[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
                        
                        
                               __________
                               

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                    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.

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