[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]


                 FLU SEASON: U.S. PUBLIC HEALTH PREPAREDNESS 
                                 AND RESPONSE

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

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                               __________

                            DECEMBER 4, 2019

                               __________

                           Serial No. 116-80
                           
                           
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           


      Printed for the use of the Committee on Energy and Commerce

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                        energycommerce.house.gov
                        
                               __________
                               

                    U.S. GOVERNMENT PUBLISHING OFFICE                    
44-337 PDF                  WASHINGTON : 2021                     
          
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                    COMMITTEE ON ENERGY AND COMMERCE

                     FRANK PALLONE, Jr., New Jersey
                                 Chairman
BOBBY L. RUSH, Illinois              GREG WALDEN, Oregon
ANNA G. ESHOO, California              Ranking Member
ELIOT L. ENGEL, New York             FRED UPTON, Michigan
DIANA DeGETTE, Colorado              JOHN SHIMKUS, Illinois
MIKE DOYLE, Pennsylvania             MICHAEL C. BURGESS, Texas
JAN 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                BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland           PETE OLSON, Texas
JERRY McNERNEY, California           DAVID B. McKINLEY, West Virginia
PETER WELCH, Vermont                 ADAM KINZINGER, Illinois
BEN RAY LUJAN, New Mexico            H. MORGAN GRIFFITH, Virginia
PAUL TONKO, New York                 GUS M. BILIRAKIS, Florida
YVETTE D. CLARKE, New York, Vice     BILL JOHNSON, Ohio
    Chair                            BILLY LONG, Missouri
DAVID LOEBSACK, Iowa                 LARRY BUCSHON, Indiana
KURT SCHRADER, Oregon                BILL FLORES, Texas
JOSEPH P. KENNEDY III,               SUSAN W. BROOKS, Indiana
    Massachusetts                    MARKWAYNE MULLIN, Oklahoma
TONY CARDENAS, California            RICHARD HUDSON, North Carolina
RAUL RUIZ, California                TIM WALBERG, Michigan
SCOTT H. PETERS, California          EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan             JEFF DUNCAN, South Carolina
MARC A. VEASEY, Texas                GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
A. DONALD McEACHIN, Virginia
LISA BLUNT ROCHESTER, Delaware
DARREN SOTO, Florida
TOM O'HALLERAN, Arizona
                                 ------                                

                           Professional Staff

                   JEFFREY C. CARROLL, Staff Director
                TIFFANY GUARASCIO, Deputy Staff Director
                MIKE BLOOMQUIST, Minority Staff Director
              Subcommittee on Oversight and Investigations

                        DIANA DeGETTE, Colorado
                                  Chair
JAN SCHAKOWSKY, Illinois             BRETT GUTHRIE, Kentucky
JOSEPH P. KENNEDY III,                 Ranking Member
    Massachusetts, Vice Chair        MICHAEL C. BURGESS, Texas
RAUL RUIZ, California                DAVID B. McKINLEY, West Virginia
ANN M. KUSTER, New Hampshire         H. MORGAN GRIFFITH, Virginia
KATHY CASTOR, Florida                SUSAN W. BROOKS, Indiana
JOHN P. SARBANES, Maryland           MARKWAYNE MULLIN, Oklahoma
PAUL TONKO, New York                 JEFF DUNCAN, South Carolina
YVETTE D. CLARKE, New York           GREG WALDEN, Oregon (ex officio)
SCOTT H. PETERS, California
FRANK PALLONE, Jr., New Jersey (ex 
    officio)
                             
                             
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................     1
    Prepared statement...........................................     3
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     4
    Prepared statement...........................................     5
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     7
    Prepared statement...........................................     8
Hon. Brett Guthrie, a Representative in Congress from the 
  Commonwealth of Kentucky, opening statement....................     9
    Prepared statement...........................................    11

                               Witnesses

Nancy Messonnier, M.D., Director, National Center for 
  Immunization and Respiratory Diseases, Centers for Disease 
  Control and Prevention, Department of Health and Human Services    13
    Prepared statement...........................................    15
    Answers to submitted questions...............................    98
Anthony S. Fauci, M.D., Director, National Institute for Allergy 
  and Infectious Diseases, National Institutes of Health.........    22
    Prepared statement...........................................    24
    Slide presentation...........................................    33
    Answers to submitted questions...............................   104
Robert P. Kadlec, M.D., Assistant Secretary for Preparedness and 
  Response, Department of Health and Human Services..............    44
    Prepared statement...........................................    46
    Answers to submitted questions...............................   109
Peter Marks, M.D., Director, Center for Biologics Evaluation and 
  Research, Food and Drug Administration, Department of Health 
  and Human Services.............................................    56
    Prepared statement...........................................    58
    Answers to submitted questions...............................   118

                           Submitted Material

Report, ``Investigation of Respiratory Illness in U.S. Border 
  Patrol Facilities,'' December 2018 to January 2019, Centers for 
  Disease Control, submitted by Mr. Ruiz.........................    88

 
        FLU SEASON: U.S. PUBLIC HEALTH PREPAREDNESS AND RESPONSE

                              ----------                              


                      WEDNESDAY, DECEMBER 4, 2019

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:30 a.m., in 
the John D. Dingell Room 2123, Rayburn House Office Building, 
Hon. Diana DeGette (chair of the subcommittee) presiding.
    Members present: Representatives DeGette, Kennedy, Ruiz, 
Kuster, Castor, Tonko, Clarke, Peters, Pallone (ex officio), 
Guthrie (subcommittee ranking member), Burgess, McKinley, 
Griffith, Brooks, Mullin, Duncan, and Walden (ex officio).
    Staff present: Kevin Barstow, Chief Oversight Counsel; 
Jesseca Boyer, Professional Staff Member; Jeffrey C. Carroll, 
Staff Director; Austin Flack, Staff Assistant; Waverly Gordon, 
Deputy Chief Counsel; Tiffany Guarascio, Deputy Staff Director; 
Zach Kahan, Outreach and Member Service Coordinator; Chris 
Knauer, Oversight Staff Director; Meghan Mullon, Staff 
Assistant; Tim Robinson, Chief Counsel; Nikki Roy, Policy 
Coordinator; Emily Ryan, GAO Detailee; Andrew Souvall, Director 
of Communications, Outreach and Member Services; Benjamin 
Tabor, Policy Analyst; C.J. Young, Press Secretary; Jen 
Barblan, Minority Chief Counsel, Oversight and Investigations; 
Brittany Havens, Minority Professional Staff Member, Oversight 
and Investigations; Brannon Rains, Minority Legislative Clerk; 
Alan Slobodin, Minority Chief Investigative Counsel, Oversight 
and Investigations; and Natalie Sohn, Minority Counsel, 
Oversight and Investigations.
    Ms. DeGette. The Subcommittee on Oversight and 
Investigations hearing will now come to order.
    Today, the committee is holding a hearing entitled ``Flu 
Season: U.S. Public Health Preparedness and Response.'' The 
purpose of today's hearing is to examine the Federal 
Government's efforts and forecast for the 2019-2020 influenza 
season and ongoing influenza-related research and innovation.
    The Chair now recognizes herself for purposes of an opening 
statement.

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

    As I said, we're here this morning to discuss the topic of 
our Nation's preparedness for this year's flu season. Ensuring 
our public health agencies have the tools they need to prepare 
and respond to seasonal and pandemic flu has and will remain a 
bipartisan effort. That's why this is the 11th hearing the 
committee has held related to influenza over the last 15 years. 
And I'm very pleased that we are having this hearing so early 
at the beginning of the flu season this year so we can talk 
about what we predict during this flu season and also encourage 
Americans to please, please, please go get their vaccinations.
    According to the CDC, a majority of States are already 
seeing increased flu activity, and history has shown that we're 
still likely weeks away from the first peak of the season that 
often occurs December through February.
    Today, we have the Nation's leading health experts about 
how people can better protect themselves and their children 
from this illness before peak flu season. And I want to thank 
all of our witnesses for being willing to come here year after 
year to address this important topic. I really feel like we're 
getting the band back together again in a way that I hope will 
be effective to let Americans know what's happening.
    You know, we know from past flu seasons that our Nation's 
preparation and response efforts are critical. During the 
particularly severe 2017 and 2018 flu season, for example, as 
many as 80,000 people died as a result of the flu. So many 
people became sick that hospitals were forced to put tents in 
parking lots to treat people who had become ill.
    The more recent 2018-2019 flu season was the longest one in 
a decade. And again, while it's still too early to tell how 
severe this year's flu season will be, given the 
unpredictability and serious nature we face, the fact that our 
Nation's flu vaccination rates continue to be well below our 
national target of 70 to 90 percent is alarming.
    Last year, for example, only 63 percent of children and 
only 45 percent of adults received a flu vaccine. While those 
rates are disappointing, the fact that they are 5 to 8 points 
higher, respectively, compared to the year before means at 
least we're going in the right direction. But we have a lot 
more to do to protect the public health. I hope that the 
witnesses today can provide us an update on the efforts 
underway to further strengthen vaccine confidence and improve 
the annual vaccination rates.
    I also look forward to hearing from the witnesses about the 
effectiveness of the flu vaccine and what research is underway 
to improve its efficacy. While last year's vaccine was up to 44 
percent effective against the H1N1 flu strain, which was the 
initial flu strain that was circulating, it was only 9 percent 
effective for the H3N2 strain, which became the dominant strain 
at the end of the season.
    And I know our witnesses will remind us, even a vaccine 
with low effectiveness is still able to protect millions of 
people from getting sick and help reduce the severity of 
symptoms for those who do. And that's why the flu vaccine 
remains the best tool we have to protect the public's health 
during these threatening times. But as I've said numerous times 
before, we can and will do better to improve the effectiveness.
    The NIH recently began conducting the first in-human trials 
for a universal flu vaccine--and I'm really looking forward to 
hearing about that--and the National Influenza Vaccine Task 
Force was recently established. These developments are 
promising, but the importance of a strong public health 
infrastructure necessary to prepare for and respond to seasonal 
flu cannot be overstated.
    I have confidence that our Federal, State, and local public 
health officials have put us in a strong position to respond to 
this year's flu season, but there's always more work to be 
done. And I'm looking forward to hearing from our witnesses 
about just what kind of work we can do.
    Another issue I know that many people will be raising is 
the issue of producing flu vaccine here domestically in the 
United States, because, God forbid, we have another flu 
pandemic, we want to make sure that we can protect our own 
people.
    And so, again, I'm thankful that we have such a 
distinguished panel today. I understand that you've brought 
slides, so we will not be disappointed. It's our job to--that 
you have the tools and the resources to remain on the cutting 
edge of science, and I hope today that you can tell us what you 
need going forward.
    [The prepared statement of Ms. DeGette follows:]

                Prepared Statement of Hon. Diana DeGette

    We are here this morning to discuss the topic of our 
Nation's preparedness for this year's flu season.
    Ensuring our public health agencies have the tools they 
need to prepare and respond to seasonal and pandemic flu has, 
and should remain, a bipartisan effort. That's why this is the 
11th hearing this committee has held related to influenza over 
the past 15 years.
    Today, we continue the committee's long history in 
addressing this critical public health issue.
    With the 2019-2020 flu season well underway, I thought it 
necessary to hold this hearing earlier than we have in past 
years.
    According to the CDC, a majority of States are already 
seeing increasing flu activity. And, history has shown us that 
we are likely still weeks away from the first peak of the 
season that often occurs December through February.
    Today, we are going to hear from the Nation's leading 
health experts about how people can better protect themselves 
and their children from this illness before peak flu season.
    We will also hear more about the forecast for this season, 
as well as the efforts that are underway across the Federal 
Government to respond as flu activity increases.
    We know from past flu seasons that our Nation's preparation 
and response efforts are critical.
    During the particularly severe 2017-2018 flu season, for 
instance, as many as 80,000 people died as a result of the flu. 
So many people became sick that some hospitals were forced to 
pitch tents in parking lots to treat those who had become ill.
    The more recent 2018-2019 flu season was the longest in a 
decade. And, while it is still too early to know exactly how 
severe this year's flu season will be, given the 
unpredictability and serious danger we face, the fact that our 
Nation's flu vaccination rates continue to be well below our 
national targets of 70 to 90 percent is highly alarming.
    Last year, for example, only 63 percent of children, and 
just 45 percent of adults, received a flu vaccine. While those 
overall rates continue to be disappointing, the fact that they 
are 5 and 8 points higher, respectively, compared to the year 
before--they are, at least, moving in the right direction.
    But we still have much more work to do to protect the 
public's health.
    I am hoping that our witnesses today can provide us an 
update on the efforts underway to further strengthen vaccine 
confidence and improve these annual vaccination rates.
    I also look forward to updates from our witnesses about the 
effectiveness of the flu vaccine, as well as what research is 
underway to improve its efficacy.
    While last year's vaccine was up to 44 percent effective 
against the H1N1 flu strain, which was the initial flu strain 
that was circulating, it was only 9 percent effective for the 
H3N2 strain, which became the dominant strain at the end of 
season.
    As I am sure our witnesses will remind us, even a vaccine 
with low effectiveness is still able to protect millions of 
people from getting sick and help reduce the severity of 
symptoms for those who do. And that's why the flu vaccine 
remains the best tool we have to protect the public's health 
during these threatening times.
    But, as I have said numerous times before, we can and must 
do more to improve our vaccines' effectiveness. The NIH 
recently began conducting the first in-human trials for a 
universal flu vaccine, and the National Influenza Vaccine Task 
Force was recently established.
    While these are certainly promising, the importance of a 
strong public health infrastructure necessary to prepare for, 
and respond to, seasonal flu cannot be overstated.
    I have confidence that our Federal, State, and local public 
health experts have put us in a strong position to respond this 
year's flu season, but there is always more work to be done--
and there are always things we can improve. I am looking 
forward to hearing from our experts today on what they believe 
we still need to do to make our national preparedness even 
stronger than it currently is.
    I'm thankful that we have such a distinguished panel of 
experts across Federal agencies here before us today. The 
Nation is fortunate to have your talent on the frontlines in 
the ongoing fight against influenza and other infectious 
diseases.
    It's our job to ensure that you have the tools and 
resources you need to remain on the cutting edge of science, 
and I hope today you can tell us what you need going forward.

    Ms. DeGette. With that, I am pleased, filling in in the 
ranking position is the ranker on the full committee today, Mr. 
Walden, for 5 minutes.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Well, thank you, Chair DeGette, we appreciate 
the hearing today. As you've said, this is a longstanding 
bipartisan tradition of this committee to check in ahead of flu 
season and find out where we stand and continue to support 
innovation in this space and other medical device space and 
prescription drug space and the whole thing. When we're trying 
to find cures for diseases, we're all on board.
    So, every year, millions of Americans put themselves at an 
increased risk of getting the flu because they don't get the 
flu vaccine. Just for the record, I have. I'm not a big guy on 
shots, but--you know, I do it every year, and I'm glad I do--
people who don't, though, are increasing the risk for the 
individuals who cannot be vaccinated, including young children 
who are not old enough to get the flu vaccine, will get the 
flu. So if you've not gotten the flu vaccine yet this year--I 
spent a night or two in a Holiday Inn, so I'm going to play 
doctor here--go get the flu vaccine. If they shouldn't, I'll 
let our panel of real, live doctors counter me on that, but I 
think that would be your counsel to all of us as well.
    If you think you may have the flu, please go see your 
doctor. There are antivirals available to reduce the symptoms 
you experience with the flu and shorten the duration of the 
flu. Great advances there.
    Our senior citizens are the group at greatest risk of 
serious flu-related complications. According to the Centers for 
Disease Control and Prevention, people 65 years of age and 
older account for about 70 to 85 percent of seasonal flu-
related deaths in recent years, and between 50 to 70 percent of 
seasonal flu-related hospitalizations. Seniors can get the 
regular flu shot or one of the two flu shots that are 
specifically designed for people 65 years of age or older--the 
high-dose flu vaccine and the adjuvanted--I'll get that--flu 
vaccine.
    I, along with some of my fellow Republican members of the 
committee, sent a letter to the director of the CDC last 
February about improving flu vaccination coverage for seniors. 
We asked whether a preferential recommendation from CDC's 
Advisory Committee on Immunization Practices, ACIP, for 
vaccinating adults 65 years of age and older with a high dose 
or an adjuvanted influenza vaccine could reduce deaths and 
hospitalizations or even improve vaccination coverage. CDC told 
us they did not believe that there was adequate information on 
these vaccines to rise to a level of ACIP making a preferential 
recommendation.
    Given what appears to be substantial evidence 
substantiating superior effectiveness for seniors with each of 
these alternatives compared to the standard-dose flu vaccine, 
and the preferential recommendations from other respected 
foreign health authorities for one of these alternatives, I do 
want to explore the reasons for CDC's hesitancy about 
supporting preferential recommendation when it appears there's 
real reason to believe it could help save lives.
    I'm also looking forward to hearing more about research 
efforts to improve the flu vaccine and hopefully develop a 
universal flu vaccine. A universal flu vaccine would provide 
long-lasting protection against multiple seasonal and pandemic 
flu viruses, and I expect Dr. Fauci will update us on HHS' 
progress in implementing the strategic plan for a universal 
influenza vaccine that was first published in February of 2018.
    Now, the President's recent Executive order promotes the 
development of better flu vaccines, and I support its emphasis 
on the need to modernize the manufacturing process for the flu 
vaccine. The current egg-based manufacturing process that's 
used for most flu vaccine doses administered in the United 
States takes about 22 to 24 weeks to produce the flu vaccine.
    Earlier this year, advisers at the World Health 
Organization delayed their recommendations for the H3N2 vaccine 
strain to include in the flu vaccine this year by a month. And 
there were considerable concerns that that delay might 
adversely affect the vaccine supply at the beginning of this 
season. Thankfully, the delay did not impact the supply.
    So I look forward to today's discussion. I hope to hear 
more about faster and more scalable manufacturing platforms, 
the role of antiviral drugs to mitigate the severity of the 
flu, and the concern over possible drug-resistant flu strains.
    [The prepared statement of Mr. Walden follows:]

                 Prepared Statement of Hon. Greg Walden

    Chair DeGette, thank you for having this hearing as we 
enter what typically is peak flu season.
    Every year, millions of Americans put themselves at an 
increased risk of getting the flu because they do not get the 
flu vaccine. They also are increasing the risk that individuals 
who cannot be vaccinated, including young children who are not 
old enough to get the flu vaccine, will get the flu. If you 
have not gotten the flu vaccine yet this year, please go get it 
today.
    If you think you may have the flu, please go see your 
doctor. There are antivirals available to reduce the symptoms 
you experience with the flu and shorten the duration of the 
flu.
    Our senior citizens are the group at greatest risk of 
serious flu-related complications. According to the Centers for 
Disease Control and Prevention, people 65 years and older 
account for about 70 to 85 percent of seasonal flu-related 
deaths in recent years and between 50 to 70 percent of 
seasonal-flu related hospitalizations.
    Seniors can get the regular flu shot or one of two flu 
shots that are specifically designed for people 65 years and 
older--the high dose flu vaccine and the adjuvanted flu 
vaccine. I, along with some of my fellow Republican members on 
the Committee, sent a letter to the Director of the CDC last 
February about improving flu vaccination coverage for seniors.
    We asked whether a preferential recommendation from CDC's 
Advisory Committee on Immunization Practices (ACIP) for 
vaccinating adults 65 years of age and older with a high-dose 
or an adjuvanted influenza vaccine could reduce deaths and 
hospitalizations or even improve vaccination coverage. The CDC 
told us that they did not believe that there was adequate 
information on these vaccines to rise to a level of ACIP making 
a preferential recommendation.
    Given what appears to be substantial evidence 
substantiating superior effectiveness for seniors with each of 
these alternatives compared to the standard dose flu vaccine 
and the preferential recommendations from other respected 
foreign health authorities for one of these alternatives, I 
want to explore the reasons for CDC's hesitancy about 
supporting a preferential recommendation when there is reason 
to believe it could help save lives.
    I am also looking forward to hearing more about research 
efforts to improve the flu vaccine and hopefully develop a 
universal flu vaccine. A universal flu vaccine would provide 
long-lasting protection against multiple seasonal and pandemic 
flu viruses, and I expect Dr. Fauci will update us on HHS' 
progress in implementing the Strategic Plan for a Universal 
Influenza Vaccine that was published in February 2018.
    The President's recent Executive Order promotes the 
development of better flu vaccines, and I support its emphasis 
on the need to modernize the manufacturing process for the flu 
vaccine. The current egg-based manufacturing process that is 
used for most flu vaccine doses administered in the United 
States takes about 22 to 24 weeks to produce the flu vaccine. 
Earlier this year, advisors at the World Health Organization 
(WHO) delayed their recommendation for the H3N2 vaccine strain 
to include in the flu vaccine this year by a month, and there 
were concerns that this delay might affect the vaccine supply 
at the beginning of this season. Thankfully, the delay did not 
impact supply.
    I look forward to today's discussion and hope to hear more 
about faster and more scalable manufacturing platforms, the 
role of antiviral drugs to mitigate the severity of flu, and 
the concern over possible drug-resistant flu strains. I want to 
thank all the witnesses for being here today. I greatly 
appreciate all your hard work and commitment to protecting 
public health.

    Mr. Walden. With that, I would yield the balance of my time 
to the gentlelady from Indiana, Mrs. Brooks.
    Mrs. Brooks. Thank you, Mr. Walden.
    It's been over a hundred years since the 1918 pandemic flu 
killed millions of people around the world, and actually, 
675,000 Americans lost their lives then. Last flu season--and I 
think most people don't realize--61,000 Americans lost their 
lives, including a hundred Hoosiers.
    Although the development of vaccines and drugs is a 
challenging process, it is so important that we continue to 
take action to modernize our influenza vaccines in this 
country.
    Led by this committee, we passed PAHPA into law earlier 
this summer, the reauthorization of PAHPA. It established a 
pandemic influenza program as well as an emerging infectious 
disease program at BARDA to deal with known and unknown 
threats. The research funded by BARDA has already significantly 
expanded our domestic vaccine production capacity from the 
ability to produce just 60 million doses of antigen influenza 
to the ability to produce more than 600 million doses. And with 
PAHPA, it supports the increase of our manufacturing capacity 
and our stockpile medical countermeasures, but we have much 
work left to do.
    I want to thank all the incredible witnesses here today for 
your expertise. You and your teams are the ones that are going 
to ensure that our Nation is better prepared for pandemic flu. 
I look forward to hearing from our witnesses.
    I yield back.
    Mr. Walden. And I yield back.
    Ms. DeGette. The Chair now recognizes the chairman of the 
full committee, Mr. Pallone, for 5 minutes for purposes of an 
opening statement.

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

    Mr. Pallone. Thank you, Chairwoman DeGette.
    Every year, influenza causes millions of illnesses, 
hundreds of thousands of hospitalizations, and tens of 
thousands of deaths across the United States. Last year, more 
than a hundred children died as a result of this preventable 
and treatable disease, and while we're still in the early 
months of this year's flu season, it has already resulted in 
the deaths of five children.
    Today, we're continuing this committee's long history of 
examining flu preparedness and response, and I want to thank 
Chairwoman DeGette in particular because I know that she 
annually--pretty much annually--has these hearings because she 
thinks it's very important. And I do want to also thank our 
ranking member of the full committee, Mr. Walden, for pointing 
out, as an example, that he had his flu shot, and I had mine 
too, because I think we do have to serve as an example.
    The flu is one of the many preventable infectious diseases 
that threaten public health. We know that seasonal flu is 
particularly challenging to address. Flu viruses are mutating 
and changing constantly, and we do not yet have the ability to 
predict how severe flu season will be, when it will peak, or 
what flu strains will dominate. We also have a lot of questions 
about why the flu vaccine is more effective for some people and 
how someone's health status may affect the body's immune 
response.
    I've been encouraged by recent efforts at the National 
Institutes of Health to study these issues with the goal of 
producing a universal flu vaccine that is effective against a 
broader range of flu strains. I'm also encouraged by the 
ongoing research supported by the Biomedical Advanced Research 
and Development Authority, or BARDA, and the ongoing leadership 
in coordination among all of the agencies testifying before us 
today. These efforts are vitally important.
    While we wait for the results of this research, it's still 
critical that we continue to stress the importance of getting 
vaccinated every year. Thankfully, cost should no longer be a 
barrier for anyone to receive their annual flu vaccine. Thanks 
to the Affordable Care Act, flu and other immunizations are 
required to be covered by health insurance at no cost to the 
patient. The Vaccines for Children Program has also provided 
free vaccinations for eligible children for nearly 25 years.
    Annual flu vaccination is the best method for preventing 
flu and its potentially severe complications. This is true even 
when the flu vaccine is less effective for various strains. For 
example, during the 2017-2018 season, the effectiveness of that 
year's flu vaccine was estimated at 40 percent overall. Yet the 
Centers for Disease Control and Prevention estimated that it 
still prevented over 6 million illnesses, 91,000 
hospitalizations, and 5,700 deaths.
    Vaccinating yourself not only increases the odds that you 
won't get sick this season, but also protects everyone you come 
in contact with. And this is particularly important for those 
more vulnerable to the flu and its symptoms, such as people 
with chronic health conditions, older parents, or a baby niece 
or nephew.
    And all of this demonstrates the importance of getting a 
flu shot, but unfortunately, 55 percent of adults were not 
vaccinated against the flu last season. So I look forward to 
hearing from the CDC about its communications and outreach 
strategies to increase the rates in the future.
    And I know that one of the issues continues to be public 
confidence in vaccines, but it's critical that we continue to 
get the word out that vaccines are safe. While harmful 
misinformation campaigns continue to proliferate online and in 
communities across the country, the agencies must continue to 
spread the message of vaccine safety. And we also have to 
continue to improve our vaccine manufacturing process to make 
flu vaccines even more effective and our ability to treat 
patients if they do come down with the flu.
    So again, I thank our witnesses for joining us, for the 
critical leadership role your agencies play in our Nation's flu 
preparedness and response efforts. And again, thank you, 
Chairwoman DeGette.
    I yield back.
    [The prepared statement of Mr. Pallone follows:]

             Prepared Statement of Hon. Frank Pallone, Jr.

    Every year, Influenza causes millions of illnesses, 
hundreds of thousands of hospitalizations, and tens of 
thousands of deaths across the United States. Last year, more 
than 100 children died as a result of this preventable and 
treatable disease. And while we are still in the early months 
of this year's flu season, it has already resulted in the 
deaths of five children.
    Today, we are continuing this committee's long history of 
examining flu preparedness and response. The flu is one of many 
preventable infectious diseases that threaten public health.
    We know that seasonal flu is particularly challenging to 
address. Flu viruses are mutating and changing constantly, and 
we do not yet have the ability to predict how severe a flu 
season will be, when it will peak, or what flu strains will 
dominate.
    We also still have a lot of questions about why the flu 
vaccine is more effective for some people, and how someone's 
health status may affect the body's immune response.
    I have been encouraged by recent efforts at the National 
Institutes of Health (NIH) to study these issues, with the goal 
of producing a universal flu vaccine that is effective against 
a broader range of flu strains. I am also encouraged by the 
ongoing research supported by the Biomedical Advanced Research 
and Development Authority, or BARDA, and the ongoing leadership 
and coordination among all of the agencies testifying before us 
today.
    These efforts are vitally important. While we wait for the 
results of this research, it is critical that we continue to 
stress the importance of getting vaccinated every year.
    Thankfully, cost should no longer be a barrier for anyone 
to receive their annual flu vaccine. Thanks to the Affordable 
Care Act, flu and other immunizations are required to be 
covered by health insurance at no cost to the patient. The 
Vaccines for Children Program has also been providing free 
vaccinations for eligible children for nearly 25 years.
    Annual flu vaccination is the best method for preventing 
flu and its potentially severe complications.
    This is true even when the flu vaccine is less effective 
for various strains. For example, during the 2017-2018 season, 
the effectiveness of that year's flu vaccine was estimated at 
40 percent overall, yet the Centers for Disease Control and 
Prevention (CDC) estimated that it still prevented over 6 
million illnesses, 91,000 hospitalizations and 5,700 deaths.
    Vaccinating yourself not only increases the odds that you 
won't get sick this season, but it also protects everyone you 
come in contact with. This is particularly important for those 
more vulnerable to the flu and its symptoms, such as people 
with chronic health conditions, older parents, or a baby niece 
or nephew.
    All of this demonstrates the importance of getting a flu 
shot, but unfortunately 55 percent of adults were not 
vaccinated against the flu last season. I look forward to 
hearing from the CDC about its communication and outreach 
strategies to increase the rates in the future.
    I know that one of the issues continues to be public 
confidence in vaccines, but it's critical that we continue to 
get the word out that vaccines are safe. While harmful 
misinformation campaigns continue to proliferate online and in 
communities across the country, the agencies must continue to 
spread the message of vaccine safety.
    We must also continue to improve our vaccine manufacturing 
process to make flu vaccines even more effective, and our 
ability to treat patients if they do come down with the flu.
    I thank our witnesses for joining us today, and for the 
critical leadership role your agencies play in our Nation's flu 
preparedness and response efforts.

    Ms. DeGette. The gentleman yields back.
    The Chair now recognizes and welcomes the ranking member of 
the subcommittee, Mr. Guthrie, for 5 minutes.

 OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN 
           CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

    Mr. Guthrie. Thank you very much. Thank you, Chair DeGette, 
for holding this hearing on such an important issue.
    This committee has a long history of conducting oversight 
of the Federal Government's response to the seasonal flu. The 
flu is a leading cause of death in the United States. Thousands 
of Americans die from flu every year, and hundreds of thousands 
of Americans are hospitalized.
    Last flu season alone, the CDC estimates that up to 42.9 
million people got sick with the flu, up to 647,000 individuals 
were hospitalized, and up to 61,200 individuals died from the 
flu. Individuals 65 years and older accounted for 90 percent of 
the deaths and 70 percent of the hospitalizations for the 2017-
2018 flu season.
    In light of this tremendous burden on our seniors, in 
February of this year, I, along with Republican leaders Walden 
and Dr. Burgess, wrote to the CDC Director about whether the 
CDC is doing enough to improve flu vaccine coverage and to 
promote high-dose and adjuvanted flu vaccines. I practiced that 
word twice, and I still couldn't get it out.
    While we examine how to improve the response to seasonal 
flu, we know the best way to prevent getting the seasonal flu 
is to get vaccinated each season. If you have not already 
gotten your flu vaccine this season, please go get your flu 
vaccine today.
    Although the flu vaccine does not have the level of 
effectiveness of other well-known vaccines, it is absolutely 
better than doing nothing. The flu vaccine saves thousands of 
lives each year. The flu vaccine also helps reduce severe 
outcomes when someone does become sick with the flu.
    According to CDC data, about 80 percent of the flu 
associated with deaths in children have occurred in children 
who were not vaccinated. Moreover, a 2017 study showed that the 
flu vaccine also reduces severe outcomes in hospitalized 
patients.
    I have questions today on how we can continue to improve 
the flu vaccine. Preliminary CDC data shows that the seasonal 
flu vaccine was only 29 percent effective for the 2018-2019, 
the lowest it has been in a decade. For more than 70 years, 
most flu vaccines administered in the United States have been 
made through the egg-based manufacturing process. We have seen 
some innovation over the last decade, however, with the 
introduction of the new manufacturing technologies, using a 
cell or recombinant DNA technology. Most of the flu vaccine 
doses distributed in the United States are still manufactured 
using egg-based process.
    Indeed, the CDC estimates that about 82 percent of the 
projected vaccine supply produced for the 2019-2020 flu season 
will be produced using egg-based manufacturing technology, 
while the remaining vaccine will be produced using the cell-
based and recombinant technology.
    During the hearing on March 2018, Dr. Rick Bright, the HHS 
Deputy Secretary for Preparedness and Response, testified that 
we can improve the effectiveness of a vaccine in four ways: 
Expand domestic capacity for the cell-based and recombinant-
based technologies; enhance the effective use of flu vaccines 
with the addition of adjuvants or higher doses of antigen; 
conduct clinical trials to expand vaccine in all age groups; 
and continue to modernize the vaccine production processes for 
speed and flexibility.
    At that hearing, Dr. Bright noted that cell-based and 
recombinant-based technologies offer greater speed and 
flexibility than the traditional egg-based manufacturing 
process. And some studies have shown that they may also be more 
effective than egg-based vaccines.
    For these reasons, I was pleased to see the President make 
modernizing and improving influenza vaccines a top priority 
through his Executive order on September 19, 2019. Modernizing 
flu vaccines will help protect lives through prevention and 
promote public health and national security.
    Pandemic and seasonal flu are interdependent, and our 
approaches to seasonal and pandemic influenza are inextricably 
interwoven. What we do in one area directly impacts the other 
area. For example, when we expanded our domestic manufacturing 
capacity for pandemic response, manufacturers then also had the 
capacity to include an additional flu strain in the seasonal 
vaccine, moving from three-strain to four-strain seasonal 
vaccines for better coverage.
    I appreciate the administration's commitment to improving 
our flu preparedness. I welcome all of today's witnesses, and 
look forward to today's discussion about how we can keep 
Americans healthy during flu season and improve our Federal 
response to both pandemic and seasonal flu.
    And I yield back.
    [The prepared statement of Mr. Guthrie follows:]

                Prepared Statement of Hon. Brett Guthrie

    hank you, Chair DeGette, for holding this hearing on such 
an important issue. This committee has a long history of 
conducting oversight of the Federal Government's response to 
the seasonal flu.
    The flu is a leading cause of death in the United States. 
Thousands of Americans die from the flu every year, and 
hundreds of thousands of Americans are hospitalized. Last flu 
season alone, the CDC estimates that up to 42.9 million people 
got sick with the flu, up to 647,000 individuals were 
hospitalized, and up to 61,200 individuals died from the flu. 
Individuals 65 years and older accounted for 90 percent of the 
deaths and 70 percent of hospitalizations for the 2017-2018 flu 
season.
    In light of this tremendous burden on our seniors, in 
February of this year, I, along with Republican Leaders Walden 
and Dr. Burgess, wrote to the CDC Director about whether the 
CDC is doing enough to improve flu vaccine coverage and to 
promote high-dose and adjuvanted flu vaccines.
    While we examine how to improve the response to seasonal 
flu, we know the best way to prevent getting the seasonal flu 
is to get vaccinated each season. If you have not already 
gotten your flu vaccine this season, please go get your flu 
vaccine today.
    Although the flu vaccine does not have the level of 
effectiveness of other well-known vaccines, it is absolutely 
better than doing nothing. The flu vaccine saves thousands of 
lives each year. The flu vaccine also helps reduce severe 
outcomes when someone does become sick with the flu. According 
to CDC data, about 80 percent of flu-associated deaths in 
children have occurred in children who were not vaccinated. 
Moreover, a 2017 study showed that the flu vaccine also reduces 
severe outcomes in hospitalized patients.
    I have questions today on how we can continue to improve 
the flu vaccine. Preliminary CDC data shows that the seasonal 
flu vaccine was only 29 percent effective for the 2018-2019 flu 
season--the lowest it has been in a decade.
    For more than 70 years, most of the flu vaccines 
administered in the United States have been made through an 
egg-based manufacturing process. We have seen some innovation 
over the last decade, however, with the introduction of new 
manufacturing methodologies using a cell or recombinant DNA 
technology.
    Most of the flu vaccine doses distributed in the United 
States are still manufactured using the egg-based process. 
Indeed, the CDC estimates that about 82 percent of the 
projected vaccine supply produced for the 2019-2020 flu season 
will be produced using egg-based manufacturing technology while 
the remaining vaccine will be produced using cell-based and 
recombinant technology.
    During a hearing in March 2018, Dr. Rick Bright, the HHS 
Deputy Assistant Secretary for Preparedness Response, testified 
that we could improve the effectiveness of our existing 
vaccines in four ways:
    (1) Expand domestic capacity of the cell- and recombinant-
based vaccines;
    (2) Enhance the effectiveness of flu vaccines with the 
addition of adjuvants or higher doses of antigen;
    (3) Conduct clinical trials to expand vaccine use in all 
age groups; and
    (4) Continue to modernize the vaccine production processes 
for speed and flexibility.
    At that hearing, Dr. Bright noted that cell-based and 
recombinant-based technologies offer greater speed and 
flexibility than the traditional egg-based manufacturing 
process, and some studies have shown that they may also be more 
effective than egg-based vaccines.
    For these reasons, I was pleased to see the President make 
modernizing and improving influenza vaccines a top priority 
through his Executive order on September 19, 2019. Modernizing 
flu vaccines will help protect lives through prevention and 
promote public health and national security.
    Pandemic and seasonal flu planning are interdependent, and 
our approaches to seasonal and pandemic influenza are 
inextricably interwoven. What we do in one area directly 
impacts the other area. For example, when we expanded our 
domestic manufacturing capacity for pandemic response, 
manufacturers then also had the capacity to include an 
additional flu strain in the seasonal vaccine--moving from a 
three strain to four strain seasonal vaccines for better 
coverage.
    I appreciate the administration's commitment to improving 
our flu preparedness. I welcome all of today's witnesses and 
look forward to today's discussion about how we can keep 
Americans healthy during flu season and improve our Federal 
response to both pandemic and seasonal flu.

    Ms. DeGette. I thank the gentleman.
    I ask unanimous consent that Members' written opening 
statements be made part of the record.
    Without objection, so ordered.
    I now want to introduce the witnesses for today's hearing. 
Dr. Nancy Messonnier, who's the Director of the National Center 
for Immunization and Respiratory Diseases, Centers for Disease 
Control and Prevention. Welcome.
    Dr. Anthony Fauci, Director, National Institute of Allergy 
and Infectious Diseases, National Institutes of Health.
    Dr. Robert Kadlec, Assistant Secretary for Preparedness at 
U.S. Department of Health and Human Services.
    And Dr. Peter Marks, Director, Center for Biologics 
Evaluation and Research, U.S. Food and Drug Administration.
    I want to thank--again, I thank all of you for coming 
before the committee. You're aware, I know, that the 
committee's holding an investigative hearing, and when we do 
so, we have the practice of taking testimony under oath.
    Does anyone have an objection to testifying under oath 
today?
    The witnesses have all responded no.
    The Chair then advises you, under the rules of the House 
and the rules of the committee, you're entitled to be 
accompanied by counsel.
    Does any of you wish to be accompanied by counsel?
    Let the record reflect the witnesses have responded no.
    If you would please rise and raise your right hand so you 
may be sworn in.
    [Witnesses sworn.]
    Ms. DeGette. Let the record reflect that the witnesses have 
responded affirmatively. And you're now under oath and subject 
to the penalties set forth in title 18, section 1001 of the 
U.S. Code.
    The Chair will now recognize our witnesses for a 5-minute 
summary of their written statement. In front of you is the 
microphone and a series of lights. The timer counts down your 
time, and the red light turns on when your 5 minutes has come 
to an end.
    Dr. Messonnier, you're now recognized for 5 minutes.

STATEMENTS OF NANCY MESSONNIER, M.D., DIRECTOR, NATIONAL CENTER 
FOR IMMUNIZATION AND RESPIRATORY DISEASES, CENTERS FOR DISEASE 
    CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN 
SERVICES; ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE 
  FOR ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF 
    HEALTH; ROBERT P. KADLEC, M.D., ASSISTANT SECRETARY FOR 
   PREPAREDNESS AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN 
SERVICES; AND PETER MARKS, M.D., DIRECTOR, CENTER FOR BIOLOGICS 
    EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES

              STATEMENT OF NANCY MESSONNIER, M.D.

    Dr. Messonnier. Good morning, Chairman DeGette, Ranking 
Member Guthrie, and members of the committee. I'm Dr. Nancy 
Messonnier, Director of the National Center for Immunization 
and Respiratory Diseases at CDC. And I want to thank the 
committee for the opportunity to discuss CDC's work to protect 
Americans from influenza.
    Influenza is a serious and ongoing public health threat. 
Each year, millions of Americans get sick, hundreds of 
thousands require hospitalization, and tens of thousands die. 
The one certainty with influenza is that it is unpredictable. 
The virus is constantly changing and generating new flu strains 
that can lead to more severe flu seasons and devastating 
pandemics.
    These changes have also allowed the virus to evade existing 
human immunity and require us to develop a new vaccine every 
single year. CDC recommends an annual flu vaccine for everyone 
6 months of age and older. Influenza vaccination remains the 
single best way for Americans to protect themselves from the 
flu.
    The 2019-2020 flu season has officially begun. National 
levels of influenza-like illness have been increasing for 
nearly a month, with the highest activity in the South and the 
West. Despite the significant benefits, the effectiveness of 
the flu vaccine and the number of Americans being vaccinated 
are not optimal. That's why we at CDC are working with our 
Federal colleagues to use cutting-edge science to make 
influenza vaccines better and ensuring providers and the public 
are choosing to vaccinate with confidence. This is a 
complicated multiyear process that must be both stepwise and 
iterative.
    Under the recently announced Executive order to modernize 
influenza vaccines, CDC will work with our partners to promote 
new technologies to improve vaccine manufacturing and 
effectiveness.
    While the long-lasting, broadly protective, universal 
vaccines that Dr. Fauci will talk about are the ultimate goal 
for flu prevention, these vaccines are still years away. In the 
nearer term, we can save millions of Americans from the flu by 
making incremental improvements to vaccines. If we increase 
vaccine effectiveness by just 5 percent, we can prevent over 
17,000 additional hospitalizations in a single year.
    Despite overwhelming and consistent scientific evidence 
that flu vaccines are safe and effective, nearly 40 percent of 
children and over half of adults did not receive their flu 
vaccine last season.
    Flu vaccines are very safe. During the 2018 to 2019 flu 
season, nearly 170 million doses of flu vaccines were 
distributed nationwide. Of these, less than 0.01 percent of 
those receiving a vaccine reported a potential adverse event. 
Injection site reactions were the most commonly reported event.
    CDC has a central role in every part of influenza vaccine 
development and administration. Over the last decade, CDC has 
significantly improved worldwide surveillance and 
characterization of influenza viruses. Global epidemiological 
and biological data is the foundation of the influenza vaccine 
virus selection and development process. We develop diagnostic 
assays for public health laboratories in the United States and 
globally, and we ship them around the world.
    CDC uses next-generation sequencing to gather and analyze 
genomic data and share this data with other stakeholders. 
Genomic data help us make better decisions about what goes in 
each year's flu vaccine and also help us to evaluate viruses 
for their pandemic potential.
    CDC has invested in each State public health department to 
have automated real-time electronic laboratory reporting of 
influenza test results to CDC using cloud-based messaging. CDC 
has supported manufacturing innovations by developing candidate 
vaccine viruses for the cell-based vaccine and providing 
genomic sequences used to make the recombinant protein vaccine.
    Genomic sequencing equipment, which once filled the room, 
now fits in the palm of your hand. We now have a mobile mini 
laboratory that can be taken on a plane as a carry-on and set 
up almost anywhere around the world. Both cell and recombinant 
vaccines have the potential to be manufactured more quickly and 
may be more effective than traditional vaccines that are grown 
in eggs.
    CDC was the first to establish a national system for the 
routine monitoring of influenza vaccine effectiveness, and 
we're currently expanding this network to add new immunity 
tests. This system provides critical information for 
manufacturers and researchers in developing enhanced vaccines 
by collecting specific data about how well the vaccine works 
each season in each population. CDC will continue to innovate 
to make incremental improvements in vaccine effectiveness and 
vaccine coverage.
    This week is National Influenza Vaccination Week, and it is 
a great opportunity to remind all of you to protect yourselves 
and your family by making sure that you and your families get 
the annual flu vaccine.
    Thank you for the opportunity to speak, and I'm happy to 
take questions.
    [The prepared statement of Dr. Messonnier follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. DeGette. Thank you so much, Doctor.
    And now, Dr. Fauci, you're recognized for 5 minutes.

              STATEMENT OF ANTHONY S. FAUCI, M.D.

    Dr. Fauci. Chairperson DeGette, Ranking Member Guthrie, 
members of the committee, thank you for giving me the 
opportunity to speak to you today about the role of the 
National Institutes of Health in their research in addressing 
seasonal and pandemic flu.
    If I could have the slide up, please.
    [Slides are attached to Dr. Fauci's prepared statement.]
    As you've heard, and many of you have mentioned, the 
current seasonal influenza vaccines are not consistently 
effective, but I want to underscore what several people have 
said today, that it doesn't really matter if it's a hundred 
percent, 50 percent, or 20 percent, it is always, always better 
to get vaccinated than not.
    Yet we need to do better. Both the seasonal flu and the 
fact that pandemics do occur--we have experience that tell us 
it happens and will happen again. In addition, we tend to be 
able to chase after potential pandemics, like the H5N1, the 
H7N9.
    This is a paper that we wrote just a little while ago, 
emphasizing the point that I'm--oops, it disappeared. Sorry, 
there you go--that we really need to do better. We need to do 
better in two aspects. We need to improve seasonal influenza 
vaccines, we need to prepare for pandemics, and we do need a 
universal vaccine. And that's what I want to talk about over 
the next couple of minutes.
    As was mentioned just a while ago, we put together a 
strategic plan and a research agenda to develop a universal 
influenza vaccine and published this in February of 2018. This 
plan is what we call an iterative plan. By ``iterative,'' 
meaning it would be a stepwise process. We are not going to get 
a universal flu vaccine next month or next year.
    This particular slide shows what we call the two major 
groups of influenza vaccines--influenza A vaccines--not 
vaccines, but viruses.
    The first group, as you see there, contains a number of 
influenza A's, including H1 and the prepandemic H5. Group 2 
contains H3 and the prepandemic H7. When we start developing a 
universal influenza vaccine, we will start with getting H3N2 or 
H1N1, all of the iterations, and then we'll move to the next 
one. And that's what that pyramid, that triangle there is on 
the right.
    The first is a highly specific vaccine, what we have today, 
what we're giving to people in today's vaccine. As you go down, 
you get broader coverage. That's what we mean when we say a 
universal influenza vaccine.
    You mentioned the issue of egg-based and the vicissitudes 
associated with that. These are various vaccine platforms. By 
``platforms'' we mean a certain mechanism whereby we have a 
vaccine that does not require growing the egg--growing the 
virus in eggs or even in cells. It's the recombinant DNA 
technology that you just mentioned.
    Let me give you an example of how we're using that to 
develop a universal flu vaccine. This is a picture of the 
influenza virus on the left. On the right is a blowup of the 
hemagglutinin protein on the surface of that virus. As you can 
see here, there are two components of it: a head and a stem. 
The vaccine induces a response predominantly against the head, 
which is good news, because if it works, it protects you.
    However, unfortunately, that particular component of the 
protein mutates readily. So from season to season, it tends to 
drift. And that's the reason why all of us should get a vaccine 
every single year. When it changes a lot, we call that a shift, 
and that's when you get a pandemic. But note that the red dots, 
which mean mutations, are very few on the stem. That does not 
change very much.
    And what investigators have done over the last few years is 
recognize that if you, for example--and this is just one 
approach to a universal flu vaccine--if you cut off the head 
and take that stem and put it on a nanoparticle, which is one 
of those platforms that I mentioned--and I have an example of 
one of them blown up 4 million times. This is the first example 
of a true universal flu vaccine that are directed against the 
group 1. And this was just put into clinical trial last spring, 
a phase 1 trial. It is currently in phase 1. We're asking about 
safety and does it induce a good immune response.
    Next year, we will try to cover the group 2. And I hope 
that as you continue to have these annual hearings, we'll be 
able to, year after year, come back to you and talk to you 
about the progress of going from the top of that pyramid all 
the way down to a true universal influenza vaccine.
    Thank you.
    [The prepared statement and slide presentation of Dr. Fauci 
follow:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    Ms. DeGette. Thank you so much, Dr. Fauci.
    Dr. Kadlec, now you're recognized for 5 minutes.

              STATEMENT OF ROBERT P. KADLEC, M.D.

    Dr. Kadlec. Thank you, Chairwoman DeGette, Ranking Member 
Guthrie, and distinguished members of the subcommittee. Thank 
you for your continued commitment to flu preparedness and the 
opportunity to testify on our efforts to develop and rapidly 
manufacture effective medical countermeasures to treat 
influenza.
    As noted, influenza is a serious threat to human health and 
poses a significant national security risk. Annually seasonal 
flu leads to hundreds of thousands of hospitalizations, tens of 
thousands of deaths, and costs $30 billion a year in lost 
productivity and healthcare costs. An influenza pandemic would 
be even worse, killing hundreds of thousands of Americans, 
costing up to $3.8 trillion.
    Mitigating both seasonal and pandemic influenza is critical 
to saving lives, protecting Americans, and reducing the 
economic and healthcare burdens that result.
    Before going further, I want to take a moment to thank you 
and your staff who worked on passing the Pandemic All-Hazard 
Preparedness and Advancing Innovation Act of 2019. It 
strengthens public health and readiness and healthcare 
readiness, bolsters response and recovery programs, and 
increases transparency.
    Specific and relevant to this hearing, it authorized an 
annual appropriation for pandemic influenza that will 
ultimately enhance the confidence of private partners to invest 
in research, development, and manufacturing activities.
    We also appreciate the past congressional supplemental 
appropriations for pandemic influenza preparedness, with a 
2005, 2006, and 2009 supplemental appropriations. We invested 
in new vaccines, antivirals, domestic manufacturing, and 
enhanced stockpiling. Continued effort and support and funding 
remains critical, however.
    ASPR's role in pandemic influenza preparedness has defined 
multiple policy documents. The 2017 HHS Pandemic Influenza Plan 
outlines ASPR's initiatives to prevent, control, and mitigate 
the effects of the influenza virus to humans. More recently, in 
September of this year, the White House released an Executive 
order on pandemic influenza preparedness. This EO identifies 
specific activities, many of which ASPR's already supporting 
with BARDA, to strengthen preparedness efforts.
    Turning to preparedness initiatives, thanks to BARDA's 
investments, we've supported the development and approval of 23 
influenza-related vaccines, antiviral drugs, devices, and 
diagnostics. Two significant items related to vaccine 
development is that now there is a licensed, cell-based 
influenza vaccine that can be administered to individuals 4 
years and older, and a licensed recombinant DNA influenza 
vaccine available for persons 18 and older.
    To enhance overall vaccine supply, we've supported 
development and licensure of adjuvanted and influenza vaccines, 
and during a pandemic, using adjuvants increase not only the 
limited vaccine supplies to protect more people, but do so 
faster.
    To treat persons infected with influenza, we're also 
developing antiviral drugs. ASPR and BARDA has funded nine 
novel antiviral advanced development projects since 2007. To 
better detect the emergence of influenza, we're supporting the 
development of in-home and wearable diagnostics to enable 
patients to take responsible actions towards earlier treatment 
to reduce the severity of the illness and nonpharmaceutical 
approaches like staying home to prevent spread of the disease.
    While medical countermeasures will aid in the response and 
potentially limit the spread, there will be a strain on our 
healthcare infrastructure. Since 2002, investments administered 
through ASPR's Hospital Preparedness Program have improved 
individual healthcare entities' preparedness and have built a 
better coordinated system.
    Beginning in 2018, ASPR has supported regional partnerships 
to enhance capabilities above what exists at the local 
coalition level. The intended goal is to enable multiple 
healthcare systems to leverage assets and support one another 
when needed.
    A second issue that impacts response capabilities is our 
dependence on medical supplies, active pharmaceutical 
ingredients, and raw materials from overseas. When considering 
the global challenges of a pandemic, this dependence would 
become a matter of national security. ASPR is now incorporating 
new technologies to support innovation for preparedness and 
response. An example is alternative administration approaches 
such as microneedle patches that deliver vaccine through the 
skin that could limit our dependence on imported needles and 
syringes and allow for faster delivery and administration of 
vaccine. We'll continue to look for other innovative 
alternatives to address our reliance on foreign supplies.
    An influenza pandemic poses a significant threat to 
national security that could result in a significant loss of 
life, negatively impact the economy, and place a tremendous 
strain on our healthcare infrastructure. Continued support from 
Congress is critical to push the needle forward to best protect 
and respond to emerging threats.
    Thank you for your time, and I look forward to discussing 
how we can continue to work together on this important issue, 
and I'll be happy to answer any questions you may have.
    [The prepared statement of Dr. Kadlec follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. DeGette. Thank you, Doctor.
    Dr. Marks, now I'll recognize you for 5 minutes for an 
opening statement.

                 STATEMENT OF PETER MARKS, M.D.

    Dr. Marks. Thank you, Chair DeGette, Ranking Member 
Guthrie, distinguished members of the subcommittee. I'm Peter 
Marks, Director of the Center for Biologics Evaluation and 
Research at the Food and Drug Administration. Thank you for the 
opportunity to describe FDA's efforts, in close coordination 
and collaboration with its Federal partners, to ensure the 
development, approval, and availability of critical safe and 
effective medical products to address seasonal and pandemic 
influenza.
    These products for influenza include drugs such as 
antiviral agents for its prevention and treatment, biologics 
including vaccine for prevention across the age spectrum, and 
devices for rapid diagnosis and supportive care.
    FDA's involvement in these products spans the entire 
product life cycle, and the agency makes use of all of its 
available regulatory tools and expedited programs, including 
those provided by Congress, as appropriate, to help advance 
products critical for public health through toward approval.
    Following approval, the agency monitors the safety of these 
products through post-market surveillance. Americans can rely 
on the fact that, in approving a medical product, FDA has 
determined that it is both safe and effective. The confidence 
in safety and effectiveness can be particularly important in 
combating increased vaccine hesitancy, which can undermine the 
public health benefits of vaccination.
    Influenza viruses continually undergo changes in their 
genetic makeup. These changes can occur from one season to the 
next. They can also occur during influenza season. Unlike other 
vaccines, the composition of influenza vaccines must be updated 
annually so that they're effective against the predominant 
circulating virus that's anticipated in the upcoming influenza 
season.
    For the 2019-2020 season, there have been more than 160 
million doses of influenza vaccine produced for use in the 
United States, and manufacturing demands for influenza vaccines 
are substantial. No other vaccine is produced, FDA-approved, 
and distributed every year across the Nation within an 
approximately 6-month timeframe.
    Manufacturing of the antigens to be included in the 
vaccines usually occurs between December and May of each year. 
FDA then approves the updated seasonal influenza vaccines by 
the end of July, and in parallel with vaccine manufacturing, 
FDA develops and calibrates reagents that are provided to 
vaccine manufacturers and our regulatory counterparts across 
the globe. Manufacturers and the FDA use these reagents to test 
the vaccines for potency and identity before FDA provides 
approval of the new formulation of the licensed seasonal 
influenza vaccines for distribution in the United States.
    Every year, FDA begins working with manufacturers at the 
earliest stages of influenza vaccine development, and we 
continue to assist them throughout the production phase. During 
this period, we engage with companies on technical and 
manufacturing issues and conduct facility inspections, as 
warranted, to ensure compliance with current good manufacturing 
practices. The rigorous timelines currently required for 
vaccine production, including strain selection, reagent 
preparation, manufacturing of vaccine components, and 
formulation, fill, and distribution of the final product leave 
little room for error or for changes in vaccine composition 
after the initial strain selection process.
    On the horizon are advances in manufacturing, as well as 
the adoption of different technologies for the production of 
antigen that could help compress the timeline for the 
production process and provide greater predictability. Certain 
technologies could offer more opportunity to adjust the 
composition of the vaccine closer in time to influenza season 
should a new influenza strain emerge after production has 
already begun.
    In this regard, FDA scientists are collaborating with 
others to develop such needed advanced manufacturing 
technologies to more efficiently produce influenza virus or 
influenza antigen. The development adoption of such advanced 
manufacturing technologies has the potential to address the 
need for maximally efficient, agile, and flexible manufacture 
of both current and next-generation influenza vaccines produced 
according to the FDA's high standards for safety and 
effectiveness on which the American public relies.
    Collaboration across the Federal Government is essential to 
meeting these challenges, and FDA looks forward to 
collaborating with BARDA, CDC, and NIH to implement the recent 
Executive order on modernizing influenza vaccines and to 
further accelerating the adoption of improved influenza vaccine 
technologies.
    As we continue to invest in the future of manufacturing and 
vaccine technology, we also need to remember the importance of 
simply ensuring that more people are vaccinated, so please get 
your flu vaccine. And we also must work hard to ensure that 
products used to treat influenza, including antivirals and 
intravenous saline, are available and that we take steps to 
prevent and address shortages. As always, FDA remains committed 
to communicating and sharing updates with the public about all 
aspects of our flu response.
    I look forward to answering your questions today. Thank 
you.
    [The prepared statement of Dr. Marks follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. DeGette. Thank you, Doctor.
    Apparently, they were getting ready for the Energy and 
Commerce holiday party early, and they turned the lights down. 
They thought we should illuminate this important issue by 
turning the lights back up.
    OK. Now it's time for the Members to ask questions, and the 
Chair will recognize herself for 5 minutes.
    And I just want to say it's really easy to forget about the 
dangers that even seasonal flu can pose. We worry about 
pandemic flu, of course--I was telling Mr. Guthrie that keeps 
me up at night--but the regular flu that occurs every year, 
people just dismiss it as like a cold or a stomach bug, but we 
shouldn't lose sight of the fact that the flu is consistently 
one of the 10 leading causes of death in the United States, and 
it leads to millions of illnesses every year. As many as 61,200 
people died of seasonal flu just last year.
    And so, Dr. Messonnier, I wanted to ask you, briefly remind 
us why the seasonal flu provides such a danger to public 
health.
    Dr. Messonnier. Sure, thank you. And I think that's a 
really great point, that people dismiss the flu and confuse it 
with common colds that are also circulating this year. Anybody 
who's had influenza can tell you that it's nothing like that, 
and it can be incredibly serious.
    The numbers for last year are preliminary, but I think 
they're a great place to start. Last year's season was one of 
the longest seasons on record, and our estimates are 40 million 
cases, 19 million office visits, 576,000 hospitalizations, 
45,000 deaths, and importantly, 143 children died last year 
from influenza, and that's really a startling number.
    Ms. DeGette. Thank you.
    Dr. Fauci, in my opening, and I know you referred to the 
fact that this virus mutates, sometimes even within one flu 
system--or flu season. Why is it so critical for us to maintain 
vigilance in protecting against this really unpredictable 
virus?
    Dr. Fauci. Well, I think you just said it, the fact that it 
is unpredictable means we need to be prepared, and the best way 
to be prepared from season to season is to develop a vaccine as 
closely matched to what you would predict the dominant 
circulating strain would be. In addition, there are other 
public health measures in addition that complement vaccine, 
such as treatment for influenza, particularly among those 
individuals who are at high risk for complications, such as the 
very young, the elderly, those with underlying conditions, 
pregnant women, et cetera.
    We need to also do things that are public health measures. 
For example, if you do have the flu or your child has the flu, 
don't go to work, don't go to school. Make sure you don't 
spread it around the community.
    Ms. DeGette. Right.
    Dr. Kadlec, what keeps you up at night when you think about 
preparedness for the next flu--big flu outbreak?
    Dr. Kadlec. Pardon me. Thank you, ma'am, I appreciate the 
question. I mean, I sleep like a baby, I wake up every 2 hours 
screaming, but----
    Ms. DeGette. Like me.
    Dr. Kadlec. Yes. But I think the key thing here is a 
pandemic. Quite frankly, I have unique background on this 
committee or this dais to have served 2 years on the Senate 
Intelligence Committee and looked at the many threats that face 
the United States. But there is no singular threat that could 
devastate our country through our health and our economy and 
our social institutions than pandemic influenza.
    Ms. DeGette. Yes.
    Dr. Kadlec. And we had four during the last century. And 
even though we've had a mild one in this first century, I think 
the risk is that we'll have another severe one, and that would 
devastate our country.
    Ms. DeGette. And I know this panel has a lot more questions 
about that, but I'll throw that back to you, Dr. Fauci. I know 
this is why--one of the reasons why it's so important that we 
continue to innovate and to advance the vaccines. What can 
Congress do--what can Congress continue to do to help in these 
efforts to modernize and streamline the flu vaccine?
    Dr. Fauci. Well, Madam Chairperson, what you can do is what 
you have been doing, and it really is very important. And all 
of us feel very strongly in a positive way how this committee 
continues to come back each year and emphasize publicly the 
importance of this.
    With regard to support, the Congress has been extremely 
supportive of the research efforts at the NIH, as well as the 
work that the CDC and other agencies do. So my direct answer to 
your question is just keep it up, please.
    Ms. DeGette. OK. All right. Just because you said so.
    Dr. Messonnier, I know that the chairman is going to ask 
you about what CDC is doing for public awareness, but maybe you 
can start giving me a brief answer to that.
    Dr. Messonnier. Thank you. You know, Dr. Fauci and I were 
here previously talking in general about vaccines and the 
concerns about vaccine hesitancy in the United States. For flu, 
we have both concern from the public about the safety of 
vaccines, and we need to reassure the public as well as 
emphasize the importance of their providers educating their 
patients about the safety and effectiveness of flu vaccine. But 
actually, if you ask people why they don't get the flu vaccine, 
what's different than other vaccines is, another reason that 
they really reflect on this, that they don't believe the flu 
vaccine works.
    Ms. DeGette. All right.
    Dr. Messonnier. I think we have to do a better job at 
educating people that, even if you can still get the flu with 
the flu vaccine, the flu is milder, and it can prevent 
hospitalizations and deaths. So it's worth getting it even for 
a year when it's not a great----
    Ms. DeGette. Thank you.
    The Chair now recognizes the ranking member for 5 minutes 
for questioning.
    Mr. Guthrie. Thank you.
    I was going through trying to figure out where you've 
already answered some of my questions so we're all kind of on 
the same page on this area, which is great, but I'll--so I may 
be repetitive, but it's important to repeat some of these 
things, sometimes.
    So, Dr. Kadlec, the September 19 Executive order directs 
HHS to estimate the cost of expanding and diversifying domestic 
vaccine manufacturing capacity using innovative, faster, and 
more scalable technologies. So, putting that into real words, 
why is it important for us to improve our domestic vaccine 
manufacturing capacity for flu? And what faster and more 
scalable technology would need to be used to expand and to 
diversify domestic capacity?
    Dr. Kadlec. Well, thank you for your question, sir. And I 
think very simply is, the reason why domestic manufacturing is 
so critical, particularly for pandemics, is if there's a 
pandemic, everybody will be taking care of themselves. And so 
the fact if we're reliant on foreign suppliers for vaccines or 
anything else, we're likely to be at the end of that line, 
because they're going to be taking care of that first.
    The second issue is, quite frankly, sir, is there are 
technologies that exist today and some that Dr. Fauci's working 
on, like messenger RNA that will permit faster and more better-
matched vaccines to basically prevent flu, both seasonal and 
pandemic.
    And specifically because of Congress' investments in the 
past, through the previous supplementals, we've developed two 
new vaccine technologies: one, recombinant cell culture, and 
the other one is recombinant DNA vaccines. And those are two 
very good and faster methods for producing. We have yet to know 
whether they are more effective than eggs. We believe so, but I 
think Dr. Messonnier can probably talk about some of the work 
that is ongoing in research, as well as Dr. Fauci to that. But 
those are two areas that I think we have leveraged it.
    Unfortunately, those technologies do not have the capacity 
yet to overtake what we do with the egg-based flu vaccines.
    Mr. Guthrie. OK. Thank you.
    And again, Dr. Fauci, in your statement, you noticed that 
alignment with the goals of the Executive order, the National 
Institute of Allergy and Infectious Diseases is conducting and 
supporting research to develop state-of-the-art vaccine 
platform technologies that could be used to develop universal 
flu vaccines as well as improve the speed and agility of the 
flu vaccine manufacturing process.
    So the question is, how are the vaccine platform 
technologies that the NIAID is currently researching different 
from flu vaccine production strategies?
    Dr. Fauci. Well, the platforms that I showed on one of 
those slides are each different way. All of them have a basis 
in recombinant DNA technology, but the critical issue about 
that is you don't need to grow the virus. And that is 
important, because when you grow the virus, it takes 5 to 6 
months from the time you grow it, the way we do in eggs today 
and some in cells, and a number of things can happen when you 
do that. You can make a choice in February or March that this 
is the strain that you want to aim for for the following 
season, but by the time you get to the following season, it 
might have changed, number one.
    Number two, there have been examples of when you put the 
virus in the egg, the virus tends to adapt to grow better in 
the egg, and it mutates. It's an RNA virus and it mutates 
readily. Most of those mutations don't mean anything. But every 
once in a while, it mutates to the point that it actually 
changes the virus enough that it's different from what you 
originally put in.
    So all of the platforms, be they recombinant DNA, messenger 
RNA, DNA, nanoparticles, viral-like particles, vectors, they 
all are recombinant technologies that don't require your 
growing the virus, and that's very important.
    Mr. Guthrie. OK. Thank you very much. Appreciate that. 
That's good.
    So, Dr. Marks, in March, Dr. Gottlieb testified as the 
Commissioner at the time, said that FDA scientists are using 
CMS data to look for differences in effectiveness in those 
receiving egg-based and cell-based vaccines, as well as 
differences in effectiveness in those that receive the standard 
dose versus a high-dose vaccine and the adjuvanted flu vaccine. 
What did CMS and FDA find by analyzing the Medicare data? And 
you can use that word if you'd like.
    Dr. Marks. I thank you very much. The adjuvanted flu 
vaccines--it took me about 4 years of medical school to learn 
how to pronounce that, so don't worry, it's OK. So thank you 
for that question.
    The FDA's recently finished a study and published a study 
that was done in conjunction with Centers for Medicare and 
Medicaid Services, using their large database. And they looked 
at six seasons' worth of standard-dose versus high-dose 
influenza vaccine. And from that, they were able to see that, 
particularly in the population of individuals over 85 years 
old, the high-dose vaccine, season after season, had better 
effectiveness, and even in the population over 65, there was a 
tendency towards better effectiveness in that population as 
well.
    Mr. Guthrie. OK. Thank you.
    My time is expired. I yield back.
    Ms. DeGette. I thank the gentleman.
    The Chair now recognizes Mr. Ruiz for 5 minutes.
    Mr. Ruiz. Thank you, Madam Chair.
    Compassionate prevention and care must be available to 
everyone in this country, and as has been alluded here, many 
people have died due to the flu virus. Just about a year ago, 
in fact, this Sunday marks 1 year when Jakelin Caal, a 7-year-
old girl, died in CBP custody because she did not have 
appropriate access to medical care. Whether or not it was the 
flu--I don't believe it was--but there has been several 
children who have died in CBP custody since then, including 
some from the flu.
    Following Jakelin's death, I visited the place where she 
had been held, and I was horrified by the conditions that I 
witnessed: facilities so crowded you couldn't even see the 
floor, bodies on top of one another, especially children with 
soiled diapers, coughing on one another. And there wasn't 
appropriate access to sanitation places to wash their hands, to 
bathe. And these are individuals whose immune systems were 
always down due to the long trek and probably poor nutrition.
    And as public health experts, I think you will all agree 
with me that such conditions create a breeding ground for a flu 
outbreak.
    Following my visit, I wrote the Humanitarian Standards for 
Individuals in CBP Custody Act, which passed the House. It 
would ensure that individuals in CBP custody would have access 
to an initial health screening, to identify high-risk, 
vulnerable people, and provide appropriate intervention to 
prevent children and the elderly and others from dying. It 
would also put in place a baseline set of humanitarian public 
health standards such as access to clean water, proper 
sanitation, and personal hygiene.
    I am concerned that, despite urging from physicians and 
physician organizations and the CDC, CBP has refused to 
administer flu vaccines to protect children and families in 
their custody.
    Dr. Messonnier, CDC submitted a report regarding its 
investigation of respiratory illnesses in U.S. Border Patrol 
facilities, including findings and recommendations to the 
Department of Homeland Security in January, this past January 
of 2019. And I would like to submit this report for the record.
    Dr. Messonnier, do the children and adults detained in 
these facilities face heightened risk of contracting influenza?
    Dr. Messonnier. As you've said, crowded conditions tend to 
be a breeding ground for respiratory infectious diseases. 
There's no specific information right now about the risk at the 
border compared to elsewhere. But I think it's important to 
remember that CDC recommends that everybody age 6 months of age 
or older----
    Mr. Ruiz. Right, everybody.
    Dr. Messonnier [continuing]. Be vaccinated.
    Mr. Ruiz. However, this report does state that there was 
higher prevalence of influenza in December 2018, January 2019, 
than the national average. So----
    Dr. Messonnier. Right. That's right. So----
    Mr. Ruiz [continuing]. In this report, it does, in 2019, 
January 2019, does show that there was higher. So----
    Dr. Messonnier. Yes.
    Mr. Ruiz [continuing]. What recommendations does CDC make 
to DHS specific to influenza vaccine and other related care for 
those detained in Border Patrol facilities?
    Dr. Messonnier. So, as you said, CDC was asked by DHS for 
technical assistance in December of 2018 and January of 2019. 
We gave preliminary recommendations orally and then issued a 
written report. And the written report says that, as consistent 
with our general infection control guidelines, priority should 
be given to screening and isolation of ill migrants, early 
antiviral treatment, and flu vaccination for all staff.
    Mr. Ruiz. Great. In fact, I'll read it here, it says, 
``Influenza vaccination should be implemented at the earliest 
feasible point of entry to allow maximum protection of migrant 
and potentially to reduce transmission in border facilities. 
Priority groups should include children aged 6 months through 
18 years and pregnant women.''
    The term ``earliest feasible point'' is very important 
here. Are vaccines--the success rate of vaccination, is it--
this is an obvious question, but is it more effective before 
they contract the influenza virus or after?
    Dr. Messonnier. So it's obviously more effective when it's 
given before.
    Mr. Ruiz. Exactly.
    Dr. Messonnier. And I would also just point out perhaps 
that, you know, HHS' ORR program routinely vaccinates----
    Mr. Ruiz. They do. ORR and ICE does. I'm specifically 
talking about CBP, and that's the point I'm making, because 
oftentimes, they stay there for 8, 14 days, when overcrowded 
conditions. So one of the reasons, perhaps they may say, ``Oh, 
well, we want to get rid--move the children or move the 
individuals to the next facility,'' but if they contract the 
flu vaccine at CBP, then receiving the vaccine at ICE or ORR is 
not going to be helpful. So that's why the recommendation was 
to vaccinate them at the earliest point of entry at CBP.
    And I ran out of time. Thank you.
    Ms. DeGette. Without objection, the CDC report is entered 
into the record.
    [The information appears at the conclusion of the hearing.]
    Ms. DeGette. The Chair now recognizes the gentleman from 
West Virginia for 5 minutes.
    Mr. McKinley. Thank you, Ms. Chairwoman.
    I think maybe, Dr. Messonnier, maybe I will focus on you. 
Did I--I want to make sure I heard your answer to the question 
why aren't--why aren't more people getting a vaccine. And I 
thought your answer was something about the public's concern 
with its effectiveness. Am I--did I state that correctly?
    Dr. Messonnier. I think that there are three reasons why 
people don't get vaccinated, speaking generally. One is 
incorrect concern about the safety of the vaccine. A second is 
misunderstanding that the vaccine--about vaccine effectiveness, 
and the third, frankly, is access. It----
    Mr. McKinley. OK. Let me focus more on that third because I 
think the first two, I don't agree with you at all. Mildred 
Smith. She's your neighbor, my neighbor. Mildred Smith has no 
idea about the effectiveness rate. None. You in academia, and 
maybe in the research, you understand that, but she doesn't 
understand that. I'd like to try to figure out more the third 
issue of access, to be able to get that and how we might do 
that, so that leads me to the next question.
    A part of that is obviously, I'm just an engineer. I don't 
practice medicine, so I'm curious how we work in--we seem to be 
working in a vacuum here in this conversation. What are they 
doing in Europe, for example? What's the outbreak? Do we have 
the same situation occur in Europe? Do they have a higher 
vaccination rate? Give me from a broader perspective than just 
the United States.
    Dr. Messonnier. I think Europe is a broad set of countries, 
and different countries have different vaccination coverage. 
But I think many countries struggle with vaccination coverage 
against flu. And a lot of countries actually don't have the 
routine recommendation that we do or the implementation 
recommendation.
    Mr. McKinley. So you're telling me that, if I were to, you 
know, Google something here on Europe, I would not find 
anything because it's limited, or the European Union does not 
pull together some data?
    Dr. Messonnier. No. I'm sorry. I misunderstood. Of course, 
there's data. I don't have it on top of mind, but I'm happy to 
provide it. But I would like to add----
    Mr. McKinley. Well, but I'd like to understand what they're 
doing in Europe about this, because I know NIH is spending a 
significant--maybe not enough but whatever. What are other 
countries doing about this? And what advances are they making 
towards this universal coverage, if that's a possibility?
    And so what's Europe doing on universal coverage, the 
research in there, and then also, who are we partnering with? 
Who's the private-sector group, because NIH can only go so far. 
NIH is not going--you don't take clinicals to market. Is there 
someone that--are there different firms in the private sector 
that are showing some participation in this?
    Dr. Messonnier. Maybe I'll just start with one fact and let 
Dr. Fauci go from there.
    One thing just to point out is that the scientific 
community for influenza is incredibly collaborative. And the 
reason we have such great situational awareness about strains 
that are circulating is because countries all over the world--
not only in Europe, but all over the world--gather strains of 
influenza, provide them to reference centers, sequence them, 
and that gives us the information globally about what's 
circulating.
    Mr. McKinley. OK. Dr. Fauci.
    Dr. Fauci. So with regard to the development of vaccines 
and the technology and the research, as with almost every 
aspect of medical research, the United States clearly dwarfs 
the other countries. However, the slide that I showed in my 
presentation about the strategic plan and research agenda that 
we put together was based on a meeting that we held in 
Rockville in the summer of 2017, and we had international 
participation.
    So we have good input from people from the Far East, from 
China, from Europe, et cetera. But the actual work that's done, 
although not everything is done in the United States, an 
overwhelming proportion of the research and the production on 
the universal flu vaccine is done in United States. European 
countries make their own vaccine.
    Mr. McKinley. I hope there's more data. I'm fascinated with 
that subject and how it might be able to get to that curve. 
Let's go back to the initial. If Messonnier did not have the 
answer, do any of you know what kind of rates? If we only have, 
what, 45--whatever the rates are.
    I've got to admit. I'm one of the guys cheating this--
cheating death on this because, as a senior citizen, I don't 
get the flu vaccine, and I know I should. I know my wife does 
it every year, and she lectures me on this, and I just haven't 
gotten around to doing it.
    So what are the rates in Europe? Do any of you know?
    Dr. Fauci. Yes, we do.
    Mr. McKinley. I figured. I didn't ask the right person.
    Dr. Fauci. In every single country--for example, I went to 
a meeting just a couple of months ago on a different subject in 
France. In France, they do not have the type of recommendation 
that we have here which, as Dr. Messonnier said, that everyone 
6 months of age or older should be vaccinated.
    In several of the top European countries, they vaccinate 
those who are at highest risk for complications: the young 
children, the elderly, those with underlying conditions. It 
would be unusual for a European country to have the broad 
recommendation that we have of everyone 6 months of age or over 
to get a vaccine.
    Mr. McKinley. Well, I'm just--the reason I'm raising that 
question, and the time's up, I've gone over, is I want to 
understand a little bit. There in socialized medicine they have 
in Europe, I want to see, does that have an impact on it, if we 
were to implement it?
    Ms. DeGette. So the gentleman's time has expired.
    Mr. McKinley. I yield back the balance of my time.
    Ms. DeGette. The Chair now recognizes Mr. Kennedy for 5 
minutes.
    Mr. Kennedy. Thank you, Madam Chair. I want to thank you 
for holding this important hearing, and the witnesses for your 
testimony and your service.
    It's clear from what we've heard so far this morning that 
public health surveillance tools are critical in monitoring and 
responding to infectious diseases such as influenza and other 
outbreaks across the country.
    Unfortunately, a June 2019 report by the Massachusetts 
Special Commission on Local and Regional Public Health found 
that, due to inconsistent funding for local public health 
agencies, my home State, like many others across the country, 
has limited capacity to collect and measure health data.
    So, beginning with Dr. Messonnier, how does CDC and its 
partners help States like mine be able to track the spread of 
influenza from around the country as well as capture 
vaccination rates?
    Dr. Messonnier. So, as you point out, public health runs on 
data. It's an incredibly crucial part of our programs. We do 
provide funding to help health departments to enable them to 
work with us on surveillance, and we've been really innovative. 
In fact, we've worked with the American Public Health Lab 
Association--sorry, Association of Public Health Labs--to build 
a data system that's electronic so that the data goes from 
regional reference labs to the cloud so that we can all have 
access to data sooner.
    That being said, the flu program happens to be at the 
forefront of how we use data, and in general, the public health 
data systems are antiquated and, unfortunately, fragmented, and 
we really do need to think about new investments if we want the 
kind of solid systems that you're talking about.
    Mr. Kennedy. So, building on that, you said antiquated and 
fragmented. What gaps exist specifically in the collection of 
that data around the spread and severity of the flu virus?
    Dr. Messonnier. Of course, what we'd all want is real-time, 
actionable data that can be used at every part of the public 
health and clinical system. We actually have a lot of data 
online now, and you can actually go to our flu site and look at 
electronic data that's posted every week that shows what the 
situation is in flu in every State. What you'd like to be able 
to do is use that same picture to click on your State and also 
understand vaccination coverage in every corner of your State 
and the capacity of the hospital system and whether hospital 
systems are overwhelmed.
    And that's what we're working on, is trying to integrate 
all of that big data to give your State health officials the 
actionable data that they need.
    Mr. Kennedy. Dr. Kadlec, do you have any ideas on the 
collection of flu and pandemic data as well?
    Dr. Kadlec. Sir, none beyond that has been identified for 
Dr. Messonnier, but I think the key thing is to what has been 
pointed out is that the systems are antiquated and fragmented. 
And there is a need to basically enhance those systems so that 
there is better real-time data, to Dr. Messonnier's point, to 
be actionable.
    Mr. Kennedy. And just to be a little more blunt then, if I 
can, are you suggesting that Congress--what actions would you 
like Congress to take? Is that funding, or is that additional 
structures that need to be put in place in order to flush out 
the system the way you would want to see it?
    Dr. Kadlec. So I think, for the purposes of this 
conversation, I would just note that there is a multiyear 
budget that has been put together that looks at pandemic 
influenza that's required by Congress. It's a multiyear for the 
public health emergency medical countermeasure which identifies 
that we probably need about $5.7 billion to support efforts by 
NIH, FDA, and ASPR. But it doesn't include what CDC needs to do 
for surveillance and its other programs, important programs for 
vaccine acceptance.
    So I think there's a way to capture this in a way going 
forward that I think would holistically represent what is 
needed to address this challenge broadly. We are responding to 
what Congress has identified in one area of this, but I think 
to Dr. Messonnier's point, there is a need to basically include 
these other very important supporting activities as part of 
that.
    Mr. Kennedy. So it's my understanding, Doctor, that during 
the 2009 H1N1 outbreak, local health departments did play a key 
role in the distribution of the vaccine. According to the 
National Association of County and City Health Officials, since 
2008 local health departments have eliminated a cumulative 
total of more than 56,000 jobs, a decrease of about 25 percent 
of the public health workforce.
    Doctor, how do you think ASPR is working with State and 
local health departments to prepare for that next flu pandemic?
    Dr. Kadlec. Well, I think critically speaking, CDC has an 
important role to play, a principal role, and we play a 
supporting role. There are two grant programs that are 
administered by the department, one by CDC dealing specifically 
with local public health departments, and the one that ASPR 
basically administers, which is really about hospital 
preparedness. And those two things are critically linked in 
doing that together. And so we really need to work together to 
make sure that we capitalize on the public health 
infrastructure.
    But you have highlighted, I think, a critical reality in 
the trends of local public health departments, which is not 
only the graying out of public health departments but certainly 
the support they need, subsidies at the State and local level 
as well as the Federal level to do this. And I think, jointly 
through CDC and ASPR, we can do better to do this, but I think, 
quite honestly, that's an area that you've highlighted that is 
a vulnerability.
    Mr. Kennedy. Thank you, sir. I yield back.
    Ms. DeGette. I thank the gentleman.
    The Chair now recognizes the gentlelady from Indiana for 5 
minutes.
    Mrs. Brooks. Thank you, Madam Chairwoman, and thank you 
again for holding this very important hearing, and thank you 
all for your work.
    I'd actually like to go back and allow Dr. Messonnier to 
answer. Is there anything further you'd like to say that Dr. 
Kadlec--and then I have some questions for Dr. Kadlec because 
you were nodding quite a bit. But is there anything else you 
would like to add?
    Dr. Messonnier. I was nodding. I think Dr. Kadlec said most 
of it, but you know, it is CDC's step program that provides 
direct funding to States and then from States to local health 
departments to specifically work on preparedness capacity.
    You can see this capacity used every day at local and State 
health departments, both to respond to the everyday 
emergencies, also to respond to the unexpected emergencies. And 
if we fail to invest in those departments, we'll obviously 
always come to regret it if we have to rely on them in an 
emergency.
    Mrs. Brooks. Thank you. Thank you.
    Dr. Kadlec, I'd like to talk with you. Committee staff 
recently participated in a pan flu tabletop exercise with ASPR, 
and thank you for that participation. One of the biggest 
takeaways was that the U.S. lacks sufficient domestic 
manufacturing capacity and/or raw materials for almost all pan 
influenza medical countermeasures. This is very concerning.
    Further, that global manufacturing capacity would not be 
sufficient to meet the demand, so specifically, we have 
concerns about the United States' supply of needles, syringes, 
surgical masks. That was raised during the exercise. We learned 
that--and I think we saw this during Ebola. Surgical masks are 
not made in the United States, and so there was a run on masks 
and other supplies during Ebola.
    Can you discuss the challenges we face with respect to 
those supplies regarding the lack of domestic manufacturing and 
the volume we need versus what we currently have access to in 
the event of a pandemic?
    Dr. Kadlec. Thank you, ma'am, for your question, and yes, 
it is a significant vulnerability as we look at particularly 
for pandemic preparedness. Eighty percent of the materials that 
we're counting on for--not only just for pandemic support, but 
generally in our healthcare system--emanate from China and 
India. So that's both raw materials, finished products, and 
active pharmaceutical ingredients.
    If you had to look specifically at a couple of areas of 
particular concern around pandemic influenza preparedness, you 
would have to look at the antiviral drug supply. Again, we have 
about 67 million courses of about 80-million-person requirement 
that we have in our stockpile, and the active pharmaceutical 
ingredient comes from Asia at the present time.
    So, once we would expend that immediate supply during a 
pandemic, in order to manufacture more, there is a number of 
generic manufacturers here domestically in the United States, 
but that active pharmaceutical ingredient is--it would be found 
in Asia and would be a critical supply material for any 
country, much less us.
    Mrs. Brooks. What are we doing as the Federal Government to 
work to address our domestic manufacturing capacity, whether 
for the API or----
    Dr. Kadlec. Ma'am, on the issues of vaccines alone, I think 
the key thing is is--I can't give you the particulars, but 
we're going to have an announcement here shortly that will 
indicate some investments domestically to expand some of our 
new technology--newer technologies for vaccine manufacturers. 
And I think the key thing there is that we're actively pursuing 
this in accordance with the Executive order.
    Obviously it's going to be a resource-limited kind of 
activity, but significantly beyond that we're really trying to 
put our arms around this vulnerability in terms of our supply 
chain to the other things that you mentioned: surgical masks, 
latex gloves, other personal protective equipment, as well as 
active pharmaceutical ingredients.
    Mrs. Brooks. Is it fair to say that, if we're better 
prepared for seasonal flu preparedness, that that would help us 
in the event of a pandemic?
    Dr. Kadlec. Yes, ma'am.
    Mrs. Brooks. And is the H7N9 flu strain still a potential 
pandemic threat? And you're all nodding yes, I suppose. And is 
our prepandemic stockpile adequate right now relative to that?
    Dr. Kadlec. Ma'am, I believe that--and I would turn to Dr. 
Messonnier and Dr. Fauci for their answer, but my understanding 
is that it's not a good match with the current circulating 
strains, so its utility would be limited.
    Mrs. Brooks. Dr. Fauci?
    Dr. Fauci. I agree. It's another example of the virus 
changing. We made a vaccine back in 2013, and we get to 2018, 
2019, and it's a bit different, so it would not be a good 
match.
    Mrs. Brooks. And given ASPR's support for developing new 
antiviral products, how would adding new antivirals to the 
stockpile increase our preparedness? And how--what is the--
what's the time that it takes and the money that it takes to 
add new antivirals to our stockpile?
    Dr. Kadlec. Ma'am, very briefly, I think the risk that 
you're trying to mitigate is the risk that, over time, 
circulating flu strains will be resistant to what we have in 
our stockpile, which is Tamiflu. And currently, there is 
evidence of that in the world today.
    The real reality is how much does it cost. Newer classes of 
antibiotics tend to be more expensive, and so it would be a 
much more significant investment in terms of replacing our 
existing stockpile.
    And we're evaluating what's the mix that we need to have 
which gives us the advantage over what we have in our 
stockpile, what do we need to buy or purchase that would 
basically minimize or mitigate our risk to future strains.
    Mrs. Brooks. Thank you.
    I yield back.
    Ms. DeGette. Dr. Kadlec, I just wanted to follow up on 
something Mrs. Brooks asked you. You said a big announcement 
about domestic production is going to be made. When will that 
announcement be made, do you expect?
    Dr. Kadlec. Ma'am, I'm hopeful by next week.
    Ms. DeGette. By next week. OK. That will be--that will be 
really good. Thank you.
    The Chair now recognizes Ms. Kuster for 5 minutes.
    Ms. Kuster. Thank you very much, and thank you, Madam 
Chair, for holding this timely hearing this week during 
National Influenza Vaccination Week.
    In my home State of New Hampshire, 40 people lost their 
lives in the last flu season, and of particular concern to me 
is the impact on seniors. You can imagine, in the winter 
driving through rural New Hampshire is hard enough, but if 
you're an ill senior, that is really difficult. So I want to 
thank you all for being with us.
    I want to focus in on--the seasonal flu vaccine last year 
was more effective for the first primary strain, but its 
effectiveness rate dropped significantly later in the season 
when the dominant strain in the United States changed. And, 
unfortunately, the longer season and the shift in flu strain, 
as I mentioned, led to 40 deaths in my State.
    Dr. Fauci, what do you mean when we talk about vaccine 
effectiveness, and how is it measured?
    Dr. Fauci. Vaccine effectiveness is really a percent of 
protection based on a comparison to people who are not 
vaccinated. So if you have 100 percent effectiveness, which you 
almost never have, that would be essentially everybody gets 
protected who gets vaccinated. The percentage goes down as you 
have people who are vaccinated but who actually do get 
infected.
    Ms. Kuster. Have flu symptoms?
    Dr. Fauci. Right.
    Ms. Kuster. All right. And how does the effectiveness of 
last year's vaccine compare to those in the past? And will we--
when we will know how effective this year's vaccine is?
    Dr. Fauci. Well, if you look at last year's effectiveness, 
you have to be careful to make sure that you can pick--that you 
look at H3N2 compared to H1N1 because when we vaccinate, we 
vaccinate against H3N2, H1N1, and B, actually two B's. So when 
you look at the H3N2, I believe it was 29 percent, if I'm not 
mistaken. It was 29 percent effective against H3N2.
    And if you look at the chart--I'm speaking, but Nancy has 
it. If you look at the chart that the CDC puts out, they give 
each year what the effectiveness is. It really is a wide range. 
There's a very good year where you can get 60 percent.
    The average is somewhere between 40, 50 percent or so. On a 
very bad year, you could go down to around 10 percent. When I 
say that, I say it with some degree of nervousness. It's still 
always better to get vaccinated regardless of what that percent 
is.
    Ms. Kuster. Well, I want to get to that with Dr. 
Messonnier. Why is it so important for people for whom the 
vaccine may currently be less effective, such as seniors, to 
get the flu vaccine each season?
    Dr. Messonnier. Thank you. Maybe just to go back to a 
question that you asked, this one strain, the H3N2 strain, 
which was the strain that caused that second peak last year, 
happens to be a particularly difficult strain in terms of 
vaccine effectiveness. But, if you look historically, the range 
of the effectiveness of that strain is always harder because of 
the reasons that Dr. Kadlec and Dr. Fauci mentioned earlier. 
We'll have preliminary estimates of the vaccine effectiveness, 
this season's vaccine, in February, and then our final 
estimates should be available in the summer.
    The larger issue is when Dr. Fauci referred to vaccine 
effectiveness, but we have to remember that even if the vaccine 
is not perfectly effective against any influenza, it still can 
be effective against more severe influenza and against death. 
And so, even in a year where the overall vaccine effectiveness 
is not as great, vaccine effectiveness against more severe 
illness can actually be high. It's always better to get 
vaccinated than not.
    Ms. Kuster. So we should be encouraging our constituents to 
get the vaccine. The symptoms will be milder, and we should----
    Dr. Messonnier. Everybody should get the vaccine, because 
today I can't totally predict what the season is going to be 
like, and my kids are vaccinated. My parents are vaccinated. Of 
course, I'm vaccinated.
    Ms. Kuster. And I will be as well. Thank you.
    Dr. Marks, you stated in your testimony that the FDA 
conducts, quote, ``applied scientific research to address 
current challenges in season and pandemic influenza vaccine 
production, including improving their effectiveness.'' What 
specific research efforts is the FDA currently engaged in to 
improve vaccine effectiveness rates, particularly for those 
populations less protected by recent flu vaccines?
    Dr. Marks. Thank you for that question. So we are engaged 
in research that's looking mainly to try to improve the ability 
to produce influenza vaccines on a rapid basis. We have some 
work that's going on that essentially builds off of NIH's work 
on trying to make a more effective vaccine.
    But one of our major--the major thrust of work from FDA's 
perspective is trying to be able to be agile in our 
manufacturing, to look at things like advanced manufacturing 
technologies such as continuous manufacturing, which could 
allow us to actually have seasonal influenza or pandemic 
influenza vaccines produced at a much greater quantity, in a 
much smaller footprint, on U.S. soil in the event of a 
pandemic, which I think is one of the things that, as Dr. 
Kadlec mentioned, is important for national security.
    Ms. Kuster. Great. Thank you.
    My time is up. I yield back.
    Ms. DeGette. The Chair now yields 5 minutes to the 
gentleman from Texas, Mr. Burgess.
    Mr. Burgess. Thank you, and thanks to the panel for being 
here. I apologize. I've been upstairs at a cosmetics hearing. 
That's why I look so youthful.
    Since I haven't been here, I haven't heard all of the 
questions that have been asked, so if I do something that's 
duplicative, I apologize about that. But Dr. Messonnier and 
maybe Dr. Kadlec, the issue of the vaccination at facilities 
for Customs and Border Protection has apparently come up. We 
had a hearing, I think we held a subcommittee in September, and 
also addressed this. I've traveled to many of the Customs and 
Border Protection facilities on the border in Texas, 
specifically Clint and the Ursula facility down at McAllen. I 
actually went to the Ursula facility at McAllen with a DHS 
physician who was on that trip.
    So, when this issue came up, I called that person and said, 
``Hey, does DHS not do this?'' and he said no, DHS has given--
and I forget the figure, and Dr. Kadlec, you may be able to 
supply it--but tens of thousands of doses of flu vaccine are 
administered by the Department of Homeland Security.
    I guess the issue is, if they are in a facility that's only 
going to retain them for 12 to 72 hours, and then they're going 
to a Health and Human Services facility, and we're prominently 
talking about children here going to a Health and Human 
Services facility or an ORR facility where they will be for 
perhaps several weeks, I think it makes sense to do the 
vaccination at the ORR facility.
    Now, I know there was an issue because Congress was late in 
supplying some supplemental funding for Department of Homeland 
Security. They got backed up with the number of people that 
were coming across the border in May and the early part of 
June, so people were held at CBP facilities for longer than 
what was ideal.
    But, if the difficulty is we weren't providing DHS with the 
funding to do their primary job in the first place, I don't 
know where they were supposed to get the money to buy 
additional flu vaccine, but I suppose that's a separate story.
    But can you talk at all about how you've coordinated with 
Customs and Border Protection and the Department of Homeland 
Security more specifically about your recommendations and what 
they see as their role?
    Dr. Messonnier. Sure. And I apologize for repeating myself, 
but we were contacted by DHS last December, and we provided 
technical consultation in December and January that led to an 
oral report out and then a written report which was entered 
into the record. And what we recommended was what we would 
generally say, that the priority be given to infection control, 
identification, and isolation of the migrants, early provision 
of antivirals, and priority to vaccination of the DHS staff.
    Our report goes on to say, as consistent with our general 
recommendations for everybody in the United States, we would 
recommend a flu vaccine for everybody 6 months of age and older 
at the earliest operationally feasible time.
    Mr. Burgess. So children that are held in Office of Refugee 
Resettlement facilities are going to receive the full 
complement of childhood vaccines as just part of the course. I 
think that's one of the things that's evolved since 2014.
    Dr. Messonnier. That's right.
    Mr. Burgess. Because we don't know the vaccine history, we 
just provide the vaccines. It seems like it would make sense to 
provide the flu vaccine at that interval because that's done 
relatively early in their stay in an HHS facility.
    Dr. Messonnier. That's correct. Children within ORR are 
given both the childhood vaccines and their flu vaccines, and 
my understanding is coverage is high. Another complication of 
this, as you point out, is the medical records which don't come 
with those children.
    Mr. Burgess. Right.
    Dr. Messonnier. They err on the side of protecting them 
with the vaccine.
    Mr. Burgess. And, of course, what they do come with is the 
flu sometimes because they are held in less than ideal 
facilities referred to as stash houses on the other side of the 
border and then brought over when it's convenient with the 
coyotes or the cartels. They don't provide vaccination services 
on their side, and so they end up in our facilities oftentimes 
very, very ill.
    Well, I'd like to see us do--if we're not doing a good job 
with coordinating between the two agencies, I'd like to see 
that as part of the exercise that comes out of this. Once 
again, my thanks to everyone who is on the panel.
    Some of my favorite people in the world are on this panel, 
so I appreciate you being here and participating in our hearing 
today.
    Thank you, and I yield back.
    Ms. DeGette. I thank the gentleman.
    The Chair now recognizes the gentlelady from Florida for 5 
minutes.
    Ms. Castor. Well, thank you, Chairwoman DeGette, for 
calling this hearing.
    Drs. Messonnier and Fauci, we had the benefit of your 
testimony before the subcommittee earlier this year, the 
measles hearing where you both stressed the importance of 
vaccinations for infectious diseases. And I wanted to talk a 
little bit about that in regards to the flu, but looking at the 
CDC's statistics over the last 50, 60 years.
    I think for measles what was remarkable was that in the 
1950s and 1960s, where you had hundreds of thousands of people 
dying from that disease, the measles vaccine practically 
eradicated measles, and the big concern was now that people 
were skipping that vaccine, and it could make a comeback.
    With flu, what really stands out are the high numbers still 
of people who come down with the illness, who are hospitalized 
and even die because--and that's largely because the flu 
strains change over time. Is that right?
    Dr. Fauci. Yes. Well, you compared measles with flu, which 
is something we discussed at the last hearing. So the measles 
that I, unfortunately, got infected with when I was a child is 
not particularly different from the measles that we have 
circulating right now. It just doesn't change. And that's the 
reason why a highly effective vaccine like measles, which is 97 
percent at least effective, can essentially eliminate measles 
from certain parts of the world.
    But influenza, we're constantly chasing it. It continually 
evolves. It continually mutates. And that's really the reason 
why we need to do better with seasonal flu vaccines, but we 
also need to get a universal vaccine that would cover those 
kinds of changes that occur.
    Ms. Castor. And it's so heartening to hear about the 
progress being done there, but the current vaccines are safe 
and effective. I think you've all testified to that. So I'd 
like to focus on the availability. Dr. Messonnier, is the flu 
vaccine widely available currently?
    Dr. Messonnier. Yes. Flu vaccine is widely available 
currently, and we watch carefully across the United States to 
make sure that consumers aren't experiencing any shortages. You 
know, the last thing we want is for someone to show up in a 
doctor's office asking for the flu vaccine and be turned away 
because----
    Ms. Castor. Right. And you said one of the reasons that 
people often skip it is the--skip the flu vaccine is because 
they're skeptical it's effective, and some people skip it 
because maybe they do run into a barrier. But I think working 
together over time, we've made a lot of progress on that.
    Now, under the Affordable Care Act, the vaccine is covered, 
so it should be free if you have a policy under healthcare.gov. 
Most standard insurance policies cover this because everyone 
realizes, boy, it's a whole lot less expensive to get the flu 
vaccine than to miss a week or 10 days of work, or something 
even more serious.
    I looked up for the State of Florida, the Florida 
Department of Health, floridahealth.gov. You can find, you can 
locate where your--where to get your vaccine, but it's fairly 
easy now. The Veterans Administration, you can get a free flu 
shot there. Community health centers all over your 
neighborhoods, you can get your flu vaccine.
    Oftentimes your employers, colleges, and universities do 
that because that's the last thing they want, is students and 
professors being infected. Most grocery stores and pharmacies 
now, you can walk right in because I think sometimes it's a 
convenience. People are busy with their lives.
    Are there any other barriers that we need to be working on 
to ensure that people--that there's not a cost barrier or just 
the access?
    Dr. Messonnier. Thank you for those comments, and I think, 
you know, in addition to the issue with the vaccine 
effectiveness that Dr. Fauci talked about, certainly a big 
difference between where we are with measles and influenza is 
vaccination coverage.
    And as you point out, it is a good buy for people as 
individuals and businesses to keep their employees safe. And 
health systems, we can actually show that, for example, in 
people over 65, it's much more effective from a cost 
perspective to prevent the flu than it is to take care of 
people once they get sick.
    And I think the final thing that you were mentioning is 
really important, which is we need to make it easy for people 
to make the healthy choice for themselves and their families by 
making it easy for them to get the flu vaccine.
    Half of adults are actually getting vaccinated outside 
their medical--their doctor's office. They're getting 
vaccinated at pharmacies and drug stores and supermarkets, and 
they're getting vaccinated in the workplace. Children, some 
States have actually had a lot of success in school-based 
vaccination programs where kids are vaccinated while they're in 
school, making it much more convenient for parents.
    And one of the things that we're doing is exploring all of 
those strategies to see what we can do again to make it easy 
for people to make healthy decisions.
    Ms. Castor. Well, I've had my flu shot, and everyone in my 
office, we have a Let's Get Our Flu Shot Day, and everyone--we 
apply a little peer pressure for those that might need it 
because it's so important. We want everyone to be healthy and 
well. And if you haven't gotten your flu shot yet, you better 
go out today and go ahead and do that.
    Thank you.
    Ms. DeGette. I thank the gentlelady.
    The Chair now recognizes the gentleman from Virginia for 5 
minutes.
    Mr. Griffith. Thank you very much, Madam Chair.
    Congresswoman Castor set up one of my questions very well, 
Dr. Messonnier. She said that, you know, you can go to the VA 
and get your shot. Most of the studies that have been done on 
the--let me make sure I get the wording correct--the high-dose 
vaccine have shown that it's much more effective for people 
over the age of 65, which was a part of your answer back to 
her. But, because the CDC has not made that a preferred--let me 
make sure I get--a preferred recommendation, the VA hospitals 
can't give that to people over 65, so they have to go somewhere 
else. A lot of doctors are giving it, but the VA can't give it.
    So, that being said, with the studies out there, what do we 
need to do to get the CDC to make this a preferred 
recommendation for the high-dose flu vaccine, because it looks 
like we're--you know, she mentioned it, not knowing I was going 
in this direction, that a lot of people go to the VA hospital 
and a lot of our veterans do.
    But if you're over the age of 65, you probably ought to be 
getting this not-yet-CDC-preferred treatment, but the high-dose 
vaccine, but you're not able to get it there.
    Dr. Messonnier. Actually, thank you for the opportunity to 
comment on this. There are actually nine different flu vaccines 
available this season, and eight of those are licensed for 
people over 65. So the complication is the comparison of every 
single one of those products to know which ones are better and 
which ones are not.
    CDC, as I expect you would not be surprised, is 
understandably cautious about making preferential 
recommendations because we need to be sure that a vaccine that 
we're going to prefer is not just effective this season but is 
effective, is preferential, better, every season. And since 
every flu season is so different, we tend to be cautious.
    That being said, we're taking this issue very seriously. 
Since last year, we've launched new, more robust studies to 
examine the vaccines that are available in this age group, and 
we have an interagency working group with our Federal partners 
so that we can make sure that we're covering all the watershed 
of all the studies that need to be done.
    We've also put this back to our advisory committee to ask 
them to look again at the available data and consider this 
issue. The issue will be considered as all of these issues are 
in our public meeting where folks can see the debate and see 
how they come--you know, what conclusions they come to.
    So we take the issue very seriously, but again, 
understandably cautious about making a recommendation like 
that.
    Mr. Griffith. But you said eight of the nine are actually 
considered preferred.
    Dr. Messonnier. No, licensed. Of the nine available 
vaccines, eight of them are licensed for people over 65.
    Mr. Griffith. OK. But this is dealing with the high-dose 
vaccine, and according to the data I have here, there have been 
14 studies over nine consecutive seasons, 14 million study 
participants, and only one of those studies did not say that it 
was preferred or that it was better for people over the age of 
65 to get the high-dose vaccine.
    Dr. Messonnier. So that is a comparison of one company's 
high-dose vaccine against the same company's regular dose 
vaccine.
    Mr. Griffith. Uh-huh.
    Dr. Messonnier. The problem is that there are more than one 
high-dose vaccine and also adjuvanted vaccines in that age 
group. The other issue, back to the issue Dr. Fauci was talking 
about, is that we need to make sure that it's preferential--
that it's more effective against every one of the potential 
strains of flu vaccine, which means we need more robust data, 
not just effectiveness against H1N1 but against H3N2 and both 
types of B, be confident that a preferential recommendation 
will be right every single season.
    Mr. Griffith. Well, in the absence of a preferential 
recommendation, can you work with the VA? Will you work with 
the VA to ensure that our veterans over age 65 can receive the 
high-dose vaccine if their doctor thinks that's appropriate?
    Dr. Messonnier. We're obviously always happy to work with 
the VA, and they are a part of this interagency working group 
where we're really robustly trying to get the data together to 
look at this issue really seriously.
    Mr. Griffith. Because outside of the VA, a lot of doctors 
are recommending that for their patients.
    All right. Switching gears because I've just got a few 
seconds left, and I'm just going to make a comment. If we have 
time, Dr. Kadlec and Dr. Fauci, you all can respond, but we 
keep waiting. I've been here now 9 years, which is not nearly 
as long as some of the members of this committee, and every 
year we hear that we're almost there. We're getting there. We 
hear--we see great slides, and you all do great work.
    And Dr. Burgess said you are all some of his favorite 
people. I would agree with that. You all are doing great work, 
but you know, is this year going to be any different? Are we 
going to come back next year, and again, we still won't have 
something that's a non-egg-based vaccine?
    Dr. Fauci. We certainly are better off this year than we 
were last year in our quest for a universal flu vaccine. Last 
year we didn't even have a candidate.
    This year, we're now 8 months in phase one, and by early 
2020, we'll know clearly is it safe and does it induce the kind 
of response that you would predict would be protective. So 
clearly, there's a difference between the last time we spoke at 
the hearing.
    Mr. Griffith. Yes. And there's always advancement. I'm just 
looking for that day when there's--coming from a family with a 
lot egg-based vaccine problems because of the egg-based 
situation, I'm really looking forward to the day when we can 
say that we have more than 50 percent of the vaccine out there 
is non-egg-based.
    I yield back, Madam Chair.
    Ms. DeGette. I thank the gentleman. The gentleman missed 
the slide presentation, and so we will be----
    Mr. Griffith. No. I saw the slide presentation, or I would 
have had a much more biting question. But the presentation was 
great. I saw it. It was good.
    Ms. DeGette. We'll get you a copy.
    The Chair now recognizes the gentlelady from New York for 5 
minutes.
    Ms. Clarke. Thank you, Madam Chair, and I thank our Ranking 
Member Guthrie for convening this very important hearing on the 
influenza virus and what can be done across the Federal 
Government to improve and protect public health as we near peak 
flu season here in the United States.
    I want to thank our expert witnesses for being here today 
to testify on behalf of the CDC, NIH, HHS, and the FDA.
    And while the national targets for vaccination rates for 
the past decade have ranged from 70 to 90 percent, depending on 
the population, it appears as though we are falling woefully 
short of these goals. Last season, only 43 percent of adults 
and 63 percent of children received their annual flu vaccine.
    I'd like to better understand why these vaccination rates 
continue to be so low and what we can do to improve these 
numbers overall, also, specifically, what underserved 
populations. So Dr. Messonnier, what trend has CDC identified 
in recent years with regard to flu vaccination rates, and where 
are we making progress? Where are we falling short?
    Dr. Messonnier. So I share your concern and your 
frustration that vaccination rates for influenza are lower than 
we want them to be. There has been a 5 to 8 percent increase in 
coverage from one year to the next, so the recent trends are 
optimistic, but history has shown us that, you know, that may 
not hold true.
    And I think, as you've said, we have studied this issue. 
When we survey people to ask why they don't get the flu 
vaccine, what they say is that they don't think it works, 
they're concerned that it's not safe, and ``Oh, well, flu isn't 
that serious.''
    We definitely also know that we see lower vaccination 
coverage rates in rural areas, in people of lower socioeconomic 
status, and the data really does indicate that, especially when 
people aren't convinced of the value of a flu vaccine, how easy 
it is to get the vaccine matters.
    Ms. Clarke. Are there particular populations who face 
barriers to accessing the flu vaccine, resulting in coverage 
disparities?
    Dr. Messonnier. I think that our data suggest people of 
lower socioeconomic status, people without health insurance, 
people in rural areas, this is data in children, have lower 
vaccination rates. I'm especially concerned with the issue for 
children because the vaccines for children's program provides a 
safety net for children who can't afford vaccines. Those 
children should be able to get vaccines easily, and yet 
vaccination coverage for children is still unacceptably low.
    Ms. Clarke. Dr. Marks, you've already attested to the 
safety of the flu vaccine. Unlike other vaccines, however, the 
flu vaccine is recommended every season over the course of a 
person's life. What can you tell us about the studies that have 
looked into the long-term effects of the flu vaccine to calm 
concerns people may have? And I know you've said some of it 
already here today, but I think it's worth reiterating.
    Dr. Marks. Thanks very much for that question.
    So both for childhood vaccines and for adult vaccines, 
there have been numerous studies that have looked at the 
vaccination schedules and at repeated vaccination, and FDA 
continues to use its large database surveillance systems to 
look at the safety of vaccines. All indications are that the 
current vaccine regimens are safe and effective for their--in 
their intended schedules, and there's really no reason not to 
get vaccinated routinely and that the benefits greatly outweigh 
any risks.
    Any medical intervention has small risks, but vaccines are 
among the most amazing health interventions of the 20th century 
and of the 21st century, that is, in terms of being public 
health interventions that have reduced illness and prevented 
deaths.
    Ms. Clarke. And, Dr. Fauci, according to your testimony, 
over the last 15 years, the effectiveness of seasonal influenza 
vaccines have ranged from 10 to 60 percent. Why does NIH, along 
with your fellow public health agencies, still recommend the 
flu vaccine each season?
    Dr. Fauci. Thank you for that question, and it's really an 
important question. When you talk about effectiveness, you've 
got to understand that, even if a vaccine is not effective in 
preventing infection, it can clearly mitigate the seriousness 
of the illness, prevent hospitalization, and certainly prevent 
death.
    And that's the reason why you've heard all of us say, 
regardless of what the percent efficacy is on a chart, it is 
always better to get vaccinated than not to get vaccinated, 
because some degree of protection, either against infection or 
the complications of infection, are very important and 
advantageous. So many lives are saved--many, many lives--even 
with a vaccine that is not optimally protective.
    Ms. Clarke. Very well. It is clear that more needs to be 
done to increase the number of people who get vaccinated, 
particularly for those more vulnerable to the flu and 
marginalized from care.
    And improving the vaccination rate will not only serve 
public health in the broad sense, it would also save lives. And 
I think there's an appointment at the attending physician with 
my name on it.
    I yield back, Madam Chair.
    Ms. DeGette. I thank the gentlelady.
    I want to thank the witnesses for coming today. In case 
there's any mistake, the unified, bipartisan message from this 
hearing is: Get your flu shot. This week's a good time to do it 
because it's the flu shot week, and we don't know how bad this 
season's going to be, so everybody needs to get their flu shot.
    It's hard to get such bipartisanship that we were up here 
saying the Members felt like we could all exchange opening 
statements and give each other's opening statements, and they 
would still have the same impact. So it's really important that 
people get their flu shots.
    I want to remind Members that, pursuant to the committee 
rules, they have 10 business days to submit additional 
questions for the record to be answered by witnesses who have 
appeared before the subcommittee. I ask the witnesses to 
respond promptly to any such questions should you receive any, 
and with that, the subcommittee is adjourned.
    [Whereupon, at 12:14 p.m., the subcommittee was adjourned.]
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