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


    U.S. PUBLIC HEALTH PREPAREDNESS FOR SEASONAL INFLUENZA: HAS THE 
                           RESPONSE IMPROVED?

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

                                 HEARING
 
                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                               __________

                           NOVEMBER 19, 2015

                               __________

                           Serial No. 114-102
                           
                           
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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

                                 ______

              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.................................     4
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     6
    Prepared statement...........................................     6
Hon. Fred Upton, a Representative in Congress from the State of 
  Michigan, prepared statement...................................    70

                               Witnesses

Anne Schuchat, M.D., Principal Deputy Director, Centers for 
  Disease Control and Prevention, Department of Health and Human 
  Services.......................................................     8
    Prepared statement...........................................    11
    Answers to submitted questions...............................   139
Robin A. Robinson, Ph.D., Deputy Assistant Secretary for 
  Preparedness and Response and Director, Biomedical Advanced 
  Research and Development Authority, Department of Health and 
  Human Services.................................................    19
    Prepared statement...........................................    21
    Answers to submitted questions...............................   142
Carole A. Heilman, Ph.D., Director, Division of Microbiology and 
  Infectious Diseases, National Institute of Allergy and 
  Infectious Diseases, National Institutes of Health.............    33
    Prepared statement...........................................    35
Karen Midthun, M.D., Director, Center for Biologics Evaluation 
  and Research, Food and Drug Administration, Department of 
  Health and Human Services......................................    44
    Prepared statement...........................................    47

                           Submitted Material

Subcommittee memorandum, submitted by Mr. Murphy.................    72
Correspondence of April 2015 from Department of Health and Human 
  Services personnel to committee and subcommittee leadership, 
  submitted by Mr. Murphy........................................    84
Letter of July 29, 2015, from Mr. Upton, et al., to Sylvia 
  Burwell, Secretary, Department of Health and Human Services, 
  submitted by Mr. Murphy........................................   116
Letter of September 30, 2015, from Jim R. Esquea, Assistant 
  Secretary for Legislation, Department of Health and Human 
  Services, to Mr. Upton, submitted by Mr. Murphy................   120
Memorandum of May 6, 2015, from Nicole Lurie and Influenza Risk 
  Management Group, Department of Health and Human Services, 
  submitted by Mr. Murphy........................................   131

 
    U.S. PUBLIC HEALTH PREPAREDNESS FOR SEASONAL INFLUENZA: HAS THE 
                           RESPONSE IMPROVED?

                              ----------                              


                      THURSDAY, NOVEMBER 19, 2015

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:59 a.m., in 
room 2322 Rayburn House Office Building, Hon. Tim Murphy 
(chairman of the subcommittee) presiding.
    Members present: Representatives Murphy, Griffith, Bucshon, 
Flores, Brooks, Mullin, Hudson, Collins, Cramer, DeGette, 
Castor, Kennedy, Green, and Pallone (ex officio).
    Staff present: Rebecca Card, Assistant Press Secretary; 
Brittany Havens, Legislative Associate, Oversight; Charles 
Ingebretson, Chief Counsel, Oversight and Investigations; 
Graham Pittman, Legislative Clerk; Chris Santini, Policy 
Coordinator, Oversight and Investigations; Alan Slobodin, 
Deputy Chief Counsel, Oversight and Investigations; Waverly 
Gordon, Democratic Professional Staff Member; Tiffany 
Guarascio, Democratic Deputy Staff Director and Chief Health 
Advisor; Christopher Knauer, Democratic Oversight Staff 
Director; Una Lee, Democratic Chief Oversight Counsel; and 
Elizabeth Letter, Democratic Professional Staff Member.

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

    Mr. Murphy. Good morning. We have the subcommittee hearing 
from Oversight and Investigations. Earlier this year, in 
February, this subcommittee held a hearing on last year's flu 
vaccine mismatch. This mismatch to the predominant flu virus 
resulted in more deaths and hospitalizations because of the 
vaccine's lower than usual effectiveness.
    Today, we are returning to that issue to discuss what our 
public health agencies have learned in the intervening months. 
I want to thank my friend, the Ranking Member Diana DeGette of 
Colorado, for her assistance and continued passion on this 
important topic. We work closely on this issue sending 
bipartisan letters and receiving briefings, not only on this 
year's flu vaccine, but also on our broader response to 
seasonal and pandemic flues.
    Influenza is a leading cause of death in the United States, 
especially in a severe flu season. Each year, millions of 
Americans receive flu shots to help protect against the 
illness. Getting a flu shot is important. Even in a bad flu 
season, the vaccine can reduce the symptoms and duration of the 
flu, and I encourage everyone who has not already received a 
flu shot this season to get one, even if the vaccine is not 
perfect.
    Last year, the United States experienced a severe flu 
vaccine mismatch and public health officials designed the 
vaccine based on information available in February. But the 
virus mutated before the flu season began resulting in an 
effectiveness rate of only 19 percent of the vaccine and even 
lower for senior citizens.
    We have learned, however, that even in a good year, the 
effectiveness of the vaccine is lower than it should be. In 4 
of the last 10 years, the flu vaccine effectiveness rate fell 
below 40 percent and it is clear that the seasonal flu can 
cause severe public health impacts on the same scale as a 
pandemic flu.
    The time for an updated approach to dealing with the flu 
has long passed. The committee's oversight work has made a 
difference. The Department is now treating the seasonal flu as 
a high priority. Tools and plans typically reserved for 
pandemic flu situations are being considered in the fight 
against the seasonal flu.
    An HHS Influenza Working Group has compiled 13 issues and 
recommendations to improve the influenza vaccine development 
and manufacturing process. They are working to improve 
surveillance, utilize technology to speed vaccine production, 
and make more effective vaccines. But there is still much work 
to be done.
    The issues surrounding the flu vaccine are not new. We are 
still largely manufacturing flu vaccines and detecting flu 
virus changes with technology developed during the 1940s. At 
the same time, more and more influenza viruses are emerging 
each year. Increases in travel and trade make it easier than 
ever for these viruses to spread. Our current system is not as 
responsive and effective as it should be.
    The system is badly in need of modernization and must 
better capture advances in technology over the past decades. We 
need better testing to quickly learn of mutations and 
seasonable influenza viruses. We must increase our capacity to 
create cell based and recombinant vaccine doses instead of 
heavily relying on the more problematic egg-based vaccine 
doses.
    The estimated production time for cell-based and 
recombinant vaccines is significantly quicker than egg-based 
vaccines, allowing for greater flexibility in the vaccine 
selection and manufacturing process.
    NIH, the Biomedical Advanced Research and Development 
Authority, known as BARDA, and other agencies undertaking 
research in influenza and the flu vaccine must determine what 
precisely is limiting vaccine effectiveness, particularly with 
respect to the dangerous H3N2 seasonal flu strains. We must 
also better understand how to use adjuvants to boost the 
effectiveness of the vaccine, particularly among high-risk 
populations such as the elderly and the young.
    We need a better contingency plan for vaccine mismatch uses 
whether due to antigenic drift or egg adaptation issues. The 
public health organizations must increase surveillance 
particularly in the Southern Hemisphere so we can know as early 
as possible when a seasonal flu vaccine will not be as 
effective as we hope.
    The CDC must have a more robust and effective 
communications strategy when dealing with the flu. In 
particular, healthcare professionals must be better educated 
about the use of antivirals instead of antibiotics when 
treating the flu. The CDC must also come up with a better plan 
to increase vaccination rates.
    And finally, HHS must prioritize updating its pandemic 
plans some of which have not been updated for over a decade. 
These updates which are now not expected until sometime next 
year are long overdue.
    I am encouraged by the work that has been done in the wake 
of last year's flu season, but we must also ask ourselves where 
we are falling short and what we need to do to modernize our 
response to influenza. Our Nation deserves a 21st century 
response to this problem.
    I thank our witnesses from CDC, FDA, BARDA, and NIH, and 
look forward to hearing their testimony today.
    [The prepared statement of Mr. Murphy follows:]

                 Prepared statement of Hon. Tim Murphy

    Good morning. Earlier this year, in February, this 
subcommittee held a hearing on last year's flu vaccine 
mismatch. This mismatch to the predominant flu virus resulted 
in more deaths and hospitalizations because of the vaccine's 
lower than usual effectiveness. Today, we are returning to that 
issue to discuss what our public health agencies have learned 
in the intervening months. I want to thank the ranking member 
for her assistance in this important topic. We have worked 
closely on this issue, sending bipartisan letters and receiving 
briefings, not only on this year's flu vaccine, but also on our 
broader response to seasonal and pandemic flus.
    Influenza is a leading cause of death in the United States, 
especially in a severe flu season. Each year, millions of 
Americans receive flu shots to help protect against the 
illness. Getting a flu shot is important--even in a bad flu 
season, the vaccine can reduce the symptoms and duration of the 
flu. I encourage everyone who has not already received a flu 
shot this season to get one, even if the vaccine is not 
perfect.
    Last year, the United States experienced a severe flu 
vaccine mismatch. Public health officials designed the vaccine 
based on information available in February, but the virus 
mutated before the flu season began, resulting in an 
effectiveness rate of only 19 percent for the vaccine, and even 
lower for senior citizens. We have learned, however, that even 
in a good year, the effectiveness of the vaccine is lower than 
it should be. In four of the last 10 years, the flu vaccine 
effectiveness rates fell below 40 percent. It is clear that the 
seasonal flu can cause severe public health impacts on the same 
scale as a pandemic flu. The time for an updated approach to 
dealing with the flu has long passed.
    The committee's oversight work has made a difference. The 
Department is now treating the seasonal flu as a higher 
priority. Tools and plans typically reserved for pandemic flu 
situations are being considered in the fight against the 
seasonal flu. An HHS influenza working group has compiled 13 
issues and recommendations to improve the influenza vaccine 
development and manufacturing process. They are working to 
improve surveillance, utilize technology to speed vaccine 
production, and make more effective vaccines.
    But there is still much work to be done. The issues 
surrounding the flu vaccine are not new--we are still largely 
manufacturing flu vaccines and detecting flu virus changes with 
technology developed during the 1940s. At the same time, more 
and more new influenza viruses are emerging each year. 
Increases in travel and trade make it easier than ever for 
these viruses to spread. Our current system is not as 
responsive and effective as it should be.
    The system is badly in need of modernization, and must 
better capture advances in technology over the past decades. We 
need better testing to quickly learn of mutations in seasonal 
influenza viruses. We must increase our capacity to create 
cell-based and recombinant vaccine doses, instead of heavily 
relying on the more problematic egg-based vaccine doses. The 
estimated production time for cell-based and recombinant 
vaccines is significantly quicker than egg-based vaccines, 
allowing for greater flexibility in the vaccine selection and 
manufacturing process.
    NIH, the Biomedical Advanced Research and Development 
Authority (BARDA), and other agencies undertaking research into 
influenza and the flu vaccine must determine what precisely is 
limiting vaccine effectiveness, particularly with respect to 
the dangerous H3N2 seasonal flu strains. We must also better 
understand how to use adjuvants to boost the effectiveness of 
the vaccine, particularly among high-risk populations such as 
the elderly and the young.
    We need a better contingency plan for vaccine mismatch 
issues, whether due to antigenic drift or egg adaptation 
issues. The public health organizations must increase 
surveillance, particularly in the Southern Hemisphere, so we 
can know as early as possible when a seasonal flu vaccine will 
not be as effective as we hope.
    The CDC must have a more robust and effective 
communications strategy when dealing with the flu. In 
particular, health care professionals must be better educated 
about the use of antivirals instead of antibiotics when 
treating the flu. The CDC must also come up with a better plan 
to increase vaccination rates.
    Finally, HHS must prioritize updating its pandemic plans, 
some of which have not been updated for over a decade. These 
updates--which are now not expected until sometime next year--
are long overdue.
    I am encouraged by the work that has been done in the wake 
of last year's flu season. But we must also ask ourselves where 
we are falling short and what we need to do to modernize our 
response to influenza. Our nation deserves a 21st century 
response to this problem.

    Mr. Murphy. And I now recognize ranking member of the 
subcommittee Ms. DeGette of Colorado 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 really 
think it is so important the bipartisan work that we are doing 
on these flu issues. Oftentimes, people ask me what keeps me up 
at night and I always say having been in Congress when we had 
the H1N1 flu some years ago, the concept of a flu pandemic and 
what it could do for our country and our constituents and the 
world at large, it is what is keeping me up at night. And that 
is why I think it is important that we have a hearing every 
year. I am really happy we are having it this year before the 
flu season has started. I think it is really critical so that 
we can examine what--first of all, what is happening with the 
seasonal flu as best as we can predict, and secondly, what we 
are doing to prepare ourselves for better response to the 
seasonal flu and also more devastating potentials.
    I see we have some medical professionals in the room here 
and I am always happy to see. It looks like you are students. 
My daughter is a medical student, and so she is also very 
interested in these issues.
    Last year, I think, was a really harsh reminder that 
infectious disease is always around us and try as we might, we 
are not always 100 percent successful in treating the annual 
flu. Last year's flu vaccine was only moderately effective. 
Fortunately, it was not a severe strain, but nonetheless, it 
resulted in increased hospitalizations, particularly for 
vulnerable populations like senior citizens and young children.
    During the course of the last season, in fact, CDC 
announced that the flu vaccine had only a 23 percent 
effectiveness rate which is significantly lower than we have 
observed in recent years. That was largely because the virus 
mutated in the 8 months between the vaccine strain selection 
and the onset of the flu season. And that resulted in a 
mismatch between the strain of the virus used in the vaccine 
production and the one that we were actually circulating.
    Still, we need to protect ourselves and last year even 23 
percent was better than nothing. But Dr. Frieden reminded us 
last year that even a vaccine with a low effectiveness rate 
still protects millions of people from getting sick and we hope 
and I hear that some of the early indications are that it is a 
better match this year, but it is still kind of a crap shoot 
every year as to what is going to happen. And so that is why I 
am always happy to have these witnesses here today, some of 
whom who have been to this committee before, some are new, to 
hear about ways that we can strengthen our response for the 
future.
    I want to ask the CDC about this flu season, but I also 
want to hear how we are going to respond in the event of a 
severe flu season and what we are doing to continue to prepare 
for the inevitability of some kind of a pandemic flu.
    I was pleased to see that the administration put together a 
memorandum for the Secretary of Health and Human Services, 
based in part on lessons from last year's flu season. It offers 
several key areas where improvements could be made including 
better technology to quickly identify and isolate flu strains 
and efforts to improve vaccine manufacturing. And the plan also 
provides rough estimates of when certain activities can be 
achieved and which agencies are responsible for each goal.
    But Mr. Chairman, as you pointed out, we are still relying 
on egg-based vaccines even though we have better--we have 
cellular techniques that are better. And frankly, this is the 
eighth hearing that we have had in the last 10 years. And I 
remember 10 years ago asking about the development of a new and 
more nimble vaccine potential and here we are again talking 
about this same thing.
    And so I am really looking forward to hearing from the 
witnesses about the goals that they share and the memorandum 
that was issued and also where we are towards moving towards 
better technologies on vaccine production and what we are doing 
to improve all of the rest of our systems for more serious 
identification and prevention. The importance of a strong 
public health infrastructure that allows us to prepare and 
respond simply cannot be overstated. And we are in a good 
position, but I think our position could be improved. We need 
coordinated response capabilities, effective communication 
strategies, and critical investments so we can strengthen our 
response to all types of flu threats.
    And so let me conclude by thanking the witnesses and 
agencies here today. All of you I know are very committed to 
this effort and we look forward to partnering with you in this 
on-going fight. And I yield back. Thank you, Mr. Chairman.
    Mr. Murphy. Thank you. I don't think we have any on our 
side, and, given that we are going to be voting soon, we will 
submit those for the record.
    And Ranking Member Mr. Pallone wants to make a statement. 
You are recognized now for 5 minutes.

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

    Mr. Pallone. Thank you, I will try to shorten it, Mr. 
Chairman, in light of what you just said. I just want--
obviously, it is important for many vulnerable Americans, 
seasonal flu can be dangerous. Older Americans, pregnant women, 
and young children are all at heightened risk for flu 
complications, hospitalization, and death. And last year, we 
experienced a severe flu season across the country. 
Hospitalizations were up. Seasonal flu remains a significant 
public health burden that requires considerable attention from 
our public health officials.
    In addition, the lag time between the selection of the 
strains for the flu vaccine and the completion of the vaccine 
manufacturing process raises inherent difficulties. We can all 
get vaccinated.
    Under the Affordable Care Act, flu and other immunizations 
are required to be covered by your health insurance without any 
copayments or coinsurance. I went and got my shot this morning 
in the infirmary. It was free and it is as easy as going to the 
pharmacy around the corner, so there are really no good reasons 
not to do it. An annual flu vaccination continues to be the 
best method for preventing flu.
    Even in a year where the flu vaccine is less effective, flu 
shots still protect against and decrease the severity of flu-
related illnesses. Unfortunately, many Americans still haven't 
gotten their flu shots. Even though we have made great 
progress, vaccination lags behind in adults, particularly in 
18-to-64-year-olds. And the mismatch vaccine during the 2014-15 
flu season highlights the need to improve our vaccine 
manufacturing process as well as our capacity to conduct 
surveillance and virus characterization in cooperation with our 
global partners.
    So I just want to thank all of the witnesses for coming 
today.
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Mr. Chairman, thank you for holding this hearing today. I 
think this is an important hearing on a topic of bipartisan 
concern.
    While it is easy to get complacent about seasonal flu, it 
is important to remember that for many vulnerable Americans, 
seasonal flu can be dangerous and even deadly. Older Americans, 
pregnant women, and young children are all at heightened risk 
for flu complications, hospitalization, and death. Between 1976 
and 2007, yearly estimates of flu-related deaths in the United 
States ranged from a low of about 3,000 to a high of 50,000.
    Last year, we experienced a severe flu season. Across the 
country, hospitalizations were up. For people aged 65 and 
older, CDC recorded the highest hospitalization rates since 
they began collecting that data in 2005.
    Seasonal flu remains a significant public health burden 
that requires considerable attention from our public health 
agencies. The tendency of flu viruses to change constantly 
results in challenges to our public health capabilities. We do 
not yet have the ability to predict in advance how severe a flu 
season will be, when it will peak, and what flu strains will 
dominate. There are also many things that we still don't know 
about why the flu vaccine is more effective in certain 
individuals, and how the health status of the individual may 
affect the body's immune response.
    In addition, the lag time between the selection of the 
strains for the flu vaccine and the completion of the vaccine 
manufacturing process raises inherent difficulties. We saw this 
become a problem in the 2014-2015 flu season. The H3N2 virus 
strain that circulated during the flu season had become 
significantly different from the H3N2 virus that had been used 
to develop the vaccine, resulting in the reduced effectiveness 
of the vaccine.
    But here's what we do know, and what we can all do. We can 
all get vaccinated. Under the Affordable Care Act, flu and 
other immunizations are required to be covered by your health 
insurance without any copayments or coinsurance. I am going to 
get my flu shot today. It's free, and it's as easy as going to 
the pharmacy around the corner, so there are really no good 
reasons not to do it.
    Annual flu vaccination continues to be the best method for 
preventing flu and its potentially severe complications in both 
children and adults. Getting the flu vaccine reduces flu-
associated illness and adverse health outcomes. For instance, 
in the 2013-2014 flu season, vaccination prevented an estimated 
7.2 million influenza-associated illnesses, 3.1 million 
medically attended illnesses, and 90,000 hospitalizations.
    Even in a year where the flu vaccine is less effective, flu 
shots still protect against and decrease the severity of flu-
related illnesses. Moreover, flu shots don't only protect the 
vaccinated. Vaccinating yourself not only increases the odds 
that you won't get sick this season, but also protects everyone 
you come in contact with, such as your older parents, or your 
sister's new baby.
    Unfortunately, many Americans still haven't gotten their 
flu shots. Although we have made great progress in getting 
children vaccinated, particularly young children, vaccination 
rates lag behind in adults, particularly in 18-to-64-year-olds. 
I look forward to hearing from CDC about what strategies have 
been effective in improving vaccination rates in the past, and 
how we can continue to improve vaccination rates going forward.
    Additionally, the mismatched vaccine during the 2014-2015 
flu season highlights the need to improve our vaccine 
manufacturing process, as well as our capacity to conduct 
surveillance and virus characterization in cooperation with our 
global partners. I look forward to hearing from BARDA, CDC, 
NIH, and FDA about new technologies and initiatives to better 
detect emergent viruses, enhance vaccine effectiveness, and 
speed vaccine production.
    I want to thank all the witnesses for coming today. I look 
forward to hearing from each of you about what your agencies 
are doing to improve flu surveillance, vaccine manufacturing 
processes, and vaccination rates.

    Mr. Pallone. If I could submit my full statement to the 
record, Mr. Chairman, I would ask unanimous consent to do that.
    Mr. Murphy. Without objection, we will do that. And if any 
other Members have an opening statement, I will ask unanimous 
consent the Members have those submitted without objection and 
will be entered into the record.
    I would now like to introduce the witnesses on the panel 
for today's hearing. Dr. Anne Schuchat is the Principal Deputy 
Director for the Centers for Disease Control and Prevention. 
Dr. Robin Robinson is the Director of the Biomedical Advanced 
Research and Development Authority, otherwise known as BARDA, 
within the Office of the Assistant Secretary for Preparedness 
and Response. Dr. Carole Heilman is the Director of the 
Division of Microbiology and Infectious Diseases within the 
National Institute of Allergy and Infectious Disease, the 
National Institutes of Health. And Dr. Karen Midthun is the 
Director of the Center for Biologics Evaluation and Research at 
the U.S. Food and Drug Administration. We probably have about a 
century of education at that table. Thank you.
    I will now swear in the witnesses. You are aware that the 
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?
    [No response.]
    Seeing none, 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 you desire to be advised 
by counsel during your testimony today?
    And everybody says no. So in that case, please rise and 
raise your right hand. I will swear you in.
    Do you swear the testimony you are about to give is the 
truth, the whole truth, and nothing but the truth?
    All the witnesses have answered in the affirmative. You are 
now under oath and subject to the penalties set forth in Title 
18 Section 1001 of the United States Code. We will recognize 
you each for a 5-minute summary of your statement. Please try 
and keep it on time because we are tight for votes.
    Doctor, you are first.

 STATEMENTS OF ANNE SCHUCHAT, M.D., PRINCIPAL DEPUTY DIRECTOR, 
   CENTERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT OF 
  HEALTH AND HUMAN SERVICES; ROBIN A. ROBINSON, PH.D., DEPUTY 
ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE AND DIRECTOR, 
    BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, 
  DEPARTMENT OF HEALTH AND HUMAN SERVICES; CAROLE A. HEILMAN, 
   PH.D., DIRECTOR, DIVISION OF MICROBIOLOGY AND INFECTIOUS 
    DISEASES, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS 
  DISEASES, NATIONAL INSTITUTES OF HEALTH; AND KAREN MIDTHUN, 
 M.D., DIRECTOR, CENTER FOR BIOLOGICS EVALUATION AND RESEARCH, 
 FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                            SERVICES

                   STATEMENT OF ANNE SCHUCHAT

    Dr. Schuchat. Good morning, Mr. Chairman, and members of 
the committee. I am Dr. Anne Schuchat, Deputy Director of the 
Centers for Disease Control and Prevention.
    I shared with the committee last February in the midst of 
the 2014-15 season that influenza is a formidable adversary. 
The propensity of influenza viruses to change presents unique 
challenges. New flu vaccines are made each year and updated as 
needed based on our best determinations of which viruses are 
likely to be most common during the next season. The vaccine 
development process is complex and time consuming with the vast 
majority of flu vaccines still dependent on egg-based 
production technology.
    And while we tackle seasonal influenza, we must conduct 
constant global surveillance and prepare for the emergence of 
dramatically changed or shifted influenza viruses that could 
trigger the next pandemic.
    The 2014-15 season was especially severe. The H3N2 
influenza viruses that dominated posed substantial challenges. 
Even during seasons when vaccine and circulating viruses are 
well matched, we tend to see more severe disease when H3N2 
viruses are predominant. H3N2 viruses have been becoming more 
difficult to grow in eggs. And last season's H3N2 viruses were 
difficult to characterize, using the routine lab tests that 
still work well for other influenza viruses.
    The unique properties of H3N2 viruses also present 
challenges for vaccine production. Last year, we saw how 
devastating seasonal influenza can be. The severe season 
typical of H3N2 years was exacerbated by circulation of strains 
that had drifted away from the H3N2 strain used for vaccine 
development. We saw disappointing vaccine effectiveness against 
these viruses. We saw the highest hospitalization rates in 
people 65 and older that we have seen since this type of 
tracking began nearly a decade ago. Despite this, the vaccine 
actually worked well against influenza B viruses that also 
circulated last season.
    I will briefly mention where we are now as we head into the 
2015-16 flu season, then describe the steps we have been taking 
to improve our efforts in light of the problems we faced last 
winter.
    Currently, influenza circulation is low and flu season 
hasn't yet begun. We can't predict exactly when flu activity 
will start accelerating or which viruses will circulate most 
commonly in the weeks and months ahead. Thus far, we have seen 
more H3N2 viruses than H1N1 or B viruses.
    Current global lab data continues to indicate that most 
circulating flu viruses remain similar to the reference vaccine 
viruses used for development of the 2015-16 U.S. vaccines. 
While we can't predict how effective this season's flu vaccines 
will be, the composition of the 2015-16 U.S. vaccine was 
updated from the '14-'15 one to better match circulating 
viruses. And global data available right now, suggests that a 
vaccination with Northern Hemisphere flu vaccine should offer 
protection against the majority of viruses.
    I could speak at length about the significant improvements 
we have made to our influenza program over the last decade. 
Instead, I will describe what CDC learned from the past season 
and what we have done to improve our ability to rapidly detect, 
respond, and prevent flu.
    First, we continue to work toward better detection of 
influenza viruses and overcome challenges in characterizing 
H3N2 viruses to detect important changes to them. We are 
implementing new testing paradigms where we perform sequencing 
first on all specimens received for characterization. This 
gives actionable data much quicker than before. We are working 
with domestic and international public health partners to 
transfer this technology to them, reducing processing time by 
weeks. We are developing better assays to characterize seasonal 
viruses and enhance our ability to identify emerging viruses. 
This season we are implementing right sizing virus surveillance 
initiative with 64 public health labs.
    We have put out the call to all our international partners 
to increase frequency and numbers of specimens shipped to 
Collaborating Centers and we are trying to maintain the gains 
we have made in the last 10 years in our global surveillance. 
We are working to provide better characterized vaccine viruses 
to WHO and manufacturers for vaccine production We are 
increasing the number of viruses with the potential drift 
capability that are fully characterized as cell and egg 
propagated viruses to expand the pool of viruses available for 
vaccine composition decisions. And we are improving upon the 
vaccine virus selection process, exploring a staggered approach 
whereby decisions about difficult vaccine components are made 
closer to the season and talking to the WHO Flu Network and 
manufacturers about moving the decision time line as a whole 
closer to the season.
    Although I have spoken about things we would like to do 
better, I want to remind you the vast progress we have made in 
detecting, preventing, and responding to influenza threats over 
the past decade. Flu is a formidable opponent, but CDC is 
working 24/7 to protect Americans from this and other threats 
at home and abroad. And I am happy to answer questions.
    [The prepared statement of Dr. Schuchat follows:]
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    Mr. Murphy. Thank you. Dr. Robinson, you are recognized for 
5 minutes.

                 STATEMENT OF ROBIN A. ROBINSON

    Dr. Robinson. Good morning, Chairman Murphy, Ranking Member 
DeGette, oh sorry. Good morning. And I would recognize the 
chairman, Ranking Member DeGette, and the distinguished members 
of the subcommittee. Thank you for the opportunity to speak 
with you again today.
    I am Dr. Robin Robinson, the Director of the Biomedical 
Advanced Research and Development Authority or BARDA, and the 
Deputy Assistant Secretary to the Assistant Secretary for 
Preparedness and Response or ASPR, as well as a former 
developer of influenza vaccines in industry.
    ASPR is charged with coordinating Federal public health and 
medical preparedness and response to public health emergencies, 
providing integrating public policy and strategic direction 
over the national response framework, and through BARDA 
oversees advanced research and development and procurement of 
novel and innovative medical counter measures such as vaccines, 
therapeutics, diagnostics, and medical devices for the entire 
Nation to address medical consequences of manmade and naturally 
occurring threats like the 2009 H1N1 pandemic, the 2013 H7N9 
influenza outbreak, and the recent bola epidemic.
    We have funded and successfully managed the advanced 
development of more than 80 medical countermeasures for 
pandemic influenza and 18 receiving FDA approval and licensure 
since 2007 and 6 in the last 3 years. Additionally, we 
developed and procured vaccines and antivirals used in the 2009 
H1N1 pandemic and stockpiled vaccines that were prepared 
against H5N1 and H7N9 viruses.
    Through partnerships with NIH, CDC, FDA, industry, and 
academia, we have met and overcome many, but not all, of the 
challenges inherent to making vaccines for seasonal and 
pandemic influenza. These achievements include first 
modernization of influenza vaccines through the development and 
licensure of new cell- and recombinant-based influenza vaccines 
and antigen-sparing adjuvanted vaccines; second, shortening 
pandemic influenza vaccine manufacturing time lines through 
advancements such as synthetic biology and new vaccine potency 
assays; third, establishment and maintenance of pre-pandemic 
influenza vaccine stockpiles for H5N1 and H7N9 viruses; fourth, 
multi-fold expansion of domestic pandemic influenza vaccine 
production to meet U.S. pandemic vaccine needs; and lastly, 
providing emergency response capabilities to develop, 
manufacture, and test new pandemic influenza vaccines through 
our national medical countermeasure response infrastructure.
    Despite these significant accomplishments, our influenza 
vaccine preparedness work is not over. Incremental 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, 
novel adjuvants, and heterotypic prime/boost vaccine strategies 
may afford more durable and broader immunity and spark renewed 
interest and efforts to develop more effective influenza 
vaccines with universal potential.
    With the National Institute of Allergy and Infectious 
Disease, we are supporting the development of several new 
influenza vaccine candidates that may be more effective against 
a wider range of influenza viruses and that may serve both 
seasonal and pandemic influenza needs. Additionally, the 
National Institute of Allergy and Infectious Disease and we are 
supporting new methods to help forecast the select seasonal and 
pandemic influenza vaccine strains based on evolutionary 
biology technologies.
    With our HHS partners, we are bringing a number of our 
advancements in pandemic influenza vaccines to address virus 
antigenic drift and seasonal influenza vaccine mismatch issues. 
These actions include better virus surveillance and 
characterization, new seasonal virus risk assessment tools, 
faster preparations of better candidate vaccine viruses, faster 
potency assays and reagent lot variation and more effective 
influenza vaccines.
    Beyond the successes that we have achieve domestically, 
improved global coordination is critical. We have engaged our 
global partners and industry several times this year on our 
improvement efforts for seasonal influenza vaccines. Recently, 
we evaluated several of these actions in a tabletop exercise 
with HHS agencies, WHO, representatives from other countries, 
and vaccine manufacturers. The exercise showed that several of 
these mitigation measures may improve the way that we prepare 
candidate vaccine strains and make seasonal influenza vaccines.
    In addition, the exercise provided improved framework on 
how the U.S. and global partners may manage viral antigenic 
drift and vaccine mismatches better.
     In conclusion, influenza viruses that may cause seasonal 
epidemics and potential pandemics continue to evolve and 
change, infect animals and man and pose significant threats to 
global and domestic public health. Last year's limited seasonal 
influenza vaccine effectiveness and this year's arrival of H5 
avian influenza viruses in U.S. poultry underscore our urgent 
and compelling need to complete the mission.
    To be better prepared, our Nation must continue to invest 
in domestic seasonal and pandemic preparedness and work with 
key global partners. Thank you for your generosity and I look 
forward to your questions.
    [The prepared statement of Dr. Robinson follows:]
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    Mr. Murphy. Thank you. Dr. Heilman, you are recognized for 
5 minutes.

                 STATEMENT OF CAROLE A. HEILMAN

    Dr. Heilman. Mr. Chairman, Ranking Member DeGette, and 
members of the subcommittee, thank you for the invitation to 
discuss the National Institutes of Health's (NIH) response to 
the public health threat posed by influenza. The National 
Institute of Allergy and Infectious Diseases (NIAID) is the 
lead NIH institute for research on immunologic, allergic, and 
infectious diseases, including influenza.
    The NIAID mission balances research addressing current 
medical challenges with the capacity to respond rapidly to new 
threats from emerging and re-emerging infectious diseases, 
including seasonal and pandemic influenza. Given the morbidity 
and mortality of influenza in the United States every year, and 
the disease's economic burden, there remains a concerted U.S. 
interagency and international effort to study the global 
emergence and spread of novel influenza viruses to ensure that 
we are prepared not only for the coming flu season, but also 
for strains with pandemic potential.
    As part of this response, NIAID's long-standing influenza 
research program spans basic translational and clinical 
research and includes efforts to develop a universal influenza 
vaccine that could provide durable protection against a variety 
of seasonal and pandemic influenza viruses.
    Important to NIAID's effort are on-going collaborations 
with academia, biotechnology, and pharmaceutical industries and 
other Federal partners, particularly, CDC, FDA, ASPR, and 
BARDA.
    NIAID's basic research on influenza focuses on 
understanding how influenza virus strains, including those with 
potential pandemic potential, evolve and causes illness in 
animals and humans. Many of the ways NIAID contributes 
fundamental knowledge about influenza is through our Centers of 
Excellence for Influenza Research and Surveillance Program 
which studies the global emergency and spread of novel 
influenza viruses and provides critical information to the 
World Health Organization.
    NIAID also is using bioinformatic approaches to learn more 
about how influenza changes over time and how it can be 
prepared to rapidly respond to these changes. For example, 
NIAID is supporting the development of antigenic cartography, a 
computational method to understand evolutionary changes to 
influenza. This method is now being applied to data from WHO 
Collaborating Centers to help provide information relevant to 
the strain composition of the annual seasonal influenza 
vaccine.
    In addition, an NIAID supported computational method, known 
as antibody landscaping, has enabled scientists to visualize 
how the human immune system responds to a lifetime of influenza 
infections. This technique is also being employed to design 
antigenically advanced vaccines that may allow us to vaccinate 
against influenza strains that have not get emerged.
    To help diagnose and promptly treat influenza, NIAID 
supports the development of diagnostic tools that examine the 
molecular makeup of influenza viruses to quickly distinguish 
between seasonal strains and those with pandemic potential. 
NIAID is also supporting development of clinical assays to 
determine influenza's sensitivity to neuraminidase inhibitors, 
drugs that can lessen the severity and duration of influenza 
and potentially prevent influenza in close contacts of patient.
    NIAID is also responding to the emergency of antiviral 
resistance influenza strains by exploring new and better 
treatment options including broad spectrum antiviral drugs, RNA 
polymerase inhibitors and peptide inhibitors.
    As we all know, annual influenza vaccination is the primary 
method to prevent seasonal influenza. Because influenza viruses 
evolve as they spread from person to person, the strains used 
in the influenza vaccine must be reevaluated every year. While 
recent analysis suggests that strains in the current seasonal 
influenza vaccine match the current circulating influenza 
strains, the mismatch experienced during 2014 and '15 flu 
season underscores the importance of NIAID's sustained support 
for influenza research and in particular, work towards a more 
broadly cross-protective or universal influenza vaccine that 
could generate long-lasting protection against influenza 
strains over multiple seasons and enhance pandemic 
preparedness.
    NIAID research on universal vaccine is focused on several 
concepts, but the common principle behind each of these 
concepts is to identify those parts of the influenza viruses 
that are similar across multiple influenza strains and then 
maximize the immune system's potential to respond to them.
    In addition to the efforts of NIAID scientists, the 
Institute in collaboration with BARDA is supporting a 
development of several potential promising universal influenza 
candidates by industry and academic partners. Although we 
cannot predict when a universal influenza vaccine will be 
publicly available, NIAID's lead effort has generated 
encouraging progress towards this goal. It is important to note 
that we develop universal influenza vaccines, promising 
candidates will need to be evaluated over several influenza 
seasons to determine the extent and durability of their 
protection.
    NIAID is also helping to address scientific challenges in 
influenza virus reduction and NIAID is supporting efforts to 
create a flexible vaccine manufacturing process for seasonal 
pandemic influenza vaccine development including modern 
molecular biological techniques to help increase production 
efficiency and shorten manufacturing time.NIAID will continue 
to focus on advancing new tools to prevent and combat seasonal 
pandemic influenza in collaboration with academic, the 
biotechnology institutes, and pharmaceutical industries and 
other Federal partners.
    Thank you for the opportunity to provide this overview of 
NIAID's influenza research program. I would be pleased to 
answer any subcommittee questions.
    [The prepared statement of Dr. Heilman follows:]
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    Mr. Murphy. Thank you. Dr. Midthun, you are recognized for 
5 minutes, and please try and keep it to 5 minutes. We are 
running over. Thank you.

                   STATEMENT OF KAREN MIDTHUN

    Dr. Midthun. Mr. Chairman, Ranking Member DeGette, and 
members of the subcommittee, I am Dr. Karen Midthun, Director 
of the Center for Biologics Evaluation and Research, the center 
within FDA responsible for regulating vaccines. Thank you for 
this opportunity to be here today to discuss FDA's role in the 
highly collaborative effort in preventing influenza through 
vaccination in the United States.
    Each year, influenza causes illness in a large proportion 
of the U.S. population and may result in serious complications 
including hospitalization and death. Influenza viruses 
continually undergo changes in their genetic makeup and 
resulting proteins that interact with the immune system. 
Therefore, the composition of influenza vaccines must be 
periodically updated to be effective against circulating 
viruses anticipated to predominate in the upcoming season. The 
strains of virus and the vaccine include two distinct subtypes 
of influenza A and one or two influenza B strains depending 
upon whether the vaccine is trivalent or quadrivalent.
    To identify vaccine strains likely to cause illness during 
the upcoming season, the WHO convenes experts to study recently 
circulating influenza viruses from around the world and recent 
global disease patterns. Based on this assessment, the WHO 
makes recommendations on the composition of 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 
a recommendation for the composition of influenza vaccines 
licensed by FDA for use in the U.S. during the upcoming season.
    Once the strains are selected, candidate influenza viruses 
that are adapted for high growth are generated and accepted by 
the World Health Organization Collaborating Centers and are 
provided to manufacturers to generate the seed viruses for 
manufacturing vaccines. FDA then confirms the antigenic 
suitability of the manufacturers' seed viruses. The 
manufacturing demands are tremendous and the time lines are 
tight. No other vaccine is produced. FDA approved and 
distributed every year across the U.S. within a 6 month time 
frame. More than 170 million doses will be manufactured.
    Given the yearly need for new vaccine, there is limited 
flexibility in the time lines for vaccine manufacturing and 
availability.
    In parallel with vaccine manufacturing, FDA develops and 
calibrates reagents that are provided to the manufacturers and 
our regulatory counterparts throughout the world. These 
reagents are used both by FDA and the manufacturers to test the 
vaccines for potency and identity before FDA approves the new 
U.S. 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.
    Every year, FDA begins working with manufacturers at the 
earliest stage of the influenza vaccine development process and 
we continue to assist throughout the production phase. We 
engage companies and technical and manufacturing issues and 
conduct facility inspections as warranted to ensure compliance 
with good manufacturing practice.
    As part of the efforts to improve public health emergency 
preparedness for seasonal and pandemic influenza, HHS staff 
with expertise in influenza convene monthly at the Pandemic and 
Seasonal Influenza Risk Management Meeting. This group 
deliberates policy and programmatic issues regarding influenza 
medical countermeasures.
    HHS has taken a series of steps to increase the probability 
that a late season change to trivalent or quadrivalent vaccine 
could be made or that a supplemental monovalent vaccine could 
be produced if warranted. Several actions by HHS for immediate 
implementation were proposed and tested and will be further 
refined based on a tabletop exercise that was conducted on 
November 10 with HHS agencies, vaccine manufacturers, and other 
global partners.
    In spite of the difficulties inherent in preparing 
influenza vaccines, we have made progress in our preparedness 
efforts in collaboration with BARDA, CDC, NIH, and other 
stakeholders and we thank Congress for support of these 
efforts. New influenza vaccines have been licensed including 
cell-based vaccines, recombinant protein vaccines, and 
quadrivalent vaccines. To enhance pandemic preparedness, FDA 
licensed an adjuvant of 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 A.
    Surveillance efforts are more extensive than ever before 
and offer the potential for early detection of emerging 
influenza viruses. The number of candidate vaccine virus 
strains available to manufacturers has increased greatly 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 methods to measure 
vaccine potency and sterility.
    To further address the challenges presented by the 
constantly changing nature of influenza viruses, scientists 
affiliate with Government, academia, and vaccine manufacturers 
are working to develop a new generation of vaccines that might 
provide longer-lasting and broader protection including against 
drifted strains. Although these development efforts are still 
in early stages, some may have the potential increase and 
broaden protection against influenza. We will work with U.S. 
Government partners, manufacturers, and other stakeholders to 
continue to facilitate the development of new vaccines and 
identify methods that have the potential to speed manufacturing 
process.
    I thank you and look forward to any questions you have.
    [The prepared statement of Dr. Midthun follows:]
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    Mr. Murphy. Thank you. Since we are going to vote soon, we 
will get to as many as we can and then take a break and come 
back.
    Let me start off and recognize myself for 5 minutes. Dr. 
Schuchat, have the influenza strains grown increasingly complex 
and are they being distributed more broadly across the globe 
now?
    Dr. Schuchat. CDC has expanded our surveillance so that we 
do have testing of viruses from more and more places, but we 
actually need to do even more. The H3N2 virus that was 
predominant last year really showed us that these strains have 
evolved away from the tools that we have been using. We have 
had to modernize our tools and move to a sequence first 
approach which helps us overcome the old HI test that wasn't 
really helping us understand the distribution of strains. So 
there have been important changes in the evolution of H3N2 that 
have made it difficult with the old tools to track what is 
going on.
    Mr. Murphy. And there has been a large increase in human 
infections with the influenza A virus over the past 20 years. 
And is it true that there are many new types of highly 
infectious influenza strains the world is racing to keep up 
with, a wider range of types?
    Dr. Schuchat. We have increased the sophistication of 
testing so we are picking up unusual types, the types that jump 
from animals to people. We have seen more of those. It is 
difficult to say whether this is happening more or we are 
finding it more. We really have increased the global capacity 
of countries all around the world to recognize influenza, test 
for it, and provide specimens that can be further 
characterized.
    Mr. Murphy. But as you are talking about those global 
aspects, is part of this also that there is the issue of 
increased international travel and trade that is also spreading 
faster and influencing some of this?
    Dr. Schuchat. There are so many factors that have made 
infectious threats greater and greater today. The closeness 
with which animals and people interact these days, some of the 
manufacturing or agricultural practices around the world, of 
course, travel and trade means that people are in contact with 
each other in different ways. So not just for influenza, but 
for many threats, we really see infections anywhere. Could be 
here at home soon.
    Mr. Murphy. So what you are talking about then is you are 
picking up more. There is increased threat and 
unpredictability, but has the flu modeling really changed to 
more accurately reflect the best information of flu viruses, 
specifically is it being changed to more accurately prepare for 
an influenza vaccine?
    Dr. Schuchat. The application of modeling approaches to the 
genetic data has advanced substantially. We have an enormous 
amount of genetic sequence data now that is being used in more 
sophisticated ways. So we think this is a very important tool 
for the future to actually use modeling really to predict what 
would be better reassortants that could make better vaccines.
    Mr. Murphy. And in another area, Doctor, are serum banks 
useful for testing candidate viruses for the flu vaccine? And 
if so, could more use of serum banks help provide better 
sampling for testing candidate viruses?
    Dr. Schuchat. I am probably not the best person to answer 
that question.
    Mr. Murphy. Who would be?
    Dr. Schuchat. But I could begin.
    Mr. Murphy. OK.
    Dr. Schuchat. Basically, the ways we are testing candidate 
vaccine viruses or that we are testing circulating viruses 
include old tools and new tools. We have been using this HI 
hemagglutinin inhibition test which was developed in the '40s 
and is really not working anymore for many of these difficult 
strains. We are switching to neutralization assays and to 
synthetic receptor models that we would like to invest in.
    Serum banks isn't sort of the cornerstone of how we would 
be going about this, but there may be others who want to try 
and answer.
    Mr. Murphy. Does anybody else have any thoughts on that? If 
not, I will go to my next question. OK.
    So are there any studies currently underway examining the 
immunological profile throughout our country to determine if 
there is any regional differences on what influence of viruses 
are predominant and what traces of immunity are in local 
populations?
    Dr. Schuchat. You know, that is a very interesting 
question.
    Mr. Murphy. That is why I asked it.
    Dr. Schuchat. OK. You know, we have expanded our Vaccine 
Effectiveness Network in the U.S. to have more communities 
included in larger numbers. One thing that we found last year 
with the difficult strain that we had in the drift was the 
vaccine effectiveness was poor generally, but in one area which 
happens to have been Pennsylvania, the vaccine worked quite 
well and we think that the strains that were circulating in 
Pennsylvania were of a different clade or subtype. They were 
the old strain, not the drifted one. So in fact, the vaccine 
worked better than most places in Pennsylvania.
    We think it is really important for us to have lots of 
viruses and to test them with the best tools so that we really 
can understand what is circulating and that we need very good 
vaccine effectiveness platforms, both in the United States and 
in the Southern Hemisphere to really understand how the 
vaccines are performing in actual use, not just predicted to 
perform through the lab assays before we start using them.
    Mr. Murphy. Thank you. My time has expired. I now recognize 
Ms. DeGette for 5 minutes.
    Ms. DeGette. Thank you, Mr. Chairman. I am always 
encouraged to hear researchers and experts come in and talk 
about the new development methods that we are beginning to 
achieve for flu vaccine, but Dr. Midthun, we are still 
primarily using egg-based technology to produce the flu vaccine 
right now in this country, correct?
    Dr. Midthun. It is correct that most of the influenza 
vaccine is produced with egg-based technology.
    Ms. DeGette. And one of the problems with egg-based 
technology is that obviously it takes time if the virus should 
mutate or need to be changed. Is that correct?
    Dr. Midthun. It does take time, but it also takes time if 
you make the product using cell-based or recombinant 
technologies. There may be some time savings, but nonetheless 
you need to be able to have the virus that will grow well in 
the cell base as well as well as the----
    Ms. DeGette. But the other problem, as we have seen in past 
hearings, is that if you have some kind of pandemic, then the 
additional problem to the time it takes to grow the virus in 
the eggs is the egg availability. We saw that with the avian 
flu and other things. Is that correct?
    Ms. DeGette. You know, I might ask Dr. Robinson to add 
here, but actually a lot has been invested in both----
    Ms. DeGette. But all I am asking is it takes a lot longer 
if you have to rapidly grow vaccine in eggs to get the eggs, 
yes or no?
    Dr. Midthun. It depends. In general, it is possible to get 
a virus that will grow more quickly in a cell-based system than 
an egg-based system.
    Ms. DeGette. Look. I have 5 minutes. Yes or no. If you have 
to increase egg production it takes a long time. Is that right? 
OK, never mind. You are not going to answer my question.
    Let me ask you, Dr. Robinson, because you testified that we 
have developed a lot of these new technologies, but they are 
not being used on a routine basis for the seasonal vaccine. 
Isn't that correct?
    Dr. Robinson. So both recombinant and cell-based vaccines 
are licensed for seasonal purposes.
    Ms. DeGette. That is correct, but they are not being used 
widely. Isn't that correct?
    Dr. Robinson. That is correct.
    Ms. DeGette. OK, why is that?
    Dr. Robinson. They are competing when the incumbent vaccine 
industry where you have egg based and they are new to the 
enterprise and they are fighting it out in the markets.
    Ms. DeGette. Part of the problem is it is a market-based 
technology?
    Dr. Robinson. Correct.
    Ms. DeGette. And so it costs more money, right?
    Dr. Robinson. So far, that is correct.
    Ms. DeGette. How do you see the markets moving particularly 
with development of pandemic types of vaccines? Would we be 
able to be nimble enough to use those new technologies if we 
had some kind of pandemic flu and how long would it take us to 
ramp up?
    Dr. Robinson. So to answer your question, yes, they are 
part of what we do for pandemics. They have been part of what 
we have developed and they are part of our capacity to make the 
U.S. independent of other countries providing those vaccines.
    Ms. DeGette. How long would it take? Because right now, we 
don't have a stockpile of pandemic flu vaccine.
    Dr. Robinson. We have stockpiles for H5N1 and H7N9. The new 
pandemic----
    Ms. DeGette. Some of those are 10 years old, right?
    Dr. Robinson. And we are actually testing those exactly 
right now in fact to see whether or not they are still good.
    Ms. DeGette. Can you supplement your testimony to let us 
know if they are still good?
    Dr. Robinson. I would be happy to.
    Ms. DeGette. Once you finish that. That would be good. But 
so let us say we had a new strain of avian flu or some other 
kind of pandemic flu. How long would it take us to develop 
those vaccines then?
    Dr. Robinson. Having been around for the H1N1, we took 
about 23 to 25 weeks for us to start to actually have vaccine 
available in October of 2009. H7N9, 2013, we actually broke 
that record by several weeks, in fact, and we now have more 
tools that we can actually do it a little bit faster if we 
start for a new pandemic virus.
    Ms. DeGette. So you think you could go down to like 20 
weeks?
    Dr. Robinson. Our goal, our aspirational goal is to 
actually have the vaccine in 4 months.
    Ms. DeGette. OK, so the problem is, of course, which we all 
understand is if you see a pandemic flu, 4 months is going to 
be a long time to try and develop a new vaccine. Are there ways 
that you think with our support we could get that even shorter?
    Dr. Robinson. Certainly if we can keep all of these 
manufacturers going for seasonal influenza vaccine markets, 
then we have a greater chance to have those available and make 
larger predominance of those vaccines available, both seasonal 
and pandemic.
    Ms. DeGette. I am out of time and I know we are trying to 
get a lot of questions in, but I am going to have a lot more 
answers that I would love it if you guys could respond in 
writing. Thank you.
    Mr. Murphy. Thank you. We will have time for Mr. Collins 
for 5 minutes.
    Mr. Collins. Thank you, Mr. Chairman. Maybe to follow up a 
little bit on Ms. DeGette's questions, Dr. Robinson, on the 
pandemic flu, the H5N1 that has been stockpiled for 10 years, 
what is your--since it has never jumped to humans, H5N1, right?
    Dr. Robinson. There has been a number of individuals that 
have been infected with H5N1. It is highly lethal.
    Mr. Collins. Right, but didn't jump.
    Dr. Robinson. It is not easily transmitted.
    Mr. Collins. Correct.
    Dr. Robinson. From man to man.
    Mr. Collins. Correct. So on what basis did you characterize 
or decide how to produce the H5N1 vaccine since it has never 
really jumped from animals to humans?
    Dr. Robinson. So we have been working over about 10 years 
putting together the H5N1 vaccine development plans with our 
colleagues at FDA, NIH, and also at CDC and with industry 
partners. And we actually were able to successfully make the 
first one that was licensed in 2007, more recently with 
adjuvants were licensed 2013. And we were able to actually show 
that we can actually produce at very high levels, and we can do 
it quickly. We actually had experience in 2013 for another 
avian influenza virus, H7N9, in which we were able to use egg, 
cell, and even recombinant technologies to make those vaccines 
sooner using all the new methods that we have.
    Mr. Collins. So let us say that something happens and it 
does become a pandemic. Is your organization looking at any 
post-symptomatic treatments for a person--it is so deadly, 
especially in this case, healthy individuals, for any kind of 
post-symptomatic treatments?
    Dr. Robinson. So we have invested very heavily in new 
antiviral drug candidates and some of those have actually been 
approved by the FDA. Preamivir was in 2014. We are looking at 
non-neuraminidase inhibitor type of molecules and also 
immunotherapeutics, antibodies that be used to treat----
    Mr. Collins. Monoclonal or polyclonal?
    Dr. Robinson. In our case, monoclonals. There a number of 
good candidates out there and we have started supporting those.
    Mr. Collins. Why not a polyclonal?
    Dr. Robinson. So if there are good candidates, we certainly 
wouldn't be looking at those presently. The monoclonals look 
like they have several advantages.
    Mr. Collins. I am not sure what the advantages are since 
they target a specific--on anything that mutates as rapidly as 
this virus----
    Dr. Robinson. So they actually are targeted to regions of 
the virus that do not mutate. They are highly conserved.
    Mr. Collins. So is your opinion the stockpile we have 
adequate if something were to happen?
    Dr. Robinson. So for the antiviral drug stockpile that we 
have, the Strategic National Stockpile is responsible for. It 
is designed and is equipped to handle what we would have for 
severe influence of pandemic.
    Mr. Collins. So a question on the adjuvant. You have done 
that only to make it a more potent, if you will, vaccine that 
would----
    Dr. Robinson. So for originally why we actually used 
adjuvants is because it was going to take so much vaccine and 
so many eggs at the time when we started the work that we 
couldn't have enough.
    Mr. Collins. Makes it more potent.
    Dr. Robinson. Makes it more potent. But it actually also 
allows now, we understand, for the vaccine to actually protect 
against different strains of influenza.
    Mr. Collins. I know our time is running out, but make a 
question for Dr. Schuchat, the elderly sometimes are more at 
risk just because of their health. Is that a population where 
we might decide to have two versions of even the seasonal 
vaccine, one adjuvanted, one not, and have those over whatever 
65 or in poor health, have the adjuvanted vaccine?
    Dr. Schuchat. You know, right now there are more than one 
formulation for the elderly, so a high dose vax formulation has 
been licensed for the elderly and adjuvanted formulations are 
under review. So I think we really do focus on the elderly who 
suffer the most from influenza in most seasons with 
hospitalizations and deaths and in a pandemic typically, not 
the 2009 one, but typically would also suffer extensively. And 
we do think better vaccines are important for that population. 
There has been a lot of progress and there is more progress we 
look forward to in the future.
    Mr. Collins. But currently, there is not an adjuvanted 
version of the seasonal?
    Dr. Schuchat. That is right, not yet. But there is one that 
is under review.
    Mr. Collins. Yes.
    Dr. Midthun. Yes, we have a license application for an 
adjuvanted vaccine for individuals for seasonal vaccine, 65 
years of age and older which was discussed in advisory 
committee 2 months ago and is currently under review. It shows, 
it compared the immune response to the adjuvanted versus the 
unadjuvanted and it did not actually show that the adjuvanted 
vaccine indicated a superior immune response, but nonetheless, 
we are considering this for licensure.
    Mr. Collins. Thank you very much. My time has expired. I 
yield back.
    Mr. Murphy. Thank you. We have about 3 \1/2\ minutes left 
in the vote. So we are going to break. We will back in about 
40, 45 minutes, my guess. We will get right back to questions. 
We should get in all the questions in from all the Members 
before the second series of votes after that. So we will be 
back. Thank you. We are in recess.
    [Recess.]
    Mr. Murphy. All right, we will reopen the hearing here, and 
now I will recognize the gentleman from Texas, Mr. Green, for 5 
minutes.
    Mr. Green. Thank you, Mr. Chairman. And I thank our 
witnesses for understanding our vote schedule on the floor and 
hope you had some rest between the questions earlier.
    I represent a very urban district in Houston. It is 
actually medically underserved and so 20 years ago we started 
doing vaccinations for children in our elementary schools in 
August just before school started so we would raise our 
vaccination rate. And we have been doing that since then and it 
has been really successful. We partner with our local school 
districts, our county health department, Texas Children's 
Hospital, and so in a sense we have raised in our ZIP Codes, 
the percentage of children who are immunized. And I always talk 
about immunizations are the cheapest medical dollar we can ever 
spend because it is most effective.
    Last weekend, we actually did a flu vaccine effort. Texas 
Children's Hospital did children's vaccines. Walgreens, our 
pharmacy, one of our chain pharmacies in our community, did 
adults and the seniors. We didn't get a good turnout because 
this was our first as compared to having 20 years of 
experience, people expect us in August to do the children's 
vaccines. But my concern was last year because of the 
effectiveness of the vaccine and we want more people to get the 
vaccine, but when you hear that it is 20 percent or so, give or 
take, efficiency, what can we do to help make sure that you 
have the tools to make that efficiency much better?
    I know flu mutates. It is really a challenge. But we would 
hope we could do better than 20 percent. And I know that has 
been other questions and I would be glad to see what Congress 
can do to help the agencies be able to do a better job.
    Doctor, if you want to start?
    Dr. Schuchat. Sure, I can start and I can pass it along. 
The people represented here, our institutions have been working 
really closely together to improve influenza vaccine both a 
seasonal flu vaccine pandemic and then future vaccines that 
might be even better. But from the CDC perspective, the more 
viruses from more places that we have characterized really well 
gives us information that can lead to better candidate vaccine 
viruses that we can then turn over to FDA to make sure they are 
OK and to industry to produce. So sustaining that investment in 
strong surveillance around the world including newer approaches 
here at home with more samples coming in of the minority 
strains that we have and then sequence first so we get the 
information right that is actionable.
    I did just want to say that that issue of will people even 
want to get vaccinated after the year that we had last year? We 
have been investing in communication research to really 
understand what is going on in people's minds, what are their 
attitudes so that we can sustain better and better immunization 
coverage going forward.
    Mr. Green. OK, anybody else have----
    Dr. Robinson. Yes, sir. We have had the mantra for a number 
of years of more and better vaccines sooner. We built capacity 
in the United States to have more. We are working on getting it 
made sooner. We are making it with new technologies and not 
just for cell- and recombinant but also even for egg-based to 
make those actually be made faster. That better part, actually 
more effective and efficacious vaccines is the one that NIH, 
Dr. Heilman and we are working on to actually address the 
problem of it being not 23 percent, but 75, 80 percent every 
year, year in and year out. That is our goal. We may never be 
able to attain it, but it is what we want to do and that is why 
the universal flu vaccine initiative that we work on and to be 
able to have funding to go forward with that, not just for one 
year, but multiple years, because that may take a long time to 
get there. But it will be the ultimate answer to this.
    Dr. Heilman. I just want to thank you for your support of 
NIH and your recognition that research is really a foundation 
point for which to move forward on. And I think as Robin and 
Anne and Karen can attest to, you know, the ability for us all 
to get together to work on a common goal, we each have a 
contribution to this. So even though the things that we do are 
kind of a little bit more downstream, upstream, you know, it 
really does impact the opportunities for not just next season, 
but for seasons afterwards. We constantly want to evolve and 
improve whatever we are doing, so appreciation for the 
recognition that research has.
    Mr. Green. I am almost out of time. Previously, in our 
committee both the Oversight and Investigations and our Health 
Subcommittee over the years, we were actually concerned about 
enough flu vaccines. I know a few years ago, there was a 
shortage early on. But again, it is hard. If we are going to 
continue vaccinate folks and say oh, I don't want one because 
it is not effective and I will get a sore arm anyway or 
something like that, we don't want to give people a reason 
because again for the elderly and for the disabled, the flu 
vaccine is so important because their immune systems are 
already challenged and we need to make sure it is as effective 
as we can.
    Mr. Chairman, I thank you. And thank you for calling the 
hearing today.
    Mr. Murphy. Thank you. Now I will recognize Mr. Mullin of 
Oklahoma for 5 minutes.
    Mr. Mullin. Thank you, Mr. Chairman. Thank you for holding 
this. I have to admit I am one of those people that I am not 
sure if I have ever received a flu vaccine and however, there 
are a lot of people that are very consistent on getting one and 
I understand the importance of it. But I am concerned with the 
stockpiles that we have had.
    Dr. Robinson, you have said in your opening testimony and 
the effort to stockpile the vaccines against a flu outbreak, 
but at the same time we also know that the flu changes 
constantly. And so for stockpiling it, how are we testing it? 
How are we knowing that what we are going to send out is 
actually going to be effective because we have already had one 
case, actually several cases that the vaccine that we sent out 
wasn't actually the one that we needed to target.
    Is there something we can help you with? Is there a way 
that you are testing? Can you help me understand that a little 
bit?
    Dr. Robinson. Thank you for the question. It is very 
appropriate because I want to explain that the vaccine that we 
stockpile is what we call pre-pandemic vaccines for viruses 
that potentially could cause a pandemic, like the avian 
influenza H5N1, the H7N9 viruses. For example, the H5N1 viruses 
appeared in 1998. We thought we got rid of them and they 
reappeared in 2003 and we still see cases and they spread from 
Southeast Asia across Asia into the Middle East and Europe.
    We are always watching those viruses and we actually do a 
periodic risk assessment with our colleagues across the board 
here with CDC, FDA, NIH, and others in the Department and with 
experts across the world in which we look at that risk 
assessment to say is this virus still something to worry about? 
And so the stockpiles that we have, we actually made--every day 
that we have those stockpiles, they break a record. Usually we 
think that the flu vaccines you can only keep them around for 
about 12 months, maybe 18 months. Some of these are 8 and 9 
years old. The potency of those vaccines is still very high.
    Mr. Mullin. How often do you test? Do you do a random test?
    Dr. Robinson. No, we actually test every 3 months.
    Mr. Mullin. All?
    Dr. Robinson. All the lots that we have and----
    Mr. Mullin. Every 3 months?
    Dr. Robinson. Every 3 months. And now we are actually 
testing those in the clinic to actually answer the question to 
say a vaccine that has been around for 8 years versus one that 
is newly made, when we put those into people do they get the 
same immune response and just as important, do they well 
tolerate the vaccine.
    Mr. Mullin. So while we are looking at stockpiling for 
potential outbreaks, does that hurt us actually being able to 
manufacture enough of the current flu outbreak? Because we seem 
like we have shortages constantly.
    Dr. Robinson. The time in which the manufacturers make 
these vaccines is when they are not making seasonal influenza 
vaccines. So it does not impact the ability for them to make 
their capacity for seasonal flu.
    Mr. Mullin. Dr. Schuchat, did I say that right? OK, and I 
apologize. We have been hearing from doctors back in Oklahoma 
that they are having a hard time getting the vaccine, 
especially for children right now. And so we contacted the 
Oklahoma Health Department and they said there was a shortage, 
that they were having a hard time getting a hold of it. Are you 
familiar with this?
    Dr. Schuchat. You know, the flu vaccine distribution so far 
this year is quite good with 133 million influenza vaccine 
doses shipped around the country so far. But we do know that a 
couple of the companies have had some limited or delayed 
production of one or two of the pediatric formulations. It is 
still a lot of vaccine that is out there, but there may be some 
particular practices that don't have all the pediatric vaccine 
they want.
    We also learned that there are some States that the way 
that they handle the vaccine for children vaccine that CDC buys 
and it is shipped to central distributors and managed by the 
States, that there are probably more efficient ways for them to 
allocate the vaccines to the pediatricians and their 
communities. So CDC and the Association of Immunization 
Managers are working with the State health departments to 
really try to make sure we are streamlining those distributions 
so that the docs are getting the product when they need them.
    Mr. Mullin. How often do you look at the product to say do 
we need to change it or not? And the reason why I say this is 
because my Larra, my 7-year-old daughter who was 6 at the time, 
last year she got two different strains of the flu.
    Dr. Schuchat. I am so sorry.
    Mr. Mullin. She got the shot. The first one she got and she 
still got it. The second one they said there wasn't a vaccine 
for it yet.
    Dr. Schuchat. OK, well one thing I can say is that we do 
vaccine effectiveness studies every year to see how well the 
vaccine is performing. You know the vaccines are often changed 
each year and people get vaccinated every year. And we have a 
network that is studying how well the vaccines actually protect 
people. We have expanded that network and we have increased how 
intensively they are working so we can get information sooner.
    Last year, we were able to present interim results in 
January, the earliest ever, to know how the products were 
working.
    Mr. Mullin. Dr. Schuchat, thank you so much. And Dr. 
Robinson, appreciate your insight on that. I yield back.
    Mr. Murphy. Can I ask a follow-up question to what Mr. 
Mullin has asked? In terms of stockpiles, Dr. Robinson, what 
are the size of these stockpiles? Are they thousands, tens of 
thousands, millions?
    Dr. Robinson. For H5N1s, we have tens of millions of doses 
and for H7N9, we have millions of doses.
    Mr. Murphy. It is just the two areas you have?
    Dr. Robinson. Those are the two viruses. For H5N1, we have 
four different strains of H5N1 viruses represented in that 
stockpile and for H7N9 we have one strain.
    Mr. Murphy. And you were saying they are effective for 8 
years so far?
    Dr. Robinson. So far for the H5N1 vaccines, the potency is 
still very high for those stockpiles.
    Mr. Murphy. And you are holding on to those that if it 
erupts again, you are ready to go?
    Dr. Robinson. So far, we don't have to throw them away. We 
can still use them and we can use with adjuvants to provide 
greater cross protection against even new H5N1 virus.
    Mr. Murphy. OK. Thank you. Mrs. Brooks, you are recognized 
for 5 minutes.
    Mrs. Brooks. Thank you, Mr. Chairman. And thank you for 
holding and highlighting this important issue. The hearing 
though is a reminder that public health threats like influenza 
are also threats and can be threats to our national security. 
The same issues we saw with last year's seasonal flu drifting 
and mismatched strains can happen with other influenza strains 
that can cause even deadlier pandemics. And obviously, the 
pandemic we experienced in 2009 with the H1N1 killed, as I have 
been told, 18,000 Americans and most people don't realize that. 
And if we think about that, we weren't prepared for that threat 
then and thousands of Americans lost their lives.
    I am very proud to be working on some bipartisan 
legislation with my colleague, Congresswoman Eshoo, who has 
been a leader in this space, and other colleagues on this 
committee to improve our biodefense enterprise.
    H.R. 3299, the Strengthening Public Health Emergency 
Response Act, would improve the medical countermeasure 
development process, would provide new incentives for the 
development of these live-saving countermeasures and would 
strengthen our public health response capabilities.
    And so, Dr. Robinson, in part because of this legislation, 
my questions are going to be directed primarily to you because 
obviously, it is the job of Congress to ensure that BARDA is 
doing, and I thank you, all of you for your work, but BARDA is 
doing everything it can to develop those medical 
countermeasures as quickly and as effectively as possible for 
pandemic outbreaks, and in the spirit of the focus today for 
pandemic influenza.
    But I am going to ask you and maybe because I am a lawyer, 
I have some very specific questions I would like your answers 
to and I understand we have a former colleague on the 
committee, Congressman Dingell. A series of simple yes or no 
questions. I would like to ask you because they are relevant to 
the types of issues that we have identified in H.R. 3299. And 
if you wouldn't mind just giving me a yes or no and we can get 
into further discussion a bit later.
    Do you believe that additional incentives are needed to get 
the private sector more involved in this risky, time-consuming, 
and costly endeavor of developing medical countermeasures?
    Dr. Robinson. Yes.
    Mrs. Brooks. Thank you. Do you believe that the creation of 
the priority review voucher limited to the 12 material threats 
identified by the Department of Homeland Security already, 
would be a useful incentive to get the private sector 
interested in medical countermeasure development?
    Dr. Robinson. Yes.
    Mrs. Brooks. Did Congress give BARDA a unique national 
security mission, something no other agency in HHS has 
currently?
    Dr. Robinson. Yes.
    Mrs. Brooks. When Congress gave BARDA this unique mission, 
was BARDA also provided with unique contracting authority?
    Dr. Robinson. Originally, yes.
    Mrs. Brooks. And do you believe it would be helpful to 
further expedite the medical countermeasures contracting 
process, to expedite that contracting process?
    Dr. Robinson. We always look for ways to expedite.
    Mrs. Brooks. Thank you. And would it be helpful for you to 
have direct control over BARDA's advanced development and 
procurement contracts for medical countermeasures? Would that 
be helpful, yes or no?
    Dr. Robinson. It would be helpful, anything that we can do 
to expedite, yes.
    Mrs. Brooks. OK. Thank you. And I understand that it has 
changed over time from its origin from when BARDA was created, 
but that is the basis and part of what Congresswoman Eshoo and 
my work is designed to do. And I would really like to ask all 
of you and Governor Ridge and Senator Lieberman have just 
released this incredible report, multiple recommendations. Can 
you talk to us, starting with you Dr. Robinson, whatever time I 
have left, in what more we can be doing as a Government to 
build up a robust, domestic production capability?
    Dr. Robinson. Thank you for that question. I will answer 
briefly, but I can talk for hours on this.
    Mrs. Brooks. And we will at another time then.
    Dr. Robinson. At this point, we need to continue the 
mission that we set out to do and that is to go forward with 
the early development that NIH does and advanced development 
that BARDA does to actually have those products available, not 
just for man-made threats and pandemic influenza, but emerging 
infectious diseases which Ebola showed it could be either one.
    Secondly, where we can't stockpile, we need to do so. But 
in other instances, we need to have emergency response 
capabilities when we can't stockpile to actually have those 
available and have those capabilities of those technologies and 
many of those platform technologies going forward. We have made 
great strides with FDA being able to move us forward quickly 
and be able to have absolutely the regulatory capability to do 
that. I think we can do more though and they need to be funded 
to provide that capability going forward.
    Mrs. Brooks. Thank you. And thank you all very much for 
your work. I yield back.
    Mr. Murphy. The gentlelady yields back. I now recognize the 
gentleman from Virginia, Mr. Griffith, for 5 minutes.
    Mr. Griffith. Thank you very much, Mr. Chairman. In 2014, 
the Centers for Disease Control and Prevention Advisory 
Committee for Immunization Practices, ACIP, updated its adult 
vaccine schedule to recommend that older adults get a 
pneumococcal vaccine in conjunction with routine influenza 
immunization with a routine influenza immunization and a 
follow-up pneumococcal vaccine within 6 months.
    When the recommendations were published, primary care 
physicians expressed some concern about the logistics of these 
recommendations and about Medicare reimbursement. Since that 
time, the Centers for Medicare and Medicaid Services announced 
it would cover the second pneumococcal vaccine.
     Dr. Schuchat, can you update us on these new 
recommendations and what CDC has done to work with primary care 
physicians on addressing their concerns and confusion?
    Dr. Schuchat. Thank you so much. The pneumococcal conjugate 
vaccine that targets 13 types was recommended initially by ACIP 
for everybody 65 and over in addition to the earlier 
polysaccharide vaccine, the 23-valent type, that we also have 
recommended for everybody 65 and over.
    The summer of 2014--sorry, the summer of 2015, we updated 
those recommendations to simplify them because we had heard 
about the confusion that primary care physicians had and we 
changed them to make them simpler so that you get one 
pneumococcal conjugate vaccine when you turn 65 or later and 
the second one a year or more later.
    CMS does cover two doses of pneumococcal vaccines and it 
doesn't matter which one comes first, but we regularly 
recommend getting a conjugate first. It is very important for 
seniors who are often hospitalized and can die and it is 
particularly important in influenza season because pneumococcal 
pneumonia frequently follows flu. So we recommend everybody 65 
and over get an annual flu shot, and get an pneumococcal 
vaccine, the conjugate one, followed a year or more later by 
the 21-valent polysaccharide.
    Mr. Griffith. Also when ACIP makes its recommendations, 
does it consider how to ensure uptake is as efficient and 
streamlined as possible?
    Dr. Schuchat. It is a very important part of the 
recommendations. We have practitioners and public health 
experts who are members of the ACIP and we work closely with 
partners to implement the ACIP recommendations and make it 
easier for people to protect themselves and their families. So 
we work very closely with the American College of Physicians, 
the American Academy of Family Physicians and so forth to 
really make sure that it is easy to get a vaccine and to 
protect yourself and your family.
    Mr. Griffith. OK. According to the CDC's estimates, four in 
ten seniors are not vaccinated for pneumonia, meanwhile flu 
vaccination rates have not significantly increased for seniors 
in the last 15 years. How is CDC working with the internal 
medicine physicians and family physicians to improve 
vaccination rates among seniors and ensure seniors get the 
recommended flu and pneumococcal vaccines when appropriate?
    Dr. Schuchat. You know, one of the challenges with adults 
is that they still think vaccines are for kids and so both 
providers for adults, as well as adults themselves, often don't 
recognize that vaccines can be lifesaving for all of us.
    In addition to working with the clinical community, CDC 
works closely with the private sector and you know, everybody 
has seen pharmacies and chain stores really take up providing 
vaccines. There are now better insurance efforts that mean 
everybody has access to recommended vaccines with no copay, no 
deductible, as long as they are vaccinated in an in-network 
provide and there are public insurers that cover the vaccine.
    The good thing for 65-year-olds and over is that Medicare 
coverage is very good for the pneumococcal and the flu vaccine.
    Mr. Griffith. Well, I appreciate those answers. Appreciate 
you all being here.
    Mr. Chairman, I appreciate you holding this hearing and I 
would say that while I was not in the room and I apologize for 
that I was trying to do a couple of things at the same time. I 
was listening to some of the testimony earlier and I have some 
of the same concerns that Ms. DeGette has in regard to egg-
produced vaccines. So just note that she is not the only voice 
up here that is concerned about that issue.
    Mrs. Brooks. Would the gentleman yield the balance of his 
time?
    Mr. Griffith. Yes.
    Mrs. Brooks. Thank you. I have a very brief question, a 
follow-up question for Dr. Robinson. Can you share with me what 
is the status of the 2005 HHS pandemic preparedness plan and 
has it been updated since it was issued by Bush administration?
    Dr. Robinson. Yes, fortunately, the Department is in a very 
strident effort right now to update that. We expect that it 
will be available at the end of next summer. The entire 
Department represented here and others are actively working on 
that, using that pandemic plan and the National Strategic Plan 
as a base and then go forward with that and have combined a 
number of different efforts that have been going on for a 
number of years to funnel it towards that plan.
    Mrs. Brooks. Thank you. I yield back.
    Mr. Murphy. Ms. DeGette, I am going to re-recognize you for 
followup.
    Ms. DeGette. Thank you, Mr. Chairman. I don't really have 
questions. I just want to say that I recognize that we have 
come a long way and I appreciate the efforts of all of the 
agencies, but I am still concerned about some of the market 
forces that we had discussed during my questioning. I am 
concerned that those market forces are really keeping us stuck 
in some old ways of thinking, and I think that probably all of 
us would like to work with the agencies to figure out how to 
update that so that we can be in the 21st century. And that is 
my main goal.
    And Mr. Chairman, I really thank you for holding this 
hearing. I think it is something we should do every year about 
this same time. And I encourage all of you to continue your 
good work, both on the seasonal flu vaccinations and readiness 
and also on the longer-term issues around pandemic flu. Thank 
you, Mr. Chairman.
    Mr. Murphy. Thank you. I just have a followup to a couple 
of things that Mr. Griffith and Ms. Brooks said here. So when 
you are talking about seniors then is the vaccine less 
effective for seniors? And if so, why?
    Dr. Schuchat. Many vaccines are less effective in seniors 
than in younger people. The influenza vaccine is often less 
effective in seniors. There have been a lot of efforts to try 
to overcome that. We think about it as senescence of the immune 
system and it is particularly worse in the very elderly. So 
both influenza vaccines and pneumococcal vaccines work less 
well in the elderly than they work in younger populations. That 
said, getting vaccinated is the best way to protect yourself. 
And so we recommend everybody 65 and over be vaccinated against 
the pneumonia with the pneumococcal vaccines. And we recommend 
everybody, 6 months and over get an annual flu vaccination.
    Mr. Murphy. So finally, I would ask each person is the flu 
vaccine less effective against H3N2 flu strain compared to 
other strains targeted by the vaccine? Does anybody have any 
comments on that?
    Dr. Schuchat. The review of vaccine effectiveness data from 
the past decade provides us some clues that on average the 
vaccines that we are using are less effective against the H3N2 
strains, even in years where there is a reasonably good match. 
On the other hand, we still see efficacy most years, not all, 
but most years and we strongly recommend people get vaccinated.
    At this time of year, we don't know what strain is going to 
dominate and how well the vaccine is going to work, but we do 
know that being vaccinated protects you substantially compared 
to not being vaccinated.
    Mr. Murphy. Thank you. Anyone else want to comment on that? 
Then let me also echo what some of the Members have said here, 
because these hearings have been going on for a decade. And we 
want to see that your agencies are updating also their 
scientific approach to this, not only trying to guess what the 
next nasty bug is going to be coming around, and trying to 
predict that, develop a vaccine, and find out that it mutates 
faster than we can manufacture them.
    But do we need different scientific designs on that?
    I hope that when we approach this again in the coming 
months, first of all, I hope that this is more accurate for 
this year's vaccine. We hope people get it. We hope people eat 
right, rest right, and exercise so the person won't work on a 
person that is weak and sickly anyways or less effective. But 
we want to be able to come back and say lessons learned, 
lessons applied much more effective and I thank you all for 
your testimony today. We really appreciate you being here 
today, and with that--I might want to add here that I ask 
unanimous that the correspondence between the committee and 
HHS, CDC, BARDA, NIH, as well as HHS's May 6th memorandum be 
introduced into the record.
    [The information appears at the conclusion of the hearing.]
    Mr. Murphy. And without objection, the documents be entered 
into the record.
    We ask also that, as you receive questions, you respond 
back to the committee quickly. Members have 10 business days to 
submit those questions to the record. And with that, I now 
adjourn this hearing. Thank you.
    [Whereupon, at 12:06 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

                 Prepared statement of Hon. Fred Upton

    Continuing our longstanding efforts on flu preparedness, 
today's discussion follows up our hearing last February that 
focused on a very harsh flu season with a mismatched vaccine 
that had an overall effectiveness of only 19 percent. Although 
the official statistics for last flu season are not available 
yet, in such a severe flu season, we would see up to 50,000 
deaths, more than 400,000 hospitalizations, and an economic 
burden of about $87 billion. I, like others on this 
subcommittee, expressed my belief at that February hearing that 
we can--and must--do better in addressing this major public 
health threat to protect folks in Michigan and across the 
country.
    Earlier this year, the World Health Organization (WHO) 
warned that flu strains have grown increasingly complex, and 
have been distributed broadly across the globe. This diversity 
and geographic distribution is unprecedented since the advent 
of modern tools for flu virus detection and analysis. Last 
year's poorly matched seasonal flu vaccine and the bird flu H5 
viruses that killed millions of birds in the Midwestern U.S. 
earlier this year are the most recent examples of this 
complexity. The WHO cautioned that the consequences of so many 
flu viruses emerging are ``unpredictable'' and ``potentially 
ominous.''
    Since the February hearing, our committee has been 
conducting bipartisan oversight into how to improve the U.S. 
public health response on seasonal flu and the adequacy of HHS 
efforts in monitoring the impacts of the bird flu outbreak. I 
am pleased to learn that Secretary Burwell and HHS leadership 
have made the response to seasonal flu vaccine mismatch a 
greater priority, and that HHS has been working throughout the 
year on various actions to improve seasonal flu preparedness. I 
look forward to discussing the details about these actions, and 
how they are expected to improve the response.
    Flu is a major public health challenge. The actions from 
HHS and its agencies are a good start. We recognize, however, 
that much work needs to be done. We will also be asking 
questions to make sure our preparedness efforts are addressing 
all potential problems and gaps. Our discussion today is aimed 
at being constructive, and detailing ways we can work with HHS 
to improve our flu response to save thousands of lives.
    I appreciate the hard work and dedication of the folks at 
HHS, the CDC, the FDA, BARDA, and the NIH on flu preparedness. 
I look forward to today's testimony, and continuing the work to 
improve the U.S. flu response. Our collective efforts are about 
keeping Americans healthy during the flu season. From babies 
who are 6 months old to the elderly, and everyone in between, 
folks in Michigan and across the country should have the peace 
of mind and faith that their flu shot will keep them healthy. 
Our bipartisan work continues.

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