[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
H1N1 PREPAREDNESS: AN OVERVIEW OF VACCINE PRODUCTION AND DISTRIBUTION
=======================================================================
JOINT HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
AND THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
NOVEMBER 18, 2009
__________
Serial No. 111-82
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
?
COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
HILDA L. SOLIS, California JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas TIM MURPHY, Pennsylvania
JAY INSLEE, Washington MICHAEL C. BURGESS, Texas
TAMMY BALDWIN, Wisconsin MARSHA BLACKBURN, Tennessee
MIKE ROSS, Arkansas PHIL GINGREY, Georgia
ANTHONY D. WEINER, New York STEVE SCALISE, Louisiana
JIM MATHESON, Utah PARKER GRIFFITH, Alabama
G.K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
(ii)
Subcommittee on Health
FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan NATHAN DEAL, Georgia,
BART GORDON, Tennessee Ranking Member
ANNA G. ESHOO, California RALPH M. HALL, Texas
ELIOT L. ENGEL, New York BARBARA CUBIN, Wyoming
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado STEVE BUYER, Indiana
LOIS CAPPS, California JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah JOHN SULLIVAN, Oklahoma
JANE HARMAN, California TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas MICHAEL C. BURGESS, Texas
JOHN BARROW, Georgia
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
------
Subcommittee on Oversight and Investigations
BART STUPAK, Michigan, Chairman
BRUCE L. BRALEY, Iowa GREG WALDEN, Oregon
Vice Chairman Ranking Member
EDWARD J. MARKEY, Massachusetts ED WHITFIELD, Kentucky
DIANA DeGETTE, Colorado MIKE FERGUSON, New Jersey
MIKE DOYLE, Pennsylvania TIM MURPHY, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas
DONNA M. CHRISTENSEN, Virgin
Islands
PETER WELCH, Vermont
GENE GREEN, Texas
BETTY SUTTON, Ohio
JOHN D. DINGELL, Michigan (ex
officio)
C O N T E N T S
----------
Page
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 1
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 3
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 5
.................................................................
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 7
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 8
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, opening statement................................. 9
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 10
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, opening statement............................... 11
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 12
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 13
Hon. Roy Blunt, a Representative in Congress from the State of
Missouri, opening statement.................................... 14
Hon. Michael F. Doyle, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 15
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 15
Hon. Jane Harman, a Representative in Congress from the State of
California, opening statement.................................. 16
Hon. Phil Gingrey, a Representative in Congress from the State of
Georgia, opening statement..................................... 17
Hon. Mike Ross, a Representative in Congress from the State of
Arkansas, opening statement.................................... 18
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 18
Hon. Tammy Baldwin, a Representative in Congress from the State
of Wisconsin, opening statement................................ 19
Hon. John Sullivan, a Representative in Congress from the State
of Oklahoma, opening statement................................. 20
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, opening statement..................................... 20
Hon. Janice D. Schakowsky, a Representative in Congress from the
State of Illinois, opening statement........................... 21
Hon. Jim Matheson, a Representative in Congress from the State of
Utah, opening statement........................................ 22
Hon. Zachary T. Space, a Representative in Congress from the
State of Ohio, opening statement............................... 23
Hon. Betty Sutton, a Representative in Congress from the State of
Ohio, opening statement........................................ 23
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 24
Prepared statement........................................... 25
Hon. Christopher S. Murphy, a Representative in Congress from the
State of Connecticut, opening statement........................ 27
Hon. Donna M. Christensen, a Representative in Congress from the
Virgin Islands, opening statement.............................. 27
Hon. Anthony D. Weiner, a Representative in Congress from the
State of New York, opening statement........................... 28
Hon. Bruce L. Braley, a Representative in Congress from the State
of Iowa, opening statement..................................... 29
Prepared statement........................................... 31
Hon. John P. Sarbanes, a Representative in Congress from the
State of Maryland, opening statement........................... 33
Hon. Eliot L. Engel, a Representative in Congress from the State
of New York, opening statement................................. 33
Witnesses
Anne Schuchat, Director, National Center for Immunization and
Respiratory Diseases, Centers for Disease Control and
Prevention..................................................... 35
Prepared statement........................................... 37
Answers to submitted questions............................... 205
Nicole Lurie, Assistant Secretary for Preparedness and Response,
Department of Health and Human Services........................ 50
Prepared statement........................................... 53
Jesse Goodman, Acting Chief Scientist, Deputy Commissioner for
Scientific and Medical Programs, Food and Drug Administration.. 76
Prepared statement........................................... 79
Paul Perreault, President, CSL Biotherapies, Incorporated........ 110
Prepared statement........................................... 113
Answers to submitted questions............................... 211
Vas Narasimham, President, Novartis Vaccines USA;................ 118
Prepared statement........................................... 120
Answers to submitted questions............................... 216
Ben Machielse, Executive Vice President of Operations, Medimmune. 132
Prepared statement........................................... 134
Answers to submitted questions............................... 221
Phillip Hosbach, Vice President, Immunization Policy and
Government Relations, Sanofi Pasteur........................... 150
Prepared statement........................................... 152
Answers to submitted questions............................... 227
David Lakey, Commissioner, Texas Department of State Health
Services....................................................... 166
Prepared statement........................................... 169
Answers to submitted questions............................... 232
Jeffrey Levi, Executive Director of Trust for America's Health... 180
Prepared statement........................................... 182
Answers to submitted questions............................... 238
H1N1 PREPAREDNESS: AN OVERVIEW OF VACCINE PRODUCTION AND DISTRIBUTION
----------
WEDNESDAY, NOVEMBER 18, 2009
House of Representatives,
Subcommittee on Health, Joint With the
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittees met, pursuant to call, at 10:07 a.m., in
Room 2123, Rayburn House Office Building, Hon. Frank Pallone,
Jr., [chairman of the Subcommittee on Health] presiding.
Present: Representatives Waxman, Dingell, Pallone, Eshoo,
Stupak, Engel, Green, DeGette, Doyle, Harman, Schakowsky,
Gonzalez, Baldwin, Ross, Weiner, Matheson, Barrow, Christensen,
Castor, Sarbanes, Murphy of Connecticut, Space, Sutton, Braley,
Whitfield, Shimkus, Blunt, Buyer, Pitts, Walden, Sullivan,
Murphy of Pennsylvania, Burgess, Blackburn, and Gingrey.
Staff Present: Kristin Amerling, Chief Counsel; Bruce
Wolpe, Senior Advisor; Karen Nelson, Deputy Committee Staff
Director for Health; Ruth Katz, Chief Public Health Counsel;
Sarah Despres, Counsel; Stephen Cha, Professional Staff Member;
Allison Corr, Special Assistant; Mike Gordon, Chief
Investigative Counsel; Dave Leviss, Chief Oversight Counsel;
Erika Smith, Professional Staff Member; Ali Neubauer, Special
Assistant; Karen Lightfoot, Communications Director, Senior
Policy Advisor; David Kohn, Press Secretary; Jen Berenholz,
Deputy Clerk; Matt Eisenberg, Staff Assistant; Alan Slobodin,
Minority Chief Counsel, Oversight; Ryan Long, Minority Chief
Counsel, Health; Aarti Shah, Minority Counsel, Health; Karen
Christian, Minority Counsel, Oversight; and Kevin Kohl,
Research Analyst.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. The meeting will come to order.
Today we are having a joint hearing of the Health
Subcommittee and the Oversight and Investigations Subcommittee,
and the hearing is titled H1N1 Preparedness, an Update of
Vaccine Production and Distribution.
We are going to begin with opening statements from the
members of the subcommittees. The chairman and ranking members
of the two subcommittees will be recognized first for a 5
minute opening statement, followed by 5 minute statements by
the Chairman and ranking member of the full committee and the
Chairman Emeritus. Other members of the subcommittees will then
be recognized for 2 minute opening statements. I am going to
begin by recognizing myself.
Let me explain that the purpose of this hearing is to get
an update from the main stakeholders involved in the
manufacturing and distribution of the H1N1 vaccine and to shed
some light on where we currently are in the process and what we
can expect moving forward.
The most recent estimates from the Centers For Disease
Control are truly alarming. Over the past 6 months, it is
likely that 22 million people in our country have been infected
with the disease and about 98,000 have been hospitalized. To
date, it is estimated that 3,900 individuals have lost their
lives to H1N1.
Unlike regular flu that affects predominately the elderly
population, the vast majority of H1N1 deaths have occurred in
people between the ages of 18 to 64. Even more tragically, the
CDC estimates that 540 of these deaths have occurred in
children. These numbers are significantly higher than earlier
estimates, and as we move further into flu season, we can only
expect to see them increase even more.
We now know that this virus and vaccine is unlike flu
vaccines that we have produced before in it is extremely
difficult to grow. Early estimates on vaccine amounts were
based on how vaccines usually behaved in the production phases.
Unbeknownst to anyone involved in this process, H1N1 proved to
be very different, and though the manufacturers have been able
to speed the growth of the vaccine by selecting the fastest
growing strains, we still are lagging behind where we
originally thought we would be with our production numbers.
Fortunately though, this particular vaccine appears to be
highly effective in creating an immune response in individuals,
and for adults, one small dose of the vaccine will produce
enough of a response to protect from H1N1. But these early
delays in production are now rearing their ugly head as our
country watches the disease spread and take lives while vaccine
is still hard to come by.
To date, nearly 42 million doses are available for
distribution, which is about half of what we originally
expected to have by this time. It is no wonder therefore that
story after story in the papers and on the news highlights the
frustration that the American people are facing in trying to
get the vaccine that will protect them from the disease. We
hear accounts of individuals waiting in line for hours at
clinics, some cannot find clinics in their neighborhood at all,
and areas are still waiting to receive even the first doses of
the vaccine.
There is a school district in my hometown, for example,
that is yet to receive the vaccine, and understandably the
parents are irritated. And this frustration is exacerbated by
accounts of places in the country that seem to have more than
enough vaccine in some areas, where getting this vital
protection from H1N1 poses no difficulty at all. So we are
getting a lot of disparities from one place to the next, and,
naturally, people are confused and they are angry.
So that is why myself and Chairman Stupak are holding this
hearing today. I personally would like to better understand how
the production of vaccine is going; when, for example, we will
be able to expect enough vaccine so that all individuals who
want it can get it; and will this happen before flu season is
over.
I would also like to understand more about the distribution
process. I understand that the States make their own
distribution plans and do the ordering for their States through
the CDC. But how are these plans created and how do States make
the determination where to start with vaccine distribution and
which distributors to prioritize?
We have a number of very important individuals with us
today who have been working around the clock on these issues,
and I would like to welcome you all. We appreciate your taking
the time to provide us with this update today.
We understand how difficult this process has been. We are
not here to beat you up, but we are here to try to get some
answers, and particularly where we go from here.
With that, I would like to let me just thank again Bart
Stupak, Chairman Stupak, for working with me to put this
hearing together.
I guess we are going to go to Mr. Walden at this point for
an opening statement.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. Thank you very much, Mr. Chairman, and thank
you for convening this important hearing.
H1N1 has been dominating the news and parents and the
general public's concern for the last couple of months, as we
all know. I am hopeful this joint subcommittee hearing can help
answer questions and discuss solutions to the challenges
arising from the first flu pandemic in 40 years.
As many of you, I have firsthand experience with H1N1. I
think I was probably the first Member of Congress to go on
record as being diagnosed as likely having H1N1. I had not been
vaccinated, because, like the majority of my fellow Members of
Congress, I don't fall into the CDC's priority groups. And like
millions of other people across the country who have had H1N1,
I felt rotten for a few days. It is not something you want and
it is not something you want to pass on to others. But I did
follow my doctor's advice and the CDC's directions and stayed
home here in D.C. to rest for at least 2 days after my fever
broke, which is what I was told do to do. Luckily, I was
fortunate and recovered quickly.
Others have not been so fortunate. Last week, we learned
that approximately 4,000 people, 540 of them children, have
died from H1N1. The fact that this flu hit young children so
hard and the constant news reports about rising pediatric
deaths have scared the daylights out of parents.
You see this fear played out in the number of parents
lining up with their small children at public vaccination
clinics for hours at a time and flooding their pediatricians'
offices with phone calls trying to hunt down the vaccine.
From the folks I hear from in my district, they can't find
the vaccines. Based on statements made by HHS and CDC, parents
had counted on being able to vaccinate their children by
October or November. Originally CDC projected 40 million doses
would be available by the end of October. Ultimately, only 23
million doses were available. Instead, parents hear reports
every day on the news about rising pediatric deaths and vaccine
shortages and delays. Some wait in line for hours, only to be
told when they get there, there is no vaccine left.
Today, I hope we can get some concrete answers about when
the vaccine will be available. I also want to hear from HHS and
the vaccine manufacturers about the reasons for the delay and
what can be done now in and in the future.
HHS Secretary Sebelius was before the full Energy and
Commerce committee on September 15th, and at that time she
testified by mid-October a ``large-scale campaign'' for
vaccinations would be underway. She also stated repeatedly that
there would be ``enough vaccine for everyone.'' Secretary
Sebelius now says the vaccine manufacturers painted an overly
rosy picture of their production. Is that the case, or did the
virus seed not perform as expected?
I don't think finger pointing exercises are particularly
helpful at a time when we are facing one of the biggest public
health issues in recent years and a somewhat panicked public.
But there have been repercussions, no doubt about it.
I also want to learn about how HHS has assisted States and
local health departments in preparing for this pandemic. For
example, in my district, hospitals are implementing their
incident command plans due to emergency rooms being hit with
waves of patients with flu-like systems. These spikes of
patients are coming at a time when doctors, nurses and hospital
staff are either home sick with the flu or taking care of their
children that are home from school because of the flu.
So we are looking at a situation of increased patient
volume and decreased staff capacity. Hospital administrators
are monitoring staff levels and patient volumes in some cases
on an hourly basis so if they reach a tipping point, the
hospitals can cancel elective surgeries to ensure there is
adequate staffing to care for patients in the emergency room
and those admitted to the hospital.
When I called the 18 hospitals in my district, each one of
them asked, where is the vaccine that we were told was coming?
So let's get the facts on the table about the reasons for the
delay and when HHS knew about it; if there were production
issues, how can they be corrected; and if there are
communication issues between the manufacturers and HHS and HHS
and the public, how they can be fixed so parents are not
unnecessarily confused?
When the administration promised enough vaccine for
everyone, the people want to know that it is coming. I am very
interested to hear from Dr. Lurie and Dr. Schuchat about what
direction HHS and CDC have given hospitals in how to prevent
this confusion in the future.
So I hope this isn't the last hearing we have on this
issue. This is the first pandemic in 40 years and the first
since Congress began providing funding starting in 2006 for
pandemic preparedness. At that time, we were deeply concerned
about the possibility of a pandemic spreading a bird flu that
could be 40 percent in mortality. Fortunately, this one has not
proven to be as deadly. I believe Congress has appropriated $13
billion for this effort. This is an area where we need
continued oversight so we can figure out what worked, what
didn't, and what we should do going forward.
So I am particularly interested in the technologies for
vaccine production and whether we can do better in the future.
I understand that one of the manufacturers, MedImmune, has been
able to meet its delivery schedule, in part due to the
different kind of technology that company uses to make a live
attenuated vaccine. Even though MedImmune grows the virus in
chicken eggs, which is uncertain and unpredictable in yielding
a sufficient supply, they have received better results.
I know that as part of its pandemic preparedness planning,
HHS has awarded contracts to companies to look into cell-based
vaccine production, as well as other ways to improve yields and
production times. So I would like to know about the status of
these efforts and whether we are doing enough to ensure that we
are prepared for a pandemic influenza.
I welcome the witnesses and look forward to discussing
these important public health issues with them. Thank you for
your testimony.
Thank you for the hearing, Mr. Chairman.
Mr. Pallone. Thank you, Mr. Walden.
Chairman Stupak.
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. Thank you, Mr. Chairman, and thanks for working
with me and our O&I staff in putting together this hearing. I
look forward to doing this joint hearing today. I think we have
a good hearing lined up. As you said, we are not here to point
fingers but try to find out how we can do things better in the
future.
Today, we continue our committee's oversight of the 2009
pandemic H1N1 flu by examining more closely the production and
distribution of H1N1 vaccine. This will be the third hearing
the Energy and Commerce committee held this year on the H1N1
influenza.
According to the Center for Disease Control and Prevention,
as of November 13th, 2009, influenza activity was widespread in
46 States, almost all which was likely H1N1 influenza. There
have been 22 million infections, 9,800 hospitalizations, and
3,900 deaths from the H1N1 virus, 540 of which have been
confirmed pediatric deaths. This is a conservative figure,
because not every child who dies from flu-related causes has
been diagnosed with the flu. To date, there have been more
pediatric deaths from the H1N1 than usually occurs in the
entire annual flu season.
In September, Secretary Sebelius testified before the
Energy and Commerce Committee indicating that by mid-October,
the U.S. Department of Health and Human Services would be up
and running with vaccines. In fact, CDC had projected that 40
million doses of H1N1 vaccine would be on hand by October 13th,
but not even 13 million doses had arrived by October 22nd.
News reports have indicated that because of shortages in
vaccines, doctors were dealing with worried and panicked
parents who wished to have their children vaccinated while
State and local health care departments are experiencing long
lines that can produce up to 5 hour waits for parents,
children, pregnant women and seniors.
There have also been news reports indicating that private
businesses, such as J.P. Morgan and Goldman Sachs, have been
receiving the vaccines before individuals in the high risk
category. And let's not forget about the reports citing
military officials saying terrorists subjects being held at
Guantanamo Bay would receive the vaccine before most Americans.
Like many districts around the country, my own district in
northern Michigan has been affected by the H1N1 in a variety of
ways. Since the outbreak began, Michigan has had over 500
schools shut down because 25 percent or more of their student
bodies were absent with flu-like symptoms. Since September 1st,
1,226 people have been hospitalized in Michigan with flu-like
symptoms, a 35 percent increase over last week, when 801 cases
were reported.
The Oversight Investigation Subcommittee, along with the
Health Subcommittee, have a responsibility not to merely rely
on media accounts, but to get to the bottom of the situation.
While we are not here to point fingers at who is to blame for
the delay in the production and distribution of vaccines, we do
need to shed some light on the process between the government
and the manufacturers.
Given the urgency of the circumstances and the need for
expeditious action, cooperation between drug manufacturers and
Federal agencies is imperative to ensure that our country is
prepared to respond to H1N1 and future pandemics.
When the H1N1 virus initially broke out, we knew very
little, including how Americans would react to the vaccine, and
if we would need more than one dose per individual. A vaccine
didn't even exist. We did not know how different H1N1 vaccines
were from the vaccinations for the seasonal flu.
In addition to discussion the specifics of H1N1 vaccine
production and distribution, I hope we can shed some light
today on our outdated vaccine process. It is my understanding
that the manufacturing process for the H1N1 vaccine relies on
obsolete egg-based influenza vaccine technologies that are
subject to certain inherent uncertainties and delays such as
incubation periods.
As a result, we will continue to face similar challenges in
responding to future influenza outbreaks, both outbreaks of
novel strains, such as the 2009 H1N1 strain and the pandemic or
seasonal influenza we face every year. Many experts, including
the CDC director Tom Frieden, have said that it is important to
develop new technologies such as cell-based vaccine production.
We will hear from four of the five manufacturers that the
U.S. Government has contracted with to produce and distribute
H1N1 vaccines. These manufacturers will give us an in-depth
knowledge of the production challenges that they face and share
their thoughts on how we can improve this process as we move
forward. GlaxoSmithKline was not invited to testify at the
hearing as their vaccination was just recently approved by the
FDA.
Joining the manufacturers is Dr. David Lakey, Commissioner
of the Texas Department of State Health Services, who will be
the voice of the State health departments across the country,
and Dr. Jeffrey Levi, the Executive Director of Trust for
America's Health, a nonpartisan organization dedicated to
making disease prevention a national priority.
I look forward to hearing from all of our witnesses today
and delving deeper into the challenges that both the government
and industry are facing with the H1N1 pandemic.
Thank you, Mr. Chairman. I yield back.
Mr. Pallone. Thank you, Chairman Stupak.
The gentleman from Kentucky, Mr. Whitfield.
Mr. Whitfield. Thank you very much, Mr. Chairman. I suspect
that every member of this panel has received many phone calls
from their district, as I have, complaining about the shortage
and wanting some answers and expressing their fear for their
children and their family members.
As you said, we have had about three hearings on this
subject matter, but today I really want to focus from my
perspective on really the relationship and the interaction
between the Federal Government, the State government and the
manufacturers in the distribution process.
Number two, why have there been production delays
specifically? Why? And why has there been difficulty in growing
the virus? Is it because of technology? Is it because of
process? Is it something else?
Then, third of all, I would like to touch on how does the
U.S. compare in getting this vaccine out with other countries
and how do our problems compare to those problems?
With that, I yield back the balance of my time.
Mr. Pallone. Thank you.
The full committee chairman, Mr. Waxman.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Mr. Chairman. I want to
thank you and Chairman Stupak for holding this joint
subcommittee hearing on the H1N1 virus and how we are
responding to it.
The reports on H1N1 are sobering. As of last week, 46
States are now battling the disease. CDC estimates that perhaps
22 million people have been infected with H1N1 and as many as
98,000 have been hospitalized and about 4,000 have died,
including 540 children. This is a harsh reminder that we don't
need a bio-terror attack or other man-made disaster to threaten
our health and make us worry for our children.
In several ways, we have been well-prepared. The Federal
and State governments have been preparing for a pandemic for
several years. Our surveillance worked and we were able to
catch the H1N1 relatively early in its spread. Federal and
state governments have developed and exercised pandemic plans.
Public education has been commendable.
There are five safe and effective FDA-approved H1N1 flu
vaccines now available, and FDA has the authority for emergency
use authorization to allow for unapproved but promising drugs
and other products to be used to prevent and treat H1N1 flu.
FDA has used this authority to make antivirals, diagnostics and
personal protective gear available in the fight against this
flu.
But there are clear gaps in our preparedness. We had
widespread disease before we had vaccines, and vaccine supplies
have been more limited than we had hoped. At the same time,
hospitals and other health care providers have been stretched
to capacity.
We know that the best way to protect ourselves from the
flu, H1N1 or seasonal flu, is to get vaccinated. Because of
this, the Obama administration contracted to purchase 195
million doses of H1N1 vaccine. They also picked up the full
cost to the States for purchasing the vaccine. The hope was
that a robust vaccine supply would arrive before infections
began to soar and everyone worked as quickly as possible to
meet that goal.
These hopes were not met. The past several weeks have
reminded us that the process of making flu vaccines is
unpredictable and challenging. Millions of chicken eggs have to
be injected with virus and then the virus has to grow.
Unfortunately, this virus initially grew much more slowly than
anticipated, and this lag has caused most of the delay in
producing and delivering needed vaccine supplies.
There is understandable frustration in the face of a
growing number of infections and long lines at vaccination
clinics. Parents are understandably concerned about getting
their children immunized as quickly as possible.
I want to make sure that everyone who needs the vaccine has
access to it. At the same time, there have been unprecedented
levels of collaboration among Federal agencies, the vaccine
manufacturers and the States, and according to experts, the
manufacturers' ability to produce a vaccine within 6 months
after identifying the virus is impressive.
These efforts, while significant, are not enough for those
people who are still seeking immunization. I look forward to
today's testimony so we can understand where we are in the
epidemic and the vaccine Nation effort. We also need to learn
how the process can be improved. Both in the short-term so that
people can be protected from this disease as quickly as
possible, and in the long term, so that when we face the next
flu pandemic, we can be even better prepared than we have been
this year.
I thank the witnesses for appearing today. I look forward
to their testimony.
Mr. Pallone. Thank you, Chairman Waxman.
Next we have the gentleman from Illinois, Mr. Shimkus.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. Thank you, Mr. Chairman. I too want to mention
our sincere prayers for those who have lost family and loved
ones during this illness. They are throughout the country, and
I think a lot of districts have been affected.
Information has been good as far as there is more people
washing their hands, there is more people covering their
mouths, as Greg Walden mentioned, staying at home, and that is
a thing where information has been very, very helpful.
Information has also been harmful, and that is this rush and
this fear of people lining up for the injections or the mist
sprays.
So my concern is we have got to be real about the
projection of information to the public, because the public
will respond appropriately. I think the rosy expectations have
really caused this dilemma that we are in.
The other thing that I think we should focus on is this is
something that we have had a year in essence to prepare for.
What if, in our first thoughts about a pandemic after September
11th, is there is something we cannot prepare for, we do not
know what has hit, and how do we ramp up, get information out,
and then respond? I think that is as critical a question in the
Homeland Security terrorist debate as responding to something
we can prepare for.
So there are a lot of things we can learn about in the
hearing today, and I appreciate the first panel and the follow-
on panel. I think we will be very attentive to your testimony
and I think there will be a lot of good questions offered by
members.
I yield back my time, Mr. Chairman. Thank you.
Mr. Pallone. Thank you, Mr. Shimkus.
Chairman Dingell.
OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Dingell. Mr. Chairman, I thank you, and I want to
commend you and Chairman Stupak for holding this hearing, which
is very important.
Since the initial outbreak in March of the H1N1 influenza
in Mexico, the Federal Government, State and local public
health departments, health providers, vaccine manufacturers and
many others who have been working overtime to produce and
distribute the H1N1 vaccine and to educate the public on
precautions that can be taken to prevent the spread of the
influenza.
Since April, 42 people in Michigan have died since
contracting any strain of influenza. More than 1,200 have been
hospitalized and over 584,000 have reported flu-like symptoms.
Across 48 States, there have been 3,900 deaths from H1N1 virus,
9,800 hospitalizations and 22 million infections. The high
number of deaths from H1N1, in particular the high number of
pediatric deaths has increased the demand for the vaccine, a
demand that is unlikely to cease at any time soon.
This vaccine first became available in the beginning of
October, and as of November 5, approximately 35 million doses
have become available. This is well below the CDC prediction of
40 million doses by the end of October. There is no doubt that
manufacturing a vaccine in short order is a difficult task and
this country has had difficulties with flu vaccines before.
This task requires scientists to identify the virus
correctly, determine the appropriate and most effective method
for a vaccine, and then manufacture millions of vaccines to be
distributed, all with the pressure of completing the task
quickly and, most importantly, safely.
I know that there are many unforeseen roadblocks to
manufacturers, whether it be the difficulty in producing the
vaccines in an egg-based system, a shortage of appropriate egg
supply and equipment, and equipment failures, amongst other
things. While this shortfall is a disappointment, I believe we
better serve the American people when we focus on producing a
safe and effective vaccine and having it made available in a
safe and efficient manner.
History has taught us that prioritizing speed over safety
is shortsighted when it comes to flu outbreaks. In February of
1976, two recruits at Fort Dix fell sick from the H1N1 flu
strand. Congress responded swiftly. That August, the National
Influenza Program was produced and one week later was signed
into law by President Ford. We were forced to deal with the
costly consequences of our actions, which ultimately led to
great public mistrust of immunizations as the program was
mishandled and lives were lost.
It is appropriate to respond to the national threats, but
we need to remember to be deliberate and thoughtful and wise in
our response.
The H1N1 outbreak and the distribution of the vaccine
provides the Federal Government with an opportunity and the
responsibility to closely examine our pandemic response system.
For HHS and CDC in particular, this means examining the way in
which our government communicates with the public. For FDA,
this means examining the methods in which the vaccines are
approved.
For many of my colleagues and for many of those testifying
today, my goal is to ensure the safety and health of the
public, while at the same time looking forward to how we can
best prepare for future pandemics and how we can learn from the
ongoing events of the day.
This will include examining the national strategic
stockpile and whether it is adequately supplied, preparing our
scientists and manufacturers with the most effective and
efficient technology to create and produce vaccines, as well as
looking to whether or not the Congress has provided adequate
funding for HHS, CDC and FDA to give them the resources needed
to carry out their missions.
Today, I believe this hearing will be helpful in answering
these questions and others, and I look forward very much, Mr.
Chairman Pallone and Mr. Chairman Stupak, to working with you
and hearing what our witnesses have to say today as we seek to
mitigate the outbreak of H1N1.
Thank you, Mr. Chairman. I yield back the balance of my
time.
Mr. Pallone. Thank you, Chairman Dingell.
Next is the gentleman from Texas, Mr. Burgess.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Dr. Burgess. Thank you, Mr. Chairman.
Like so many other Members of Congress on a Sunday
afternoon in April, a football game was interrupted with a
notice of a public health emergency about a new kind of flu. We
had a conference call later that day for Members of Congress, I
don't know how many were actually on the call, but I remember
thinking at that time, our greatest danger here is not
anticipating how aggressive this virus could be if we are truly
faced with the novel influenza for which most of us do not have
preexisting immunity.
And that is sort of where we are today. Fortunately, the
story is not nearly as bad as it could have been and many of us
feared it might be, but nonetheless, it points up some of the
difficulties that have been encountered.
Mr. Chairman, I will say I am grateful we have had three
hearings, but it seems to me when we were preparing for a
possible avian flu pandemic in 2004, 2005 and 2006, we had many
more hearings for just the preparation for that possible
pandemic than we have had after we find ourselves in the throes
of this illness.
Now, we do have to ask ourselves, how could we have
misanticipated the ability to produce vaccine? We saw this
coming, we knew it was coming, we had reports over the summer
from the southern hemisphere that it wasn't as bad as it could
have been, and yet there were some particularly vulnerable
populations which would need perhaps aggressive use of
vaccination protocols, and we find ourselves in our districts
without being able to provide even the vaccines for those high
risk individuals.
In fairness, I do want to say I have had good cooperation
from the CDC, the Department of Homeland Security, the
Department of Health and Human Services, that came to my
district in August and had a roundtable with school districts
in my area so they could be better prepared. The Fort Worth
Independent School District took a lot of heat last April and
May for closing their school district early, but they were
frightened of what might happen with not anticipating the
severity of this illness.
Then just finally, on a personal note, I want to thank Dr.
Lakey for being here from the Texas Department of Health. He
has also been good enough to do conference calls with members
of the Texas delegation as we worked our way through some of
the difficulties with the distributional issues of getting the
vaccine where it is needed.
I will also just thank Dr. Hamburg at the Food and Drug
Administration, who was kind enough to take my call after the
news reports said that Texas was getting expired Tamiflu to
protect its citizens. And this was one of the problems we
encountered in 2005. We produced a lot of anti-viral, the
illness doesn't materialize, and how long is the shelf life?
And, indeed, there were tests done to ensure that that shelf
life was longer than what was stamped on the box. It was just
an unfortunate public relations aspect that we didn't correct
that. But I was very grateful to Dr. Hamburg for calling me and
helping me through that particular public relations crisis.
Thank you, Mr. Chairman, for the consideration. I yield
back the balance of my time.
Mr. Pallone. Thank you, Mr. Burgess.
The gentlewoman from California, Ms. Eshoo.
OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Ms. Eshoo. Thank you, Mr. Chairman, for holding this
important joint hearing on H1N1 preparedness, production and
distribution. I appreciate the witnesses being here today and I
look forward to their testimony.
As we have heard from our constituents or experience in our
own families, the H1N1 pandemic has proven to be widespread and
really highly contagious. Since the vaccine was first slated
for distribution in mid-October, I, along with, I am sure
probably all of my colleagues, have received countless calls
from constituents asking when they can get the vaccine. Lines
of patients have been out the door and around the block, and
the news has been filled with stories of empty clinics and
angry parents.
While I don't think there is one source to point out
relative to production and distribution problems, I am
interested in looking at the systemic reasons for the somewhat
antiquated vaccine process we have today.
For more than half a century, the United States has been
using egg-based technology to create vaccines. While it is safe
and effective, it is a slow-moving process. Across Europe,
vaccine developers are using the faster process of
incorporating mammalian cells to grow vaccine. As we begin to
explore cell-based technology, I would pose the question, will
there be an adequate FDA approval process for these new
vaccines?
I am also interested in hearing from the vaccine
manufacturers on how they ramped up production, in some cases
to ten times their normal production schedule. We know that
production has been delayed for H1N1, a harmful but relatively
moderate virus, compared to something more lethal like the
Spanish flu. But in the case of a stronger virus with a higher
fatality rate, would our country be able to produce enough
vaccine for everyone in a short time period?
So I look forward to questioning the witnesses. I welcome
them again, and learning more about how we can improve vaccine
production in our country. And, again, I thank the chairmen for
this joint and important hearing.
I yield back.
Mr. Pallone. Thank you, Ms. Eshoo.
The gentleman from Pennsylvania, Mr. Murphy.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy of Pennsylvania. Thank you, Mr. Chairman.
As we look at how we are handling this latest crisis in our
government, I reflect back on a few years ago when we were
faced with the sudden and unanticipated problem of Hurricane
Katrina which led to an unfortunate between 1,300 and 1,800
lives lost from the hurricane and the flood itself. But it also
resulted in a flood of Members of Congress repeatedly and
bitterly attacking the administration and anybody else in town
because of the government's mismanagement of the whole issue.
Now, of course, it begs the question, who do we blame this
time for where we are, or should we stop that game and simply
get down to the business of understanding we want a painfully
candid and brutally honest assessment of what is happening,
what has gone right, what has gone wrong, do we have any
weaknesses, and what do we need to do about it. I would hope it
is this case instead, that we use this hearing as an
opportunity to be honest with each other.
We are all deeply concerned of the thousands who have lost
lives, the thousands who have been hospitalized, and, quite
frankly, the millions who are worried that they might be
affected by this latest virus hitting our Nation.
We recognize the incredible scientific achievements, and
quite frankly, I would like to compliment the manufacturers for
working so hard in trying to develop the vaccines and the nasal
systems for sending out these things to help us deal with this
virus.
But we still have a long way to go, and we are having this
hearing today, quite frankly, because we are concerned.
Something is not going right. Was it the goals were set too
high, too unrealistic? Was it done somehow to assuage the
worries of the public about something we were not ready to do,
or can we really meet those goals?
I am looking forward to hearing from all the witnesses
today. We have a very talented panel before us. I am excited to
hear what you have to say. But more than anything else, let's
use this as an opportunity to be honest, not political, and
really work for some solutions.
I yield back my time.
Mr. Pallone. Thank you.
The gentleman from Texas, Mr. Green.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman. I want to thank you for
holding this hearing today and giving us an update on H1N1
vaccine production and distribution.
Texas has ordered its full allocation of 3 million doses of
the vaccine, but that order has not been filled due to the slow
production and supply of the vaccines. I worry that States like
Texas, which is the second largest State, whether they are
receiving their fair share of these vaccinations. We are a
border State and with that comes a great deal of border issues,
along with swift transmission of infectious diseases.
I welcome Dr. Lakey, who is the Commissioner of the Texas
Department of State Health Services, who will be testifying on
our second panel today. He assured me that Texas is receiving
its fair share of vaccines and the State is continuing to order
of the maximum the amount. The issue is whether the commitments
of production are being met and why they are not.
I would like to highlight a piece of legislation I
sponsored along with our colleague Representative Tim Murphy,
H.R. 2596, the No Child Left Unimmunized Against Influenza Act.
The bill would allow HHS to perform a voluntary multistate
demonstration project to test the feasibility of using the
Nation's elementary schools and secondary schools as influenza
vaccination centers in coordination with school nurses, school
health programs, local health departments, community health
care providers, State insurance agencies and private insurers.
I am pleased the bill was included in H.R. 3962, the
Affordable Health Care For America Act, that was passed out of
the House. Schools are logical places to vaccinate our
children. Parents can opt into the program and not have to take
time off from work to get their child vaccinated, which in a
blue collar district like ours is hard to do.
Again, the issue is why haven't the production goals been
met? Did we fill the requests from the various States?
I thank our witnesses who are here today. It appears we
will know what problems have occurred with H1N1 vaccination
production and distribution and how we can fix it, and I hope
we will learn from the mistakes and hopefully make it much
better.
I yield back my time.
Mr. Pallone. Thank you.
The gentleman from Missouri, Mr. Blunt.
OPENING STATEMENT OF HON. ROY BLUNT, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MISSOURI
Mr. Blunt. Thank you, Mr. Chairman, and thank you Chairman
Stupak for holding this hearing.
This is an important topic, obviously, and one we ought to
be concerned about. I have been concerned about both the
vaccine distribution process and, frankly, the misleading
overestimates of vaccine availability. I believe Mr. Waxman,
the Chairman of the full committee, said in his statement that
the administration's hopes were not met. Well, apparently hope
does not get the job done here.
In addition to their hopes not being met, I think it is
outrageous that suspected terrorists at Guantanamo Bay and Wall
Street people, people who work on Wall Street, were apparently
slated for access to the vaccine ahead of the people that
health care professionals said were in danger.
Since October, 43 million vaccines have been made
available, but that falls far short of the 159 million people
considered to be at high risk because of these complications.
It also falls short of the government's original projection
that 120 million vaccines would be available by mid-October.
In fact, just last week, the government was still
estimating that 8 million vaccines were going to be shipped,
when only 5 million were released. I don't know how we could be
this far into this process and still be 40 percent off in our
one week estimate. So I will be interested to hear the answers
to those questions.
In Missouri alone, there have been 60 school closings this
year since the beginning of the year. Last year, during the
same period, there were none. Since October 4th, approximately
21,700 people in Missouri have possible cases of H1N1 flu.
During the first 6 months of last year's flu season, there were
28 cases of all kinds of flu. Sadly, last week in Missouri, the
eighth person died from complications with H1N1.
I want to know and the people I work for want to know where
this problem came about, the failure to understand the problem,
to recognize the problem, to move forward with the problem; and
with vaccine delivery, how long ago did we know that the
vaccines were not going to be available and what could we have
done about it?
Mr. Chairman, I expect some of those questions to be
answered today, and I am grateful to you for holding this
hearing.
Mr. Pallone. Thank you, Mr. Blunt.
The gentleman from Pennsylvania, Mr. Doyle.
OPENING STATEMENT OF HON. MICHAEL F. DOYLE, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Doyle. Thank you, Mr. Chairman. I want to thank you for
holding this hearing on the issue of H1N1 preparedness at such
a relevant time.
As the Centers for Disease Control have recently reported,
the H1N1 strain has now claimed over 4,000 lives since April of
this year. Of those, over 500 were children. I am very sad to
report that just this past week, a newborn baby died at
Children's Hospital of Pittsburgh located in my district of
suspected H1N1 influenza. If confirmed as being an H1N1 death,
this will be the first reported infant death.
In the State of Pennsylvania alone, 9,600 cases have been
reported. Nearly 1,800 of them have been in my Congressional
District. This is indeed a very serious problem.
This pandemic is different than what we are used to dealing
with every fall as the target is an unlikely and unusual
population. This strain is mostly affecting younger people,
with more than 70 percent of the reported cases in Pennsylvania
involving people under the age of 25. Antivirals are playing an
increasingly important role in fighting this epidemic, and I am
happy that the FDA has recognized this by issuing emergency use
authorization for intravenous administration of these
potentially lifesaving drugs.
I do have serious concerns about the reports of the
difficulty doctors have had in obtaining enough vaccines for
their patients, and I am anxious to hear our witnesses testify
to this. This year's distribution plan for the vaccine was
unprecedented, and I am extremely interested in the opinions of
our panel of its effectiveness. I think that this hearing will
serve as an important venue to hear from all sides of this
issue and help us all work together so that in the future, we
know what works and we know what must be improved upon.
I look forward to hearing from our witnesses, and I want to
thank you all for your testimony today. Again, I want to thank
the committee for holding this important briefing.
I yield back.
Mr. Pallone. Thank you.
The gentlewoman from Tennessee, Ms. Blackburn.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Ms. Blackburn. Thank you, Mr. Chairman, and I want to say
thank you to each of you for taking your time to prepare and to
come and to be in front of us. We do appreciate it.
I join other members on this panel in extending our
sympathies to those who have lost life or who have found a
serious complication to their health through this process.
I bring a perspective of being a grandmother and also a
good friend to lots of school teachers that have kept me
informed of what is happening on this. As a grandmom, I have a
daughter who has an 18 month old and a 5 month old, and I know
the ``mommy blogs'' have just been filled with the frustration
of young mothers trying to get to this vaccine. It has been
like playing ``Where's Waldo'' trying to find who has it.
We have done a disservice to these young mothers because
you all knew this was coming, appropriate preparations were not
made, and these are some of the questions we are going to want
to get to today.
I want to talk with you about the delays and what you think
has caused those, the communications processes, and where the
breakdowns have been between you all and HHS, because we had
different messages that were coming out. That is confusing to
the public. I think also the processes that were in place for
approval, for distribution, and then certainly looking at the
diagnosis-confirmation portion of that.
Then let's talk about lessons learned and how we moved
forward. Dr. Schuchat, I pulled a Reuters article, a comment
you made in here where you say ``I think the key barrier to our
immunization effort is really the fragility of the public
health infrastructure.''
I would love to explore that comment with you. Thank you
all. Thank you, Mr. Chairman. I yield back.
Mr. Pallone. Thank you.
The gentlewoman from California, Ms. Harman.
OPENING STATEMENT OF HON. JANE HARMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Ms. Harman. Thank you, Mr. Chairman. So far, there have
been 3,900 deaths in the U.S. from the H1N1 flu, with 266
deaths in California. This compares favorably, it is less than
annual deaths that are expected from the seasonal flu. I
suppose that is good news. But I agree with Chairman Waxman
that this is our rehearsal for a major terror attack from some
sort of biological weapon, and I think our grades are very
mixed.
In terms of preparing the public, I think we have done very
well, and I commend the panel and I commend others in our
Federal Government for making the case calmly and providing
lots of details for what the public is supposed to do. I would
give that an A.
In terms of preparing the vaccine, we have had a lot of
mixed results, and I suppose that could be a B-minus.
But in terms of distributing the vaccine, I would give us a
D-minus. A lot of that is the lack of preparation to States and
localities for exactly what they should do with scarce
resources.
I was personally scared because I have a pregnant daughter-
in-law who had to spend weeks in New York City finding a doctor
who had the vaccine. She did get vaccinated.
But in my district, the Beach City Health District, one of
the first providers able to offer the vaccine, had a drive-in
event recently. People drove more than 100 miles from as far as
Santa Barbara and San Diego, turning what was supposed to be a
local event into a regional scramble. The line of cars leading
to the clinic backed up for miles, police were deployed to
manage the unexpected crowds, and all this mayhem was just for
3,000 doses of vaccine. It was a disaster and now other areas
are not doing the same thing.
As my time expires, the distribution piece was a failure,
and I hope our witnesses have learned from this and they will
move forward much more effectively.
Thank you, Mr. Chairman.
Mr. Pallone. Thank you, Ms. Harman.
The gentleman from Georgia, Mr. Gingrey.
OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA
Dr. Gingrey. Thank you, Mr. Chairman. Today, the
Subcommittee on Health and the Subcommittee on Oversight and
Investigations will have an important opportunity to shed some
light on our government at work and what is a matter of life
and death, and hopefully we will be able to gain a few answers
to the many questions our constituents have asked us about H1N1
preparedness and the Obama administration's response.
Mr. Chairman, from fiscal year 2004 to 2009, this Congress
appropriated almost $7 billion for pandemic flu preparation.
Congress also provided an additional $6.4 billion in the fiscal
year 2009 supplemental, bringing the total since fiscal year
2004 for pandemic flu preparation to almost $13.4 billion.
Without question, the promotion of the public health and
safeguarding the lives of all Americans is an important
national priority. But we also have a solemn duty to thoroughly
scrutinize every dime we appropriate, because every single dime
is one more IOU that will be thrown upon the backs of our
children and grandchildren, likely for decades to come. Both
the American people's physical health and fiscal health have to
be priorities for this Congress.
Mr. Chairman, I make this point because I have concerns
about this government's response to H1N1, and I believe that it
may be a microcosm of what is in store if the health care
legislation this House passed 10 days ago becomes law. When
this government prioritizes KSM, Khalid Sheikh Mohammed to
receive a vaccine, when this government has enough vaccine for
Guantanamo Bay but not for Grandma Kay, we have a big problem.
Is this what the American people expected? Is this what the
American people deserve? At the same time, this Congress
continues to put them and their children further and further
into debt.
Mr. Chairman, I think not. I hope that today we will be
able to pull back the curtain for the American people so they
can see how the government attempts to manage their health and
their collective pocketbook.
I yield back.
Mr. Pallone. Thank you.
The gentleman from Arkansas, Mr. Ross.
OPENING STATEMENT OF HON. MIKE ROSS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ARKANSAS
Mr. Ross. Thank you, Mr. Chairman. I would like to thank
the Chairman and ranking member for having the Energy and
Commerce Committee hold today's hearing on H1N1 preparedness.
Over the course of this year, we have seen the strain of
influenza spread to a global proportion and lead to a
declaration of national emergency. According to the CDC, as of
November 13, 2009, influenza activity was widespread in 48
States, almost all of which is likely H1N1 influenza.
Furthermore, there have been 9,800 hospitalizations, 22 million
infections and 3,900 deaths from the H1N1 virus, 540 of which
have been confirmed pediatric deaths.
Both public and private sectors have attempted to work
together in an expedited effort to ensure adequate vaccine
production and delivery to patients. Unfortunately, such
efforts have fallen short and we have seen major delays in
access to this much-needed vaccine. As a result, we have
thousands of individuals, including those in high-risk
categories, still waiting for the vaccine as we fight this
pandemic.
I am also deeply concerned about the impact of H1N1 on our
children and our schools. During seasonal flu outbreaks, 95
percent of deaths are usually among those older than 65, but
for the swine flu, 95 percent of the deaths are occurring in
those younger than 65, and typically among those far younger
than that. My concern is that every parent who wants to get
their child vaccinated should have the opportunity to do so.
The delays in getting the vaccine to the American people must
be addressed and fixed now.
Clearly there are problems with the current process in
place that could have been prevented. The public deserves
answers as to why there is such a shortage in supply of a
vaccine when H1N1 has posed such a serious health threat for
months.
I look forward to hearing answers to these and other
related questions.
With that, Mr. Chairman, I yield back.
Mr. Pallone. Thank you.
The gentleman from Pennsylvania, Mr. Pitts.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. Thank you, Mr. Chairman, and thank you Chairman
Stupak for convening this joint hearing.
I am sure that all of us have received phone calls and e-
mails from anxious parents wondering if they will be able to
obtain the H1N1 vaccine for their children. I am sure we have
all been stopped by constituents back home wondering when the
vaccine will be available in their area and worried that there
is a shortage.
Today we will hear from the government departments and
agencies tasked with responding to the H1N1 pandemic and from
the manufacturers of the vaccine itself to determine how much
vaccine has been produced and how much more is on the way and
how it is being distributed and allocated. I also anticipate
that we will suggestions for how production and distribution
could occur more smoothly in the future.
On our second panel, I would like to specifically welcome
Phil Hosbach, Associate Vice President of Immunization Policy
and Government Relations, the head of the Sanofi Pasteur global
influenza pandemic crisis team. The U.S. headquarters for
Sanofi Pasteur is in my home State of Pennsylvania. The
Pennsylvania site is also the only domestic manufacturing sight
of injectable flu vaccine, and the employees there have been
working around the clock to produce both seasonal and H1N1
influenza vaccines.
I would also like to welcome Paul Perreault, President of
CSL Biotherapies, which has its headquarters in King of
Prussia, Pennsylvania, right outside my district.
Mr. Chairman, again, I thank you. I look forward to hearing
the testimony of all of our witnesses, and I yield back my
time.
Mr. Pallone. Thank you.
The gentlewoman from Wisconsin, Ms. Baldwin.
OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF WISCONSIN
Ms. Baldwin. Thank you, Mr. Chairman, for holding this very
important hearing.
I want to highlight three issues that I hope our witnesses
will address according to their expertise during our hearing
this morning.
Clearly a thorough response to any public health emergency
such as a flu epidemic requires a partnership between local,
State and Federal public health agencies and labs, and I am
concerned about resource shortages at the State and local
level, particularly with regard to personnel and modern
information technology and communications. I have a bill on
that matter and would like to hear your insights on how those
resource shortages have affected our response to this flu,
H1N1.
Secondly, I would like an update on the State of
innovations and improvements that many of my colleagues have
referenced that will help us do a better job next time. Cell-
based manufacturing technologies, the use of adjuvants and
alternative methods of vaccine delivery beyond injection or
nasal sprays.
Lastly, and I think most importantly to me, I would like
the witnesses' comments on our lack of domestic manufacturing
of H1N1 and seasonal flu vaccine. This is of great concern to
me, and I asked this of our Secretary of Health and Human
Services when she last appeared before the committee. It
appears that we have five contracts with five manufacturers for
H1N1 vaccine. Only one does its bulk manufacturing in the
United States, in the State of Pennsylvania.
I think that if we were to ever face much greater flu that
presents much greater virulence, it would be a question mark
whether we would be able to get supplies of vaccine from
production sites in other countries. Any country that hosts
vaccine manufacturers would want to assure that their own
population was protected first before permitting the export. So
I am very concerned about the lack of domestic manufacturing
presence and would like your comments on that.
I yield back.
Mr. Pallone. Thank you.
The gentleman from Oklahoma, Mr. Sullivan.
OPENING STATEMENT OF HON. JOHN SULLIVAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OKLAHOMA
Mr. Sullivan. Thank you, Mr. Chairman. Thank you for
holding this joint hearing today on the national H1N1 swine flu
preparations, especially on the current status of the vaccine
production and distribution. I am interested today in examining
the lessons learned from both the administration and vaccine
manufacturers in terms of responding to this national public
health emergency.
To date, manufacturers have delivered 48.5 million doses of
H1N1 vaccine, and the Department of Health and Human Services
had hoped to have as many as 120 million doses by now.
Obviously there is a large gap between what the administration
promised and what they were able to coordinate and deliver. I
am concerned that the administration's plan was overly
optimistic and that this has led to confusion with the American
public.
Since September 1, 890 Oklahomans have been hospitalized
due to complications from influenza and 27 persons have died.
Ninety percent of the H1N1 related deaths have been persons
less than 65 years old.
Health officials in my State announced yesterday that all
Oklahomans who wants to reduce the risk of H1N1 infection are
now eligible to receive H1N1 influenza vaccine. While vaccine
supplies are limited, demand from priority groups has dipped to
a point where all Oklahomans can begin to receive vaccine. H1N1
influenza activity has been widespread in Oklahoma since early
September, and even though statewide monitoring has recently
shown a decline in influenza linked to hospitalizations, this
virus is expected to circulate throughout the winter months.
The possibility also exists that another surge of H1N1 flu may
follow the current one and we need to be prepared for this
contingency.
I look forward to hearing the testimony of our witnesses
today and examining how we can continue responding to this
public health emergency, and I yield back the balance of my
time.
Mr. Pallone. Thank you. The gentlewoman from Florida, Ms.
Castor.
OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA
Ms. Castor. Well, thank you, Chairman Pallone, and good
morning to our witnesses. The CDC and Secretary Sebelius and
all of you have done exceptionally well in your public health
outreach. You have kept Americans informed about the risk in
basic prevention methods to combat the spread of the virus such
as hand washing and the use of alcohol-based sanitizers. And I
appreciate Secretary Sebelius' visit to Florida last week. She
visited the East Manatee Family Health Care Center in
Bradenton, Florida. And we met personally with representatives
from the health department, community health centers, and other
providers throughout the area to review local distribution of
the vaccine, particularly to people in the high risk categories
like pregnant women and young children and others with asthma
and diabetes.
My greatest concern right now is the spread of
misinformation, especially on the Internet. Just over the past
weekend I was talking with a doctor who I know who is also--who
works in Tampa General Hospital. He is married to an OB/GYN.
And they were explaining to me that they are running into the
problem of pregnant women and others in high risk categories
that have read something on the Internet that has discouraged
them from receiving the vaccine. And after talking with them I
went online to see what is out there, and they are right, there
is a lot of misinformation on the Internet.
One Web site calls it a complete load of nonsense, that
mainstream media and American public health officials state
that the benefits of H1N1 vaccine far outweigh the risks. They
are frightening pregnant women who are at high risk to think
that they might miscarry if they are vaccinated. This Web site
reports that the vaccine is responsible for death, paralysis,
seizures and other ailments.
So we have got our work cut out for us. But it doesn't stop
there. In September a major cable news network did a segment
with a so-called infectious disease expert advising parents not
to vaccinate their children and declared that he would not
vaccinate his own children, claiming that the vaccine and
others are not safe and they cause more serious devastating
conditions.
So in your testimony would you please address how we can
effectively combat the spread of misinformation and continue to
empower communities with accurate information and continue to
encourage those, especially in the high risk categories, to
receive the vaccination.
Thank you. I yield back.
Mr. Pallone. Thank you. The gentlewoman from Illinois, Ms.
Schakowsky.
OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS
Ms. Schakowsky. Thank you, Chairmen Pallone and Stupak.
I wanted to put on the record the effective manner in which
my State of Illinois is handling the H1N1 flu vaccine and
administration. The Illinois Department of Public Health has an
H1N1 specific Web site that contains a wealth of information
about vaccine availability and prevention information.
The City of Chicago set up six free clinics to administer
H1N1 vaccines at city colleges. Chicago vaccinated nearly
51,000 people in the 7 days following the opening of the free
clinics.
There are a number of issues surrounding the infection and
death rates in Illinois that lack sufficient explanation. Maybe
you have these answers. Why is the highest number of H1N1
deaths among adults age 25 to 29? These numbers defy all the
things that we previously knew about flu viruses. Do we have
the correct distribution system? Is giving the vaccine to banks
and companies likes Goldman Sachs and NBC the best way to
distribute the vaccine?
Our current lack of research data limits our ability to
draw concrete conclusions, and if we are unable to draw
conclusions there is no way we could construct an adequate or
effective response plan which only increases all of our risk.
So I hope to hear about the public health plans and
research efforts under way to help us better understand the
disease and innovation prevention and treatment methods that
are emerging.
I thank all of the witnesses for being here today to help
shed more light on the situation, particularly as we are
learning new information every day, and I look forward to your
testimony.
I will yield back.
Mr. Pallone. Thank you. The gentleman from Utah, Mr.
Matheson.
OPENING STATEMENT OF HON. JIM MATHESON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF UTAH
Mr. Matheson. Well, I want to thank both Chairmen Stupak
and Pallone for holding this hearing today. My State is not
unlike my colleagues here on the committee. We have had our
outbreaks of H1N1 in schools and communities. We have seen over
623 hospitalizations due to the influenza this year as well as
14 deaths. Our State has worked with the Federal Government and
manufacturers to make as many vaccines available as possible to
our residents, and I am looking forward to hearing how we can
better improve our strategy and coordination for responding to
this public health crisis.
To date my State of Utah has received a total of just over
296,000 doses, and providers have reported having administered
just over 176,000 doses of the vaccine as of November 7th.
While our State supply of vaccine continues to arrive in weekly
shipments, the vaccine is still in limited supply.
I represent the State with the youngest population in the
country. So I continue to be worried about making sure our
children get access to this vaccine in a timely fashion. I am
also concerned by several recent reports in the uptick of
counterfeit medications.
The U.S. Food and Drug Administration has issued warnings
to consumers to use extreme care when purchasing products over
the Internet that claim to diagnose, prevent, treat, or cure
the H1N1 influenza virus. The agency issued this warning after
the FDA recently purchased and analyzed several products
represented online as Tamiflu.
The FDA notes on its Web site that one of the orders which
arrived in an unmarked envelope with a postmark from India
consisted of unlabeled white tablets taped between two pieces
of paper. When analyzed by the FDA the tablets were found to
contain talc and acetaminophen but none of the active
ingredient.
I am working on legislation to proactively address the rise
in counterfeit medications with my colleague, Mr. Buyer.
Counterfeiting is a lucrative business, and I hope that my
colleagues will proactively work with me to address this issue
with any drug safety legislation to come before this committee.
Thank you, Mr. Chairman. I yield back the balance of my
time.
The Chairman. Thank you. The gentleman from Ohio, Mr.
Space.
OPENING STATEMENT OF HON. ZACHARY T. SPACE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OHIO
Mr. Space. Thank you, Mr. Chairman, for conducting this
important hearing. We have heard today already a couple of
allusions to Guantanamo Bay and I think one to even Katrina.
And I am as concerned as anybody about the specter of Khalid
Sheikh Mohammed getting this vaccine before my son. And I guess
I would like your assessment as to whether that is in fact
happening.
But more importantly, I think it is important that we
understand what we can do as a legislative body at this point
to enhance our ability to manufacture and distribute the
vaccine in a better way. We have obviously seen far too many
deaths across the country. Certainly Ohio and my congressional
district has been no exception to that.
But I am also interested in hearing your opinions
concerning other ways that we can combat this H1N1 pandemic
apart from administering the vaccine. My colleague from Florida
referenced the misinformation campaign that seems to be
occurring out there. I am curious as to the educational
component that we can promote in simple things like hand
washing and things that our constituents can do to put
themselves in a better position.
And finally your assessment as to those who are most likely
to get sick and die if they contract the virus, what they can
do. In particular, diabetes. I understand that the obese have a
particular risk factor. And how we can again from a legislative
perspective at this point in time do everything we can to
maximize our ability to combat this troubling epidemic.
Thank you, and I yield back my time.
Mr. Pallone. Thank you. The gentlelady from Ohio, Ms.
Sutton.
OPENING STATEMENT OF HON. BETTY SUTTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OHIO
Ms. Sutton. Thank you, Mr. Chairman, and I appreciate you
holding this hearing today. So much has changed since this
committee held its first hearing on H1N1 back in April. At that
time the H1N1 flu was just breaking and there were only 91
confirmed cases in the U.S., including a young boy in my
district. There was also no vaccine and the government was just
beginning to formulate a Federal response to the growing
pandemic.
So we have traveled some distance since then. Now nearly 8
months later over 22 million Americans have had the H1N1 flu,
and there is a vaccine in production, as we all know, and it is
being distributed free of charge to the American people.
However, there have been challenges along the way, and we have
heard that discussed here today, with manufacturing and
distribution of the vaccine. And because of the slow rate of
vaccine production, demand has outpaced supply and the vaccine
remains difficult for people to obtain. It is difficult even
for those in high risk populations sometimes.
So it is very important that we have this hearing and we
figure out ways to address these challenges that we are facing
currently and the ones that may be ahead. We have seen moms
with young children and pregnant women and the elderly standing
in lines hoping to get the vaccine, and we want them to get it.
We have heard the reports of Wall Street employees having
access to the vaccine. And it certainly undercuts the public's
confidence in the distribution process, which is important. And
it is important that we correct the record so that people
understand what is and isn't happening.
But it is also just critically important that we do
everything we can to effectively deal with H1N1 from this point
forward, and frankly this won't be the last flu challenge that
we have, so that we can formulate the proper way to respond to
these kinds of challenges in the future.
I yield back.
Mr. Pallone. Thank you. The gentleman from Indiana, Mr.
Buyer.
Mr. Buyer. I pass.
Mr. Pallone. The gentlewoman from Colorado, Ms. DeGette.
OPENING STATEMENT OF HON. DIANA DeGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you very much, Mr. Chairman. I want to
thank both of our chairmen for having this hearing today. I
will submit my statement for the record because I am sure every
single thing I had in there has been said by other members of
the committee. But let me just say this.
The Oversight and Investigations Committee has had a number
of hearings over the years on flu pandemics. The good news
about what has happened with this pandemic is our public
campaign, our awareness has been terrific, as Congresswoman
Harman said. The problem is we still do not have an alternative
to the egg-based vaccines, and we were assured at the September
15th hearing that we had that, we were ramping up production,
we knew H1N1 was coming and those vaccines would be readily
available very, very soon.
That obviously has been the big problem with our response
to this pandemic. Now, it is not so bad because as it has
turned out this particular strain, while fatal and we feel
badly about the fatalities that we have had, is not as virulent
as say the avian flu. But I will tell you what, if this had
been a virulent flu strain like the avian flu we would have
millions of casualties already.
Now, my own daughter, who is a Type I diabetic, spent weeks
going around Denver trying to get a vaccine only to finally get
it last week. And I have got to say over the 13 years I have
been on this committee we have got to fix this problem. We
can't wait until we have the next pandemic to say that we have
got to get an alternative to egg-based vaccines.
And so again to both of our chairman I want to thank you
for having this hearing. And I want to say that at least this
Member of Congress intends to keep pushing even when this is
out of the headlines to make sure we find these alternatives,
because if we don't it will be on our shoulders the next time
we have a pandemic and it is a virulent pandemic that causes
millions of deaths.
So I intend to do everything I can to make sure that that
will not happen the next time.
[The prepared statement of Ms. DeGette follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. I thank the gentlewoman. Next is the gentleman
from Connecticut, Mr. Murphy.
OPENING STATEMENT OF HON. CHRISTOPHER S. MURPHY, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF CONNECTICUT
Mr. Murphy of Connecticut. Thank you very much, Mr.
Chairman. To Chairman Pallone and Stupak, I appreciate this
hearing today. I appreciate it especially as a parent of a
current 15-month-old H1N1 patient at home. He is doing fine,
but I am looking forward to the testimony today. For a number
of reasons. One, I think that this conversation about how our
Federal Government is interacting with State governments is
important, and I know you are going to spend some time talking
about how you turn your recommendations for distribution
systems into best practices.
But I would also like to hear about your interactions with
States regarding preventative measures. We have had a number of
long-term school closures in Connecticut due to outbreaks, and
I think one of the difficult things for local school districts
has been an inability to really get the best information
regarding how they should approach small or larger size
outbreaks in school systems, in day care settings, and so I
think a lot of us would be interested in hearing about how you
are disseminating those recommendations down to school
districts and to other settings in which you have a lot of
kids.
And second, just to partner and build on the remarks of
Representative Baldwin and Representative DeGette, I think a
lot of us are very interested in the progress we are making
this season, but also for next season, on alternative
processes. I know that HHS has already given out some fairly
large research grants to companies, one actually located in my
district, Protein Sciences, to start building some nonegg-based
processes that have I think some real potential, and I am
interested in whether you think any of those processes might
come online this season or whether we are looking out into the
next outbreak or to the next season for some of these
alternative processes.
But again I think there are a lot of questions but I think
that you have answered many of them so far. I think you have
done a great job in disseminating information and getting
information out to the public, and I think that this hearing
can just help you build on that.
I yield back.
Mr. Pallone. The gentlewoman from the Virgin Islands, Mrs.
Christensen.
OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A
REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS
Mrs. Christensen. Thank you, Mr. Chairman, and I thank all
of the Chairs and the ranking members for having this hearing.
As a physician and a former public health administrator, you
can imagine this issue is of great concern. And as someone who
has managed emergencies in the past, I know how important
communication is and managing them and controlling panic and
controlling the spread of the disease in this case.
Since the spring, when we were first made aware of the
H1N1, it is now widespread I think in 48 States and at least
two Territories. As of the last report there are 80 cases in
the Virgin Islands, I am sure there are more now, and one
death. And 444 cases and 34 deaths in Puerto Rico. And I am
very concerned that half of the children that died from H1N1
between April and August were African American and Hispanic
children, which is considerably more than the percentage that
both groups represent in the population. So I would like to
hear something of what is being done to outreach to those
communities, as I have asked before.
I want to say that several years ago I introduced the Rapid
Cures Act, which would increase research to shorten the time
from bug to drug and vaccine. I didn't introduce it in this
Congress because I was assured that the research was being done
and I thought we would be further along. But the shortage shows
that we are probably not, and I am hoping also that the
limitations that we have faced in providing adequate vaccine
will allow real valuable lessons going forward, and I look
forward to the testimony of our witnesses.
Mr. Pallone. Thank you. Mr. Weiner.
OPENING STATEMENT OF HON. ANTHONY D. WEINER, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW YORK
Mr. Weiner. Thank you, Mr. Chairman. Mr. Chairman, I want
to thank the members of the panel both for their work and for
being here today. I represent the community around Saint
Francis Prep, which represents I guess the closest thing to the
American Ground Zero for this virus. You know frankly we have--
this is the problem with trying to deal with a complicated
health thing in the context of 24-hour news. And a lot of
people who look at this through the lens of their own
experience, we have swung wildly from poll to poll between this
as an enormous problem that is going to smite us all to this is
not that big a deal. We have the very same people who have been
traveling the country saying get government out of our health
care are now saying how come government isn't doing a better
job with our health care.
I certainly hope that you have had a strong and stern
talking to to those viruses that refuse to grow fast enough. I
hope that any of those viruses that haven't been performing
have been summarily dismissed. And I look forward to an
oversight report by the GAO about how it is that we are
recruiting a virus that does such a poor job of growing in
chicken eggs when we ask it to.
But the bottom line of all of this is to some degree we
have all participated in a small way to dealing with this
notion of frenzy around this. Even the Vice President of the
United States I think probably regrets saying he would
recommend his family members not get on a subway in New York
City, where you can catch things, but I am not sure swine flu
is going to be at the top of your list.
The point is that we to some degree in government, we too
exaggerate our ability sometimes to be able to be a fulcrum
against Mother Nature and the laws of medicine and to some
degree chemistry and physics and the like. And I think that you
should be commended for trying to keep a level conversation
tone here even in the face of many different cross currents. We
should try to learn each time we have one of these instances
what we can do better. And I think to some degree a lot of what
you have done now is based on lessons that have been learned.
But I think that it is also important that we as the
legislative branch empower you all to do the jobs you can and
then do our best to give you the elbow room to try to make
smart medical decisions in what is an environment that is often
hypertense, hypersensitive, and often polluted with a lot of
misinformation.
So I appreciate your being here to help us do that.
Mr. Pallone. Thank you. The gentleman from Georgia, Mr.
Barrow.
Mr. Barrow. I thank the chairman, and with my thanks to the
witnesses for their participation, their work and their
testimony, I will waive an opening.
OPENING STATEMENT OF HON. BRUCE L. BRALEY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF IOWA
Mr. Pallone. The gentleman from Iowa, Mr. Braley.
Mr. Braley. Thank you, Mr. Chairman. It has been a long
time since the word ``smite'' has been uttered in this hearing
room. And unlike my youthful colleague from Connecticut, my
three children are in another high risk category, college
students. But I am very concerned about the delay in
productions of vaccine and the shortages of both the H1N1 and
the seasonable flu vaccine and the process of vaccine
distribution. There have been severe shortages in my State of
Iowa which, by the way, is the number one egg production State
in the country, and I would like to speak out on behalf of all
eggs who have been criticized.
Vaccine shortages that led to the cancelation of flu shot
clinics in my State left thousands of Iowans without access to
the flu vaccine and left them vulnerable to the virus. And as
of last Friday the Iowa Department of Public Health had
confirmed 19 H1N1-related deaths in Iowa, including one child
and 18 adults. And those victims include people from Dubuque
and Black Hawk Counties, both of which are in my district, and
more than 500 Iowans have been hospitalized with the H1N1
virus.
That is why you can imagine how outraged I was to learn a
couple of weeks ago that some of the biggest companies in New
York, my apologies, Mr. Weiner, including Goldman Sachs,
Citigroup, JPMorganChase, and Time Warner, were receiving large
doses of this vaccine for their employees. I don't think that
it is appropriate or fair that big Wall Street firms be given
priority access to the vaccine while thousands of Iowans are
going without it.
I sent a letter on November 5th to Secretary Sebelius
expressing my serious concerns about the distribution process
and urging her to ensure that the vaccine is distributed based
on risk and need, not based on wealth or profession or zip
code. I haven't received a response to my letter. So I hope
that you folks today can shed some light on this process, what
additional corrective measures, if any, have been taken and
explain to me and my constituents why these companies were
receiving the vaccine when so many of my constituents were
forced to go without. And I am talking about seniors,
immunocompromised individuals and children.
I look forward to hearing the testimony of the witnesses
today and learning when the Iowans that I represent who would
like to receive these vaccines and would like to receive them
soon will receive access and what is being done to promote
expansion of the availability of the virus.
So thank you.
[The prepared statement of Mr. Braley follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. The gentleman from Maryland, Mr. Sarbanes.
OPENING STATEMENT OF HON. JOHN P. SARBANES, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MARYLAND
Mr. Sarbanes. Thank you, Mr. Chairman. I will be very
brief. We are looking forward to your testimony. I will be
curious to hear you describe where things have gone compared to
where you thought they would be the last time we had a hearing,
so that at the beginning of this process you made projections,
you talked about certain contingencies, and I would be
interested to know how the advance of the disease has panned
out against those original projections because it helps us make
judgments as you project further. And that would be both with
respect to advance of the disease and with respect to the way
we are responding to it.
And I just want to echo what Congressman Braley just said,
and that is if there are going to be delays in the distribution
and if what has been manufactured is less than what we hoped to
have at our disposal at this point in time it becomes even more
critical--I mean it is always critical that the distribution be
done in a fair way, but it becomes even more critical that it
be done fairly because the larger context is that there are
shortages and it makes people, I think, much more resentful,
and rightly so, when they see an unequal distribution and one
that is not occurring according to the criteria that you have
laid out.
So I think there is probably a lot of interest in having
you address that in your testimony. And I yield back my time.
Mr. Pallone. Thank you, Mr. Sarbanes.
Mr. Engel.
OPENING STATEMENT OF HON. ELIOT L. ENGEL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW YORK
Mr. Engel. Thank you very much, Mr. Chairman. And I too
will be brief. I am delighted that we are holding this hearing
this morning, and I look forward to listening to the witnesses.
Obviously what has gone on with the swine flu is something that
Americans are asking lots and lots of questions. And we are
hearing that this is something that is easily spread and yet we
were told several months ago that there would be adequate
vaccines and there aren't. And I know people have been
contacting my office to find out where they can get vaccines.
And I think what happened here is that people's expectations
were rising when the government announced that there would be
no problem and people would have enough vaccines for use. I
think if that had not been stated or said perhaps people's
expectations wouldn't be so high. But the double whammy of not
having enough vaccines, plus the announcement that there would
be enough for people has made people, have made people think
that something is terribly wrong.
I have had some discussions with some of the people
testifying today, and they have helped me to understand what
has happened, but I think that we really need to ensure that
something like this really never happens again. I know that
people in my district have been wondering. My Staff Director
had his two little boys just last week both come down with
swine flu. And people have been calling my office and wanting
to know where they can get vaccinated, and we have been trying
to help them the best we can. But people are confused and angry
at the same time.
So I look forward to the testimony and to hear what the
witnesses have to say. And I thank you, Mr. Chairman, for
holding this very important hearing, and I yield back.
Mr. Pallone. Thank you, Mr. Engel. I believe we have
concluded our opening statements. So we will now proceed to the
witnesses. Let me call or introduce the first panel. Starting
with my left is Dr. Anne Schuchat, I hope I am pronouncing it
right, who is Director of the National Center for Immunization
and Respiratory Diseases at the Centers for Disease Control and
Prevention. And then we have Dr. Nicole Lurie, who is the
Assistant Secretary for Preparedness and Response at the
Department of Health and Human Services. And finally, Dr. Jesse
Goodman who is Chief Scientist and Deputy Commissioner for
Science and Public Health for the Food and Drug Administration.
Now, in accordance with the policy of the Oversight and
Investigations Subcommittee, I have not done this before but
because of the policy of the Oversight and Investigations
Subcommittee all testimony at today's hearing will be taken
under oath. And I am to advise you that you have a right under
the rules of the House to be advised by counsel during your
testimony. And I have to ask you initially if you wish to be
represented by counsel and, if so, you would have to State your
counsel's name.
Dr. Schuchat.
Dr. Schuchat. No, thank you.
Mr. Pallone. No. Dr. Lurie.
Dr. Lurie. No, thank you.
Mr. Pallone. You said no. And Dr. Goodman.
Dr. Goodman. Thank you, no.
Mr. Pallone. No. OK. So then we are going to stand. Each of
you should stand. We are going to take an oath. Or you are
going to take an oath I should say.
Let the record reflect that the witnesses replied in the
affirmative. You are now under oath. Thank you.
[Witnesses sworn.]
Mr. Pallone. And we will start with a 5-minute opening
statement from Dr. Schuchat. I think you all know that you can
submit a longer statement for inclusion in the record, but we
would like you try to stick to the 5. Thank you.
TESTIMONIES OF DR. ANNE SCHUCHAT, DIRECTOR, NATIONAL CENTER FOR
IMMUNIZATION AND RESPIRATORY DISEASES, CENTERS FOR DISEASE
CONTROL AND PREVENTION; DR. NICOLE LURIE, ASSISTANT SECRETARY
FOR PREPAREDNESS AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES; AND DR. JESSE GOODMAN, ACTING CHIEF SCIENTIST, DEPUTY
COMMISSIONER FOR SCIENTIFIC AND MEDICAL PROGRAMS, FOOD AND DRUG
ADMINISTRATION
TESTIMONY OF DR. ANNE SCHUCHAT
Dr. Schuchat. Thank you, Chairmen Pallone and Stupak,
Ranking Member Walden, and members of the subcommittee. I am
really pleased to be back to talk with the committee about our
comprehensive response to the H1N1 pandemic and to answer your
questions.
A brief update on the situation. As you've heard, we
released new estimates for the toll the virus has taken in the
first 6 months of the pandemic: 22 million infected or ill,
98,000 hospitalized and, sadly, almost 4,000 deaths. The virus
is spreading in--considered widespread in 46 States. In many
areas it is beginning to decrease, the burden of illness, but
in some it is still on the upswing. There has been no change in
the illness pattern, still disproportionately a younger
person's disease, many people with underlying conditions or
pregnancy disproportionately affected with severe
complications.
So far no change in the virus. It hasn't become more
virulent or changed genetically. We still think the vaccine is
an excellent match with this virus that is circulating.
But unfortunately, the trajectory that the virus will have
is unpredictable. We do not know how long this wave will last,
whether there will be multiple waves. We know that flu season
can last until May usually. We don't know how much seasonable
flu strains we will have, many unknowns. And that makes it even
more important that we strengthen our response.
Without the investments of Congress in preparedness and
strengthening our ability to cope with a pandemic we would be
in much worse shape than we are today. I will go through CDC's
response, and others will talk more broadly.
We rapidly identified and characterized the virus, we
developed candidate vaccine strains, we carried out
epidemiologic and laboratory surveillance in the U.S. and
abroad to understand what was going on and direct our
interventions. Our aggressive response has been science based.
We have rapidly deployed lifesaving anti-viral medicines and
other material from our strategic national stockpile.
Laboratory kits were prepared in record time and disseminated
to all of the public health labs here in the U.S. and to 150
other countries. We deployed field teams to support the State
and local response and continue to support the State and locals
in what's very much an implementation effort at the front
lines.
We have issued science-based guidelines on prevention and
mitigation. We expected disease to increase this fall before
vaccine was available, so we worked very actively with other
sectors to make the best use of antiviral medicines in high
risk people or in severe illness, to work with education on
ways to better intervene in schools without as disruptive
effects as we saw last spring. We focused on businesses and
health care workers, and so forth. Communication has been a
priority for all of us and we have done outreach with new media
and old media and many partners.
Of course the heart of our response is the vaccination
effort right now. It's been unprecedented in the speed with
which we've gotten this vaccine. But of course like everyone I
am disappointed in the initial production and we've been held
captive really to this slow growing virus.
However, today I can announce that there are 49.9 million
doses of H1N1 vaccine that are available for the States to
order. It's not as much as we wanted to have by now or frankly
what we needed to have by now, but every dose that's coming out
is being rapidly moved to places where it can go into people
and help protect them.
At CDC we work to develop recommendations to prioritize the
use of scarce vaccine for those at highest risk of disease or
most likely to spread. We have a distribution system that gives
each State a pro rata population based share of the vaccine
trying to have as fair a process as possible. The States and
local health authorities are the implementers. They are
deciding where that vaccine gets shipped. They are working very
closely with the provider community, the local health
departments, hospitals, with community health centers, with
others, schools for instance, where vaccination efforts can go
forward rapidly.
Thirty-four States so far have initiated school located
vaccination efforts to really reach large numbers of children
promptly. Not as many have been able to be completed because of
the supply but more are happening every day, and we know that
the State of Maine expects to finish their school located
program by the end of this week.
We've done all this mindful that the environment we live in
makes communication and emphasis on the safety of vaccines the
forefront for many. And so we've done this without cutting any
corners on safety and have strengthened our safety monitoring
system to address any unanticipated problems.
We are working hard with partners across government and in
particular with the State, local, and tribal authorities who
are directing the program where they are. They have been
working tirelessly to make this succeed, and I'm happy to
detail some of the efforts they've been making in the comment
period.
When we have the opportunity to look back on this public
health challenge, we'll have time to reflect on the remarkable
scientific accomplishments that made it possible to rapidly
detect and track a previously unseen virus and get a vaccine
developed in record time. We'll have time to more
systematically search for lessons in production and delivery
that we can apply in a future pandemic and to rebuild the
public health system that we all rely on. But today we need to
quickly adapt from our recent experience and maintain our focus
on the days, weeks and months just ahead.
We'll have more vaccine to put in the path of this virus.
And it's our commitment to continue to work closely with our
State and local public health partners to ensure that it's as
effectively delivered to those who need it most.
I will look forward to answering your questions.
[The prepared statement of Dr. Schuchat follows:]
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Mr. Pallone. Thank you, Dr. Schuchat.
Dr. Lurie.
TESTIMONY OF DR. NICOLE LURIE
Dr. Lurie. Thank you. I, too, am very pleased to be able to
talk to you today about our pandemic response.
Mr. Pallone. Maybe put that mic a little closer to you
there.
Dr. Lurie. Is that better?
Mr. Pallone. Yes. Talk into it directly if you can.
Dr. Lurie. Thank you for your foresight in helping to
rebuild our country's vaccine infrastructure. As a result, when
we decided to pursue vaccine for H1N1 this spring we had
preexisting contracts with manufacturers already licensed in
the U.S. to get us out of the block quickly to contract for
manufacturing vaccine and preparedness efforts have helped
hospitals and health care systems also be ready.
My office has a four-fold response related to this
pandemic: First, to coordinate across department response and
work with the interagency; secondly, to stimulate the
development of and contract with for vaccines and antivirals;
third, to monitor and ensure that we can backstop States and
communities if they get overwhelmed and request our help; and
finally, to stay prepared for any other emergency, not to take
our eye off the ball.
This whole response has been a public-private partnership
from the get-go. Starting with vaccines, as you know, we
developed a new vaccine with unprecedented speed. And this was
really made possible by investments in basic and clinical
science, manufacturing regulatory processes, and would not have
been possible at all without our partnerships with industry.
And while modest amounts of vaccine came ahead of schedule, as
the graphic over here details on the left, a combination of
poor production yields, late completion of seasonable vaccine,
problems with new filling lines, decisions in the home country
of one manufacturer, cost delays in the availability of
vaccine, not just for the U.S. but around the world. And while
the number of doses that's been produced and distributed and
administered continue to grow we remain vigilant.
To ensure a steady supply of vaccines we talk with
manufacturers almost every single day. We constantly monitor
the progress of every lot produced, working to make up ground
wherever possible. And right now we have full time staff in the
facilities of two of the manufacturers.
In addition, Secretary Sebelius and I have spoken directly
with CEOs actually on several occasions seeking to identify
opportunities to work together to be sure that there are no
arcane kinds of obstacles in the way. And while these delays
are really frustrating to everyone, we do need to remember that
the virus is the real enemy here. And the way forward, as we've
been talking about this morning, is to improve our country's
domestic manufacturing capacity, using newer, faster and more
predictable technology so that the virus of the future does not
defeat us.
Antivirals have been another critical aspect of our
response, and I just want to point out that we supported the
development of new antivirals, issuing the first emergency use
authorization for an intravenous antiviral, and we have
procured over 30,000 doses across three types of antiviral
drugs.
We are also focused on ensuring the health care system and
communities throughout the country remains able to care for
those who need it. CMS can now grant 1135 waivers to decompress
hospitals and other facilities when they are getting
overburdened, letting them use those emergency plans. And we
stand ready to deploy Federal assets when necessary, including
vaccination teams, clinical and laboratory staff, and temporary
medical facilities. And our first ever vaccination team is
headed to Delaware to do just that.
We have also partnered closely with the private sector
health care system, including health insurers, pharmacists, big
box stores, AMA, and the public health community to find ways
to pay for vaccine administration so cost is not a barrier to
people who want to be vaccinated.
Let me shift for a minute to lessons learned. Clearly the
support of Congress in the past few years have been critical in
enabling us to respond so quickly to this pandemic. And yet it
is clear the chronic underinvestment in public health, whether
at the Federal, State or local levels or on the manufacturing
infrastructure, has real world consequences, and we cannot
afford to let this happen again ever.
While we have made vaccine in record time without cutting
any corners, in retrospect our original projections were based
on the collective experience with seasonable flu and with H5N1
vaccine manufacturing, and we are optimistic in the face of
what's proved to be a daunting challenge provided by Mother
Nature, and despite the best efforts of Federal Government and
our partners in the private sector.
Congress and the public have rightfully asked for
projections about numbers of doses, and we want to be
transparent, but at the same time provide all of the caveats
about the uncertain nature of these projections.
This has been a real challenge, especially as measures are
captured with shorter and shorter sound bites that omit detail
about such caveats, and this has led to frustration for
everyone involved, especially the public.
As an important part of this transparency and part of our
public-private partnership we will start releasing this week,
together with all five vaccine manufacturers, the number of
projected doses by manufacturer for successive 2-week periods.
In this past week storm-related delays nearly derailed
shipment of vaccine to many States from Maine to Alabama. And I
want to credit the hard work of CDC and ASPR staff who worked
all weekend to be sure the vaccine could be ordered and shipped
so the clinics could go on as planned.
But we are far from done with the science of advanced
development related to vaccines and with building manufacturing
capacity in the United States. We are excited that the first
cell based facility will open or have its ribbon cutting next
week in North Carolina.
But my fear frankly is when this is over we will decide we
don't need to worry about a pandemic for the next 30 years.
Nothing could be more dangerous. Despite these challenges, I
think that much of what we have learned and frankly continue to
learn through this pandemic and in the investments we have made
to address it will serve us well in confronting future public
health emergencies as well as for day-to-day public health for
years to come.
I, too, look forward to your questions.
[The prepared statement of Dr. Lurie follows:]
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Mr. Pallone. Thank you, Dr. Lurie.
Dr. Goodman.
TESTIMONY OF DR. JESSE GOODMAN
Dr. Goodman. Chairman Stupak, Chairman Pallone, and members
of the subcommittee, I really appreciate the opportunity to be
here today to describe FDA's activities in this response.
First, when this influenza virus emerged in the spring we
said this can't be business as usual and we immediately set up
an incident command system response with several teams, for
example, in antivirals and vaccines. And this enabled us to
mount a very flexible and rapid response with our partners
inside and outside of government.
In vaccines, our vaccine team acted immediately along with
CDC to begin the steps to produce a vaccine even before there
was a decision or knowledge that we were going to need one.
As you heard, in record time vaccine was produced and
became available, and I can assure you everyone in this effort,
government and industry, has done everything possible to get as
much vaccine to as many people as quickly as possible without
cutting corners. And I know this committee is concerned that a
vaccine be safe.
A very important perspective here is that the entire world
is struggling with the biology of this virus, the challenge of
reduced manufacturing yields, and frankly the entire world is
struggling with inadequate vaccine manufacturing
infrastructure.
Yet despite these challenges we face in the United States
and the frustration we have been talking about, this country is
one of the first to mount an effective large scale immunization
campaign.
Now, many people have asked us at the FDA how can we be
confident in a vaccine produced so quickly. We have this
paradoxical situation where many people really want vaccine and
many people don't trust it.
Well, I would like to say that the answer is
straightforward and to reassure the American people. The
vaccines we've approved are made with methods that are tried
and true. Every year FDA and vaccine manufacturers follow a
series of very specific careful steps to produce new influenza
vaccines every single year, and these steps have produced safe
vaccines year after year, adding up to hundreds of millions of
doses manufactured and used in the United States. And we
followed this exact same scientific and regulatory approach for
this 2009 H1N1 vaccine.
In response to some of the disinformation that was
mentioned, I think by Congresswoman Castor, one of the things
we have done, for example, is my Commissioner, Dr. Hamburg,
with our working together, sent a letter to every physician in
the United States to explain about the vaccine, how it was
produced, and to provide a balanced review of the benefits and
risks of the vaccine. But clearly we have a lot more work to do
there.
You heard from the others that your investments in pandemic
preparedness have been critically important. With respect to
domestic capacity, I want to say that in May FDA in an
accelerated manner licensed an additional facility at Sanofi-
Pasteur in Swiftwater that the company has said has
dramatically increased its ability to produce vaccine and that
is helping us now so that's important. But clearly we have
much, much more to do.
I would also say during this response we have worked with
HHS to bring online multiple additional filling lines to help
make sure we can get the vaccine that's produced out there as
quickly as possible.
Now, on September 15th we licensed four vaccines against
the influenza virus, a fifth last week, and I also wanted to
point out that again in a very collaborative effort with the
CSL manufacturer who submitted data to us we were able to
extend the approval of CSL's vaccine to include children down
to 6 months of age who we are very concerned with.
Now, while we expect these vaccines to have the same
excellent safety record as seasonable vaccine every year, we
are taking nothing for granted. The same intensive oversight of
these facilities, the enhanced safety monitoring Dr. Schuchat
mentioned, and I want to point out that every single lot of
vaccine must be evaluated, tested, and then released by both
FDA and the manufacturer before it is used in people.
Now, because of the limited time I won't go into the work
we have done on antivirals and diagnostics. I do want to say
that we have prevented, for example, through emergency use
authorizations discarding of antivirals that we scientifically
know is safe to use, and that has helped avoid shortages.
Diagnostics have been fielded in record time, within weeks of
the new disease, thanks to CDC's effort and our work with them
collaborating to evaluate those.
You've heard about protecting the public from fraudulent
and counterfeit products. We almost immediately put a team in
place to surf the Internet, to deal with consumer complaints.
My favorite is the magic wand that can protect against
everything, including anthrax and H1N1. But you also heard
there are issues of counterfeit and unapproved medications. We
are continuing to be very vigilant in this respect, and we have
actually put a widget out there so others can spread the word
with the list of counterfeit products.
Now, looking ahead, I really do feel much has been
accomplished in a very short time, and it is because of these
strong collaborative efforts that the people you are seeing
here and many more are talking every single day. We are talking
with the States, we are talking with the manufacturers, and
this has been going on from day one. But we need to ask
ourselves, and we are asking ourselves, what do we need to do
more both right now for this epidemic and moving forward.
Clearly you've heard about we need more capacity, we need
cell-based manufacturing, and we at FDA are very committed to
make that happen. We recently last year or the year before
provided guidance so we could get cell-based vaccines, but we
also want those to be safe. We are supporting with HHS
development of recombinant and newer technologies that can help
us respond even faster. And I think, as I heard from one
member, this is important not just about flu, this is important
about other emerging infectious diseases. If we had SARS, if we
had a bioterrorist attack, we need a strong technologically
advanced vaccine infrastructure.
Now, due to time I think I will stop there, but just to say
that we at FDA are very committed to working with our partners
and you to protect the health of the American people. We've
moved forward with a very flexible rapid response while taking
our responsibility about the safety of these products very
seriously. We really want to encourage strengthening our
infrastructure here.
I also want to mention again that this is a global issue,
and we in the United States can work with global partners to
strengthen the global response. None of us are safe and well
protected from infectious diseases until we all are.
So I thank you for your support for public health, your
support for the FDA, and your interest in this issue. Thank you
very much.
[The prepared statement of Dr. Goodman follows:]
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Mr. Pallone. Thank you, Dr. Goodman, and thank you to all
of you. The way we proceed now is we have a 5-minute period of
questions from members going back and forth, Democrat,
Republican. For members who passed on their opening they get 7
minutes. They get to add their opening to the 5. I'm going to
start with myself. And I want to start with Dr. Schuchat.
The big concern--the biggest concern that I hear from my
constituents is about the distribution. And I know that the CDC
has guidelines for distribution, but basically leaves the
distribution up to the States as long as they meet those
guidelines. My concern is whether that's a good way to go about
it. I mean I suppose you assume that the States and the
localities, since they are closer to people, would have a
better--would be the best way to distribute, but that's been
seriously questioned in the last few months or so. And of
course being from New Jersey the biggest issue has been the
Wall Street companies; Goldman Sachs, Citigroup. I literally,
being from New Jersey, hear about this constantly.
Why is it that New York, I guess you know, gave Goldman
Sachs and Wall Street firms the opportunity to do this? I'm
told that employer-based distribution is one of--meets your
guidelines. And perhaps it was assumed that they would do well
since they have health clinics and have a good distribution
amongst their employees.
But I guess the concern would be, you know, if you leave
the distribution to those who do it best and the ones that do
it best happen to be, you know, high-powered Wall Street firms,
then there are two concerns. One would be does that make sense
given that maybe a hospital or a school might not do as well a
job at distributing but there is a greater need.
And then the second thing is whether or not some of these
firms would only give it to high risk people as opposed to
maybe their CEOs or somebody else. So I mean that's the
concern. I mean, my question really would be why does the CDC
leave it up to the States to create the plan for distribution
and wouldn't it perhaps be better to have some other Federal
mechanism rather than doing it this way? And what, you know
what prevents somebody like Goldman Sachs getting it when it
maybe should be going to a clinic and monitoring how they go
about it?
Dr. Schuchat. Thank you. The CDC issues national standards
about the populations at greatest risk for disease that are
recommended to receive vaccine when there is a scarce
situation. So we issue that as a national level setting. We
leave it to the States or the large cities like New York City
to find the best ways to put vaccine in the path of the
priority populations, to identify the venues.
New York City actually put hospitals and doctors' offices
first. They put employer clinics in a lower tier and small
numbers of doses went to some employers----
Mr. Pallone. But the problem that I'm hearing, you know, I
don't have a lot of time, is that in some of those cases, I
don't remember which Wall Street firm it was, they actually had
excess and didn't need it. So you know you could argue that
maybe they are getting fewer dosages but you know it may very
well be that maybe all or most of what they got should have
gone to the hospitals because there is a greater high risk pool
there. How do we prevent that?
Dr. Schuchat. I think that issue was of concern to all of
us. Dr. Freiden sent a letter out to all of the health officers
reminding people about our priority groups and how critical it
is for all of us to adhere to them. Every provider or venue
that gets vaccine signs an agreement that they are going to
follow the recommended target populations.
Mr. Pallone. And I understand that--I'm not suggesting,
although some have, that Goldman or others are giving it to
people other than the high risk, although some are concerned
about that. But it is just that have you thought about the fact
that if you do it that way or if the States do it that way it
may be giving it to people that have a better distribution
network within their employers but they may not have as great a
need? It is sort of like when there is a grant program and the
guy that does the best, has the best grant application person
gets the grant whereas maybe there is a greater need for the
person who doesn't have an expert to do it, you know.
Dr. Schuchat. We have had a major commitment to vulnerable
populations and to the underserved and to make sure that we are
not leaving behind those without good access. Most of the
States have carried out these larger mass clinics to get people
who do not have doctors' offices to go to.
Mr. Pallone. If you can just--I don't know if you have it,
but I would like to see, maybe get back to me at some point to
talk about why this kind of distribution is better as opposed
to maybe looking at some kind of a Federal alternative. I don't
know to the extent that you've looked at that, but if you could
get back to us at some point.
Dr. Schuchat. Thank you.
Mr. Pallone. And then the other thing I wanted to ask Dr.
Lurie is that when Secretary Sebelius testified before the
committee on September 15th, I mean basically she left us with
the feeling that we are on track in terms of adequate supplies
of vaccine. I know that turned out not to be the case, some of
you explained why and I'm sure we will get more questions from
the other panel. But you did mention underfunding, and I don't
remember her saying anything about lack of funding. You said
that underfunding or chronic underfunding was one of the
contributing factors. That's the first time I have heard that,
and I was a little disturbed because I don't remember her
mentioning it.
Dr. Lurie. Let me try to clarify here. I think the chronic
underfunding has been in the vaccine infrastructure overall, as
opposed to the response. So it would have been wonderful if we
had had more manufacturing capacity in the United States by
this point, if we had had cell-based or recombinant
technologies that could surge and really produce large amounts
of vaccine.
But, you know, while we have invested in that over the past
few years, we need to continue to make a much more robust
investment. So that is the kind of chronic underfunding for the
vaccine manufacturing capacities.
I think we all know that the chronic underfunding in State
and local public health has been a different kind of problem.
But Congress has been extraordinarily responsive to the very
acute needs that we have had to deal with in this pandemic, and
what I would like to see us in the situation of is that we can
sort of apply prevention in that sense too and really get ahead
of this for the next pandemic.
Mr. Pallone. Again, as I said, I don't want to beat you
guys up today, but when it is something like that that Congress
can make a difference, it really is important that if the
Department or anybody feels that there is a need for more
funding, to detail that to us.
Again, I would ask you maybe to get back and give us more
information about this chronic underfunding in writing, because
a lot of things that come up here, we can't do anything about.
But that is certainly something we could.
Dr. Lurie. We look forward to working with you on that.
Mr. Pallone. Thank you.
Mr. Walden.
Mr. Walden. Thank you very much, Mr. Chairman.
Dr. Lurie, thank you, and thank you all for your testimony.
I note Secretary Sebelius did state in retrospect that the
vaccine manufacturers had painted a ``rosy'' picture. Now, some
of you have indicated you have been in contact almost on a
daily basis with these same manufacturers. My understanding is
the seed that they used to produce this vaccine was made
available to them on June 23rd. We had testimony September 15th
from Secretary Sebelius saying everything seemed to be on track
and fine.
So explain, did the manufacturers, weren't they straight
with you? What is this rosy picture piece? Is that blaming the
manufacturers?
Dr. Lurie. I don't think there is anybody to blame here. I
don't think that there is a smoking gun, and I want to make
that really clear. It is a very complicated process.
What we have tried to do is put together a little graphic
here that shows you all of the different points where things
can break down. So I think in the very beginning when we had
that seed strain and started making vaccine, everybody was very
optimistic. Nobody anticipated how hard it was going to be to
get this thing to grow. Manufacturers got a new seed, they
started having increases in their yields.
Mr. Walden. I don't mean to cut you off, but they only give
us 5 minutes here to solve the whole vaccination issue.
When did you first learn vaccine production was going to be
delayed?
Dr. Lurie. Well, what I should say is we learned at several
points along the way. We learned over the summer that there
were problems with this vaccine growing. We learned in the fall
that there were problems----
Mr. Walden. My understanding on that is that regular
vaccine or the traditional flu vaccine would produce about 3
doses per egg, and this was producing like a tenth of a dose or
something?
Dr. Lurie. Somewhere between .2 to .5 or something. So that
was very challenging. What I will say is at every step along
the way when we got information that things were not going as
quickly as possible, we actually downgraded our estimates and
we got that information out to the American public as quickly
as possible.
Mr. Walden. I guess what we are trying to get at here is I
was here for that hearing on September 15th, and I walked away
thinking, wow, that is a pretty strong statement, to say we are
going to have vaccine for everybody on schedule on time and 20
million doses in October, or whatever the number was, and then
we got people waiting in line for hours. I mean, people are
really frustrated.
Dr. Lurie. I think we are all really frustrated. I don't
have any doubt about that.
Mr. Walden. But did the Secretary know when she testified
in September of these delays?
Dr. Lurie. When she testified in September, those initial
getting-the-virus-to-grow problems had been largely cleared out
of the way. Then, you know, as happens, other problems
happened. Problems in getting production lines up and running,
for example, just took longer than they could have, so it
actually took longer to get from the big vats of vaccine into
vials that you could actually ship out to States, just as
another kind of example. And at every step along the way. Even
now we still have problems. You know, if a dose gets shipped
here and a temperature sensor goes off, or like the storm,
things happen.
So at every step of the way things happened. When the
Secretary testified, she was using the best available
information she had at the time.
Mr. Walden. Let me move on to a different topic then,
because one of my colleagues who had to leave wanted me to ask
if we could have for the committee the contracts you entered
into with the manufacturers, if we could? Is that something you
can provide?
Dr. Lurie. Absolutely.
Mr. Walden. And one of the questions that has come up is in
the contracts, did the manufacturers or did you request
knowledge as to whether or not these offshore manufacturers,
which is all but one, I understand, that their countries, like
we have the authority, can say, produce the drugs for us first
and then you can ship to the U.S.?
Was that discussed with each of these manufacturers, and
did HHS know ahead of time kind of where we might get a
manufacturer that is required by their in-country law to
provide the vaccine there first, and we might have been relying
on that shipment here? Did that pose problems that we know?
Dr. Lurie. Let me say first that these contracts are all
structured so that manufacturers don't get paid until they
produce vaccine. I just want to make that clear, because I
think that there has been a lot of confusion about that. We
have worked very hard to be responsible stewards of society's
resources in that respect.
Yes, almost every country has what this country has----
Mr. Walden. So you knew going in.
Dr. Lurie. Going in, or early on into this, we did know
that other countries had this.
I also want to just say that despite the problem in
Australia, CSL has worked very, very hard to get us vaccine as
soon as it got freed up.
Mr. Walden. I understand. The final question, because it
is, I believe, in your testimony, is your reference to this
vaccination team that has been sent to Delaware. What is that
about and why Delaware, other than maybe the Vice President's
home?
Dr. Lurie. Because they requested it. So one of the things
that we did in working with our colleagues at CDC and State and
local health departments is we said we want to do everything we
can to help everybody be successful and get vaccinators out
there. So if, within your State, you don't think you can
mobilize the resources to get populations vaccinated, we
actually through the National Disaster Medical System have
trained about 15 teams now that on request could go out and
help gets those vaccines into arms and noses. There is one out
there, I think next week, to help college kids.
Mr. Walden. Are there other States requesting that, and how
do they do that?
Dr. Schuchat. Just to add that CDC has also received
requests and we have adapted. So Dr. Lurie is describing one
mechanism. CDC has got other mechanisms. But everybody's shared
goal is to support the States in succeeding.
Mr. Walden. That is terrific. So those vaccination teams
are available through HHS, limited numbers, and States can
apply, and you are communicating, I assume, with our governors
on you how they can do that?
Dr. Lurie. Yes, we are.
Mr. Walden. Thanks for your indulgence, Mr. Chairman.
Mr. Pallone. Chairman Stupak.
Mr. Stupak. Thank you, Chairman Pallone.
Let me ask a couple of questions because I am a little
confused on a couple of things. What I have heard everyone say,
or Dr. Schuchat, you said next time we will have more time, we
will have more vaccines, we have learned.
Dr. Lurie, you said we have gathered data from around the
world and the H1N1 has not mutated significantly since the
spring and we are doing what other countries do. And Dr.
Goodman, you said the entire world is struggling with the
biology of this virus and that you worked with foreign
governments and the World Health Organization.
Can you show Exhibit 4 for me.
When I was looking at this, HHS has put out a timeline, the
2009 H1N1 activity timeline, and I noticed the antivirals was
very important, the page I looked at. On the antivirals here, I
saw here on April 28th HHS released its 11 million treatment
courses, 25 percent of the Federal antiviral stockpile held in
the Strategic National Stockpile to States in anticipation of
State influenza efforts. The Secretary approves a procurement
of 13 million treatment courses to replenish those to the
States and Mexico.
We know it heart started in Mexico, at least on this side
of North America, and this was in the spring. Mexico was having
trouble. We sent them 13 million treatments. April 30th, HHS
provides 400 treatment courses, one percent of the Nation's
stockpile to Mexico to help spread the virus. And I have no
problem with doing that.
But what did we learn from all these countries? Because it
seems like the problems, and we had supply to help out Mexico,
that, number one, there was a shortfall. Number two, we are
trying to come up with vaccine formulary. Number three, does
only one dose work or do we need two doses? And four, what
about the young people, especially the pediatric deaths seen in
this county? Didn't we see that, all the same things in Mexico?
Go ahead.
Dr. Schuchat. I can probably begin and let others finish.
We have worked very closely with the global community to learn
as much as possible about the behavior of the virus in people
everywhere, particularly with----
Mr. Stupak. How about these questions? Did we realize there
would be a shortfall from at looking at Mexico, did we find a
vaccine formulary, did we realize only one dose would work, and
the young people being injured. Didn't we learn that from
Mexico and working with the other countries?
Dr. Schuchat. One dose seems to work in children 10 and
adults.
Mr. Stupak. My question is, did we learn this in April from
working with other countries?
Dr. Schuchat. No, there was no vaccine in April.
Mr. Stupak. Why did you ship it to Mexico then if there is
no vaccine?
Dr. Schuchat. No, we shipped antivirals to help them,
because they had people dying in hospitals.
Mr. Stupak. Yes, they had people dying in Mexico. So what
did we learn from that?
Dr. Schuchat. We learned that the clinical severity in
Mexico is very similar to here. Their initial reports of very
severe disease were because they hadn't actual looked broader
in the community. They found a lot more mild disease once they
started looking. So we learned that the clinical picture in
Mexico turned out just the same as what we have had, the same
in Australia, the same really around the world.
Mr. Stupak. So then it still took us 6 months after
shipping to Mexico and everything else to learn, number one, we
are going to have a shortfall; number two, that we didn't
release the license to these manufacturers until September
15th; we didn't realize we needed only one dose, according to
your timeline until September 11th; and that young people were
going to die.
Dr. Schuchat. Right. The vaccine clinical trials were
carried out during the summer, and so decisions on licensure
were based on product submissions to the FDA.
Mr. Stupak. Let me go to this question then. If we are
having all these problems, we know there is these shortfalls,
all this is going on, and you have your emergency use
authorization, then this adjuvant, are we the only country that
doesn't require an adjuvant, that we said no adjuvant? If we
are learning from all the rest of the countries, other
countries aren't using adjuvant, why are we insisting--we are
non-use, right?
Dr. Schuchat. We are not using adjuvant.
Mr. Stupak. Other countries are using adjuvant, right?
Dr. Schuchat. Some are using adjuvant.
Mr. Stupak. Why aren't we? Especially when our suppliers
are telling us we can quadruple the amount of vaccines
available if we would have used it when we realized we have all
these short supplies, and you have an emergency authorization,
emergency use authorization, and the President issued a
national disaster declaration on October 24th. So you are
looking at the rest of the world, Novartis and some of the
other manufacturers tell us, look, we can quadruple your supply
just by using the adjuvant, and we say no, we are not going to
do it.
Dr. Lurie. Let me see if I can sneak in, and maybe Dr.
Goodman would also like to comment. Adjuvants haven't been
licensed in the United States. We haven't had a lot of
experience with them.
Mr. Stupak. Correct, but the rest of the world has.
Dr. Lurie. Their safety profile was not known, and so we
got all of our top scientists together and we made a decision
that if the situation got a lot worse, then we would use
adjuvants.
Mr. Stupak. How much worse does it have to be before we use
adjuvants?
Dr. Lurie. We also thought since the unadjuvanted vaccine
also worked quite well, that that was a better alternative.
Mr. Stupak. But we receive 25 percent less than what we
could have if we used the adjuvant. What is the problem with
the adjuvant, other than we haven't done the tests here in this
country?
Dr. Lurie. Well, as you know, the public's confidence in
our vaccine system and in vaccines in this country is very,
very fragile. We made a commitment not to cut corners and to
use vaccine that had been demonstrated to be safe and
effective.
Mr. Stupak. But it seems like we rely upon data from the
rest of the world when it is our convenience, but then yet when
we look at the track record of the rest of the world and this
adjuvant, whether or not we add or not, suddenly we decide to
go different. The M-59 adjuvant that Novartis talks about says
look. The rest of the world, they had to change because the
United States told them to change the formulary. So were we
taking into concerns the needs of other people, or just our own
people based upon our own interests? Then we could have had
more supply out there if we would have looked at what Novartis
and others say works.
Dr. Schuchat. You know, one thing you may not be aware of
is that the demand for the vaccine is actually much higher here
than it is in Europe, and there is quite a bit of skepticism in
Europe. So I think we have a very complex environment.
Mr. Stupak. I agree. We hit it a little quicker than
Europe. Europe may hit it here pretty quick, right?
Dr. Schuchat. Absolutely. But I think the other point is,
as Dr. Lurie says, at several steps since last spring, the
government has reevaluated the adjuvant decision. We have
looked to our external advisory groups. We have considered is
this a scenario where it makes sense? And we don't feel that we
have reached that point, given where we are with production.
Mr. Stupak. OK.
Dr. Goodman. Chairman Stupak, maybe I can add one thing
that may be helpful to you. One is that we are working very
hard with the manufacturers. In fact, we have asked NIH and the
manufacturers to study these adjuvants, including with H1N1, to
give us more data.
The other point I wanted to make is that the vaccine you
mentioned, that is marketed in Europe, so there is one
previously approved adjuvanted flu vaccine in Europe. However,
that was only previously approved for the elderly. So in terms
of the kind of broad experience with millions of people, that
is only in the elderly, who were not a focus population for
this vaccine.
Finally, I do want to point out that it is not those
identical vaccines that would be available here for our
citizens, but vaccines where the vaccine material itself is
manufactured in other facilities and then combined with those
adjuvants, and there is much less information about that
combination. And, again, that is why it is important for NIH
and the manufacturers who have been very cooperative to provide
this information.
So we don't have enough data about those at this point or
at the beginning of the pandemic for them to meet the standard
of FDA licensure. However, we have said all along, and the
senior scientists at every agency at a scientific level are
meeting periodically and reassessing this decision. In fact, a
decision was made to go ahead and stockpile adjuvants and have
them ready if they are needed. The good news has been that the
normal doses of non-adjuvanted vaccine have induced an
excellent response, just like every year.
Mr. Stupak. But if you are stockpiling to determine if they
are going to be needed what is the breaking point when you
determine they are needed, if you already stockpiled it and it
can give you four times more vaccine?
Dr. Goodman. Yes. I think that initially, for example,
exactly what you are asking, a break, a breaking point would
have been if a normal does didn't give a good response. Another
breaking point would be if the virus changed dramatically and
it looked like an adjuvanted vaccine could provide better
protection.
But I think we are very open to this, and we have really
tried to walk a line based on the science. It is very complex
science, and we look forward to getting more information, and
we are committed to continuing to assess it going forward.
Dr. Lurie. Let me just add that----
Mr. Stupak. One minute. He has been generous with the time.
I am way over. And the next panel is coming up I am going to
ask them the same questions.
I still think we could have quadrupled our supply and taken
care of our supply if we weren't so shortsighted in this.
Mr. Pallone. Thank you.
We have 8 minutes left. We have three votes. Mr. Shimkus
says he would like to go next before we break and then after
him, we will break and come back.
Mr. Shimkus. Thank you, Mr. Chairman. I am just going to be
pretty short. But I appreciate Bart's focus, because in my
opening statement, I hope that we do an after-action review on
this process to help us be prepared, because the questions that
he is raising are really the questions that I would have under
a terrorist attack, biological or weapons of mass destruction.
And it really keys in to what Bart has said.
We have to have a way to streamline the process and get
approvals quickly, and that would be the debate on egg versus
cell and how quickly--I understand the FDA's responsibility.
But if you have a massive possible pandemic, we better have a
way to subvert the regular order for the needs of the whole and
move rapidly.
Just like Bart's comments on the adjuvant. I hope there is
a process in place, and if there is not one, I am former
military and after every training exercise you do an after-
action review. Will that be done, Dr. Schuchat?
Dr. Schuchat. What I can say is we have actually had
several in-process reviews already, and we are committed to
after-action reviews as part of our routine procedures.
Mr. Shimkus. Dr. Lurie?
Dr. Lurie. I would add to that, and I would also add that
there are processes in place now through emergency use
authorizations so that if this pandemic were to become much
more severe, et cetera, we would be able to shift to other
products under an emergency use authorization, and that has
been part of our pandemic planning since 2005.
Mr. Shimkus. Because if something hits that we don't even
know about and we are looking at this timeline, then I guess we
just identify it and then isolate people until we can roll out,
you know, some----
Dr. Schuchat. There are several mitigation steps, and one
of the things we did this summer was update guidance for
mitigation, what to do with the current level of severity and
what we might do if the virus mutated and was much more severe.
So no automatic school closures in this setting, but if things
changed substantially, we would go to much more disruptive
interventions. So we do have things that were available to us,
knowing that vaccine supply might not come soon enough.
Dr. Goodman. I really appreciate your comments, and we want
to have a very agile public health response, especially in an
emergency. I do want to mention that in that respect, it took
us about a day or two when there was a need for antiviral, not
approved for children under 1-year old, but to treat children
under 1-year old, to work with our colleagues at NIH and CDC
and issue an emergency use authorization. Full transparency to
the public. Not the kind of data required for approval, but
appropriate risk-benefit weighing and a public health response.
This is a tool you in Congress have given us, and we are
ready to use it when there is the right emergency. And as
recently as the last couple of weeks with respect to the
adjuvant question, the senior scientists of every agency have
sat together and revisited that decision and decided, do we
want at this point to switch to adjuvants? It is a very complex
discussion. But that is being revisited in action and we are
committed to continuing to revisit it after action.
The biggest improvements we can make are strengthening this
infrastructure and getting new technologies ready ahead of
time. We are better prepared than we were a few years ago,
thanks to your investment, but we have a long way to go.
Mr. Shimkus. And I will just end by saying I think
education is a key. The positive aspect is the public is really
better stewards of everybody else's public health by better
health practices, and that will be the key thing before we can
roll into this.
Thank you, Mr. Chairman, for letting me get this in.
Mr. Pallone. Thank you, sir. We have three votes and we
will come right back after that. The subcommittee is in recess.
[Recess.]
Mr. Pallone. The subcommittee will reconvene.
Our next member is the gentlewoman from Wisconsin, Ms.
Baldwin.
Ms. Baldwin. Thank you, Mr. Chairman.
I mentioned in my opening statement three topics that I
hoped to hear more on. I know that I won't get a chance to
exhaust those three topics in Q and A, but let me start with
Dr. Lurie on the issue generally of domestic production of
vaccine.
You had been asked a question by Mr. Walden that I think
time didn't permit you to finish answering regarding the
policies in other countries where vaccine is manufactured, and
I wondered if you could basically generalize those policies,
but also tell us specifically what happened in the case in
Australia?
Dr. Lurie. Sure. I think many countries, including the
United States, in the United States we have the Defense
Production Act, and basically what that tells us is that if we
need material for the safety and security of this country, that
we can prioritize that. And I think many countries have that
kind of situation that they need to prioritize for their home
country.
That is why it is so important for us to get to domestic
manufacturing capacity in the United States. It is actually
something that we learned and realized during our pandemic
planning early on, and in fact, even earlier than that when we
realized several years ago that we were down to just one
licensed flu manufacturer in the United States. And I think
people have worked very hard to get to the point that we are
today, and now we need to the get to the point where we have
much more domestic manufacturing capacity.
I think in the case of CSL, they are based in Australia and
they have a similar kind of arrangement and requirement with
the Australian government. You remember that the southern
hemisphere has its outbreak at a different time, so Australia
was experiencing a pretty severe outbreak and decided that it
needed vaccine first for its home country.
Now, when that happened, CSL let us know that right away.
We immediately were able to downgrade our projected numbers of
doses of vaccines and at the same time we worked very closely
with the manufacturer so that as soon as they met their
requirement for their home country, they were able to start
making and shipping doses to us.
In addition, I think as you heard, they have also submitted
additional data recently so that their vaccine can be used down
to a lower age in children. That was really recently licensed.
Ms. Baldwin. I, also in my opening statement, talked a
little bit about using this pandemic, this seasonal flu as well
as the H1N1, to learn and to innovate, and I am wondering what
your thoughts are in three particular areas. One is faster
manufacturing processes, whether it is cell-based or other
opportunities there; use of adjuvants; and alternative methods
of vaccine delivery, something other than injection and nasal
spray.
If we were to have a very virulent influenza next year,
where would be in a year that we aren't today? What is your
sort of time horizon for when these innovations are going to be
generally more available?
Dr. Lurie. I think that is really a great question. I
think, again, BRTA is in, right now, year three of a five-year
strategic plan to really try to move us toward more modern
manufacturing technologies and manufacturing capacity in the
United States.
As I said, the first cell-based facility has its ribbon
cutting next week in North Carolina, but it actually I don't
think it is going to be able to make flu vaccine for another
year. But when all is said and done, that ought to get us to
the point where they will be able to make I think 150 million
doses. So that is still far short of the capacity, the surge
capacity, we would need in a public health emergency.
In addition, cell-based vaccines still require the virus to
grow in cells, so we need to move toward recombinant
technologies and other kinds of technologies. We have invested
in some of those. I think there is a lot of promise in a number
of the new methodologies. I can't yet predict when they are
going to come on line.
But I also want to say that it is great to be able to do
those things, but once you do them, we can't forget that we
have to manufacture to scale with whatever those are. So we
have to be thinking now about, you know, how those new
technologies and manufacturing capacity meet one another, so
not everything is done one after another. So that is I think
another real challenge that we have.
With regard to adjuvants, I think we all know and believe
that adjuvants have a lot of promise. And just to reiterate,
adjuvants really are used for two reasons. One is so you need
less vaccine. The other is if you don't get a good immune
response to that vaccine, they help you get a better immune
response. It is a substance that you mix with the vaccine.
There is a lot of work going on right as we speak to
understand the experience with adjuvants, trials being done by
the manufacturers, as well as by NIH mixing one company's
adjuvant with another company's vaccine to make sure those
things are safe and effective. Depending on the outcome of
those trials, I would expect that if they are promising, that
the manufacturers will submit applications to the FDA. But we
are not there yet.
Then in terms of the alternative methods, people are
working on things like patches, a transdermal method. Some
people are work on vaccines that you can eat. There is a lot of
very exciting breakthroughs in the science that I think are
going to move us far forward. Some are more ready than others.
But it would be great if you could use a patch instead of a
shot, for example.
Mr. Baldwin. It is my understanding some of that technology
also may have an impact on increasing the effectiveness of the
vaccine. For example, skin micro-needle application versus
injection.
Dr. Lurie. Right. And I think we are continuing to learn
more about those. But I think a lot of these new technologies
are very promising in terms of also being able to get a better
immune response. It is really the immune response and it is
sort of how it gets into the body to make that immune response
that is the difference in some of these technologies.
I don't know, Dr. Goodman might want to amplify on that.
Dr. Goodman. I would want to add one thing, which is there
is a lot of amazing innovation incredibly promising
technologies.
We have licensed cell-based vaccines in this country, just
not for influenza. That has been a real challenge. We have
licensed recombinant vaccines in this country, just not yet for
influenza. And I think those things are making some real
technological progress, and those are things we are going to
see progress in very soon.
But one thing I wanted to say is we see, even in the most
sophisticated manufacturing technologies, there are still
challenges producing large amounts of things consistently and
of high quality. So even with some of the most advanced
biotechnology products out there today, this is complex,
challenging manufacturing, and it is not like just--I mean, the
egg has been amazingly efficient and for some of the problems
relatively reliable. Clearly it is an old technology. It has
many disadvantages.
But I am just pointing out that some of the newer
technologies are going to need the same kind of care, and that
what works in a mouse or works in a very small production is
not always the same and sometimes takes some time to get it to
industrial scale and be sure it is going to be safe and high
quality for people.
But we are all working together to accelerate that, because
our goal should be for an emerging infectious disease threat,
to have vaccines much, much faster, much, much faster, and
there is promising technology that can help us do that.
Mr. Pallone. Thank you.
I want to thank all of you for your comments today. I know
that we did have some questions that I and others asked if you
could get back to us in writing. The process is that members
can submit additional questions in writing to you and usually
they are supposed to be submitted within the next 10 days. So
you may get some additional written questions to respond to as
well.
But thank you very much really for such an important issue
and that you are so involved in.
You had some comment?
Dr. Lurie. I wonder if it might be oK if I responded to
something I heard in a couple of comments earlier.
Mr. Pallone. Of course.
Dr. Lurie. I was very concerned and we haven't really had a
chance to I think correct some misunderstandings here, and that
has to do with vaccines going to Guantanamo or vaccines going
to terrorists.
There is no vaccine on its way to Guantanamo. There is no
plan to vaccinate terrorists or Khalid Sheikh Mohammed ahead of
anybody else right now. That is a program that is handled by
DOD. But I think it is one of those things that gets out there
in a sound bite and it sort of travels virally and there is a
lot of misinformation out there. There is no vaccine on its way
there.
Mr. Pallone. All right. Thank you very much.
Did you not--I am sorry, Mr. Gingrey is here. He hasn't had
a chance to ask questions. So, go ahead. The gentleman from
Georgia is recognized.
Dr. Gingrey. Mr. Chairman, thank you. I am pleased that the
first panel is still here.
You know, I have some concerns. In the interest of full
disclosure, I have been a bit of a doubting Thomas as a
physician-member about our response to this crisis, this
pandemic as it is now, and, of course, my great concern was us
creating a pandemic of fear. I think we have certainly done
that, and we also have since 2006 when we were dealing with
avian flu probably in the aggregate have appropriated something
like $12 billion or $13 billion. Feel free to correct me if I
am wrong on my numbers, but a lot of money.
And, of course, as we track this and the concern was
whether or not to develop and spend billions of dollars in the
process and develop a vaccine specific to H1N1, different, of
course, from the regular vaccine that we will be producing for
seasonal flu. I think the decision was going to be made, I
guess was made, on the basis of how virulent this strain became
and what kind of changes might occur, was it getting worse. And
I think you have said in your testimony, maybe all three of
you, that the strain really hasn't gotten worse and the
virulence has not increased.
But one thing that I did notice here lately was that all of
a sudden we went from 1,000 deaths in the United States
literally overnight to 4,000, and that is, I find, a little
disingenuous. But there has been this explanation that, oh,
well, we originally were basing cases of H1N1 on laboratory
evidence, but now we are using a mathematical formula that we
kind of extrapolate or estimate. Some people maybe in the CDC
ought to go to work for the Census Bureau with those kind of
calculations.
I have real concerns about that. In fact, I brought along
with me a blank death certificate where it says ``cause of
death'' and ``contributing factors'' and that sort of thing. I
would be really curious to know how many of those 4,000 cases
does the death certificate say the cause of death is H1N1 viral
influenza.
Dr. Schuchat. Thanks for those comments. Communication is
really important to all of us and being clear and not
confusing. We did not overnight go from 1,000 deaths to 4,000
deaths. All along we have been talking about using a variety of
surveillance systems appropriate to the period of the pandemic
and the efficiency of data collection, and we have said that
reported cases underestimate the true burden of disease.
With seasonal influenza, when we talk about how many deaths
or how many hospitalizations there are, that is not based on
individual reporting by doctors and health departments and so
forth. It is based on looking at a lot of different data
sources and modeling those data.
What we did last week was release estimates that took
information from a couple very good surveillance systems:
Hospitalization data from our emerging infections program
network in 10 different States; information from 30 or 35
States, depending on the week, about laboratory confirmed
hospitalizations and laboratory confirmed deaths. We use those
two as a ratio to understand from hospitalizations how many
deaths might there be.
We looked at the influenza-like illness surveillance
system, our sentinel providers, to divide up States into high,
medium and low at any one time in terms of how common the
transmission was. And then we used correction factors based on
community surveys done to really understand how many illnesses
are in the community, based on household telephone surveys, for
everyone who actually goes and sees a doctor, how many people
that see a doctor get a lab test.
Dr. Gingrey. Dr. Schuchat, with all due respect, because my
time is limited, I want to make one other point. I appreciate
your explanation. I hope all of the panelists, all three
doctors understand my concern.
The State University of West Georgia is in my district in
Carrollton, Georgia, and they weren't having a problem getting
access to the vaccine. I know that has been the main theme of
this hearing, why we didn't develop, I don't know, millions,
literally 50 million vaccines by a date certain in October, and
it was only 15 million or whatever.
But the State University of West Georgia had no problem.
They had plenty of vaccines. They have 11,500 students, and
only 141 were willing to be vaccinated. A lot of them are very
concerned. Let me give you a quick quote.
``Most students are saying that they haven't gotten the
swine flu yet, so they believe that they are not going to get
it at all,'' said Shandra Jones, a student, who is from
Franklin, Georgia. There are also people telling students not
to get the shot. There are some who are afraid of the side
effects of the shot, and they've read about 1976 and Guillain-
Barr Syndrome. They believe that the government did not test
the shot enough.''
Mr. Chairman, I know I have extended beyond my time. If the
panel, if you would allow them as a courtesy to respond to
this, because I think this is a huge issue. I don't care, if we
have got 100 million vaccines and 10 percent of the population
is willing to take the vaccine, even those that are high risk,
what have we really accomplished here?
Mr. Pallone. I am going to let you answer Mr. Gingrey's
question, but also I have to be careful here, Dr. Lurie,
because you opened it up to the Guantanamo thing. Chairman
Stupak wants to say something too. So we will do those two and
then be done--no, we are not done. Mr. Green is here. I give
up.
All right, Mr. Gingrey. Respond to Mr. Gingrey.
Dr. Schuchat. Sure. You raised one of the most challenging
aspects of this pandemic. At the very same time people are
waiting in line, driving hours to find vaccine, we have supply
way in excess of demand in some communities. We have huge
information needs to fill, and I think we are really committed
to break the myths about the safety of this vaccine, what we do
know and what we don't know.
There is a Web site, flu.gov, that has a lot of information
about myths and facts that might help some of the college
students understand what is the case. We have actually planned
for some more outreach for youth, such as college students, to
try to reach them and have them understand what is the threat
to them, what are the risks or not about the vaccine.
But we have this very exquisitely challenging time where do
we risk raising demand in some communities like that, at the
same time we have so much extra demand versus our supply
elsewhere. And that is one the reasons why we have really
focused on State and local support, because in your community,
your public health experts understand on the ground, you know,
we got a supply-demand mismatch the other way at West Georgia
College, whereas in the national level, we may not really
understand the community supply and demand.
So really one of our reasons to focus on State and local
distribution or direction of where the vaccine goes is because
of that trust of the community and that awareness of what is
going on with your local community. So I think, if you want to
get back to Gitmo--OK.
Mr. Pallone. Are you done with Mr. Gingrey's response?
Mr. Green, let me just explain what happened is it looked
like we were done and there was nobody here, so Dr. Lurie asked
to take some time to talk about terrorists in Guantanamo, and
Mr. Stupak just wanted to clarify and ask a question about
that. Then we will go to you.
Mr. Stupak. Dr. Lurie, you don't have anything to do with
the military and getting the control of the drug to the
military, do you?
Dr. Lurie. No, this whole program is run by the Department
of Defense.
Mr. Stupak. Right. Some you don't know if people at
Guantanamo have received it. If anyone at Guantanamo has got
it. You don't know if the 218 international terrorists we hold
in U.S. jails has received it. You don't know that, because
that is handled by a different party?
Dr. Lurie. Well, what I can tell you is like all militarily
installations run by the Department of Defense, and they have
pretty strict criteria, just like we prioritize vaccine going
to U.S. Forces, deployed health care workers, civilians and
contractors, civilians, et cetera.
Mr. Stupak. The point is under oath you said they did not
receive it. You don't know that. When Major Diana R. Haynie
says they will be receiving it on November 2nd, they could
already have the vaccines down in Guantanamo. This was November
2nd and it is now, what, the 18th. Sixteen days ago. They could
have it there. You don't really have any personal knowledge of
it?
Dr. Lurie. No, I am sorry. What I was trying to do was
correct a misconception about how the vaccine was distributed.
I do not have personal knowledge of that.
Mr. Stupak. Correct. I realize uniformed personal first are
required to do it, and even these detainees will have a right
to accept it or refuse it. But the point being, this was
released at November 2nd at the time of the height of the
shortages, and the American people are upset about it.
I have no problem. I just say you are under oath. Don't be
testifying to things you don't have any personal knowledge of.
Dr. Lurie. Fair enough.
Mr. Pallone. All right. Mr. Green.
Mr. Green. Thank you, Mr. Chairman. I appreciate the
patience of our witnesses. You have been here a long time, plus
you had to listen to our opening statement. But that is just
the way it works here some times.
I appreciate your being here. I guess the frustration is
because we have had, both the Health Subcommittee and I
benefit, I am on both the Health Subcommittee and the
Oversight, and we have had a number of hearings since the
spring, and the most recent one in September, and it seems like
the best plans that we had just didn't pan out. And it is not
necessarily with the delivery system. We will hear from that at
the next panel. We have the Commissioner, but we will also have
on the manufacturing side the next panel.
But there has been talk for many years about what we need
to do for pandemics, and yet here we have what relatively can
be major. A month ago we had a Homeland Security hearing in
Houston, Texas, and we had 1,000 people died. Now it is up to
4,000. If it had been something much worse than H1N1, we would
be sitting here and saying why are we having tens of thousands
of people dying from avian flu?
What do we need to do, or the agencies, all your agencies
and even Congress, need to do to live up to the plans and
expectations that we had from the earlier hearings where we
were going to have enough vaccine, the distribution system was
there. Right now we don't know if the distribution system is
there simply because we don't have enough vaccines, all we know
something is working because people are lining up all over the
country to receive it.
The other question I have is my concern that the lack of
regular flu vaccine, or at least the participation, and the one
thing we know now is hopefully next year or the next flu season
we will have H1N1 in with the seasonal flu, but that we need to
make a national effort to increase the seasonal flu
vaccinations. That comes from all of us. We have seen a little
up-tick because of the fear of H1N1, but I want to see what we
can do to--the cheapest thing we can do for the business
community is a flu shot for their employees.
So with that, and the time I have, 2\1/2\ minutes for all
three of you.
Dr. Schuchat. I think there are several things we could do
to strengthen our response for seasonal flu as well as for a
future pandemic, which I do believe we will have. We have a
public health infrastructure that is weak right now. It has
suffered many job losses, many furloughs, and it leaves us a
little bit of a weakened core to respond to this kind of thing.
We do not sufficiently use information technology that
could help connect the electronic health records in the private
health care system with public health needs. We could do much
better targeting of priority groups if we had better
information systems. Some States have immunization registries
that work pretty well, but they don't often reach to adults. We
don't have a strong adult immunization program in the U.S.
Adult providers haven't yet really stepped up the way
pediatricians have to use prevention at the forefront.
Mr. Green. I appreciate that, and we are going to run out
of time, but we are talking about pediatricians, and we have a
really robust vaccination system for children. We know H1N1
targets children and young adults. I had my 62nd birthday three
weeks ago, and for the first time I said I am glad I am 62,
because H1N1 doesn't hit us that much. But we have that system
now. The problem is we don't have the vaccinations.
Dr. Schuchat. Right. I think there is two things though. We
certainly need a more robust vaccine production with the new
technology, broader manufacturing capacity. But with children,
if you look at this pandemic, it is really disproportionately
affecting school age children, and they don't go to the
pediatricians very often and they don't get vaccinated very
often compared to younger children, 1-year-olds and 2-year-
olds. So there is a tremendous opportunity to strengthen
immunization for school age children.
Many States are having great experiences with school-
located vaccinations for H1N1. Those could be models for
seasonal flu, for instance, in the future. But there is a lot
of work to do before we would realize the very efficient
delivery system that we would like to have.
Dr. Lurie. Certainly. And I would really second Dr.
Schuchat's comments about really strengthening the public
health infrastructure at all levels. In addition, as we have
talked about some already this morning, we do need to get to
much more robust manufacturing technologies.
We talked about the fact that there are some promising new
developments, and we need to continue to invest in pulling
those kinds of technologies along so that they can make
vaccines faster and more reliably. And then those new
developments have to somehow meet the large scale safe
manufacturing capacity so that were we to have another emerging
infectious disease, another kind of pandemic, that would be
able to get vaccine out in very large quantities much faster
and not be reliant on the vagaries that we have now.
Mr. Green. Mr. Chairman, I know I have run out of time, but
those of us who are from the sugar cube generation that dealt
with polio, I know we use that example many times in our
hearings, I think our agencies need to look at that and say how
do we deal with this. Because next time it won't just make us
sick for a few days, it may be killing a lot more people than
just 4,000, because we lose 36,000 people every year from
regular seasonal flu. But I am worried about the pandemic on
something much more serious.
Thank you, Mr. Chairman.
Mr. Pallone. Thank you.
I guess I am going to say thank you again. I won't repeat
what I said again though. Thank you so much, and again get back
to us with any written comments. We would appreciate it.
Now we will call the second panel.
Mr. Stupak. [presiding.] We will call our second panel up.
This panel includes Mr. Paul Perreault, the President of CSL
Biotherapies, Incorporated; Dr. Vas Narasimham, President of
Novartis Vaccines USA; Dr. Ben Machielse is Executive Vice
President of operations for MedImmune; Dr. Phillip Hosbach is
Vice President of Immunization Policy and Government Relations
for Sanofi Pasteur; Dr. Lakey is Commissioner of the Texas
Department of State Health Services; and Dr. Jeffrey Levi is
Executive Director of Trust For America's Health.
TESTIMONIES OF PAUL PERREAULT, PRESIDENT, CSL BIOTHERAPIES,
INCORPORATED; DR. VAS NARASIMHAM, PRESIDENT, NOVARTIS VACCINES
USA; BEN MACHIELSE, EXECUTIVE VICE PRESIDENT OF OPERATIONS,
MEDIMMUNE; PHILLIP HOSBACH, VICE PRESIDENT, IMMUNIZATION POLICY
AND GOVERNMENT RELATIONS, SANOFI PASTEUR; DR. DAVID LAKEY,
COMMISSIONER, TEXAS DEPARTMENT OF STATE HEALTH SERVICES; AND
DR. JEFFREY LEVI, EXECUTIVE DIRECTOR OF TRUST FOR AMERICA'S
HEALTH
Mr. Stupak. I welcome all of our witnesses to testify here
today. In accordance with the policy of the Oversight and
Investigations Subcommittee, witness testimony will be taken
under oath. Please be advised that under the rules of the
House, you have the right to be advised by counsel during your
testimony.
Do any of you wish to be represented by counsel?
Everyone is shaking their head no, so I will take that as a
no. Therefore I am going to ask you to please rise and raise
your right hand to take the oath.
[Witnesses sworn].
Mr. Stupak. Let the record reflect the witnesses have
replied in the affirmative. You are now under oath.
We will now hear a 5-minute opening statement from each of
our witnesses. You may submit a longer statement for inclusion
in the hearing record.
Mr. Perreault, we will start with you, for 5 minutes,
please, sir, your opening statement.
TESTIMONY OF PAUL PERREAULT
Mr. Perreault. Thank you, and good afternoon, Chairman
Stupak and Chairman Pallone and members of the committee. I am
Paul Perreault, President of CSL Biotherapies, Incorporated,
the U.S. distributor of influenza vaccines manufactured by our
parent company CSL Limited, located in Melbourne, Australia.
I am pleased to be here today to discuss our experience in
manufacturing the H1N1 vaccine specifically for the United
States. CSL Biotherapies believes that it is important to
understand how the government and industry can best work
together to help assure vaccine availability for influenza
pandemics.
I want to assure this committee that CSL Biotherapies is
committed to providing the entire amount of both the H1N1 bulk
antigen and the finished vaccine doses that we have agreed to
in our contract with the Department of Health and Human
Services. We take the H1N1 pandemic very seriously and have
been a leader in developing and delivering to combat this
virus.
CSL has manufactured vaccine since its founding in 1916.
Our world class influenza vaccine production facilities have
the capacity to produce up to 80 million doses of trivalent
seasonal influenza vaccine annually. Our seasonal flu vaccine
Afluria was launched in the United States in October 2007 and
indicated for ages 18 and above. And as you heard Dr. Goodman
state, last week Afluria and our H1N1 vaccines received FDA
approval for administration to individuals 6 months through 17
years of age as well. Afluria and our H1N1 vaccine come in
multi-dose vials and thimerosal-free pre-filled syringes.
CSL initiated the western world's first human trials with
the 2009 H1N1 vaccine and published our research findings in
the New England Journal of Medicine demonstrating the efficacy
of a single 15 microgram dose. These data, along with the rules
of clinical trials in infants and children, were communicated
rapidly to regulatory and public health authorities in the
United States and globally, recognizing their value to public
health decisionmaking.
In May 2009, HHS and BARDA approached CSL Biotherapies to
inquire whether we might be able to provide an H1N1 vaccine for
the United States. CSL Biotherapies entered into a one-year
special contract initiated on May 28th, 2009, to provide 36
million dose equivalents of H1N1 bulk antigen to the United
States Government. CSL Biotherapies did not have a previous
pandemic contract with the United States Government.
As part of the agreement signed in May, CSL Biotherapies
made it clear that the company had a preexisting contractual
obligation with the Australian government to provide vaccine to
that nation first, should WHO declare a pandemic. I want to
stress this had no impact on fulfilling our schedule submitted
to BARDA.
On June 1, 2009, CSL received the first H1N1 virus vaccine
seed from the New York Medical College. The yields from this
lot were approximately one-third to one-half of the average
H1N1 seasonal influenza yield. As a result of these low yields,
CSL formally communicated to BARDA a delay to the overall
timing of the H1N1 bulk antigen delivery.
On the 18th of August, CSL received a new vaccine virus
seed that was introduced into the manufacturing process. Yield
improvements in excess of 80 percent compared to the previous
seed were observed. A revised supply schedule was sent to HHS
on September 14th incorporating production on this seed lot.
CSL remains committed to maximizing the yield and
availability of H1N1 vaccine. CSL has invested in fill-and-
finish capabilities in Europe and Kankakee, Illinois, to
improve the availability of influenza vaccine. The Kankakee
facility has achieved licensing of its new state-of-the-art
syringe fill-and-finish line this past September.
I would like to recommend measures to help assure
availability of pandemic vaccine. First I would recommend there
be a focus on producing a greater assortment of influenza seed
lots earlier that can be utilized in the creation of future
pandemic influenza vaccines. The poor yields resulting from the
first available seed lot had a significant effect on reducing
the amount of available H1N1 vaccine. If the 10-week gap in
identifying the second higher yielding seed lot could have been
avoided, higher output could have occurred sooner.
Second, new adjuvants can help to enhance the immune
response and reduce required dosing, which would make more
antigen available for additional vaccinations. Supportive
environment for development of new adjuvants with influenza
vaccine could facilitate in this advancement.
Finally, more education about the benefit of influenza
vaccination and the achievement of higher vaccination rates
closer to CDC recommendations would help to prevent influenza
and support readiness.
Our passion at CSL Biotherapies is to help save and improve
lives, and we wish to do our part in protecting the United
States population from H1N1 and seasonable influenza. We'll
continue to work with the government collaboratively.
Thank you for the opportunity to speak before the
committee, and I welcome the opportunity to answer any
questions.
[The prepared statement of Mr. Perreault follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you.
Doctor, would you like to testify? Pull that up and turn
that mic on please.
TESTIMONY OF VAS NARASIMHAM
Dr. Narasimham. Good afternoon.
I want to thank Chairman Stupak, Chairman Pallone, Ranking
Member Walden, and the distinguished members of the committee
for the opportunity to speak with you today.
Novartis Vaccines and Diagnostics is a leading global
vaccine manufacturer headquartered in Cambridge, Massachusetts.
Along with our predecessor companies, we have been a leader in
the development and supply of influenza vaccines to the United
States for over 25 years.
Today, I would like to highlight to the committee Novartis
Vaccines' commitment to U.S. influenza pandemic preparedness in
our dedication to prevent every possible illness and death from
influenza. We commend HHS for its global leadership in pandemic
preparedness over the last 5 years. We have had a broad and
successful partnership with HHS, including active
collaborations on cell culture vaccines, adjuvants, stockpiles
and new production facilities.
Novartis Vaccines has committed approximately $1 billion in
influenza vaccine development and production since 2006.
Importantly, with HHS support we are constructing the first flu
cell culture manufacturing facility in the United States
located in Holly Springs, North Carolina, with its ribbon
cutting later this month. This facility will help ensure the
rapid availability of pandemic vaccine for the American people
in the future.
For this pandemic, we have continued our commitment to U.S.
pandemic response and public health. First, in May, we
voluntarily dedicated the entire vaccine output from our
manufacturing facility in Liverpool, England, to the United
States. This facility represents over half of our global egg-
based manufacturing capacity. We did this because of our long
partnership with HHS, foregoing the potential opportunity to
quadruple the output of this facility using our MF59 adjuvant.
Second, our entire organization has worked around the clock
to support U.S. vaccine production. We've made large new
investments, added 300 additional staff, accelerated new
production lines, and have been operating our production
facility with a high level of quality and efficiency.
Third, we rapidly started and enrolled a broad range of
clinical trials in more than 9,000 children and adults in less
than 3 months. Our data showed in early September a single
dose, as opposed to two, is adequate for adolescents and
adults; and we recently showed that a half dose might be
sufficient.
Fourth, we have prepared for HHS to use our MF59 adjuvant
that is currently licensed and being used exclusively in our
products outside the U.S. for H1N1. We have demonstrated in
recent U.S. Pivotal clinical trials that our adjuvant could
significantly increase U.S. H1N1 vaccine supply.
Fifth, we successfully supplied 27 million doses of
seasonable flu vaccine to the U.S. by early October.
Now, most importantly, in partnership with the U.S.
Government, we have overcome tremendous challenges to produce a
safe and effective pandemic vaccine in less than 3 months.
These challenges have included low yields, multiple production
uncertainties and compressed timelines. Despite these
challenges, as of today, Novartis Vaccines has shipped over 18
million unadjuvanted doses to the U.S. Government; and we are
fully on track with our production, a tremendous joint
accomplishment.
We also believe, based on the experience this year, there
are important opportunities to improve pandemic preparedness in
the future. These opportunities include the need to move
manufacturing into the 21st century for influenza vaccines
using new technology such as our cell-culture-based technology
now being used--licensed for seasonable pandemic use in Europe.
There is a need to accelerate regulatory pathways for novel
influenza adjuvants and pandemic vaccines. We need to develop
new testing methodologies to speed up vaccine formulation and
quality release, which can often slow down vaccine
availability. We need to maintain the strategic national
stockpile for rapid deployment in the case of a severe
pandemic. And, finally, as noted by other members, we must
support seasonable influenza vaccination demand to ensure that
suppliers are not forced out of the market, as has happened in
the past.
Novartis Vaccines continues to do everything possible to
maximize the rapid supply of a safe and effective vaccine in
close collaboration with HHS. We believe that when taken into
full context the productive public-private partnership to
produce, test, and deliver a safe and effective H1N1 vaccine to
the U.S. has been a remarkable success. We are fully committed
together with HHS now and in the future to ensure we achieve
our shared goal of preventing every influenza case in the
United States.
Thank you. I welcome your questions.
[The prepared statement of Dr. Narasimham follows:]
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Mr. Stupak. Thank you Doctor.
Dr. Machielse, your testimony please. Turn that green light
on and pull it forward. Thank you.
TESTIMONY OF BEN MACHIELSE
Mr. Machielse. Chairmen Stupak and Pallone, Ranking Members
Walden and Deal, members of the committee, thank you for the
opportunity to address you today.
My name is Ben Machielse. I'm the Executive Vice President
of Operations for MedImmune, and I'm also chairing the
MedImmune's H1N1 preparedness committee.
MedImmune has changed the landscape of influenza
vaccination when we launched FluMist in 2003, representing the
first innovative development in flu vaccines in over 60 years.
This year, MedImmune has contracted with BARDA to deliver
nearly 42 million doses of intranasal vaccine based on our
FluMist technology. Between September, 2009, and February,
2010, we plan to deliver those doses.
The 42 million doses of H1N1 vaccine, along with fulfilling
our commitment of 10 million doses of seasonal vaccine,
represent an increase of 700 percent in MedImmune's vaccines
production compared to last season. Importantly, MedImmune's
manufacturing for H1N1 had no impact on our commitment to
deliver 10 million doses of seasonal vaccine. In fact, we were
able to accelerate seasonal delivery and we delivered the first
H1N1 vaccine this season to BARDA.
Due to manufacturing efficiencies and high vaccine yields
unique to our technology, the intranasal vaccine was the first
available and remains a significant proportion of the vaccine
available to date. We have finished the manufacturing of all 42
million bulk doses of vaccine, all of which is now on U.S.
soil. We are now in the process of filling the vaccine in the
specialized single-dose nasal sprayers. As of Friday, November
13th, we have shipped approximately 13.2 million doses and are
over 96 percent on track with delivering the orders BARDA has
placed.
MedImmune's unique technology provided the significant
search capacity for both vaccines. This success validates
MedImmune's technology as a strategic asset in pandemic
preparedness.
As a result of MedImmune's excess bulk vaccine we have
submitted a proposal to BARDA regarding an alternative delivery
device in order to further contribute to public health effort.
The development and manufacturing process for our
intranasal vaccine differs from that of the shot in several
important ways. We develop our own unique master virus seed to
grow the vaccine, while most of other manufacturers rely on CDC
or other reference labs to generate the master virus seed.
Critical to pandemic preparedness efforts is that we use a
patented technology known as reverse genetics to rapidly create
multiple strains and then we can select one that grows well in
eggs and has the other necessary properties, too. Like the
shot, our vaccine is also produced in eggs. However, unlike the
shot, we generate between 60 and 100 doses of vaccine per egg.
Longer term, replacing egg-based technology cell culture
manufacturing would be a key advancement for influenza
vaccines. In fact, we believe that cell culture technology used
to manufacture intranasal vaccine will have similar yield
advantages as to the one I mentioned in the egg-based
technology.
MedImmune has an R&D program focused on the development of
the cell-culture-based vaccine. However, FDA requirements have
increased the cost and duration of the development program by
several years, and this program is now on hold while MedImmune
and HHS evaluate the appropriate path forward.
Now is the time to collectively evaluate what we have
accomplished and what we can do better. It is critical that the
U.S. government continue to encourage a high level of
seasonable vaccination as well invest in public education
campaigns that increase awareness of the benefits and options
in influenza vaccination.
Additionally, it's key that government agencies and
industry jointly develop a blueprint for processes and
requirements across a number of key areas, including, for
example, clinical development, regulatory requirements, and
distribution, to avoid any roadblocks that could delay delivery
of vaccine in the future.
In the few years that BARDA has been in existence, we
believe they have done a remarkable job. MedImmune is pleased
to be delivering intranasal vaccine in line with BARDA's
expectations, and we look forward to building up our successful
relationship in collaboration with the U.S. Government.
I will be pleased to answer any questions.
[The prepared statement of Mr. Machielse follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, Doctor.
Mr. Hosbach, your testimony please.
TESTIMONY OF PHILLIP HOSBACH
Mr. Hosbach. Good afternoon, Mr. Chairman. Thank you for
the opportunity to testify before the subcommittees regarding
H1N1 influenza pandemic production development and delivery.
My name is Phil Hosbach. I am the Vice President of
Immunization Policy and Government Relations for Sanofi
Pasteur, and I am currently responsible for coordinating the
company's worldwide and U.S. Pandemic response teams.
Sanofi Pasteur is the largest manufacturer of influenza
vaccine globally and in the United States, producing about 45
percent of the U.S. annual influenza vaccine supply. We are the
only manufacturer of an activated flu vaccine on U.S. soil, and
all of our seasonable and H1N1 vaccines for the U.S. market are
produced in Swiftwater, Pennsylvania. This site, which includes
two state-of-the-art influenza vaccine manufacturing
facilities, and one of those was just licensed this year, as
you heard from Dr. Goodman, they are operating 24 hours a day,
7 days a week, with more than 2,000 dedicated people involved
in some way in getting the vaccine out the door. Many of these
people have made great personal sacrifices to ensure that we
produce the largest number of H1N1 vaccine doses in the
shortest amount of time while ensuring vaccine safety and
regulatory compliance.
I would like to start my remarks today by focusing on what
a remarkable achievement the U.S. response to this pandemic
really is. Thanks to the close collaboration of industry with
HHS, FDA, and CDC, we are better prepared for this pandemic
than we would have been at any other time in history.
The virus was identified in late April. Manufacturers
received the seed strains from CDC in late May. Less than 4
weeks later, large-scale manufacturing was initiated; and by
late October there was an FDA-approved vaccine being
administered.
It truly is a success story. Nevertheless, we certainly
understand the committee's interest in this process, as there
are always opportunities to improve.
Sanofi Pasteur began shipping H1N1 vaccine on September
29th, which was earlier than anticipated. We have received
orders from HHS for 75.3 million doses of bulk antigen to be
delivered by the end of the year. We will meet this commitment.
While Sanofi Pasteur represents only 75 million doses of
the 250 million doses purchased by HHS, I am proud to say we
represent almost 50 percent of what has been delivered to CDC
to date. Sanofi Pasteur has largely succeeded in producing the
H1N1 vaccine as initially projected. However, there were some
factors that impacted even our considerable abilities and
extensive preparation.
The most significant factor initially was the lower-than-
expected production yield for the seed strain. It is an
unfortunate fact of Mother Nature, but we sometimes see lower-
yielding strains even for seasonal flu. However, the initial
yields for H1N1 were exceptionally low. Utilizing our
expertise, we have been able to optimize the productivity of
the seed virus. Our current H1N1 yield should not be a
significant factor going forward.
Since April 30th, we have participated in weekly phone
calls with HHS agencies, including BARDA, CDC, FDA, and NIH,
during which we provided ongoing updates. We have always been
transparent about our progress. We now project that we'll not
only catch up completely but we may even be ahead of schedule
in the coming weeks.
The media coverage regarding H1N1 vaccine shortages have
spurred some to question whether the egg-based manufacturing
technology might be outdated. The egg-based vaccine production
method we currently used has seen many technological
advancements and is a very sophisticated process that has
proven adaptable to emergency situations like the current
pandemic. In fact, this year provides us with an opportunity to
directly prepare the availability of flue vaccines prepared
with egg-based technology and those produced in Europe using
cell culture. In the end, each of the methods used produce
clinical lots within similar time frames; and large-scale
production was initiated at nearly the same time.
Contrary to popular perception, cell culture is not a new
vaccine production process. It's been around about 25 years and
does not save substantial time when it comes to producing
influenza vaccine. It does not produce a safer or more
effective vaccine and does not necessarily increase yields,
which was a critical variable this year.
The production of an influenza vaccine involves many steps,
many of which are the same regardless of the technology or
medium used. For example, growing antigen or any medium can
only begin after the seed virus is isolated and is sent to
manufacturers by CDC. Following no matter which production
method is used, all vaccines must undergo rigorous quality
control and safety testing. This testing accounts for
approximately 85 percent--and I repeat--85 percent of the
production time.
This year, Sanofi Pasteur faced the unprecedented and
complex challenge of producing two influenza vaccines
simultaneously. I am proud of the work of our people, that our
people have done in ensuring that Sanofi Pasteur will not only
meet its commitment to deliver 75 million H1N1 doses to HHS but
also meet its promise to deliver all 50 million doses of
seasonal vaccine to its customers before the peak of the annual
flu season. It is important to note that we still have a very
long flu season ahead of us.
Again, it is a credit to all involved that we have been
able to respond as well as we have to this pandemic. While it
is important and appropriate to discuss where improvements can
be made, I believe it is equally important to recognize the
accomplishments.
Mr. Chairman, thank you again for allowing me the
opportunity to testify; and I look forward to any questions.
[The prepared statement of Mr. Hosbach follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you.
Dr. Lakey.
TESTIMONY OF DAVID L. LAKEY
Dr. Lakey. Chairman Stupak, Chairman Pallone, and Ranking
Member Walden, my name is David Lakey. I'm the Commissioner of
the Texas Department of Health Services, and it is an honor to
be here today.
I've been in this position for 3 years and had the
opportunity to serve in multiple public health events,
including Hurricanes Dolly, Ike, and Gustav. My background is
that I'm an infectious disease physician trained in both
pediatric and adult infectious disease; and, like members that
have testified earlier, I have been affected by this. I was the
first State health officer to be infected, and my family was
also infected.
History has taught us that pandemics occur. The challenges,
the timing, and severity of the next pandemic, with the last
one being 40 years ago, State and Federal governments have
planned and exercised their plans over many years.
The challenge in 2009 was that this pandemic was
significantly different than the high-severity pandemic that
many of us had planned for. And it also occurred in our
continent and, therefore, we were having to respond as we were
also figuring out this disease and defining the severity.
Because of these differences, our State and Nation as a
whole had to rapidly flex our plans to match this situation.
This ability to adjust your plans according to what you see is
a critical component to any successful response. This flexing
of our plans included modifying our plans related to the
distribution of the novel H1N1 vaccine.
Previous pandemic plans had anticipated a high-level, high-
severity pandemic; and many of those had focused on mass
vaccination clinics. However, mass vaccination clinics have
many challenges, as I have listed in the information that I
have given you.
We have also looked at school-based clinics; and they have
their own challenges, like I've listed in the information that
I have provided. And so both of those strategies have
significant challenges.
In light of our real-world experience, Texas and many other
States decided that we needed to adjust these plans related to
the severity of this pandemic. We decided to use the private
sector and the public health providers, the local health
departments, the SUHCs that are in our State as much as
possible to direct to provide the vaccine to the patients that
they usually care for. This method allows us to target the
vaccine to those priority populations. We've also worked with
pharmacies to figure out how we can provide vaccines to
pharmacies so they can provide it in that private sector.
Now, different States are using alternative strategies
based on their experience, their public health infrastructure.
Public health is structured in many different ways across the
United States in the resources and the capabilities that each
State had.
In order to facilitate this, Texas had to develop new
resources, new tools in order for us to register providers and
to pre-identify individuals within each priority population;
and we made that Web-based application and linked it to our
primary flu information source at www.TexasFlu.org.
Currently, we have 12,600 health care providers in Texas
that are part of this distribution system. They have registered
to receive vaccine. And, of those, we have been able to
apportion vaccine to 7,000 providers in our State. In order to
complement the system, we have worked with 211 in order to
address concerns from health care providers or from the general
public in order to steer them to where we can find vaccine.
Due to the limited supply that has been discussed today,
States have had to further adjust these plans to help ensure
the most vulnerable individuals are protected. For example,
Texas so far has been allocated 3.7 million doses. Of that,
we've been able to order 3.3 million doses. However, that's the
amount of vaccine that we were told that we would have
available back a month ago in mid-October. Because of the
limited supplies, we've had to target our populations based on
risk and the type of vaccine that was available and then
gradually expand those groups as additional vaccine became
available to us.
I've outlined the system for the distribution of vaccine to
providers in the State of Texas in the information that I've
provided you.
I note that once the FDA approves and releases a lot the
CDC informs the States about the amount and the type of vaccine
that is available and then a lot of additional work has to take
place. We have to match the providers that we know that want
vaccine with the vaccine that is available, ensure that they
still want that vaccine, and make sure that they're ready to
accept that vaccine. It is a challenge to match the current
priority groups and to the providers that these populations
serve, and we also have to ensure that we have good geographic
distribution across a large State like Texas. This can be a
complicated and a tedious process.
We have been adjusting our plans as we have gone through
this event and recently adjusted our plans to ensure that 20
percent of all the allocation that came to our State went to
the local health department so they could fill in the gaps that
that private provider base was not supplying.
I would like to finish my time by mentioning several of the
challenges that we in State public health have faced as part of
this pandemic.
Note this pandemic only occurred 7 months ago; and, as has
been noted here, a lot of work has taken place across the
United States in that relatively short amount of time.
Furthermore, all this work was accomplished in a background of
significant reductions in public health across the United
States. We estimate approximately 15,000 public health
positions have been eliminated over the last year across the
United States.
Now, despite the success, there is a national perception
that we are falling short, partly because I believe we set
expectations too high about the amount of vaccine that would be
available initially and the national supply hasn't been
adequate to meet the public demand that was created.
Additionally, we created the perception that vaccine would be
available to all priority groups immediately. These priority
groups account for almost half of the U.S. population, and
because of the supply limitations we as a State then had to
narrow down those priority groups in order to get the best use
of that limited resource.
There's also confusion about that process of how vaccines
are allocated, ordered, and shipped and the steps that go in to
ensuring it gets to the individuals that need it. And there's
differences between how the States manage that because of the
different structures within public health and their State.
These misperceptions have led to false impressions that States
are either not pulling down their full allotment or, second,
that they're not being allotted the amount that should be
according to their population. And both of those impressions
are false.
There is also a challenge in developing tools to link
individuals that are seeking vaccine with the providers that
have the vaccine. Various tools have been developed, including
Web-based tools, but there's challenges with those tools. That
the providers that we're shipping doses to may only receive a
small amount of vaccine. If we put their name on a Web page we
may steer a lot of individuals to those sites and give another
false impression that vaccine would be available, and I think
that would compound the current challenges that we are having.
Instead of doing that, we in the State of Texas have worked
with 211 and provided them a list of the providers and have
steered individuals to 211; and then we can give individual
guidance on where they can seek a vaccine in their community.
And we've also, as I noted earlier, sent additional vaccine to
the local health providers.
Mr. Stupak. Please summarize.
Dr. Lakey. OK. I think we also have a challenge related to
the public health that has been funded, and that's been alluded
to earlier today, the intermittent nature in which some of the
funds have come down, one-time funding, and that has been
difficult.
But I would like to say thank you for the funds that have
been made available to the public health emergency response
funds this last year. Those have been very important.
And, finally, I would like to say that we really appreciate
the commitment of the CDC and the Office of the Assistant
Secretary for Preparedness and Response for how they've engaged
local and State public health. We have continuous dialogue with
them in order to work out issues and figure out how we can best
serve the population of the United States.
Thank you.
[The prepared statement of Dr. Lakey follows:]
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Mr. Stupak. Thank you Doctor.
Dr. Levi, your testimony.
TESTIMONY OF JEFFREY LEVI
Dr. Levi. Thank you Chairman Stupak, Chairman Pallone, and
Ranking Members Walden and Mr. Green. Thank you for this
opportunity to speak to you today about our preparation and
response to the 2009 H1N1 pandemic. I'm here on behalf of Trust
for America's Health, a nonprofit, nonpartisan advocacy
organization dedicated to saving lives by making disease
prevention a national priority.
While I understand that today's hearing is a result of
considerable frustration with the current H1N1 vaccination
program, I wanted to emphasize four critical points:
First, the public health system at all levels of government
has moved with remarkable speed in approving an H1N1 vaccine
and getting vaccines to as many Americans as supply has
permitted. We've moved as fast as or faster than any other
country in the world.
Second, the vaccine is well matched to the circulating
virus. It has been proven to be safe and effective in clinical
trials and offers the best possible protection against the
disease.
Third, whatever our concerns with production capacity are
today, had the Federal Government not made the multi-billion
dollar investments in enhanced vaccine production capacity
since 2005 we would be in far worse shape. The limits on supply
we are experiencing are the limits imposed by the science and
technology. The decision to use a central purchasing and
distribution approach has assured that as supply has become
available it has been equitably distributed across the Nation.
And, finally, the Federal Government has been remarkably
transparent with the American people about this pandemic since
it began last spring. Public health officials have leveled with
the American people, making appropriate adjustments and
recommendations as our understanding of the nature of the
pandemic has evolved and as supply issues have arisen.
The response to this pandemic has mobilized all levels of
government. While the Federal Government has assumed
responsibility for distributing vaccines to State and local
health departments, each locality is then responsible for
developing its own policies and systems for administration of
the vaccine. This has posed a number of challenges,
particularly in a context of vaccine shortages.
First, local health officials received constantly shifting
information about how much vaccine would be available and when.
This is clearly an issue that has not only created confusion
among the American people, it has also made the job of local
health officials far more difficult.
Second, the largest mass vaccination campaign in U.S.
History is taking place when State and local health departments
are experiencing devastating losses because of the recession.
While the Federal Government has rapidly pumped almost $1.5
billion into State and local health departments for pandemic
response, this does not address the underlying decline in the
core capacity of health departments.
And, third, public confusion may well have been exacerbated
by the fact that each State and locality has determined how to
distribute its supply once received from the Federal
Government. Although each health department based their plans
on a larger supply of vaccine, HHS may want to revisit this
issue and consider some standardization in future emergencies.
It is our hope that this hearing will contribute to the
public's understanding of the complexities of the current
pandemic influenza vaccine campaign. Among the key initiatives
TFAH maintains are critical to the success of the response to
this and future epidemics are, first, an education campaign is
needed to assure the American people about the safety and
effectiveness of influenza vaccines and all vaccines in
general. It is important to remind Americans that even with the
delays in vaccine availability they should get vaccinated as
soon as they can. We have not seen the end of this pandemic.
FDA should move forward in assessing new technologies that
are already in use in other countries, including the use of
adjuvants and cell-based vaccines. However, to have moved
forward on an expedited basis without the standardized review
would probably have undermined an already fragile confidence in
the vaccine system.
Congress and the administration should also come to a
consensus on what is an appropriate level of investment in new
technologies. This pandemic has demonstrated the Nation still
has a long way to go, not just in vaccine technology but with
regard to diagnostics and antiviral treatments as well as
personal protection equipment. The Biological Advance Research
and Development Agency has been chronically underfunded since
its inception. Its support is critical to moving promising
developmental technologies into mass production. Professional
estimates suggest that BARDA needs an annual appropriation of
$1.7 billion, rather than the current $275 million to achieve
its mission.
We need to provide ongoing support to State and local
health departments in building capacity to respond to public
health emergencies. Just as we don't fund fire departments at
the moment the fire breaks out, we must move away from
emergency funding mechanisms to respond to public health
emergencies. This is one reason TFAH supports the mandatory
funding for core public health functions that is part of the
House health reform bill.
Finally, Congress and the administration should assure
replenishment of the Strategic National Stockpile for supplies
that have been distributed to States such as N95 respirators,
surgical masks, and antivirals. We do not know what demand the
future wave of this pandemic strain will require of the SNS,
nor can we forget the potential for other pandemic strains
emerging, such as the H5N1 bird flu that was a primary concern
until last spring.
This pandemic has shown our government at its best and
highlighted many of the ongoing weaknesses in our public health
system. As we continue to ramp up our response to this
pandemic, we must also take steps necessary to assure that when
the next public health crisis occurs a stronger system is in
place and capable of responding quickly, effectively, and
nimbly.
Thank you, and I look forward to your questions.
[The prepared statement of Mr. Levi follows:]
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Mr. Stupak. Thank you, and thank you all for your
testimony.
Dr. Narasimham, how do you say your last name?
Dr. Narasimham. Narasimham.
Mr. Stupak. Narasimham. Let me ask you about November 3rd.
You signed a letter back to us, to the committee. We asked a
number of questions of all the companies--the four or (c)
companies here, and one that had caught my eye was found on
page 3, point number 5.
You said, while the government ordered bulk doses of our
proprietary adjuvant MF59 which enhances the potency of the flu
vaccine, it, based on recently available data, could have
quadrupled the number of doses supplied. The government
ultimately determined that the use of adjuvant was not
warranted to combat the pandemic and elected not to license or
use the emergency use authorization.
These are a number of the questions I asked the previous
panel:
It's my understanding--and correct me if I'm wrong--do
other countries use your MF59 doses with the adjuvant in it?
Dr. Narasimham. That's correct. We have two H1N1 vaccines
licensed in Europe and in other parts of the world with MF59,
and we're exclusively providing adjuvanted vaccines outside the
United States.
Mr. Stupak. Is there a safety issue with that? I think the
FDA said they had not approved it. And if my memory serves me
correctly you've been trying to get this approved in the U.S.
since 2007.
Dr. Narasimham. The MF59 is not approved in the U.S., but
we have licensed it in Europe in 1997. We have a pretty broad
range of clinical studies now, up to 200,000 subjects in
noncontrolled trials and about 40,000 subjects in controlled
clinical studies. To date, we have not seen any significant
safety signal, so we've continued to provide that data to FDA
on an ongoing basis.
Mr. Stupak. In my 15 years here, I have always been on drug
companies to make sure these things are safe. You said it's
been licensed since 1997 in the rest of the world?
Dr. Narasimham. That's correct, in the elderly. And for the
H1N1 now we have it licensed down to 6 months of age. So for
the H1N1 the adjuvanted vaccines overseas are licensed from 6
months through the elderly.
Mr. Stupak. I thought I heard Dr. Goodman on the last panel
indicate that they've ordered a stockpile of this MF59 from
your company.
Dr. Narasimham. That is correct. We are maintaining a
stockpile in Louisville, Kentucky.
Mr. Stupak. And I asked him, then when were they going to
use it? When do we get to the point, whether it's adjuvanted or
not, we're going to use it? Because the pandemic is so great
here in the United States. Have they ever discussed that with
you?
Dr. Narasimham. We had a discussion with them in early May
as to how to proceed. And the decision at that point was to
only use licensed platforms, U.S.-licensed platforms moving
forward. Through the summer and into September, we've
maintained the capability to always use the adjuvant in case
the data suggested that was needed. We continue to stand ready
to do that, but to date--and we also have prepared the EUA
application in collaboration with HHS. We have not been asked
to date to move forward with that.
Mr. Stupak. I think in your testimony you said that you
started discussing this in 2007--whether you should use
adjuvant or not with the FDA in 2007. You applied for a license
in 2008, is that correct?
Dr. Narasimham. We applied for a new drug application, an
IND, an investigational new drug, in 2008; and we've been going
back and forth with the FDA since then.
Mr. Stupak. Do you see this--the adjuvant issue, that just
won't be with H1N1 but really any kind of a vaccine. Is that
because you can quadruple it, at least in this case at least
quadruple your doses?
Dr. Narasimham. That's correct. There are a number of
benefits from the adjuvant.
One is you improve the immunogenicity so that if you have
children or the elderly who do not respond you can actually
make them respond to the vaccine. You can increase the number
of doses.
Another valuable thing of the adjuvant, which was not as
relevant in this case, is if the virus changes--so in the
spring, if the virus changes, there might be the need to
revaccinate everyone in the U.S. Whereas with the adjuvant you
can cover a certain amount of variation in the virus we've seen
in our clinical studies. Now, we haven't looked at that yet in
this case, but it would at least provide you that flexibility.
Mr. Stupak. Dr. Levi, is it fair to ask you--is it fair to
say that this is something we ought to look at as a country? I
mean, the FDA hasn't licensed it. I know you mentioned in your
testimony about making sure drugs are safe and approved, and
that's my concern and I'm sure everyone's concern on this
panel. Are we missing something here? Is there something we
should look at closer?
Dr. Levi. It's definitely something we should look at
closely. I believe the FDA is doing this in a good-faith
manner. I think when you think about who we are targeting for
this vaccine, the bulk of the data for using the adjuvanted
vaccine occurs with the elderly. That's not who's targeted in
this vaccine, and so we're just beginning to get the kind of
data that would be associated with kids.
But I think the larger question is we have so much vaccine
hesitancy in this country, so much inaccurate knowledge about
whether vaccines are safe and particularly whether this flu
vaccine is safe, to add on through an emergency use application
a new element that may indeed be safe could well have
undermined the efficacy of this campaign.
Mr. Stupak. So this one has been around for, as I have
said, I think 1997 or so and then approved. Would it be prudent
to maybe leave the decision to the parent whether or not they
wanted their child to be vaccinated with an H1N1 vaccine that's
juvenated as opposed to not.
Dr. Levi. It is sometimes hard to understand why there is
so much hesitancy around vaccines in general and this
particular vaccine. I think we had a real public health
question as to whether people would accept a vaccine that had a
new product in it.
Now, if things had been worse and this had been a much more
severe pandemic, we may have needed to go that way anyway,
because whatever risk around hesitancy might have been overcome
by fear of the virus itself. But I don't think that's where we
are. I do believe that we need to move expeditiously in
preparation for any future pandemic to be able to better
address these questions about adjuvants and other technologies.
Mr. Stupak. My time is up.
Mr. Walden, for questions please.
Mr. Walden. Thank you very much, Mr. Chairman.
For those of us who don't spend our lives in the world
you're in, can somebody give me like a 20-second explanation of
an adjuvant? Doctor.
Dr. Narasimham. Sure. Adjuvants have actually been used in
vaccines in the United States since the 1920s. There's one
called alum that's been used extensively. Adjuvants are
actually additives that we put in the vaccine that actually
boost the immune response. So, in this case, what we would do
is we would make the vaccine as we normally would make it, add
in the adjuvant, and then see how the vaccine performs. And
typically a lot less vaccine is needed and the immune response
is higher.
Mr. Walden. And in your clinical trials overseas did I hear
you say correctly that you haven't seen any adverse response--
well, maybe not any adverse response. You always have some. But
nothing out of the band you would look at.
Dr. Narasimham. In our clinical trials--I also just wanted
to correct, we have now 25,000 subjects that are nonelderly. So
it's not that we don't have data on elderly. We have quite a
robust data set in the nonelderly population. We only see--we
see reactions comparable to seasonal vaccine for adverse
events.
Mr. Walden. And when in 2008 did you apply to FDA for
approval?
Dr. Narasimham. We did not apply--just to clarify, we did
not apply for approval.
The first step is to file an IND, which would then allow us
to take the steps to file for the approval. Our intention has
been to use our European data to try to move forward. The
question always has been how much data needs to be repeated in
the U.S. that was done in Europe.
Mr. Walden. And when in 2008 did you do the first
application?
Dr. Narasimham. I can get back to you on the exact date. I
think it was mid-2008.
Mr. Walden. And what else do you hear from FDA that you
need to supply that you haven't?
Dr. Narasimham. I think they would like to see adequately
controlled, randomized studies under FDA oversight that
demonstrate the safety and benefit of the vaccine. We have a
lot of data. A lot of it--most of it has been generated not
under FDA oversight, with EMEA European oversight. And the
question for us as a company is how much of this can we
realistically be expected to repeat. And, of course, with flu
vaccines being as profitable--or not as profitable as they
are--or as profitable as they are, which is to say they're not.
Mr. Walden. OK. So going back then--well, let me run this--
if this were the feared Avian flu that we had hearings on and
the potential of four out of every ten dying because of it, I
guess we would declare some sort of emergency and take whatever
risk there is. But if you're using this MF59 in Europe and
you're not seeing any real problems, I just wonder what it
would take here to get going on that. What does FDA--we should
ask FDA.
Dr. Narasimham. I can't speak for the agency. My
understanding is, if the severity was such or if the
unadjuvanted vaccines had not worked, they would have looked at
this much more seriously. With H1N1, it's very difficult to get
the unadjuvanted vaccines to work. So, hence, the MF59
becomes--adjuvants in general become much more important.
In this case, because they had an unadjuvanted vaccine that
worked, I think they were more reluctant to move with the
adjuvant. I would say that HHS and BARDA has funded a lot of
our work with adjuvants so that the U.S. Government has
supported a lot of the work that we've done.
Mr. Walden. But looking at it from where you are today with
the FDA, what kind of time line do you think you and the FDA
are on? And I realize they are your regulator and approver and
you have to be really nice here. I don't mean to put you on the
spot. Just for my sake and the public's sake, what kind of time
line?
Dr. Narasimham. The way we look at this is we have an H1N1
adjuvant, we have a seasonable adjuvant, and we have an H5N1
adjuvant. Our goal is to get ideally all of these licensed as
soon as possible. We would be willing, of course, to file as
soon as we can find a pathway with FDA that makes sense. But I
think we would be unwilling to repeat large clinical studies
and incur all the costs again, if that's what's ultimately
going to be required, unless the government helped us.
Mr. Walden. Are we the only country that doesn't allow the
adjuvant in our vaccine?
Dr. Narasimham. At least for Novartis the only country that
we do not supply adjuvanted vaccines to is the United States.
Mr. Perreault. If I could just comment. CSL has a unique
adjuvant as well that we developed in Australia, and we did put
it into the H5N1 that we supplied to Australia during that time
frame a few years ago.
Mr. Walden. And H5N1 is what?
Mr. Perreault. That's the bird flu, Avian flu.
We also have multiple research programs going on with
partner companies who are developing vaccines utilizing our
adjuvant, and this adjuvant is being manufactured in Kankakee,
Illinois.
Mr. Walden. It's manufactured here. We just can't use it
here.
Mr. Perreault. It's being used in clinical trials with new
vaccines that are being developed by other companies that we
partner with.
Mr. Walden. And as you've used it in other countries, if I
understood you correctly.
Mr. Perreault. We've done the studies for H5N1 in
Australia.
Mr. Walden. And did you find any outlier effect?
Mr. Perreault. It was safe and efficacious.
Dr. Narasimham. And we're also able to produce MF59 in the
Holly Springs facility; and we expect the MF59 suite in Holly
Springs, North Carolina, to be operational in December.
Mr. Walden. All right. My time is expired. I know we have
other members here who want to ask questions. Thank you, Mr.
Chairman. Thank you of the panel.
The Chairman. Chairman Pallone.
Mr. Pallone. Thank you.
I was going to use my time with Dr. Lakey here because
you're the State guy. And I don't know if you were here when I
asked the first panel, but all my questions were about
distribution and also about funding, because Dr. Lurie brought
it up.
Basically, you know that CDC has left it up to the States
to decide how to distribute the vaccine. So I wanted to know
how a State decides which entities will distribute vaccine, you
know, how many doses they receive; and, essentially, do you
agree with the CDC that these decisions should be left to the
States or should they be dictated by the Federal Government
maybe a little bit more strictly?
I know they have guidelines, but--I don't know if you were
here before, but I've been getting all these criticisms in New
Jersey about the Wall Street firms getting the vaccine because
they can distribute it better than some other places. And we're
hearing in my own State of New Jersey and in New York about
major disparities, one school district versus another that gets
it, one gets it, the other doesn't. I just want your response.
I know you're a State official, so you probably think States
are great, but I would just like your response.
Dr. Lakey. Let me provide some background related to how we
do this.
We have the ACIP guidelines, the high-risk groups. And then
those were further prioritized into a group taking it from 159
million to about 49 million. And so the challenge for us has
been the changing landscape of how much vaccine is going to be
available. Because your strategy to deliver a vaccine changes
depending on how much vaccine you have. You can't run a mass
vaccination clinic if you only have 100 doses, and you can't
provide a school-based clinic if you're not immunizing healthy
young kids.
And so States looked at those priority groups; and I think
most States looked at health care workers, pregnant women, and
very young kids as those top individuals that we needed to
start our immunization program with. The challenge was that the
first vaccine that was available was the nasal spray, and so we
couldn't immunize pregnant women with the nasal spray.
Mr. Pallone. Just to interrupt you, I've had that
phenomenon, too, where one of my school districts has the nasal
spray but doesn't have the vaccine and they want the vaccine
instead of the nasal spray.
Dr. Lakey. And so it's a matching of the vaccine you have
available with your priority groups and your distribution
system, what systems do you have available. And so a lot of us
State health officials tried to move from large vaccination
clinics to using the private sector.
Mr. Pallone. So you use employers as well the way New York
does?
Dr. Lakey. Well, we're providing it to the physicians, the
health care systems----
Mr. Pallone. So you don't actually--I know I'm
interrupting, but I'm running out of time. You don't actually
do like what New York has done or maybe New York City has done,
where they would go to large employers like Citigroup or
Goldman Sax that have health clinics and have them do the
distribution.
Dr. Lakey. I have 13,000 registered providers on our
system, and it's a combination of many of those. There may be
some occupational health, but they're the minority. Most of
these are pediatricians, ObGyn, family practitioners in the
State.
Mr. Pallone. Do you think that--I mean, I'm asking you to
criticize another State, but, I mean, would you--New York
obviously uses some of these large employers. Do you think that
makes sense?
Dr. Lakey. Well, I don't know the details of New York. From
what I have gathered is that they have been trying to meet the
priority groups and trying to reach pregnant women in different
ways that they can do it, but I cannot speak for the State
health officers.
Mr. Pallone. Let me ask you this. You did mention the
challenges of intermittent public health funding. And Dr. Lurie
brought up funding challenges. I was a little critical because
I don't remember the Secretary mentioning that when she was
here. And, of course, if you need money, this is the place to
come, for the most part, these days. Talk to me a little bit
about that. I mean, to what extent the lack of funding or
intermittent nature of it has been a problem.
Dr. Lakey. Sure. I think there is a couple of issues here.
One is, the Federal funds that have been made available,
you know, after 9/11, a lot of funds were made available, it
peaked, and then it gradually declined. And so we receive now
about half of what we were receiving earlier on.
We also had in 2006 one-time funding related to pandemic
flu. And so that money was utilized to put together plans. But
you can't hire people for long term on one-time funding, and so
that funding went away. Those plans were made. But you can't
continue that process after those funds have went away.
Mr. Pallone. But you obviously feel that it makes sense for
the States to have a lot of discretion here. In other words,
you wouldn't suggest that the Federal guidelines be
strengthened or made more detailed at this point. You believe
the States should have the leeway to pretty much do what they
want pursuant to the existing guidelines.
Dr. Lakey. I guess, for clarification, that's for the folks
that are being vaccinated right now----
Mr. Pallone. In terms of the distribution.
Dr. Lakey. The distribution system?
I think where we are right now folks are titrating up those
groups. I think they base that on their capacity as a State.
What were the resources? What was their history with delivering
vaccine? And then they use those systems.
And so you have--public health is structured many different
ways across the United States. And they use that uniqueness of
their system, who they could reach the quickest, in order to
determine their priority groups, using the same basic
philosophy trying to get pregnant women, young kids, health
care workers from the beginning, but then how they message that
and adjusted that was dependent on what that State system was.
Mr. Pallone. All right. Thank you. Thank you, Mr. Chairman.
Mr. Stupak. Mr. Shimkus for questions, please.
Mr. Shimkus. Thank you, Mr. Chairman; and thank you to the
panelists for being here.
We have spent a lot of time on adjuvant and how it boosts
this. But I want to focus a little bit on the nasal spray. And
so, Dr. Machielse, I know in your written and opening
statements you mentioned the--I guess it's intranasal
technology and the ability to get 80 to 100 versus 1 through 7
doses. Can you explain that to us and why that's--I mean, if
we're talking about needing a lot of doses, from the layman's
point of view it sounds like a good thing to be focusing on.
Mr. Machielse. I can explain it. I think there are two
reasons for that.
One is, I think we at MedImmune, we develop our own seed
strain; and using the reverse genetics we can quickly screen
multiple variants of the vaccine and select for growth
properties immunogenicity. So, for instance, for the H1N1
vaccine, we basically screened 23 variants and did not lose any
time; and we were in commercial production at scale on July
3rd.
I think the other important factor is--so we were able to
actually immediately create an H1N1 strain which produces as
much as we have seen in the past.
And then the other advantage of the live attenuated
technologies is it is actually sprayed in the nose. The virus
replicates there and creates an immunoresponse. So if you
compare it to the inactivated vaccine you need a very, very
small dose. Maybe if you compare it from--let's call it
quantitative burst--a factor of 50 or lower. So I think that is
a very important attribute, to actually consider this
technology as part of pandemic preparedness. And I could tell
you we have manufactured over 100 million bulk doses, and we
could easily have gone up to 200 million doses by--bulk doses
by the end of this year.
Mr. Shimkus. And what piqued my interest was also some of
the comments when Chairman Pallone got into the discussion a
little bit in the nasal spray issue is not for pregnant women.
But there's a lot of other--I mean, the other two groups, there
would be no prohibition for them, is that true?
Mr. Machielse. That's correct.
Mr. Shimkus. I think he mentioned a school that didn't want
to do nasal spray.
Mr. Machielse. I think that we are not--you know, we do not
have pregnant women in our label and we cannot administer the
intranasal spray to that population. But the majority of the
risk population is covered by the intranasal vaccine. So I
think what's also very important is that there is enough
education to actually objectively make people aware of the
choices available in the flu vaccination technology. Because
maybe people now react on the intranasal vaccine, but it may be
the same fear factor for the adjuvanted vaccine. And I think
those assumptions in the public could be avoided by a targeted
education campaign where it is emphasized that the safety and
efficacy of the general vaccines available in the U.S. is good.
Mr. Shimkus. Thank you.
Dr. Lakey, the title of the hearing is An Update on Vaccine
Production and Distribution; and when I initially read that I
always think distribution is can a drug get from point A to
point B. I think what a better title for this would have been
in the decision-making matrix of who gets it. Not--for me--
there is no distribution problem as far as you see when this is
produced to delivery to an end point user, is there?
Dr. Lakey. For the most part, no. There is--so that is in
the private sector. It is manufactured, we order it, and it is
shipped. That system seems to work for the most part. There
have been weather events, et cetera, that have slowed that
down, but for the most part that distribution system has
worked.
Mr. Shimkus. What else do you think we need to do? Because
you probably listened to the opening statements. My concern is,
if we can't get this right, how do we do something? What do we
need to do to prepare ourselves better for H5 or something that
could--may turn out to be a bigger problem?
Dr. Lakey. Well, I guess I've learned through other events,
such as hurricanes, et cetera, that you have to take time
afterwards to critically look at what went well and what you
could have done better and just learning from your experiences.
I think there's been good discussion today of what we can
do to improve the availability of vaccine. I think making sure
that we communicate effectively to individuals' real
expectations and not set artificially high expectations.
Because I think the general public will respond when we give
them the right expectations.
Mr. Shimkus. And I agree.
My time is expired. Thank you, Mr. Chairman. Thank you,
panel.
Mr. Stupak. Thank you, Mr. Shimkus.
Mr. Green for questions, please.
Mr. Green. Thank you, Mr. Chairman.
And, Dr. Lakey, I appreciate you being here and glad we got
to meet earlier and appreciate what you've done for 3 years as
the Commissioner of Health in Texas.
And I guess one of my interests is on the delivery system.
Although our big issue here is why we don't have enough
vaccines, obviously. And I know you experience it every day in
Texas like a lot of us hear from our offices. But one of the
challenges you mentioned is associated with school-based
clinics and vaccinations. And I notice in today's Houston
Chronicle some of my school districts in the Houston area are
actually doing it--Alief, Humble. And I was wondering are you
having any resistance from schools, particularly schools that
have school-based clinics, to providing the H1N1 for their
students?
Dr. Lakey. I think what you are seeing in Texas is a mosaic
of different strategies working together to get individuals
immunized. I think some schools--there are school systems that
have a lot of experience with school-based clinics, and those
seem to work. There are other school systems that haven't done
that well, haven't done it in the past.
There are some challenges, making sure that you get
parental consent so you don't immunize a child that hasn't
provided consent, the parents haven't provided consent, and
other just logistical challenges.
There are folks that you have to have there to provide
immunizations, et cetera. We are using some of the funds that
were provided by Congress to be able to hire individuals to
allocate that.
But all those things have to come together. So that's one
part of our system. We're able to do that now in Texas because
as we've titrated up the number of groups we've been reaching
the high-risk individuals, you know, the children with asthma,
et cetera. And so we're now able to expand out to some of the
healthy kids in our State.
Mr. Green. Can you tell us how public health emergency
funds help you and other State public health departments set up
and operate the H1N1 program?
Dr. Lakey. Excuse me again, sir?
Mr. Green. How the public health emergency funds that you
receive help with that.
Dr. Lakey. The public health emergency funds came in three
components, and they've been critical to our ability to
respond.
The first part had to do with getting surveillance systems.
Again, public health has been cut and so having feet on the
ground in order to investigate cases, figure out whether it is
H1 or not, that's been critical to hire those individuals.
We've been able to improve our laboratory capacity. Having
the individuals in the laboratory to process samples, that has
been a critical component of our system. We've been able to
develop the vaccine ordering system in order to make sure that
we have that technology in order to accomplish this.
About 81 percent of the funds that came in public health
emergency response three we sent out to the local health
departments so that they could hire the individuals to be able
to respond.
Again there's been significant cuts at the local level in
public health. A lot of those public health departments are
shrinking and can't provide that investigation, the delivery of
vaccine, all those different manpower components without the
funds that were allocated in order to hire those individuals.
Mr. Green. Dr. Levi, I know you released a report
coauthored with the American Academy of Pediatrics that states
that school age children are the population most responsible
for transmission of influenza and has the highest rate of
attack. That report also sites in 2005 a school-based pilot
program in the State of Maryland where FluMist was administered
to children in several Maryland secondary and elementary
schools and the results were that the program showed
significant reduction in respiratory illnesses within
households of children who received these vaccines versus
schools that do not participate.
It seems like that report, and I am sure there is other
proof that shows school-based facilities, of course, with the
parents' permission, but that making it available to parents is
a successful way to deliver that.
Mr. Levi. Absolutely. And certainly using school-based
facilities for both immunizations and the other types of health
care are critically important. That is why there is some major
provisions in the health care legislation that would expand
that capacity. This is a tremendous opportunity to reach kids.
A lot of our pandemic planning assumed that kids would not
be--it would be more like seasonal flu and the elderly would be
most vulnerable. As it turned out, young kids were the most
vulnerable. So if we had a strengthened school-based clinic and
immunization program, we would certainly be in better shape
today.
Mr. Green. Mr. Chairman, my last question actually is for
the reason we are here, and it is to ask our producers of the
vaccination, I know there has been a lot of discussion
regarding benefits of new technologies to produce flu vaccines
and the cell culture is the newest one. But I understand there
is no difference, we wouldn't be producing faster vaccines
using cell as compared to the eggs. And if each of you, as
brief as you could, could respond to that, is there something
we could do to make it quicker, whether it is eggs or the cell?
Mr. Hosbach. Cell culture is not a game changer, and I
think I will steal that phrase from Tony Fauci. The game
changer probably is something along the lines of a universal
flu vaccine, which you could stockpile that covers all
different variants of flu strains over the course of seasons.
However, that is a long ways away.
In terms of saving time, whether it is cells or eggs, you
are, again, dealing with Mother Nature. You have to adapt the
virus to the system that you are utilizing. And perhaps with
cells make you save 2 or 3 weeks. But in terms of capacity and
overall production capacity, I don't think it is really a game
changer. You get vaccine out there about the same time.
In fact, the two facilities we have based in the U.S., they
have the potential to produce 150 million trivalent seasonal
doses. If you convert that to a monovalent, that is 450 million
doses of an H1N1 type vaccine. So there is plenty of capacity
right here on U.S. soil with the one new facility and our
existing facility.
What we really need to look at why aren't we immunizing as
many people as we should be immunizing on a season basis, when
36,000 people die every year and 200,000 people are
hospitalized. We have recommendations from the ACIP that 275
million people should be immunized on an annual basis. We are
lucky to immunize 100 million people.
If you want to sustain influenza immunization, production,
development of new technologies, we really need to make sure we
get more people immunized for the benefit of public health and
for sustaining our manufacturing capabilities.
Mr. Green. OK. So the capacity is here, whether it is
production in the United States, and I know we have one
production in Australia, which is fine. But we have the
capacity to produce 400 million vaccines?
Dr. Narasimham. I think there is an important dynamic here
for this vaccine. What we saw with the avian influenza is that
an unadjuvanted 15 microgram dose was not sufficient. In fact,
many manufacturers thought it took 90 micrograms, right, which
is six times as much, which means that the supply collapses.
So as the only manufacturer here that actually produces
cell-culture-based vaccines, we actually have two licensed cell
culture vaccines now in Europe. We are producing it for Europe,
unadjuvanted and adjuvanted, seasonal and pandemic. And what
our belief is with cell culture, you get some speed gain. Our
expectation is a little different view is that it is on the
order of 6 to 8 weeks, but it is not massive. I mean, it is
going to be on that range as to the gain you get with cell
culture.
But as Dr. Machielse also mentioned, with reverse genetics
and using some new technologies, cell culture allows you to
actually meet the need of many of the changing viruses that are
out there. The worst case scenario for the American public is
you rely on a single technology, that technology doesn't work
when it is a different influence a strain, and then suddenly
you have a real crisis on your hand.
So I think it is a wise strategy to invest in multiple
different technologies, simply because we don't know how any
one virus will behave.
Mr. Stupak. Quickly, because we have to get to Mr. Burgess.
We have votes here soon.
Dr. Machielse. For us, you know, the eggs are working well.
But I think if you can have the cell culture technology also
available, it derisks the supply. In effect, if you have a
really bad avian flu going around, it may affect the supply of
eggs and those kind of things.
I think the scalability of cell technology is very
critical, and I think especially if you think about the live
attenuated flu technology. We have a facility in Frederick,
Maryland, with two 2,500 liter bio-reactors. With the cell
culture inter-nasal technology, we could manufacture half a
billion doses in that facility. If you think about the cost
efficiency you could generate, I think the cell culture at
scale could be a very interesting asset and guarantee or
further guarantee supply of flu vaccine.
Mr. Stupak. Mr. Burgess, for questions.
Before you start, I should mention that you are one of the
members that had written to myself and Chairman Pallone and
asked for this hearing, along with other members. We appreciate
it.
We will start with the questions.
Dr. Burgess. You are kind to point out that I didn't whine.
You just finished up on an excellent point, Doctor. Mike
Leavitt came and testified here in, I guess it was 2005, that
it was going to be very, very difficult to develop the number
of eggs that would be needed to produce the vaccines if we
culled all our chickens the month before.
Let me just ask a couple of questions of all four of our
manufacturers, and I would appreciate brief answers. But when
in the sort of timeline that has been going on since last
April, when did you find out about the delay? When did you
really appreciate we were a month behind?
Mr. Perreault. I will respond first. I think that we did
not, because we did not participate in the pandemic RFP that
was put out by the U.S. Government a couple of years ago, our
contract was a bit different. So we started the negotiation in
May and finished in May, which is the fastest I have ever done
a government contract, by the way, which was quite nice to see.
And we had to submit at that time our schedule that we assumed,
based on average yields, when we signed the contract.
Within 3 weeks, we could see that the virus was not growing
well. So we started at the beginning of June, and we could see
the seed strains we had were not developing. In fact, they were
a half to a third of what we expected. Again, our expectations
were set on 10 years of seasonal assays. But as all of the
manufacturers here will tell you, each new flu season is a new
flu season. You just can't tell. And I think you have a medical
background as well, or are a physician, so you understand that.
But I think we knew right away. We had weekly conference
calls with HHS and BARDA, and we informed them and put a new
delivery schedule in July.
Dr. Burgess. So you did conference calls, and that would be
in June?
Mr. Perreault. We communicated in June, and then put a new
delivery schedule together in July based on our assumptions.
Dr. Burgess. What was Novartis' experience?
Dr. Narasimham. With Novartis, we saw the reduced yields in
July. And I just would point out for clarity's sake, we
actually can't confirm yields until we receive FDA reagents,
and those reagents were really made available in August. But
with initial testing, we saw the reduced yields in July. We
communicated our situation weekly with HHS, as did all the
manufacturers.
Dr. Burgess. Well, MedImmune is different, but what about
Sanofi Pasteur?
Mr. Hosbach. Actually, it is the same for us in terms of
realizing we first started out on a very conservative estimate
in terms of yield of the virus, and it actually was about 60
percent of what we thought it was going to be, even on a
conservative number. And we had weekly phone calls with BARTA-
HHS and schedules were revised all throughout the way
periodically as we gained new information.
Dr. Burgess. Well, I am a little concerned, because I had
some conversations in August with CDC and NIH and was given
assurances that when school started, we would be well on our
way to having, depending upon the approval process, well on our
way to having satisfactory doses by mid-October. And that was
kind of the timeline that I was laboring under.
Let me ask you a question. In the end of October, Secretary
Sebelius at a Senate hearing said she was going to put out a
call to the manufacturers to accelerate production, but I am
going to assume you had already done so at that point, is that
correct? Is there anything you did differently as a result of
that call?
Mr. Perreault. At CSL, what we did is when we did receive
the call, we took another look at our ability to fill and
finish vaccine. Producing the antigen is one piece of it. Then
you have to actually get it into a formulation and put it
either into vials or syringes.
Our manufacturing plants for fill-and-finish of flu vaccine
are inside plants that produce other therapies. So our CSL
business includes protein plasma therapies for rare diseases.
So we had to adjust our lines and our manpower in order to see
if we could free up some manufacturing slots, and we did that.
Dr. Burgess. You did that as a result of the call on
October 29th?
Mr. Perreault. We were evaluating all along the way, but
that was also a call to reinforce what we had been discussing
with BARTA.
Dr. Burgess. Let me just ask any of the manufacturers, was
it problematic for you that you were at the point where you
were gearing up for the seasonal flu and suddenly had this H1N1
task added to the equation?
Dr. Narasimham. I think it was just a compression of the
timelines. We had to complete our seasonal flu, at least for
the case of Novartis, complete our planned season flu doses,
which was what we were requested to do, and then we started in
our case H1N1 in July, which obviously brings us to have a very
short timeframe, a short runway to sort of get the plane off
the ground.
Dr. Burgess. But still there has been difficulty getting
seasonal flu vaccine out. I know our community has been lacking
for several weeks. Are we back on schedule with the seasonal
flu?
Dr. Narasimham. In our case, we completed our seasonal
deliveries in early October.
Dr. Burgess. Completed them. But the House physician here
is out, for example. My Wal-Mart back home is out. I know I
could get the MedImmune, and I should do that. But for the
other vaccine, in our area it has been harder to come out. I
know Dr. Lakey may know more about what difficulty we are
encountering there.
Let me just ask MedImmune, on the issue of adjuvants, are
there adjuvants that you use with your attenuated live virus?
Dr. Machielse. We don't use any adjuvants.
Dr. Burgess. Because your yield and the method of
immunogenicity is such that the yield is so high?
Dr. Machielse. It is live virus, and basically it
replicates in the nasal cavity. You don't need an adjuvant.
I just want to highlight that we completed our seasonal
manufacturing also in time and were even able to accelerate it
to free up more manufacturing capacity for H1N1.
Dr. Burgess. Thank you.
Dr. Lakey, let me just ask you, because Texas has had some
problems, and some of them made their way into the front page
of the newspapers. But when did you learn that Texas was going
to be having some difficulty delivering on the vaccine
shipments?
Dr. Lakey. I think we learned as vaccine was coming out
that it wasn't what we had anticipated. So in early October, as
I recollect, was when we figured out that what we were being
told we were going to get was not what we had been told in the
past.
Dr. Burgess. Do you feel that CDC and HHS shared
information with you in a timely fashion?
Dr. Lakey. We have had multiple calls with the CDC and the
Office of the Secretary of Preparedness and Response, and they
showed predictions, but a lot of them changed pretty quickly.
Dr. Burgess. Now, have they been helpful in helping you
adapt to the change in the vaccine availability?
Dr. Lakey. The CDC has been very helpful to us in the State
of Texas when there have been issues that have arisen. We have
called them individually. We have conference calls two times a
week with their leadership, with all the State health officers,
to discuss issues and to have a question and answer time
period. So they have been available and have answered
questions.
Dr. Burgess. And how about the manufacturers themselves?
Have they similarly responded with information when you needed
it, or do your communications go directly through CDC?
Dr. Lakey. My communication would go through the CDC. The
manufacturers would discuss that information with the CDC. So
there hasn't been a direct conversation between State health
departments and the manufacturers.
Dr. Burgess. And you and Mr. Pallone talked a little bit
about funding. Do you get the feeling that the level of
funding, the $1.5 billion, was not satisfactory? Do you have an
idea in mind of what would bring us to a level of funding that
would be satisfactory?
Dr. Lakey. So this is for the funding right now? The
Association of State and Territorial Health Officials talked to
State health officers to figure out what they think they would
need. That survey thought that about $800 million would need to
be available in order to continue this response through March.
Some State health departments are in better shape than
others. Some, I believe about half of them, are predicted to
run out of their FIR funding by the end of this year. So,
again, State health departments are in different situations,
but when we have tried to look at this systematically
throughout the United States, the number was about $800 million
to get all State health departments through the end of this
pandemic.
Dr. Burgess. Now, you have indicated to me that you see the
number of cases has actually diminished over what it was even
just a few weeks ago, and yet we are coming up to the holiday
season between Thanksgiving and Christmas. People will be
traveling a great deal in this country. I just remember my days
in the clinics, you would typically see a great increase in
viral syndrome around Christmastime and the weeks shortly
after.
Now, could we anticipate a resurgence of the number of
cases toward the end of the year because of the amount of
travel people are going to be doing?
Dr. Lakey. That is correct. So, as a State, we monitor the
percentage of visits to physicians that are for influenza-like
illness. We peaked in Texas around 13 percent. We have gone
down to about 7 percent. But the nature of pandemics is they
occur in waves and we predicts there will be a third wave. The
challenge will be how that third wave corresponds to the
seasonal flu. Do we hit one and then the other, or do we have
seasonal flu on top of H1N1, which would be a challenge for
State health departments.
Mr. Stupak. Mike, I have to wrap it up.
Dr. Burgess. Just as a final thought. We are right next
door to Mexico, which is where this began a year ago. Is there
any thought what might be happening to the evolution of the
pandemic in Mexico? Will they be on their second, third or
fourth wave around February or March, around the same timeframe
this was introduced last year?
Dr. Lakey. I don't know if I can intelligently answer that.
I think we predict they are going to have an additional wave. I
think what we have--one of the challenges for us is there
correspondence between the severity and socioeconomic factors?
So in poorer areas of our State or in poorer countries, do we
have more significant disease. So we are wrestling with that
currently.
Dr. Burgess. It definitely impacted us last year. When they
became ill, we developed symptoms very quickly in our State.
Dr. Lakey. Infectious diseases do not respect borders. It
came across our border very rapidly, and throughout the
southern part--the hardest part of Texas, the part of Texas
that was hit the hardest, was our southern border. If you look
at our fatality rates, et cetera, there is a significance
difference of our border versus the rest of our State.
Dr. Burgess. Thank you, doctor.
I yield back, Mr. Chairman.
Mr. Stupak. Just to summarize, we are going to have votes
in a few minutes, and we will finish up with the panel and
finish up this hearing.
Dr. Lakey, it is fair to say we are going to get another
wave of this H1N1? Right now, it seems like we are at a calm
before the storm. Is that because there is more vaccines out
there, or what is it? We are going to get hit again, are we
not?
Dr. Lakey. I am not sure if it is--there is probably
several factors interacting. One, the natural history of
pandemics coming in waves, and I think that is what we are
seeing. And you will see differences across the United States.
Activity is decreasing in Texas, it is rapidly increasing in
other parts of the State, in the New England part of the
Nation.
But the natural history of pandemics is they occur in
waves. So our goal as we vaccine individuals is that we can
blunt that third wave, and that is why it is not too late to
immunize individuals. Even though this wave is decreasing, we
need to block the third wave.
Mr. Stupak. So as Mr. Burgess said, as we move about during
this holiday season of Thanksgiving and Christmas, that could
spread it in areas that have not seen the intensity we have
seen in other parts of the country.
Dr. Lakey. As we get into the colder season, as people are
more inside, as the humidity changes, as the environment is
more conducive to the spread of infectious diseases, it is
likely there will be additional spread.
Mr. Stupak. And then we could very well have the seasonal
flu on top of it?
Dr. Lakey. Exactly, sir.
Mr. Stupak. OK. Let me ask you this question, just to
summarize. It is my understanding from listening throughout
this hearing there really was a pretty good cooperation with
the government in working this one out between communications,
coordinations, and even moving some contracts fairly quickly.
Is that fair to say?
I mean, usually we are on the government, but it sounds
like this time actually all the preparedness they have done for
a pandemic has actually worked out fairly well. Is that fair to
say?
You are all nodding your head ``yes.''
Mike, any other questions before we close it down? Wrong
question to ask.
Dr. Burgess. I am disturbed because Secretary Sebelius did
indicate to us we would have the doses that we needed. And,
again, my calls to the CDC and HHS, although they were off the
record in August, yes, I got the information that they had
studied what was happening in the southern hemisphere, it
wasn't as bad as what they thought, but there were certain
populations that would definitely be at risk, but not to worry,
we would have the vaccine done and approved and in the hands of
providers certainly by mid-October.
At that point, the fear was what if it is worse when the
school year initiates on the first of September and we have to
push this stuff out the door before the clinical trials are
finished at the end of September. So I am still uneasy about
all of that timeline.
My very first statement on this was when I had that very
first conference call, I was worried that we were going to
underestimate the severity of this virus, and, I mean, it is
just incumbent upon us to constantly stay vigilant and not get
complacent about our ability to fight it off.
Mr. Stupak. There is no doubt we had rosy forecasts from
the Secretary that has not held true. But I think between the
low egg production of the virus and the condensed timeline and
the great demand, it probably has led to the frustrations that
we all feel, and that is the purpose of this hearing, to get to
it. And I think we learned from this panel and the previous
panel.
But overall, I think the government cooperation in working
together and trying to resolve this has been pretty good,
probably above par.
So with that, let me conclude this hearing.
That concludes all questioning. I want to thank all of our
witnesses for coming today and for your testimony. The
committee rules provide that the members have 10 days to submit
additional questions for the record.
That concludes our hearing. This joint hearing of the
Health and Oversight and Investigations Subcommittee is
adjourned.
[Whereupon, at 3:06 p.m., the subcommittees were
adjourned.]
[Material submitted for inclusion in the record follows:]
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