[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
govinfo.gov/committee/house-energy
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
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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
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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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