
    H3N2 starts off the season, and one of the B strains will be
    quite common later on. So we are not out of the woods. It is
    important for people to be thinking about this. And we
    particularly want people to know that if they develop flu-like
    symptoms, and they are pregnant or they are very elderly, or
    have other immuno-compromising conditions, early treatment with
    antivirals could be very helpful to them. So they should speak
    with their clinician.
        Mr. Pallone. All right, let me go back now. I did have a
    question of Dr. Midthun. The flu vaccine comes in different
    forms. There is the high-dose shot recommended for seniors, a
    quadrivalent nasal spray recommended for young children, and a
    recombinant trivalent, I don't know if I am pronouncing it
    right, recombinant trivalent shot recommended for those with
    egg allergies. How do you communicate to different groups about
    the variety of vaccines, and can the greater number of options
    for vaccines increase the rates?
        Dr. Midthun. As you point out, there are a number of
    different options now, and what we try to do is really
    communicate clearly the information that we provide on our Web
    site in our package inserts as to what groups were studied and
    for which age groups the product is indicated. So, for example,
    the high-dose vaccine you were referring to was actually
    evaluated in individuals 65 years of age and older, and was
    shown to decrease the rate of influenza by 23 percent, relative
    to those who got the normal dose vaccine. And likewise,
    quadrivalent vaccines are now available for four different
    manufacturers; three are inactivated and one is the live
    attenuated. They are indicated for somewhat different groups
    across that spectrum, and again, that information is put
    forward.
        The recombinant vaccine that you mentioned has only so far
    been evaluated and shown to be safe and effective in 18 years
    of age and above, and so again, our prescribing information
    will reflect that. But I think I should really turn to Dr.
    Schuchat because that is really the advisory committee on
    immunization practices, which is an advisory committee for the
    CDC that then recommends how these vaccines should be used.
        Dr. Schuchat. And just briefly, we recommend people get
    vaccinated with the vaccine that is available. And so while
    providers and pharmacists get all that information about the
    different types, it is much more important to get a vaccine
    than to worry about which one is there.
        Mr. Pallone. All right, thank you. Thank you, Mr. Chairman.
        Mr. Murphy. Thank you.
        I now recognize the vice chairman of the subcommittee, and
    welcome aboard as vice chairman, Mr. McKinley of West Virginia.
        Mr. McKinley. Thank you, Mr. Chairman. Just a quick
    observation on this--what I have heard and read in your
    testimony and done a little research is, this whole process of
    designating which vaccine we are going to come up with in
    September just seems archaic. In fact, it seems more of a game
    of chance and probability. And by virtue of us continuing this
    process, erroneously now with this mismatch, we have 50,000
    Americans who are going to die this year. Fifty thousand
    Americans. That is more than died in combat in Vietnam, over a
    decade of that warfare. And they are going to die because of a
    game of chance and probability.
        I am just astounded by that. I wonder what better
    techniques can we use to predict ahead. And that leads me then
    to the second question perhaps, or maybe associated with that,
    is that the high-dose vaccine has been found to be 24 percent
    more beneficial to senior citizens, and you have a meeting
    coming up late in February and it is not on the agenda as a
    possibility for September. Could one of you explain just
    briefly why that is not on the agenda if it has been proven to
    be helpful for senior citizens?
        Dr. Schuchat. Yes. Let me answer sort of both parts. The
    high-dose vaccine is one of the licensed vaccines that is
    recommended, and the company that makes it doesn't make enough
    of it for all people 65 and over----
        Mr. McKinley. Um-hum.
        Dr. Schuchat [continuing]. But they have been increasing
    the production. So it is included in the September and February
    recommendations. The recommendations are really just which
    vaccines to--which virus strains to target, and then there are
    all these different formulations like high-dose.
        The other thing I just wanted to comment on about is sort
    of the mismatch. I want to just point out that in the past 20
    years, this is the fourth time that we have had an important
    mismatch between one of the circulating viruses and the vaccine
    and what dominates. So it is very disturbing when we have this
    and we have excess disease burden, but the vast majority of
    recommended strains have actually been on track. Even though,
    when we have a good match, a well-matched vaccine type, we have
    a lot of morbidity and mortality from influenza, and I think it
    is one of these diseases that we as scientists take very
    seriously, but the American public takes a bit for granted. So
    we wish that we had more people vaccinated each year, and that
    we wish that people who need to get the antivirals would get
    them early, but we have work to do in terms of the medical
    community and the public----
        Mr. McKinley. Thank you.
        Dr. Schuchat [continuing]. And in having them take----
        Mr. McKinley. Thank you, doctor. Is----
        Dr. Schuchat [continuing]. It seriously.
        Mr. McKinley. I want to build a little bit of background
    for the chairman and his chart. When it was discovered first in
    May, I guess it was, that--or March, there was some anomaly
    showing up. May, 17 percent, September, 50 percent. It was
    obvious there was a problem with it. So if I go back to
    Robinson's testimony, he said that the PCAST report recommended
    improving vaccine manufacturing to meet a national goal of
    making the first dose within 12 weeks. Now, yes, it would have
    taken to go to a national supply to go 6 months, which again,
    is a real concern about the production, and some of the
    techniques that we can use to reduce that--but if we could have
    produced a vaccine, knowing in September it was 50 percent, so
    September, October, November, the 1st of December, we could
    have had a modified drug, even if it is limited supply, that we
    could have tried--whether it is an antigen or a new vaccine
    entirely, wouldn't you have recommended let us try this and do
    trials, see what the result is, did we solve it, can we do this
    in 12 weeks and the next time? So my question: Did you do it?
    Did you try to do anything to modify the vaccine that was
    wrong?
        Dr. Schuchat. Um-hum. I want to stress that we were not----
        Mr. McKinley. It is a yes or no, isn't it?
        Dr. Schuchat. There were many activities taken to address
    the emergence of drifted strain, including preparing a
    candidate vaccine virus----
        Mr. McKinley. Did you try and modify it?
        Dr. Schuchat. The issue of protection is both what strains
    are dominant, what efficacy the vaccine has, and how many
    people can get the vaccine. So a highly effective vaccine with
    very few doses available may not be as good as a moderate- or a
    low-efficacy vaccine and a lot of doses available.
        Mr. McKinley. I will take your answer----
        Dr. Schuchat. I don't think that----
        Mr. McKinley [continuing]. As a no, that you didn't try
    and----
        Dr. Schuchat. No, what I am saying is that we did begin to
    prepare the candidate vaccine virus so that companies would be
    able to produce a vaccine against the drifted strain. This
    particular strain has been quite challenging to produce
    vaccines against.
        Mr. McKinley. Thank you. Fifty thousand Americans died.
        Mr. Murphy. Now recognize Ms. Castor for 5 minutes.
        Ms. Castor. Thank you very much.
        Dr. Schuchat, on average, maybe take the last 10 or 20
    years, how many Americans suffer each year from influenza, how
    many are hospitalized, and how many die?
        Dr. Schuchat. Thank you. Yes, for the past 5 years or so,
    we have ranged between 19 and 35 million cases of influenza
    illness each year, between 110,000 and almost 600,000
    hospitalizations each year, and 5,300 to 39,000 deaths
    attributable to influenza. Those are in the past 5 years. In
    that same period, the vaccination efforts we have had have been
    reducing the full burden by about 16 to 17 percent. You know,
    we would have more disease, deaths, and hospitalizations
    without vaccination, but it is not as high a prevented----
        Ms. Castor. Um-hum.
        Dr. Schuchat [continuing]. Fraction as we see for measles,
    where we are preventing 99 percent, you know, of the disease.
    And that is partly because we don't have high coverage.
        Ms. Castor. How many are vaccinated?
        Dr. Schuchat. Well, we have gone from 19 percent of
    Americans getting vaccinated against flu, to 46 percent. So
    that is a big improvement, but it is not the majority yet. The
    other factor though besides the coverage is the effectiveness,
    and even in a good year, we are seeing vaccines that work about
    60 percent efficacy, and so that is why we are very committed
    to the interagency work on developing vaccines that could have
    higher effectiveness, particularly in the most vulnerable
    populations.
        Ms. Castor. And when it comes to the deaths, what age
    range? We know the elderly are more vulnerable, but what are
    the----
        Dr. Schuchat. Yes, you know, the vast majority of deaths
    are in seniors, but unfortunately, we do have children die
    every year. More than 60 children have died so far this flu
    season, and I fear that is not going to be the end of it. So we
    know that statistics say if you are elderly, if you have
    medical immunocompromising conditions, if you are under 2, you
    have more chance of being hospitalized or dying from flu, but
    many parents can tell you that their child was perfectly
    healthy and they actually lost a child. So I really want
    parents and the general public to know to take flu seriously.
        Ms. Castor. And this year, it is a particularly severe flu
    season with higher rates of hospitalization and mortality. This
    is especially worrisome for those vulnerable populations;
    children, the elderly, pregnant women, and others with weakened
    immune systems. Dr. Midthun, the severity of this year's flu
    can be partially attributed to the fact that it is an H3N2
    predominant year. Tell us what that means in simple terms. The
    fact that this is an H3N2 predominant year. Dr. Midthun.
        Dr. Midthun. I think oftentimes in H3N2 prevalent years,
    there may be more morbidity and mortality, although I think it
    is very important to remember that all influenza can cause
    morbidity and mortality. H1N1 was responsible for 2 pandemics,
    1918 and the one in 2009. And also B strains can be very
    serious, especially for children, and cause very serious
    outcomes. But Dr. Schuchat may want to add to that.
        Dr. Schuchat. Yes. Overall, the H3N2 serious years have
    higher total morbidity and mortality, but as Dr. Midthun says,
    the H1N1 has a predilection for younger people.
        Ms. Castor. Uh-huh. So you were talking about the
    effectiveness of the current vaccine before this year's flu
    vaccine shows 23 percent effectiveness. I want to hear more
    about how we assess the flu vaccine effectiveness, and better
    understand this. How do we gather information on infections and
    mortality and then test for vaccine effectiveness?
        Dr. Schuchat. One of the things that the investments in
    influenza have permitted, the resources that CDC has gotten
    over the past several years, is expansion of the systems by
    which we track influenza, and track influenza vaccine coverage,
    and track influenza vaccine effectiveness. So we have much
    better data today than we had several years ago. We are able to
    provide estimates in the middle of the year of how many people
    have gotten vaccinated, as well as how well the vaccine is
    working so far.
        We work with State and local health departments in the
    surveillance systems, and we work with academic university
    partners in measurement of influenza vaccine effectiveness,
    essentially, comparing people who have influenza laboratory-
    confirmed disease with others to look back at their vaccination
    history and basically quantify the vaccine effectiveness that
    way. We release our data every week on something called
    FluView. It is on our Web site. And so you can essentially look
    in October 3 and see the first information about the drifted
    strain. So every week as that comes out, you can follow what is
    going on. But in mid-January, in fact, we sped up the vaccine
    effectiveness estimates so that the public would know them as
    quickly as possible.
        Ms. Castor. Well, I know I marched my whole office down to
    get the flu vaccine, but I think this is very important that
    people understand what the experts are saying today, that this
    mismatch, parents with children need to be especially careful
    because of the predilection for younger folks. But in America,
    if we only have 46 percent, and that is kind of high watermark
    for flu vaccinations, we can do a whole lot better. So thank
    you very much.
        Mr. Murphy. Thank you.
        And now I recognize Dr. Burgess for 5 minutes.
        Mr. Burgess. Thank you, Mr. Chairman.
        And, Dr. Schuchat, let me just pick up for a moment on what
    you were discussing with the vice chair of the subcommittee,
    Mr. McKinley. Now, you had a drifted strain that kind of
    appeared on the scene. The Southern Hemisphere designation is
    out of phase with what the vaccine release in the Northern
    Hemisphere, correct? So you had identified the drifted strain
    when the recommendation was made for the inclusion in the
    vaccine that was released in the Southern Hemisphere, is that
    correct?
        Dr. Schuchat. Yes, that is right.
        Mr. Burgess. So why not then come forward with a
    recommendation for a booster shot or some additional protection
    for people in the Northern Hemisphere if we already were
    developing a different vaccine based on a drifted strain for
    the Southern Hemisphere? Your neighbors to the north might have
    been interested in that, don't you think?
        Dr. Schuchat. You know, the manufacturing capacity to
    respond in September to vaccine strain recommendations in large
    number of doses would get us a large number of doses probably
    February or so. So I mean Dr. Robinson might be able to comment
    a little bit more, but the ability for us to make a Northern
    Hemisphere recommendation for a vaccine in September, and have
    doses in time for the flu season, would be very low. And we
    take that type of step when we are worried about a pandemic,
    and I think the committee is raising the question of should we
    take that type of step when it is not a pandemic situation but
    a drift.
        Mr. Burgess. We would like you to react with a little bit
    more clarity and be flexible when so many lives are on the
    line, as Mr. McKinley outlined. And I mean, look, we are
    dealing with a, what, a 40 percent uptake of the vaccine as it
    is. If people read the headlines and say only 1 in 5 are
    protected anyway, I would just as soon not get stuck.
        Dr. Schuchat. Yes.
        Mr. Burgess. So I would think you, as an agency, you would
    want to have that flexibility and want to show utility for
    people that we are on top of this, we are working on this 24
    hours a day, 7 days a week, 12 months out of the year. We are
    monitoring your health and your safety when it comes to the flu
    virus, and we can't be perfect every time, but when we are not,
    we are going to be there to help you stave off the effects. I
    mean, again, that is what I am hearing as a result of this
    hearing. And as Dr. Fauci acknowledged, we have had these
    hearings before. We had a hearing when we only had a trivalent
    vaccine, and we talked about a quadrivalent vaccine. I mean
    these things, they are important, people do pay attention to
    them. Our vaccine rates for influenza are lower than they
    should be for the country.
        Dr. Schuchat. Um-hum.
        Mr. Burgess. I have gotten my flu shot every year except
    2004 when it was politically inadvisable for a Member of
    Congress to receive a flu shot because there was a shortage----
        Dr. Schuchat. Right.
        Mr. Burgess [continuing]. Because of the serratia
    contamination that occurred in one of the manufacturing labs.
    Separate story, but every other year I step up and get the
    vaccine because I meet a lot of people every day, I ride on an
    airplane twice a week, this is just a commonsense reaction to
    what is an inevitability on the ground.
        I want to shift gears for just a moment, and I do feel
    obligated to talk about the measles issue because it has
    achieved so much in the way of headlines, and I am going to
    breach--I am going to violate HIPAA, and I just want to tell
    HHS that I am going to violate HIPAA. I am going to release
    sensitive clinical information about myself. So I never had the
    measles vaccine. I didn't have it because I was too old. I mean
    I was--well, when I was a child in the '50's, it hadn't--it
    wasn't there, it wasn't available. I don't remember every
    scraped knee, every sniffle from my childhood, but I remember
    the measles.
        Dr. Schuchat. Um-hum.
        Mr. Burgess. It was bad. I mean you can see--and I see in
    Harrison's here online, hard, shaking chills. I mean that--it--
    yes, hard, shaking chills doesn't even begin to describe it.
    The chills are so hard they are painful. You want to cover up,
    you want to pull a blanket around yourself, but you don't want
    anything touching your skin. That is measles. I mean it is a
    different disease. And we had forgotten about it, quite
    frankly, because, you know, you just never see it, and now we
    are faced with the prospect that we are seeing it. It is
    important for parents to have their children vaccinated.
        Dr. Schuchat. Um-hum.
        Mr. Burgess. There are things that can happen to you as a
    consequence of having had the measles. I remember in medical
    school learning about subacute sclerosing panencephalitis, and
    I remember asking at the time why do I have to learn about
    this, no one is going to get it anymore. But, in fact, people
    may get it because it is a consequence of having had an
    infection with measles. So these issues are important.
        Now, if I recall correctly, and suddenly somehow this is
    interjected into presidential politics, which is inappropriate
    because, if I recall correctly, since President Gerald Ford,
    there has not been a Federal mandate for any vaccination. And I
    will ask that question generally to the panel, Dr. Fauci, am I
    correct on that?
        Voice. Microphone.
        Dr. Fauci. When President Ford essentially mandated through
    the department that there be massive vaccination for the 1976
    influenza, that famous catastrophic event with the Guillain-
    Barre, but I don't think there has been official mandating
    about----
        Mr. Burgess. Correct. So these are State-mandated vaccines
    that people have to take before attending public schools, and
    there is a reason for that. It should be a State mandate. There
    is no one asking for a Federal mandate. It doesn't mean that
    the vaccination is not important. And for people who are
    listening and paying attention today, please have your children
    vaccinated.
        Thanks, Mr. Chairman. I will yield back.
        Mr. Murphy. Thank you.
        I now recognize Mr. Green for 5 minutes.
        Mr. Green. Thank you, Mr. Chairman. Thank our panel for
    being here.
        Data from the National Immunization Survey found that fewer
    than half of children and adults are vaccinated by November of
    this current flu season. My numbers said 40.3 percent, but,
    doctor, you said 46 percent. Forty-six percent of the people
    and 6 months or older received the flu vaccine. These numbers
    seem similar to what we have seen in the last few years.
        I wanted to hear why these vaccination rates continue to be
    so low and what we can do to improve it, although I have to
    admit, the recent news that it is only 20 percent--23 percent
    effective, and those of us who are much older it may only be 12
    percent, that would probably tell people not to get it. But
    somehow along the way, we need to do it, and encourage much
    more than 46 percent to be able to get that. The data showed
    that nearly 60 percent of the people had not taken advantage of
    it. Is that accurate?
        Dr. Schuchat. The 46 percent that are vaccinated is based
    on last year's end of season, so the 40-some percent was the
    early, you know, by November, how many had gotten vaccinated.
        You are right that the majority still haven't gotten the
    flu vaccine, and this is something that we think is going to
    take years of work. Part of the issue is whether there is a
    concern about the disease, and part of the issue is whether
    there is confidence in the intervention. And as you know, the
    intervention has different efficacy, different years. So it is
    not a simple message and it is one that we work hard to
    communicate honestly and clearly.
        Mr. Green. Well, I guess part of the problem is if we think
    it is bad now with the news coverage about the less
    effectiveness, what can we do to make sure that next year we
    have, one, an effective flu vaccine--I know it is almost like
    throwing darts against the wall--and that way we will convince
    more people to get it, because, again, the more people
    vaccinated, the more we will defeat it.
        Dr. Schuchat. The vaccine prediction is most of the time
    good. So out of the last 20 years, this is the fourth time
    where there has been an important mismatch. And in some of the
    previous times where there has been mismatch, there has still
    been much higher efficacy than what we are seeing this year.
    This year will be a difficult year to follow in terms of our
    messaging. We do want people to know that influenza can be
    serious, and that the vaccine is still the most effective way
    to reduce your risk, but we also want people to know about
    antivirals, because we think those are also underutilized and
    could actually reduce the duration of the illness, and even
    reduce the chance of being hospitalized in some patients. And
    so we think it is important to get both messages out.
        Mr. Green. Is there anything that Congress could do
    because, when you found out that the effectiveness was so low--
    I know there were some questions earlier from Dr. Burgess
    saying, OK, we need a booster for those of us who got the
    vaccine--are there resources available where you could do that
    and make it an issue, saying, you know, it is only 23 percent
    but this booster will get you to 50 percent?
        Dr. Schuchat. You know, I think the resources that have
    been provided have been incredibly valuable, and there is both
    a short-term and a long-term strategy. You know, the short-term
    strategy, to use available tools better, and to make
    incremental improvements in the production and distribution of
    vaccine, and the long-term strategy that Dr. Fauci and Dr.
    Robinson were talking about with the research and investments
    in universal vaccines. So I think we can't just do one or the
    other, we really have to do both, but it will be years before
    there is that really much, much, much better flu vaccine. And
    we are fortunate that we have a lot of options now and a much
    better supply horizon than we have had, you know, 5 or 10 years
    ago. So I think we really need to just stick with it and make
    those incremental improvements, and make sure that the public
    gets the correct information, the accurate information, that we
    are honest when he have a year like this where it is quite
    difficult. And unfortunately, the vaccine is only preventing
    about 23 percent of what it might be, but that is still
    significant protection.
        Mr. Green. Well--and again, since the percentage is lower
    for the most vulnerable population of the elderly, we need to
    encourage the elderly to--even if it is only, I don't know what
    percentage it was, 12 percent, because it still gives them that
    12 percent. But we would sure like to see it up above the
    efficiency much better.
        Dr. Schuchat. Yes. Ironically, the elderly are the best at
    getting vaccinated. It is about 70 percent or so of them, but
    the vaccine works the worst in that population. And they really
    do rely on the rest of the population being protected to have
    more confidence that they will be safe too. So it is one of
    those vaccine-preventable diseases where the more people that
    are immunized, the better. And, of course, in the future we
    hope that we will have even more effective tools.
        Mr. Green. I know this has come up before, but----
        Mr. Murphy. Thank you.
        Mr. Green [continuing]. Ranking Members Pallone and DeGette
    yesterday talked about the measles outbreak in Disneyland, and
    I know that is a concern too that--to do it. And let me just
    follow up, Mr. Chairman, I remember when I was in the fifth
    grade, the whole county, we got a polio vaccine. Was that
    mandated by the Federal Government?
        Dr. Schuchat. You know, in that era, you didn't need to
    mandate polio vaccines. People were lining up. I think the
    whole country was so thrilled that there was a polio vaccine
    licensed----
        Mr. Green. Um-hum.
        Dr. Schuchat [continuing]. In 1955 because that was such an
    incredible scourge. The mandates, the school requirements,
    really were shown in the 1980's to massively reduce the risk of
    measles outbreaks in schools, and it was really only when
    States required kindergarten entry to have measles vaccine
    documentation that we started to get a better handle on----
        Mr. Green. Thank you.
        Dr. Schuchat [continuing]. Measles, and then----
        Mr. Green. Yes.
        Dr. Schuchat [continuing]. Of course, in 2000, we were able
    to eliminate native measles here in the U.S.
        Mr. Murphy. The gentleman's time has expired. Thank you.
        I now recognize Mr. Griffith of Virginia for 5 minutes.
        Mr. Griffith. Thank you, Mr. Chairman.
        Let me try to get some blanks filled in here. I don't have
    the answers. The meeting took place with WHO in CDC and FDA and
    others in February. In March, we know that there was a drift
    that was picked up of about 10 percent, is that correct?
        Dr. Schuchat. Actually, it was lower than that.
        Mr. Griffith. About 7 percent I think I saw in your
    testimony.
        Dr. Schuchat. It was like 4 percent.
        Mr. Griffith. OK. Do we know what April was, because we
    have a few numbers on the chart but we have a lot of question
    marks? And if you don't----
        Dr. Schuchat. In April----
        Mr. Griffith [continuing]. You can provide it----
        Dr. Schuchat [continuing]. Fourteen viruses were shown that
    had reduced susceptibility to the strain, and that was out of
    127, so that would be 11 percent.
        Mr. Griffith. OK. And then we have a number from May. Then
    June and July, we don't have another number on this chart until
    September. What were you all seeing in June, July and August?
        Dr. Schuchat. In June, July, and August, there were 88
    viruses identified from the whole world that had reduced
    reaction, and so that comes to 36 percent.
        Mr. Griffith. OK.
        Dr. Schuchat. With reduced, you know, that were mismatch.
        Mr. Griffith. And then there is another meeting, and there
    is a different Southern Hemisphere recommendation made, and we
    don't make the--I think that is five. If you can get us the
    other numbers just so we can kind of track it, that would be
    great. But then----
        Dr. Schuchat. Absolutely.
        Mr. Griffith [continuing]. My question comes up, and I am
    happy for anybody to answer it, why didn't we have the
    manufacturing capacity for the virus to do turn somewhere in
    this process, I think you said by June, July, we were in the 36
    percent range, recognizing that flu season doesn't generally
    hit in a big way for another fair number of months, why does
    the United States lack that manufacturing capacity, and as a
    subpart of that, if there was the capability of producing, and
    I am trying to pronounce this correctly, monovalent vaccine,
    why didn't we do so? And if you all could focus on that. Any
    member of the panel please.
        Dr. Schuchat. Yes, maybe I can start and let Dr. Robinson
    continue.
        I think one thing to recognize in the summer is that we
    were looking at increasing proportions of H3N2 that were not
    well matched to the vaccine, but we still had the other 2 or 3
    different strains that were in the vaccine. So the concept of
    producing a monovalent vaccine--we might have been asking the
    American public to take a monovalent vaccine plus the tri or
    quadrivalent seasonal vaccine. As we have been hearing, the
    American public isn't all that keen to get one flu vaccine a
    year. Would they really be lining up to get 2? But there are,
    of course, major limitations in the manufacturing capacity to
    make 2 different products for the same season. So I will let
    Dr. Robinson answer that.
        Mr. Griffith. Dr. Robinson?
        Dr. Robinson. Thank you. During the manufacturing season,
    they are producing three or four vaccine strains all the way to
    June, maybe even July if it is a tough year for them. At that
    time--and most of those are egg-based. At that time, they
    within the summer are putting those together, we call them
    blending and putting together, to go forward with the vaccine
    that was released in September to go out on the shelves.
        The ability to have what was called a competent vaccine
    that could be very quickly--that is certainly true, it can be
    maybe faster than some of the egg-based vaccines, but the
    capacity that we have right now with the licensed vaccine, the
    only one recombinant-based vaccine, is very, very small. It
    would have only been able to produce maybe hundreds of
    thousands of----
        Mr. Griffith. OK. Let me----
        Dr. Robinson [continuing]. Doses.
        Mr. Griffith. Let me ask the why on that. Is it because
    there is not a profit----
        Dr. Robinson. No, no.
        Mr. Griffith [continuing]. To be made?
        Dr. Robinson. One instance, it is a new vaccine----
        Mr. Griffith. OK.
        Dr. Robinson [continuing]. And, two, since it is a new
    vaccine, they are just scaling up to the market. This is an
    incumbent market, very competitive, and they were licensed in
    2013. We are actually supporting their efforts in building a
    much larger facility to produce maybe tens of millions of
    doses, and so that they actually can going forward be able to
    produce, say, 50 million doses in 4 months of a monovalent
    vaccine for a pandemic or, maybe in this case, another
    influenza vaccine.
        Mr. Griffith. So you anticipate that our capacity will be
    greater in the next couple of years than it is today to react?
        Dr. Robinson. Indeed, it will be, because we will actually
    have the cell-based influenza vaccine facility down in North
    Carolina that has a large capacity, and we will be able to have
    that product on the market. But again, they are limited in that
    they are making seasonal flu vaccine at the same time that we
    may have wanted to do that.
        The other thing is that these manufacturers also produce
    vaccines for the Southern Hemisphere. So when they came off of
    making the vaccine for the Northern Hemisphere, then they
    started back to actually making the vaccine for the Southern
    Hemisphere. So we would have had to make a decision and tell
    them in September, stop doing that and go forward with the new
    vaccine. And we know that that is a difficult midcourse shift.
        Mr. Griffith. But if we----
        Dr. Robinson. The future will be----
        Mr. Griffith. But we could have done that even in, say,
    July when we knew we were at 36 percent that had drifted?
        Dr. Robinson. It would have been very, very difficult, sir.
        Mr. Griffith. OK. All right. I appreciate it. I see my time
    is up and yield back.
        Mr. Murphy. All right, I want to clarify something. So you
    said 36 percent, June, July, and we have a 50 percent cutoff.
    So some time in September the 50 percent number was significant
    enough to say, OK, we need to do something different in the
    Southern Hemisphere. What is the magic number where you say we
    need to make a change here?
        Dr. Schuchat. Actually, it wasn't that there was something
    different, it is that every September the strains are reviewed
    worldwide. All----
        Mr. Murphy. Why not----
        Dr. Schuchat [continuing]. Of them.
        Mr. Murphy. Why not August? What I am concerned about is,
    we want to break through, if there is some bureaucratic
    hurdles, this committee wants to help----
        Dr. Schuchat. Thank--yes.
        Mr. Murphy [continuing]. But if you say, well, we don't
    look at this until--we don't really meet and discuss this until
    September, that is not a lot of solace for what Mr. McKinley
    was raising for the hundreds of thousands of seniors who are
    going to be sick. What--what is--what do we do?
        Dr. Schuchat. Right. In September every year, the groups
    convene to review all the data for the Southern Hemisphere
    production, and that is because it takes that long to get
    vaccine that will be ready by that time. It is not----
        Mr. Murphy. I am not----
        Dr. Schuchat [continuing]. Because we are not looking all
    the way between.
        Mr. Murphy. Yes, but you have already said you can get a
    vaccine ready in 12 weeks when you need a monovalent strain
    when there was a pandemic.
        Dr. Schuchat. Not----
        Mr. Murphy. Wasn't that done in 2009, you did something
    quickly----
        Dr. Schuchat. No.
        Mr. Murphy [continuing]. Dr. Robinson?
        Dr. Robinson. OK, go ahead.
        Dr. Midthun. No----
        Mr. Murphy. I want to be clear.
        Dr. Midthun [continuing]. I think in 2009 the virus emerged
    in April. In May it was recognized that it was causing
    significant disease, and at that time a decision was made
    across the HHS that a monovalent vaccine would be pursued. And
    so all stops were pulled out to do that, but in point of fact,
    the first vaccine was not available from--for that H1N1
    monovalent until the end of October, and the bulk of vaccine
    was not available until late December, into January. So just
    point taken that the manufacturing process itself takes many
    months, and although we----
        Mr. Murphy. To get to the critical number. I know it is Mr.
    Tonko's turn, but we are talking about just to start to give it
    to some seniors and high-risk group.
        Mr. Tonko, you are recognized for 5 minutes.
        Mr. Tonko. Thank you, Mr. Chair. And welcome to the panel.
        There has been much discussion here today about parents and
    the advice they get about having their children vaccinated or
    not vaccinated. I would like to ask it from yet another
    perspective. Yesterday, a United States senator asserted that
    routine vaccinations could cause, and I will quote, ``walking-
    talking normal children to wind up with profound mental
    disorders.''
        And so my request of the panel is a simple yes-or-no
    response. Is there any shred of credible evidence that shows
    that this, in fact, is the case? Dr. Schuchat?
        Dr. Schuchat. Not the vaccines we are using today.
        Mr. Tonko. Dr. Midthun?
        Dr. Midthun. No, not for the vaccines we are using today,
    although I think it is important to note that any vaccine can
    have some safety issues associated with it, but typically, they
    are very rare, and that is why we also have the Vaccine Injury
    Compensation Program.
        Mr. Tonko. Dr. Robinson?
        Dr. Robinson. I am in agreement with Dr. Schuchat and Dr.
    Midthun.
        Mr. Tonko. Dr. Fauci?
        Dr. Fauci. Agree.
        Mr. Tonko. Pardon me?
        Dr. Fauci. Agree with my colleagues.
        Mr. Tonko. Thank you for clarifying.
        In addition to promoting vaccination, Dr. Schuchat, how
    else does the CDC work to prevent spread of the flu? For
    example, does the CDC recommend symptomatic individuals to stay
    home from work?
        Dr. Schuchat. Yes, we have a multipronged approach to
    prevention. The best protection is to get vaccinated. We also
    recommend sensible measures like washing your hands, covering
    your cough, staying home when you are sick, staying away from
    other people when you are sick. And then, of course, if you are
    ill, and particularly those with underlying conditions or the
    elderly, we think prompt antivirals can be important, and so
    talk to your clinician about that.
        Mr. Tonko. Are there any data showing how many flu
    transmissions occur in the workplace when symptomatic
    individuals do come to work?
        Dr. Schuchat. I don't have that data, but there have been
    analyses showing the value of vaccination to reduce workplace
    absenteeism and to improve productivity.
        Mr. Tonko. Um-hum.
        Dr. Schuchat. So we think it is a good thing for health,
    and it is also a good thing for the workplace to be protected
    against flu. To stay home for when you are sick for a variety
    of conditions is good counsel.
        Mr. Tonko. I do know that in speaking with my constituents,
    there are a number of working moms and dads who can't afford to
    take time off of work because it would mean they are not paid,
    and so they attempt to come to work even though they really
    shouldn't. In your opinion, would paid leave policies help to
    prevent the transmission of the flu and other illnesses by
    encouraging more workers to stay home when they are indeed
    sick?
        Dr. Schuchat. We think the easier it is for people to do
    the right thing, the better.
        Mr. Tonko. OK, thank you.
        Dr. Midthun, the FDA has licensed a number of new vaccines
    since the year 2009. How have these new vaccines contributed to
    preparedness efforts in the last several years?
        Dr. Midthun. Thank you for that question. I think what they
    have done, especially with regard to the cell-culture-based
    vaccine and the recombinant protein vaccine, is they offer an
    alternative manufacturing platform relative to the egg-based
    manufacturing that was the basis for the vaccines that had been
    approved up until that time. And it is always important to have
    a diversified way in which you can manufacture vaccines. It
    also widens the platform available in the event of a pandemic
    because, typically, the pandemic vaccines are made on the same
    manufacturing platforms that the seasonal vaccines are made on,
    and so it really provides greater diversity and more
    resilience.
        Mr. Tonko. And, doctor, in your testimony you talked about
    work to speed up the manufacturing process for existing
    vaccines. Can you tell us more about that work?
        Dr. Midthun. Yes. It is actually a very strong
    collaboration between BARDA, CDC, NIH, and ourselves, and it
    looks at a number of different aspects. One aspect is to look
    at the potency testing that is done for vaccines. Right now,
    that relies on reagents that are made by immunizing sheep, you
    develop antiserum, this usually is a process that can take up
    to 2 months. And so, obviously, having potency assays that are
    much more rapid would really decrease the time that it takes to
    do this, to make these reagents. And so there are some
    approaches using more modern platforms, and in conjunction with
    some of our colleagues, there actually are some tests that are
    being planned that will be embarked upon later this year to
    compare some of these newer assays to the standard assay that
    is used right now, the radial immunodiffusion test, to see how
    these compare to each other in actual testing of vaccine
    samples that the manufacturers are providing to us. And some of
    the manufacturers have actually expressed interest in also
    participating in the testing to see what the feasibility is. So
    that is one aspect that we are working on.
        Another one that has been very important, and that the CDC
    and others have really done a lot of work on, but we have also
    contributed to, is to try to identify high-growth viruses that
    will lead to good yield when you grow the virus in the eggs or
    in the cell culture. As you recall, Dr. Fauci was referring to
    the fact that that can often be a rate-limiting step. And so
    trying to develop viruses that you know will yield high growth
    when these new strains emerge could really facilitate and take
    time off that process.
        And then also there was the sterility testing, and the FDA
    actually changed its regulations in 2012 to allow for more
    flexibility in sterility testing. Up until that time, it was
    very prescriptive and this 14-day test by USP had to be used,
    but now manufacturers can come in with novel testing, and we
    actually know that some, you know, testing that has been
    described in the literature could actually be accomplished in
    5, 6 days potentially.
        Mr. Tonko. Thank you.
        Mr. Murphy. Thank you.
        Mr. Tonko. I yield back, Mr. Chairman.
        Mr. Murphy. Thank you.
        I now recognize a new member of the subcommittee, Dr.
    Bucshon, who is a cardiothoracic surgeon by training, and is
    here from Indiana. Welcome to the subcommittee, and you are
    recognized for 5 minutes.
        Mr. Bucshon. Thank you, Mr. Chairman. First of all, I would
    like to associate myself with the unanimous comments of our
    expert panel in recommending that parents get their children
    immunized to prevent childhood diseases. All my children are
    immunized.
        Based on the testimony we have heard today, it seems like
    we could have had a monovalent vaccine available by maybe
    December, and if that is true, Dr. Schuchat, do you lack the
    authority to make that happen in that way, because through the
    testimony, I think a lot of members have asked what can we do
    to help, but for us, for Congress, to help, we have to have a
    specific thing to help with. So is there new authority or any
    other authority that would be helpful to make this happen?
        Dr. Schuchat. I don't believe so. The key issues is a risk
    assessment and trying to predict the most likely course of
    events, but I believe there are authorities if the decision is
    made to go ahead with the monovalent, whether for pandemic or
    for drift.
        Mr. Bucshon. OK. As a healthcare provider, I know that, you
    know, liability is a significant issue in our American
    healthcare system, and not only physician malpractice, but
    product liability is a substantial issue, I know, that has an
    effect on the healthcare industry. Anyone can comment on this.
    Do product liability issues affect our ability to act in a more
    nimble way when it comes to vaccines, because you do have
    private companies that produce these. And so let us start with
    that and then I will spearhead off from there.
        Dr. Schuchat. The Vaccine Injury Compensation Program
    exists so that product liability won't be a factor, so that we
    can make sure that we have vaccines made but the people who are
    injured by vaccines are compensated. And so the funding from
    that comes from an excised tax on every vaccine dose that is
    sold, so that we know that vaccines are very safe, but there
    are sometimes rare, important complications, and the Injury
    Compensation Program exists for those families who have been
    injured.
        Mr. Bucshon. OK. Thanks for clarifying that, and I think
    that is important to understand.
        Dr. Midthun, from the FDA's standpoint, is there--how do I
    want to say this--a risk-averse regulatory process? It seems
    like at the FDA, you know, over a number of years--but for a
    variety of reasons have--I think been, in my view, sometimes
    overly cautious with new products or changing quickly. Do you
    see that as an issue, you know, and that comes into the
    liability issue again, is there resistance or reluctance to
    quickly move based on the concern about these type of things?
        Dr. Midthun. No, I don't see that. I think in the influenza
    domain, we, every year, are primed to approve the new vaccine
    strains that are recommended for inclusion in the vaccine those
    years. I think also our record of having approved since 2003--I
    think in 2003 we had three licensed influenza vaccines. Today
    we have 16 licensed influenza vaccines, including our cell-
    based, recombinant-based, quadrivalent, high-dose, and also I
    should point out that many of those we actually approved using
    accelerated approval, which actually allows us to approve
    something based on the new response that is likely to predict
    clinical benefit. And so we have used accelerated approval
    regulations to approve many of those and get them to market
    more quickly. So I think we--and also I should point out we
    approved the novel adjuvanted H5N1 vaccine in 2013. So I think
    that we really looked very carefully, and balanced the benefits
    and the risks, and are really very flexible.
        Mr. Bucshon. Great. That is good to hear.
        There is a recent CDC study that looked at clinician
    practices on patients that come to the emergency room with--and
    the data is striking, only 16 percent of patients with
    laboratory-confirmed influenza were prescribed antiviral drugs.
        So the first question I have, do they work? Do the
    antiviral drugs work?
        Dr. Schuchat. Yes, last week there was a new meta-analysis
    of all the published and unpublished randomized control trial
    data on Oseltamivir, and it shed new light on the benefits as
    well as potential risks that--there is----
        Mr. Bucshon. So they----
        Dr. Schuchat [continuing]. Benefit for the work.
        Mr. Bucshon. Short answer, they do work, because I am
    running out of time.
        Dr. Schuchat. Yes.
        Mr. Bucshon. Because surprisingly, 30 percent of the
    patients with laboratory-confirmed influenza were--30 percent
    were prescribed one of three common antibiotics, which are for
    bacteria, not viruses. Is there anything that we can do to
    better, you know, as a physician, better make the, you know,
    change that practice? Maybe Dr. Fauci can answer that.
        Dr. Fauci. Yes, that is another whole issue of
    antimicrobial resistance, which we have even discussed before
    this committee. So certainly, over the last year, there has
    been an extraordinary effort on the part of the Congress and
    the administration in everything from executive orders to 5-
    year plans to counter the kinds of practices that lead to
    antimicrobial resistance, and one of the most common, as I am
    sure you are aware, sir, is that someone comes in with a viral
    infection and they get an antibiotic. That is very, very
    common, unfortunately.
        Mr. Bucshon. I yield back, Mr. Chairman.
        Mr. Murphy. Thank you.
        I now recognize a new member to the committee, Ms. Yvette
    Clarke, who represents--Ms. Schakowsky is next? I am sorry, I
    thought Clarke was next.
        Ms. Schakowsky. I was here earlier.
        Mr. Murphy. All right, thank you.
        Ms. Schakowsky. Thank you, Mr. Chairman.
        So if the vaccine that we are using now has been viewed as
    23 percent effective, and usually in the past it has been 50 to
    60 percent effectiveness, are we seeing--maybe it is Dr.
    Schuchat, are we seeing a commensurate increase in the
    incidents of flu?
        Dr. Schuchat. Yes. When we compare this season with 2 years
    ago, the 2012/13 season, the last big H3N2 season, much of the
    pattern is similar, but our hospitalizations in the elderly are
    much higher at the same time this year. So we will get the end-
    of-season statistics, but it has been a very bad year for the
    elderly.
        Ms. Schakowsky. I see. So the lab tests predicted 23
    percent----
        Dr. Schuchat. Um-hum.
        Ms. Schakowsky [continuing]. But you are seeing it actually
    out in the country, that it is also much higher?
        Dr. Schuchat. Right. Yes, we are seeing, you know, both the
    lab mismatch and then our vaccine effectiveness low estimate,
    and then the incidents of the hospitalizations is high.
        Ms. Schakowsky. OK. With the passage of the Affordable Care
    Act in 2010, we took important steps on preventive medical
    coverage for free, and since the law went into effect,
    approximately 76 million Americans have received no-cost
    coverage for preventive services. So I am wondering if we are
    seeing that there actually was an impediment to getting these
    preventive services, vaccines, because of the cost, and now
    without the cost, that more people are making that available to
    themselves.
        Dr. Schuchat. For influenza vaccine, I think it is too soon
    for us to see, but we do know that there are important
    disparities in influenza vaccination coverage, and that insured
    people have been more likely to be vaccinated than uninsured.
    So I think that over the years ahead, we may start to see some
    progress there.
        Ms. Schakowsky. So we do think, although we don't have the
    new data----
        Dr. Schuchat. Um-hum.
        Ms. Schakowsky [continuing]. That cost has been a barrier
    in the past----
        Dr. Schuchat. That is right. We----
        Ms. Schakowsky [continuing]. Is that what you think?
        Dr. Schuchat. And we know even for the workplace, for
    instance, when workplaces will offer flu vaccine for free for
    workers or, particularly for healthcare workers, the uptake is
    better than when it is out-of-pocket, off-site, need-to-seek
    vaccine.
        Ms. Schakowsky. I think it is great that we are having this
    hearing today because this whole question of vaccines, as many
    of my colleagues have mentioned, has really been in the news,
    and it is disturbing that a number of high-profile political
    figures have weighed in on this in a negative way, I would say,
    that this is, you know, parents should make the decision, and I
    have seen some children that have been deeply affected by
    vaccines in a negative way. What I am wondering is, what is the
    public health outreach effort to make sure that--you heard my
    colleague Marsha Blackburn talking about the mom blogs. I mean
    there is a lot that is going on, not only on television, and I
    am glad you were on, Dr. Fauci, and that is very important that
    we get the message out in every medium, but I am just wondering
    if we are also just looking at how people are communicating
    with each other in the social media and getting the facts out.
        Dr. Schuchat. Yes, we spend quite a bit of time and
    attention monitoring the social media as well as the general
    media, and we work closely at the national level, but also at
    the State and local level, on communication, both direct to
    consumer as well as through clinicians and other trusted
    partners, because we think getting information that speaks to
    you close to where you are is really important in your health
    behaviors.
        I would just like to say that the vast majority of parents
    vaccinate their kids against most of the recommended diseases
    on time, and yet there are some minor voices that get a lot of
    attention.
        Ms. Schakowsky. Exactly. I think maybe we need to make sure
    we communicate with all political voices as well that are out
    there to make sure that we are communicating the science, the
    facts, that suggest that all parents should vaccinate their
    children.
        So I yield back.
        Mr. Murphy. All right, now we recognize Mr. Flores from
    Texas, who is also new to this committee. Third term in
    Congress, and we welcome him to this subcommittee.
        Mr. Flores. Thank you, Mr. Chairman. I also want to thank
    the panel, particularly for your positive comments regarding
    the benefits of having children vaccinated for measles. I have
    an extended family member who has not done that for her
    children yet, and it just baffles me why she can't do that. And
    so I hope she is hearing this today, that she heard your
    comments, and that she will do so.
        I want to talk about the weakness in the strain selection
    process, and talk about the opportunities to mitigate that
    weakness. And I want to focus my questions to you, Dr.
    Robinson, because BARDA is a tool, I think, that we have to do
    this.
        And so my first question is this. Is BARDA funding any
    projects or initiatives to develop two things: one, better
    testing technologies, or two, better approaches for making the
    vaccine candidates?
        Dr. Robinson. So the answer is yes on both. In my
    testimony, I identified that we were supporting the development
    of evolutionary biology methods that would actually help the
    existing methods inform what strains are out there. There are
    only so many ways a virus can mutate.
        Mr. Flores. Right.
        Dr. Robinson. And we know that you can do the experiments
    to show which ones would predominate, and that may actually
    inform which ones we may see the next season. And certainly,
    the underpinning of that the NIH has funded over the years, and
    so we are moving forward primarily for our pandemic purposes,
    but certainly could be used in seasonal. So that is one way
    towards the selection, and then informing new vaccine designs.
        Mr. Flores. OK.
        Dr. Robinson. Secondly, with the technologies, we have
    supported with our colleagues here from NIH, CDC, and FDA, new
    technologies to make these vaccines, whether it be cell-based
    or recombinant. And working with the NIH, we are looking at
    universal flu vaccine candidates with a number which Dr. Fauci
    enumerated of going forward. It is not because those
    technologies haven't been tried before, but as he explained,
    there is a limitation in how the body actually sees these viral
    proteins. And so there are some new ways now that we can do
    that, we couldn't do before.
        Mr. Flores. And in terms of looking at BARDA's priorities,
    where would you say that getting these better technologies for
    the strain selection process is in your sort of list of all the
    things you have to do on your wish list?
        Dr. Robinson. Yes. Well----
        Mr. Flores. Is it in the top third, or the middle, or the
    bottom, or----
        Dr. Robinson. No, it is at the top.
        Mr. Flores. OK.
        Dr. Robinson. Yes.
        Mr. Flores. Great. Sounds like we should keep it there,
    from what I am hearing today.
        The third question is how can we expedite the development
    and deployment of better technologies, say, use of genetic
    sequencing, to detect virus change, which you have talked
    about, to ensure that the U.S. has a vaccine that can be
    matched to a drifted H3N2 strain?
        Dr. Robinson. Certainly, one of the ways that we actually
    have employed with biosynthetic technology work with the Craig
    Venter Institute and then one of the manufacturers. We did that
    in 2013 with H7N9 to actually come up--what we didn't need the
    traditional way of having the virus actually sent from one
    laboratory to another. We actually had the nucleotide sequences
    available, then using that, and actually made the virus seed
    strains and went forward with H7N9. Regardless of if it is an
    egg-based or cell-based or recombinant, we can do that.
        Mr. Flores. OK.
        Dr. Robinson. And we are moving forward with those efforts
    also.
        I just want to say one other thing that Dr. Midthun had
    talked about, and that is high production yield seed strains.
    Why is that important? It means that the virus doesn't have to
    be passaged to eggs or cells or medium many times because, very
    early on, we can actually have high production seed strains,
    and that is why the manufacturers keep passaging the virus to
    get high production. If we had that immediately, then the virus
    that actually is in the vaccine is going to be very similar to
    the circulating virus.
        Mr. Flores. Um-hum.
        Dr. Robinson. Much more so.
        Mr. Flores. OK. And then the last question I have: I have
    always been fascinated with the initiatives to try to develop
    the universal flu vaccine, and I appreciate what Dr. Fauci
    talked about today, and educating the committee and
    subcommittee on how to do that.
        What role does BARDA play in the development, deployment
    and stockpiling of a universal flu vaccine?
        Dr. Robinson. So certainly hand in hand with the NIH, we
    are moving forward with the development, not only for seasonal,
    as I had pointed out, for pandemic purposes. It may serve as a
    primer for future pandemic vaccines. Again, you may only need
    one dose of the pandemic vaccine as opposed to two which you
    normally would need. And so we can stockpile that vaccine or
    actually have it as part of our commercial products that are
    out there every year.
        Mr. Flores. OK. Thank you for your responses. As you know,
    this is important to me because you have a facility in my
    district that I think is doing some great work.
        Mr. Chairman, I yield back.
        Mr. Murphy. Thank you.
        And now I recognize Ms. Clarke of New York, the Brooklyn
    area, as a new member of the subcommittee. Welcome. You are
    recognized for 5 minutes.
        Ms. Clarke. Thank you very much, Mr. Chairman.
        Being the low one on the totem pole, oftentimes, it comes
    with the territory.
        Let me welcome our panelists as well, and pick up on some
    of the line of questioning that my colleague Mr. Tonko raised
    with respect to research.
        So, Dr. Fauci, your testimony discussed the potential for a
    universal flu vaccine that could provide protection against
    numerous strains of the flu over several seasons. What can you
    tell us about the research on this vaccine?
        Dr. Fauci. OK. So the research on this vaccine, as I had
    mentioned, really starts off with the fundamental basic
    observation that a part of the protein that is the target of
    the vaccines that we have developed over decades is one that,
    unfortunately, has a component of it that tends to change from
    season to season. We refer to that as a drift. Big change is
    the shift. The part that doesn't change is the part that we
    have just recently recognized on the thin stem part of the
    protein that we now know that if you show it to the immune
    system in a certain way, and you can only do that by molecular
    biological techniques because, generally, when you show the
    immune system the whole virus, the part that you really wanted
    to make an immune response is crowded out and covered by the
    larger part. So now you are essentially teasing it out and
    showing the immune system just the part that you want to make a
    response again. And we have done that. We have done it with a
    number of different platforms, and we have shown now in a small
    animal, in a ferret, and now even in a human, that, A, it is
    feasible, B, it is safe, and C, it does induce the kind of
    response that you would predict would have a much broader
    effect.
        So that is the real first solid step. We have to perfect
    that, and then we have to show in a broad study that it
    actually does protect against multiple strains.
        Ms. Clarke. That sounds very promising, Dr. Fauci.
        Dr. Robinson, you mentioned in your testimony a new
    initiative to support development of new flu vaccine candidates
    that offer broader, longer-lasting immunity. Can you tell us
    more about this initiative?
        Dr. Robinson. Certainly. We are working with Dr. Fauci with
    many of the candidates that he has talked about, and in
    addition, there are other ways in which we can broaden the
    immunity. Some might be with adjuvants, and other designs of
    the vaccines going forward, and not only for seasonal but for
    pandemic purposes.
        Ms. Clarke. So it sounds like we are moving into the 21st
    century.
        Dr. Robinson. Yes.
        Ms. Clarke. Very well. Very well. I would like to shift a
    bit to the idea of strains, the strain selection process, Dr.
    Midthun. Can you outline the role of the FDA's Vaccines and
    Related Biological Products Advisory Committee in the strain
    selection process, and when does this process actually begin?
        Dr. Midthun. The process is actually year-round. CDC and
    other WHO collaborating centers for influenza are monitoring
    influenza strains year-round to be looking for trends, changes,
    emerging situations, so that is going on all the time. Then you
    have----
        Ms. Clarke. How does the advisory committee arrive at its
    recommendations on the selection of a strain?
        Dr. Midthun. OK. So what happens in usually February or
    early March, when the Vaccines Advisory Committee meets, is
    that we have experts come and present the data on the influenza
    strains that have been circulating over really the last year,
    and those strains are evaluated to see which appear to be
    prevalent, and really based on those data a decision is made
    about which vaccine strains should be included in the vaccine
    manufacturing. And then once that recommendation is made, of
    course, the manufacturers then use that information to start
    manufacturing their vaccines. But I think a very important
    point to note is that, typically, manufacturers actually start
    manufacturing the vaccine before the advisory committee is even
    held. They usually start in January. Why? Because they are
    aware of the data also. As I mentioned, this is an ongoing
    process year-round, and so they will usually anticipate what
    they think will be the strain that is not going to change. They
    do this at risk, but the point is that----
        Ms. Clarke. That is what I was going to ask----
        Dr. Midthun [continuing]. It is a process----
        Ms. Clarke [continuing]. Has there ever been an incident
    where perhaps the advisory committee did not necessarily agree
    and the manufacturer is already proceeding?
        Dr. Midthun. Yes, that can happen. I mean you would have to
    ask individual manufacturers----
        Ms. Clarke. Yes.
        Dr. Midthun [continuing]. But I suspect that that has
    definitely happened, although, typically, I think they will go
    with something that they think, based on the data, is unlikely
    to change. But it really is a process where we make the
    recommendation in February, but clearly, there is a lot of work
    that precedes that and there is a lot of work that continues
    after that to actually have vaccine available. And usually
    vaccine becomes available in July, August, that time frame, and
    then it is continued to be released really throughout the end
    of October. So you can see it is a process that, even though
    you do a recommendation in February, and much work starts
    before that even, it really does take many, many months to
    actually have vaccine available for the influenza season----
        Mr. Murphy. Thank you.
        Dr. Midthun [continuing]. Which, you know, typically can
    begin, you know, October, November, although sometimes not
    until later.
        Mr. Murphy. Thank you.
        Ms. Clarke. Thank you.
        Mr. Murphy. Thank you.
        Now I recognize another new member for the committee, Susan
    Brooks of Indiana, who has a second term of Congress.
    Previously she was in the Homeland Security Committee and was a
    U.S. Attorney. We look forward to you being a part of this
    committee. You are recognized for 5 minutes.
        Mrs. Brooks. Thank you, Mr. Chairman. I do want to thank
    all of the witnesses for your work with respect to the public
    health and safety of our citizens. On Homeland Security, I
    chaired the subcommittee on emergency preparedness response and
    communications, and this is something that we know everyone is
    passionate about. I think, obviously, when we have an epidemic
    the way we have right now, the public pays a lot more attention
    to it, but I think the public also expects us to get it right.
    And the public is expecting us to leave no stone unturned and
    to continue to ask the questions and figure out how can we do
    it better, how can we do it faster, what mistakes have we
    learned from in the past, and what do we do to keep our country
    safe.
        This year is a much higher death toll, as you have said. In
    Indiana, there were 72 deaths statewide. The year before, 70.
    We have already had 108 deaths in Indiana, and it is just the
    end of January, and the flu season, as I understand it, goes
    often in through May, so we have a lot that we are very, very
    concerned about. I spoke with the head of our Marion County,
    which is Indianapolis' Public Health Department, and she has
    indicated that the flu has gotten so severe in Indianapolis
    that she is barring anyone under the age of 18 from visiting
    hospitals. So if you are 15 years old and your mom is in the
    hospital, you can't visit your mom. So we have reached, just to
    let you know, as I am sure you know, and you are very focused
    on this, but these types of precautions are obviously being
    taken for the safety of the patients, but we also know, as we
    have heard, vulnerable, you know, whether they are children or
    seniors, are so vulnerable. But yet one of the things she also
    shared with me, and she was explaining the ag. culture
    technology that we use, and it takes a long time, but yet she
    shared the new cell mediated technology that you have mentioned
    in production is faster, but yet it is not widely used. And so
    I would like to explore why.
        You mentioned a cell-based facility in North Carolina. Can
    we please talk a bit more about if these technologies are out
    there, why are they not being more widely used? And I don't
    know if, Dr. Schuchat, you want to start, and Dr. Robinson.
        Dr. Schuchat. Yes, I will just make an overview comment
    that production of flu vaccine has been increasing over the
    past decade, with more, you know, factories in the U.S., more
    companies, more products, but we also have to work on demand,
    and the more vaccine we use every year, the more the companies
    will make. They don't make lots of vaccine at a risk. And so it
    is a cycle that is interdependent. But Dr. Robinson can talk
    about the cell-based plant and some of the other manufacturing
    efforts.
        Mrs. Brooks. And is that correct, that a cell-based
    technology would allow vaccines to be produced faster? Is that
    correct or is that not correct?
        Dr. Fauci. Not significantly faster. The cell-based is more
    consistent, whereas eggs, you know, it depends on supply of
    eggs, whereas you can keep growing up cells. I think that is a
    common misconception that there is a game-changing difference
    in the amount of time it takes. And the answer to that, and I
    am sure Robin will verify that, isn't the case. You both have
    to grow the virus, that is the problem, as opposed to in a
    recombinant DNA or molecular technology, be able to make it
    more quickly. So even though we welcomed the transition, and
    hope we even do more from egg to cell, the answer for the time
    frame itself is not going to be solved by cell-based
    technology.
        Mrs. Brooks. What is the answer to shorten the time of
    production?
        Dr. Fauci. And that is what I just said when I was talking
    about changing from a need to grow the virus, to the ability to
    do it from a molecular way where you actually develop a vaccine
    by recombinant DNA technology, which doesn't require your
    having to grow the virus. That is really the major
    transformation from one platform to another.
        Mrs. Brooks. Dr. Robinson, how do we----
        Dr. Robinson. No, I agree with them. I mean that is where
    we see the biggest savings in time is with recombinant
    vaccines, but they are new and they are just with very limited
    capacity, they will grow in time. With the cell-based vaccines,
    we may even be able to shave a couple of weeks off than what we
    have with the standard egg-based vaccines at this time.
        The other issue is that it is a new product, and this is a
    very competitive industry, and they are trying to get their
    market share at this time. And as they improve to be equal to
    or better, then they will actually become more commonplace in
    the overall vaccine supply.
        Mrs. Brooks. So are you saying that there is just one
    manufacturer that is manufacturing in that manner?
        Dr. Robinson. That is cell-based in the U.S., there is only
    one licensed manufacturer.
        Mrs. Brooks. Is there any issue in the licensing process?
        Dr. Midthun. No, there is no issue in the licensing
    process. We have approved one cell-based manufacturer and one
    recombinant-based manufacturer. We basically work with anyone
    who wants to come in and make a product, and we are there to
    facilitate that process, but it really is up to, you know, the
    sponsor to come in and say we would like to do this. Certainly,
    you know, BARDA has done much to support some of these new
    technologies, and certainly, again, we are grateful for the
    support you have given in that regard.
        Mrs. Brooks. OK.
        Mr. Murphy. Thank you.
        Mrs. Brooks. Thank you.
        Mr. Murphy. We now recognize another new member of the
    committee, Markwayne Mullin of Oklahoma. We welcome you, and
    you are recognized for 5 minutes.
        Mr. Mullin. Thank you, Mr. Chairman.
        Dr. Robinson, my State of Oklahoma has been hit
    particularly hard this year. According to Walgreens, Oklahoma
    City is the number one place for prescriptions to be issued out
    for Tamiflu. Tulsa is number five. I think we have had
    somewhere like 50 deaths, and in the neighborhood of 1,300
    individuals being hospitalized. My family was hit real hard
    this year. Out of my five kids, four got it. My fourth
    daughter, who is 6, received actually two different strains of
    the flu. My wife and all my family missed the swearing in
    because of the flu. And now it is kind of ironic that I am
    sitting up here talking about this.
        Just some follow-up questions. My understanding is, part of
    the challenge of being able to respond to the mismatch vaccine
    is the burden of regulations, but underneath declaration of
    maybe an emergency, those regulatory burdens change. Is that
    correct?
        Dr. Robinson. Certainly, if a public health emergency is
    declared then we can move forward, but there are regulatory
    issues, I think Dr. Midthun may want to testify----
        Mr. Mullin. No, I just wanted a yes or no on it. If it is
    declared an emergency, those regulatory burdens change quite a
    bit, right? OK.
        In 2009, the President declared a public emergency during
    the swine flu, or the H1N1, crisis. That is correct, right?
        Dr. Robinson. Correct.
        Mr. Mullin. How many cases of swine flu had been confirmed,
    not deaths but had been confirmed in the U.S., when the
    President declared that public emergency?
        Dr. Robinson. I think Dr. Schuchat can answer that.
        Dr. Schuchat. I don't have the numbers, but there was a----
        Mr. Mullin. It was 20.
        Dr. Schuchat [continuing]. An enormous change in the
    epidemiology----
        Mr. Mullin. We do have the number, there were 20 of them
    that was in that----
        Dr. Schuchat. Well, but instead of flu coming down, it was
    going up after the season----
        Mr. Mullin. Right.
        Dr. Schuchat [continuing]. With a completely different
    strain.
        Mr. Mullin. But there was----
        Dr. Schuchat. So----
        Mr. Mullin. But there was an emergency declared with only
    20 confirmed cases in the U.S. There has already been 50 deaths
    in just my State of Oklahoma.
        Dr. Schuchat. Um-hum.
        Mr. Mullin. So I am trying to make a comparison here.
        I believe the flu season goes through May in the Northern
    Hemisphere, is that correct? Right?
        Dr. Schuchat. It can extend to May. It can end earlier.
        Mr. Mullin. OK, what exactly is the definition of a public
    health emergency? Dr. Robinson, do you want to take that? What
    are the criteria of us meeting a public emergency?
        Dr. Schuchat. Yes, a public health emergency is not a
    black-and-white definition.
        Mr. Mullin. So there is no set of specific criteria that we
    can look at, like the number of deaths or hospitalization to
    determine what is in the public's best interest as far as a
    health emergency?
        Dr. Schuchat. Yes, the issue with a pandemic is that the
    potential impact is exceptionally greater than the normal
    range. It----
        Mr. Mullin. So it doesn't matter how many deaths we have,
    it is just 100 percent of----
        Dr. Schuchat. One would be----
        Mr. Mullin [continuing]. CDC to make that----
        Dr. Schuchat. One would be declaring that much in advance
    of seeing the deaths, because of the time needed to take steps
    to intervene.
        Mr. Mullin. Would it help if Congress or you guys could
    come up with maybe some criteria that we could look at that
    could maybe trigger it, rather than just waiting for the next
    crisis to happen, or, honestly, a public outcry?
        Dr. Schuchat. I think we could probably provide the
    language about a public health emergency. What I was trying to
    say was that it is not the same for each condition, for each
    disease or----
        Mr. Mullin. I understand there is some type of flexibility
    and, you know, there has got to be a little bit of more
    understanding of what we are dealing with, but it seems odd
    that there is no criteria at all for us to understand it----
        Dr. Schuchat. Yes, I----
        Mr. Mullin [continuing]. When something like the swine flu,
    that just had 20 cases in the country, was declared an
    emergency by the President, and yet we have a pandemic going on
    right now with the flu, and we could have maybe changed some of
    this with the regulatory burdens going through if we would have
    declared it an emergency faster, where maybe we could have got
    help to individuals.
        Dr. Schuchat. In 2009, a new strain emerged from animals
    that had genetic re-assortment that was completely unique to
    humans. And so what we are dealing with with the drift is
    slight changes, a very different scenario. But what you
    indicate is correct that the ultimate burden of disease from a
    drifted H3N2 strain may end up being greater than a completely
    new to humans re-assortment like the H1N1----
        Mr. Mullin. So----
        Dr. Schuchat [continuing]. Swine-origin pathogen in 2009.
        Mr. Mullin. Could you maybe help us maybe draw some type of
    criteria that needs to be laid out so the next time this
    happens, we could have something to compare it to?
        Dr. Schuchat. We would be happy to provide follow-up on the
    public health emergency and how that is defined. Sure.
        Mr. Mullin. Thank you. I yield back.
        Mr. Murphy. Thank you. Gentleman yields back.
        I now recognize another new member of our committee and
    subcommittee, Chris Collins of New York, a second term in
    Congress. Welcome aboard, and you are recognized for 5 minutes.
        Mr. Collins. Thank you, Mr. Chairman.
        I will be as quick as I can to get the information really
    directed more at Dr. Fauci and Dr. Schuchat.
        And I appreciate your issue of the jump on swine flu, the
    same thing we were worried about with the bird flu, that didn't
    happen. That is the good news of RNA viruses, they don't jump
    off to--but if they do, it can be devastating. So my question
    is really on the universal vaccine discussion. And I don't
    think it has been made clear here. We have DNA viruses and we
    have RNA viruses. And when we talked about the vaccine for HPV,
    the vaccine for herpes, smallpox, chickenpox, those are all DNA
    vaccines. And it is relatively straightforward to get a vaccine
    for a DNA-based virus. Then you have your RNA viruses; HIV,
    Ebola, West Nile, SARS, influenza. They mutate a lot, that is
    what they do, but they don't jump species much.
        So my question is this: Since we are talking about an RNA
    virus, so you can't compare influenza with HPV, you can't
    compare influenza with herpes, and I don't think that was made
    clear, but now that we are talking about an RNA-based virus, I
    guess my question is this, because they mutate, drift so often,
    that is the insidious nature of RNA viruses, which is why the
    answer to a lot of the questions coming here is more because
    they do mutate, that is the basis of that virus. So how is it
    that since measles is an RNA virus, polio is an RNA virus,
    rubella is an RNA virus, and so is mumps, so you have mumps,
    measles, rubella, and polio on the one hand, RNA, and we have
    vaccines for them, what is the difference in the reason we
    don't have vaccines for things like influenza?
        Dr. Fauci. You have asked a very complicated question, and
    I can tell you that there is not a one-to-one relationship of
    whether you can or cannot get a vaccine, whether it is an RNA
    or a DNA vaccine. And also, RNA viruses do jump species. I mean
    the----
        Mr. Collins. Rarely.
        Dr. Fauci. Yes--well, HIV, influenza, I mean, there is the
    fowl virus that jumps, HIV, the chimp virus that jumps, so----
        Mr. Collins. Yes, but much less----
        Dr. Fauci. Yes.
        Mr. Collins [continuing]. Likely than a DNA virus.
        Dr. Fauci. But the things that go into whether or not--your
    point is very well taken, that if you have in general, and----
        Mr. Collins. Um-hum.
        Dr. Fauci [continuing]. You have to be really careful when
    you pick this one or the other one, in general, a virus that
    has a proofreading mechanism, which RNA viruses have----
        Mr. Collins. Right.
        Dr. Fauci [continuing]. They don't correct their mistakes
    when they mutate, allows it to do what influenza does----
        Mr. Collins. Right. Right.
        Dr. Fauci [continuing]. Drift. It allows it to do what HIV
    does. If you give it one drug, it will mutate to be resistant
    unless you give it----
        Mr. Collins. Sure.
        Dr. Fauci [continuing]. Three drugs.
        Mr. Collins. Sure.
        Dr. Fauci. You are perfectly correct on that. However, it
    really isn't specifically that. These are easy to make one
    against, and these are difficult. It just doesn't work that way
    because there are a lot of other things that go into whether or
    not you are going to have a successful vaccine. But the
    fundamental principles that you mentioned are correct.
        Mr. Collins. So how did we end up with one for measles,
    polio, and why has it been so god-awful, if not impossible, to
    get one for HIV or influenza? Is there any----
        Dr. Fauci. Well, the body makes a very good immune response
    against measles, even when it is a serious disease. Ultimately,
    the body will completely clear measles in the----
        Mr. Collins. Right.
        Dr. Fauci [continuing]. Overwhelming majority of people. So
    we already know the body has the capability of inducing an
    effective immune response, therefore, you follow what the body
    does and you induce the same response that natural infection
    does. With HIV, the body does not make an adequate immune
    response against HIV, so there is no proof of----
        Mr. Collins. Yes, but now, HIV, that is where the immune
    system doesn't even see the viral particles.
        Dr. Fauci. Well----
        Mr. Collins. Now, that is different than influenza.
        Dr. Fauci. Well, I am sorry, sir, it does see it, it just
    doesn't make a good response.
        Mr. Collins. It doesn't react to it.
        Dr. Fauci. It doesn't make a good response----
        Mr. Collins. Right.
        Dr. Fauci [continuing]. Against it.
        Mr. Collins. Right, but that is what is unique about HIV.
        Dr. Fauci. Exactly. You need the body's ability to do it
    naturally to mimic it. That is what vaccines are all about;
    mimicking natural infection without----
        Mr. Collins. Sure.
        Dr. Fauci [continuing]. Hurting the host.
        Mr. Collins. So one real quick question for Dr. Schuchat.
    They use adjuvant-based vaccines in Europe. We don't do it
    here. The question on the monocrobial, if we did that with an
    adjuvant, we could extend that production, we could produce
    much less, extend it, because you were saying production is the
    big issue. If it was adjuvant-based, you wouldn't need as much.
    Should we be looking at that as a natural part of the
    monocrobial?
        Dr. Schuchat. You know, I think that adjuvanted influenza
    vaccines hold a lot of promise, and I know that the FDA has
    licensed one so far in the U.S. In terms of extending the
    supply and also----
        Mr. Collins. Right.
        Dr. Schuchat [continuing]. And also potentially expanding
    the immune response. As you heard from some of the measles
    discussions, here in the U.S. our population has a lot of
    questions about vaccines and about their safety, and they have,
    even in 2009 when we were doing community engagement around
    H1N1 vaccination, we had lots of questions about whether there
    would be adjuvants in those vaccines or not. In Europe, they
    use adjuvanted----
        Mr. Collins. Right.
        Dr. Schuchat [continuing]. H1N1 vaccines and we didn't. Our
    public really needs to come along with us in the scientific
    endeavor, and so I think that is an area where the FDA is
    really critical in reviewing the safety data.
        Mr. Collins. Yes. Thank you very much.
        Yield back, Mr. Chairman.
        Mr. Murphy. Thank you, Mr. Collins.
        And now as a tradition of this committee, if another member
    of the committee wishes to be part of this, we will welcome
    back a former member of the subcommittee for this special
    visit, Mrs. Ellmers of North Carolina. You are recognized for 5
    minutes.
        Mrs. Ellmers. Thank you, Mr. Chairman, and thank you to our
    ranking member also, for allowing me to be part of this
    important subcommittee hearing on this very timely issue. And
    to our panel, thank you for being here today.
        And I just want to point out a couple of things. One, in
    October, looking at this issue and knowing the importance of it
    moving forward, especially when it comes to vaccine production,
    I had the honor of hosting a roundtable discussion in the
    Research Triangle. Dr. Midthun and Dr. Robinson, thank you
    again for participating in that very important discussion. We
    learned a lot from that. As we all know, Chairman Upton is
    leading the 21st Century Cures Initiative, and the vaccine
    space fits right in there. And I am working on very important
    legislation right now to actually bolster vaccine production
    and bring vaccines to market. As we know, it is very, very
    important. And I have also the honor of having the facility in
    Holly Springs, North Carolina, which has been referred to
    already, which will be addressing the issue of seasonal and
    pandemic vaccine production, using the cell culture technology.
    Very important to my district. And I also want to point out,
    and I think this is something that we need to look at into the
    future when we are trying to solve these problems. This was a
    public-private partnership between Novartis, HHS, and BARDA.
    So, again, thank you all for your input today. This is a very,
    very difficult situation, but I believe that we can get ahead
    of it and we can move forward, and we can identify ways that we
    can improve upon this process.
        Dr. Schuchat, I have a question for you. In the legislation
    that I am working on right now, my bill, we create mechanisms
    to help increase the communication and sharing between the CDC
    and industry, and ways that we can get that information out to
    impact public health. In your opinion, how can the CDC work
    more closely in partnership with industry to reduce the risk
    and uncertainty of investing in the novel vaccines?
        Dr. Schuchat. We appreciate the chance to work closely with
    industry as they are doing their early development and
    research.
        Mrs. Ellmers. Um-hum.
        Dr. Schuchat. We welcome companies to come meet with us to
    share their ideas, and we----
        Mrs. Ellmers. Um-hum.
        Dr. Schuchat [continuing]. Share all of the information----
        Mrs. Ellmers. Um-hum.
        Dr. Schuchat [continuing]. We have in terms of the public
    health burden----
        Mrs. Ellmers. Um-hum.
        Dr. Schuchat [continuing]. Need and likely interest in
    terms of public or providers.
        Mrs. Ellmers. Um-hum.
        Dr. Schuchat. So we do that regularly, and we welcome the
    opportunity to do it systematically.
        Mrs. Ellmers. Dr. Midthun, again, thank you for being here,
    and again, thank you for being a participant in the roundtable
    discussion that I had back in the District in October. As we
    are looking at vaccine manufacturers to more readily export
    vaccines from the U.S. and make them available to people around
    the world, again, the legislation that we are working on right
    now helps to expedite the licensure process. In addition to
    expediting export licenses, what else can the FDA do to help
    speed up production and approval on delivery of flu vaccine
    availability?
        Dr. Midthun. No, I think we currently use all the expedited
    pathways that are available. So we can use accelerated
    approval, which we----
        Mrs. Ellmers. Um-hum.
        Dr. Midthun [continuing]. Have done for numerous influenza
    vaccines.
        Mrs. Ellmers. Um-hum.
        Dr. Midthun. We also did recently for the 2 meningococcal B
    vaccines that we approved; one in October and one just last
    month. We also used the breakthrough designation which
    basically means that there is a very concerted interactive
    approach early on and throughout the process with industry to
    really accelerate the development of products. So we use all of
    these tools, and they are very important. They, of course, do
    rely on having certain science.
        Mrs. Ellmers. Um-hum.
        Dr. Midthun. So, for example, to use----
        Mrs. Ellmers. Sure.
        Dr. Midthun [continuing]. Accelerated approval, you
    typically rely on what we call a surrogate endpoint. Usually in
    the case of a vaccine it would be some immune response. But you
    need to have information that actually indicates that this
    immune response is----
        Mrs. Ellmers. Um-hum.
        Dr. Midthun [continuing]. Is really likely to predict
    clinical benefits. So there is also a scientific piece that is
    very, very important that others, for example----
        Mrs. Ellmers. Um-hum.
        Dr. Midthun [continuing]. In industry, NIH, and other
    partners, need to work on----
        Mrs. Ellmers. Um-hum.
        Dr. Midthun [continuing]. To make that kind of----
        Mrs. Ellmers. Um-hum.
        Dr. Midthun [continuing]. Process available, but we work
    very closely, obviously, with our sponsors to facilitate
    whatever their development plans are.
        Mrs. Ellmers. Thank you. And one last comment that I would
    like to make, Mr. Chairman, if you would indulge me. One of the
    concerns that was raised by Mr. Tonko from New York, having to
    do with the issues that our families are dealing with, with
    sick children and having to take time off of work, I would
    advocate for my good friend, Martha Roby from Alabama, she has
    a wonderful bill, Working Families Flexibility Act, that
    actually addresses this issue and allows our workforce to be
    able to take part in the availability and ability to use
    overtime and bank it so that in the event that pediatric
    appointments need to be made, or any of these things, families
    can make those choices. So I would advocate to the co-
    sponsorship of that bill. It is a very good bill, and it
    addresses the very issues that we are talking about today.
        Mr. Murphy. Thank you.
        Mrs. Ellmers. So thank you, Mr. Chairman, and I----
        Mr. Murphy. Thank you.
        Mrs. Ellmers [continuing]. Yield back.
        Mr. Murphy. And I want to thank the panelists. Look, I
    think we are all frustrated, we need to be speeding up this
    process and the science, and if there are other legislative
    things we need to do, please let us know. This is the day after
    Groundhog Day, and I don't want to be here with another
    Groundhog Day a couple of years from now running into the same
    problems, with the same issues, and having the same crisis with
    so many Americans getting sick and dying for whatever this is.
    So I ask----
        Ms. DeGette. Would the gentleman yield for one second?
        Mr. Murphy. Yes.
        Ms. DeGette. I completely agree with the Chairman, but I
    will say I want to commend this panel and others at the CDC and
    NIH because, having been on this committee now for 18 years, we
    really have made advances from when we first started with those
    early hearings on egg-based technologies. We just need to
    accelerate that. So anything we can do to help, we are here to
    help. Thank you.
        Mr. Murphy. Appreciate that. I ask unanimous consent that
    Members' written opening statements be introduced into the
    record, and without objection, the documents will be entered in
    the record.
        In conclusion, thank you again to the witnesses and Members
    that participated in today's hearing. I remind Members they
    have 10 business days to submit questions for the record, and I
    ask that all witnesses agree to respond promptly to those
    questions.
        And with that, this committee is adjourned. Thank you.
        [Whereupon, at 12:34 p.m., the subcommittee was adjourned.]
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