[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]                            



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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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