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74–853 2012

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 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

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 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

PARKER GRIFFITH, Alabama 

ROBERT E. LATTA, Ohio 

(II) 


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(III) 

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

JOHN D. DINGELL, Michigan 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JANE HARMAN, California 

CHARLES A. GONZALEZ, 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 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

BART STUPAK, Michigan, Chairman 

BRUCE L. BRALEY, Iowa 

Vice Chairman 

EDWARD J. MARKEY, Massachusetts 

DIANA DEGETTE, Colorado 

MIKE DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

MIKE ROSS, Arkansas 

DONNA M. CHRISTENSEN, Virgin Islands 

PETER WELCH, Vermont 

GENE GREEN, Texas 

BETTY SUTTON, Ohio 

JOHN D. DINGELL, Michigan (ex officio) 

GREG WALDEN, Oregon 

Ranking Member 

ED WHITFIELD, Kentucky 

MIKE FERGUSON, New Jersey 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


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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 


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VI 

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 


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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 


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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 


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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 availVerDate Mar 15 2010 01:31 Sep 27, 2012 Jkt 074853 PO 00000 Frm 00009 Fmt 6633 Sfmt 6633 E:\HR\OC\B853.XXX B853

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able 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 


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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 


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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, 


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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 


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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 


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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. 


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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 


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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 distribuVerDate Mar 15 2010 01:31 Sep 27, 2012 Jkt 074853 PO 00000 Frm 00017 Fmt 6633 Sfmt 6633 E:\HR\OC\B853.XXX B853

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tion. 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 


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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. 


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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? 


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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. 


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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 Dminus. 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-inlaw 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 


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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. 


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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. 


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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. 


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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 


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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 socalled 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? 


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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. 


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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 


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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-monthold 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 longterm 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. 


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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 


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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. 


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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 


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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. 


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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 foVerDate Mar 15 2010 01:31 Sep 27, 2012 Jkt 074853 PO 00000 Frm 00041 Fmt 6633 Sfmt 6633 E:\HR\OC\B853.XXX B853

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cused 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 inVerDate Mar 15 2010 01:31 Sep 27, 2012 Jkt 074853 PO 00000 Frm 00056 Fmt 6633 Sfmt 6633 E:\HR\OC\B853.XXX B853

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travenous 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 publicprivate 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 


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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 


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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 cellbased 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. 


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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 

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pitals 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 

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gress 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 


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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 gettingthe-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. 


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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, 


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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 

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plies, 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 apVerDate Mar 15 2010 01:31 Sep 27, 2012 Jkt 074853 PO 00000 Frm 00105 Fmt 6633 Sfmt 6633 E:\HR\OC\B853.XXX B853

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proved 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 nonadjuvanted 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 


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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. 


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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 


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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. 


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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. 


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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 


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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 


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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 


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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, 21⁄2 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 


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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. 


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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 


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H1N1 vaccine come in multi-dose vials and thimerosal-free prefilled 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 


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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:] 


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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. 


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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 


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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-ofthe-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. 


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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 


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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 midOctober. 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. popuVerDate Mar 15 2010 01:31 Sep 27, 2012 Jkt 074853 PO 00000 Frm 00173 Fmt 6633 Sfmt 6633 E:\HR\OC\B853.XXX B853

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lation, 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. 


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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— 


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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. 


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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. 


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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. 


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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. 


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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. 


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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 


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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 


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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 

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sion, 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 


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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 


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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 adVerDate Mar 15 2010 01:31 Sep 27, 2012 Jkt 074853 PO 00000 Frm 00206 Fmt 6633 Sfmt 6633 E:\HR\OC\B853.XXX B853

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just 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? 


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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? 


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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.’’ 


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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 midOctober. 

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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