[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
EXAMINING THE U.S. PUBLIC HEALTH RESPONSE
TO SEASONAL INFLUENZA
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
FIRST SESSION
__________
FEBRUARY 3, 2015
__________
Serial No. 114-6
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Chairman Emeritus Ranking Member
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
JOSEPH R. PITTS, Pennsylvania ELIOT L. ENGEL, New York
GREG WALDEN, Oregon GENE GREEN, Texas
TIM MURPHY, Pennsylvania DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee MICHAEL F. DOYLE, Pennsylvania
Vice Chairman JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington KATHY CASTOR, Florida
GREGG HARPER, Mississippi JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey JERRY McNERNEY, California
BRETT GUTHRIE, Kentucky PETER WELCH, Vermont
PETE OLSON, Texas BEN RAY LUJAN, New Mexico
DAVID B. McKINLEY, West Virginia PAUL TONKO, New York
MIKE POMPEO, Kansas JOHN A. YARMUTH, Kentucky
ADAM KINZINGER, Illinois YVETTE D. CLARKE, New York
H. MORGAN GRIFFITH, Virginia DAVID LOEBSACK, Iowa
GUS M. BILIRAKIS, Florida KURT SCHRADER, Oregon
BILL JOHNSON, Ohio JOSEPH P. KENNEDY, III,
BILLY LONG, Missouri Massachusetts
RENEE L. ELLMERS, North Carolina TONY CARDENAS, California
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota
7_____
Subcommittee on Oversight and Investigations
TIM MURPHY, Pennsylvania
Chairman
DAVID B. McKINLEY, West Virginia DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
LARRY BUCSHON, Indiana JOHN A. YARMUTH, Kentucky
BILL FLORES, Texas YVETTE D. CLARKE, New York
SUSAN W. BROOKS, Indiana JOSEPH P. KENNEDY, III,
MARKWAYNE MULLIN, Oklahoma Massachusetts
RICHARD HUDSON, North Carolina GENE GREEN, Texas
CHRIS COLLINS, New York PETER WELCH, Vermont
KEVIN CRAMER, North Dakota FRANK PALLONE, Jr., New Jersey (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
(ii)
C O N T E N T S
----------
Page
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 3
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 5
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, opening statement.................................... 6
Prepared statement........................................... 7
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 9
Witnesses
Anne Schuchat, M.D., Director, National Center for Immunization
and Respiratory Diseases, Centers for Disease Control and
Prevention, Department of Health and Human Services............ 11
Prepared statement........................................... 14
Answers to submitted questions............................... 112
Karen Midthun, M.D., Director, Center for Biologics Evaluation
and Research, Food and Drug Administration, Department of
Health and Human Services...................................... 26
Prepared statement........................................... 28
Robin A. Robinson, Ph.D., Director, Biomedical Advanced Research
and Development Authority, Office of the Assistant Secretary
for Preparedness and Response, Department of Health and Human
Services....................................................... 37
Prepared statement........................................... 39
Answers to submitted questions............................... 115
Anthony S. Fauci, M.D., Director, Nationa Institute of Allergy
and Infectious Diseases, Nationl Institutes of Health.......... 51
Prepared statement........................................... 53
Submitted Material
Subcommittee memorandum.......................................... 99
Letter of February 2, 2015, from Mr. Pallone, et al., to Mr.
Upton, et al., submitted by Ms. DeGette........................ 109
EXAMINING THE U.S. PUBLIC HEALTH RESPONSE TO SEASONAL INFLUENZA
----------
TUESDAY, FEBRUARY 3, 2015
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:02 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Tim Murphy
(chairman of the subcommittee) presiding.
Members present: Representatives Murphy, McKinley, Burgess,
Blackburn, Griffith, Bucshon, Flores, Brooks, Mullin, Hudson,
Collins, Cramer, Upton (ex officio), DeGette, Schakowsky,
Castor, Tonko, Clarke, Kennedy, Green, Welch, and Pallone (ex
officio).
Also present: Representative Ellmers.
Staff present: Charlotte Baker, Deputy Communications
Director; Sean Bonyun, Communications Director; Leighton Brown,
Press Assistant; Noelle Clemente, Press Secretary; Brad Grantz,
Policy Coordinator, Oversight and Investigations; Brittany
Havens, Legislative Clerk; Charles Ingebretson, Chief Counsel,
Oversight and Investigations; Emily Newman, Counsel, Oversight;
Alan Slobodin, Deputy Chief Counsel, Oversight and
Investigations; Peter Bodner, Democratic Counsel; Elizabeth
Letter, Democratic Professional Staff Member; and Nick Richter,
Democratic Staff Assistant.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy. Good morning. Today we convene the first
meeting of this session of the Subcommittee on Oversight and
Investigation of the 114th Congress. I welcome back Members who
served here last session, particularly, my friend and
colleague, Diana DeGette, the ranking member from Colorado, and
the new members from the 114th Congress, which we hope, as we
come up, you may introduce them today, and I will introduce
ours on our side.
The subcommittee is here to examine a very serious U.S.
public health response to seasonal influenza. America is
experiencing a severe flu season with an unstable predominant
strain that could result in one of the deadliest and costliest
flu seasons in recent memory. An estimated 50,000 people will
die. Over 200,000 will be hospitalized, and most of these will
be senior citizens.
Last February, when public health officials needed to
decide what strains would go into this year's seasonal flu
vaccine, the FDA bet on the wrong predominant strain. Just a
few weeks after the FDA's decision, doubts were already
beginning to creep in the scientific community about the FDA's
decision. By September, the U.S. vaccine was such a poor match
for the dominant strain of flu that the World Health
Organization, with consultation from the CDC, revised the
vaccine formula, but not for the United States. It was changed
for the Southern Hemisphere nations. In other words, the
American people were stuck with a vaccine that wasn't going to
work for nearly 4 out of 5 people, and for nearly 9 out of 10
seniors. Despite a growing body of knowledge that the vaccine
for the United States would not be effective, production went
forward anyway for a number of reasons that we hope to discuss
today.
With a mismatched strain, this year's vaccine is estimated
to be only 23 percent effective. It is even lower for the
elderly at 12 percent. While this season's vaccine has a lower-
than-usual effectiveness, CDC is still recommending
vaccinations for everyone 6 months or older. In addition to
vaccination, CDC has also recommended that all high-risk
patients should be treated with antiviral drugs as soon as
possible when influenza is suspected.
So what are agencies doing to communicate with the public?
Many are choosing not to vaccinate against the flu because they
hear the vaccine doesn't work, so why bother. We are seeing a
similar result with measles vaccinations but for very different
reasons, and now we are paying the piper for more than 100
cases have been stricken with a disease of measles that had
once been eradicated from our shores.
False rumors still exist that vaccines and a preservative
for multi-dose vaccines, which once used a microscopic amount
of mercury as a preservative to prevent bacteria growth, led to
autism. There is no credible evidence to support that claim. In
fact, mercury is not used as a preservative in the MMR vaccine,
and in developing nations where vaccination rates have
increased, autism rates have not changed. So in addition to
understanding why this year's flu vaccine missed so badly, and
what should be done to protect the public in future years, I
hope we can use this platform to educate the public and advance
vaccine development in the interest of public health.
Now on to the flu vaccine. We must know: Did the Federal
Government do everything it could at the right time to respond
to the challenge of this year's flu season? As I noted, the CDC
knew in late September that there was a significant mismatch,
as great as 50 percent, with the U.S. vaccine, however, the CDC
did not issue a health advisory in response to this mismatch
until more than 2 months later. Did the CDC make the right
public health decision to delay the health advisory, especially
on delaying a recommendation to treat high-risk patients with
antivirals? Could vaccine manufacturers have developed a new
vaccine for high-risk groups? The CDC and the FDA tell us that
the significant change in the strain could not have been
addressed any earlier than September 2014, way too late to make
changes in the U.S. vaccine. However, one flu expert at the
University of Utah School of Medicine has stated on the record
that there was a pretty good indication that the drifted strain
by April or May 2014, that probably would have led to a
decision to change at that time if strain selection decisions
for manufacturing were made in May instead of February.
In hindsight, it was a bad decision, and thousands will
die. Surely there are lessons to be learned here to do
something different in the future, and we want to know how we
can partner with these agencies to come up with some solutions.
In 2009, when there was a similar outbreak of the swine
flu, Federal agencies declared a public health emergency and
responded by producing a monovalent, or single strain, vaccine
to protect the public in a very short time. In only 12 weeks,
they had developed this new vaccine. Here, we must know, was a
monovalent rescue vaccine targeting the drifted strain a
possible response? Who made the decision to not go forward with
a different vaccine? If not, was this partly because the FDA
and other agencies lacked emergency authority to respond? Did
they recognize the problem and ask for authority to respond
quicker? If an astounding 50,000 deaths and 200,000-plus
hospitalizations does not equal an emergency then what is?
Shouldn't we be treating this problem with more urgency, and is
there even a backup plan in the event a vaccine mismatch to a
deadly strain exists?
HHS has set a goal for vaccines to vaccinate 70 percent of
their population as part of the Healthy People 2020
initiatives, but overall vaccination rates in the U.S. have
been around 45 to 46 percent in the last few years. CDC has not
even met its target of 50 percent. Does the CDC have an
effective strategy to increase vaccination rates, or is there a
better strategy for reducing flu deaths than seeking further
increases of vaccination rates in all subgroups?
So we are here today to challenge some of the policies and
decisions, but in the spirit of us all working together to make
improvements in the public health response to seasonal flu. I
am encouraged by the potential of ongoing research and
innovation. We appreciate the cooperation and attendance of
these excellent witnesses from the CDC, the FDA, NIH, and
BARDA. We need your input to help us decide how we change this
system for the better. I welcome our witnesses today, and thank
them for help in this inquiry.
[The prepared statement of Mr. Murphy follows:]
Prepared statement of Hon. Tim Murphy
Today we convene the first meeting of the Subcommittee on
Oversight and Investigations in the 114th Congress. I welcome
back members who served here last session, particularly my
friend and colleague, Diana DeGette, the ranking member, and
our new members for the 114th Congress.
The subcommittee is here to examine the U.S. public health
response to seasonal influenza. America is experiencing a
severe flu season with an unstable predominant strain that
could result in one of the deadliest and costliest flu seasons
in recent memory. An estimated 50,000 people will die. Over
200,000 will be hospitalized, most of these will be senior
citizens.
Last February, when public health officials needed to
decide what strains would go into this year's seasonal flu
vaccine, the FDA bet on the wrong predominant strain. Just a
few weeks after the FDA's decision, doubts already were already
beginning to creep in the scientific community about the FDA's
decision. By September, the US vaccine was such a poor match
for the dominant strain of flu that the World Health
Organization, with consultation from the CDC, revised the
vaccine formula--But, not for the United States. It was changed
for the Southern Hemisphere nations.
In other words, the American people were stuck with a
vaccine that wasn't going to work for nearly 4 out of 5 people
and nearly 9 out of 10 seniors. Despite a growing body of
knowledge that the vaccine for the United States would not be
effective, production went forward anyway for a number of
reasons we will discuss today.
With a mismatched strain, this year's vaccine is estimated
to be only 23 percent effective. It's even lower for the
elderly (12 percent).
While this season's vaccine has lower-than-usual
effectiveness, CDC is still recommending vaccination for
everyone 6 months or older. In addition to vaccination, CDC has
also recommended that all high-risk patients should be treated
with antiviral drugs as soon as possible when influenza is
suspected. What are agencies doing to communicate to the
public?
Many are choosing not to vaccinate against the flu because
they hear the vaccine doesn't work, so why bother. We're seeing
a similar result with measles vaccinations but for very
different reasons, and now we're paying the piper as more than
100 have been stricken with a disease of measles that had once
been eradicated from our shores.
False rumors still exist that vaccines and a preservative
for multi-dose vaccines, which once used a microscopic amount
of mercury as a preservative to prevent bacteria growth, led to
autism. There is no credible evidence to support that claim. In
fact, mercury is not used as a preservative in the MMR vaccine,
and in developing nations where vaccination rates have
increased, autism rates have not changed.
So in addition to understanding why this year's flu vaccine
missed so badly--and what should be done to protect the public
in future years--I hope we can use this platform to educate the
public and advance vaccine development in the interest of
public health.
Now on the flu vaccine, we must know: Did the Federal
Government do everything it could at the right time to respond
to the challenge of this year's flu season?
As I noted, the CDC knew in late September that there was a
significant mismatch--as great as 50 percent--with the U.S.
vaccine. However, the CDC did not issue a health advisory in
response to this mismatch until more than two months later. Did
the CDC make the right public-health decision to delay the
health advisory, especially on delaying a recommendation to
treat high-risk patients with antivirals? Could vaccine
manufacturers have developed a new vaccine for high risk
groups?
The CDC and the FDA tell us that the significant change in
the strain could not have been addressed any earlier than
September 2014, way too late to make changes in the U.S.
vaccine. However, one flu expert at the University of Utah
School of Medicine has stated on the record that there was a
pretty good indication about the drifted strain by April or May
2014, that ``probably'' would have led to a decision to change
at that time if strain selection decisions for manufacturing
were made in May instead of February. In hindsight it was a bad
decision--and thousands will die. Surely there are lessons to
be learned here to do something different in the future.
In 2009, when there was a similar outbreak of the swine
flu, Federal agencies declared a public health emergency and
responded by producing a monovalent--or single strain--vaccine
to protect the public in a short time. In only 12 weeks they
had developed this new vaccine. Here we must know--was a
monovalent ``rescue'' vaccine targeting the drifted strain a
possible response? Who made the decision not to go forward with
a different vaccine?
If not, was this partly because the FDA and other agencies
lacked emergency authority to respond? Did they recognize the
problem and ask for authority to respond quicker?
If an astounding 50,000 deaths and 200,000-plus
hospitalizations does not equal an emergency then what is?
Shouldn't we be treating this problem with more urgency?
Is there even a backup plan in the event of a vaccine
mismatch to a deadly strain?
HHS has set a goal for States to vaccinate 70 percent of
their population as part of the Healthy People 2020 initiative,
but overall vaccination rates in the U.S. have been around 45
to 46 percent the last few years. CDC has not even met its
target of 50 percent vaccination. Does CDC have an effective
strategy to increase vaccination rates? Or is there a better
strategy for reducing flu deaths than seeking further increases
of vaccination rates in all subgroups?
So we're meeting here today to challenge some aof the
policies and decisions, but in the spirit of us all working
together to make improvements in the public health response to
seasonal flu. I am encouraged by the potential of ongoing
research and innovation. We appreciate the cooperation and
attendance of witnesses from CDC, FDA, NIH and BARDA. We need
your input to help us decide how we change this system for the
better.
I welcome our witnesses today and thank them for their help
in this inquiry.
Mr. Murphy. And I recognize the ranking member for 5
minutes.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you so much, Mr. Chairman. I am really
happy that our first hearing of this new Congress is on an area
of bipartisan concern and interest. And I want to join you in
welcoming our new members on both sides of the aisle to this
committee. This is a venerable committee that has a long
history of bipartisan investigations, and I think it is going
to be a really important year to continue this trend.
Flu preparedness and response is incredibly important, and
this committee has a long history of hearings and
investigations on this issue. What we need to do is come
together in support of a strong public health infrastructure
that prevents outbreaks, and responds quickly and appropriately
when they occur.
These past several months have been a harsh reminder that
infectious disease is all around us. Last October and November,
this subcommittee convened hearings on the Ebola outbreak and
the dire situation in West Africa. We saw and, frankly,
continue to see, the deadly consequences of a breakdown in the
public health infrastructure there. Fortunately, we are now
seeing the lowest number of new Ebola cases since last June,
largely because of international efforts both to build and
operate effective Ebola treatment centers, and also education
of local populations on Ebola prevention and control. But, you
know, it is interesting because as much attention as we have
given to Ebola in this country, far more people die every month
from influenza than they do of Ebola, and this is a continuing
problem.
This month, we are hearing about the measles outbreak,
which was linked to Disneyland in California and has now spread
to at least 14 States. Infectious disease experts at the CDC
and the State health departments have mounted a fast and
aggressive response to prevent this highly contagious disease
from spreading.
And, Mr. Chairman, I know you have received a letter from
me and Ranking Member Pallone and Ranking Member Green asking
this committee to hold a targeted hearing on the measles
outbreak and the urgent public health threat. I would like to
make a copy of that letter part of the record, Mr. Chairman.
[The information is available at the conclusion of the
hearing.]
And, while that letter is pending, I want to commend you,
Dr. Fauci. I saw you on the news last night telling all of the
families in America to get their measles vaccine, and I really
appreciate that. I want to add from this podium, as the mother
of two daughters, one of whom is immunocompromised: Vaccinate
your children against measles. There is no reason not to, and
there is every reason that they could be a threat to themselves
and other children if they don't get that vaccine. So I just
want to pile onto that. It is very, very important.
But on to the flu, which is the topic of this hearing, the
predominant strain of flu is H3N2, which is resulting in
increased hospitalizations, particularly for vulnerable
populations like seniors and young children. And the CDC
announced several weeks ago that the flu vaccine has only 23
percent effectiveness. That is significantly lower than in
recent years, and as the chairman mentioned, it is largely due
to changes in the virus that have resulted in a mismatch
between the strain of the virus used in vaccine production and
the one actually circulating. But even with a 23 percent
effectiveness, we still need to protect ourselves as much as we
can. Dr. Frieden reminded us several weeks ago that even a
vaccine with 23 percent effectiveness will still prevent
millions of people from getting sick. And so, therefore, as the
chairman said, people also need to get this vaccine. And it is
not too late; flu season is still going on. We have to do
everything we can to protect our vulnerable populations; young
children, seniors, pregnant women, and others with compromised
immune systems.
So I am looking forward to hearing from our wonderful
witnesses today about what we can do to mitigate the effects of
this flu season, and how doctors and hospitals are prepared to
respond. I also want to look to the future. What can we do to
inform our prevention and response efforts in future flu
seasons? I want to hear about the research and technological
developments in diagnostics, antiviral treatments, and
vaccines.
In our last hearing on this topic in February 2013, we
heard about FDA approval of quadrivalent vaccines and cell base
technology. Today, I am hoping our witnesses can give us
encouraging news about the development of a universal flu
vaccine.
So regardless of the particular effectiveness rate in a
given season, the flu vaccine remains the best tool that we
have to protect as many people as possible, and we need to have
ongoing work on that. This flu season reminds us that it is
almost impossible to predict what the strain will be, but it
underscores the importance of a strong public health
infrastructure.
And so, Mr. Chairman, I just want to say I appreciate the
witnesses coming today. I hope we can all work together to move
the country toward better flu preparedness.
Mr. Murphy. I thank the gentlelady. And now recognize the
chairman of the full committee, Mr. Upton, for 5 minutes.
OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Upton. Well, thank you, Mr. Chairman.
This is an important issue, that is for sure, and it has
been an especially harsh flu season, and preliminary estimates
show that this year's vaccine is only 23 percent effective in
preventing folks from going to the doctor for treatment, even
lower for high-risk groups, which is often the case I know.
Usually, the flu vaccine is about 50 to 60 percent
effective, and I, like many folks back in Michigan and across
the country, would like to see us do better in addressing this
major public health threat.
Every year, between 5 and 20 percent of Americans get the
flu. In a severe flu season like this one, there could be more
than 50,000 deaths, over 200,000 hospitalizations, and more
than $10 billion spent on direct medical costs. The flu is and
should be a top priority for all of U.S. public health.
This year's vaccine, we know, is less effective because it
is not a good match for the flu strain that has become
dominant. The flu virus strain changed significantly during the
6 months after the strain selection decision for the U.S. was
made. The World Health Organization, in September, recommended
changing the flu vaccine for the Southern Hemisphere to use in
their upcoming flu season that starts in April but by the time
the change in virus was evident, it was too late to change the
U.S. vaccine.
Now, it is worth pointing out that the CDC continues to
recommend vaccinations in the U.S., even with a lower
effectiveness, and that high-risk patients should be treated as
soon as possible with all antiviral drugs.
When we learned that there was a shift in the virus, what
options were available to respond to the mismatch in viruses?
Was there a way to deploy a rescue vaccine targeting just the
changed virus? Was there a way to improve the effectiveness of
this year's vaccine by adding substances to boost the immune
response? Those are some of the questions that we need to have
answered as we proceed with this hearing.
And I appreciate the folks that are testifying today and
yield to Dr. Burgess and then to Marsha Blackburn.
[The prepared statement of Mr. Upton follows:]
Prepared statement of Hon. Fred Upton
Thank you, Mr. Chairman, for convening this hearing on the
U.S. public health response to seasonal influenza. We remain in
the midst of a particularly harsh flu season and preliminary
estimates show that this year's vaccine is only 23 percent
effective in preventing folks from going to the doctor for
treatment, even lower for high-risk groups. Usually, the flu
vaccine is about 50-60 percent effective. I, like many folks
back in Michigan and across the country, believe we can do
better in addressing this major public healththreat.
Every year between 5 percent and 20 percent of Americans
get the flu virus. In a severe flu season like this one, there
could be up to 50,000 deaths, over 200,000 hospitalizations,
and more than $10 billion spent on direct medical costs. The
flu is, and should be, a top priority for U.S. public health.
We understand that the reason this year's vaccine has lower
effectiveness is because it is no longer a good match for the
flu strain that has become dominant. The flu virus strain
changed significantly during the six months after the strain
selection decision for the U.S. vaccine was made, and we have
been told it was too late to change the vaccine for the U.S. As
a result of the evidence of change in the virus, the World
Health Organization in September 2014 recommended changing the
flu vaccine for the Southern hemisphere to use in their
upcoming flu season that starts in April. The CDC continues to
recommend vaccination in the United States, even with the lower
effectiveness, and that high-risk patients be treated as soon
as possible with anti-viral drugs.
While it is difficult to know when or how seasonal flu
viruses are likely to change, leading to a need to change the
vaccine for that year, we have made significant improvements in
the past 10 years and it seems like we should be able to do
better. There were known weaknesses in the surveillance system.
In 2011, the World Health Organization conference found that a
key test used to check for flu virus changes was not very
effective in detecting evidence of changes in the deadliest flu
strain. Our understanding is that this same test is still used.
What tests were used as an alternative to the inadequate test?
And when we learned that there was a shift in the virus,
what other options were available to respond to the mismatch in
viruses? Was there a way to deploy a rescue vaccine targeting
just the changed virus? Was there a way to improve the
effectiveness of this season's vaccine by adding substances
that boost the immune response?
Improving our response to a severe flu season with a
mismatched vaccine could mean saving thousands of lives. My
concerns and questions do not diminish my admiration and
support for the dedication of the U.S. public health agencies
working on flu preparedness. It is because of their talent and
hard work that I believe improvement is really possible. We can
work together to make that happen. I am also eager to learn
about the latest research and innovation, and how we can better
support and leverage these advances to improve our response to
seasonal influenza.
I welcome all our witnesses, and look forward to their
testimony.
Mr. Burgess. I thank the chairman for yielding. And, Mr.
Chairman, thank you for holding the hearing today.
In fiscal year 2014, the estimated Federal investment in
seasonal flu preparedness exceeded $850 million. The public-
private partnership driving research and development has had
successes, but we must do better.
First, communication between agencies and with the public
must improve. If there is a mismatch in the vaccine, which
became apparent in May or even as late as September, it is
unacceptable that advisories were not issued until December.
Second, there must be transparency and consistency in the
regulatory pathways for innovation in vaccines. Experts have
recognized the promise of adjuvanted flu vaccines for over a
decade, yet not one is licensed in the United States, and no
guidance has been issued. Third, greater emphasis must be
placed on modernizing the development and manufacture of flu
vaccines. I would add my acknowledgement to the ranking member
of the subcommittee, I too at one time was promised a universal
flu vaccine, I think in this committee at a hearing just like
this. That was probably in 2004 or 2005. We are still waiting.
We want to see it.
So I appreciate the opportunity to be able to speak on
this. I look forward to hearing from our witnesses.
And I will yield the balance of the time to Mrs. Blackburn,
Vice Chair of the full committee.
Mrs. Blackburn. Thank you, Mr. Chairman. And I want to
continue our conversation about vaccinations. And, yes, we are
talking about flu today, but there is another issue out there
and Ms. DeGette mentioned this. Vaccine politics injected into
2016, measles outbreak infects politics and debate.
Now, this is far too serious an issue to be treated as a
political football. People still die from measles. And the CDC
Web site tells us it was eliminated from the U.S. in 2000, but
yet we are seeing this outbreak. And I have to tell you, it is
of tremendous concern to me as a mother and a grandmother. I am
hearing so much about this from my constituents, and they want
to know some answers, they want to know how you all are
addressing this. And I will tell you, when I hear about
counties in California that have lower immunization rates than
the Sudan and Chad, this is something that is of concern to me.
I am a Rotarian. We have invested decades into eliminating
and wiping out polio, and then to hear this about the U.S., I
am concerned.
We know the measles outbreak started in California. It has
affected over 100 people in 14 States, and that most of those
people were not vaccinated. So we do want to veer off and ask
you some questions in this realm today.
And I yield back.
Mr. Murphy. The gentlelady yields back. I now recognize Mr.
Pallone for 5 minutes.
Mr. Pallone. Thank you, Mr. Chairman, and thanks for
holding this hearing today.
I have to tell Ms. DeGette that this is actually the first
time that I have been a member of the O&I Subcommittee, so I am
very happy.
Ms. DeGette. And we are happy to have you, Mr. Pallone.
Mr. Pallone. Thank you.
Mr. Murphy. Welcome aboard. It is the best subcommittee in
Congress.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you. So this year, we are seeing a
severe flu season. Across the country, hospitalization rates
are higher, especially for seniors over age 65, and for young
children, and public health experts predict these flu activity
levels will continue and even increase in the next few weeks.
The Centers for Disease Control and Prevention continues to
recommend that we all get the flu vaccine. Initial estimates
show that this year's flu vaccine is 23 percent effective,
meaning that 23 percent of those vaccinated for the flu will
still have to visit a doctor because of the flu. But despite
being less effective this year than the recent past, flu shots
will still protect against and decrease the severity of flu-
related illnesses. Moreover, flu shots don't only protect the
vaccinated, they also protect those who have not been
vaccinated from getting sick, and as members of Congress, I
think we all have to play a role to ensure that message gets
out and it is not too late to get your flu vaccine.
This hearing is also a good opportunity to talk about how
we can improve vaccination rates. We took important steps in
the ACA to provide coverage for preventative services like
immunizations. Since the law went into effect, nearly 76
million Americans have received no-cost coverage for
preventative services, and as millions more receive coverage
through the ACA, we hope to see the vaccination rate improve so
that we can realize the benefits of a better-protected
population. However, we still must improve public awareness,
and continue to improve access to these preventative services.
This is especially of concern as we hear reports of the measles
outbreak that began at Disneyland, and is now spreading
throughout the country. Just yesterday, the President urged all
parents to get their children vaccinated against measles, and I
would certainly echo his comments.
Dr. Tom Frieden, who heads the CDC, is warning that the
U.S. could see a large outbreak of measles. There are now over
100 cases in 14 States, and measles is extremely contagious, 90
percent of those exposed to the disease will be infected unless
they have been vaccinated. According to Dr. Frieden, there has
been growing evidence that more parents are not vaccinating
their children against measles, and that these lower
vaccination rates have led to the latest increase in measles
cases. The CDC is further assuring families, and parents
especially, that the measles vaccine is safe and effective, and
we were able to eliminate measles in the U.S. in 2000, largely
because of a highly effective vaccination program. So it is
important to reiterate that measles is a preventable disease
for which there are safe, effective and available vaccines.
So I look forward to hearing from our public health
officials today about how we can improve vaccination rates for
the flu, but we also need to learn how we can improve
vaccination rates for the future for other infectious diseases,
including measles.
I know that Ms. DeGette mentioned that both herself and Mr.
Green and myself sent a letter yesterday asking for a hearing
with regard to the measles public health emergency, and I hope
that we can actually see that occur. I think it would be very
important. And I just want to thank everyone.
And I would now yield the balance of my time to
Representative Castor.
Ms. Castor. Well, thank you for yielding the time, and good
morning. Thank you, Mr. Chairman and Ranking Member DeGette,
for holding this important hearing to better understand the flu
and the flu vaccine.
Vaccines are incredibly valuable tools to protect and
improve the health of all of our neighbors. And as we have seen
with the recent and surprising measles outbreak, vaccines
protect lives. According to reports, there have been 102 cases
of measles reported across 14 States, and those who do not
vaccinate their children are putting them at risk, and they are
putting others at risk. Vaccines are safe and effective.
I want to give particular thanks to Dr. Schuchat from the
Centers for Disease Control for traveling to the Tampa Bay area
a few months back to raise awareness with another important
vaccine, the anti-cancer vaccine of HPV. Thank you for meeting
with our public health students, and anti-cancer advocates to
explain. See, Florida had one of the lowest rates of HPV
vaccines, and we can save lives and prevent cancer if people
will understand the importance of the HPV vaccine. Your visit
was a great boost to our efforts to prevent cancer through the
HPV vaccine, so thank you again for the work you do to educate
the public on vaccinations.
You know, we are so fortunate to live in America where we
have studied and investigated and tested all of these vaccines
to ensure that they are safe and effective. So thank you to all
the panelists for all the work you do, and I look forward to
your testimony.
I yield back.
Mr. Murphy. Thank you.
I would now like to introduce the witnesses on the panel
for today's hearing. First is Dr. Anne Schuchat. Did I
pronounce that correctly? The director of the National Center
for Immunization and Respiratory Diseases at the Center for
Disease Control and Prevention. Dr. Karen Midthun is the
director for the Center for Biologics Evaluation and Research
at the U.S. Food and Drug Administration. Dr. Robin Robinson,
the director of Biomedical Advanced Research and Development
Authority, otherwise known as BARDA, within the Office of the
Assistant Secretary for Preparedness and Response. And Dr.
Anthony Fauci is the director of the National Institute of
Allergy and Infectious Diseases at the National Institutes of
Health. I welcome you all here and we look forward to your
testimony.
I will now swear in the witnesses.
You are aware that this committee is holding an
investigative hearing, and when doing so, has the practice of
taking testimony under oath. Do any of you have any objections
to testifying under oath? Seeing no objections, the Chair then
advises you that under the rules of the House and the rules of
the committee, you are entitled to be advised by counsel. Do
any of you desire to be advised by counsel during your
testimony today? Everybody has said no. In that case, if you
would please rise and raise your right hand, I will swear you
in.
[Witnesses sworn.]
Mr. Murphy. Thank you. You are now under oath, and subject
to penalties set forth in Title XVIII, section 1001 of the
United States Code. You may each now give a 5-minute summary of
your written statement. Make sure you pull the microphone close
to you, and watch that red light.
Dr. Schuchat, you can begin.
STATEMENTS OF ANNE SCHUCHAT, M.D., DIRECTOR, NATIONAL CENTER
FOR IMMUNIZATION AND RESPIRATORY DISEASES, CENTERS FOR DISEASE
CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES; KAREN MIDTHUN, M.D., DIRECTOR, CENTER FOR BIOLOGICS
EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES; ROBIN A. ROBINSON,
PH.D., DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY, OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS
AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND
ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH
STATEMENT OF ANNE SCHUCHAT
Dr. Schuchat. Good morning, Mr. Chairman, and members of
committee. I am Dr. Anne Schuchat, Director of the National
Center for Immunization and Respiratory Diseases at the Centers
for Disease Control and Prevention.
Influenza virus is a formidable adversary. Influenza's
propensity to change presents unique challenges. New flu
vaccines must be developed each year based on the predictions
of which viruses are likely to be most common during the next
season. Vaccine development is complex and time-consuming,
typically requiring vaccine candidates that grow well in eggs
and provide immunity in humans. And while we tackle seasonal
flu, we must conduct constant global surveillance and prepare
for the emergence of dramatically changed or shifted influenza
virus that could trigger the next pandemic.
Over the past decade, we have made significant improvements
in our ability to detect, prevent, and respond to influenza,
yet, despite our improvements, the current severe influenza
season has been difficult. My colleagues and I represent
agencies that work together to respond to seasonal and pandemic
flu. The NIH supports research on vaccines, diagnostic tools,
and antiviral drugs for seasonal and pandemic influenza. The
Food and Drug Administration regulates influenza vaccines,
convening public health and influenza disease experts to
recommend which influenza virus strains should be included in
FDA-licensed vaccines.
The Biomedical Advanced Research and Development Authority,
BARDA, supports advanced research, development, and procurement
of innovative medical countermeasures to address manmade and
emerging infectious diseases, including influenza pandemics.
And at CDC, we support surveillance and diagnostic capacity to
rapidly detect, prevent, and respond to annual influenza
epidemics, and novel and pandemic influenza threats.
Our CDC systems provide the scientific basis for global
vaccine virus selection for seasonal flu, vaccine as well as
for pandemic vaccine stockpiling. We monitor for genetic
changes in the flu virus, and identify how these changes affect
disease transmission and severity. We build public awareness
and provide our knowledge about prevention and early treatment,
and support public sector delivery of routine and emergency
immunizations.
The 2014/15 influenza season has proven a particularly bad
season. The virus that is predominant, H3N2, is associated with
more severe disease. The vaccine we are using is not well
matched to circulating H3N2 strains. Antivirals can be
important aids in some patients, but clinicians are
underutilizing them.
How do we find ourselves with vaccine that isn't well
matched to the circulating H3N2 viruses? When the 2014/15 flu
vaccine strains were selected last February, the drifted virus
we are seeing now was not yet detected. A small number of these
drifted viruses were first detected in March 2014, and CDC
continued to monitor them throughout the summer, looking for
genetic patterns and geographic spread.
In September 2014, when we began promoting seasonal
vaccination, about \1/2\ of the H3N2 viruses circulating were
like the vaccine component. When the influenza season took off
at the end of November, only \1/3\ of the H3N2 viruses CDC
detected were like the vaccine component. Our early vaccine
effectiveness estimate found people vaccinated had about 23
percent lower risk of influenza infection requiring a medical
visit. While this is lower than we usually see, the vaccine is
providing some protection.
Influenza viruses follow their own schedules, not ours. New
strains can emerge at any time. Some appear and die out, and
others persist and spread. Our actions are proportional to
risks. We work year-round to detect and characterize viruses of
concern that circulate globally, monitor their emergence and
geographic spread, and develop viable vaccine candidates for
drift viruses as they occur. When we detected relatively small
numbers of the drifted H3N2 strain late last spring, CDC began
preparing candidate vaccine virus strains.
As the Nation's public health agency, we are committed to
provide the information people need to protect their patients'
and families' health, and to be transparent in our assessments
and the evidence base that supports our recommendations.
As a physician and a public health professional, I too wish
we could guarantee better protection each year, yet, we have
made significant advances on several fronts. Our surveillance
network is characterizing more viruses with improved methods.
Significantly more Americans get flu vaccine each year, and
information on viruses, disease, and vaccination is released
more rapidly.
In closing, this flu season has caused more suffering and
serious disease than many previous years, and there will be
more challenging seasons ahead, but collaboration across the
agencies, and with our public and private partners, holds
promise for the future, including progress toward development
of universal influenza vaccines, since better, broader, and
long-lasting protection could transform our approach to this
challenging virus.
[The prepared statement of Dr. Schuchat follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you.
Dr. Midthun, you are recognized for 5 minutes. Thank you.
Make sure the microphone is turned on and it is close to you.
Thank you. You still have to turn it on. Press the--there you
go.
STATEMENT OF KAREN MIDTHUN
Dr. Midthun. Thank you. Mr. Chairman and members of the
subcommittee, I am Dr. Karen Midthun, Director of the Center
for Biologics Evaluation and Research, the center within FDA
that is responsible for regulating vaccines. Thank you for the
opportunity to be here today to discuss our role in a highly
collaborative, multi-partnered effort in preventing influenza
through vaccination in the U.S.
Influenza viruses continually undergo changes in their
genetic makeup, and the resulting proteins that interact with
the immune system. Due to these continuous changes, the
composition of influenza vaccines must be periodically updated
so that they are effective against what are anticipated to be
the predominant circulating viruses in the upcoming influenza
season.
The strains of virus in the vaccine include 2 distinct
subtypes of influenza A, H1N1, and H3N2, and 1 or 2 influenza B
strains, depending upon whether the vaccine is trivalent or
quadrivalent. To identify virus strains likely to cause illness
during the upcoming season, the World Health Organization
convenes influenza and public health experts to study recently
circulating influenza viruses from around the world, and recent
global disease patterns. After careful evaluation of the
assessment, WHO makes recommendations on the composition of the
influenza vaccines, usually in late February for the upcoming
season in the Northern Hemisphere, and in September for the
upcoming season in the Southern Hemisphere. The recommendations
must be made months in advance because of the time required for
manufacturing, testing, lot release, and distribution of a very
large number of vaccine doses.
Each year, following the WHO recommendations, FDA convenes
its vaccines and related biological products advisory
committee, typically in late February or early March. The
committee considers the WHO recommendations and reviews
information regarding viruses that caused illness in the
previous year, how these viruses are changing, and disease
trends. Based on the data available at the time of the meeting,
the committee makes recommendation for the composition of the
influenza vaccines licensed by FDA for the upcoming season in
the U.S. Once the strains are selected, candidate influenza
viruses that are adapted for high growth are generated and
accepted by WHO collaborating centers, and are provided to
manufacturers who generate the seed viruses for manufacturing
vaccines. The manufacturing demands are tremendous and the
timelines are tight. No other vaccine is produced, FDA approved
and distributed every year across the U.S. within a six-month
time frame.
This season, more than 150 million doses were manufactured.
Given the yearly need for a new vaccine, there is limited
flexibility in the timelines of vaccine manufacturing and
availability. And parallel with vaccine manufacturing, FDA
develops and calibrates reagents which are used by both FDA and
the manufacturers to test vaccines for potency and identity
before FDA approves the new formulation for distribution.
Manufacturers submit their vaccine testing results, along with
samples from each lot, to FDA for lot release. As FDA releases
lots, the manufacturers can make these lots commercially
available throughout the U.S.
In February 2014, when the strain selection recommendation
for the current influenza season was made, it reflected the
circulating viruses. The drifted H3N2 viruses were first
detected in March 2014 and were uncommon. Over the ensuing
months, the drifted strains gradually increased. By late
September, when WHO made its recommendations for the 2015
Southern Hemisphere influenza vaccine, the drifted H3N2 strains
were common, prompting a recommended change in the upcoming
Southern Hemisphere vaccine composition. Because of the
manufacturing time required, there was not enough time to make
a similar change for the current Northern Hemisphere influenza
season. The drifted strains have caused the majority of
influenza cases this season, however, vaccination is still
important to prevent disease and minimize the public health
burden of influenza. Influenza vaccines contain three or four
influenza viruses, so even when there is a less than ideal
match or lower effectiveness against one virus, the vaccine may
protect against the other viruses.
FDA has made progress in our preparedness efforts and
collaboration with BARDA, CDC, NIH, manufacturers, and other
stakeholders, and we thank Congress for your support of these
efforts. New influenza vaccines have been licensed, including
cell-based, recombinant protein vaccines and quadrivalent
vaccines. To enhance pandemic preparedness, FDA licensed an
adjuvanted H5N1 avian influenza vaccine, and has worked with
U.S. Government partners and manufacturers to facilitate the
development of candidate vaccines directed at H7N9 avian
influenza. Surveillance efforts are more extensive than ever
before, and offer the potential for early detection of emerging
viruses. The number of candidate vaccine virus strains
available to manufacturers has greatly increased over the last
few years, providing them with more options to increase vaccine
yields. We continue efforts with our Government partners to
develop high-yield candidate vaccine strains, as well as more
modern, faster testing methods for vaccine potency and
sterility. To further address the challenges presented by the
constantly changing nature of influenza viruses, scientists and
Government laboratories, academic institutions, vaccine
manufacturers, are all working to develop new generation
vaccines that might provide longer-lasting and broader
protection against influenza viruses, including drifted
strains. Although these development efforts are still in early
stages, some may have the potential to increase and broaden
protection against influenza.
FDA will continue to work with its Government partners,
manufacturers, and other stakeholders to facilitate development
of new vaccines, and identify methods that have the potential
to speed the manufacturing process for existing vaccines. Our
goal is to better protect the American public against
influenza.
Thank you.
[The prepared statement of Dr. Midthun follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you.
Now, Dr. Robinson, you are recognized for 5 minutes.
STATEMENT OF ROBIN A. ROBINSON
Dr. Robinson. Good morning, Chairman Murphy, Ranking Member
DeGette, and distinguished members of the subcommittee. Thank
you for the opportunity to speak with you today. I am Dr. Robin
Robinson, Director of the Biomedical Advanced Research and
Development Authority, and Deputy Assistant Secretary for
Preparedness and Response, as well as a former developer of
influenza vaccines in industry.
BARDA is the Federal Government agency mandated to support
advanced research and development, and procurement of novel and
innovative medical countermeasures such as vaccines,
therapeutics, diagnostics, and medical devices for the entire
Nation to address the medical consequences of manmade and
naturally occurring threats like the H1N1 pandemic, the 2013
H7N9 influenza outbreak, and the current Ebola epidemic.
Pandemic influenza is one of our primary concerns. We
understand that preparedness for pandemic influenza is directly
tied to seasonal influenza. Medical countermeasures for
seasonal influenza underpin the vaccines, antivirals, and
diagnostics used for pandemic influenza. BARDA has invested in
the advanced development of medical countermeasures that have
utility for both seasonal and pandemic influenza preparedness.
BARDA transitions medical countermeasures from early
research and development at NIH, into advanced development
toward FDA approval and potential procurement. BARDA has funded
and successfully managed the advanced development of more than
60 medical countermeasures for pandemic influenza. More than 20
of these medical countermeasures for influenza have been FDA
approved, with 6 receiving approval in the last 3 years, as Dr.
Midthun indicated. Additionally, BARDA developed and procured
vaccines and antivirals used in the 2009 H1N1 pandemic, and
stockpiled vaccines for preparedness against H5N1 and H7N9
viruses. BARDA, through partnerships with NIH, CDC, FDA,
industry, and academia, has met and overcome many but not all
of the challenges inherent to making medical countermeasures
associated with seasonal and pandemic influenza. Specifically,
BARDA, with our partners, has made major progress in the
following pandemic areas.
First, modernization of influenza vaccine manufacturing
through the development and licensure of new cell- and
recombinant-based influenza vaccines, and antigen-sparing
pandemic vaccines with adjuvants towards meeting our strategic
goal of more and better influenza vaccines sooner. These new
vaccines were part of our successful H7N9 response in 2013.
Second, shortening influenza vaccine manufacturing time by
weeks, effected through the Influenza Vaccine Manufacturing
Improvement initiative, as recommended by PCAST, to optimize
the generation of high-yielding vaccine seed strains, and
alternative potency and sterility assays. Many of these
improvements, such as biosynthetic technology, were employed
during the H7N9 vaccine response in 2013, which was the fastest
on record.
Third, establishment and maintenance of pre-pandemic
influenza vaccine stockpiles for H5 and H7N9 viruses that may
be used to immunize tens of millions of persons at the onset of
an influenza pandemic with these viruses.
Fourth, and last, multi-fold expansion of domestic pandemic
influenza vaccine production capacity, afforded by retrofitting
of older manufacturing plants, building new state-of-the-art
manufacturing facilities for making 21st century influenza
vaccine, and establishing three centers for innovation and
advanced development and manufacturing, with rapid, nimble, and
flexible manufacturing capabilities through public-private
partnerships with industry.
The new national infrastructure responded in 2013 to the
H7N9 outbreaks, and today, in the Ebola epidemic. Despite these
significant accomplishments, our pandemic preparedness work is
not over. Making a more effective influenza vaccine remains a
significant scientific challenge. Indeed, progress towards more
effective influenza vaccines has been noted in recent years,
but much more is needed.
Going forward, there is reason for hope that more effective
influenza vaccines may be within our grasp. The discovery of
new influenza viral targets within the last 4 years has renewed
interests and efforts to develop new universal influenza
vaccine candidates.
Developing more effective pandemic influenza vaccines is
one of our top priorities, and BARDA will support new methods
based on evolutionary biology that may help forecasting and
selection of new seasonal and pandemic influenza vaccine
strains.
In parallel, we are launching this month an initiative to
support advanced development of new, more effective influenza
vaccine candidates that may elicit greater, broader, longer
immunity in all populations against divergent influenza virus
variants, and that may serve as primers for pandemic influenza
vaccines.
In conclusion, influenza viruses with pandemic potential
continue to evolve and change, infect animals and man, and pose
significant threats to global and domestic public health. This
year's limited seasonal influenza vaccine effectiveness, and
the arrival of the first human case of H7N9 virus in North
America underscore our urgent need to complete this mission. To
be better prepared, our Nation must continue to invest in
domestic pandemic preparedness, and work with key global
partners.
I thank you for this opportunity to discuss how we can be
better prepared for seasonal and pandemic influenza, and I look
forward to your questions.
[The prepared statement of Dr. Robinson follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Dr. Robinson.
Dr. Fauci, you are recognized for 5 minutes.
STATEMENT OF ANTHONY S. FAUCI
Dr. Fauci. Mr. Chairman, Ranking Member DeGette, members of
the committee, I appreciate the opportunity to discuss with you
today very briefly the role of the National Institute of
Allergy and Infectious Diseases in research addressing both
seasonal and pandemic influenza.
[Slide shown.]
As shown on this slide, the NIH research agenda is really
based on the traditional approach that the NIH has taken with
all diseases; namely, fundamental basic research, clinical
research, and field research, the provision of research
resources both to the academic community, as well as to the
biotech and pharmaceutical companies. The endgame is to
ultimately produce interventions in the form of diagnostics,
therapeutics, and vaccines. You have heard about the
diagnostics and therapeutics. We can talk about them a little
bit later. I want to focus the remainder of my remarks on a
subject of obvious importance; namely, the development of
influenza vaccines.
[Slide shown.]
Traditionally, the classic what we call platforms, or the
way you develop the vaccine, have been based on growing the
virus itself either in eggs, which is somewhat cumbersome, or
more recently using it in cell lines, which are a bit more
predictable. You either have a live attenuated vaccine or an
inactivated vaccine, and that has been the traditional approach
towards vaccines. It is cumbersome, it takes a long period of
time because you have to grow the virus.
[Slide shown.]
Our researchers, both at the NIH and our grantees and
contractors, over the last several years have been attempting,
with some success, to make a conversion to what we call a
recombinant DNA technology, molecular-based approach that would
obviate the need to actually continue to grow the virus to make
a vaccine. Several of these are illustrated on this slide. We
don't have time to go into each and every one of them, but they
are particularly suited to develop a vaccine that we are all
hoping for, and that Dr. Burgess mentioned in his 5-minute
remarks, and that is a universal influenza vaccine.
[Slide shown.]
This is the cover of a Nature Medicine article that I wrote
with my colleague, Dr. Gary Nabel, the former director of the
Vaccine Research Center, namely, how we can induce what I
called unnatural immunity; namely, immunity that a normal
vaccine induction or the virus itself doesn't induce, and that
is broad protection against subsequent exposures to different
types of influenzas that have a tendency to drift over a period
of years, and sometimes to even shift, which gives us a
pandemic.
[Slide shown.]
Now, the reason we can do this, and I just want to point
out on this slide, on the lower right is a blown-up schematic
of the influenza virus. The proteins that coat the outside are
referred to as hemagglutinin, and that is where we get the H
for H3, H2, or H1. It is a designation of a major protein. The
other one is N for neuraminidase. But notice how those proteins
are clustered on the surface of the virus, so that what the
immune system sees generally is just the top, what we refer to
as the head or the bulb of that protein.
[Slide shown.]
If you look at this slide, that head is where most of the
antibodies that protect you and me against influenza are made.
That is the good news. The sobering news is that is a variable
region, which tends to change as influenzas drift from season
to season and change an awful lot when it goes to a pandemic.
If you look at the little stem, the thin part of that
protein, that the immune system doesn't see very well,
interestingly, we found out several years ago that that is the
part--that is what we called highly conserved. It doesn't
change from necessarily a Texas H3N2 to a different type, a
Singapore or a variety of others. They stay the same, which
means that if you can induce an immune response against that
unchangeable one, you might be able to get what we call a
broader reactivity.
[Slide shown.]
And over the last several years, we have made considerable
progress as shown on this slide here, where a number of
candidates have used molecular techniques to essentially show
the body predominantly the part of that protein that doesn't
change. And there are a number of ways of doing that. Instead
of giving the body the entire virus, either killed or
attenuated, by molecular techniques, you show the body only the
part that you want it to respond to, unencumbered by the
physical structures that don't allow the body to see it. And we
now have done this in several candidates--in mice, in ferrets,
and what we call phase one studies in humans--which means we
know it is safe, we know it can induce the kind of response
that is more broad. In collaboration with BARDA, we are now
starting to produce that to go into larger trials. And as Dr.
Burgess said, we are not there yet, but we are clearly many
steps further than what we were the last time I testified
before this committee.
So I will stop there and be happy to answer any questions.
[The prepared statement of Dr. Fauci follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you.
I will now recognize myself for opening questions for 5
minutes.
But let me just start off, and I know that a lot of
concerns about vaccines and autism. As a psychologist, I have
seen many a child with autism. It is a deeply concerning
problem with the families. Past publications have been
discredited, and data was deemed fraudulent. Multiple studies
said there is no link between developmental disorders such as
autism and vaccines.
I want to ask each of you, do you agree, Dr. Schuchat? Dr.
Midthun, do you agree? Dr. Robinson, do you agree? Dr. Fauci,
do you agree? And--yes, you can say this verbally. Should
parents have their children vaccinated? Dr. Schuchat?
Dr. Schuchat. Vaccines save lives and are the best way for
parents to protect their children----
Mr. Murphy. Yes, right.
Dr. Schuchat [continuing]. From vaccine-preventable
diseases.
Mr. Murphy. Dr. Midthun, yes or no? Yes?
Dr. Midthun. Yes. I have three children, and they were all
vaccinated on time with all the recommended vaccines.
Mr. Murphy. Dr. Robinson?
Dr. Robinson. Absolutely.
Mr. Murphy. Dr. Fauci?
Dr. Fauci. Definitely.
Mr. Murphy. OK. Dr. Schuchat, flu expert Dr. Andrew Pavia
at the University of Utah School of Medicine said, ``By April
or May, there was good evidence of the drifted A/Switzerland
strain. It wasn't clear it was going to be a dominant strain,
but there was a pretty good hint, we probably would have chosen
the vaccine differently.'' Dr. Schuchat, do you agree that
there was good evidence of the drifted strain by, say, April or
May of this last year?
Dr. Schuchat. We were certainly keeping a close eye on this
drifted strain last May, and that is when the CDC began to
develop a candidate vaccine virus, but as you know, it can be
very challenging to develop candidate vaccine viruses, and to
take it from a candidate to all the way to production of
vaccine, all the way to production of hundreds of millions of
doses of vaccine.
Mr. Murphy. But by May, there was evidence of a 17 percent
mismatch. Do you think that 17 percent mismatch was a concern
at that point, and were there any discussions about that at
CDC?
Dr. Schuchat. Yes, there were. In fact, in March, we
started to reach out to the global community, the international
WHO collaborating centers, when we saw the first handful of
this drifted strain to ask others were they seeing it.
I think it is important to realize that strains emerge and
can disappear, and in the spring, it is very difficult to know
which ones will still be around in the summer or fall. We
actually respond to these new drifted strains by working on
candidate vaccine viruses, but it is very difficult with
influenza to predict what strains will dominate, whether it is
going to be an H3N2 year or a H1N1 year. And so we continue to
go through the routine seasonal flu work while we are also
developing the candidate vaccine virus----
Mr. Murphy. Well, let me ask about this pattern. We have
here, I am looking at the mismatch notes, by March there is
about a 10 percent mismatch drift, by May, 17 percent. We
understand by September it was already up to 50 percent. Do we
know in these gaps of April or June or July or August what
those drift rates were? Was there a problem by those times that
was being seen?
Dr. Schuchat. Yes, we have information for the summer. It
is important to remember that there is very limited influenza
circulating here in the U.S. in the summer, and it takes off in
the fall. That is one of the reasons we do global worldwide
surveillance----
Mr. Murphy. Sure, but right here----
Dr. Schuchat [continuing]. And we have greatly increased
the numbers there.
Mr. Murphy. But here in September, a decision was made for
the World Health Organization to change this for the Southern
Hemisphere. And so I am wondering, because there are big gaps
here, were there discussions between all your agencies that we
ought to be doing something differently other than telling
people to have some kind of an antiviral medicine?
Dr. Schuchat. Thanks. I think it is important--Dr. Fauci
talked about the idea of drift and the idea of shift, and I
think the members remember in 2009 where, in the spring of
2009, we did decide it was important to go forward with a
monovalent vaccine----
Mr. Murphy. Right.
Dr. Schuchat [continuing]. Against a pandemic. We think of
pandemics as having catastrophic risk because they generally
are defined by a new strain that the population has no
protection against at all. It is so differing from----
Mr. Murphy. But you could do that fairly quickly during
that--the issue of the Swine--from 2009. Once it reached this
level where we are now only 23 percent effectiveness, and about
12 percent for senior citizens, a high-risk group for death,
for mortality and morbidity, why not move forward at this point
with at least a monovalent strain for high-risk groups and
high-risk geographical areas?
Dr. Schuchat. The time between developing a candidate
vaccine virus, which we started working on in May, and the
ability to have a lot of doses is about 6 months. So it really
wouldn't be available----
Mr. Murphy. But you did it in 12 weeks in 2009.
Dr. Schuchat. The large amounts of vaccine were only
available in November in 2009, after having really started in
May.
Mr. Murphy. But you did it in a much shorter time, but not
the 6 months. My point is, when you identify something that is
going to have that level of mortality and morbidity, and it can
be done in a short period of time, were your agencies talking
with each other and saying--clearly, a decision was made in
September, hey, for the Southern Hemisphere, we need to change
that, but for the Northern Hemisphere it says let us keep going
with what we have, recognizing that it is only effective for 1
out of 5 people and 1 out of 10 seniors. It seems to me that
you need a different decision-making process.
Dr. Schuchat. Thanks. I think another point that is
important to make is the difference between the laboratory
mismatch and the clinical protection. In 2003/04, we had a
laboratory mismatch. It turned out that when we measured
clinical protection, protection was about 50 to 60 percent in
different populations. So seeing that in the lab in that
hemagglutinin inhibition testing that there is drift or that
there is a difference between the strain and the vaccine, and
the strains that are circulating, doesn't perfectly predict how
the vaccines will work in practice. So I think it is very
important to differentiate that decision to make a monovalent
vaccine against a pandemic where we know there is not going to
be the widespread protection because people haven't seen the
strain before, and where it is a race against time in terms of
the--although it is challenging with current technology, the
value of trying to make a vaccine is worth it.
Mr. Murphy. I am way over time. I need to----
Dr. Schuchat. By which--OK.
Mr. Murphy [continuing]. Pursue other members.
I recognize Diana DeGette for 5 minutes.
Ms. DeGette. Thank you very much, Mr. Chairman.
Well, following up on the chairman's question, Dr.
Schuchat, would it be fair to say, and really yes or no would
work here, would it be fair to say that the way we are going to
be able to substantially reduce the time between when we
identify a strain and developing the vaccine will be what Dr.
Fauci is talking about, which is development of new platforms
and ways to get the vaccine?
Dr. Schuchat. Absolutely.
Ms. DeGette. Now, Dr. Fauci, I want to turn to you because,
over the years, you have come and talked about the development
of these vaccines. I remember when we had a hearing in this
committee when we were trying to move from the egg to the cell
vaccine. And now you say you have the cell techniques, but you
also say that you are getting ready to go into larger clinical
trials on these new platforms, is that correct?
Dr. Fauci. That is correct, Ms. DeGette. The important
point is that we really think that anything that needs to grow
the virus----
Ms. DeGette. Right.
Dr. Fauci [continuing]. And produce it just is a time sink.
So that is the point that I made on the----
Ms. DeGette. Right.
Dr. Fauci [continuing]. Slide.
Ms. DeGette. No, and we actually, even those of us who only
took high school biology, understood that point.
Dr. Fauci. Yes.
Ms. DeGette. So----
Dr. Fauci. Yes.
Ms. DeGette [continuing]. Good work again. But what I want
to know is now that you have done your phase 1 trials, and you
are trying to move beyond that, what is your time frame for
that?
Dr. Fauci. Well, you know, it is going to really depend on,
first of all, testing it in a season to show that even though
you don't specifically have it against this particular strain,
that it is covering that strain. So when you are trying to
prove universality, you want to test it in a season in which it
is a broader response. One of----
Ms. DeGette. Right.
Dr. Fauci. Yes. One of----
Ms. DeGette. So would that be like next season----
Dr. Fauci. Well, we----
Ms. DeGette [continuing]. Do you think?
Dr. Fauci [continuing]. Actually are going to try now, in
collaboration with BARDA, to make enough of that new concept to
be able to test it----
Ms. DeGette. Test it in this season.
Dr. Fauci [continuing]. In the following season.
Ms. DeGette. Dr. Robinson, you are----
Dr. Fauci. Following season.
Ms. DeGette [continuing]. You are nodding your head, yes.
Is----
Dr. Robinson. Yes, the following season.
Ms. DeGette. OK. So what can Congress do to help you with
that? Do you need additional resources? What do you need to be
able to start to expedite that research?
Dr. Fauci. Well, I mean, obviously, you ask a scientist if
they need resources, the answer is an automatic knee-jerk----
Ms. DeGette. Well----
Dr. Fauci [continuing]. Of course we can do better with
more resources, but we actually need your continued support to
keep the focus on the need for this, because when we do these
tests, remember, we don't have control over the companies that
make the contracts with the various----
Ms. DeGette. Right.
Dr. Fauci [continuing]. Health organizations that
distribute this, but I think the focus that this committee has
continually put on this has been very helpful to us.
Ms. DeGette. Now, in your written testimony, you talk about
the difference between seasonal flu and pandemic flu. Can you
briefly explain that to us?
Dr. Fauci. So I mentioned in my oral testimony a few
moments ago that influenza viruses tend to change slightly. We
call that a drift.
Ms. DeGette. Right.
Dr. Fauci. Right.
Ms. DeGette. Every season.
Dr. Fauci. That is a little bit. Now, if it changes
slightly, even if you don't get the vaccine match right, there
is enough background immunity in the community against similar
viruses that the vast majority of the population are not going
to have a catastrophic outbreak where people would be
completely unprotected.
Ms. DeGette. Right.
Dr. Fauci. When you have an influenza that has what we call
a shift, not a drift, that means major changes, so when you
look at the general population, the overwhelming----
Ms. DeGette. Right. They don't have that.
Dr. Fauci [continuing]. Majority don't have any background
protection. So it is almost as if you are totally naive to this
new----
Ms. DeGette. And that is what happened in----
Dr. Fauci [continuing]. Virus.
Ms. DeGette [continuing]. 2009 and 2010.
Dr. Fauci. Indeed. The bad news, it happened in 2009. The
somewhat comforting news is that it wasn't a particularly
virulent----
Ms. DeGette. Right. Exactly. And that is what we----
Dr. Fauci [continuing]. Virus. So we----
Ms. DeGette [continuing]. Were worried about.
Dr. Fauci [continuing]. Were lucky.
Ms. DeGette. So, Dr. Robinson, now, you said in your
testimony that there remains significant technical challenges
before a substantially better influenza vaccine is available,
and I would assume that the biggest concern for both of you
gentlemen, well, for all four of our witnesses, would be that
if we don't develop that significantly better vaccine system,
and we get a virulent pandemic flu, is that right, Dr.
Robinson?
Dr. Robinson. That is right. I mean, as Dr. Fauci pointed
out, we actually have new ways to actually make these vaccines
by looking at a different portion of one protein. We normally
make the vaccines against the hemagglutinin and our immunities
to that, the head of that, and now we can actually look at the
stalk which we are making these candidates. We may be able,
that way, to protect against many different drifted strains and
serve as a primer for a pandemic so that you have one dose of
this, so you only need one dose of pandemic vaccines instead of
maybe two.
Ms. DeGette. Yes, and so what we are concerned about, or
what I am concerned about, what keeps me awake at night, is if
we don't do enough, both Congress and also our research
institutions, to be able to have that vaccine available if we
get a virulent pandemic flu. Dr. Fauci?
Dr. Fauci. So another important point besides the fact that
all of the issues, the advantages of this universal flu
vaccine, namely, molecular biology rather than growing----
Ms. DeGette. Right.
Dr. Fauci [continuing]. The critical issue is if you--if we
get it right, you could actually stockpile it.
Ms. DeGette. Right.
Dr. Fauci. So we wouldn't have to worry about the chart
that the chairman put up about it changing and trying to keep
up with it----
Ms. DeGette. Right.
Dr. Fauci [continuing]. Because if you stockpile it, you
could stockpile it the same way you stockpile polio vaccine,
measles vaccine, et cetera. That is really the endgame.
Ms. DeGette. Thank you. Thank you very much, Mr. Chairman.
Mr. Murphy. Thank you.
Now recognize Mrs. Blackburn, vice chair of the full
committee, for 5 minutes.
Mrs. Blackburn. Thank you, Mr. Chairman. And as I said
earlier, I want to focus on measles because we are hearing so
much about this. And bear in mind, I have a daughter who has
two children. They are in kindergarten and pre-K, and I can
tell you, and I am sure you all and your teams, are fully aware
that a lot of the mommy blogs are focused on this issue right
now. And it is a big issue with our constituents.
And, Dr. Schuchat, let me come to you first. I just want to
be sure what the known knowns are about the measles virus. If
you would elaborate for just a second. We are hearing 102
cases, that out of these only five had a vaccination against
measles. Do you know what the rate is how they are affecting
elderly as well as children? If you will give us just 1 minute
on this.
Dr. Schuchat. Yes, so far, there have been 102 people from
14 States that have developed measles in 2015. There are
another 11 cases of measles from the end of 2014 that were
linked to the Disneyland outbreak. Not all of the 102 cases
this year are linked with Disneyland, but the majority are.
The majority of people in these outbreaks so far have not
been vaccinated. Only a small number are known to have been
vaccinated. Important to remember that there are about 20
million measles cases around the world each year, and so
measles is literally a plane ride away. When it gets into
communities like the United States now, in certain pockets
where a lot of people are unimmunized, it has a chance to
spread. And so that is why California is really working day and
night to follow every lead and put an end to it there. And that
is why the health departments in every State are really on
alert right now.
Mrs. Blackburn. OK. Let me ask you this. As a physician,
and a representative of our Nation's public health agency, if
you are talking to a parent, should they be more fearful of the
disease, measles, or the measles vaccine?
Dr. Schuchat. Every parent wants their child to be healthy
and safe, and I absolutely respect that. As a physician and as
a public health expert, I can tell you the measles, mumps,
rubella, or MMR, vaccine is very effective and very safe.
Measles can be serious, and I would hate for a parent to
think that everything will be fine, and have a bad outcome with
their child. So I strongly recommend people talk with their
physicians and get the right information, but personally, I
would definitely have my child vaccinated.
Mrs. Blackburn. Thank you.
Dr. Fauci, same question to you.
Dr. Fauci. Same answer from Dr. Schuchat. There is no
doubt, if you do a risk/benefit of the vaccine versus the
disease, I think it is very, very clear that you have one of
the most highly effective vaccines against any virus, and you
have a highly contagious disease, measles, that can have
serious complications, so to me it is really a slam dunk what
the decision would be.
Mrs. Blackburn. So if it were your child or grandchild, you
would say vaccinate?
Dr. Fauci. Without a doubt, and I have done that with my
three children.
Mrs. Blackburn. Excellent. Thank you, sir.
Dr. Robinson, I am going to let you off the hook today. I
usually have quite a group of questions for you. And I do, I
have some questions on Tamiflu and on the stockpile and the
shortage, but as one of my researchers from Vanderbilt told me
this weekend, we don't always get the flu right and had a way
of terming how we go about looking at this. I am going to, in
the interest of time, submit these and would love a response
from you.
And I yield back.
Mr. Murphy. Thank you. The gentlelady yields back.
Now Mr. Pallone is recognized. Thank you.
Mr. Pallone. Thank you, Mr. Chairman. I wanted to start out
with Dr. Midthun. I am concerned about the low flu vaccine rate
for children. By November 2014, only 42 percent of children
between the ages of 6 months and 17 years have been vaccinated
for the flu, and I think we need to change this. And, of
course, the measles outbreak raises more concerns about
childhood vaccination. Yesterday, we mentioned that Ms.
DeGette, Mr. Green, and myself called for a separate hearing on
the outbreak, and the importance of vaccination to prevent the
spread of measles.
I am sorry, actually, my question is of Dr. Schuchat. What
can we do to increase childhood vaccination rates, both for the
flu and for other infectious diseases?
Dr. Schuchat. You know, I think that parents' decisions to
vaccinate their kids are often related to their sense of the
threat and their sense of the value of the intervention. And we
are so fortunate in this country that our disease rates have
been quite low, that many parents don't realize these diseases
are still out there, and that if their children aren't
vaccinated, they will come back. So with the measles outbreak,
I think most parents who weren't vaccinating didn't realize
measles was still around and could be dangerous.
In terms of the value of the intervention, it is important
for parents to have all the information they need about the
safety, the effectiveness, the risks, and benefits. It is
important to me that parents know that the immunization system
is deeply committed to transparency, to monitoring vaccine
safety, to sharing information about risks when we determine
them, and to updating our recommendations whenever there is new
data. Right now, we know that the vaccines we are giving are
saving lives and saving money. For each dollar we put in, we
get about $10 back for the childhood immunization series.
So what we do to try to support and promote immunization is
a strong public-private partnership between healthcare
professionals, doctors and nurses, and pharmacists, and
community groups and consumer groups, to get information where
it is needed, when it is needed, in many different formats. We
know that most people trust their doctors and nurses more than
they trust me or other public figures, and so we really try to
support the doctors, nurses, pharmacists, that are that
frontline.
Mr. Pallone. Well, thank you. Let me continue with you. I
know that the flu activity began in early December, and
continued to increase through the end of 2014. Has the flu
activity peaked for this year, and what data do you evaluate to
make that determination?
Dr. Schuchat. We are well along in the season, but it is
difficult to say whether there will be a long tail or not. In
many areas it is flattening off but not deeply declining yet.
And sometimes later in the season, we see another strain
increase. We have had many seasons where one of the H1N1 or
H3N2 starts off the season, and one of the B strains will be
quite common later on. So we are not out of the woods. It is
important for people to be thinking about this. And we
particularly want people to know that if they develop flu-like
symptoms, and they are pregnant or they are very elderly, or
have other immuno-compromising conditions, early treatment with
antivirals could be very helpful to them. So they should speak
with their clinician.
Mr. Pallone. All right, let me go back now. I did have a
question of Dr. Midthun. The flu vaccine comes in different
forms. There is the high-dose shot recommended for seniors, a
quadrivalent nasal spray recommended for young children, and a
recombinant trivalent, I don't know if I am pronouncing it
right, recombinant trivalent shot recommended for those with
egg allergies. How do you communicate to different groups about
the variety of vaccines, and can the greater number of options
for vaccines increase the rates?
Dr. Midthun. As you point out, there are a number of
different options now, and what we try to do is really
communicate clearly the information that we provide on our Web
site in our package inserts as to what groups were studied and
for which age groups the product is indicated. So, for example,
the high-dose vaccine you were referring to was actually
evaluated in individuals 65 years of age and older, and was
shown to decrease the rate of influenza by 23 percent, relative
to those who got the normal dose vaccine. And likewise,
quadrivalent vaccines are now available for four different
manufacturers; three are inactivated and one is the live
attenuated. They are indicated for somewhat different groups
across that spectrum, and again, that information is put
forward.
The recombinant vaccine that you mentioned has only so far
been evaluated and shown to be safe and effective in 18 years
of age and above, and so again, our prescribing information
will reflect that. But I think I should really turn to Dr.
Schuchat because that is really the advisory committee on
immunization practices, which is an advisory committee for the
CDC that then recommends how these vaccines should be used.
Dr. Schuchat. And just briefly, we recommend people get
vaccinated with the vaccine that is available. And so while
providers and pharmacists get all that information about the
different types, it is much more important to get a vaccine
than to worry about which one is there.
Mr. Pallone. All right, thank you. Thank you, Mr. Chairman.
Mr. Murphy. Thank you.
I now recognize the vice chairman of the subcommittee, and
welcome aboard as vice chairman, Mr. McKinley of West Virginia.
Mr. McKinley. Thank you, Mr. Chairman. Just a quick
observation on this--what I have heard and read in your
testimony and done a little research is, this whole process of
designating which vaccine we are going to come up with in
September just seems archaic. In fact, it seems more of a game
of chance and probability. And by virtue of us continuing this
process, erroneously now with this mismatch, we have 50,000
Americans who are going to die this year. Fifty thousand
Americans. That is more than died in combat in Vietnam, over a
decade of that warfare. And they are going to die because of a
game of chance and probability.
I am just astounded by that. I wonder what better
techniques can we use to predict ahead. And that leads me then
to the second question perhaps, or maybe associated with that,
is that the high-dose vaccine has been found to be 24 percent
more beneficial to senior citizens, and you have a meeting
coming up late in February and it is not on the agenda as a
possibility for September. Could one of you explain just
briefly why that is not on the agenda if it has been proven to
be helpful for senior citizens?
Dr. Schuchat. Yes. Let me answer sort of both parts. The
high-dose vaccine is one of the licensed vaccines that is
recommended, and the company that makes it doesn't make enough
of it for all people 65 and over----
Mr. McKinley. Um-hum.
Dr. Schuchat [continuing]. But they have been increasing
the production. So it is included in the September and February
recommendations. The recommendations are really just which
vaccines to--which virus strains to target, and then there are
all these different formulations like high-dose.
The other thing I just wanted to comment on about is sort
of the mismatch. I want to just point out that in the past 20
years, this is the fourth time that we have had an important
mismatch between one of the circulating viruses and the vaccine
and what dominates. So it is very disturbing when we have this
and we have excess disease burden, but the vast majority of
recommended strains have actually been on track. Even though,
when we have a good match, a well-matched vaccine type, we have
a lot of morbidity and mortality from influenza, and I think it
is one of these diseases that we as scientists take very
seriously, but the American public takes a bit for granted. So
we wish that we had more people vaccinated each year, and that
we wish that people who need to get the antivirals would get
them early, but we have work to do in terms of the medical
community and the public----
Mr. McKinley. Thank you.
Dr. Schuchat [continuing]. And in having them take----
Mr. McKinley. Thank you, doctor. Is----
Dr. Schuchat [continuing]. It seriously.
Mr. McKinley. I want to build a little bit of background
for the chairman and his chart. When it was discovered first in
May, I guess it was, that--or March, there was some anomaly
showing up. May, 17 percent, September, 50 percent. It was
obvious there was a problem with it. So if I go back to
Robinson's testimony, he said that the PCAST report recommended
improving vaccine manufacturing to meet a national goal of
making the first dose within 12 weeks. Now, yes, it would have
taken to go to a national supply to go 6 months, which again,
is a real concern about the production, and some of the
techniques that we can use to reduce that--but if we could have
produced a vaccine, knowing in September it was 50 percent, so
September, October, November, the 1st of December, we could
have had a modified drug, even if it is limited supply, that we
could have tried--whether it is an antigen or a new vaccine
entirely, wouldn't you have recommended let us try this and do
trials, see what the result is, did we solve it, can we do this
in 12 weeks and the next time? So my question: Did you do it?
Did you try to do anything to modify the vaccine that was
wrong?
Dr. Schuchat. Um-hum. I want to stress that we were not----
Mr. McKinley. It is a yes or no, isn't it?
Dr. Schuchat. There were many activities taken to address
the emergence of drifted strain, including preparing a
candidate vaccine virus----
Mr. McKinley. Did you try and modify it?
Dr. Schuchat. The issue of protection is both what strains
are dominant, what efficacy the vaccine has, and how many
people can get the vaccine. So a highly effective vaccine with
very few doses available may not be as good as a moderate- or a
low-efficacy vaccine and a lot of doses available.
Mr. McKinley. I will take your answer----
Dr. Schuchat. I don't think that----
Mr. McKinley [continuing]. As a no, that you didn't try
and----
Dr. Schuchat. No, what I am saying is that we did begin to
prepare the candidate vaccine virus so that companies would be
able to produce a vaccine against the drifted strain. This
particular strain has been quite challenging to produce
vaccines against.
Mr. McKinley. Thank you. Fifty thousand Americans died.
Mr. Murphy. Now recognize Ms. Castor for 5 minutes.
Ms. Castor. Thank you very much.
Dr. Schuchat, on average, maybe take the last 10 or 20
years, how many Americans suffer each year from influenza, how
many are hospitalized, and how many die?
Dr. Schuchat. Thank you. Yes, for the past 5 years or so,
we have ranged between 19 and 35 million cases of influenza
illness each year, between 110,000 and almost 600,000
hospitalizations each year, and 5,300 to 39,000 deaths
attributable to influenza. Those are in the past 5 years. In
that same period, the vaccination efforts we have had have been
reducing the full burden by about 16 to 17 percent. You know,
we would have more disease, deaths, and hospitalizations
without vaccination, but it is not as high a prevented----
Ms. Castor. Um-hum.
Dr. Schuchat [continuing]. Fraction as we see for measles,
where we are preventing 99 percent, you know, of the disease.
And that is partly because we don't have high coverage.
Ms. Castor. How many are vaccinated?
Dr. Schuchat. Well, we have gone from 19 percent of
Americans getting vaccinated against flu, to 46 percent. So
that is a big improvement, but it is not the majority yet. The
other factor though besides the coverage is the effectiveness,
and even in a good year, we are seeing vaccines that work about
60 percent efficacy, and so that is why we are very committed
to the interagency work on developing vaccines that could have
higher effectiveness, particularly in the most vulnerable
populations.
Ms. Castor. And when it comes to the deaths, what age
range? We know the elderly are more vulnerable, but what are
the----
Dr. Schuchat. Yes, you know, the vast majority of deaths
are in seniors, but unfortunately, we do have children die
every year. More than 60 children have died so far this flu
season, and I fear that is not going to be the end of it. So we
know that statistics say if you are elderly, if you have
medical immunocompromising conditions, if you are under 2, you
have more chance of being hospitalized or dying from flu, but
many parents can tell you that their child was perfectly
healthy and they actually lost a child. So I really want
parents and the general public to know to take flu seriously.
Ms. Castor. And this year, it is a particularly severe flu
season with higher rates of hospitalization and mortality. This
is especially worrisome for those vulnerable populations;
children, the elderly, pregnant women, and others with weakened
immune systems. Dr. Midthun, the severity of this year's flu
can be partially attributed to the fact that it is an H3N2
predominant year. Tell us what that means in simple terms. The
fact that this is an H3N2 predominant year. Dr. Midthun.
Dr. Midthun. I think oftentimes in H3N2 prevalent years,
there may be more morbidity and mortality, although I think it
is very important to remember that all influenza can cause
morbidity and mortality. H1N1 was responsible for 2 pandemics,
1918 and the one in 2009. And also B strains can be very
serious, especially for children, and cause very serious
outcomes. But Dr. Schuchat may want to add to that.
Dr. Schuchat. Yes. Overall, the H3N2 serious years have
higher total morbidity and mortality, but as Dr. Midthun says,
the H1N1 has a predilection for younger people.
Ms. Castor. Uh-huh. So you were talking about the
effectiveness of the current vaccine before this year's flu
vaccine shows 23 percent effectiveness. I want to hear more
about how we assess the flu vaccine effectiveness, and better
understand this. How do we gather information on infections and
mortality and then test for vaccine effectiveness?
Dr. Schuchat. One of the things that the investments in
influenza have permitted, the resources that CDC has gotten
over the past several years, is expansion of the systems by
which we track influenza, and track influenza vaccine coverage,
and track influenza vaccine effectiveness. So we have much
better data today than we had several years ago. We are able to
provide estimates in the middle of the year of how many people
have gotten vaccinated, as well as how well the vaccine is
working so far.
We work with State and local health departments in the
surveillance systems, and we work with academic university
partners in measurement of influenza vaccine effectiveness,
essentially, comparing people who have influenza laboratory-
confirmed disease with others to look back at their vaccination
history and basically quantify the vaccine effectiveness that
way. We release our data every week on something called
FluView. It is on our Web site. And so you can essentially look
in October 3 and see the first information about the drifted
strain. So every week as that comes out, you can follow what is
going on. But in mid-January, in fact, we sped up the vaccine
effectiveness estimates so that the public would know them as
quickly as possible.
Ms. Castor. Well, I know I marched my whole office down to
get the flu vaccine, but I think this is very important that
people understand what the experts are saying today, that this
mismatch, parents with children need to be especially careful
because of the predilection for younger folks. But in America,
if we only have 46 percent, and that is kind of high watermark
for flu vaccinations, we can do a whole lot better. So thank
you very much.
Mr. Murphy. Thank you.
And now I recognize Dr. Burgess for 5 minutes.
Mr. Burgess. Thank you, Mr. Chairman.
And, Dr. Schuchat, let me just pick up for a moment on what
you were discussing with the vice chair of the subcommittee,
Mr. McKinley. Now, you had a drifted strain that kind of
appeared on the scene. The Southern Hemisphere designation is
out of phase with what the vaccine release in the Northern
Hemisphere, correct? So you had identified the drifted strain
when the recommendation was made for the inclusion in the
vaccine that was released in the Southern Hemisphere, is that
correct?
Dr. Schuchat. Yes, that is right.
Mr. Burgess. So why not then come forward with a
recommendation for a booster shot or some additional protection
for people in the Northern Hemisphere if we already were
developing a different vaccine based on a drifted strain for
the Southern Hemisphere? Your neighbors to the north might have
been interested in that, don't you think?
Dr. Schuchat. You know, the manufacturing capacity to
respond in September to vaccine strain recommendations in large
number of doses would get us a large number of doses probably
February or so. So I mean Dr. Robinson might be able to comment
a little bit more, but the ability for us to make a Northern
Hemisphere recommendation for a vaccine in September, and have
doses in time for the flu season, would be very low. And we
take that type of step when we are worried about a pandemic,
and I think the committee is raising the question of should we
take that type of step when it is not a pandemic situation but
a drift.
Mr. Burgess. We would like you to react with a little bit
more clarity and be flexible when so many lives are on the
line, as Mr. McKinley outlined. And I mean, look, we are
dealing with a, what, a 40 percent uptake of the vaccine as it
is. If people read the headlines and say only 1 in 5 are
protected anyway, I would just as soon not get stuck.
Dr. Schuchat. Yes.
Mr. Burgess. So I would think you, as an agency, you would
want to have that flexibility and want to show utility for
people that we are on top of this, we are working on this 24
hours a day, 7 days a week, 12 months out of the year. We are
monitoring your health and your safety when it comes to the flu
virus, and we can't be perfect every time, but when we are not,
we are going to be there to help you stave off the effects. I
mean, again, that is what I am hearing as a result of this
hearing. And as Dr. Fauci acknowledged, we have had these
hearings before. We had a hearing when we only had a trivalent
vaccine, and we talked about a quadrivalent vaccine. I mean
these things, they are important, people do pay attention to
them. Our vaccine rates for influenza are lower than they
should be for the country.
Dr. Schuchat. Um-hum.
Mr. Burgess. I have gotten my flu shot every year except
2004 when it was politically inadvisable for a Member of
Congress to receive a flu shot because there was a shortage----
Dr. Schuchat. Right.
Mr. Burgess [continuing]. Because of the serratia
contamination that occurred in one of the manufacturing labs.
Separate story, but every other year I step up and get the
vaccine because I meet a lot of people every day, I ride on an
airplane twice a week, this is just a commonsense reaction to
what is an inevitability on the ground.
I want to shift gears for just a moment, and I do feel
obligated to talk about the measles issue because it has
achieved so much in the way of headlines, and I am going to
breach--I am going to violate HIPAA, and I just want to tell
HHS that I am going to violate HIPAA. I am going to release
sensitive clinical information about myself. So I never had the
measles vaccine. I didn't have it because I was too old. I mean
I was--well, when I was a child in the '50's, it hadn't--it
wasn't there, it wasn't available. I don't remember every
scraped knee, every sniffle from my childhood, but I remember
the measles.
Dr. Schuchat. Um-hum.
Mr. Burgess. It was bad. I mean you can see--and I see in
Harrison's here online, hard, shaking chills. I mean that--it--
yes, hard, shaking chills doesn't even begin to describe it.
The chills are so hard they are painful. You want to cover up,
you want to pull a blanket around yourself, but you don't want
anything touching your skin. That is measles. I mean it is a
different disease. And we had forgotten about it, quite
frankly, because, you know, you just never see it, and now we
are faced with the prospect that we are seeing it. It is
important for parents to have their children vaccinated.
Dr. Schuchat. Um-hum.
Mr. Burgess. There are things that can happen to you as a
consequence of having had the measles. I remember in medical
school learning about subacute sclerosing panencephalitis, and
I remember asking at the time why do I have to learn about
this, no one is going to get it anymore. But, in fact, people
may get it because it is a consequence of having had an
infection with measles. So these issues are important.
Now, if I recall correctly, and suddenly somehow this is
interjected into presidential politics, which is inappropriate
because, if I recall correctly, since President Gerald Ford,
there has not been a Federal mandate for any vaccination. And I
will ask that question generally to the panel, Dr. Fauci, am I
correct on that?
Voice. Microphone.
Dr. Fauci. When President Ford essentially mandated through
the department that there be massive vaccination for the 1976
influenza, that famous catastrophic event with the Guillain-
Barre, but I don't think there has been official mandating
about----
Mr. Burgess. Correct. So these are State-mandated vaccines
that people have to take before attending public schools, and
there is a reason for that. It should be a State mandate. There
is no one asking for a Federal mandate. It doesn't mean that
the vaccination is not important. And for people who are
listening and paying attention today, please have your children
vaccinated.
Thanks, Mr. Chairman. I will yield back.
Mr. Murphy. Thank you.
I now recognize Mr. Green for 5 minutes.
Mr. Green. Thank you, Mr. Chairman. Thank our panel for
being here.
Data from the National Immunization Survey found that fewer
than half of children and adults are vaccinated by November of
this current flu season. My numbers said 40.3 percent, but,
doctor, you said 46 percent. Forty-six percent of the people
and 6 months or older received the flu vaccine. These numbers
seem similar to what we have seen in the last few years.
I wanted to hear why these vaccination rates continue to be
so low and what we can do to improve it, although I have to
admit, the recent news that it is only 20 percent--23 percent
effective, and those of us who are much older it may only be 12
percent, that would probably tell people not to get it. But
somehow along the way, we need to do it, and encourage much
more than 46 percent to be able to get that. The data showed
that nearly 60 percent of the people had not taken advantage of
it. Is that accurate?
Dr. Schuchat. The 46 percent that are vaccinated is based
on last year's end of season, so the 40-some percent was the
early, you know, by November, how many had gotten vaccinated.
You are right that the majority still haven't gotten the
flu vaccine, and this is something that we think is going to
take years of work. Part of the issue is whether there is a
concern about the disease, and part of the issue is whether
there is confidence in the intervention. And as you know, the
intervention has different efficacy, different years. So it is
not a simple message and it is one that we work hard to
communicate honestly and clearly.
Mr. Green. Well, I guess part of the problem is if we think
it is bad now with the news coverage about the less
effectiveness, what can we do to make sure that next year we
have, one, an effective flu vaccine--I know it is almost like
throwing darts against the wall--and that way we will convince
more people to get it, because, again, the more people
vaccinated, the more we will defeat it.
Dr. Schuchat. The vaccine prediction is most of the time
good. So out of the last 20 years, this is the fourth time
where there has been an important mismatch. And in some of the
previous times where there has been mismatch, there has still
been much higher efficacy than what we are seeing this year.
This year will be a difficult year to follow in terms of our
messaging. We do want people to know that influenza can be
serious, and that the vaccine is still the most effective way
to reduce your risk, but we also want people to know about
antivirals, because we think those are also underutilized and
could actually reduce the duration of the illness, and even
reduce the chance of being hospitalized in some patients. And
so we think it is important to get both messages out.
Mr. Green. Is there anything that Congress could do
because, when you found out that the effectiveness was so low--
I know there were some questions earlier from Dr. Burgess
saying, OK, we need a booster for those of us who got the
vaccine--are there resources available where you could do that
and make it an issue, saying, you know, it is only 23 percent
but this booster will get you to 50 percent?
Dr. Schuchat. You know, I think the resources that have
been provided have been incredibly valuable, and there is both
a short-term and a long-term strategy. You know, the short-term
strategy, to use available tools better, and to make
incremental improvements in the production and distribution of
vaccine, and the long-term strategy that Dr. Fauci and Dr.
Robinson were talking about with the research and investments
in universal vaccines. So I think we can't just do one or the
other, we really have to do both, but it will be years before
there is that really much, much, much better flu vaccine. And
we are fortunate that we have a lot of options now and a much
better supply horizon than we have had, you know, 5 or 10 years
ago. So I think we really need to just stick with it and make
those incremental improvements, and make sure that the public
gets the correct information, the accurate information, that we
are honest when he have a year like this where it is quite
difficult. And unfortunately, the vaccine is only preventing
about 23 percent of what it might be, but that is still
significant protection.
Mr. Green. Well--and again, since the percentage is lower
for the most vulnerable population of the elderly, we need to
encourage the elderly to--even if it is only, I don't know what
percentage it was, 12 percent, because it still gives them that
12 percent. But we would sure like to see it up above the
efficiency much better.
Dr. Schuchat. Yes. Ironically, the elderly are the best at
getting vaccinated. It is about 70 percent or so of them, but
the vaccine works the worst in that population. And they really
do rely on the rest of the population being protected to have
more confidence that they will be safe too. So it is one of
those vaccine-preventable diseases where the more people that
are immunized, the better. And, of course, in the future we
hope that we will have even more effective tools.
Mr. Green. I know this has come up before, but----
Mr. Murphy. Thank you.
Mr. Green [continuing]. Ranking Members Pallone and DeGette
yesterday talked about the measles outbreak in Disneyland, and
I know that is a concern too that--to do it. And let me just
follow up, Mr. Chairman, I remember when I was in the fifth
grade, the whole county, we got a polio vaccine. Was that
mandated by the Federal Government?
Dr. Schuchat. You know, in that era, you didn't need to
mandate polio vaccines. People were lining up. I think the
whole country was so thrilled that there was a polio vaccine
licensed----
Mr. Green. Um-hum.
Dr. Schuchat [continuing]. In 1955 because that was such an
incredible scourge. The mandates, the school requirements,
really were shown in the 1980's to massively reduce the risk of
measles outbreaks in schools, and it was really only when
States required kindergarten entry to have measles vaccine
documentation that we started to get a better handle on----
Mr. Green. Thank you.
Dr. Schuchat [continuing]. Measles, and then----
Mr. Green. Yes.
Dr. Schuchat [continuing]. Of course, in 2000, we were able
to eliminate native measles here in the U.S.
Mr. Murphy. The gentleman's time has expired. Thank you.
I now recognize Mr. Griffith of Virginia for 5 minutes.
Mr. Griffith. Thank you, Mr. Chairman.
Let me try to get some blanks filled in here. I don't have
the answers. The meeting took place with WHO in CDC and FDA and
others in February. In March, we know that there was a drift
that was picked up of about 10 percent, is that correct?
Dr. Schuchat. Actually, it was lower than that.
Mr. Griffith. About 7 percent I think I saw in your
testimony.
Dr. Schuchat. It was like 4 percent.
Mr. Griffith. OK. Do we know what April was, because we
have a few numbers on the chart but we have a lot of question
marks? And if you don't----
Dr. Schuchat. In April----
Mr. Griffith [continuing]. You can provide it----
Dr. Schuchat [continuing]. Fourteen viruses were shown that
had reduced susceptibility to the strain, and that was out of
127, so that would be 11 percent.
Mr. Griffith. OK. And then we have a number from May. Then
June and July, we don't have another number on this chart until
September. What were you all seeing in June, July and August?
Dr. Schuchat. In June, July, and August, there were 88
viruses identified from the whole world that had reduced
reaction, and so that comes to 36 percent.
Mr. Griffith. OK.
Dr. Schuchat. With reduced, you know, that were mismatch.
Mr. Griffith. And then there is another meeting, and there
is a different Southern Hemisphere recommendation made, and we
don't make the--I think that is five. If you can get us the
other numbers just so we can kind of track it, that would be
great. But then----
Dr. Schuchat. Absolutely.
Mr. Griffith [continuing]. My question comes up, and I am
happy for anybody to answer it, why didn't we have the
manufacturing capacity for the virus to do turn somewhere in
this process, I think you said by June, July, we were in the 36
percent range, recognizing that flu season doesn't generally
hit in a big way for another fair number of months, why does
the United States lack that manufacturing capacity, and as a
subpart of that, if there was the capability of producing, and
I am trying to pronounce this correctly, monovalent vaccine,
why didn't we do so? And if you all could focus on that. Any
member of the panel please.
Dr. Schuchat. Yes, maybe I can start and let Dr. Robinson
continue.
I think one thing to recognize in the summer is that we
were looking at increasing proportions of H3N2 that were not
well matched to the vaccine, but we still had the other 2 or 3
different strains that were in the vaccine. So the concept of
producing a monovalent vaccine--we might have been asking the
American public to take a monovalent vaccine plus the tri or
quadrivalent seasonal vaccine. As we have been hearing, the
American public isn't all that keen to get one flu vaccine a
year. Would they really be lining up to get 2? But there are,
of course, major limitations in the manufacturing capacity to
make 2 different products for the same season. So I will let
Dr. Robinson answer that.
Mr. Griffith. Dr. Robinson?
Dr. Robinson. Thank you. During the manufacturing season,
they are producing three or four vaccine strains all the way to
June, maybe even July if it is a tough year for them. At that
time--and most of those are egg-based. At that time, they
within the summer are putting those together, we call them
blending and putting together, to go forward with the vaccine
that was released in September to go out on the shelves.
The ability to have what was called a competent vaccine
that could be very quickly--that is certainly true, it can be
maybe faster than some of the egg-based vaccines, but the
capacity that we have right now with the licensed vaccine, the
only one recombinant-based vaccine, is very, very small. It
would have only been able to produce maybe hundreds of
thousands of----
Mr. Griffith. OK. Let me----
Dr. Robinson [continuing]. Doses.
Mr. Griffith. Let me ask the why on that. Is it because
there is not a profit----
Dr. Robinson. No, no.
Mr. Griffith [continuing]. To be made?
Dr. Robinson. One instance, it is a new vaccine----
Mr. Griffith. OK.
Dr. Robinson [continuing]. And, two, since it is a new
vaccine, they are just scaling up to the market. This is an
incumbent market, very competitive, and they were licensed in
2013. We are actually supporting their efforts in building a
much larger facility to produce maybe tens of millions of
doses, and so that they actually can going forward be able to
produce, say, 50 million doses in 4 months of a monovalent
vaccine for a pandemic or, maybe in this case, another
influenza vaccine.
Mr. Griffith. So you anticipate that our capacity will be
greater in the next couple of years than it is today to react?
Dr. Robinson. Indeed, it will be, because we will actually
have the cell-based influenza vaccine facility down in North
Carolina that has a large capacity, and we will be able to have
that product on the market. But again, they are limited in that
they are making seasonal flu vaccine at the same time that we
may have wanted to do that.
The other thing is that these manufacturers also produce
vaccines for the Southern Hemisphere. So when they came off of
making the vaccine for the Northern Hemisphere, then they
started back to actually making the vaccine for the Southern
Hemisphere. So we would have had to make a decision and tell
them in September, stop doing that and go forward with the new
vaccine. And we know that that is a difficult midcourse shift.
Mr. Griffith. But if we----
Dr. Robinson. The future will be----
Mr. Griffith. But we could have done that even in, say,
July when we knew we were at 36 percent that had drifted?
Dr. Robinson. It would have been very, very difficult, sir.
Mr. Griffith. OK. All right. I appreciate it. I see my time
is up and yield back.
Mr. Murphy. All right, I want to clarify something. So you
said 36 percent, June, July, and we have a 50 percent cutoff.
So some time in September the 50 percent number was significant
enough to say, OK, we need to do something different in the
Southern Hemisphere. What is the magic number where you say we
need to make a change here?
Dr. Schuchat. Actually, it wasn't that there was something
different, it is that every September the strains are reviewed
worldwide. All----
Mr. Murphy. Why not----
Dr. Schuchat [continuing]. Of them.
Mr. Murphy. Why not August? What I am concerned about is,
we want to break through, if there is some bureaucratic
hurdles, this committee wants to help----
Dr. Schuchat. Thank--yes.
Mr. Murphy [continuing]. But if you say, well, we don't
look at this until--we don't really meet and discuss this until
September, that is not a lot of solace for what Mr. McKinley
was raising for the hundreds of thousands of seniors who are
going to be sick. What--what is--what do we do?
Dr. Schuchat. Right. In September every year, the groups
convene to review all the data for the Southern Hemisphere
production, and that is because it takes that long to get
vaccine that will be ready by that time. It is not----
Mr. Murphy. I am not----
Dr. Schuchat [continuing]. Because we are not looking all
the way between.
Mr. Murphy. Yes, but you have already said you can get a
vaccine ready in 12 weeks when you need a monovalent strain
when there was a pandemic.
Dr. Schuchat. Not----
Mr. Murphy. Wasn't that done in 2009, you did something
quickly----
Dr. Schuchat. No.
Mr. Murphy [continuing]. Dr. Robinson?
Dr. Robinson. OK, go ahead.
Dr. Midthun. No----
Mr. Murphy. I want to be clear.
Dr. Midthun [continuing]. I think in 2009 the virus emerged
in April. In May it was recognized that it was causing
significant disease, and at that time a decision was made
across the HHS that a monovalent vaccine would be pursued. And
so all stops were pulled out to do that, but in point of fact,
the first vaccine was not available from--for that H1N1
monovalent until the end of October, and the bulk of vaccine
was not available until late December, into January. So just
point taken that the manufacturing process itself takes many
months, and although we----
Mr. Murphy. To get to the critical number. I know it is Mr.
Tonko's turn, but we are talking about just to start to give it
to some seniors and high-risk group.
Mr. Tonko, you are recognized for 5 minutes.
Mr. Tonko. Thank you, Mr. Chair. And welcome to the panel.
There has been much discussion here today about parents and
the advice they get about having their children vaccinated or
not vaccinated. I would like to ask it from yet another
perspective. Yesterday, a United States senator asserted that
routine vaccinations could cause, and I will quote, ``walking-
talking normal children to wind up with profound mental
disorders.''
And so my request of the panel is a simple yes-or-no
response. Is there any shred of credible evidence that shows
that this, in fact, is the case? Dr. Schuchat?
Dr. Schuchat. Not the vaccines we are using today.
Mr. Tonko. Dr. Midthun?
Dr. Midthun. No, not for the vaccines we are using today,
although I think it is important to note that any vaccine can
have some safety issues associated with it, but typically, they
are very rare, and that is why we also have the Vaccine Injury
Compensation Program.
Mr. Tonko. Dr. Robinson?
Dr. Robinson. I am in agreement with Dr. Schuchat and Dr.
Midthun.
Mr. Tonko. Dr. Fauci?
Dr. Fauci. Agree.
Mr. Tonko. Pardon me?
Dr. Fauci. Agree with my colleagues.
Mr. Tonko. Thank you for clarifying.
In addition to promoting vaccination, Dr. Schuchat, how
else does the CDC work to prevent spread of the flu? For
example, does the CDC recommend symptomatic individuals to stay
home from work?
Dr. Schuchat. Yes, we have a multipronged approach to
prevention. The best protection is to get vaccinated. We also
recommend sensible measures like washing your hands, covering
your cough, staying home when you are sick, staying away from
other people when you are sick. And then, of course, if you are
ill, and particularly those with underlying conditions or the
elderly, we think prompt antivirals can be important, and so
talk to your clinician about that.
Mr. Tonko. Are there any data showing how many flu
transmissions occur in the workplace when symptomatic
individuals do come to work?
Dr. Schuchat. I don't have that data, but there have been
analyses showing the value of vaccination to reduce workplace
absenteeism and to improve productivity.
Mr. Tonko. Um-hum.
Dr. Schuchat. So we think it is a good thing for health,
and it is also a good thing for the workplace to be protected
against flu. To stay home for when you are sick for a variety
of conditions is good counsel.
Mr. Tonko. I do know that in speaking with my constituents,
there are a number of working moms and dads who can't afford to
take time off of work because it would mean they are not paid,
and so they attempt to come to work even though they really
shouldn't. In your opinion, would paid leave policies help to
prevent the transmission of the flu and other illnesses by
encouraging more workers to stay home when they are indeed
sick?
Dr. Schuchat. We think the easier it is for people to do
the right thing, the better.
Mr. Tonko. OK, thank you.
Dr. Midthun, the FDA has licensed a number of new vaccines
since the year 2009. How have these new vaccines contributed to
preparedness efforts in the last several years?
Dr. Midthun. Thank you for that question. I think what they
have done, especially with regard to the cell-culture-based
vaccine and the recombinant protein vaccine, is they offer an
alternative manufacturing platform relative to the egg-based
manufacturing that was the basis for the vaccines that had been
approved up until that time. And it is always important to have
a diversified way in which you can manufacture vaccines. It
also widens the platform available in the event of a pandemic
because, typically, the pandemic vaccines are made on the same
manufacturing platforms that the seasonal vaccines are made on,
and so it really provides greater diversity and more
resilience.
Mr. Tonko. And, doctor, in your testimony you talked about
work to speed up the manufacturing process for existing
vaccines. Can you tell us more about that work?
Dr. Midthun. Yes. It is actually a very strong
collaboration between BARDA, CDC, NIH, and ourselves, and it
looks at a number of different aspects. One aspect is to look
at the potency testing that is done for vaccines. Right now,
that relies on reagents that are made by immunizing sheep, you
develop antiserum, this usually is a process that can take up
to 2 months. And so, obviously, having potency assays that are
much more rapid would really decrease the time that it takes to
do this, to make these reagents. And so there are some
approaches using more modern platforms, and in conjunction with
some of our colleagues, there actually are some tests that are
being planned that will be embarked upon later this year to
compare some of these newer assays to the standard assay that
is used right now, the radial immunodiffusion test, to see how
these compare to each other in actual testing of vaccine
samples that the manufacturers are providing to us. And some of
the manufacturers have actually expressed interest in also
participating in the testing to see what the feasibility is. So
that is one aspect that we are working on.
Another one that has been very important, and that the CDC
and others have really done a lot of work on, but we have also
contributed to, is to try to identify high-growth viruses that
will lead to good yield when you grow the virus in the eggs or
in the cell culture. As you recall, Dr. Fauci was referring to
the fact that that can often be a rate-limiting step. And so
trying to develop viruses that you know will yield high growth
when these new strains emerge could really facilitate and take
time off that process.
And then also there was the sterility testing, and the FDA
actually changed its regulations in 2012 to allow for more
flexibility in sterility testing. Up until that time, it was
very prescriptive and this 14-day test by USP had to be used,
but now manufacturers can come in with novel testing, and we
actually know that some, you know, testing that has been
described in the literature could actually be accomplished in
5, 6 days potentially.
Mr. Tonko. Thank you.
Mr. Murphy. Thank you.
Mr. Tonko. I yield back, Mr. Chairman.
Mr. Murphy. Thank you.
I now recognize a new member of the subcommittee, Dr.
Bucshon, who is a cardiothoracic surgeon by training, and is
here from Indiana. Welcome to the subcommittee, and you are
recognized for 5 minutes.
Mr. Bucshon. Thank you, Mr. Chairman. First of all, I would
like to associate myself with the unanimous comments of our
expert panel in recommending that parents get their children
immunized to prevent childhood diseases. All my children are
immunized.
Based on the testimony we have heard today, it seems like
we could have had a monovalent vaccine available by maybe
December, and if that is true, Dr. Schuchat, do you lack the
authority to make that happen in that way, because through the
testimony, I think a lot of members have asked what can we do
to help, but for us, for Congress, to help, we have to have a
specific thing to help with. So is there new authority or any
other authority that would be helpful to make this happen?
Dr. Schuchat. I don't believe so. The key issues is a risk
assessment and trying to predict the most likely course of
events, but I believe there are authorities if the decision is
made to go ahead with the monovalent, whether for pandemic or
for drift.
Mr. Bucshon. OK. As a healthcare provider, I know that, you
know, liability is a significant issue in our American
healthcare system, and not only physician malpractice, but
product liability is a substantial issue, I know, that has an
effect on the healthcare industry. Anyone can comment on this.
Do product liability issues affect our ability to act in a more
nimble way when it comes to vaccines, because you do have
private companies that produce these. And so let us start with
that and then I will spearhead off from there.
Dr. Schuchat. The Vaccine Injury Compensation Program
exists so that product liability won't be a factor, so that we
can make sure that we have vaccines made but the people who are
injured by vaccines are compensated. And so the funding from
that comes from an excised tax on every vaccine dose that is
sold, so that we know that vaccines are very safe, but there
are sometimes rare, important complications, and the Injury
Compensation Program exists for those families who have been
injured.
Mr. Bucshon. OK. Thanks for clarifying that, and I think
that is important to understand.
Dr. Midthun, from the FDA's standpoint, is there--how do I
want to say this--a risk-averse regulatory process? It seems
like at the FDA, you know, over a number of years--but for a
variety of reasons have--I think been, in my view, sometimes
overly cautious with new products or changing quickly. Do you
see that as an issue, you know, and that comes into the
liability issue again, is there resistance or reluctance to
quickly move based on the concern about these type of things?
Dr. Midthun. No, I don't see that. I think in the influenza
domain, we, every year, are primed to approve the new vaccine
strains that are recommended for inclusion in the vaccine those
years. I think also our record of having approved since 2003--I
think in 2003 we had three licensed influenza vaccines. Today
we have 16 licensed influenza vaccines, including our cell-
based, recombinant-based, quadrivalent, high-dose, and also I
should point out that many of those we actually approved using
accelerated approval, which actually allows us to approve
something based on the new response that is likely to predict
clinical benefit. And so we have used accelerated approval
regulations to approve many of those and get them to market
more quickly. So I think we--and also I should point out we
approved the novel adjuvanted H5N1 vaccine in 2013. So I think
that we really looked very carefully, and balanced the benefits
and the risks, and are really very flexible.
Mr. Bucshon. Great. That is good to hear.
There is a recent CDC study that looked at clinician
practices on patients that come to the emergency room with--and
the data is striking, only 16 percent of patients with
laboratory-confirmed influenza were prescribed antiviral drugs.
So the first question I have, do they work? Do the
antiviral drugs work?
Dr. Schuchat. Yes, last week there was a new meta-analysis
of all the published and unpublished randomized control trial
data on Oseltamivir, and it shed new light on the benefits as
well as potential risks that--there is----
Mr. Bucshon. So they----
Dr. Schuchat [continuing]. Benefit for the work.
Mr. Bucshon. Short answer, they do work, because I am
running out of time.
Dr. Schuchat. Yes.
Mr. Bucshon. Because surprisingly, 30 percent of the
patients with laboratory-confirmed influenza were--30 percent
were prescribed one of three common antibiotics, which are for
bacteria, not viruses. Is there anything that we can do to
better, you know, as a physician, better make the, you know,
change that practice? Maybe Dr. Fauci can answer that.
Dr. Fauci. Yes, that is another whole issue of
antimicrobial resistance, which we have even discussed before
this committee. So certainly, over the last year, there has
been an extraordinary effort on the part of the Congress and
the administration in everything from executive orders to 5-
year plans to counter the kinds of practices that lead to
antimicrobial resistance, and one of the most common, as I am
sure you are aware, sir, is that someone comes in with a viral
infection and they get an antibiotic. That is very, very
common, unfortunately.
Mr. Bucshon. I yield back, Mr. Chairman.
Mr. Murphy. Thank you.
I now recognize a new member to the committee, Ms. Yvette
Clarke, who represents--Ms. Schakowsky is next? I am sorry, I
thought Clarke was next.
Ms. Schakowsky. I was here earlier.
Mr. Murphy. All right, thank you.
Ms. Schakowsky. Thank you, Mr. Chairman.
So if the vaccine that we are using now has been viewed as
23 percent effective, and usually in the past it has been 50 to
60 percent effectiveness, are we seeing--maybe it is Dr.
Schuchat, are we seeing a commensurate increase in the
incidents of flu?
Dr. Schuchat. Yes. When we compare this season with 2 years
ago, the 2012/13 season, the last big H3N2 season, much of the
pattern is similar, but our hospitalizations in the elderly are
much higher at the same time this year. So we will get the end-
of-season statistics, but it has been a very bad year for the
elderly.
Ms. Schakowsky. I see. So the lab tests predicted 23
percent----
Dr. Schuchat. Um-hum.
Ms. Schakowsky [continuing]. But you are seeing it actually
out in the country, that it is also much higher?
Dr. Schuchat. Right. Yes, we are seeing, you know, both the
lab mismatch and then our vaccine effectiveness low estimate,
and then the incidents of the hospitalizations is high.
Ms. Schakowsky. OK. With the passage of the Affordable Care
Act in 2010, we took important steps on preventive medical
coverage for free, and since the law went into effect,
approximately 76 million Americans have received no-cost
coverage for preventive services. So I am wondering if we are
seeing that there actually was an impediment to getting these
preventive services, vaccines, because of the cost, and now
without the cost, that more people are making that available to
themselves.
Dr. Schuchat. For influenza vaccine, I think it is too soon
for us to see, but we do know that there are important
disparities in influenza vaccination coverage, and that insured
people have been more likely to be vaccinated than uninsured.
So I think that over the years ahead, we may start to see some
progress there.
Ms. Schakowsky. So we do think, although we don't have the
new data----
Dr. Schuchat. Um-hum.
Ms. Schakowsky [continuing]. That cost has been a barrier
in the past----
Dr. Schuchat. That is right. We----
Ms. Schakowsky [continuing]. Is that what you think?
Dr. Schuchat. And we know even for the workplace, for
instance, when workplaces will offer flu vaccine for free for
workers or, particularly for healthcare workers, the uptake is
better than when it is out-of-pocket, off-site, need-to-seek
vaccine.
Ms. Schakowsky. I think it is great that we are having this
hearing today because this whole question of vaccines, as many
of my colleagues have mentioned, has really been in the news,
and it is disturbing that a number of high-profile political
figures have weighed in on this in a negative way, I would say,
that this is, you know, parents should make the decision, and I
have seen some children that have been deeply affected by
vaccines in a negative way. What I am wondering is, what is the
public health outreach effort to make sure that--you heard my
colleague Marsha Blackburn talking about the mom blogs. I mean
there is a lot that is going on, not only on television, and I
am glad you were on, Dr. Fauci, and that is very important that
we get the message out in every medium, but I am just wondering
if we are also just looking at how people are communicating
with each other in the social media and getting the facts out.
Dr. Schuchat. Yes, we spend quite a bit of time and
attention monitoring the social media as well as the general
media, and we work closely at the national level, but also at
the State and local level, on communication, both direct to
consumer as well as through clinicians and other trusted
partners, because we think getting information that speaks to
you close to where you are is really important in your health
behaviors.
I would just like to say that the vast majority of parents
vaccinate their kids against most of the recommended diseases
on time, and yet there are some minor voices that get a lot of
attention.
Ms. Schakowsky. Exactly. I think maybe we need to make sure
we communicate with all political voices as well that are out
there to make sure that we are communicating the science, the
facts, that suggest that all parents should vaccinate their
children.
So I yield back.
Mr. Murphy. All right, now we recognize Mr. Flores from
Texas, who is also new to this committee. Third term in
Congress, and we welcome him to this subcommittee.
Mr. Flores. Thank you, Mr. Chairman. I also want to thank
the panel, particularly for your positive comments regarding
the benefits of having children vaccinated for measles. I have
an extended family member who has not done that for her
children yet, and it just baffles me why she can't do that. And
so I hope she is hearing this today, that she heard your
comments, and that she will do so.
I want to talk about the weakness in the strain selection
process, and talk about the opportunities to mitigate that
weakness. And I want to focus my questions to you, Dr.
Robinson, because BARDA is a tool, I think, that we have to do
this.
And so my first question is this. Is BARDA funding any
projects or initiatives to develop two things: one, better
testing technologies, or two, better approaches for making the
vaccine candidates?
Dr. Robinson. So the answer is yes on both. In my
testimony, I identified that we were supporting the development
of evolutionary biology methods that would actually help the
existing methods inform what strains are out there. There are
only so many ways a virus can mutate.
Mr. Flores. Right.
Dr. Robinson. And we know that you can do the experiments
to show which ones would predominate, and that may actually
inform which ones we may see the next season. And certainly,
the underpinning of that the NIH has funded over the years, and
so we are moving forward primarily for our pandemic purposes,
but certainly could be used in seasonal. So that is one way
towards the selection, and then informing new vaccine designs.
Mr. Flores. OK.
Dr. Robinson. Secondly, with the technologies, we have
supported with our colleagues here from NIH, CDC, and FDA, new
technologies to make these vaccines, whether it be cell-based
or recombinant. And working with the NIH, we are looking at
universal flu vaccine candidates with a number which Dr. Fauci
enumerated of going forward. It is not because those
technologies haven't been tried before, but as he explained,
there is a limitation in how the body actually sees these viral
proteins. And so there are some new ways now that we can do
that, we couldn't do before.
Mr. Flores. And in terms of looking at BARDA's priorities,
where would you say that getting these better technologies for
the strain selection process is in your sort of list of all the
things you have to do on your wish list?
Dr. Robinson. Yes. Well----
Mr. Flores. Is it in the top third, or the middle, or the
bottom, or----
Dr. Robinson. No, it is at the top.
Mr. Flores. OK.
Dr. Robinson. Yes.
Mr. Flores. Great. Sounds like we should keep it there,
from what I am hearing today.
The third question is how can we expedite the development
and deployment of better technologies, say, use of genetic
sequencing, to detect virus change, which you have talked
about, to ensure that the U.S. has a vaccine that can be
matched to a drifted H3N2 strain?
Dr. Robinson. Certainly, one of the ways that we actually
have employed with biosynthetic technology work with the Craig
Venter Institute and then one of the manufacturers. We did that
in 2013 with H7N9 to actually come up--what we didn't need the
traditional way of having the virus actually sent from one
laboratory to another. We actually had the nucleotide sequences
available, then using that, and actually made the virus seed
strains and went forward with H7N9. Regardless of if it is an
egg-based or cell-based or recombinant, we can do that.
Mr. Flores. OK.
Dr. Robinson. And we are moving forward with those efforts
also.
I just want to say one other thing that Dr. Midthun had
talked about, and that is high production yield seed strains.
Why is that important? It means that the virus doesn't have to
be passaged to eggs or cells or medium many times because, very
early on, we can actually have high production seed strains,
and that is why the manufacturers keep passaging the virus to
get high production. If we had that immediately, then the virus
that actually is in the vaccine is going to be very similar to
the circulating virus.
Mr. Flores. Um-hum.
Dr. Robinson. Much more so.
Mr. Flores. OK. And then the last question I have: I have
always been fascinated with the initiatives to try to develop
the universal flu vaccine, and I appreciate what Dr. Fauci
talked about today, and educating the committee and
subcommittee on how to do that.
What role does BARDA play in the development, deployment
and stockpiling of a universal flu vaccine?
Dr. Robinson. So certainly hand in hand with the NIH, we
are moving forward with the development, not only for seasonal,
as I had pointed out, for pandemic purposes. It may serve as a
primer for future pandemic vaccines. Again, you may only need
one dose of the pandemic vaccine as opposed to two which you
normally would need. And so we can stockpile that vaccine or
actually have it as part of our commercial products that are
out there every year.
Mr. Flores. OK. Thank you for your responses. As you know,
this is important to me because you have a facility in my
district that I think is doing some great work.
Mr. Chairman, I yield back.
Mr. Murphy. Thank you.
And now I recognize Ms. Clarke of New York, the Brooklyn
area, as a new member of the subcommittee. Welcome. You are
recognized for 5 minutes.
Ms. Clarke. Thank you very much, Mr. Chairman.
Being the low one on the totem pole, oftentimes, it comes
with the territory.
Let me welcome our panelists as well, and pick up on some
of the line of questioning that my colleague Mr. Tonko raised
with respect to research.
So, Dr. Fauci, your testimony discussed the potential for a
universal flu vaccine that could provide protection against
numerous strains of the flu over several seasons. What can you
tell us about the research on this vaccine?
Dr. Fauci. OK. So the research on this vaccine, as I had
mentioned, really starts off with the fundamental basic
observation that a part of the protein that is the target of
the vaccines that we have developed over decades is one that,
unfortunately, has a component of it that tends to change from
season to season. We refer to that as a drift. Big change is
the shift. The part that doesn't change is the part that we
have just recently recognized on the thin stem part of the
protein that we now know that if you show it to the immune
system in a certain way, and you can only do that by molecular
biological techniques because, generally, when you show the
immune system the whole virus, the part that you really wanted
to make an immune response is crowded out and covered by the
larger part. So now you are essentially teasing it out and
showing the immune system just the part that you want to make a
response again. And we have done that. We have done it with a
number of different platforms, and we have shown now in a small
animal, in a ferret, and now even in a human, that, A, it is
feasible, B, it is safe, and C, it does induce the kind of
response that you would predict would have a much broader
effect.
So that is the real first solid step. We have to perfect
that, and then we have to show in a broad study that it
actually does protect against multiple strains.
Ms. Clarke. That sounds very promising, Dr. Fauci.
Dr. Robinson, you mentioned in your testimony a new
initiative to support development of new flu vaccine candidates
that offer broader, longer-lasting immunity. Can you tell us
more about this initiative?
Dr. Robinson. Certainly. We are working with Dr. Fauci with
many of the candidates that he has talked about, and in
addition, there are other ways in which we can broaden the
immunity. Some might be with adjuvants, and other designs of
the vaccines going forward, and not only for seasonal but for
pandemic purposes.
Ms. Clarke. So it sounds like we are moving into the 21st
century.
Dr. Robinson. Yes.
Ms. Clarke. Very well. Very well. I would like to shift a
bit to the idea of strains, the strain selection process, Dr.
Midthun. Can you outline the role of the FDA's Vaccines and
Related Biological Products Advisory Committee in the strain
selection process, and when does this process actually begin?
Dr. Midthun. The process is actually year-round. CDC and
other WHO collaborating centers for influenza are monitoring
influenza strains year-round to be looking for trends, changes,
emerging situations, so that is going on all the time. Then you
have----
Ms. Clarke. How does the advisory committee arrive at its
recommendations on the selection of a strain?
Dr. Midthun. OK. So what happens in usually February or
early March, when the Vaccines Advisory Committee meets, is
that we have experts come and present the data on the influenza
strains that have been circulating over really the last year,
and those strains are evaluated to see which appear to be
prevalent, and really based on those data a decision is made
about which vaccine strains should be included in the vaccine
manufacturing. And then once that recommendation is made, of
course, the manufacturers then use that information to start
manufacturing their vaccines. But I think a very important
point to note is that, typically, manufacturers actually start
manufacturing the vaccine before the advisory committee is even
held. They usually start in January. Why? Because they are
aware of the data also. As I mentioned, this is an ongoing
process year-round, and so they will usually anticipate what
they think will be the strain that is not going to change. They
do this at risk, but the point is that----
Ms. Clarke. That is what I was going to ask----
Dr. Midthun [continuing]. It is a process----
Ms. Clarke [continuing]. Has there ever been an incident
where perhaps the advisory committee did not necessarily agree
and the manufacturer is already proceeding?
Dr. Midthun. Yes, that can happen. I mean you would have to
ask individual manufacturers----
Ms. Clarke. Yes.
Dr. Midthun [continuing]. But I suspect that that has
definitely happened, although, typically, I think they will go
with something that they think, based on the data, is unlikely
to change. But it really is a process where we make the
recommendation in February, but clearly, there is a lot of work
that precedes that and there is a lot of work that continues
after that to actually have vaccine available. And usually
vaccine becomes available in July, August, that time frame, and
then it is continued to be released really throughout the end
of October. So you can see it is a process that, even though
you do a recommendation in February, and much work starts
before that even, it really does take many, many months to
actually have vaccine available for the influenza season----
Mr. Murphy. Thank you.
Dr. Midthun [continuing]. Which, you know, typically can
begin, you know, October, November, although sometimes not
until later.
Mr. Murphy. Thank you.
Ms. Clarke. Thank you.
Mr. Murphy. Thank you.
Now I recognize another new member for the committee, Susan
Brooks of Indiana, who has a second term of Congress.
Previously she was in the Homeland Security Committee and was a
U.S. Attorney. We look forward to you being a part of this
committee. You are recognized for 5 minutes.
Mrs. Brooks. Thank you, Mr. Chairman. I do want to thank
all of the witnesses for your work with respect to the public
health and safety of our citizens. On Homeland Security, I
chaired the subcommittee on emergency preparedness response and
communications, and this is something that we know everyone is
passionate about. I think, obviously, when we have an epidemic
the way we have right now, the public pays a lot more attention
to it, but I think the public also expects us to get it right.
And the public is expecting us to leave no stone unturned and
to continue to ask the questions and figure out how can we do
it better, how can we do it faster, what mistakes have we
learned from in the past, and what do we do to keep our country
safe.
This year is a much higher death toll, as you have said. In
Indiana, there were 72 deaths statewide. The year before, 70.
We have already had 108 deaths in Indiana, and it is just the
end of January, and the flu season, as I understand it, goes
often in through May, so we have a lot that we are very, very
concerned about. I spoke with the head of our Marion County,
which is Indianapolis' Public Health Department, and she has
indicated that the flu has gotten so severe in Indianapolis
that she is barring anyone under the age of 18 from visiting
hospitals. So if you are 15 years old and your mom is in the
hospital, you can't visit your mom. So we have reached, just to
let you know, as I am sure you know, and you are very focused
on this, but these types of precautions are obviously being
taken for the safety of the patients, but we also know, as we
have heard, vulnerable, you know, whether they are children or
seniors, are so vulnerable. But yet one of the things she also
shared with me, and she was explaining the ag. culture
technology that we use, and it takes a long time, but yet she
shared the new cell mediated technology that you have mentioned
in production is faster, but yet it is not widely used. And so
I would like to explore why.
You mentioned a cell-based facility in North Carolina. Can
we please talk a bit more about if these technologies are out
there, why are they not being more widely used? And I don't
know if, Dr. Schuchat, you want to start, and Dr. Robinson.
Dr. Schuchat. Yes, I will just make an overview comment
that production of flu vaccine has been increasing over the
past decade, with more, you know, factories in the U.S., more
companies, more products, but we also have to work on demand,
and the more vaccine we use every year, the more the companies
will make. They don't make lots of vaccine at a risk. And so it
is a cycle that is interdependent. But Dr. Robinson can talk
about the cell-based plant and some of the other manufacturing
efforts.
Mrs. Brooks. And is that correct, that a cell-based
technology would allow vaccines to be produced faster? Is that
correct or is that not correct?
Dr. Fauci. Not significantly faster. The cell-based is more
consistent, whereas eggs, you know, it depends on supply of
eggs, whereas you can keep growing up cells. I think that is a
common misconception that there is a game-changing difference
in the amount of time it takes. And the answer to that, and I
am sure Robin will verify that, isn't the case. You both have
to grow the virus, that is the problem, as opposed to in a
recombinant DNA or molecular technology, be able to make it
more quickly. So even though we welcomed the transition, and
hope we even do more from egg to cell, the answer for the time
frame itself is not going to be solved by cell-based
technology.
Mrs. Brooks. What is the answer to shorten the time of
production?
Dr. Fauci. And that is what I just said when I was talking
about changing from a need to grow the virus, to the ability to
do it from a molecular way where you actually develop a vaccine
by recombinant DNA technology, which doesn't require your
having to grow the virus. That is really the major
transformation from one platform to another.
Mrs. Brooks. Dr. Robinson, how do we----
Dr. Robinson. No, I agree with them. I mean that is where
we see the biggest savings in time is with recombinant
vaccines, but they are new and they are just with very limited
capacity, they will grow in time. With the cell-based vaccines,
we may even be able to shave a couple of weeks off than what we
have with the standard egg-based vaccines at this time.
The other issue is that it is a new product, and this is a
very competitive industry, and they are trying to get their
market share at this time. And as they improve to be equal to
or better, then they will actually become more commonplace in
the overall vaccine supply.
Mrs. Brooks. So are you saying that there is just one
manufacturer that is manufacturing in that manner?
Dr. Robinson. That is cell-based in the U.S., there is only
one licensed manufacturer.
Mrs. Brooks. Is there any issue in the licensing process?
Dr. Midthun. No, there is no issue in the licensing
process. We have approved one cell-based manufacturer and one
recombinant-based manufacturer. We basically work with anyone
who wants to come in and make a product, and we are there to
facilitate that process, but it really is up to, you know, the
sponsor to come in and say we would like to do this. Certainly,
you know, BARDA has done much to support some of these new
technologies, and certainly, again, we are grateful for the
support you have given in that regard.
Mrs. Brooks. OK.
Mr. Murphy. Thank you.
Mrs. Brooks. Thank you.
Mr. Murphy. We now recognize another new member of the
committee, Markwayne Mullin of Oklahoma. We welcome you, and
you are recognized for 5 minutes.
Mr. Mullin. Thank you, Mr. Chairman.
Dr. Robinson, my State of Oklahoma has been hit
particularly hard this year. According to Walgreens, Oklahoma
City is the number one place for prescriptions to be issued out
for Tamiflu. Tulsa is number five. I think we have had
somewhere like 50 deaths, and in the neighborhood of 1,300
individuals being hospitalized. My family was hit real hard
this year. Out of my five kids, four got it. My fourth
daughter, who is 6, received actually two different strains of
the flu. My wife and all my family missed the swearing in
because of the flu. And now it is kind of ironic that I am
sitting up here talking about this.
Just some follow-up questions. My understanding is, part of
the challenge of being able to respond to the mismatch vaccine
is the burden of regulations, but underneath declaration of
maybe an emergency, those regulatory burdens change. Is that
correct?
Dr. Robinson. Certainly, if a public health emergency is
declared then we can move forward, but there are regulatory
issues, I think Dr. Midthun may want to testify----
Mr. Mullin. No, I just wanted a yes or no on it. If it is
declared an emergency, those regulatory burdens change quite a
bit, right? OK.
In 2009, the President declared a public emergency during
the swine flu, or the H1N1, crisis. That is correct, right?
Dr. Robinson. Correct.
Mr. Mullin. How many cases of swine flu had been confirmed,
not deaths but had been confirmed in the U.S., when the
President declared that public emergency?
Dr. Robinson. I think Dr. Schuchat can answer that.
Dr. Schuchat. I don't have the numbers, but there was a----
Mr. Mullin. It was 20.
Dr. Schuchat [continuing]. An enormous change in the
epidemiology----
Mr. Mullin. We do have the number, there were 20 of them
that was in that----
Dr. Schuchat. Well, but instead of flu coming down, it was
going up after the season----
Mr. Mullin. Right.
Dr. Schuchat [continuing]. With a completely different
strain.
Mr. Mullin. But there was----
Dr. Schuchat. So----
Mr. Mullin. But there was an emergency declared with only
20 confirmed cases in the U.S. There has already been 50 deaths
in just my State of Oklahoma.
Dr. Schuchat. Um-hum.
Mr. Mullin. So I am trying to make a comparison here.
I believe the flu season goes through May in the Northern
Hemisphere, is that correct? Right?
Dr. Schuchat. It can extend to May. It can end earlier.
Mr. Mullin. OK, what exactly is the definition of a public
health emergency? Dr. Robinson, do you want to take that? What
are the criteria of us meeting a public emergency?
Dr. Schuchat. Yes, a public health emergency is not a
black-and-white definition.
Mr. Mullin. So there is no set of specific criteria that we
can look at, like the number of deaths or hospitalization to
determine what is in the public's best interest as far as a
health emergency?
Dr. Schuchat. Yes, the issue with a pandemic is that the
potential impact is exceptionally greater than the normal
range. It----
Mr. Mullin. So it doesn't matter how many deaths we have,
it is just 100 percent of----
Dr. Schuchat. One would be----
Mr. Mullin [continuing]. CDC to make that----
Dr. Schuchat. One would be declaring that much in advance
of seeing the deaths, because of the time needed to take steps
to intervene.
Mr. Mullin. Would it help if Congress or you guys could
come up with maybe some criteria that we could look at that
could maybe trigger it, rather than just waiting for the next
crisis to happen, or, honestly, a public outcry?
Dr. Schuchat. I think we could probably provide the
language about a public health emergency. What I was trying to
say was that it is not the same for each condition, for each
disease or----
Mr. Mullin. I understand there is some type of flexibility
and, you know, there has got to be a little bit of more
understanding of what we are dealing with, but it seems odd
that there is no criteria at all for us to understand it----
Dr. Schuchat. Yes, I----
Mr. Mullin [continuing]. When something like the swine flu,
that just had 20 cases in the country, was declared an
emergency by the President, and yet we have a pandemic going on
right now with the flu, and we could have maybe changed some of
this with the regulatory burdens going through if we would have
declared it an emergency faster, where maybe we could have got
help to individuals.
Dr. Schuchat. In 2009, a new strain emerged from animals
that had genetic re-assortment that was completely unique to
humans. And so what we are dealing with with the drift is
slight changes, a very different scenario. But what you
indicate is correct that the ultimate burden of disease from a
drifted H3N2 strain may end up being greater than a completely
new to humans re-assortment like the H1N1----
Mr. Mullin. So----
Dr. Schuchat [continuing]. Swine-origin pathogen in 2009.
Mr. Mullin. Could you maybe help us maybe draw some type of
criteria that needs to be laid out so the next time this
happens, we could have something to compare it to?
Dr. Schuchat. We would be happy to provide follow-up on the
public health emergency and how that is defined. Sure.
Mr. Mullin. Thank you. I yield back.
Mr. Murphy. Thank you. Gentleman yields back.
I now recognize another new member of our committee and
subcommittee, Chris Collins of New York, a second term in
Congress. Welcome aboard, and you are recognized for 5 minutes.
Mr. Collins. Thank you, Mr. Chairman.
I will be as quick as I can to get the information really
directed more at Dr. Fauci and Dr. Schuchat.
And I appreciate your issue of the jump on swine flu, the
same thing we were worried about with the bird flu, that didn't
happen. That is the good news of RNA viruses, they don't jump
off to--but if they do, it can be devastating. So my question
is really on the universal vaccine discussion. And I don't
think it has been made clear here. We have DNA viruses and we
have RNA viruses. And when we talked about the vaccine for HPV,
the vaccine for herpes, smallpox, chickenpox, those are all DNA
vaccines. And it is relatively straightforward to get a vaccine
for a DNA-based virus. Then you have your RNA viruses; HIV,
Ebola, West Nile, SARS, influenza. They mutate a lot, that is
what they do, but they don't jump species much.
So my question is this: Since we are talking about an RNA
virus, so you can't compare influenza with HPV, you can't
compare influenza with herpes, and I don't think that was made
clear, but now that we are talking about an RNA-based virus, I
guess my question is this, because they mutate, drift so often,
that is the insidious nature of RNA viruses, which is why the
answer to a lot of the questions coming here is more because
they do mutate, that is the basis of that virus. So how is it
that since measles is an RNA virus, polio is an RNA virus,
rubella is an RNA virus, and so is mumps, so you have mumps,
measles, rubella, and polio on the one hand, RNA, and we have
vaccines for them, what is the difference in the reason we
don't have vaccines for things like influenza?
Dr. Fauci. You have asked a very complicated question, and
I can tell you that there is not a one-to-one relationship of
whether you can or cannot get a vaccine, whether it is an RNA
or a DNA vaccine. And also, RNA viruses do jump species. I mean
the----
Mr. Collins. Rarely.
Dr. Fauci. Yes--well, HIV, influenza, I mean, there is the
fowl virus that jumps, HIV, the chimp virus that jumps, so----
Mr. Collins. Yes, but much less----
Dr. Fauci. Yes.
Mr. Collins [continuing]. Likely than a DNA virus.
Dr. Fauci. But the things that go into whether or not--your
point is very well taken, that if you have in general, and----
Mr. Collins. Um-hum.
Dr. Fauci [continuing]. You have to be really careful when
you pick this one or the other one, in general, a virus that
has a proofreading mechanism, which RNA viruses have----
Mr. Collins. Right.
Dr. Fauci [continuing]. They don't correct their mistakes
when they mutate, allows it to do what influenza does----
Mr. Collins. Right. Right.
Dr. Fauci [continuing]. Drift. It allows it to do what HIV
does. If you give it one drug, it will mutate to be resistant
unless you give it----
Mr. Collins. Sure.
Dr. Fauci [continuing]. Three drugs.
Mr. Collins. Sure.
Dr. Fauci. You are perfectly correct on that. However, it
really isn't specifically that. These are easy to make one
against, and these are difficult. It just doesn't work that way
because there are a lot of other things that go into whether or
not you are going to have a successful vaccine. But the
fundamental principles that you mentioned are correct.
Mr. Collins. So how did we end up with one for measles,
polio, and why has it been so god-awful, if not impossible, to
get one for HIV or influenza? Is there any----
Dr. Fauci. Well, the body makes a very good immune response
against measles, even when it is a serious disease. Ultimately,
the body will completely clear measles in the----
Mr. Collins. Right.
Dr. Fauci [continuing]. Overwhelming majority of people. So
we already know the body has the capability of inducing an
effective immune response, therefore, you follow what the body
does and you induce the same response that natural infection
does. With HIV, the body does not make an adequate immune
response against HIV, so there is no proof of----
Mr. Collins. Yes, but now, HIV, that is where the immune
system doesn't even see the viral particles.
Dr. Fauci. Well----
Mr. Collins. Now, that is different than influenza.
Dr. Fauci. Well, I am sorry, sir, it does see it, it just
doesn't make a good response.
Mr. Collins. It doesn't react to it.
Dr. Fauci. It doesn't make a good response----
Mr. Collins. Right.
Dr. Fauci [continuing]. Against it.
Mr. Collins. Right, but that is what is unique about HIV.
Dr. Fauci. Exactly. You need the body's ability to do it
naturally to mimic it. That is what vaccines are all about;
mimicking natural infection without----
Mr. Collins. Sure.
Dr. Fauci [continuing]. Hurting the host.
Mr. Collins. So one real quick question for Dr. Schuchat.
They use adjuvant-based vaccines in Europe. We don't do it
here. The question on the monocrobial, if we did that with an
adjuvant, we could extend that production, we could produce
much less, extend it, because you were saying production is the
big issue. If it was adjuvant-based, you wouldn't need as much.
Should we be looking at that as a natural part of the
monocrobial?
Dr. Schuchat. You know, I think that adjuvanted influenza
vaccines hold a lot of promise, and I know that the FDA has
licensed one so far in the U.S. In terms of extending the
supply and also----
Mr. Collins. Right.
Dr. Schuchat [continuing]. And also potentially expanding
the immune response. As you heard from some of the measles
discussions, here in the U.S. our population has a lot of
questions about vaccines and about their safety, and they have,
even in 2009 when we were doing community engagement around
H1N1 vaccination, we had lots of questions about whether there
would be adjuvants in those vaccines or not. In Europe, they
use adjuvanted----
Mr. Collins. Right.
Dr. Schuchat [continuing]. H1N1 vaccines and we didn't. Our
public really needs to come along with us in the scientific
endeavor, and so I think that is an area where the FDA is
really critical in reviewing the safety data.
Mr. Collins. Yes. Thank you very much.
Yield back, Mr. Chairman.
Mr. Murphy. Thank you, Mr. Collins.
And now as a tradition of this committee, if another member
of the committee wishes to be part of this, we will welcome
back a former member of the subcommittee for this special
visit, Mrs. Ellmers of North Carolina. You are recognized for 5
minutes.
Mrs. Ellmers. Thank you, Mr. Chairman, and thank you to our
ranking member also, for allowing me to be part of this
important subcommittee hearing on this very timely issue. And
to our panel, thank you for being here today.
And I just want to point out a couple of things. One, in
October, looking at this issue and knowing the importance of it
moving forward, especially when it comes to vaccine production,
I had the honor of hosting a roundtable discussion in the
Research Triangle. Dr. Midthun and Dr. Robinson, thank you
again for participating in that very important discussion. We
learned a lot from that. As we all know, Chairman Upton is
leading the 21st Century Cures Initiative, and the vaccine
space fits right in there. And I am working on very important
legislation right now to actually bolster vaccine production
and bring vaccines to market. As we know, it is very, very
important. And I have also the honor of having the facility in
Holly Springs, North Carolina, which has been referred to
already, which will be addressing the issue of seasonal and
pandemic vaccine production, using the cell culture technology.
Very important to my district. And I also want to point out,
and I think this is something that we need to look at into the
future when we are trying to solve these problems. This was a
public-private partnership between Novartis, HHS, and BARDA.
So, again, thank you all for your input today. This is a very,
very difficult situation, but I believe that we can get ahead
of it and we can move forward, and we can identify ways that we
can improve upon this process.
Dr. Schuchat, I have a question for you. In the legislation
that I am working on right now, my bill, we create mechanisms
to help increase the communication and sharing between the CDC
and industry, and ways that we can get that information out to
impact public health. In your opinion, how can the CDC work
more closely in partnership with industry to reduce the risk
and uncertainty of investing in the novel vaccines?
Dr. Schuchat. We appreciate the chance to work closely with
industry as they are doing their early development and
research.
Mrs. Ellmers. Um-hum.
Dr. Schuchat. We welcome companies to come meet with us to
share their ideas, and we----
Mrs. Ellmers. Um-hum.
Dr. Schuchat [continuing]. Share all of the information----
Mrs. Ellmers. Um-hum.
Dr. Schuchat [continuing]. We have in terms of the public
health burden----
Mrs. Ellmers. Um-hum.
Dr. Schuchat [continuing]. Need and likely interest in
terms of public or providers.
Mrs. Ellmers. Um-hum.
Dr. Schuchat. So we do that regularly, and we welcome the
opportunity to do it systematically.
Mrs. Ellmers. Dr. Midthun, again, thank you for being here,
and again, thank you for being a participant in the roundtable
discussion that I had back in the District in October. As we
are looking at vaccine manufacturers to more readily export
vaccines from the U.S. and make them available to people around
the world, again, the legislation that we are working on right
now helps to expedite the licensure process. In addition to
expediting export licenses, what else can the FDA do to help
speed up production and approval on delivery of flu vaccine
availability?
Dr. Midthun. No, I think we currently use all the expedited
pathways that are available. So we can use accelerated
approval, which we----
Mrs. Ellmers. Um-hum.
Dr. Midthun [continuing]. Have done for numerous influenza
vaccines.
Mrs. Ellmers. Um-hum.
Dr. Midthun. We also did recently for the 2 meningococcal B
vaccines that we approved; one in October and one just last
month. We also used the breakthrough designation which
basically means that there is a very concerted interactive
approach early on and throughout the process with industry to
really accelerate the development of products. So we use all of
these tools, and they are very important. They, of course, do
rely on having certain science.
Mrs. Ellmers. Um-hum.
Dr. Midthun. So, for example, to use----
Mrs. Ellmers. Sure.
Dr. Midthun [continuing]. Accelerated approval, you
typically rely on what we call a surrogate endpoint. Usually in
the case of a vaccine it would be some immune response. But you
need to have information that actually indicates that this
immune response is----
Mrs. Ellmers. Um-hum.
Dr. Midthun [continuing]. Is really likely to predict
clinical benefits. So there is also a scientific piece that is
very, very important that others, for example----
Mrs. Ellmers. Um-hum.
Dr. Midthun [continuing]. In industry, NIH, and other
partners, need to work on----
Mrs. Ellmers. Um-hum.
Dr. Midthun [continuing]. To make that kind of----
Mrs. Ellmers. Um-hum.
Dr. Midthun [continuing]. Process available, but we work
very closely, obviously, with our sponsors to facilitate
whatever their development plans are.
Mrs. Ellmers. Thank you. And one last comment that I would
like to make, Mr. Chairman, if you would indulge me. One of the
concerns that was raised by Mr. Tonko from New York, having to
do with the issues that our families are dealing with, with
sick children and having to take time off of work, I would
advocate for my good friend, Martha Roby from Alabama, she has
a wonderful bill, Working Families Flexibility Act, that
actually addresses this issue and allows our workforce to be
able to take part in the availability and ability to use
overtime and bank it so that in the event that pediatric
appointments need to be made, or any of these things, families
can make those choices. So I would advocate to the co-
sponsorship of that bill. It is a very good bill, and it
addresses the very issues that we are talking about today.
Mr. Murphy. Thank you.
Mrs. Ellmers. So thank you, Mr. Chairman, and I----
Mr. Murphy. Thank you.
Mrs. Ellmers [continuing]. Yield back.
Mr. Murphy. And I want to thank the panelists. Look, I
think we are all frustrated, we need to be speeding up this
process and the science, and if there are other legislative
things we need to do, please let us know. This is the day after
Groundhog Day, and I don't want to be here with another
Groundhog Day a couple of years from now running into the same
problems, with the same issues, and having the same crisis with
so many Americans getting sick and dying for whatever this is.
So I ask----
Ms. DeGette. Would the gentleman yield for one second?
Mr. Murphy. Yes.
Ms. DeGette. I completely agree with the Chairman, but I
will say I want to commend this panel and others at the CDC and
NIH because, having been on this committee now for 18 years, we
really have made advances from when we first started with those
early hearings on egg-based technologies. We just need to
accelerate that. So anything we can do to help, we are here to
help. Thank you.
Mr. Murphy. Appreciate that. I ask unanimous consent that
Members' written opening statements be introduced into the
record, and without objection, the documents will be entered in
the record.
In conclusion, thank you again to the witnesses and Members
that participated in today's hearing. I remind Members they
have 10 business days to submit questions for the record, and I
ask that all witnesses agree to respond promptly to those
questions.
And with that, this committee is adjourned. Thank you.
[Whereupon, at 12:34 p.m., the subcommittee was adjourned.]
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