[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:]


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    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:]


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    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:]


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    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:]


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    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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