[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
EXAMINING U.S. PUBLIC HEALTH PREPAREDNESS FOR AND RESPONSE EFFORTS TO
SEASONAL INFLUENZA
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTEENTH CONGRESS
SECOND SESSION
__________
MARCH 8, 2018
__________
Serial No. 115-107
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
30-456 PDF WASHINGTON : 2019
-----------------------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Publishing Office,
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center,
U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free).
E-mail, [email protected].
COMMITTEE ON ENERGY AND COMMERCE
GREG WALDEN, Oregon
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
FRED UPTON, Michigan BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
MICHAEL C. BURGESS, Texas ELIOT L. ENGEL, New York
MARSHA BLACKBURN, Tennessee GENE GREEN, Texas
STEVE SCALISE, Louisiana DIANA DeGETTE, Colorado
ROBERT E. LATTA, Ohio MICHAEL F. DOYLE, Pennsylvania
CATHY McMORRIS RODGERS, Washington JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey DORIS O. MATSUI, California
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia JERRY McNERNEY, California
ADAM KINZINGER, Illinois PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida PAUL TONKO, New York
BILL JOHNSON, Ohio YVETTE D. CLARKE, New York
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
CHRIS COLLINS, New York SCOTT H. PETERS, California
KEVIN CRAMER, North Dakota DEBBIE DINGELL, Michigan
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
JEFF DUNCAN, South Carolina
7_____
Subcommittee on Oversight and Investigations
GREGG HARPER, Mississippi
Chairman
H. MORGAN GRIFFITH, Virginia DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
JOE BARTON, Texas JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas KATHY CASTOR, Florida
SUSAN W. BROOKS, Indiana PAUL TONKO, New York
CHRIS COLLINS, New York YVETTE D. CLARKE, New York
TIM WALBERG, Michigan RAUL RUIZ, California
MIMI WALTERS, California SCOTT H. PETERS, California
RYAN A. COSTELLO, Pennsylvania FRANK PALLONE, Jr., New Jersey (ex
EARL L. ``BUDDY'' CARTER, Georgia officio)
GREG WALDEN, Oregon (ex officio)
(ii)
C O N T E N T S
----------
Page
Hon. Gregg Harper, a Representative in Congress from the State of
Mississippi, opening statement................................. 1
Prepared statement........................................... 3
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 4
Prepared statement........................................... 5
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 6
Prepared statement........................................... 8
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, prepared statement........................ 85
Witnesses
Anne Schuchat, M.D., Acting Director, Centers for Disease Control
and Prevention, Department of Health and Human Services........ 10
Prepared statement........................................... 12
Answers to submitted questions............................... 101
Anthony S. Fauci, M.D., Director, National Institute of Allergy
and Infectious Diseases, National Institutes of Health,
Department of Health and Human Services........................ 18
Prepared statement........................................... 20
Slide presentation........................................... 31
Answers to submitted questions............................... 106
Rick Bright, Ph.D., Deputy Assistant Secretary for Preparedness
and Response, and Director, Biomedical Advanced Research and
Development Authority, Office of the Assistant Secretary for
Preparedness and Response, Department of Health and Human
Services....................................................... 43
Prepared statement........................................... 45
Answers to submitted questions \1\........................... 110
Scott Gottlieb, M.D., Commissioner of Food and Drugs, Food and
Drug Administration, Department of Health and Human Services... 56
Prepared statement........................................... 58
Answers to submitted questions............................... 112
Submitted Material
Subcommittee memorandum.......................................... 86
----------
\1\ Dr. Bright did not answer submitted questions for the record
by the time of printing.
EXAMINING U.S. PUBLIC HEALTH PREPAREDNESS FOR AND RESPONSE EFFORTS TO
SEASONAL INFLUENZA
----------
THURSDAY, MARCH 8, 2018
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:56 a.m., in
room 2123, Rayburn House Office Building, Hon. Gregg Harper
(chairman of the subcommittee) presiding.
Members present: Representatives Harper, Griffith, Burgess,
Brooks, Collins, Walberg, Walters, Carter, Walden (ex officio),
DeGette, Schakowsky, Castor, Tonko, and Ruiz.
Also present: Representative Green.
Staff present: Jennifer Barblan, Chief Counsel, Oversight
and Investigations; Adam Buckalew, Professional Staff Member,
Health; Karen Christian, General Counsel; Ali Fulling,
Legislative Clerk, Oversight and Investigations, Digital
Commerce and Consumer Protection; Ed Kim, Policy Coordinator,
Health; Jennifer Sherman, Press Secretary; Alan Slobodin, Chief
Investigative Counsel, Oversight and Investigations; Austin
Stonebraker, Press Assistant; Natalie Turner, Counsel,
Oversight and Investigations; Hamlin Wade, Special Advisor for
External Affairs; Christina Calce, Minority Counsel;
Christopher Knauer, Minority Oversight Staff Director; and
Miles Lichtman, Minority Policy Analyst.
OPENING STATEMENT OF HON. GREGG HARPER, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MISSISSIPPI
Mr. Harper. Good morning.
This year, like so many previous years, we have had a bad
flu season. After months of record-breaking, widespread flu
activity, the CDC has reported that the flu season has finally
peaked. We are probably still going to see flu activity until
the middle of April, so if you have the flu or flu symptoms, it
certainly is important to see your doctor and stay at home.
Influenza is a leading cause of death in the United States,
especially in a severe flu season. Every year, thousands of
Americans die from the flu and thousands more are hospitalized
from flu-related complications. Since 2010, the flu has caused
between 12,000 and 56,000 deaths per year.
This year was no exception. Tragically, as of February the
24th, there have already been 114 influenza-associated
pediatric deaths this season. Some of those deaths have
occurred in my home State of Mississippi. Although we have
enhanced our preparedness for the flu in recent years, there is
still room for improvement.
The best way to prevent the flu is by getting your flu
shot. Millions of Americans receive a flu shot every year to
help protect them against this illness. Unfortunately, there
are many Americans that do not do that. Last year, only 59
percent of children and about 43 percent of adults received flu
vaccination.
Even though only a little over half of Americans typically
get vaccinated, CDC estimates that flu vaccination prevented
3,000 pneumonia and influenza deaths during the 2015-2016 flu
season alone. Increasing the number of Americans that get the
annual flu vaccine will prevent more deaths and illnesses.
Not only can the flu vaccine help prevent an individual
from getting the flu, but it also helps reduce severe outcomes
when someone does get sick with the flu. During past seasons,
about 80 percent of flu-associated deaths in children have
occurred in children who were not vaccinated.
Similarly, a recent study found that receiving the flu
vaccine reduced severe outcomes in hospitalized patients by
reducing deaths, reducing ICU admissions, reducing ICU length
of stays, and reducing overall length of stay for hospital
patients.
While the flu vaccine is currently the best tool to prevent
illness, there is room for improvement. The CDC recently
announced that this year's flu vaccine was only about 36
percent effective in preventing an individual from getting the
flu. The vaccine's effectiveness varied from different age
groups and for different strains of the virus. For example, the
vaccine was 59 percent effective in children. However, it was
much less effective in adults. For all age groups, the vaccine
was only 25 percent effective this season against the deadliest
strain of the flu, H3N2.
The vaccine's reduced effectiveness against H3N2, the most
virulent and predominant strain of the flu this season, is
especially concerning. Historically, we have struggled to make
an effective vaccine against H3N2.
For example, during the 2014-2015 flu season, this
committee closely examined the flu vaccine's reduced
effectiveness due to the mismatch between the H3N2 strain used
to develop the vaccine and the H3N2 strain that was actually
circulating.
During the 2014-2015 season, the flu vaccine was only 9
percent effective because the H3N2 virus had mutated before the
flu season began. This experience reminded us of the importance
of being able to rapidly detect and respond to changes in the
challenging and circulating flu viruses.
According to the FDA, this year, the vaccine's reduced
effectiveness against the H3N2 virus was not caused by a
mismatch. One factor that may explain why the flu vaccine was
not that effective against the H3N2 strain is a mutation caused
by the vaccine and egg adaptation through the egg-based
manufacturing process.
Currently, about 80 to 85 percent of the flu vaccines are
manufactured through the egg-based manufacturing process. When
an inactivated flu virus is grown in chicken eggs during the
vaccine manufacturing process, genetic changes can occur in the
virus that make the vaccine less effective in humans. Some
researchers think that egg adaptation might be especially
problematic for the H3N2 virus.
Of course, there are many different factors that also might
explain the flu vaccine's reduced effectiveness for H3N2. This
issue needs to be thoroughly investigated so we can improve the
vaccine manufacturing process, if necessary, and improve the
vaccine's effectiveness in the future.
I appreciate the hard work and dedication of the people at
HHS to improve our flu preparedness, including those at CDC,
NIH, ASPR, and FDA. One of our top priorities is to keep
Americans healthy during flu season and improve the Federal
public health response. And I look forward to today's
testimony.
[The prepared statement of Mr. Harper follows:]
Prepared statement of Hon. Gregg Harper
Good morning. This year, like so many previous years, we've
had a bad flu season. After months of record-breaking
widespread flu activity, the CDC has reported that the flu
season has finally peaked. We're probably still going to see
flu activity until the middle of April, so if you have the flu
or flu symptoms, it is important to see your doctor and stay
home.
Influenza is a leading cause of death in the United States,
especially in a severe flu season. Every year, thousands of
Americans die from the flu and thousands more are hospitalized
from flu-related complications. Since 2010, the flu has caused
between 12,000 and 56,000 deaths per year. This year was no
exception. Tragically, as of February 24, there had already
been 114 influenza-associated pediatric deaths this season.
Some of these deaths have occurred in my home State of
Mississippi.
Although we've enhanced our preparedness for the flu in
recent years, there is still room for improvement. The best way
to prevent the flu is by getting your flu shot. Millions of
Americans receive a flu shot every year to help protect them
against illness. Unfortunately, there are a lot of Americans
who do not get vaccinated. Last year, only 59 percent of
children and about 43 percent of adults received the flu
vaccination. Even though only a little over half of Americans
typically get vaccinated, CDC estimates that flu vaccination
prevented 3,000 pneumonia and influenza deaths during the 2015-
2016 flu season alone. Increasing the number of Americans that
get the annual flu vaccine will prevent more deaths and
illnesses.
Not only can the flu vaccine help prevent an individual
from getting the flu, but it also may help reduce severe
outcomes when someone does become sick with the flu. During
past seasons, about 80 percent of flu-associated deaths in
children have occurred in children who were not vaccinated.
Similarly, a recent study found that receiving the flu vaccine
reduced severe outcomes in hospitalized patients by reducing
deaths, reducing ICU admissions, reducing ICU length of stay,
and reducing overall length of stay for hospital patients.
While the flu vaccine is currently the best tool to prevent
illness, there is room for improvement. The CDC recently
announced that this year's flu vaccine was only about 36
percent effective in preventing an individual from getting the
flu. The vaccine's effectiveness varied for different age
groups and for different strains of the virus.
For example, the vaccine was 59 percent effective in
children; however, it was much less effective for adults. For
all age groups, the vaccine was only 25 percent effective this
season against the deadliest strain of the flu, H3N2.
The vaccine's reduced effectiveness against H3N2, the most
virulent and predominant strain of the flu this season, is
especially concerning. Historically, we have struggled to make
an effective vaccine against H3N2. For example, during the
2014-2015 flu season, this committee closely examined the flu
vaccine's reduced effectiveness due to the mismatch between the
H3N2 strain used to develop the vaccine and the H3N2 strain
that was circulating. During the 2014-2015 season, the flu
vaccine was only 19 percent effective because the H3N2 virus
had mutated before the flu season started. This experience
reminded us of the importance of being able to rapidly detect
and respond to changes in the circulating flu viruses.
According to the FDA, this year the vaccine's reduced
effectiveness against the H3N2 virus was not caused by a
mismatch. One factor that may explain why the flu vaccine was
not that effective against the H3N2 strain is a mutation caused
by the vaccine and egg adaptation through the egg-based
manufacturing process.
Currently, about 80 to 85 percent of the flu vaccines are
manufactured through the egg-based manufacturing process. When
an inactivated flu virus is grown in chicken eggs during the
vaccine manufacturing process, genetic changes can occur in the
virus that make the vaccine less effective in humans. Some
researchers think that egg adaptation might be especially
problematic for the H3N2 virus. Of course, there are many
different factors that also might explain the flu vaccine's
reduced effectiveness for H3N2. This issue needs to be
thoroughly investigated so we can improve the vaccine
manufacturing process if necessary and improve the vaccine's
effectiveness in the future.
I appreciate the hard work and dedication of the people at
HHS to improve our flu preparedness, including those at CDC,
NIH, ASPR, and FDA. One of our top priorities is to keep
Americans healthy during flu season and improve the Federal
public health response. I look forward to today's testimony.
Mr. Harper. The Chair will now recognize the ranking
member, Ms. DeGette, for purposes of an opening statement.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you so much, Mr. Chairman.
I am always happy to have this flu hearing, which we seem
to do every year. Looking at the witnesses, I feel like we are
getting the band back together again to talk once again about
what we can do.
I appreciate you all coming, and I am hoping that this year
we can actually make some progress in talking about all of
these issues that the chairman mentioned.
We have had in this subcommittee seven hearings on flu
preparedness since 2004. Most recently, in 2015, we had two
hearings after the country was hit with a particularly severe
2014 and '15 flu season, in which the H3N2 strain of flu
predominated. This year, again, we are experiencing a severe
flu season caused by the H3N2, and that is really a stark
reminder of how the flu is very, very serious.
Hospitalizations have been high throughout the country. A
hundred and fourteen children have died. As an example, my home
State of Colorado set two records, not good records, this year,
with nearly 4,000 people hospitalized due to flu and 160 flu
outbreaks in long-term-care facilities.
As the chairman mentioned, this year's flu vaccine was only
36 percent effective, and that is of concern. Even I had the
flu, and I had my vaccine, too.
And so, you know, this really is something that one would
think in the year 2018 we would be able to tackle in a more
meaningful way.
I understand that the FDA's Vaccine Advisory Committee just
met to make recommendations for next year's vaccine. I am
looking forward to hearing from the FDA about how data on this
year's vaccine effectiveness helped to inform the
decisionmaking for next year.
I am also hoping, as usual, to hear more about research
efforts to produce a more broadly protective vaccine or even a
universal vaccine that can target all strains of flu.
And, Mr. Chairman, we have talked in these various hearings
over the years about the egg-based vaccines. And the mutation
of the virus within the egg is only one of the problems with
egg-based vaccines. When you look at the more remote but yet
very real threat of a pandemic flu, if you are relying on egg-
based vaccines, you can't be very nimble in producing vaccines
in an effective and fast way.
And so I think that, this year, if it is any good news, a
silver lining about the ravages of this flu season, maybe it
will make the public understand how important this issue is for
our public health agencies to address.
And I know all of our witnesses will remind us, even a
vaccine with a low effectiveness rate will still protect
millions from getting sick or may help mitigate the symptoms
when people do get sick. And so, until we fix this system in a
broader way, the flu vaccine is still our best tool.
But, unfortunately, the number of Americans who got a flu
shot this year has not changed from our last hearing in 2015. I
am hoping that that is another thing we can discuss, about how
we can persuade people to get the vaccine and concrete steps
that perhaps we can take next year.
As I said, we also have to work towards better treatment
methods--in particular, more effective antiviral medications so
that people who do become sick can be cared for before their
illness becomes more serious. And I understand there are some
of these medications in the pipeline right now. Maybe some of
our witnesses can talk about these drugs that are in the
pipeline, and also maybe they can talk about some of the spot
shortages we saw this past season.
Finally, the importance of a strong public health
infrastructure cannot be overstated. Because of the critical
work of Federal and State public health experts, we are always
in a good position, but there is still more that needs to be
done. And I am looking forward to hearing how we can coordinate
our strategies across all levels of Government.
So, Mr. Chairman, again, I want to thank the witnesses who
are here today, some of which I have worked with for years.
They are true public servants and truly dedicated to tackling
this issue. And I know they will be our partners in this
committee as we continue to go forward.
Thanks, and I yield back.
[The prepared statement of Ms. DeGette follows:]
Prepared statement of Hon. Diana DeGette
Thank you, Mr. Chairman, for convening this important
hearing. This is a bipartisan issue, and I look forward to
finding areas where we can work together on preparing our
Nation against this threat.
Flu preparedness and response is incredibly important, and
the committee has a long history of addressing this issue. We
have held seven hearings on flu preparedness since 2004. Most
recently, in 2015, we held two hearings after the country was
hit with a particularly severe 2014-15 flu season in which the
H3N2-strain of flu predominated.
This year, we are again experiencing a severe flu season
caused by H3N2. It has been a stark reminder of just how
serious the flu can be.
Hospitalizations have been high throughout the country, and
114 children have died.
As an example, my home State, Colorado, has set two records
this year, with nearly 4,000 people hospitalized due to flu,
and 160 flu outbreaks in long term care facilities.
I am troubled by the news that this year's flu vaccine was
only 36 percent effective, although I realize that this number
is different for different age groups.
I want to hear from our witnesses today about what ``36
percent effective'' means, and what research must be done to
help our seasonal flu vaccine offer more protection.
I understand that FDA's vaccine advisory committee actually
just met to make recommendations for next year's vaccine. I
hope that FDA will tell us how data on this year's vaccine
effectiveness helped to inform decision for next year.
I also hope that we will hear more about research efforts
designed to produce a more broadly protective vaccine, or
perhaps even a universal vaccine that can target all strains of
flu.
I know that the flu virus is particularly hard to vaccinate
against, but I also know that we have some of the brightest
minds in the country working on this issue.
I am sure that I echo the thoughts of many of my colleagues
when I say that work towards better vaccine must be a priority
for our public health agencies.
As our witnesses will remind us today, though, even a
vaccine with a low effectiveness rate will still protect
millions from getting sick. The flu vaccine remains the best
tool we have to protect as many people as possible.
Only around forty percent of Americans received a flu shot
this year. This number has not changed from the last time we
had a flu hearing, in 2015. We can and must do better, and I
hope that our witnesses today are prepared to discuss concrete
steps that we can take to increase vaccination rates in this
country.
We also must work towards better treatment methods, in
particular more effective antiviral medications, so that people
who do become sick can be cared for before their illness
becomes more serious.
I hope that our witnesses today will describe the new drugs
in the pipeline. I also hope that they are prepared to address
the spot shortages we saw this past season, which may have
prevented some individuals from being treated as quickly as
they otherwise might have been.
Finally, the importance of a strong public health
infrastructure that allows us to prepare and respond cannot be
overstated.
Because of the critical work of our Federal and State
public health experts, we are in a good position, but there is
always more work to be done. We need coordinated response
capabilities, effective communication strategies, and critical
investments so we can strengthen our response to seasonal flu.
I look forward to hearing about how far we have come and
what more needs to be done to strengthen our national
preparedness.
Mr. Chairman, let me conclude by acknowledging and thanking
the witnesses and the agencies before us today. We are
fortunate to have your talent on the frontlines in the ongoing
fight against infectious diseases, including influenza.
We should thank you by ensuring that you always have the
tools and resources you need to remain on the cutting edge of
science and preparedness, and I hope you can tell us what you
need going forward.
I look forward to working together to move the country
toward better flu preparedness.
Ms. DeGette. Oh, also, I would ask unanimous consent to put
Mr. Pallone's opening statement in the record. He will not be
able to come today.
Mr. Harper. Without objection.
[The prepared statement of Mr. Pallone appears at the
conclusion of the hearing.]
Mr. Harper. The gentlewoman yields back.
The Chair now recognizes the chairman of the full
committee, Mr. Walden, for the purposes of an opening
statement.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. I thank the chairman, and I thank our witnesses
for being here today.
You know, this has been, I think, one of the most severe
flu seasons in the United States that we have seen. Nearly
50,000 people die in a single season. Today, we are currently
experiencing a severe flu season with a predominantly deadly
strain, by all accounts. It is vital to find ways to reduce
deaths and hospitalizations from this challenging and changing
virus.
At Energy and Commerce, and this subcommittee in
particular, we have a long history, as you have heard, of
connecting these oversight hearings and trying to be as helpful
as we can to you all as we work on the public policy.
During our last hearing, in November of 2015, we explored
many important issues, including how the Department of Health
and Human Services could help improve our ability to respond to
seasonal flu vaccine mismatches.
For more than 70 years, most flu vaccines have been made
through an egg-based process, and over the last decade we have
seen some innovation in the manufacture of the annual flu
vaccine. The FDA approved the first flu vaccine manufactured
using cell culture technology in 2012. And the FDA approved the
first flu vaccine manufactured using recombinant DNA technology
in 2013.
And in addition to new manufacturing technologies and
methodologies, we have also seen new types of flu vaccine made
available for the American people. Historically, flu vaccines,
I understand, have been offered to protect against three
different strains of flu virus. And, in 2012, the FDA approved
the first flu vaccine that offered protection against four
different strains. In '09, the FDA approved the first high-dose
flu vaccine for older adults, and some data show that the high-
dose flu vaccine is more effective in older individuals than
the normal dose.
Now that we have different ways to manufacture the flu
vaccine, we need to ensure we have enough data and information
to make sure we are making the most effective seasonal flu
vaccine possible. The FDA recently announced that preliminary
data show that the cell-based flu vaccine might be somewhat
more effective, I understand, in preventing the flu than the
egg-based vaccine this season. We need to understand why that
might be and why there are differences in effectiveness so we
can improve vaccine manufacturing processes as necessary.
As Subcommittee Chairman Harper has said and emphasized,
the annual flu vaccine is still the best defense. Every year,
thousands of lives are saved because people get that vaccine.
And so, if you do get the flu, there are antivirals, as we
all know. And we have heard--I can't remember a flu season
where more people I know have said, ``Oh, yeah, I got Tamiflu''
or ``Somebody I know got Tamiflu'' or whatever the antivirals
are. So that is an important part of this, as well. And I would
love for you to talk a bit about what has been in the press
about the Japanese product, apparently, in Japan that might cut
off the flu even sooner and what you see on that one, if
anything.
And one day we hope to have a universal vaccine. We are
encouraged by the National Institute of Allergy and Infectious
Disease's recent release of a strategic plan for developing a
universal flu vaccine.
I am also glad we have all of you here today and the
director of the Biomedical Advanced Research and Development
Authority here to share the information that you all are
working on. So thank you.
[The prepared statement of Mr. Walden follows:]
Prepared statement of Hon. Greg Walden
Thank you, Mr. Chairman, for holding this hearing on the
very important issue of public health preparedness for and
response efforts to the seasonal influenza. America is
experiencing a severe flu season with a predominant deadly
strain. In a bad flu season, more than 50,000 people die,
nearly as many as the Nation lost during the Vietnam War. It is
vital to find ways to reduce deaths and hospitalizations from
this challenging virus.
This is the reason why the committee has a long history of
conducting oversight of the effectiveness of the flu vaccine
and the Federal Government's overall response to the seasonal
influenza. During our last hearing in November 2015, we
explored many important issues including how HHS could help
improve our ability to respond to seasonal flu vaccine
mismatch.
For more than 70 years, most flu vaccines have been made
through an egg-based process. Over the last decade, we have
seen some innovation in the manufacturing of the annual flu
vaccine. FDA approved the first flu vaccine manufactured using
cell culture technology in 2012, and FDA approved the first flu
vaccine manufactured using recombinant DNA technology in 2013.
In addition to new manufacturing methodologies, we've also
seen new types of flu vaccines available for Americans.
Historically, flu vaccines have offered protection against
three different strains of the flu virus. In 2012, however, FDA
approved the first quadrivalent flu vaccine that offered
protection against four different strains of the flu virus. In
2009, FDA approved the first high-dose flu vaccine for older
adults and some data shows that the high-dose flu vaccine is
more effective in older individuals than the normal dose.
Now that we have different ways to manufacture the flu
vaccine, we need to ensure that we have enough data and
information to make sure we're making the most effective
seasonal flu vaccine possible. FDA recently announced that
preliminary data shows that the cell-based flu vaccine might be
somewhat more effective in preventing the flu than the egg-
based vaccine this season. We need to understand why there
might be a difference in effectiveness, so we can improve the
vaccine manufacturing process if necessary.
As Subcommittee Chairman Harper appropriately emphasized in
his opening statement, the annual flu vaccine is the best way
to prevent the flu. Every year, thousands of lives are saved by
the flu vaccine. According to the CDC, flu vaccination during
the 2015-2016 flu season prevented about 5.1 million illnesses,
2.5 million medical visits, 71,000 hospitalizations, and 3,000
pneumonia andinfluenza deaths. That's a lot of people that were
helped by the flu vaccine. Even with below-average overall
effectiveness, this year's vaccine was about 60 percent
effective for children aged 6 months to 8 years.
If you do get the flu, there are antivirals available to
treat your illness. We look forward to hearing from CDC today
about their education and outreach strategies to ensure
providers and patients are aware of the importance of
antivirals to treat the flu.
One day, we hope to have a universal vaccine and we're
encouraged by the National Institute of Allergy and Infectious
Diseases' recent release of a strategic plan for developing a
universal flu vaccine. I know that we're still a long way from
having a universal vaccine, but I'm looking forward to hearing
updates from NIH today on our progress in achieving this goal
and the challenges that we face indeveloping a universal
vaccine. I'm also glad that we have BARDA here today to share
information about their work in helping to develop better flu
vaccines and improve seasonal and pandemic influenza
preparedness.
I would be remiss if I didn't mention the related issues of
pandemic influenza preparedness. Last year, the committee wrote
to HHS about the status of the Pandemic Influenza Plan, which
had not been updated in quite some time. I was pleased that HHS
released the updated plan not long after receiving our letter,
and recognized that pandemic and seasonal influenza planning
are interdependent because of the continually changing nature
of flu viruses.
I appreciate the hard work and dedication of the people at
HHS to protect Americans from the flu and its deadly
consequences. I'm looking forward to our conversation today and
to learning more about how we can continue to improve our
preparedness for, and response to, the seasonal influenza.
Mr. Walden. And, with that, I would yield the remainder of
my time to the chairman of the Health Subcommittee, the good
doctor from Texas, Dr. Burgess.
Mr. Burgess. Thank you, Mr. Chairman.
And I want to thank our witnesses for taking the time to
testify before us today. Most of you are well-known to this
subcommittee.
The flu has hit many of our districts with astonishing
force this year. The district that I represent in north Texas,
our public health departments were strained. We had schools
that had to close temporarily to prevent the spread of flu
amongst children. Since the start of this flu season, more than
400 people in my area have been hospitalized as a result of the
flu. Twelve reported influenza-associated deaths, including one
pediatric death.
Earlier this year, the Health Subcommittee was briefed by
Dr. Fauci and someone from the CDC about the development and
effectiveness of this year's flu vaccine. The timing of this
particular hearing is appropriate, given that we are just past
the peak of flu season, and now people are working on the
development of next year's vaccine, and we are all anxious to
hear what awaits for next year.
Mr. Chairman, thank you for holding this important and
timely hearing, and I certainly look forward to hearing from
our witnesses. And I yield back.
Mr. Harper. The gentleman yields back.
I ask unanimous consent that the Members' written opening
statements will be made part of the record.
Without objection, they will be entered into the record.
Additionally, I ask unanimous consent that Energy and
Commerce members not on the Subcommittee on Oversight and
Investigations be permitted to participate in today's hearing.
Without objection, so ordered.
I now would like to introduce our witnesses for today's
hearing.
First, today, we have doctor Anne Schuchat, the Acting
Director for the Centers for Disease Control and Prevention.
We welcome you today.
Second, we have Dr. Anthony Fauci, the Director of the
National Institute of Allergy and Infectious Diseases at the
National Institutes of Health.
Then we have Dr. Rick Bright, the Deputy Assistant
Secretary for Preparedness and Response and Director of the
Biomedical Advanced Research and Development Authority at the
Office of the Assistant Secretary for Preparedness and
Response, which means there's no way that gets on a business
card.
But we're glad to have you here.
And, finally, the Honorable Scott Gottlieb, who serves as
the Commissioner for the U.S. Food and Drug Administration.
I want to thank you each for being here. This is a very
important topic, and we look forward to having this discussion
today.
Are you each aware that the committee is holding an
investigative hearing and, when so doing, we have the practice
of taking testimony under oath? Does anyone have an objection
to testifying under oath?
Seeing none, the Chair then advises you that, under the
rules of the House and the rules of the committee, you are
entitled to be accompanied by counsel. Do any of you desire to
be accompanied by counsel for the purposes of today's hearing?
Seeing none, in that case, if you would please rise and
raise your right hand, and I will swear you in.
[Witnesses sworn.]
Mr. Harper. You are now under oath and subject to the
penalties set forth in title 18, section 1001 of the United
States Code. And you may now each give a 5-minute summary of
your written statement.
And we will begin first with Dr. Schuchat, and you are now
recognized for 5 minutes.
STATEMENTS OF ANNE SCHUCHAT, M.D., ACTING DIRECTOR, CENTERS FOR
DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES; ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE
OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF
HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES; RICK BRIGHT,
PH.D., DEPUTY ASSISTANT SECRETARY FOR PREPAREDNESS AND
RESPONSE, AND DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND
DEVELOPMENT AUTHORITY, OFFICE OF THE ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES; AND SCOTT GOTTLIEB, M.D., COMMISSIONER OF FOOD AND
DRUGS, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN SERVICES
STATEMENT OF ANNE SCHUCHAT
Dr. Schuchat. Good morning, Mr. Chairman and members of the
committee.
Influenza is a formidable adversary. The virus is ever-
changing, it is with us every year, and it's too often able to
outsmart our immune systems. At CDC, we have worked with
domestic and global partners to build cutting-edge systems to
characterize influenza viruses and the disease they cause and
to monitor vaccine effectiveness.
We know that people are concerned about this flu season,
and that concern is warranted. Influenza can be a very serious
threat to the health of Americans. And despite the progress
we've made, we have much more work to do.
I'll provide brief updates about this season and the work
that CDC is doing to improve the tools for influenza prevention
and control.
As you've heard, this has been a severe season.
Hospitalizations have broken records. Influenza-like illness
presenting to doctors' offices and emergency departments at its
peak was about as high as we saw during the pandemic of 2009.
Too many children have died already from influenza this season.
We had intense activity in virtually the whole country at the
same time, and that contributed to some of the spot shortages
of antivirals. We are not over with the season. Disease is
decreasing, but the B strains are starting to be as common as
the H3N2 strains.
As you've heard, the vaccine effectiveness this season was
lower than usual. It was at 36 percent overall and even lower
for the H3N2 strains that dominated. Children did receive
better protection from the flu vaccine--59 percent
effectiveness in children and about 50 percent effectiveness
against the H3N2 strain--a reminder that vaccinating children
can be lifesaving against flu. Sadly, the vast majority of
children who die from influenza have not received any vaccine
at all.
There are many theories about why influenza vaccines work
less well against the H3N2 strains. One theory is that there
are egg-adapted changes that occur in the process of developing
the vaccine. There may be differences in effectiveness based on
prior immunization or prior exposure to flu strains.
We are still characterizing the viruses for this year. We
do not think there was antigenic drift, but there may be some
changes in the viruses that could account for the severe
season. That's still under study.
Some vaccine is better than no vaccine protection. We wish
the vaccines worked better, but we do know that the vaccines
are providing protection to many and they're mitigating the
severity of the disease.
CDC has three objectives in our work with vaccines. We want
to maximize use of the current vaccines. We want to support the
NIH's leadership in developing a universal vaccine. And, in the
near term, we want to improve the current vaccines that we
have.
We have made significant progress since the 2009 pandemic.
We have more data than ever before. We have more information on
vaccine effectiveness from our multi-State network. We are
producing more potential vaccine candidates. We are collecting
more information on the genomic characteristics of the viruses
using next-generation sequencing. We are working with
pharmacies, long-term-care facilities, and insurers to address
the spot shortages of antivirals and were able to smooth things
out a bit during this season, but we know people were still
frustrated.
But, despite the progress we've made, there is much more to
learn about influenza. And we think that investing in that
learning can have direct implications for prevention and
control.
In closing, I know this has been a difficult flu season and
a heartbreaking one for too many families. Flu continues to be
a priority for the CDC. We are literally working 24/7 on this
issue. And we are all, across HHS, committed to working
together to find ways and tools to help Americans reduce their
risk of getting sick.
I look forward to answering your questions.
[The prepared statement of Dr. Schuchat follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Harper. Thank you very much.
The Chair will now recognize Dr. Fauci for 5 minutes for
the purposes of his opening statement.
STATEMENT OF ANTHONY S. FAUCI
Dr. Fauci. Thank you very much, Mr. Chairman, Ranking
Member DeGette, Chairman Walden, members of the committee.
Thank you for giving me the opportunity to talk to you about
the role of the National Institute of Allergy and Infectious
Diseases at the NIH in addressing seasonal and pandemic
influenza.
All right. Next slide.
As you can see, as I have testified before this committee
multiple times, that the NIH research in this case in influenza
is multifaceted, involving basic research, research resources,
clinical research, ultimately with the development of
countermeasures in the form of diagnostics, therapeutics, and
vaccines. For the purpose of today's discussion, I'll focus
only on vaccines.
If I can have the next slide.
As seen in this slide, as mentioned before--and let me
start off by reiterating what you said, what Ms. DeGette said,
and what Anne Schuchat said, is that it is always better to get
vaccinated than not to get vaccinated.
But, in that reality, we can do better with the vaccines
that we have, because the current influenza vaccines are not
consistently effective. We have an example of that this year.
Also, pandemics occur, and the responses are generally not very
effective. We've seen that with the 2009 pandemic flu, and we
continue to chase after potential pandemics like H5N1, H7N9.
Next slide.
The major challenges in influenza vaccinology is we need to
improve on the current influenza vaccines. We need to improve
the production of these from egg-based to cell-based to
recombinant DNA technology, and I'll get back to that in a
moment. And, also, we need to, as Anne mentioned, develop
universal influenza vaccines for broad coverage.
Next slide.
Egg-based technology is time-honored indeed, it has been
effective, but it's antiquated. We need to graduate into the
21st century. Cell-based is better, but recombinant DNA
technologies that I'll get into in a moment, which will be the
tools to which we develop a universal flu vaccine, is the way
of the future.
Next slide.
When you talk about improving seasonal influenza
preparedness, that essentially marries you to preparing for a
pandemic. And I'll explain what I mean.
Next slide.
I wrote an article just recently when we got into the
problem of the growing in eggs, with the adaptation in eggs
leading to a less effective vaccine, to emphasize the need for
a universal flu vaccine.
Next slide.
Now, let me talk to you a little bit about that, because
there are some mechanisms that are simple now but nonetheless
were not fully appreciated before we really understood the
structural biology of these viruses.
On the left-hand part of this slide is an influenza model.
That's the virus. The arrow points to one protein, the
hemagglutinin molecule, which is the part that binds to the
cell receptor that gets you and I sick when we get the flu.
Next slide.
Now, a very interesting thing was noticed several years
ago, is that this is made up, this molecule, of a head and a
stem. Now, this is the way it really looks like, but if you
want to emphasize it, think of a broccoli with a head and a
stalk or a mushroom with a cap and the stalk. The head is the
part that the immune system makes a response against. That's
the good news.
The bad news is that that head is one that has many
mutations that change from season to season--the drift that Dr.
Schuchat spoke about and that Ms. DeGette spoke about. The
stem, however, has few mutations. The little red dots are the
mutations. So the trick is, how do you make a response
selectively against the part of the virus that does not change
as opposed to one that does change?
Next slide.
There are a number of ways of doing that. I'm going to just
show you one example among many.
Investigators at the NIH and funded by the NIH have a
situation now where they can take that molecule, that
hemagglutinin, and essentially shave off the head. It's called
a headless stem. Now, normally, that would fall apart, but it
doesn't fall apart, because investigators at the Vaccine
Research Center have made mutations in the molecule to keep it
stable.
And what we've done, we've put on what's called a
nanoparticle. That's on the far right of the slide. This is
what it looks like 10 million times blown up. So this is a
little particle, but all of these are stems, so that when the
immune system sees that, it doesn't get distracted about
anything else and it focuses in on making an antibody or a
cell-mediated response against something that does not change.
Next slide.
Now, we recently, in June of this year, had a workshop in
Rockville, Maryland, where we called together experts from the
United States and throughout the world to help us at NIH to
develop what we call a pathway to a universal influenza
vaccine.
Next slide.
And I'm happy to say that just a few days ago we recently
published our strategic plan and our research agenda in The
Journal of Infectious Diseases to help us get to the goal that
I've just been describing over the last 5 minutes.
Thank you.
[The prepared statement of Dr. Fauci and his slide
presentation follow:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Harper. Thank you very much for that testimony.
Dr. Bright, we'll now recognize you for 5 minutes for the
purposes of your opening statement.
STATEMENT OF RICK BRIGHT
Dr. Bright. Great. Thank you.
Chairman Harper, Ranking Member DeGette, and distinguished
members of this committee, thank you for the opportunity to
speak with you today on behalf of our Assistant Secretary for
Preparedness Response, the ASPR, to discuss influenza and
progress towards the development and availability of effective
flu vaccines.
I'm Rick Bright, the Director of the Biomedical Advanced
Research and Development Authority, known as BARDA, and also
the Deputy Assistant Secretary for Preparedness and Response.
ASPR's mission is to save lives and protect Americans from
21st-century threats. BARDA is a component of ASPR that was
created to ensure that we have medical countermeasures to
protect people from the dire threats we face as a nation. And
make no mistake, influenza is one of the most dangerous of
those threats.
BARDA was established and empowered with special
authorities in the Pandemic and All Hazards Preparedness Act.
Guided by a national strategy on pandemic influenza and largely
funded through supplemental appropriations, we have proven what
can be done when the Government is able to hire the best
people, work with the best partners, and remain focused on the
strategic fight against influenza. We have shown that the BARDA
model works.
With our industry and our Federal partners, BARDA has
achieved 34 approvals from the FDA for drugs, vaccines, and
diagnostics against a wide range of threats. We have increased
domestic flu vaccine capacity over tenfold in world-class
production facilities. We have shortened the vaccine response
time with modern technologies.
And we have diversified vaccine production platforms, most
of that right here in America. No one can rival BARDA's success
in expanding capacity and pushing new products to the
marketplace. We are proud of these new flu vaccines and the
adjuvants now being produced in Pennsylvania, North Carolina,
Connecticut, and New York. These include the world's first
recombinant flu vaccine and the world's largest cell-based
vaccine production facility.
And we are not done yet. Everything that BARDA and our
partners have done and accomplished for pandemic influenza can
make our seasonal influenza vaccines better and more responsive
to the ever-changing virus. Building on our success, we are
poised and we are partnered to make better flu vaccines
available right now.
Most vaccines today are still made in eggs. Although the
process is optimized for efficiency, it has not changed much
for decades, and it is no match for a rapidly changing virus.
Cell- and recombinant-based technologies are now used to make
licensed vaccines, and they offer speed and greater flexibility
and may even be more effective than traditional egg-based
vaccines.
Despite these advantages, marketplace competition and
limited domestic production capacity have largely kept these
approaches on the shelf, representing only a fraction of the
seasonal vaccine on the marketplace today.
There are actions to improve influenza vaccines now that
can produce dramatic near-term benefit in parallel with the
long-term efforts being undertaken across the Government to
develop a universal flu vaccine. To make better, faster flu
vaccines now, we propose, in collaboration with our industry
partners, to take the following steps to improve the
effectiveness of our existing vaccines:
First, we must expand domestic capacity of the cell- and
recombinant-based vaccines. Second, we must enhance their
effectiveness with the addition of adjuvants or higher doses of
antigen. Third, we need to conduct clinical trials to expand
their use in all age groups. And, finally, we need to continue
modernizing the vaccine production processes for speed and
flexibility.
While we are grateful for the supplemental funding that
disrupted the status quo and fueled our progress, those funds
have been fully obligated. To win this battle, it is critical
that we sustain these hard-won gains and we implement these
steps to reduce the threat we face every year from influenza.
And the near-term vaccine improvement activities are only
one piece of the puzzle. Equally important is the ongoing work
funded by BARDA to develop diagnostics that can detect
influenza sooner as well as more effective drug treatment
options to treat sick people. These priorities, combined with
improved vaccines, represent a comprehensive approach to
protecting the Nation and the world against influenza.
Together with our Federal and our industry partners, we
have made tremendous progress. However, the threat remains. We
stand at a unique moment in time, where we have tools and
capabilities to dramatically enhance our fight against
influenza. I look forward to working with this panel, your
committee, and congressional colleagues.
Thank you for the opportunity to present to you today.
[The prepared statement of Dr. Bright follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Harper. Thank you very much.
The Chair now recognizes Scott Gottlieb for 5 minutes for
the purposes of his opening statement.
STATEMENT OF SCOTT GOTTLIEB
Dr. Gottlieb. Thank you, Mr. Chairman and Ranking Member
DeGette and members of the subcommittee. Thank you for the
invitation to testify on our response to the 2017-2018 seasonal
flu.
This flu season has been particularly hard. I agree with my
colleagues that investing in and working towards a universal
flu vaccine is crucial. Unfortunately, given where we are today
in the development process, that reality is still many years
off.
While we should continue to focus on the discovery of a new
breakthrough vaccine, we must also consider what immediate and
intermediate steps we can take to enhance the production of
existing licensed vaccines and what should be done to invest in
advanced domestic manufacturing to ensure that new and existing
technologies are scalable so that manufacturers meet domestic
and global demand.
There have been successes in developing alternatives to
egg-based vaccines, such as cell-based and recombinant
technologies, in part because of the collaborations and work by
BARDA. However, despite these advances in vaccine development,
the majority of manufacturers are still continuing to produce
egg-based vaccines.
There are reasons for this. The egg-based process works,
and the vaccines are safe and effective. But, even more so, it
would require an enormous investment to fundamentally change
manufacturing.
However, we believe it's worth better understanding the
potential of cell-based or recombinant alternatives. Some
studies have found that cell-based or recombinant vaccines
could be more efficacious than egg-based vaccines, but more
data and analyses are needed.
As one step to better understanding the differences between
egg-based and cell-based technologies, we're using CMS data to
compare Medicare patients that received the cell-based vaccines
to those who received an egg-based vaccine to determine which
vaccine was more effective in that population.
As we consider greater investments in alternative vaccine
development processes, it's important to note, however, that
there are also challenges with these new cell-based approaches.
To help address these challenges, FDA is working to help
develop more effective cell lines that can be better scaled
through continuous manufacturing. We're also looking at how we
develop a more robust recombinant vaccine manufacturing process
to increase yield while reducing cost.
Continuous manufacturing holds great promise for both cell-
based and recombinant vaccines because supply could be more
easily ramped up on short notice. This would allow us to more
rapidly address newly emerging strains or strain drift. Getting
all the necessary preparatory work done is one limiting step of
the egg-based processes.
The FDA can help industry make investments in these new
manufacturing technologies and facilitate such a transition. We
need to develop a science-based framework that includes the
regulatory tools and guidelines for products to be developed in
these systems and to be properly evaluated. And, ultimately,
our investment will provide regulatory clarity for this kind of
new technology. That regulatory framework can increase the
efficiency and reduce the cost of transitioning to this kind of
new cell-based and recombinant product development
manufacturing.
More immediately, as we prepare for next year's flu season
and analyze the data from this year, we're trying to better
understand why this year's vaccine was less effective against
H3N2. At FDA's recent advisory committee meeting, the data
presented continued to suggest that the strains selected for
the 2017 and 2018 vaccines and used by manufacturers reasonably
match the circulating strains. This includes the H3N2 strain.
Although adapting circulating virus strains from
manufacture can lead to differences between the circulating
strains and the one used for manufacturing and although those
changes could affect vaccine effectiveness, the case this year
is likely to be much more complex.
And this year is not the first time we've seen vaccines be
less effective again H3N2. Recent flu vaccines have proven, on
average, to be only about 33 percent effective against the H3N2
viruses. Given this, we're looking at several factors to better
understand why effectiveness tends to be lower against this
strain.
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 get vaccinated with available
vaccines each flu season. And we also must work hard to ensure
that products used to treat the flu, including antivirals and
IV saline, are available and that we take steps to address any
potential shortages.
As always, FDA remains committed to communicating and
sharing updates with the public about all aspects of our flu
response. And I look forward to answering your questions today.
Thank you.
[The prepared statement of Dr. Gottlieb follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Harper. Thanks to each of you for your opening
statements. And, you know, this is an incredible panel of
witnesses that are here today, that cover the entire spectrum
of people that are daily dealing with this important issue. So
thank you for this time, this education you're giving us.
And so I'm going to recognize myself to ask the first set
of questions. And this is for each of you, just for quick
responses, if you would just reply to this.
This year has been an especially difficult and severe flu
season. A lot of lives have been lost, and many people have
been hospitalized. Would you get the vaccine and have your
loved ones get it also?
Dr. Schuchat. Yes. I get the vaccine every year and make
sure my whole family does.
Dr. Fauci. Same here. I got the vaccine this year and every
year over the last as many years as I can remember, as have my
wife and three children.
Dr. Bright. Absolutely.
Dr. Gottlieb. Absolutely, sir. I go to the pediatrician
with my children, and the pediatrician gives it to me and gives
it to them.
Mr. Harper. That's great.
All right. If you get the flu after getting the flu
vaccine, is having gotten the flu vaccine likely to reduce the
severity of the illness?
Dr. Schuchat. Yes. There are studies now that have shown
reduced severity following immunization even when the disease
itself isn't prevented.
Dr. Fauci. That is true, and that's an important point that
many people don't appreciate, because they say, ``I did get the
flu even though I got vaccinated.'' What they don't realize,
that it is likely--not likely, but it is possible that having
gotten the flu without the vaccine would have wound them up in
the hospital, particularly if they were someone in the risk
groups that are more prone to getting complications.
Mr. Harper. Dr. Bright?
Dr. Bright. Absolutely. There's data to support that the
vaccine, even if it's not the most effective vaccine, still
does a lot to reduce the severity of illness and reduce
hospitalization.
Dr. Gottlieb. I would just echo those statements.
Mr. Harper. Great.
Now, I've heard some concerns that some individuals are
worried that they may get the flu from the flu vaccine. Is that
possible?
Dr. Schuchat. No. The flu vaccine cannot cause the flu.
Dr. Fauci. Very few things that you say are impossible, but
this is impossible.
Mr. Harper. OK.
Dr. Bright. Agreed.
Dr. Gottlieb. I agree as well, sir.
Mr. Harper. That's great. There are those misconceptions
out there, that when I had this esteemed group here I wanted to
make sure that people realize those important facts going
forward.
Dr. Schuchat, if I may talk to you for a moment, this year
we've seen a lot of headlines about the flu vaccine's reduced
effectiveness. Later, we're going to ask questions about why we
likely saw reduced effectiveness in the flu vaccine, but,
first, however, I want to ask about vaccine effectiveness for
children this year.
You had answered the effectiveness of that was 59 percent
effective, much better than it was in adults. But why was it
more effective on children than it was, say, older adults?
Dr. Schuchat. We don't have all the answers, but there are
a couple of possible explanations. One is children's immune
response is often better than adults, particularly better than
older adults.
A second is your response to an influenza vaccine may
differ when it's the first time you've ever been exposed to
influenza or the vaccine. You may have a better response. Some
people think that the first influenza you're ever exposed to,
through the vaccine or nature, has a long-term effect on your
immune response.
But we were very pleased to see the better response in
children this year.
Mr. Harper. So how do we communicate that? Why is it
especially important for school-age children to get vaccinated?
How do we communicate that? And, certainly, you would agree
that's true?
Dr. Schuchat. Yes, we have simplified our recommendations
for children, and now we recommend everybody 6 months and over
get a flu vaccine every year. The first time you're getting a
flu vaccine, if you're a young child, you're supposed to get
two doses of the vaccine.
Communication about vaccination has to be multisectoral. We
think the healthcare provider, pediatricians, are the most
important influence on kids getting vaccinated, but we also use
trusted channels, social media, and other influencers.
Mr. Harper. We've obviously seen that the number of
children receiving the flu vaccine has remained steady at just
under 60 percent, and the number of adults receiving flu
vaccines remains fairly steady, between 41 and 43 percent.
So how do we do that, not just for children but for adults
also, to communicate to America the importance of being
vaccinated with a flu vaccine?
Dr. Schuchat. Yes, there is a nuanced message, because
being open and honest is really important and not promising
that the vaccine will, you know, cure cancer--although we have
a vaccine that does that, actually, the HPV vaccine. Sorry. But
I think Americans want us to be open and honest about vaccine
information.
We know that flu vaccines can prevent disease and reduce
severity, and we know that they can also prevent spread.
Children are very important in getting flu disease but also in
spreading it. And so getting higher coverage among children is
in the whole public's interest.
Mr. Harper. That's great. Thank you very much.
The Chair now recognizes Ranking Member DeGette for the
purposes of questions.
Ms. DeGette. Thank you, Mr. Chairman.
Dr. Fauci, I think everybody on this panel agrees with you
when you said that we need to get away from the antiquated
production model, which the egg is.
And I know the chairman, particularly, appreciated your
slideshow. He's new to this subcommittee, so he hasn't seen it
before. And he told me he was a chemistry major, so I'm happy
to have him to educate me.
So the recombinant-based vaccine was only 3 percent last
year, from what I understand. I'm wondering if you can talk to
me, what the barriers are for moving from the current methods
that we have, the egg-based methods which are used for the
majority, to this cutting-edge vaccine.
And I'm going to ask everybody else for their opinion, too,
on that.
Dr. Fauci. Yes. I think there are a few barriers, at least
two, that stand out. One is that there are still scientific
challenges to get the very best recombinant DNA technology. And
there are three or four or five in addition to the one that was
used in the 3 percent from protein sciences, the flu block.
There are things that are even better than that.
So we need--and that was part of what I put, Congresswoman
DeGette, in the strategic plan, that there are scientific gaps
in the arena of what we call platform technology, is different
types of vaccine. That's the first one, scientific obstacle.
The second one that's important is that, whenever you have,
as Dr. Gottlieb mentioned, whenever you have something that's
time-honored and works and is safe, there is an understanding--
fundamental underlying inertia for companies to make a change
to something in which they were going to have to make a major
investment in resources to switch over from one to the other.
Because you have one that you know that works----
Ms. DeGette. Sort of.
Dr. Fauci [continuing]. One that you know is safe. They're
going to have to make an investment.
But the thing that I think we need to emphasize is that
we've got to go there. We can't stay stuck in the old
technologies.
Ms. DeGette. Thank you.
Dr. Bright, do you want to add to that?
Dr. Bright. I think everything Dr. Fauci said is spot-on, I
mean, but, in addition to those, it's about the capacity and
the yields of the new technology. So we've had 70 years to
optimize the efficiency and the yields for an egg-based
vaccine. We've had about 5 years to try to work on optimization
of recombinant and cell-based vaccines. So it's remarkable to
see the progress that's being made in those companies to
improve the efficiency of production and the yields of those
vaccines.
Another challenge, however, though, the vaccine is blended
together in the marketplace, so there hasn't been a focus on
getting the differentiated data set to show the benefit and
effectiveness of egg-based or non-egg-based vaccines. We all
know the benefits of non-egg-based vaccines is speed and
flexibility. Those are critical for a pandemic response. That's
critical if we had to change late season for a virus drift.
We're also getting the additional data now to understand the
true effectiveness difference.
Ms. DeGette. So, Dr. Gottlieb, did you want to add
anything?
Dr. Gottlieb. I agree with my colleagues.
I'll just add, you know, with the recombinant processes,
one of the challenges still is the cell culture and the yield
you're able to derive using the recombinant process. And, you
know, while we've commented that we observed better efficacy
with the cell-based vaccine this year relative to the egg-based
vaccine, it is the case that in some years we observe better
efficacy with the egg-based process versus a cell-based
process.
And so I think the underlying message here, from my
standpoint, is the egg-based process is safe and effective; it
works. The challenge with it----
Ms. DeGette. Sort of.
Dr. Gottlieb [continuing]. Is it's hard to scale----
Ms. DeGette. Right.
Dr. Gottlieb [continuing]. And it's hard to make a
midseason change.
Ms. DeGette. And it's also hard if you have a pandemic flu
that hits.
I'm wondering if any of you can--Dr. Schuchat, did you want
to add? I didn't want to leave you out.
Dr. Schuchat. Yes, just to say that the investments in
vaccine effectiveness studies on a large scale are really
worthwhile. It's only recently that we could tell you that the
effectiveness against H3N2 is less than against H1N1 and B or
that children have higher----
Ms. DeGette. Because the studies were--and so, aside from
funding, I'll ask any of you--I don't have much time left--is
there anything else Congress can do to move this along? Because
I remember years ago asking the same questions. I'm glad we've
made some progress, but clearly we're going to have to get to
the gold standard.
Dr. Gottlieb. I mean, if I may just quickly comment,
Congresswoman, as part of the President's budget this year, we
did put forward a proposal to try to make investments in
continuous manufacturing. That was geared towards this kind of
an opportunity----
Ms. DeGette. Yes.
Dr. Gottlieb [continuing]. To try to establish the
regulatory parameters to enable these innovations to come
forward.
Ms. DeGette. Yes.
Anyone else?
Dr. Bright. And, again, I mean, it does go back to funding
in some ways, but just to support, to encourage the movement to
the modernized technologies, in addition to expanding their
domestic capacities that we have and when we need them.
Ms. DeGette. OK. I think you can say we have got bipartisan
support for that on this committee.
Right, Mr. Chairman?
Mr. Harper. I believe that's true.
Ms. DeGette. Yes.
Mr. Harper. That's great.
Ms. DeGette. Thank you. I yield back.
Mr. Harper. The gentlewoman yields back.
The Chair will now recognize the chairman of the Energy and
Commerce Committee, Greg Walden, for the purposes of questions.
Mr. Walden. Thank you, Mr. Chairman.
And, again, thanks to our very distinguished panel of
witnesses not only for your help in crafting public policy here
today but also the great work you do every day to improve the
lives and the health of Americans and, frankly, people around
the world.
Dr. Gottlieb, one of the treatments that's available for
individuals who get the flu is the antivirals. We've talked
some about that today. Are antiviral drugs more effective the
earlier they are given?
Dr. Gottlieb. They are, Congressman.
Mr. Walden. And how do they work?
Dr. Gottlieb. The currently available----
Mr. Walden. To a layperson.
Dr. Gottlieb [continuing]. Antiviral drug works by blocking
a different step in the replication cycle of the virus itself
than the one that the vaccine targets. The vaccine targets the
ability of the virus to attach to the cell membrane in the
lungs.
Mr. Walden. All right.
And, last week, the FDA issued a press release warning of
fraudulent and unapproved flu products. Why did you feel that
press release was necessary, to warn consumers to be cautious?
Dr. Gottlieb. Because we see a lot of efforts online to try
to entice consumers to purchase products that we know are
fraudulent, that are making false claims, false and misleading
claims, that are claiming to have antiviral and antiflu
effects, when, in fact, they are not approved for those
purposes, including dietary supplements.
Mr. Walden. And if consumers feel like they've been
defrauded, what should they do?
Dr. Gottlieb. Well, they should certainly--I think any
consumer that feels they might have used a product that was
making an inappropriate or fraudulent claim should certainly
contact their medical provider and certainly refer the
information to FDA.
Mr. Walden. All right.
And, recently, as I mentioned in my comments at the
beginning, a new antiviral drug was approved in Japan, or is in
that process, that supposedly has the potential to treat the
flu in just one dose.
Are you familiar with that product? And can you talk to us
a little bit about whether that's the case and what we might
see here?
Dr. Gottlieb. So I'm familiar with the product. I would
defer to my colleagues on the panel a little bit.
I will just say that what the sponsor has said publicly is
that they plan to submit an application at some point this
year. And they currently have disclosed that they have some
studies ongoing in the U.S. looking at a high-risk population.
This is a drug that acts at a different point in the
replication cycle, mechanistically an earlier stage in
replication than the other drug that you referenced, so it is
differentiated. And the other, you know, potential opportunity
is that the onset of action appears to be earlier than the
currently available antiviral.
I think the bottom-line message is that we are very
interested in having a spectrum of antiviral drugs that act
differently, at different points in the virus. In case the
virus itself becomes resistant to one approach at targeting the
virus, we have backups and we have alternative approaches.
Mr. Walden. Very good.
Other members of the panel want to comment on that
specifically? And then I have one other question.
Dr. Bright. If I can add to that, yes, so BARDA has been
engaged with this company developing this drug for quite some
time, as well as some other companies that we're supporting to
develop new classes of antiviral drugs for influenza.
It's critical to note that we have not had a new class of
antivirals approved for influenza in over 20 years.
Mr. Walden. Wow.
Dr. Bright. We rely on a single class of influenza
antivirals now. And the virus, as we know, continues to change,
and resistance to that class of antivirals continues to emerge.
And it's very concerning in avian influenza viruses, such as
pandemic strains H5N1, H7N9, to see these high levels of
resistance emerging to that class of drugs.
So it's remarkable that this company took the lead in
developing a new class of antiviral drug. It has attributes of
a single dose. Instead of 5 days at twice-a-day dosing, it
brings down the viral load in the patient very rapidly, faster
than the currently approved antiviral drugs. And it has this
new mechanism of action, so if a virus becomes resistant to the
only approved class of drugs we have now, this drug would still
work. And it could also be used potentially in combination with
the existing class of drugs.
Another thing exciting about this drug is that they've
partnered now with a U.S.-based company. That U.S.-based
company has taken the lead in bringing that to the FDA for
discussions and consideration for approval in the United
States. And their plans are to transfer the knowledge and the
capability to manufacture that drug in the United States in the
near term.
So, again, it's one of about a dozen or a half-dozen
promising candidates with new mechanisms of action, several of
those supported by BARDA, and even monoclonal antibodies, to
make better treatments for flu.
Mr. Walden. Yes, Dr. Fauci?
Dr. Fauci. So I can't help myself on this, Mr. Chairman,
for the benefit of Chairman Harper, is that Rick Bright said
that this is very extraordinary, that the company did this.
However, the first recognition of this particular mechanism was
in a paper from 1979 in the Proceedings of the National Academy
of Sciences----
Mr. Walden. Who authored that?
Dr. Fauci [continuing]. By the National Institutes of
Health. OK? It's entitled, ``Transfer of 5,-terminal cap of
globin mRNA to influenza viral complementary RNA during
transcription.''
So it just goes to show you, I mean, that basic science is
the root of everything we do, even something that 20 years
later turns into a product made by a Japanese company.
Thank you.
Mr. Walden. We'll let you--that's good. You know? And
that's part of why we did 21st Century Cures, to continue that
funding and that cycle and all.
I was hoping to ask a question about domestic manufacturing
of vaccines and threats and opportunities, but my time has
expired, and maybe we can get some of that as the hearing
continues.
Thank you again for your good work and for being here.
Mr. Harper. The gentleman yields back.
The Chair will now recognize the gentlewoman from Illinois,
Ms. Schakowsky, for 5 minutes.
Ms. Schakowsky. I want to thank you, Dr. Fauci, for that
addendum and the information. I think it's really important to
appreciate how much our researchers and the Federal Government
contribute to addressing these.
So I have some basic questions as just an ordinary consumer
and person. I think, Dr. Schuchat, you might be the person to
ask. Can you tell us generally how easy it is to spread the flu
virus person to person?
Dr. Schuchat. Yes. It varies by strains, but, of course,
this is one of the more infectious or contagious viruses that
we have. And so, in a household, spread is frequent. In a
school, spread is frequent.
It can be spread through respiratory droplets or through
fomites, sort of, on your hand. That's why you've seen us so
many times say cover your nose when you cough or sneeze and
don't touch your eyes or mouth after you're--you know, with
your hands--you know, sort of, wash your hands frequently.
Ms. Schakowsky. And how long is a person contagious with
the flu? Is it possible for a person to be contagious and not
know it?
Dr. Schuchat. You can be contagious before you develop
symptoms, and usually we say about 24 or 48 hours after the
fever goes down. Again, with influenza, it varies by virus and
by year. But that's sort of the general facts.
Ms. Schakowsky. Twenty-four hours to 48 hours after the
fever.
Dr. Schuchat. After the fever goes down.
Ms. Schakowsky. Goes down. Right.
So the CDC recommends that people stay home for 24 hours
after their fever breaks. But I wanted to point out, according
to the Bureau of Labor Statistics, 28 percent of workers have
no access at all to paid sick leave. And this is particularly a
problem for those in the lowest-wage jobs. One-third of lower-
paid workers, including those who work in fields such as food
preparation, have no paid sick leave. And, in fact, the United
States is the only industrialized country in the world without
paid sick leave.
I leave this to anyone, really. Can you explain why it's
important for people to stay home when they're sick?
Dr. Schuchat. We're really trying to limit the spread of
the virus. And so staying home while you're sick will help you
heal but also keep you from the spreading to others.
Ms. Schakowsky. So, in 2016, the National Bureau of
Economic Research found that if paid sick leave were mandated
it would prevent 100 flu-like infections per week for every
100,000 people. So, when people can stay home when they're
sick, people are less likely to get the flu.
So I know this is not your jurisdiction, but I think it's
just important to note that some of the cautions that we
suggest for people are really hard to abide by if you are
depending on that paycheck for that day. I think we need to
think about it. It's a public health issue. Paid sick leave is
a public health issue.
I wanted to also note that Heather Holland in Texas, a
Texas mother, 38 years old, died because she could not afford
the co-pay for Tamiflu, which was $116. And she had insurance,
so this was a co-pay.
So, first of all, Tamiflu, would it have helped her if she
took it in time? And what do we say about that? $116 for a low-
income family is a lot of money even when insured.
Can someone comment on that?
Dr. Schuchat. Yes, I can just say that, in response to the
spot shortage of antiviral medicines this year, we worked
closely with manufacturers and pharmacies and insurers, and we
learned that there was actually plenty of supply, but much of
what was available was brand product rather than the generics,
the newer generics.
We did, in the midst of the season, get some agreement by
pharmacies or the pharmacy benefit managers and insurers to
offer the brand as either generic or preferred brand, which
would give a lower co-pay.
But, of course, you know, that's a very, very sad story. We
don't know that antivirals will cure a person. The best data
suggest they shorten the course of illness. And, of course,
being able to start them quickly is what we think helps reduce
the severe complications.
Ms. Schakowsky. So, then, in conclusion, let me just say,
paid sick leave and affordable pharmaceuticals, very important
issues that we need to grapple with as we put in context this
flu virus.
Thank you.
Mr. Harper. The gentlewoman yields back.
The Chair will now recognize the gentleman from Virginia,
Mr. Griffith, for 5 minutes.
Mr. Griffith. Thank you very much, Mr. Chairman. It's been
very informative. I appreciate all the testimony. You all are
doing some great things.
I will tell you that it's kind of interesting and it was
timely, on February 28, just a week or so ago, I got an email
from a constituent who apparently keeps up with a lot of these
issues. And he started talking in his email about NanoFlu and
what was going on and how we might be able to push that
particular product forward.
And one of the things that he raised in his comments that I
thought was very interesting, he says that they are planning--
they have already done phase 1, so I guess we are coming to
you, Dr. Gottlieb. But he said they have already done phase 1
human trials, they don't plan to do phase 2 until the third
quarter of 2018 because, obviously, you want the flu to be out
there to a certain extent in order to be able to test it.
And he said, you know, I don't--and I'm going to quote from
his email: I do not understand why the FDA and CDC do not push
a vaccine like this ahead. It would seem to me they might push
for phase 2 in Australia this year and possibly a phase 3 this
year in the U.S. That could make the vaccine available for flu
season starting in the fall of 2019.
If the Government is really serious about speeding up the
slow approval process and reducing health costs, a process like
this would help to do it. And I ask the question because it
makes some sense. Why are we using the Australian flu season to
start testing some of these new ideas? You've indicated--
several of you have--that there may be 20 or 30 or 40 new
products out there, and wouldn't we be able to shorten that
time period, particularly in the live trials, if we did some of
it here and some of it there where they have the opposite
seasons and a different flu season as well?
So I'll start with you and welcome anybody's comments.
Dr. Gottlieb. I'll just kind of briefly, Congressman, I'm
not sure I'm familiar with the product. I think this is a
recombinant vaccine that you're referring to.
Mr. Griffith. I believe that it is, too. I'm not well
enough versed in it to say, but yes--and it's been tested
mostly, comparing it to the vaccine for senior adults. But
since I'm apparently rapidly approaching that category, very
interested. I turn 60 later this month.
Dr. Gottlieb. I will just say, it is not uncommon to see
products tested in the southern hemisphere, so I'm not sure
what the particular circumstance here is, but that is a common
phenomenon with new products. You'll see them tested there to
help accelerate the development process.
Mr. Griffith. So I can tell Paster Jones that you all are
not against it?
Dr. Gottlieb. You could pass on to anyone that we are
willing to actively engage with any sponsor that is developing
an innovative product in this space.
Dr. Fauci. Mr. Griffith, it's not a testing in Australia
versus here. The product that your constituency was referring
to is the nanoparticle that has gone into phase 1, the one I
showed you the model of.
Mr. Griffith. Right.
Dr. Fauci. The reason it's not going to go into phase 2
from the standpoint of until the end of the year is really a
production capability, it's what Dr. Gottlieb referred to when
he said what we haven't gotten efficient yet is the yield of
this.
So we don't have enough GMP product to start a phase 2
until the end of 2018. It's not that we--that the FDA is
holding us up or anything, it's just that we don't have enough
product.
Mr. Griffith. Well, I really appreciate that. Dr. Bright,
did you want to weigh in?
Dr. Bright. I was going to weigh in and say that it's very
typical. When you develop any new vaccine, it's difficult and
takes time. When you develop an influenza vaccine, you have to
time it with an outbreak of influenza. So as long as it's under
a USIND, we are very flexible in allowing the companies to get
the data and conduct clinical studies wherever flu might be in
the world, as long as it's following that IND process.
Mr. Griffith. Well, that's great. And I appreciate you all
helping me answer that question. And I know that Mr. Jones, who
I spoke with yesterday, makes sure I could say his name in
public, he'll be very pleased to hear that as well.
Let me ask this, because the chairman brought it up just--
and if you all can get to it briefly, the domestic supply and
the threat of maybe having our supply mostly offshore of our
flu vaccines. And it doesn't matter to me who wants to respond
to that. I guess that would be ASPR, is that correct?
Dr. Bright. We work very hard--it's a very important
question. We worked very hard over the last years and invested
great sums of money to make sure that we can develop these
vaccine and get them licensed. It is critical now that we
expand that domestic manufacturing capacity, so not only they
are able to meet a seasonal market demand, but they are also
available when we need them for a pandemic. And in a pandemic
situation we know we cannot import vaccines from other
countries easily. So the domestic manufacturing capability for
these modern technologies for recombinant cell-based is
absolutely critical to our national security.
Mr. Griffith. And I appreciate that and my time is just
about up. But I would say, could you please let us know what we
can do to assist in trying to get more onshore production?
And I yield back.
Mr. Harper. The gentleman yields back. The Chair now
recognizes the gentlewoman from Florida, Ms. Castor, for 5
minutes.
Ms. Castor. Thank you, Mr. Chairman, and thank you to all
the witnesses for being here and everything you do to help keep
Americans healthy and safe. We're now exiting peak flu season,
but we're entering allergy season. And what I've learned over
the past decade is that our allergy seasons are longer and more
intense, we have hotter days. Back home in Florida the pollen
is already raging.
What advice do you give to families with children and
others in vulnerable populations that are on alert because of
the intensity of the flu season as they begin to deal with
allergies? When is the appropriate time to head right to the
doctor's office and get checked out if you have a flu? Is it
the onset of fever? Dr. Fauci?
Dr. Fauci. If the question you're asking is the overlap
between the two, how do you know which one it is, well, the
recommendations that we get from the CDC, and I'll yield to Dr.
Schuchat in a second, but what we say is that if you have
symptoms that persist, number one, that's certainly something
you want to go to a physician for.
If you have a situation where you look like you're
recovering and then you have a relapse, it could possibly be a
bacterial infection. But, importantly, if you fall into one of
the risk categories--elderly, underlying disease like heart
disease, chronic lung disease, diabetes, obesity, pregnancy,
child from birth to 4 years old--you should not hesitate to see
a physician because that's the group that really would benefit
from getting an antiviral drug like Tamiflu.
And that's the reason why the CDC recommends that we do
that, and, Ann, you might want to----
Dr. Schuchat. Yes, and I would just say that even though
we're pleased that the peak of the season seems to have passed,
there's still a lot of flu out there. And the B strains are
more common right now than they were a few weeks ago. So we
certainly look for fever with flu or flu-like illness.
But as Dr. Fauci did describe, the warning signs, things
like getting better and then getting worse is a warning sign,
difficulty breathing, a very high persistent fever. For
children, you know, not being very responsive or being hard to
wake up. Those are really important things to----
Ms. Castor. You know, and I continued to hear the refrain
from folks that don't get a flu shot that they don't get it
because last time they got it, it made them sick, and that's
the reason that they don't get the flu shot.
What do you say to them?
Dr. Schuchat. You know, the influenza vaccines don't cause
flu. There can be some feeling of not feeling that well, but in
general we give flu vaccines during a season where there is a
lot of other stuff out there, and so the symptoms are rarely
related to the vaccine itself.
Dr. Fauci. We had a season this year, because before we had
the peak of flu, there was a lot of parainfluenza and even
respiratory syncytial virus among adults that we were seeing,
at least at our clinical center at the NIH. So that was before
the onset of the flu. And people were saying, well, I already
got the flu, therefore I don't need the vaccine. Well, they are
wrong on two accounts. One, because they likely did not have
the flu, they had something else. And even if you have the flu,
you should still get a vaccine because there are other
components in the vaccine that could protect you against the
other flu that is circulating besides just H3N2.
Dr. Bright. And if I might add. This is an area for
innovation that is just screaming out to give patients more
information, more knowledge about what they might be exposed to
in the home. And that's one of the reasons that we're trying to
drive diagnostics out of centralized laboratories into the
homes of the patients so they have actionable information to be
able to distinguish that they have a bacterial infection or a
viral inflection or flu or some other area. So they can take
responsible action to get treated sooner and to take actions to
reduce the spread of that virus.
Ms. Castor. Thank you. And preliminary estimates are that
this year's flu vaccine shows 36 percent effectiveness. I want
to hear more about how we assess vaccine effectiveness to
better understand this measure.
Dr. Schuchat, how do we test for vaccine effectiveness, and
what does it mean that the vaccine is 36 percent effective? And
is it true that this effectiveness was different for different
age groups?
Dr. Schuchat. Yes. We have a multistate, multisite network
that tests vaccine effectiveness, and they evaluate people who
come in with symptoms consistent with influenza, do laboratory
testing of them. Those who have confirmed laboratory-proven
influenza are enrolled as cases, and those who have those
symptoms but didn't have laboratory-confirmed influenza are
enrolled as controls. We compare vaccination history verified
with the records in them, and then do sort of math to calculate
what the vaccine effectiveness is against particular types and
particular age groups.
The larger the sample, the more we can look at ages and
narrow categories and look at the different types. We do
interim estimates in January and February each year, and then
end-of-season estimates. If we had a larger sample, a larger
network, we would be able to more reliably look at the age
groups, but potentially also look at different types of vaccine
like the cell-based or the egg-based.
Ms. Castor. And I guess your overriding message is, no
matter what percentage you come up with, it benefits you, and
your neighbors, and your family to get your flu shot?
Dr. Schuchat. The flu vaccine is the best way to protect
yourself and your family against influenza. And some protection
is better than no protection.
Ms. Castor. Thank you very much.
Mr. Harper. The gentlewoman yields back. The Chair now
recognizes the gentleman from Texas, Dr. Burgess, for 5
minutes.
Mr. Burgess. Thank you, Mr. Chairman. While we're on the
commercial to get your flu shot, I want to thank Dr. Fauci
personally because he told me in December I better get it, and
I did, and I didn't get the flu this year. So I thank you for
that. And it has been a tough year back in Texas.
Dr. Bright, you said that there had not been a new
antiviral introduced in the past 20 years. Did I understand
that correctly?
Dr. Bright. That is true. Well, 1999 with the approval of
oseltamivir and zanamivir.
Mr. Burgess. So let me--I guess this question is for Dr.
Fauci and Dr. Gottlieb, Dr. Fauci as far as the scientific
side, Dr. Gottlieb as far as the regulatory side. Why is this
so difficult? A virus is a pretty simple organism, nowhere near
as sophisticated as a mammalian cell. It seems like selective
toxicity, you talk about it a little bit in that--in that paper
that you showed us. It seems like that should be pretty
straightforward.
Dr. Fauci. It seems that way, but--and you're right, there
are targets in the replication cycle, polymerase and other--
pronase and other inhibitors that we have for that. The
interesting thing is that we--even though we're doing the
fundamental basic research to examine that, we have not had an
overwhelming amount of interest on the part of companies, which
is the reason why BARDA has been so important in helping to
chaperone the companies along to get involved in this.
So it really is, you're right, it isn't a completely
insurmountable scientific problem. It has a replication cycle.
Remember, when we pull all of that effort into looking at the
various aspects of the replication cycle of HIV, we came up
with now a total of 30 effective drugs. There's no reason why,
with the right scientific and industry interest in it, that we
couldn't do to same thing. And I just yield to my colleagues to
my left to amplify that.
Mr. Burgess. Well, Dr. Gottlieb, then I assume that on the
regulatory side that is something--that is work you'd be
prepared to take up?
Dr. Gottlieb. Well, absolutely. And I think there's a lot
of interest in seeing differentiated products put forward that
can address the flu for a whole host of reasons, not least of
which is the strategic rationale of having that available. I
will just comment that, you know, the standards for approval
are relatively straightforward, and I think the agency would
show a lot of interest and a lot of high level attention to
products that were put forward to try to address both pandemic
flu as well as the seasonal flu.
I will comment, that there have been safety issues
associated with products that have been in early stages of
development in the past. But one of the bigger challenges,
quite frankly, and this is a little bit outside of my remit,
but they have been commercial challenges. Just the ability to
get a commercial return on a property to target the seasonal
flu.
And I will remind the committee that at the time that the
agency approved Tamiflu, the agency was roundly criticized by
many outside groups, not by Congress, but by outside groups,
for that approval, who commented that a drug that diminished
flu symptoms by 1.42 days wasn't something the agency ought to
be approving.
And so our mindset has changed around this, but in some
quarters not entirely.
Mr. Burgess. That's an incredibly important point. I was in
practice at that time, and that did temper your judgment about
writing this prescription, regardless of cost. If it's really
only marginally effective, why put someone through the
potential side-effects that possibly would occur.
Dr. Bright, you provide the market that Dr. Fauci
referenced is not readily available, so it's hard to incent
companies to take these challenges on. But you provide the
market, right? You're going to be the one--the bulk purchaser
of this stuff?
Dr. Bright. Well, the marketplace for antivirals for
seasonal flu is the marketplace. And I don't think there's full
appreciation and recognition of the impact and benefit that one
could receive from getting an antiviral drug in a timely manner
when they are infected with influenza.
We had a new antiviral, same class from the Tamiflu,
approved by a company, BioCryst, called Peramivir, just a few
years ago, and there's still very little up-take of that new
antiviral drug. And it is a single-dose, IV-administered drug.
So there is hesitancy in the marketplace to develop new
antiviral drugs, even with benefits and reducing viral load and
saving the--reducing the severity of illness, if the
marketplace and the patients and the healthcare system doesn't
understand and appreciate the power of that drug.
Mr. Burgess. Let me just ask you a related question. You
talked about bringing down the viral load. Kind of encountered
when Ebola was causing all of the problems, the rapid reduction
of the viral load caused kind of a Herxheimer reaction in some
patients, and that caused some concern. Is that--is that
something, a phenomenon with which you are concerned with these
types of medications?
Dr. Bright. We haven't seen that with the influenza
antiviral drugs. Reduction of viral load, we believe would lead
to less transmission. We believe it would lead to less severe
illness in influenza antivirals.
Mr. Burgess. Yes, Dr. Fauci.
Dr. Fauci. And in Ebola, that was more a viremia, as
opposed to what you see with influenza, which is mostly a local
reaction in the lung. So you would you not expect a Herxheimers
with that.
Mr. Burgess. Very good. Thank you, Mr. Chairman. I yield
back.
Mr. Harper. The gentleman yields back. The Chair will now
recognize the gentleman from New York, Mr. Tonko, for 5
minutes.
Mr. Tonko. Thank you, Mr. Chairman. And welcome to our
panelists. Data from the National Immunization Survey found
that fewer than half of children and adults were vaccinated by
November of this current flu season. Only about 40 percent of
people 6 months and older received the flu vaccine. These
numbers appear to be just about what they were in the last
couple of flu seasons. I'm just interested in hearing from this
panel about why you believe these numbers continue to be in
that realm, and just how do you approach that as an
organization?
Dr. Schuchat, the data show that nearly 60 percent of
Americans did not take advantage of that flu vaccination, is
that an accurate number?
Dr. Schuchat. You know, the numbers that you're citing are
from November, and those are our early results. By the end of
the season, what we've seen in the last several years, is that
about 48 percent of Americans get the flu vaccine, it's much
higher in children, about 59 percent, and 43 or so in adults.
There's a lot of mixed messages. And when we--the thing with
influenza, when we have a year like this where it's so severe,
everybody actually knows how bad it can be, but then there's
also questions about whether the vaccine is helpful or not.
It's really important for the clinicians and for us in
public health to remind people that the vaccine has provided
protection, particularly in children, and that getting the
vaccine each year is worthwhile.
Mr. Tonko. And, Dr. Schuchat, again, and Dr. Gottlieb,
perhaps, what have your organizations been doing to improve the
rate, if anything?
Dr. Schuchat. Right. We do quite a bit of research on
communication. We've done, I think, more than 30 studies to
test messages over the past 18 years to try to understand what
motivates individuals, as well as what influences clinicians in
giving a strong recommendation. One of the biggest factors for
patients is a strong recommendation from their doctor.
We've seen an increase in OB/GYNs recommending the vaccine
and more women who were pregnant getting the flu vaccine each
year, really after they saw how severe it was in 2009 when you
were pregnant and got influenza. But we've probably hit a wall
right now. And after this season, there's a lot of concern
that--we don't know how the medical community or public is
going to react, so we're out there doing research right now and
testing messages for next fall.
We do use multiple channels in doing communication about
vaccine, both traditional channels and social media, trying to
find influencers and address the myths that people have.
Mr. Tonko. Uh-huh. And Dr. Gottlieb.
Dr. Gottlieb. I would just comment, I think the CDC has the
most robust platform for communicating, but we not only echo
the CDC recommends and their statements, but put out a number
of our own to try to build on that. I think one of the things
we did this season in particular was try to be very transparent
about what we were learning about the vaccine effectiveness as
we learned it. To continue to remind providers, in particular,
and consumers, that this vaccine still had efficacy, and it had
efficacy in particular against H1N1 and the B virus, which tend
to peak later in the season.
So even if people perceived it as being less efficacious
against H3N2, there was still a lot of value in getting
vaccinated because later in the season you tend to see an
upswing in the H1N1 and B virus, as we're seeing right now. And
the vaccine was actually quite effective against those strains.
Mr. Tonko. And in terms of the 100 percent number that,
obviously, is something that sounds like you shoot for, how
important is it to reach that?
Dr. Schuchat. With many vaccines, there's direct
protection, but also indirect protection and, at a certain
level, the higher proportion of the population that's
vaccinated, they may actually be helping others not get sick.
So, in particular, I think the pediatric vaccination is
important for the children, it's also important for the adults
that often get flu from their kids or from their grandkids.
Mr. Tonko. Representative Castor touched on this a bit.
This season we saw many new reports focused on the fact that
the vaccine was only 36 percent effective. In addition, some
inaccurate and misleading social media posts have warned people
against vaccinating themselves or their children.
Dr. Schuchat, does CDC have any way of tracking how these
media sources impact the number of people who are actually
vaccinated?
Dr. Schuchat. We do assess attitudes periodically and try
to understand whether there are rumors that are resonating or
not. You know, when we do research on ``why didn't you get
vaccinated for influenza?'' we hear more often about the--well,
``I heard that's not an effective vaccine'' rather than
concerns about safety or concerns about cost. But I think that
it varies for each vaccine what the barriers are or what the
concerns are.
We work hard through our messaging, but also through
partners and others to get the word out. You know, sometimes
the faith-based community can reach a lot of people in some
areas. There are mommy bloggers that are influential in some
circles. Friends and family can be influential. Our most
critical audience are clinicians and healthcare providers
because doctors, nurses, pharmacists have a lot of influence on
people's behavior.
Mr. Tonko. Thank you very much. Anyone else that wants to
comment on that? If not, I yield back and thank you, Mr.
Chairman.
Mr. Harper. The gentleman yields back. The Chair now
recognizes the gentlewoman from Indiana, Mrs. Brooks, for 5
minutes.
Mrs. Brooks. Thank you, Mr. Chairman. And thank you to all
the panelists for being here, and thank you for your service.
As the panel here may or may not know, Congresswoman Eshoo and
I recently started a biodefense caucus. I would encourage all
of the Members here to consider joining our caucus. And this is
in a lead-up to the hopeful reauthorization of PAHPA. But I
want to go back a little bit because during the 21st Century
Cures debate, we did get signed into law the return of
contracting of authority to BARDA.
And I'm curious, Dr. Bright, this was something--we wanted
it restored, it was in the original passage when BARDA was
created, but it's my understanding there's been some hesitation
by the contracting office to move the contracting back over to
BARDA. Has that contracting authority yet been properly
restored use since it was authorized and passed into law under
21st Century Cures?
Dr. Bright. Thank you for the question, and we are so
grateful for 21st Century Cures to include that in the law that
passed. It's critically important. It has not been finalized
yet, but it's important to know that it is part of an overall
realignment of the entire ASPR organization, and we look
forward to the full implementation of that very soon.
Mrs. Brooks. And what is the holdup?
Dr. Bright. The holdup is the alignment with the overall
realignment of ASPR. So it's fully intended that Dr. Kadlec,
our ASPR and I, are in full alignment to implement this as
quickly as possible. We anticipate it will be done in a matter
of months.
Mrs. Brooks. OK. We'll continue to ask questions until we
hear that what was authorized in the 21st Century Cures has
been implemented.
I do have a question, though, in the original PAHPA, it's
my understanding that BARDA was also given other transaction
authority to reduce regulatory burden on the Federal
contracting process that could both inhibit innovation and our
preparedness. Is BARDA able to use that other authority that
was in the original--in the original PAHPA bill?
Dr. Bright. BARDA has been using other transactional
authorities. Now, we have six of those in place with different
industry entities. The process of getting the other
transactional authorities is still--a process is going to
outside senior procurement executive that we're working on
improving the effectiveness and efficiency of that process now
with our ASPR, but we are finding ways to utilize that OTA,
other transactional authority, effectively.
Mrs. Brooks. OK. Thank you. Sorry, you're on the hot seat
today, however, with the reauthorization of PAHPA coming--due
to expire in September, talk to me about the administration's
fiscal year 2019 request of $250 million for pandemic
influenza.
Can you explain, at BARDA, authorization of pan flu
program, BARDA, I assume is beneficial, assuming it is
authorized or reauthorized, would you agree?
Dr. Bright. It's absolutely essential, yes.
Mrs. Brooks. Can you share with us how those funds would be
used to prepare for the next influenza pandemic?
Dr. Bright. I described for you a lot of the work that has
been done already with the investment that we've been provided
and supplemental funds, and those funds are all obligated. And
we've made great strides with our industry partners to make our
country better prepared for pandemic influenza, but there is a
lot of work still to be done.
As I said, we need to expand the access and availability of
the vaccines we created so they are useful and available for
all ages. We still need to develop additional antiviral drugs.
We need more drugs, more treatment options to treat people who
are severely ill and hospitalized with influenza. And we need
to do a better job with our diagnostics as well. We need to
make sure the diagnostics are in the hands of the people who
need them so they can get treated sooner and they can take
responsible actions to reduce the spread of that virus. All of
that work is yet to be done.
In the context of still sustaining what we've built, we
have to sustain the infrastructure, that is our response
capability for pandemic in our Nation. So in the context of
sustaining and filling the gaps, that's how we would support
and use those funds.
Mrs. Brooks. And in my 47 seconds left, can you talk about
the importance of sustained and robust funding? Sustained being
the critical word here, and why is that so critically
important?
Dr. Bright. The sustainment of the funding, because we rely
on these facilities of these companies to be available and
producing a vaccine that is warm based, so when we need it, we
need it quickly, that they have the staff in place and the
capabilities in place, and that the FDA is able to continue
reviewing and approving that facility.
It's important that we don't let our eye off the ball for
sustainment. If the factories close, we have no response, we
gain nothing. At the same time we must sustain our momentum in
conducting and supporting the phase 2 and phase 3 clinical
studies for additional recombinant-based technologies for
vaccines, for the platform-based technologies in the regional
manufacturing process across our country so we can rely on
those quickly when he would need them for a pandemic.
Mrs. Brooks. Thank you. I yield back.
Mr. Harper. The gentlewoman yields back. The Chair will now
recognize the gentlewoman from California, Mrs. Walters, for 5
minutes.
Mrs. Walters. Thank you, Mr. Chairman. California was hit
particularly hard this year by the flu season. In my home of
Orange County, especially suffered with well over twice the
number of flu cases compared to last year. Orange County had at
least a dozen influenza-related deaths in individuals under the
age of 65. Yet, we all know that seniors are particularly
susceptible to the flu. The CDC states that at least 75 percent
of flu-related deaths occur in people 65 and older.
My district is home to a large retirement population so I
am especially concerned about the health of this group during
flu season. While the overall flu vaccine effectiveness rate
for this year is 36 percent, the effectiveness rate can vary
depending on age group. For instance, last year the overall
effectiveness rate was 40 percent, and the effectiveness rate
for seniors was only 25 percent.
One would suspect the vaccine effectiveness rate is lower
for vulnerable populations like seniors, but I notice that the
2016-2017 vaccine effectiveness rate was much more effective
for children, another vulnerable population. Some of my
colleagues have asked what accounts for the variability in flu
vaccine effectiveness among age groups, what can be done to
improve vaccine effectiveness for seniors?
Dr. Schuchat. I can begin. There have been efforts to
develop different influenza vaccine products, particularly for
seniors and others with weaker immune systems. One such
approach is a high-dose product that has been licensed. Another
approach is adjuvanted. A key strategy that we have at CDC is
to make sure that patients and clinicians know that people at
high risk for complications, including seniors, get promptly
treated with antivirals if they do get sick. But the immune
system does age, and we think that the frailer, elderly have a
poor response to many vaccines, including flu.
Dr. Fauci. Whenever we have a situation, for example, when
we are making a vaccine for a possible pandemic, we always test
it not only in healthy adults, but we also test it in the
elderly to make sure that the dose and the regimen that we have
gives a comparable response that a younger person would have.
So that's part of the testing. And as Dr. Schuchat said, the
two major areas or the higher dose, which is recommended for
seniors, it's a much higher dose than the dose that you give to
a healthy young person, as well as using adjuvants, which is a
product that is not a vaccine but boosts the response to the
vaccine.
Dr. Bright. If I could add, too. This is a lesson from
pandemic influenza vaccine development that we can transition
to seasonal influenza vaccine development. We know in a
pandemic vaccine we have to have higher doses of antigen and we
have to have adjuvants in those vaccines that makes them
immunogenic and effective across all age groups.
I recently in the last two weeks visited the senior
leadership of each of the licensed influenza vaccine
manufacturers for the United States, and talked to them about
this challenge about what their thoughts and strategies and how
we can improve the effectiveness of our existing vaccines while
we wait for the universal flu vaccine. Each of them is poised
and strategic in thinking about ways to add the adjuvant and
increase the dose of their vaccine. They are all partnered and
interested in utilizing cell-based and recombinant-based
vaccines as well to try to improve the effectiveness over the
egg-based vaccines.
Dr. Gottlieb. I'll just comment very briefly,
Congresswoman. We're actively looking at data as to the
relative effectiveness of the vaccine with the MF59 adjuvant
and the high does vaccine in elderly patients relative to the
normal vaccine, the regular-dose vaccine with the 15 micrograms
of antigen.
I think if we do observe differences between the high-dose
vaccine--the efficacy of the high does vaccine or the vaccine
with the adjuvant in it relative to the regular seasonal flu
vaccine. It could offer some clues as to why the vaccine
overall was less effective against H3N2. We will have that data
available, hopefully, shortly. We're working very closely with
CMS to drive those results and we are going to make it
available as soon as we have it.
Mrs. Walters. OK. And, Dr. Schuchat, in 2009, the FDA
approved a high-dose version of the flu vaccine for elderly
individuals. There is a study that indicates the high-dose
vaccine was 24.2 percent more effective in preventing the flu
in adults aged 65 and older, as compared to the standard-dose
vaccine.
Can you elaborate on whether the high-dose vaccine would
significantly reduce flu-related deaths among seniors?
Dr. Schuchat. Even a 20-some percent superior response is
still not, you know, 100 hundred percent, because of the weaker
immune response that seniors get. We have the market of the
higher-dose product has been increasing since it became
available. CDC doesn't recommend a preference for the high-dose
over the regular-dose vaccine. One of the things we found is
that the vaccine that they have at the doctors' office or the
pharmacy is the one that you should get because there may not
be the other product if you're looking for it.
But I think the additional studies that FDA is doing with
CMS, and we've done with CMS in the past, have helped us build
this evidence base of what's the best way to protect seniors.
Mrs. Walters. Thank you, and I'm out of time. Thank you.
Mr. Harper. The gentlewoman yields back. The Chair will now
recognize the gentleman from Texas, Mr. Green, for 5 minutes.
Mr. Green. Thank you, Mr. Chairman. Thank you and the
ranking member for allowing me to wave on. I am an alumni of
this subcommittee. And thank you for allowing me to be here. I
want to thank the Chair for holding this hearing on the current
flu season.
The 2017-2018 flu season has been one of the worst in
recent years, resulting in tens of thousands of
hospitalizations, and likely thousands of flu-related deaths
around the county. There has been some advances in both vaccine
technology and in antiviral drugs, which hopefully can both
reduce the number of people who get the flu and help those who
do get it to recover more quickly.
I understand there's a new vaccine production method based
on recombinant protein technology that makes it less likely for
a vaccine to mutate, as it is being grown. Dr. Bright, BARDA
has supported development of several vaccines based on this
technology, as well as the development of cell-based vaccines
and antigen sparing vaccines. Can you explain why BARDA has
chosen to support research on these vaccine production methods
rather than the egg-based production methods?
Dr. Bright. Thank you for that question. We primarily focus
on supporting those new modern technologies to be able to
respond faster and more effectively to a pandemic response. We
know that we can cut out steps necessary to make a vaccine in
the egg. You don't need a virus to grow--to produce vaccines in
the recombinant system. You can start from a gene sequence and
rapidly go into production of your vaccine. This affords us
great flexibility and great speed compared to egg-based
vaccines.
We're learning now that investments in those new
technologies might also offer advantages of a potentially more
effective flu vaccine. What's critical to know about this, too,
is it's one thing to license those vaccines and make them
available, but if they're not available in sufficient supply
and don't have the capacity to produce it, then they are not
penetrating the marketplace, and those companies are frail and
are vulnerable, at risk of going out of business after huge
investment, if that vaccine is not used.
Mr. Green. Thank you. Commissioner Gottlieb, preliminary
data suggests that some of the newer vaccines such as high-dose
vaccines may offer greater protection. Is there enough data on
these vaccines for the FDA to recommended these vaccines over
others? If not, what type of data would the FDA need to make
such a recommendation?
Dr. Gottlieb. Congressman, we're still evaluating, at least
from this season, some of the data relative to the high-dose
vaccine and the vaccine with the adjuvant to see its relative
effectiveness against H3N2. And when we start to speculate
around different theories around why the vaccine overall--and
vaccines historically might be--have been less efficacious
against H3N2. One of the theories that you would put on the
table, certainly, is perhaps you might require a higher dose of
antigen in order to have an adequate immune response against
H3N2.
So it's something that we're going to need to consider
among many other possibilities on why historically we haven't
seen a robust immune response from the--against H3N2 from
vaccines generally, when we look back around past seasons. The
one thing we did observe so far this season was that the
vaccine produced in cells, the cell-based vaccines, we had
about 20 million doses produced in cells this year. Those do
appear to be--to have provided more protection on a relative
basis of around 20 percent than the egg-based vaccines. And,
again, we aren't sure of the reasons why, but it does lead to
some hypotheses around why maybe generally speaking we haven't
seen as much--as robust response against H3N2 historically as
we'd like.
Mr. Green. I know there are a number of new antivirals in
the pipeline, including some that may treat the virus at the
beginning of the life cycle. Dr. Bright, can you explain why
these drugs differ from those currently on the market, and how
they might help us treat the flu in a new way?
Dr. Bright. Absolutely. I think that's important to
recognize. The one class of drug that we have that's effective
on the market today is called a neuraminidase inhibitor. It
binds to an active pocket of a surface protein of the virus and
it really blocks the virus after it's already replicated from
breaking away from an infected cell and going on to infect
other cells.
These new antiviral drugs are working on the replication
cycle of the virus before it reproduces itself and buds away.
Because they work in a different part of the virus life cycle,
they also can be effective if the virus mutates and becomes
resistant to the single class of drug that we have available in
the market today. So it's critical that we have these different
approaches to antiviral drugs.
Mr. Green. Thank you. Mr. Chairman, I know I'm out of time
and your courtesies, I have some other questions that I'd like
to submit if it's allowed.
And thank our panel for being here today. We're looking for
that light at the end of the tunnel, and I just appreciate each
of you all partnering with each other to deal with it.
Obviously, the flu is terrible, but you know there are a lot of
other bugs out there that we'd like to deal with, too. Thank
you, Mr. Chairman.
Mr. Harper. The gentleman yields back. And I will remind
Members that they do have 10 business days to submit questions
for the record, and I ask the witnesses to agree to respond
promptly should you get additional questions in writing.
I want to thank you for your time being here today. It's
very informative. And, Dr. Fauci, I enjoyed the slide
presentation, I felt like I should get some college credit for
that--to see that.
Dr. Fauci. You got it.
Mr. Harper. But to visualize that and to see how it's
better to attack the stem instead of the head, and actually
give you a good visual was very informative. And, you know, one
day we'll be in here and we'll be discussing that effective
universal flu vaccine that we know we all desire to see. And I
was going to say, I hope we continue to take steps, even if
they are nanoparticle steps, to get to that conclusion. But,
again, thanks each of you for being here. The subcommittee
hearing is adjourned.
[Whereupon, at 12:35 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Frank Pallone, Jr.
Mr. Chairman, since 2010, influenza has caused millions of
illnesses, hundreds of thousands of hospitalizations, and
perhaps as many as 56,000 deaths throughout the country. This
is a very serious issue that should concern all of us who play
a role in advancing public health.
Right now, we are in the middle of a particularly bad flu
season. According to the CDC, more than 23,000 people have been
hospitalized this season, mostly due to the H3N2 strain of flu.
Tragically, more than 100 children have already died this year.
Seasonal flu is particularly challenging for our public
health agencies to address. Flu viruses tend to mutate and
change constantly, and we do not yet have the ability to
predict in advance how severe a flu season will be, when it
will peak, or what flu strains will dominate. There are also
many things that we still do not know about why the flu vaccine
is more effective for certain people, and how someone's health
status may affect the body's immune response.
I am encouraged by the recent initiative announced by NIH
which intends to study these very issues, with the goal of
producing a universal flu vaccine that is effective against a
broader range of flu strains. I know that the Biomedical
Advanced Research and Development Authority (BARDA) is
supporting vital research in this area, as well.
This is all critically important. And while we wait for the
results of this research, we know that there is one thing we
can all do to help stop the spread of the flu--we can all get
vaccinated.
Thanks to the Affordable Care Act, flu and other
immunizations are required to be covered by health insurance
without any copayments or coinsurance. It is free, and it is as
easy as going to the pharmacy around the corner. So there is no
good reason for Americans not to get a flu shot.
Annual flu vaccination continues to be the best method for
preventing flu and its potentially severe complications in both
children and adults. Getting the flu vaccine reduces flu-
associated illness and adverse health outcomes.
This is true even in a year where the flu vaccine is less
effective. For example, during the 2014-15 flu season, the
vaccine was only 20 percent effective at preventing infection.
Nonetheless, that vaccine formulation still prevented an
estimated 1.6 million illnesses, nearly 50,000 influenza-
associated hospitalizations and an estimated 1,500 deaths.
Moreover, flu shots do not only protect the vaccinated.
Vaccinating yourself not only increases the odds that you won't
get sick this season, but also protects everyone you come in
contact with, such as your older parents, or your sister's new
baby.
Unfortunately, up to 60 percent of Americans were not
vaccinated against the flu this year. I look forward to hearing
from CDC about what strategies have improved vaccination rates
in the past, and how we can continue to increase the rates
going forward.
Additionally, the fact that the vaccine was only 36 percent
effective this year highlights the need to improve our vaccine
manufacturing process, as well as our ability to treat patients
if they do become infected.
I look forward to hearing from today's witnesses about new
technologies and initiatives to enhance the effectiveness of
vaccines and of antiviral medications.
I want to thank all the witnesses for coming today. The
work your agencies are doing is a key part of our Nation's flu
preparedness efforts. I look forward to hearing from each of
you about what your agencies are doing to improve flu vaccine
effectiveness, vaccination rates, and influenza treatment
methods.
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
[all]