DEPARTMENTS OF LABOR, HEALTH AND HUMAN 

SERVICES, EDUCATION, AND RELATED AGENCIES 

APPROPRIATIONS FOR 2010 

HEARINGS 

BEFORE A 

SUBCOMMITTEE OF THE 

COMMITTEE ON APPROPRIATIONS 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

SUBCOMMITTEE ON THE DEPARTMENTS OF LABOR, HEALTH AND 

HUMAN SERVICES, EDUCATION, AND RELATED AGENCIES 

DAVID R. OBEY, Wisconsin, Chairman 

NITA M. LOWEY, New York 

ROSA L. DELAURO, Connecticut 

JESSE L. JACKSON, JR., Illinois 

PATRICK J. KENNEDY, Rhode Island 

LUCILLE ROYBAL-ALLARD, California 

BARBARA LEE, California 

MICHAEL HONDA, California 

BETTY MCCOLLUM, Minnesota 

TIM RYAN, Ohio 

JAMES P. MORAN, Virginia 

TODD TIAHRT, Kansas 

DENNIS R. REHBERG, Montana 

RODNEY ALEXANDER, Louisiana 

JO BONNER, Alabama 

TOM COLE, Oklahoma 

NOTE: Under Committee Rules, Mr. Obey, as Chairman of the Full Committee, and Mr. Lewis, as Ranking 

Minority Member of the Full Committee, are authorized to sit as Members of all Subcommittees. 

CHERYL SMITH, SUE QUANTIUS, NICOLE KUNKO, 

STEPHEN STEIGLEDER, and ALBERT LEE, 

Subcommittee Staff 

PART 7 

MEMBER BRIEFING—2009 H1N1 INFLUENZA 

PREPAREDNESS AND RESPONSE 

( 

Printed for the use of the Committee on Appropriations 

U.S. GOVERNMENT PRINTING OFFICE 

53–853 WASHINGTON : 2009 


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COMMITTEE ON APPROPRIATIONS 

DAVID R. OBEY, Wisconsin, Chairman 

JOHN P. MURTHA, Pennsylvania 

NORMAN D. DICKS, Washington 

ALAN B. MOLLOHAN, West Virginia 

MARCY KAPTUR, Ohio 

PETER J. VISCLOSKY, Indiana 

NITA M. LOWEY, New York 

JOSE ́ E. SERRANO, New York 

ROSA L. DELAURO, Connecticut 

JAMES P. MORAN, Virginia 

JOHN W. OLVER, Massachusetts 

ED PASTOR, Arizona 

DAVID E. PRICE, North Carolina 

CHET EDWARDS, Texas 

PATRICK J. KENNEDY, Rhode Island 

MAURICE D. HINCHEY, New York 

LUCILLE ROYBAL-ALLARD, California 

SAM FARR, California 

JESSE L. JACKSON, JR., Illinois 

CAROLYN C. KILPATRICK, Michigan 

ALLEN BOYD, Florida 

CHAKA FATTAH, Pennsylvania 

STEVEN R. ROTHMAN, New Jersey 

SANFORD D. BISHOP, JR., Georgia 

MARION BERRY, Arkansas 

BARBARA LEE, California 

ADAM SCHIFF, California 

MICHAEL HONDA, California 

BETTY MCCOLLUM, Minnesota 

STEVE ISRAEL, New York 

TIM RYAN, Ohio 

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland 

BEN CHANDLER, Kentucky 

DEBBIE WASSERMAN SCHULTZ, Florida 

CIRO RODRIGUEZ, Texas 

LINCOLN DAVIS, Tennessee 

JOHN T. SALAZAR, Colorado 

JERRY LEWIS, California 

C. W. BILL YOUNG, Florida 

HAROLD ROGERS, Kentucky 

FRANK R. WOLF, Virginia 

JACK KINGSTON, Georgia 

RODNEY P. FRELINGHUYSEN, New 

Jersey 

TODD TIAHRT, Kansas 

ZACH WAMP, Tennessee 

TOM LATHAM, Iowa 

ROBERT B. ADERHOLT, Alabama 

JO ANN EMERSON, Missouri 

KAY GRANGER, Texas 

MICHAEL K. SIMPSON, Idaho 

JOHN ABNEY CULBERSON, Texas 

MARK STEVEN KIRK, Illinois 

ANDER CRENSHAW, Florida 

DENNIS R. REHBERG, Montana 

JOHN R. CARTER, Texas 

RODNEY ALEXANDER, Louisiana 

KEN CALVERT, California 

JO BONNER, Alabama 

STEVEN C. LATOURETTE, Ohio 

TOM COLE, Oklahoma 

BEVERLY PHETO, Clerk and Staff Director 

(II)


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DEPARTMENTS OF LABOR, HEALTH AND 

HUMAN SERVICES, EDUCATION, AND RELATED AGENCIES APPROPRIATIONS FOR 

2010 

WEDNESDAY, NOVEMBER 4, 2009. 

MEMBER BRIEFING—2009 H1N1 INFLUENZA 

PREPAREDNESS AND RESPONSE 

WITNESSES 

THOMAS R. FRIEDEN, M.D., M.P.H., DIRECTOR, CENTERS FOR DISEASE 

CONTROL AND PREVENTION 

NICOLE LURIE, M.D., MSPH, ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE 

ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF 

HEALTH 

DONALD E. WILLIAMSON, M.D., ALABAMA DEPARTMENT OF PUBLIC 

HEALTH 

ROB FULTON, DIRECTOR OF PUBLIC HEALTH, SAINT PAUL—RAMSEY 

COUNTY DEPARTMENT OF PUBLIC HEALTH, SAINT PAUL, MINNESOTA 

Mr. OBEY. Good morning, everybody. I wish we were not here 

today under these circumstances, but we have a problem that has, 

frankly, frustrated me, and I am sure a lot of other people, for at 

least the last 5 years. 

Let me welcome subcommittee members and our panelists to this 

briefing on the H1N1 pandemic. Frankly, this committee, in my 

view, has had both a positive and negative effect on the issue of 

preparing the Nation against the threat of a pandemic. 

Early on in 2005, President Bush requested $7.1 billion to boost 

vaccine production capacity, to stockpile antivirals, and boost State 

and local emergency preparedness. Congress responded by appropriating $1.1 billion less than the President requested. 

Since 2007, it has been the flip side of that. This committee has 

been consistently pushing to do more than both the executive 

branch and the Senate appear to be comfortable doing. 

In April of 2007, the committee proposed nearly $1 billion in supplemental funding for pandemic activities, but that investment 

never saw the light of day because that bill was vetoed. 

In November of 2007, the committee tried again with $953 million in the regular fiscal year 2008 Labor-HHS bill, but that bill 

was also vetoed, and the end result of all of the yinging and 

yanging was a 70 percent cut in the amount that the committee 

tried to provide. 


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The committee tried again in January of 2009 with $420 million 

in the House version of the Recovery Act for pandemic preparedness, but even those limited resources met with resistance from the 

Senate. That provision was ultimately stripped from the final bill 

at the insistence of a number of Senators who asserted that pandemic funding had nothing to do with the economy and should not 

be in the final Recovery package. 

Since the unexpected emergence of the novel H1N1 virus in April 

of 2009, we have been racing against the clock to get ahead of the 

virus. In the spring of 2009, the Obama administration requested 

$3.5 billion in emergency supplemental funding and requested 

some flexible authorities. In response the committee in June of 

2009 provided an additional $7.7 billion to address this extraordinary challenge. The committee pushed hard for those investments because we wanted the country to be ready when the second 

wave of the pandemic hit. 

The Nation has made significant strides since the initial outbreak of H1N1 flu, in no small measure due to the very people sitting before us here today, who have been working around the clock 

since April. Yet, despite some successes, so far the virus seems to 

be winning. According to CDC, some 48 States report widespread 

influenza activity. Nearly 6 million people have been affected, more 

than 21,000 people have been hospitalized, and more than 800 people have died, including at least 114 children. 

In 2004, this committee on both sides of the aisle began asking 

questions about the insufficient supplies of vaccines and fluctuating 

demand for seasonal flu virus and the steps that the government 

could take to boost production levels, including guaranteeing some 

government purchases so that manufacturers could boost production levels and have an incentive to invest in new technologies. 

I would urge members of the subcommittee to go back and take 

a look at our April 2004 subcommittee hearing and October 2004 

subcommittee hearing on this issue, and I think you will have a 

clearer picture of why it is so frustrating to see how little progress 

we have made over that time in dealing with this production issue. 

Five years later, it is clear that we are still using 1950s-era technologies and we are years away from state-of-the-art technologies 

that have been in use in other countries for at least a decade. 

U.S. vaccine production capacity is still completely inadequate. 

H1N1 vaccine supplies are lagging far behind the need. By the end 

of the year, we still may not have enough vaccine to expand beyond 

covering high-risk groups to the general population. 

Moreover, the country faces other public health challenges. For 

example, the distribution pipeline to States, local communities, and 

private providers for seasonal and H1N1 vaccines, antivirals and 

N95 respirators is plagued with rusty plumbing. Many providers 

have no idea how many of those critical supplies they will receive 

and when they will receive them. State and local health departments are further hampered in confronting this public health problem by steep budget shortfalls that have resulted in the loss of approximately 15,000 public health jobs since 2008. I find that number both disturbing and astounding. 

With this briefing we hope that we can have a substantive and 

somewhat informal conversation with HHS State and local public 


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health officials so that we can ascertain exactly what the facts are 

regarding our current level of emergency preparedness at the Federal, State, and local levels so that we can understand how quickly 

response efforts can get ahead of the spreading virus instead of 

being behind the curve and identify the lessons learned to date so 

that we can be better prepared in the future. 

When I was initially talking about this problem, I had intended 

to simply have a briefing for me, as chairman of the committee, to 

try to figure out what our problems were. But the more I thought 

about it, the more I thought we ought to simply have a briefing for 

the entire subcommittee. 

Given the fact that there is so much public concern, so much 

public confusion about what the facts are, we thought that it would 

also be useful to invite—or at least provide access to whatever 

members of the press who wanted to participate, in the hopes that 

they perhaps could do a better job of conveying information to people than we have been able to do so far. 

To keep this issue focused on substance and to try to keep it 

somewhat more organized than would usually be the case in a 

hearing setting, I have asked the staff to be prepared after our 

guests after they have made their comments, I am going to ask the 

staff to proceed to ask what they consider to be the most pertinent 

questions that need to be gotten out of the way. After that, we will 

turn to any member who wants to ask questions for five minutes 

until we are interrupted by so many roll calls that we wind up 

leaving in chaos, as is often the case when we are trying to get 

something done in competition with what is happening on the floor. 

So let me simply ask Mr. Tiahrt if he has any comments he 

would like to make before we turn to our friends on the other side 

of the table. 

Mr. TIAHRT. Thank you, Mr. Chairman. I think that we are 

where we are today. I think there is a tendency in Washington, 

D.C. to try to assess some sort of blame on why we are where we 

are today. But each administration gets about 4,000 people that 

they get to appoint and about 31⁄2 million people work for the Federal Government. So the reason we are where we are, we can point 

a lot of fingers in a lot of directions. 

Since we are moving into sort of a briefing format rather than 

a hearing, I just wanted to say that there are problems with the 

number of manufacturers we have in America. We have fewer now 

than we did a decade ago. I think some of that is based on what 

barriers the Federal Government has placed in front of creating 

businesses and keeping jobs here in America, excessive regulation, 

a tax structure that punishes success, it is the litigation system, 

and it is our failure to be energy independent. 

When you add all these things together, it becomes less expensive to manufacture products that are necessary for the health and 

well-being of this country overseas. When we get overseas, for example, the New York Times has reported that the manufacturing 

of liquid flu antivirals similar to Tamiflu can be made, but we have 

not gotten approval from the FDA. So when we move jobs offshore 

and capacity offshore for building very important products like 

Tamiflu because of our own barriers created by this Federal GovVerDate Nov 24 2008 04:32 Dec 19, 2009 Jkt 053853 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 E:\HR\OC\A853.XXX A853

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ernment and its elected officials, then we wonder how we get in 

these kind of situations. 

I think what we ought to do now rather than try to assess blame 

is to move forward to find the best solutions to provide necessary 

things. We have some capacity. We have enough capacity to get the 

vaccine to our detainees in Guantanamo Bay, and yet we don’t 

have you have enough for our seniors here in America. So I think 

we ought to move forward to figure out how we are going to recover 

from that because we do have millions of doses less than we 

thought we have. 

I have other questions, but I am ready to move forward, Mr. 

Chairman. 

Mr. OBEY. Mr. Lewis. 

Mr. LEWIS. Thank you, Mr. Chairman, just for recognizing me. 

The last time we were in session like this I had my first introduction to Doctor Gerberding. I must say we said many of the same 

things you raised. There is little doubt this is a big, big challenge, 

and I would hope we can proceed with this briefing with as little 

partisan politics as possible. 

Mr. OBEY. Let me simply say that this briefing is not about 

blame. We are all on the same side. And I know everybody is doing 

their best and we are all a whole lot better at predicting the past 

than we are the future. We are simply interested in what is happening. We would like to take a hard, frank look at any things that 

need to change in the future in order to strengthen our capacity to 

deal with this in the future. 

With that, let me simply ask each of you to take roughly five 

minutes and simply give us whatever comments you would like to 

give us before we move to staff questioning and then member questioning. 

Let me simply run through the list of persons who will be giving 

us information. First, we will have Dr. Tom Frieden, who was 

named Director for the Centers for Disease Control and Prevention 

in June 2009, and is leading the work on the H1N1 virus. Second, 

Dr. Nicole Lurie, who was named the Assistant Secretary for Preparedness and Response in July 2009, and has the responsibility 

for coordinating all emergency preparedness and response activities 

at HHS. 

Then, Dr. Tony Fauci, who is well known as the Director of the 

National Institute of Allergy and Infectious Diseases. Dr. Fauci, together with Dr. Lurie, is leading HHS efforts on vaccine development and safety. 

Fourth, Dr. Donald Williamson is the State Health Officer in 

Alabama, the Alabama Department of Public Health. He will be introduced by Congressman Bonner. 

Finally, Mr. Rob Fulton, Director of St. Paul—Ramsey County, 

Minnesota Department of Public Health, who will be introduced by 

Congresswoman McCollum. 

In addition, we have in the audience Dr. Karen Midthun in case 

there are any questions pertaining to the FDA. 

Why don’t we begin with Dr. Frieden. 


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OPENING STATEMENT

Dr. FRIEDEN. Thank you very much, Mr. Chairman, Ranking 

Member Tiahrt, and members of the committee. The influenza 

virus is the enemy, and it is a difficult one to deal with. It is difficult to predict, it changes rapidly, and has the potential to cause 

enormous illness and death. Our way to address this issue is, as 

you said, Mr. Chairman, dated and requires updating. 

I am pleased to have been asked to work under the leadership 

of Secretary Sebelius to ensure that the administration implements 

a comprehensive plan to address H1N1 throughout this season. 

I bring to this the experience of having been Health Commissioner in New York City during the spring and having experienced 

firsthand the enormous challenge in terms of the number of cases, 

the challenges to the health care systems and hospitals, and the illness and death H1N1 can cause. 

First, to briefly update you on where we stand with the situation. 

As you mentioned, Mr. Chairman, the virus continues to spread 

widely. It is now widespread in 48 States. There have been as of 

now many, many millions of cases of H1N1 influenza in this country. We have had well over 20,000 hospitalizations and more than 

a thousand deaths, including, as you mentioned, 114 at least 

among children. Those deaths, in terms of the pediatric deaths, 

adult deaths, and hospitalizations, are based on estimates. A little 

counterintuitively, sometimes the most accurate information is actually from estimations, particularly for hospitalizations. 

H1N1 PATTERN OF ILLNESS

So far, there has been no change in the pattern of illness. H1N1 

is not more severe than seasonal flu. Ninety percent of deaths from 

seasonal flu are among the people over age 65. Ninety percent of 

the deaths in H1N1 are people under the age of 65. This is a 

younger people’s disease. In addition, it disproportionately affects 

people who have underlying conditions. More than two-thirds have 

had more than one or more underlying conditions, whether it is 

asthma, diabetes, lung disease, or heart disease. 

I would comment that the increase in obesity and diabetes is not 

helping us here, and our need to address that more effectively is 

very important. 

As there has been no change in the pattern of illness, there has 

been no change in the genetic pattern of H1N1. At CDC, we collect 

from around the country and around the world samples which undergo rigorous genetic testing, so we actually sequence to see if 

there are changes and monitor for the speed with which the virus 

has changed, because we know it will change. All influenza viruses 

evolve and mutate. 

H1N1 FLU COMMUNICATION

We have at this point not seen significant changes. And that is 

important because it means that the vaccine which is being produced is an excellent match for this virus and that the level of 

virulence or how deadly this strain is has not increased. It is not 

becoming more deadly. 


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Only time will tell what the future holds—how long the current 

wave will continue, how many months, how many places, how high 

it will go, and whether, when it recedes, we will have another wave 

or another strain of H1N1 this flu season. 

Flu season lasts until May. CDC’s role, much of which has been 

made possible with the additional support from Congress over the 

past several years, has been to identify and characterize the virus, 

to develop a vaccine strain, to rigorously monitor the spread of the 

disease in the U.S. and globally, and then to coordinate response 

through communication—simple things: Staying home, covering 

cough, washing hands—and detailed guidelines for key sectors— 

businesses, health care settings, schools—trying to ensure that, to 

the greatest extent possible, while protecting the public health, we 

support people continuing to go about their business and help kids 

continue learning, people continuing working, and ensure that 

workplaces are as safe as possible. 

H1N1 FLU VACCINATION CAMPAIGN

With treatment—we have to emphasize that there is effective 

treatment. Unfortunately, many people who should be getting 

treated aren’t. Only half of people with diabetes or asthma who had 

influenza-like symptoms went to a provider at all. So we need to 

continue to get the message out that if you are severely ill or if you 

have an underlying condition, such as asthma or diabetes, it is important that if you have the flu, you see your provider promptly. 

Not everyone who has the routine flu needs to be tested, but for 

those who have an underlying condition or are severely ill, it is important. 

Here, also I think we have challenges in our health care system 

in terms of its coordination, its information systems, and its focus 

on prevention. 

The vaccination campaign is an unprecedented effort. We have 

substantial amounts becoming available, but not nearly as much as 

we thought would be available or hoped would be available. With 

20–20 hindsight it is clear we should have been more skeptical 

about the projections that were being made by vaccine manufacturers and we anticipated that having five different manufacturers 

would have provided more insurance than it has. It is important 

to ensure that the vaccine that we do have gets to people who need 

it as rapidly as possible. 

RESPONDING EFFECTIVELY TO H1N1 FLU

We have taken no shortcuts in terms of safety and we are rigorously monitoring for any potential problems with the vaccine. We 

said in September that there would be bumps in undertaking this 

effort, and indeed that is the case. But we are working very hard 

with our partners throughout the U.S. Government and, most importantly, relying on State, local, and tribal health departments, 

health care institutions, and the public to address this as a shared 

responsibility that everyone can do something to address. 

We are faced with the challenges that you mentioned with State 

and local infrastructure, which have significant problems with laboratory capacity, workforce challenges, and resources available. We 

are committed to doing everything we can to respond as effectively 


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as we can and also communicating rapidly and openly with the 

Congress and the public. 

Thank you. 

[The statement of Dr. Frieden follows:] 


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OPENING STATEMENT

Dr. LURIE. Good morning. Thank you, Chairman Obey, Ranking 

Member Tiahrt, and members of the subcommittee. I too am 

pleased to be able to talk to you today about our efforts to respond 

to H1N1 in the U.S., and I, too, would personally like to take the 

opportunity to thank the committee for its continued support 

through the investments you have outlined, and despite the frustrations, we began rebuilding the vaccine infrastructure in this 

country several years ago, and as a result, when we decided to pursue vaccine in the spring, we actually had preexisting contracts in 

place with manufacturers already licensed here, enabling us to get 

out of the box quickly with contracts to manufacture the vaccine. 

My office, as you alluded to, has a four-fold role related to this 

pandemic. First is to coordinate the HHS response and to work 

with the interagency. Second is to stimulate the development of 

and contract for the vaccines and antivirals. Third is to ensure that 

we can information back out to States and communities as we get 

vaccine rolled out. Fourth, and importantly, to stay prepared for 

any other emergency. 

The H1N1 effort has been a public-private partnership. In terms 

of vaccine, I think, as you heard, we have developed this new vaccine with really unprecedented speed, and this was made possible 

by a whole series of investments and I want to say, in basic and 

clinical science, in manufacturing capacity and in regulatory processes. And obviously vaccine would not have been possible without 

our important partnerships with industry. 

But while modest amounts of vaccine came a little bit ahead of 

schedule, a combination of poor production yield, late completion of 

seasonal vaccine, some problems in new filling lines, decisions in 

manufacturing, all combined to cause delays in the availability of 

the vaccine, and I will point out not just for the United States, but 

for the world. 

The number of doses that has been produced, distributed, and 

administered continues to grow steadily. As of today, States have 

available 32.3 million doses and more are expected by the end of 

the week. But we also have to remain vigilant to ensure the steady 

supply of vaccine. We talk with the manufacturers every week, if 

not every day. We conduct site visits to our manufacturing partners 

to see what is going on and talk about how we can work together, 

and we have just completed a round of visits this past week. And 

we monitor the progress at every single lot of vaccine produced. 

Last week, Secretary Sebelius and I spoke directly with the 

CEOs of each of the manufacturing companies, seeking to identify 

opportunities to work together to speed the delivery of vaccine. And 

while these delays are frustrating to everyone, they reinforce, as I 

think you already pointed out, the need to address our country’s 

domestic manufacturing capacity using newer, faster, and more dependable technologies. And we need to do this as soon as possible. 

Antivirals have been another critical aspect of our response. 

Here, we have supported the development of new antivirals, 

issuing an emergency use authorization for the first ever intravenous antiviral medicine and we are procuring over 30,000 treatment courses of IV antivirals to treat critically ill patients. 


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We are also focused on ensuring that the health care system and 

communities throughout the country remain able to care for those 

who need it. 

You know, the President’s declaration under the National Emergencies Act was a proactive step, enabling CMS to issue 1135 waivers to hospitals and other facilities if they are getting overwhelmed. 

And we stand ready to deploy federal assets when necessary, including clinical staff, vaccination teams, laboratory support and 

temporary medical facilities. 

We’ve partnered closely with the private sector and health care 

systems, including health insurers, pharmacists, big-box stores, the 

AMA, public health authorities, to find a way to pay for vaccine administration so cost is not a barrier. 

Let me turn for a minute to some of the lessons learned. The 

support of Congress in the last few years has been critical, enabling us to respond to this pandemic. And yet it is clear that public 

investment in health, whether at the Federal, State or local level, 

has real-world consequences, and we can’t afford to let this happen 

again. 

While we have made vaccine in record time, as Dr. Frieden said, 

our original projections were based on seasonal flu and H5N1 vaccines, and we were optimistic in the face of what has proved to be 

a bigger challenge by Mother Nature. 

However, we are also far from done with the science and advanced development related to vaccines and building robust manufacturing capacity in the U.S. In other words, underinvestment in 

advanced development and infrastructure is also critical. My fear 

is that when this is all over, some will decide we don’t need to 

worry about a pandemic for the next 30 years. Nothing could be 

more dangerous. 

So despite the challenges, I believe that much of what we’ve 

learned from this pandemic will serve us well in the future as well 

as strengthen day-to-day public health. 

Thank you. 

[The statement of Dr. Lurie follows:] 


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Mr. OBEY. Dr. Fauci. 

OPENING STATEMENT

Dr. FAUCI. Thank you, Mr. Chairman, Ranking Member Tiahrt, 

members of the committee and staff, for giving me the opportunity 

to discuss very briefly with you the role of the NIH basic and clinical research endeavor in the comprehensive approach mounted by 

the Department of Health and Human Services and other government agencies in addressing the very daunting problem of this extraordinary pandemic. 

As I have testified before this committee so many times in the 

past, the mandate of the NIH is to do basic and clinical research 

in a variety of diseases. For the purposes of today’s discussion, infectious diseases in general, and specifically influenza. As shown on 

this placard on the left hand side (on your right) we have done and 

continue to do fundamental basic research and clinical research to 

address countermeasures, both therapeutics, diagnostics, and vaccines. 

Today, we will focus on vaccines. I hope during the questions period we can get into the considerable investment that was really 

made possible by the generosity of this committee in giving us 

funds to do fundamental research to bring the technology or, as we 

call it, the vaccine ‘‘platforms’’ into the 21st century to get beyond 

having to grow the virus, but to actually do it with 21st century 

technology. 

But, having said that, let me just focus for the next couple of 

minutes on the problem at hand and the activities that have occurred. 

The process of getting a vaccine for this H1N1 pandemic started, 

as you heard from Dr. Frieden and Dr. Lurie, in April. That is very 

interesting, because we usually start this process in January when 

we make a prediction what the flu would be for the next season 

and we begin with an educated guess that is almost always correct 

about matching the virus with the vaccine. In this case, it was 

April. But this was done relatively quickly, but without cutting corners. 

The CDC isolated the virus in April. Within a period of a couple 

of weeks, we at the NIH had seed viruses that we gave to our 

grantees to start looking at various components of this virus visa-vis its virulence, its transmissibility, et cetera. But more importantly, we partnered with the pharmaceutical companies that we 

had prearrangements with to get pilot lots to be given to our clinical trial units to ask some fundamental questions that were important in informing us about how to use this vaccine. 

As shown on this next placard, this is a map of the United States 

with the eight vaccine and treatment evaluation units that are 

time-honored for decades and which the NIH continually uses to 

test drugs as well as vaccines for infectious diseases that reemerge, 

and newly emerging ones. They are extensively experienced. And 

what they have done over the last several months, I think, has 

been very important to informing us about the policy about how to 

use this vaccine. 

So certain fundamental questions arise. Let me put it into perspective for you. You all remember, because I testified before this 


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committee when the H5N1 bird flu was upon us and continues to 

smolder. We made a vaccine that was FDA-approved. That was the 

good news. The sobering news is that it required an outlandish 

dose of vaccine to induce an immune response that we predict 

would be protective in even 50 percent of the people. That was not 

good news. 

So our concern right off was: Is this vaccine going to induce an 

immunogenic response that you would predict to be protective? 

So we asked a number of questions. First, in healthy adults, elderly, and children, does a dose that is comparable to the dose of 

seasonal flu induce a robust immune response? Does it require 

twice the dose; does it require two doses? And we were very 

pleased to see that in fact a single dose of 15 micrograms of 

unadjuvanted vaccine, meaning it doesn’t have a compound that is 

necessary to amplify the response, was sufficient. We were successful in showing that in a very high percentage of these healthy individuals, in fact a single dose was required. 

VACCINE TRIALS

We also had to look at children. This is very important because, 

as you know, the standard seasonal flu generally requires a single 

dose for older children between 10 and 17 and two doses for children from 9 years down to 6 months. 

I announced just a couple of days ago that our vaccine trials in 

children showed that what the FDA and the CDC and our advisory 

committees have been advising for years and years with seasonal 

flu holds true also for this vaccine. A single dose for the older children and two doses for the children who are younger. 

Importantly, pregnant women, about whom who we heard from 

Dr. Frieden, are particularly vulnerable to not only infection but to 

the complications of the infections. Again, just two days ago I announced that in pregnant women a single dose of 15 micrograms 

induced a very robust response that you would predict would be 

protective in those individuals. This is very good news for the pregnant women who have already been vaccinated and good news and 

encouragement for the pregnant women that are trying to get vaccinated. In addition, we have ongoing trials in HIV infected women 

and children and asthmatics. 

With regard to clinical trials, we now know, and as you have 

heard from both Drs. Lurie and Frieden, we are concerned and 

frustrated by the gap between the demand and supply. But as people get vaccine available to them, we know how to use it. 

I want to close just with one statement about the question I get 

asked and we all get asked so many times: What is the risk benefit? We have a very interesting, almost paradoxical situation 

where a high percentage of people don’t want to get the vaccine 

and another high percentage that do, and this gap between supply 

and demand. So when people say: Is this vaccine absolutely safe; 

there is nothing in the world that is a hundred percent safe. You 

open up your door to go to work and go out on the Beltway, that 

is not absolutely safe. So rather than saying something is absolutely safe, you say what is the risk-benefit. And when you talk 

about risk of the vaccine, we have decades of experience of making 


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vaccines very similar, same company, same materials, same process. Antiquated as it may be, it is time-honored but it is fragile. 

The risk historically is very small. We are in the middle of a pandemic and we see although the risk of serious disease is low, when 

it happens particularly to young children, people with underlying 

conditions, and pregnant women, it could be catastrophic. If you 

just look at this, the risk of getting infected and getting seriously 

ill, particularly among certain populations, is far greater than the 

risk of the vaccine. And it is for that reason that although we can’t 

say it is 100 percent safe, we recommend that those people get the 

vaccine when it becomes available. 

Thank you. 

[The statement of Dr. Fauci follows:] 


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Mr. OBEY. Thank you very much. Mr. Bonner, would you introduce our next witness? 

Mr. BONNER. I would be happy to, Mr. Chairman. Thank you 

very much. I am pleased to introduce Dr. Donald Williamson, Alabama Department of Health Officer. He has served as our Public 

Health Officer since 1992. During that time and before, he has 

been recognized repeatedly for his public health expertise and for 

his efforts on behalf of Alabama’s children as well as our 4.5 million other citizens and is one of the leading voices on public health. 

I know today he represents my home State, but he also speaks for 

his colleagues in the other 49 States. 

Like many other members of this committee, Mr. Chairman, I 

represent a district that includes large rural areas. But unlike 

some members of the committee, I also represent a city with a 

large international port and more than 50 miles of coastline. This 

represents just some of the unique challenges that come to public 

health officials like Dr. Williamson. He has met those challenges 

head on and with great success. 

Briefly, I would just like to give a tip of the hat to Dr. 

Williamson. Alabama has been a leader in several areas of public 

health, especially in the area of All Kids, our State version of 

SCHIP. It has been one of the most successful programs in the Nation in enrollment as well as in serving eligible children and Dr. 

Williamson deserves tremendous credit for that. 

So, Mr. Chairman, thank you for letting me bring to this committee someone who can talk specifically about how my States our 

State has helped in coping with the spread of H1N1. 

With that, we welcome Dr. Williamson. 

Dr. WILLIAMSON. Thank you, Mr. Bonner, for those very kind remarks. Chairman Obey, Ranking Member Tiahrt, and members of 

the subcommittee, thank you for the opportunity to describe one 

State’s experience with H1N1 2009. Many of the issues with which 

Alabama has dealt are generalizable to State public health agencies across the Nation. 

In my comments I will focus on a few critical components of that 

response. School began in Alabama in mid-August. Within days of 

the onset of school we began to observe the spread of influenza illness and H1N1 in our school system. In late, August, of Alabama 

schools had an absenteeism rate of greater than 5 percent. Fortunately, by late October that percent had declined to 4.5 percent. 

The percentage of influenza-like illness in physician offices began 

to rise shortly after the onset of school and has remained elevated, 

peaking at 12.3 percent of physician office visits. Currently, 12 percent of emergency room visits are attributable to ILI. Since early 

September, flu illness accounted for between 3 and 3.8 percent of 

all hospitalizations. Geographically, Alabama reported widespread 

inactivity for 9 or 10 consecutive weeks. At this point surveillance 

suggests that while Alabama has an ongoing outbreak, we have 

also been monitoring medical care capacity and monitored certain 

specific indicators. At no time has any bed availability been less 

than 20 percent. 

Both pediatric medical and pediatric ICU bed availability have 

hovered around 40 percent and current availability approaches 50 

percent. Adult capacity has historically been lower. General adult 


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medicine and adult ICU bed availability has ranged between 20 

and 25 percent. 

During the early phases of the outbreak, the Department received reports of pharmacists unable to obtain both tamivir and 

zanamivir in local geographic areas. In addition, we received reports of patients who were indigent or without insurance which 

paid for antiviral medication. In an effort to address those issues, 

the Department has provided almost 100,000 courses of antiviral 

medication through 832 providers. 

The antiviral stockpile in Alabama currently appears to be adequate based on our current ongoing burden of disease. As has been 

observed nationally, there is a strain on the formulary in pediatric 

preparations. The department formulated a vaccine strategy for 

Alabama based upon projections of vaccine supply provided to us 

by the Centers for Disease Control and Prevention. 

The estimates provided to the department in late September suggest that Alabama would be able to order approximately 800,000 

doses of vaccine by the week ending October 30, 2009. However, 

new projections of October 23, 2009, show that the amount of vaccine available to Alabama would be reduced to some 400,000 doses 

available to Alabama prior to the first week of November. 

Given this dramatic delay in the release of vaccine, the department was forced to reformulate its vaccine strategy. Instead of focusing vaccination efforts on the broader ACIP categories, the State 

has chosen to restrict its initial vaccination efforts to the subpriority groups identified by the ACFF. 

Likewise, we are now restricting vaccine distribution in the private sector to providers most likely to serve the target sub population, including obstetricians and gynecologists, family practice 

physicians, and hospitals. In the public sector, to maximize the 

sites at which these target populations may receive vaccine, we are 

prioritizing distribution to federally qualified health centers. 

Our school-based vaccination efforts originally planned to begin 

early October or November have been delayed to late November or 

early December. Current projections show 62 percent of the vaccine 

coming to Alabama will not be available until after December 1st. 

Based upon the current distribution schedule and assuming ongoing demand on the target population, it is likely expanding it to all 

populations of Alabamians who wish to have it may not be possible 

until late December or early January. 

In looking at some things we have learned, it is critical that estimates of vaccine delivery be realistic and credible. States develop 

their vaccination strategy based upon those estimates. A change in 

those estimates has a profound ripple effect throughout the public 

health system. Not only does a change in the available vaccine supply impact the scheduling of the clinic, it also impacts the plans for 

public information campaign. 

Any campaign encouraging expanding vaccination when the supply is limited would likely result in patients becoming disillusioned 

and frustrated because of their inability to receive the vaccine. In 

addition, the inability to provide the vaccinations will further undermine the credibility of the public health effort. 

Media campaigns must be timed to match the supply of the vaccine. If more vaccine does become available in late November, 


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media campaigns aimed at encouraging broad scale vaccination 

have a much greater chance of success and patients a greater 

chance of being vaccinated. 

In summary, while vaccination efforts have begun in Alabama, 

our long-term vaccination success depends upon the continued interest of individuals in receiving vaccinations in December and 

January, when vaccine will be more available. 

In closing, let me thank this committee. Without the support of 

this committee, we as a Nation and certainly Alabama as a State 

would be far less prepared or able to respond. 

Thank you again, Mr. Chairman and members of the committee, 

for this opportunity to share our ongoing experience with H1N1. 

[The statement of Dr. Williamson follows:] 


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Mr. OBEY. Ms. McCollum, would you introduce our next witness? 

Ms. MCCOLLUM. Thank you for the opportunity to introduce a 

person I know well, I consider a friend, Rob Fulton. He has been 

the Director of the St. Paul—Ramsey County Department of Public 

Health since 1988 and the Labor Health and Human Services Education member. He is here to brief us on H1N1. 

Rob directs an operation of large, full-service public health entity 

focusing on communicating communicable diseases, promoting the 

health in children, youth and their families, protecting the environment, reducing environmental health hazards, reducing chronic 

disease, and assuring emergency preparedness. He does this in 

many languages. One of the largest hospitals in Ramsey County 

has on hand people to interpret up to 47 different languages. 

He is the treasurer of the local public health association in Minnesota, Vice Chair of the Minnesota Block Grant Advisory Committee. He is also very active and serves on the committees of the 

Greater United Way. He is a school board member. 

The reason why I bring all this up, Mr. Chair, is he is not only 

a person who is an expert on public health and reaching out to the 

community, he is a person actively engaged in the community and 

does hear from them directly firsthand when they are fearful of 

something and when they have questions. 

Mr. Chairman, I present you Rob Fulton. 

Mr. FULTON. Thank you, Mr. Chairman, Mr. Tiahrt, members of 

the subcommittee. Ramsey County, Minnesota, has a diverse population. St. Paul—Ramsey Public Health Department has a number 

of specialty clinics that we operate for TB, STDs, family planning, 

and women’s health, as well as a large family home visiting program with over 100 families a year. We have 32 on staff that provide these services. 

We have been planning for a pandemic since the late 1990s. Federal funding to support our planning came shortly after the 9/11 

event and then the October 2001 anthrax, which I am sure you are 

all very familiar with. 

The investment that the Federal Government has made in public 

health emergency planning and especially in the recent public 

health emergency response funding has been vital assistance to us 

in dealing with this current situation. 

In late April this year is when H1N1 first reached our community. One of the biggest tasks we faced was getting accurate and 

timely information for our community about the threat of H1N1. 

We immediately began providing the mitigation information to residents of the county on how to avoid getting sick—wash your hands, 

cover your cough, stay home if you are sick. The same messages 

we gave in the 1918 pandemic are still the most effective messages 

today. As the H1N1 returned this fall, it is important we continue 

these messages until we can begin to vaccinate our residents. 

One important aspect of this communication is how to reach the 

many limited English-proficient members of our community. Our 

department, along with other local public health departments, initiated a service called Emergency Community Health Outreach, or 

ECHO. This nonprofit organization produces monthly health shows 

on our local public health television in six different languages. 


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They also have telephone message lines in different languages and 

Web site with information. 

A second major effort at the local level was to assure that as 

many of the appropriate clinics in Ramsey County as possible applied to receive H1N1 vaccine. While we have large system clinics 

among the 218 clinics we also have 63 affiliated clinics, including 

our three federally qualified health centers, health care for the 

homeless clinics, and five school districts. 

As the H1N1 vaccine became available to us in small amounts, 

our local public health department took on the responsibility of seeing that emergency medical service and other first responders not 

attached to hospitals receive vaccine. One of the dilemmas was that 

the initial vaccine provided to us by the State was the weakened 

live virus, and this type of vaccine has some limitations. 

We have also become the distributor of antiviral drugs. Minnesota has established a flu line that can help to diagnosis flu 

symptoms over the phone and prescribe antivirals to those persons 

who can best use them. For those whose health insurance does not 

cover prescriptions, the prescriptions are sent to our department 

and for the time these people can come and get the antivirals without cost. We are also the local stockpile of these antivirals that will 

distribute to our local clinics as they need them. 

Another responsibility for local public health is to be the repository and distributor of personal protective equipment, such as 

masks and N95 respirators. These supplies are coming from the 

strategic national stockpile that was distributed in part to the 

State last spring. 

So how do we do all this at the local level? We set up our incident command system last spring and reinitiated the system 4 

weeks ago. This is the formal system of managing emergency situations that we trained and exercised for the past 8 years. As of 

today, we have 135 of our 320 employees that have been assigned 

to some duties for the situation. 

The challenge for public health is that these folks have to give 

up doing their regular work in order to meet the needs of the H1N1 

pandemic. We do have some concerns. Obviously, the delays in delivery of H1N1 vaccine are causing disruptions to our plans to vaccinate as many persons as possible as quickly as possible. 

We are seeing an increasing number of illnesses in our community and hospitalizations, and we still have limited supplies of vaccine. We know that the credibility of the entire public health system is in question due to the slow arrival of the H1N1 vaccine. The 

demand for this vaccine is high right now, but slow in arriving. 

This demand may wane. For example, we are anticipating some 

7,800 doses of vaccine to focus on school children 9 and under. 

Our challenge is to distribute and vaccinate in a fair manner so 

we cannot meet what will be the high demand for vaccine in children. 

Another issue is the delay in the delivery of seasonal flu vaccine. 

While this is not an immediate problem, it could become one if we 

don’t see adequate supplies of seasonal vaccine by December. Minnesota is proud that we have the highest rates of seasonal flu vaccination for persons over 65 in this country. But this will be more 

challenging to accomplish if the delays continue. 


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We anticipate that we will be in the incident command system 

operations well into 2010. This will have a real impact on the delivery of other important services. For example, we are planning to 

move many of our home visiting services from weekly visits to biweekly visits. We are also planning to reduce the frequency of our 

food beverage and lodging inspections, and we are very concerned 

that should we have another emergency, such as a large scale 

foodborne outbreak or a tuberculosis outbreak that will require diverting our staff that we will have problems covering that. 

As you know, local and State funding for public health has been 

impacted by the poor economy, and we just eliminated 5 percent 

of our staff to meet 2010 budget goals. Wellness funding that is 

now in the health care reform bill is critical to assuring a strong 

local public health infrastructure for the future. 

In summary, local public health in the midst of the H1N1 pandemic finds itself wearing many different hats. Many of the jobs we 

are asked to do are familiar tasks, but some are not. Local public 

health workers are putting in long hours and deeply committed to 

serving our communities. 

Thank you. 

[The statement of Mr. Fulton follows:] 


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Mr. TIAHRT. Mr. Chairman, one of the things that comes up in 

the testimony that I think very important to how we direct our 

questions is the timeline to develop the vaccine. We notice that 

they had to make a selection of the virus and certain steps they 

go through, and when you have a shortage you kind of want to 

know how long it is going to take to get the vaccine. Perhaps somebody can explain the timeline. 

Mr. OBEY. I think we will get to that. The way I want to proceed 

first is to provide an opportunity for both the majority and minority 

staff to ask the more technical and exacting questions, and then we 

can move to any questions that the members might have. We will 

start with the majority first for about 20 minutes. 

H1N1 VACCINE ESTIMATES

MAJORITY STAFF. Good morning. I want to first talk about the 

H1N1 vaccine shortages that Dr. Williamson and Mr. Fulton outlined as their problems in the State and local areas. HHS’s key 

goal for vaccine preparedness under the HHS pandemic plan was 

to develop sufficient domestic manufacturing capacity to produce 

pandemic vaccine for the entire U.S. population of 300 million persons within 6 months of pandemic onset. 

While HHS, particularly BARDA and CDC, have worked 24/7 to 

address the H1N1 pandemic, we are falling miserably short of this 

goal. Following the H1N1 outbreak last spring, the Federal Government contracted with its five suppliers of seasonal flu vaccine 

to deliver 250 million doses of H1N1 vaccine to protect the U.S. 

population from the spread of the virus in the fall. Initial government estimates indicated that 160 million doses of the H1N1 vaccine would be available by October. 

Based on information provided by the vaccine manufacturers, 

HHS later revised this estimate downward to roughly 40 million 

doses. By the end of October—on October 29—CDC reported that 

24.8 million doses had been made available, still short of the lower 

estimate of 40 million. HHS’s data supplied to the committee staff 

indicate that doses sufficient to cover all priority populations will 

likely not be available until January 2010. 

Is that correct? 

Dr. FRIEDEN. As you point out, there has been a steady downgrading of the number of vaccine doses that will be available. That 

number has continued to decrease through the summer and into 

September and October. As of today, there are 32.3 million doses 

available. At this point we are focused on going week to week in 

terms of what we are anticipating coming to us. 

What we focus on at CDC is ensuring we can receive the vaccine 

7 days a week, provide for overnight shipping and facilitating 

States’ vaccine distribution, so we can get it into doctors’ offices 

and patients as quickly as possible. 

H1N1 VACCINE DELIVERY

MAJORITY STAFF. Isn’t that a concern that some of the high risk 

persons such as pregnant women and young children may have to 

wait several months to get the vaccine? 

Dr. FRIEDEN. We are very frustrated on the vaccine delivery. As 

we said in the opening remarks, we are stuck with techniques 


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which we are very confident in the safety of but which take too 

long. The initial estimates were that after the emergence of a new 

strain, it would take 6 to 9 months for a vaccine to become available. 

If you look at the previous pandemics, vaccine production has not 

made it possible to have vaccine available for the first wave of the 

disease. 

We have a flu season that lasts until May. Dr. Lurie can discuss 

in more detail the work with the manufacturers to try everything 

possible to get more vaccine. 

MAJORITY STAFF. When do you anticipate there will be enough 

vaccine to cover the priority population? 

Dr. FRIEDEN. As I said, at this point, from CDC’s standpoint, we 

are focusing one week at a time. We already have been burned, 

quite frankly, by projections that have not come to pass. Our goal 

now is to get the vaccine out as rapidly as possible and then to ensure that it is available and used by the priority patients. 

Mr. OBEY. Mr. Tiahrt raised a question. I understand you are 

shy about making predictions. Nonetheless, you must have some 

observations based on your experience to lead you to have some estimate of a timeline. 

Dr. LURIE. Maybe I can jump in here, if I can. We have been 

working extremely hard with each of the manufacturers to be sure 

that all of the stumbling blocks that we have any control of and 

that they have control of are really out of the way. Some of the 

problems that they encountered early on in terms of growth, in 

terms of filling capacity, et cetera, seem to have been very well addressed. But, to be quite honest, as I think you heard from the beginning, and as we know from history, the flu is really unpredictable. 

I think we are pretty hesitant about projecting forward more 

than week to week, largely because anything could happen. So 

while I think at this point we feel like more vaccine is coming out 

every week. At this point creating sort of more expectation, I think, 

will be more confusing than anything else. 

MAJORITY STAFF. What have you learned on the site visits? Why 

can’t more vaccine be produced by the end of the year? I think it 

goes to the timeline of the vaccine and production. 

Dr. LURIE. On the site visits what we have done is a couple of 

things. I brought along a graphic which sort of might help a little 

bit to explain things. But at this point the manufacturers really are 

where they are with their production—let me just pass this out to 

the committee. 

The manufacturers, I think, have all made a lot of progress with 

their yield and their growth, which is—the first step is really sort 

of growing this virus. So what this really tries to depict is the manufacturing process in some sense, as Mr. Tiahrt asked, and where 

we have made investments, that is the stuff in green. 

The stuff that I know you are most interested in is down the lefthand column in yellow. 

So the first problem that everybody really encountered was poor 

virus growth. 

So the yields of virus, and so the yield of vaccine, continued to 

decrease throughout the summer and into the early fall. All of the 


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manufacturers have told us now that those are—they are really 

through those, at least for now. Again, something could happen 

that could stunt that virus growth, and that is one of the reasons 

that we are hesitant to predict. 

One of the things that we did on the site visits was really to look 

at the production challenges and to try to see if we could work together to figure out were there other production challenges that together we could overcome. If one manufacturer didn’t have enough 

filling capacity, for example, we could potentially help identify a 

source for them to fill in a contract manufacturer that was licensed 

in the United States. And we have done those things. We have 

shifted all of the vaccine manufacturing, to the extent we can, to 

multidose vials first because they are faster to fill, leaving the rest 

left over, as I know you have been interested in, for the single-dose 

syringes. 

So we have really worked with them to shift everything they can 

do to get vaccine out as fast as they possibly can. And then lot by 

lot we are tracking through the process so that to the degree even 

that when a lot is ready to be released at a manufacturer, we actually have a truck waiting and pulled up at the loading dock ready 

to accept that vaccine and bring it to the distribution site. 

So we have been working sort of at every step of the process to 

get any delays out. That is what those site visits have largely been 

about. 

VACCINE MANUFACTURERS

MAJORITY STAFF. I have a question about the contracts. HHS 

purchased enough vaccine to produce 251 million doses, but has 

only contracted with manufacturers to finish 117 million doses. 

Why hasn’t HHS contracted to fill 251 million doses? 

Dr. LURIE. As you know, we need to really have a balance between being sure we have got enough vaccine throughout the time 

that people need and want it and being careful stewards of society’s 

resources here. So the biggest issue first is to get that bulk vaccine 

produced. It takes 4 to 6 weeks from when you have that bulk vaccine to do what is called fill and finish—put it in vials, sterility test 

it, to have it safe for release and ready for distribution. And so we 

have gone ahead, as you said, and issued orders for the first 117 

million to be put into vials and actually this week are issuing more 

orders for additional vaccine so that we don’t have a gap. Because 

of the delays in vaccine, that 117 million is taking us further into 

the year than we thought it would. 

We will continue to issue additional task orders in time to fill 

and finish vaccines so that there is no gap in the delivery. 

On the other hand, we don’t want at the very end of this to be 

sitting with a lot of vaccine already in vials that can’t be used. It 

is better to keep it in its bulk form so that it could be used, for 

example, in the seasonal campaign next year or potentially available to adjuvant for the developing world. 

But please be assured that we have a very steady stream of filled 

and finished product coming out of the pipeline, and we are buying 

it as fast as the manufacturers can produce it. 


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VACCINE TECHNOLOGY

MAJORITY STAFF. Next I want to ask some questions about the 

vaccine technology. Everybody has alluded to the fact that we are 

using 1950s-era technology to produce a vaccine. European countries, though, have already approved and licensed cell-based vaccine technology and are benefiting from that faster technology in 

this pandemic. As we understand the cell-based method, it doesn’t 

take as long to produce a seed strain. It allows for a more reliable 

and sterile method of replicating the vaccine in cells rather than 

chicken eggs. It has the added benefit of allowing the vaccine to be 

provided to people with egg allergies, and it can be made at least 

four weeks faster and in greater volumes than egg-based vaccine. 

HHS has invested over $1,400,000,000 for research and development and in new facilities to produce the cell-based vaccine. Six 

manufacturers have received contracts for this work, and one manufacturer, Novartis, is building a facility in North Carolina. Yet it 

appears that licensed cell-based vaccine in the U.S. is still at least 

three years away. 

When might these new facilities obtain approval from FDA to 

begin manufacturing? What actions can HHS take to expedite this 

process? 

Dr. LURIE. Let me say first that we are very encouraged both by 

the development of cell-based technologies and other new technologies, I think, that are coming down the line, and that we have 

invested in both from the basic science perspective from Dr. Fauci’s 

end and through advanced development through the BARDA end. 

The first cell-based manufacturing facility is now being built in 

Holly Springs, North Carolina, by Novartis, and we have provided 

substantial funding to help with that facility, and so that we will 

have capacity there to manufacture cell-based vaccine when it is 

available for manufacturing. 

Our understanding is that right now that manufacturing facility 

will first be available to manufacture flu vaccine, again, if all goes 

according to plan, in 2011. When the vaccine will be licensed is 

really an issue of when the company is ready with the techniques, 

with the manufacturing, when the material is submitted to FDA, 

et cetera. So I cannot speak to when the FDA would approve a license. 

CELL-BASED TECHNOLOGIES

MAJORITY STAFF. What impact would cell-based vaccine really 

have on the production capacity and manufacturing time? 

Dr. LURIE. Well, as you already said, we believe that cell-based 

technologies will get us vaccine faster, more reliably. We will avoid 

the problems with egg-based allergies, as you said, and I think we 

are very, very encouraged by that. 

I want to point out that, as you alluded to and as Members have 

alluded to, we need this manufacturing capacity in the United 

States. This cell-based facility is the first one. It is going to get us 

maybe a little shy of halfway to what our pandemic goal might be 

in terms of capacity to make vaccine for the entire United States. 

So while we are really excited about this step forward, we need to 

continue to invest in cell-based technologies, and in additional 


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manufacturing facilities, and additional new technologies to take us 

even further into the 21st century, and to then be able to take 

those technologies to scale in large-scale manufacturing in the 

United States. 

Dr. FAUCI. Could I just add to that so there is no confusion about 

the relationship between cell-based technologies and other technologies that don’t require the virus to grow? 

So it is entirely conceivable that you could have a cell-based technology that requires the virus to grow, and it will grow very poorly 

in the cells. So when you have to get the virus to grow, there is 

no guarantee that you are going to all of a sudden get away from 

all of the vicissitudes of egg-based. 

Probably more important than being more quick or quicker, like 

3, 4 weeks, whatever, is the surge capacity of cell-based, so you can 

get all of these vats of cells ready to go, and when you need to 

make more, you just pull a vat out and start growing it. We feel 

that the answer to these kinds of uncertainty is to do the kinds of 

platforms that we are doing, basic research, clinical research and 

partnering with the biotech companies to take vaccinology from influenza into the 21st century by not requiring the virus to grow. 

There are so many of those different techniques. One of them is, 

for example, to take the DNA that codes for the hemagglutinin, 

which is the important component of the immunogenicity of this, 

and inject it into an individual and have that person make a lot 

of immune response against that hemagglutinin. You don’t have to 

require the virus to grow anywhere. You could just make that DNA 

and make it in unlimited amounts. 

Those are the kinds of technology. There are about five or six 

platforms. So, although cell-based is important and that is the next 

step, which we are pushing for and have invested a lot of money 

in, that is not the endgame for us. The endgame is to get away 

from requiring the virus to grow. 

Thank you. 

COST OF NEW TECHNOLOGIES

MAJORITY STAFF. Will vaccines using either cell-based or any of 

these new technologies be more expensive? And if so, how will this 

affect both seasonal and pandemic flu prevention campaigns on a 

Federal and State level? 

Dr. LURIE. That is a great question. I am not sure at this point 

that I am able to answer whether they will be more expensive. Certainly there is a lot of investment in research and development 

that goes into making and producing any vaccine, and certainly the 

more of it you make, and the more of it you use, the lower the price 

gets, because you have all those efficiencies of scale. But I don’t 

think I could predict that now. 

Dr. FAUCI. In general, new technologies, when they start off, turn 

out to be more expensive than molecular—as you scale up and really get a lot going, and you get a predictability about how much you 

can order, the prices plummet. But right from the get-go, if you are 

starting with a new technology that is going to maybe take 10 or 

15 percent of the vaccine requirement, that technology you can almost guarantee is going to be more expensive initially and then ultimately would become much less expensive. 


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MAJORITY STAFF. Had HHS invested solely in bringing on and 

approving new technologies rather than focusing considerable resources on egg-based vaccine, would we have had this newer, faster 

and more reliable method for the H1N1 pandemic? 

Dr. LURIE. Hindsight is always a good thing, and I will confess 

that I don’t have the hindsight to be able to answer that question. 

Things always take longer than they should have. And I can remember we first started talking about the need to get away from 

egg-based technologies probably in the late 1990s, and we invested—started investing very heavily in the science at that point, 

largely under Dr. Fauci’s leadership, to move to both a cell-based 

and some of the newer technologies that he alluded to. You have 

to have those platforms ready and the techniques ready before you 

can even start to invest in the manufacturing facility and take it 

to scale. 

Having said that, yes, we could have invested more, and, yes, we 

could continue to invest more in the advanced development of all 

of these new techniques and new vaccines. And I believe that we 

need to continue to do that. 

Mr. OBEY. I am going to interrupt because I am informed that 

we are going to have some votes in about 10 minutes on the House 

floor. I would like to give the Minority an opportunity to proceed 

at this time if we can. 

Mr. Tiahrt, how do you want to proceed? 

ISOLATING FLU VIRUS

Mr. TIAHRT. There are a couple of questions that would help lay 

the ground rules of some further questioning, and like the time line 

of how much is available, and so maybe it is a projection, and I 

think that might be helpful. 

I will just refer back to your chart, if that is okay with you. I 

was a little curious about on the right-hand side, there looks like 

there is a pallet coming down from the side, and I really couldn’t 

connect that to what was going on. Do we have to airdrop this in 

or—— 

Dr. LURIE. I wish we could. 

Mr. TIAHRT. Click your heels, and we will get her home. 

Dr. LURIE. They look a little orange, too, but not quite like the 

red shoes I have on. 

So what that is really intended to convey—first of all, as we all 

know right now, we are still dependent on growing vaccine in eggs. 

Mr. TIAHRT. Was that a pallet of eggs? 

Dr. LURIE. That is a pallet of eggs, and what this is intended to 

show is that until we have these new technologies, we have had to 

invest in maintaining a steady supply of millions and millions of 

eggs. 

Mr. TIAHRT. It says here we have started the egg supply contract 

in 2004. And so how many eggs do you need? Is there one vaccine 

per egg, or is it multiple eggs that are required? 

Dr. LURIE. So one of the challenges as I think during seasonal 

flu vaccine—and my colleagues can correct me if I am a little bit 

off here—but you can get at least two, sometimes more, sometimes 

three doses of vaccine per egg. But each virus grows at a different 

rate. For this H1N1, I think when people started with the very 


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first strains, they were getting about .2, .3 doses per egg. And they 

have done a lot of work to change the strain. 

Mr. TIAHRT. Will it increase the capacity? 

Dr. LURIE. To increase that capacity. But you need millions of 

eggs is the answer. 

Mr. TIAHRT. Okay. Do we have millions of eggs now? 

Dr. LURIE. We have millions of eggs now, and we have been securing millions of eggs and millions of chickens. I learned when I 

came to this job that I was responsible for many chicken farms. So 

absolutely. 

Mr. TIAHRT. Well, so if you are going to look at a time line, and 

you need to increase the dosage, you start with what? You start 

with ordering eggs or buying chickens? 

Dr. LURIE. So what you have to do in the time line is you have 

to do a couple of things simultaneously. You have to have the eggs, 

and, you know, they have to be fertilized and embryonated eggs, 

and at the same time—— 

Mr. TIAHRT. But you don’t go to the store to get them. It takes 

a while to order them? 

Dr. LURIE. We have a steady supply and a steady order now, so 

that is not the hang-up, and that is because of investments made 

in 2004. Okay? But then when a new strain comes along, what you 

have to do is isolate the virus, get the seed strain, as Dr. Fauci alluded to in his graphic, and then it has to grow so that you can 

actually inoculate the eggs. 

Mr. TIAHRT. How long does it take to isolate a virus? Is there an 

average time, or is there a unique time? 

Dr. FRIEDEN. Just days. In fact, this virus was isolated in California by CDC work that was ongoing to identify new strains before 

the Mexican outbreak. 

Mr. TIAHRT. So they are constantly looking for a mutation to 

this—— 

Dr. FRIEDEN. Within the resource limitations that we have, yes. 

Mr. TIAHRT. Okay. So once we capture that, then how do they 

grow enough to put into the eggs? How long does that take? 

Dr. FRIEDEN. The first step is that CDC will isolate the virus, select a candidate strain that looks like it will be good for a vaccine, 

and send that to partner institutions that will then change it to a 

form that facilitates the making of vaccine. 

It took us literally days to get that done after isolating the virus. 

We provided it to partners. The partners then provide it openly to 

manufacturers, academic institutions, governments throughout the 

country and around the world. 

TIME LINE FOR VIRUS ISOLATION

Mr. TIAHRT. So from the time you isolate the virus until you inoculate the eggs is how long? 

Dr. LURIE. What we are hearing is about 10 days, 2 weeks. 

Dr. FAUCI. It really varies because there are two ways to get— 

you have to get what is called the seed virus and a reference 

strain. And what happens is that there are two ways to do that. 

You have viruses that are very good growers and adaptive to eggs, 

a Puerto Rico strain. 

Mr. TIAHRT. What is the longest it would take then? 


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Dr. FAUCI. Well, it could take several weeks. It could take a 

month if you don’t get a good reference strain or a seed virus. If 

you do it real quick, and you are lucky, you could do it days to a 

couple of weeks. If it takes a long time, you could go a month. 

Mr. TIAHRT. So if you were going to get 100,000 vaccines, it 

would take 2 to 4 weeks to get ready to inoculate the eggs, and 

then how long for it to incubate within the eggs? 

Dr. FAUCI. That takes months and months. And again, that depends on how quickly it grows. So if you have isolation within a 

few days, you get that, it takes a few weeks to get the reference 

strain or the seed virus. You grow it up, you give to the different 

companies, and they start adapting it to their egg system or whatever system they use. If it hits the ground running and it is really 

a good grower, you could start making that right away and getting 

yields within a period of a couple of months. Getting the yield for 

what you want, the whole process generally—— 

Mr. TIAHRT. Let us just use 100,000 as kind of a benchmark, 

100,000 vaccines. You want to end up with 100,000 vials—is that 

the correct term? 

Dr. FAUCI. Yeah. 

Mr. TIAHRT. I am just trying to get my arms around what is 

the—how long can we expect this process to last or to take? And 

it seems kind of nebulous now. I can’t project forward. And if I 

needed 100,000 vaccines at some point in time, when would I expect those to be available? When you order a product, it has a delivery date. What is the delivery date for 100,000 vials? 

Dr. FAUCI. Planning for the pandemic, it is always 6 to 9 months. 

So from the day the virus is identified to the day a vaccine is 

ready, then you give to the patient. 

Dr. FAUCI. But 100,000 is really a small amount of vaccine. So 

if you look at—yeah. 

Mr. TIAHRT. The time line, what is a realistic time line? 

Dr. FAUCI. If it is a real fast grower, you could knock 100,000 off 

in a few days actually if you have a big enough plant. But I think 

that the important issue to understand is that on a regular flu year 

where you have a reasonably good grower, no glitches, from the 

time you isolate the virus or make the decision of what you are 

going to put in your vaccine to the time you get it in the vial 

ranges from 6 to 9 months, 6 to 8 months. That is the time line. 

TIMEFRAME FOR H1N1 INFLUENZA VACCINE

Mr. TIAHRT. We can expect the same for the H1N1? 

Dr. FAUCI. We had hoped that that was the case, and there were 

a couple of issues, I think three issues. And I believe that was the 

question you asked right from the beginning that you wanted to get 

to. 

So if you look at the timeframe, when you decide what you are 

going to do with seasonal vaccine, you usually make your decision 

around January, and you start this process. If it is a reasonably 

good grower, you get what you need around the middle of the summer. You start getting it ready to send out in September. You get 

it out to the people who need it, and then the flu season doesn’t 

really hit you in earnest until the end of the fall, the beginning of 

the winter and well into the winter. So now what you have here 


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is a process that started in April. So right away the wiggle room 

for slow growth, you have one foot on a banana peel there because 

you have lost 3 months. 

On the other end of the spectrum, instead of having some cushion room for a flu season to start, the virus never left in the summer, and it was just waiting for the kids to come back to school 

at the end of August and the beginning of September. So instead 

of having the grace period of things really happening in earnest in 

December and January, they happened in earnest at the end of August and the beginning of September. Superimpose upon that a 

virus that doesn’t really grow very well, and you have a triple 

whammy. You start late through no fault of anybody. That is when 

the virus appeared. You have a flu waiting for you when the kids 

go back to school, and you have a slow grower. That is the issue. 

That is the issue. 

Mr. TIAHRT. So we have 6 to 9 months, which, to me, if you don’t 

have a time line, and there is all of this sort of I guess I will use 

the term slush in the schedule, and it is kind of slushy, then I am 

not sure we can properly manage it, because you can say, oh, well, 

it is going to take longer than we expected, and so that is just the 

way it is. I want to make sure that we are managing this from our 

perspective as the government. I mean, we took over General Motors in a couple of days, we took over the banking industry in a 

couple of weeks, so why can’t we take over this process and get it 

to work right in a time line that is not 50 percent off, you know, 

3 months one way or the other? 

Dr. FAUCI. That is a superb question, and it is the question that 

is frustrating us all, because the thing that really is—at this point 

in time with this technology which is being used, for which there 

was no choice but to use it because it was the only available technology, for this type of technology, as difficult as it is—and we 

swallow hard when we say it—you really can’t do anything when 

you have a virus that is not growing well except trying to wiggle 

it around to get it to grow better. So you really can’t say, well, now 

we definitely are going to have these amount of doses, which is the 

reason why Dr. Lurie has said it is very difficult now when you 

have such a fragile system to make an absolute definitive prediction. 

Mr. TIAHRT. And we are talking about the American capacity, 

correct? I mean, we are relying on worldwide production for this. 

And so how much less control do we have over the worldwide production of this? I mean, we are talking about 6 to 9 months for domestic capacity, and does that—or does that include the ability for 

Australia, which we contracted with, and then they diverted their 

supply for Australia, not a surprise. So we have limited capacity 

here, and we have this sort of slush in the schedule, does that 

apply to worldwide, or is it worse overseas like with the interruption of Australian production? 

Dr. FAUCI. Everybody has the same problem with growing this 

virus. This is a global issue. This is a global issue. This is not 

something that is peculiar to the United States. 

Mr. OBEY. Would the gentleman yield? 

Mr. TIAHRT. Yes. 


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PREPARATION OF THIMEROSAL-FREE VACCINE

Mr. OBEY. I would like to add one more complicating factor to 

this. As we know, we have had a controversy involving thimerosal. 

As I understand it, the prepared doses that were thimerosal-free 

took considerably longer to produce the same compound—has that 

controversy, in your judgment, added appreciably to the time it has 

taken to get this off the ground? 

Dr. FAUCI. I think a bit, but not substantially. That is not the 

major issue. That is not the major issue. 

Mr. OBEY. I mean, if it takes so much longer to prepare the 

doses, but not the thimerosal-free, then why does that take—why 

is that not—— 

Dr. FAUCI. If you have multidose vials that would require having 

a preservative like thimerosal, it facilitates the process rather than 

having to put single—but I don’t think that is the answer to the 

problem. The answer to the problem is the fundamental terrible 

growth of this virus earlier. 

Dr. LURIE. Thimerosal is not involved in whether the virus grows 

or not. Thimerosal is added at the end to those multidose vials as 

a preservative. So if the major problem is whether the virus grows 

and whether you get to those big vats of vaccine that is ready to 

get put in vials, thimerosal has no effect on that. 

Mr. TIAHRT. If the growth time is slow, then why do we have a 

pandemic? 

Dr. FRIEDEN. There is a difference between how it grows in the 

laboratory and how it spreads from person to person. One of the 

reasons that this virus has spread so rapidly and affects younger 

people more is that it is unfamiliar to us. So there hasn’t been a 

similar virus circulating widely in decades, and that means that it 

can spread rapidly among people who don’t have any immunity 

from having been exposed to similar viruses in the past. 

Mr. TIAHRT. So it is the strain that is unusual to our younger 

population now that allows this to grow so freely among kids under 

5. I guess that is the—what do we call that group, the risk or priority population? What is the priority population? Is it children 

that are 5 and pregnant women? 

Dr. FRIEDEN. There are five groups that are a priority for vaccination. One is health care workers who care for people with influenza and need to be protected. The second is pregnant women, who 

are at higher risk. The third is people who care for infants 6 

months or younger, because we don’t give vaccine to infants 6 

months or younger, so we protect them by protecting the people 

around them. The fourth is kids and young adults from 6 months 

to 24 years of age more likely to get the illness. And then the fifth 

is people 25 to 64 who have underlying health conditions, and if 

they get the flu, they are more likely to become severely ill. 

Mr. OBEY. Let me interrupt and say that we have got four minutes left on the clock to vote. So what I would like to do is get in 

one other person’s round of questions before we break to vote. 

Ms. Roybal-Allard. 


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VACCINE AVAILABILITY

Ms. ROYBAL-ALLARD. Thank you, Mr. Chairman, for having this 

important hearing. 

I want to go back to the shortage issue. There have been news 

media reports of people standing in lines for hours trying to get 

vaccinated only to be turned away. In Los Angeles County, for example, about 5.5 million people fall into the priority categories for 

getting vaccinated, but only about 50,000 people were vaccinated in 

the first week after the county clinic opened, and many were 

turned away because the vaccine supplies had run short. 

Now, public health experts have repeatedly told us that once people are turned away, it is very hard to get them back to be vaccinated. So my question is have the early supply shortages seriously damaged the goal of vaccinating all Americans? And where 

do you think the point of balance is between your public messaging 

intended to raise public awareness about the dangers of H1N1, 

which raises the demand for the vaccine, and the current limited 

supply of the vaccine? 

Dr. FRIEDEN. Thank you. 

As you point out, anytime someone comes to a doctor’s office or 

goes to a vaccination site, and there is not vaccine available, the 

likelihood they will return to that site is less than we wish it would 

be. That is why we are so frustrated to not have the amount of vaccine available when people want to get vaccinated. 

Our goal has always been that the vaccine should be available 

to anyone who wants to be vaccinated, starting with the priority 

groups, understanding that many people choose not to be vaccinated, and that is their choice. There is no mandatory vaccination 

as a part of this. We are currently at 32.3 million doses available 

for ordering and distribution. It is not nearly where we would like 

to be. 

What we can predict is that the demand for vaccine will be dependent on multiple factors, including how much disease is in a 

community, how high-profile that disease is, and also an extent to 

which the vaccine shortages tend to increase demand for vaccine. 

We are seeing in this season unprecedented demand for seasonal 

flu vaccine, even though the seasonal vaccine doesn’t protect you 

against H1N1, and seeing also shortages of seasonal flu vaccination. The seasonal flu vaccine distribution system is done completely differently than H1N1 is done, with 90 percent of seasonal 

flu vaccine being ordered directly from the distributors by doctors, 

pharmacies, and others. 

But absolutely the fact that there is not H1N1 and seasonal flu 

vaccine currently in providers’ offices when people want to get vaccinated means that some of those people who want to get vaccinated and would benefit from it in all likelihood unfortunately 

will not get vaccinated in the future. 

STATE AND LOCAL PLANNING

Ms. ROYBAL-ALLARD. And after the initial waiver of vaccinations, 

what will be the strategy to reach the rest of the non-high-priority 

population? And how are you communicating that message to the 

public? 


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Dr. FRIEDEN. Each State operates differently, and we at CDC 

have provided, with the support of the committee and Congress, 

about $1,500,000,000 to States and localities for planning and administration of vaccine. Some States are working through managed-care organizations, some through public vaccine clinics, some 

through private provider offices. Many are doing school-located vaccine clinics, and we have some excellent examples of each of those 

things working very well. But we have left it up to each State to 

identify the strengths within their jurisdiction, and then to support 

them in doing that. And I don’t know if my colleague from Alabama 

would like to say more. 

Dr. WILLIAMSON. Yes, ma’am. I think the answer to the target 

populations, at least in Alabama, we are trying to match the target 

population with the provider most likely to see the target population. For example, our plan, for example, originally to reach children in kindergarten through 12th grade was to do school-based 

vaccination clinics. Well, we still hope to do that, but it has been 

pushed further into the future. 

To reach pregnant women, we have obviously reached out to our 

ob/gyn community and family practice physicians, we have reached 

out to our federally qualified health centers. And we have done 

that for all of them. 

But then underlying that, we also recognize that there are going 

to be patients who don’t have a primary care provider who are in 

one of those target populations. That is why last week we held 

across our State statewide vaccination clinics throughout our county health departments. We will continue to do that. 

Our strategy is as long as the vaccine is limited, we are going 

to push vaccine into the private provider community, target the 

population. We are going to have an underlying safety net of community health centers and public health departments to serve 

other people. 

I think the concern is once there is enough vaccine, whether that 

is late December or January, then it is going to be the challenge 

of reaching out to people who have self-deferred and not come in. 

And in Alabama one of the things we have said is that while we 

are trying to reach the target population, anyone who gets in line 

we will vaccinate, because once we turn them away, we are not 

sure they will ever come back. That was the experience in 2004 

when the last vaccine shortage occurred. 

FILL/FINISH ISSUES

Mr. OBEY. Time has expired. Let me just ask one other question 

before we break. I understand that the vaccine grows the same— 

at the same speed, whether it is thimerosal-free or not. But my understanding was that filling and finishing took considerably longer 

with the thimerosal-free vaccine. 

Let me call on the clerk to simply expand on that, because I am 

still not sure whether or not there is any delay in delivery because 

of that problem. 

Dr. FAUCI. That was the point I was trying to make, Mr. Chairman, is that the—it is easier obviously to have multidose vials, 

which requires a preservative, than it is to have single small-dose, 


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thimerosal-free or prefilled syringes. There is no doubt about that. 

That is a fill/finish issue. 

The issue that we are facing is much less a delay in fill/finish 

than it is of delay in how the virus grows. So that is the reason 

why I said obviously you may be able to cut some time off in fill/ 

finishing, but the fundamental basic problem is the virus not growing well. 

Mr. OBEY. We understand that. I was just trying to figure out 

how many additional problems we have. 

Dr. LURIE. So let me maybe jump in and add to that. When it 

began to look earlier on in the fall, and maybe even earlier than 

that—I can’t recall exactly the dates—that we were going to have 

this low growth and fewer doses of vaccine, we worked with the 

companies pretty quickly to say ‘‘do everything you can to maximize the number of doses that get out there quickly regardless of 

whether that is in a prefilled syringe or a multidose vial.’’ The fastest thing to fill is a multidose vial that has thimerosal. And we 

asked the companies to differentially first fill as much as you can 

in your filling lines that use multidose vials. If you have stuff left 

over, by all means put it in prefilled syringes, but don’t hold up the 

number of doses that we are going to be able to get out quickly because of the need to fill prefilled syringes. 

So from that perspective, yes, it had a little impact. I think it 

had very little impact. 

Mr. OBEY. We are going to have to recess to vote. We will be 

back as soon as we can. 

[Recess.] 

Mr. OBEY. Ms. McCollum. 

Ms. MCCOLLUM. Mr. Chairman, people have talked about the 

time line and everything else, and I just want to really be clear 

about the amount of vaccine. 

There is misinformation in the media that the reason why the 

vaccine doses weren’t delivered on time is because there has been 

a huge government takeover of the health care system. And it is 

in the widely circulated talk radio, and it is part of an experiment 

on government health care. 

Now, the government, the Federal Government, has CDC doing 

research and investigation, NIH out there working. Everybody is 

out there doing the best that they can. So if you could just walk 

through what is a public/private partnership that you keep referring to that you went out and you asked—my understanding is the 

different organizations of the Federal Government went out and 

said, how much vaccine can you provide? The private companies 

gave you an estimate on how much vaccine was going to be available, and there was a shortfall. And are they back on track to get 

caught up? Because this was not—the Federal Government does 

not have a vaccine plan where the three of you were overseeing the 

eggs and making sure the vials were done; this is a private company that does that. 

So what have the private companies told you about why they 

were so off from what they originally promised our government, so 

that when you made the phone calls to the State, and the State 

made the phone calls to Mr. Fulton as to how much vaccine we are 

going to have, what have they done to get this back on track? And 


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how concerned are you about what we are starting to hear about 

possible shortages of the regular flu virus? 

Dr. LURIE. That is a lot of very good questions, and let me take 

a stab at this. 

I mean, this is a public/private partnership. Much of the vaccine 

development, therapeutics development and others, are all public/ 

private collaborations of one kind or another. There is a pretty substantial investment in the basic science of doing all this and the 

clinical science of this. Much of that investment has been through 

NIH. There is investment to take things that show a lot of promise, 

make it through early clinical trials, to take things to—— 

Ms. MCCOLLUM. Madam, my time is limited. I want to know 

about the shortage. 

The manufacturers gave the administration a targeted amount of 

vaccine that they thought they were going to have available. 

Dr. LURIE. And why didn’t they. 

Ms. MCCOLLUM. It is not available, and it is not—it wasn’t anything that any of you or anybody in the Federal Government had 

any control over, correct? 

Dr. LURIE. That is exactly right. That is exactly right. And largely, as I think we had talked about before the break, the biggest 

problem had to do with this growth of the virus. And the experience historically with growing virus was very different than the experience with growing this particular virus, and that is why we 

need to get away from making vaccines that depend on us to grow 

it. 

Ms. MCCOLLUM. Thank you. 

So when people are out getting misinformation saying the reason 

why we don’t have enough vaccine is because of government takeover, and because the Federal Government blew it, and, you know, 

you can’t trust them with your health care, what kind of effect does 

that have? That has a trickle-down effect when this kind of misinformation is repeated over and over and over again. And there is 

a shortage because the manufacturers in the private sector didn’t 

deliver as much as they thought they could originally on time. 

Mr. Fulton and your colleague, what kind of effect does that have 

with all the other messages you are trying to get out to reenforce 

that, when this misinformation continually is repeated, don’t trust 

the government when they tell you something about the flu? 

Mr. FULTON. Well, we usually talk about don’t trust the Federal 

Government. 

Local public health is very much in the business of communicating messages to people, and when our messages are inaccurate, that lessens our credibility. And when our credibility is 

lessened, the messages that we are getting out about, you know, 

don’t smoke, exercise and things like that are tainted by the fact 

that we have bad information. 

We cannot control the media. We have learned that from a long 

time ago. There are lots of messages that come out. I have had 

staff come in and say, gee, the other day I heard somebody on the 

radio say that you don’t need to have a fever, and you still have 

H1N1. Well, that is not the message we are getting out. Our message is this is what H1N1 looks like when you get it. 


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But there are lots of poor messages out there, and we try to do 

the best we can. If we have to tell people, yeah, we don’t have vaccine, as I mentioned in my remarks, that is going to affect our 

credibility. 

Dr. WILLIAMSON. And I would just echo that I think in this specific circumstance my concern is that our inability to deliver the 

vaccine on the schedule that it was planned have two effects. One 

is that undermines credibility, and it leads to people also questioning, well, if they didn’t produce the vaccine when they said they 

would, then is it really safe? And the second thing that I worry 

about is our ability to deliver this vaccine later in the influenza 

season when historically people aren’t looking for vaccines. 

PHARMACEUTICAL COMPANY GOOD FAITH BENCHMARKS

Mr. OBEY. Dr. Fauci, did you want to comment? 

Dr. FAUCI. Yes. 

Mr. Chairman, your point is very well taken. And I agree with 

what my colleague said here, but I don’t want anyone to get the 

impression that it is the drug companies’ fault that this is happening, because the drug companies, in good faith, contracted with 

the government to get a certain amount of doses for the flu season. 

With that comes benchmarks of when you think they will be delivered. The fact that they are not has to do with what we have said 

over and over again during this discussion, Mr. Chairman, that the 

virus doesn’t grow very well. 

But the one thing that I think would be a misrepresentation and 

unfair is that it is their fault because it didn’t grow very well. It 

is just the nature of the biology of the virus that created an expectation that we thought there would be a certain amount. That expectation was shared with the American public, and there is a disappointment that is frustrating and all. But I would hate to see it 

said that, you know, we did everything right; it is the drug companies’ fault, because it really isn’t. 

Mr. OBEY. Mr. Bonner. 

IV INJECTION

Mr. BONNER. Thank you, Mr. Chairman. 

I was initially going to ask this question of Dr. Frieden, but I 

think I am going to focus it to Dr. Lurie because she actually mentioned it in her opening statement, and it really deals with the 

issue of an IV injection. 

As the committee knows, the vast majority of H1N1 inoculations 

will be administered by either the spray or by needle, but for a 

small minority of patients—I think you referenced this, I know it 

is in your written testimony—would need to receive the antiviral 

inoculation intravenously. 

And my question to you is we have a pharmaceutical company 

in Alabama, full disclosure, not in my district, but in my home 

State, that produces the drug Peramivir that I believe you mention 

in your written statement, which is designed to be administered 

through the IV. As I understand it, the FDA has not yet approved 

this drug, but last Friday HHS issued an emergency use authorization to allow CDC to distribute this to eligible entities. 


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So my question to you is can you speak specifically about the 

emergency use authorization for this drug and whether the courses 

are going down according to the schedule? And would you anticipate CDC having enough courses to handle the potential surge of 

patients into ICUs? 

Dr. LURIE. First, let me just clarify something so that there is 

no confusion here. The vaccination that is either injected or 

through nasal spray that we have been talking about all morning 

is what you give to prevent people from getting sick. The antiviral 

is what you give to people once they are sick to prevent further 

complications. 

Most antivirals are oral. There has never been an IV form of an 

antiviral before. And with the investment that has been made, 

three companies are now working hard, or at least three companies 

are now working hard on making IV antivirals, and one of them 

is Peramivir. 

Peramivir has shown a lot of promise. It has been available as 

an investigational new drug, sort of on compassionate use, but 

hasn’t had really, really large-scale use in people yet. And so there 

is not enough accumulated experience and data for it to qualify for 

full licensure yet by the FDA. The company is still putting that 

material together, doing clinical trials, getting that experience. 

However, there was clear judgment made that there was enough 

experience with it clinically and with its safety profile that, given 

the severity of disease people were getting, it could be available 

under emergency use. 

We have bought an initial number of doses, we are watching very 

carefully the burn rate of those number of doses, and we intend to 

continue to buy IV antivirals so that we don’t run out and so that 

we have a supply of antivirals that is well ahead of what we are 

seeing now in clinical illness. 

That said, if the disease took a really terrible turn for the worse, 

you know, we would be pulling all the stops to manufacture all the 

IV antivirals we can. But that is where we are. 

Mr. BONNER. And, Dr. Williamson, along that line, how helpful 

would it be to you, as a public health official for a State, to have 

antivirals, IV antivirals, available, prepositioned, as opposed to 

being—where I understand they currently are in a single location 

in Maryland? 

Dr. WILLIAMSON. Congressman, I think I can only answer that 

based on our experience with the existing stockpile. The existing 

stockpile, having the stockpile available admittedly—that is an 

FDA-licensed product. Having the stockpile available allowed us to 

push out 100,000 doses. 

I think if there is a benefit, that benefit would be if it shortens 

the time from demand to the patient, and that, to me, would be if 

there is a benefit of it being prepositioned in the States, it would 

be if that in some way gets the drug more quickly to the patient. 

I think there are issues obviously about who is eligible and those 

sorts of things that would have to be worked through. But that 

would be the only advantage I see. 

Dr. LURIE. There is a pretty good system, I think, that’s now in 

place so if a clinician recognizes that a patient is doing badly and 

that they might need a drug, they can actually order this through 


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a Web site. There are people at the other end also to answer questions. That information is very rapidly transmitted electronically to 

the warehouse, and those doses are shipped. 

H1N1 VACCINE DISTRIBUTION

Mr. BONNER. And just so I can get a grasp, by very quickly or 

very rapidly processed, what would be the time line on something? 

If a doctor in a hospital sees a patient who, this or any—I am using 

this as an example, but really it goes to kind of the questions earlier in terms of understanding the time line and the process. What 

would be a quick response? 

Dr. LURIE. CDC is managing it, so I will let Dr. Frieden respond. 

Dr. FRIEDEN. We have a 24/7 response to this, and commit to 

have the drug delivered within 24 hours. It is maintained at the 

manufacturer’s site, vendor managed, inventoried, shipped directly 

to the point of use. And as Dr. Lurie mentioned, there is a Web 

site for on-line ordering as well, so it can be done very quickly. 

Mr. OBEY. Ms. DeLauro. 

STATE VACCINE ALLOCATION

Ms. DELAURO. Thank you very much, Mr. Chairman. And I 

apologize for coming in and out, but I want to thank you so much 

for calling the briefing, and all of you are here today to help enlighten us through this briefing. 

I am going to try to get through three questions fast, given the 

time allotment. The Post yesterday, the Washington Post, had an 

illustrative article regarding what is happening at the ground level 

in doctors’ offices and with pediatricians. The article pointed out 

that the system for distributing it to private doctors’ offices is 

opaque, and that it is not clear to the public or the doctors who is 

going to get what when. 

So what is the delivery system for doctors’ offices? Who decides 

who gets what, and what amounts? 

Dr. FRIEDEN. Each State receives, or each jurisdiction—there are 

63 jurisdictions—receives an allocation that is strictly based on 

population. That jurisdiction, States or some cities and territories, 

then decide how they will allocate that to schools, public clinics, 

hospitals, private doctors’ offices based on their best judgment of 

how they will get as many people vaccinated as promptly as possible. 

Ms. DELAURO. So then it becomes the State’s decision to deal 

with this and how it is done. 

Okay. I will get to the seasonal flu issue in a second, but let me 

ask this question, because we have those hearings, avian flu, seasonal flu, now H1N1. I am talking about infrastructure, you know. 

We talk about roads, we talk about bridges, we talk about modernizing our schools, we talk about broadband, all of these efforts of 

how we try to take this infrastructure and build, you know, for the 

future here. 

What is the infrastructure, Federal, State, local level, that includes—and where industry fits here—that will not have us have 

this same hearing over and over and over again? It is a little bit 

like Groundhog Day, because we are always—there is some sort of 

a shortfall. We don’t have enough of this. What is the infrastrucVerDate Nov 24 2008 03:58 Dec 19, 2009 Jkt 053853 PO 00000 Frm 00097 Fmt 6602 Sfmt 6602 E:\HR\OC\A853.XXX A853

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ture? What would it cost? How do we adequately prepare and have 

an infrastructure in place to manufacture and to distribute vaccine 

whenever something comes up here for us to have to deal with it 

so that we have got a structure in place to move forward? 

From my perspective at the moment, it seems to be that it is bifurcated, it is—we are relying on people overseas. The delivery 

mechanisms seem to be faulty in some way. How do we get this to 

be an operational system that saves you the problem of having to 

answer these questions over and over again, and us having to ask 

the questions over and over and over again? 

Dr. FRIEDEN. Thank you very much. I think if we start with the 

delivery system and work backwards, we first need to ensure that 

at the local and State level we have the infrastructure. You heard 

earlier this morning about the enormous challenges that exist 

there. We at CDC provide some guidance, training, and staffing to 

support the work of State and local health departments, but nowhere near what is needed. That infrastructure is needed to deliver 

any tool that we have available. 

VACCINE TECHNOLOGY

Ms. DELAURO. Do you all have a plan as to what it would be, 

how it would be, and what are the resources? I would guarantee, 

and I do not know if I am speaking just for myself, but I think I 

speak for—when it comes to this kind of an issue, this committee 

is willing to put resources at disposal here in order to get to where 

we need to go when it regards the public health. If you do not have 

it, I would welcome your having this kind of information to get. 

Dr. FRIEDEN. There are a variety of estimates of what it would 

take to strengthen the State and local capacity in terms of tracking 

capacity, laboratory capacity, and the workforce need. Those would 

be the three key areas at the State and local level. At the Federal 

level, there is also a need to track diseases better both in the U.S. 

and globally. This disease emerged globally, and much of our information on how it is going is dependent on what we can track globally. So there is a need for State, local, Federal and global, public 

health infrastructure in order to track and respond and deliver vaccines, deliver antivirals, monitor the course of the epidemic. 

More upstream there is a need, as Dr. Fauci and Dr. Lurie outlined, of investments in new technologies so that we can get out of 

the egg era and into an era when we can respond within weeks or 

months to a vaccine becoming available. 

Ms. DELAURO. Protein? 

Dr. FRIEDEN. There are a variety of promising potential technologies. 

Dr. LURIE. We seem to only invest after there has been a crisis. 

Ms. DELAURO. And I am asking you—— 

Dr. LURIE. We have to get ahead of this crisis. 

Ms. DELAURO [continuing]. Really, to provide us with what is the 

investment plan and what is involved, who is involved. You know, 

then it becomes—you will look to us, and then we have a responsibility to deal with it. 

Dr. LURIE. We will have to get back to you with that. 

Ms. DELAURO. Thank you. Thank you. 

Mr. OBEY. Mr. Lewis. 


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H5N1 AVIAN INFLUENZA VIRUS

Mr. LEWIS. Thank you very much, Mr. Chairman. This kind of 

discussion is not just overdue, but very welcome. During the brief 

time I had a chance to chair the committee, I got to know some of 

the people who had the privilege of working in this arena with Dr. 

Fauci. I will not forget that first discussion with Julie Gerberding, 

in which we were talking about avian flu and the prospect of its 

metastasizing and the impact potentially on humans. I thought you 

said earlier, Dr. Fauci, that perhaps avian flu responded a different 

way to vaccines that were available. That would imply metastasizing. 

Dr. FAUCI. No, no, let me clarify. As you know, the H5N1 avian 

influenza had the capability of being very virulent, but was very, 

very poor in spreading from person to person, if at all. There were 

only less than 500 cases and about 270 deaths. So it is still smoldering. But in our preparation, our pandemic influenza preparedness plan, Ms. DeLauro, that you are talking about, was to do the 

kind of things that actually were in place which really did help us 

to respond as best as we could to this one. 

We are not really where we want to be, but in specific answer 

to your question, Mr. Lewis, we made a vaccine against the H5N1, 

and the issue was that it was not particularly good in inducing a 

response in humans. So the dose that was required for that particular vaccine was outlandish. It was 90 micrograms times two, 

which would induce a response in only 50 percent of the individuals. 

When I was making my presentation, I was saying that fortunately, the H1N1 vaccine that we tested at the NIH, a standard 

15 microgram dose induces a very robust immune response with 

one dose in virtually everybody except younger children. 

So the frustration is that we do not have the vaccine available 

right now for everyone who wants it. The good news is that when 

we get it into people, it is predictive of being highly protective. 

VACCINE PRIORITY GROUPS

Mr. LEWIS. Very much along those lines, there are three groups 

of people that concern me at this moment. They very recently made 

an effort to have a daughter in our family who is pregnant get the 

vaccine. And it was not available in this environment, and so they 

found themselves standing in line over the weekend for some considerable length of time. 

That is problematical in and of itself, just the waiting in line. 

But a second group worries me a lot. That is two grandchildren 

who were in a family where the mother suffers from asthma. Who 

should be vaccinated first, the children or the mother? 

Dr. FRIEDEN. You have identified three key groups to get vaccinated. And from CDC we have said basically that all of these 

groups should get vaccinated, even though there is not enough vaccine for everyone who would want it. Now, we do not want people 

turned away and told to come back, because they may not come 

back in the future. 

There are different reasons to prioritize each of them. Pregnant 

women because they are at higher risk of hospitalization and 


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death, people with asthma because they are at higher risk of severe 

hospitalization, and kids, because they have a higher rate of getting the disease and risk of getting severely ill. 

Mr. LEWIS. What about kids under the age of 9 who also happen 

to have asthma? 

Dr. FRIEDEN. Also a high risk group, absolutely. 

Mr. LEWIS. Well, the person I was asking that for is not here 

presently. They are planning to have the first shot shortly. But you 

were suggesting they really need to have the second shot? 

Dr. FRIEDEN. For 9-year-olds and under it is required to have 2 

shots to get a robust response, as Dr. Fauci’s studies show. 

DDT USE IN AFRICA

Mr. LEWIS. Okay. If I could, Mr. Chairman, just one more item. 

When I was talking with Dr. Gerberding some time ago, we 

were—part of our discussion beyond avian flu was to discuss AIDS 

in Africa. And she said that it is good that we had an interest in 

impacting that, but indeed malaria in Africa was perhaps a greater 

challenge. And for the first time, Mr. Chairman, I heard about 

DDT and the impact it had on malaria here and otherwise. And we 

banned it from this country. But she essentially said that DDT has 

the capacity for staying lifetime in the huts of villages in Africa. 

That struck me as being amazing. It is a lot better than depending 

upon netting. But is that a reality? Are they using DDT in Africa? 

Dr. FAUCI. Yes, there is a plan now of doing multiple things. One 

is insecticide-impregnated bed nets. The other is spraying indoors 

along the rim of the huts, not globally out in the environment, but 

indoors in the huts. The other is prophylactic treatment for pregnant women. And the other is artemisin in combination therapy for 

malaria. Those are the four components of what originated as the 

President’s Malaria Initiative, which is being continued in this administration. 

Dr. FRIEDEN. And those components are highly effective. CDC 

has staff in country and all of those places working with health 

ministries. Places which have implemented those four components 

well have been able to cut malaria by 50 percent to 80 percent. 

Mr. LEWIS. I have asked a follow-up of my sources in California, 

but it might be better to ask you and see if you can help us, DDT 

was banned because of the impact it had upon humans, especially 

when used on food sources. But if we are allowing DDT to be used 

in Africa, have we got a program to try to try to follow up and see 

what impact it has upon, you know, the health and existence or life 

span of these people? 

Dr. FRIEDEN. A variety of different insecticides are used in the 

program. Some countries do allow use of DDT, but only under very 

strict procedures. If it gets mixed in with the crops, that can have 

an economic dislocation effect for the countries, and it has to only 

be used in an indoor area. The risk of DDT is the risk of going into 

the food system. But absolutely it needs to be done very carefully. 

Mr. LEWIS. The risk within the hut, if indeed it is used there— 

can have a long term—do we know if it has a long term impact 

upon the health of those children that live there? Which is really 

the kind of thrust that I would like to begin to pose. 


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Mr. Chairman, as you demonstrated so well, these issues absolutely have nothing to do with politics and it is really a helpful exchange. I appreciate it. 

Mr. OBEY. Thank you. Mr. Jackson. 

Mr. JACKSON. Mr. Chairman, if you do not mind, I would like to 

come after Mr. Honda, if that is quite all right. 

Mr. OBEY. Mr. Honda. 

CELL-BASED TECHNOLOGY AND MOLECULAR TECHNIQUES

Mr. HONDA. Thank you, Mr. Chairman. And thank the panelists 

for being here. A couple of quick questions. 

The first one just requires a written response from CDC and 

HHS. And that is the distribution of the vaccine that has already 

been out there. Santa Clara County was supposed to get about 

100,000 vaccines. That would have been 45 percent of what has 

been distributed. Or say 45 percent of the amount of vaccine we 

were supposed to get in Santa Clara County is down to about 

23,000. So it is cut almost 20,000 that is unaccounted for at the 

State level. We can’t seem to get an answer as to where they are 

or what the distribution format was. 

Can CDC or HHS find out for us or do you have oversight on the 

distribution to the local level through the State? And that is the 

first question I would like you to respond in writing, if you would 

not mind. 

H1N1 VACCINES

Mr. HONDA. Santa Clara County was supposed to get about 100,000 vaccines. 

That would have been 45 percent of what’s been distributed, and so 45 percent of 

the—the amount of vaccines we were supposed to get in Santa Clara County is 

down to about 23,000 now, so there’s—you know, there’s about 20,000 that’s unaccounted for at the state level, and we can’t seem to get answers to where they are 

or what the distribution format was. Can CDC or HHS find out for us? Or do they— 

do you have oversight on the distribution to the local level to the states? 

Dr. FRIEDEN. CDC does not have information or oversight for where and how 

many doses have been shipped to a specific local health department/private provider, as that is up to the state’s discretion and authority (with the exception of Los 

Angeles County, as they are a separately funded grantee). For information about 

local distribution in California, please contact John Talarico at 

John.Talarico@cdph.ca.gov. 

The other question I had was I also heard, and get a response 

in writing also, is it true what I heard that there is mercury being 

used in the vaccines that we are receiving that is being produced? 

And if so, why? In light of the effect that mercury has on young 

children. 

THIMEROSAL IN VACCINE

Mr. HONDA. The other question I had was I also heard—you know, if I could get 

a response in writing also—is that is it true that what I heard that there’s mercury 

being used in the vaccines that we are receiving that’s being produced? And if so, 

why, in—in light of the effect that mercury has on young children? 

Dr. LURIE. Thimerosal, a mercury-containing compound, is a preservative added 

in small amounts to multi-dose vials of some vaccines to prevent the growth of bacteria or fungi that may be inadvertently introduced into the vaccine during use. 

Contamination by germs in a vaccine could cause serious illness or death. Preservatives are not required for products formulated in single dose vials. The recently licensed inactivated (‘‘flu-shot’’) H1N1 vaccines are available in both thimerosal preservative-free single dose formulations and thimerosal preservative-containing 

multidose formulations. The live attenuated seasonal influenza vaccine (FluMist) 


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and the corresponding H1N1 live attenuated vaccine contain no thimerosal. Thimerosal has a long record of safe and effective use preventing bacterial and fungal contamination of vaccines. 

In 1999, in response to the FDA Modernization Act (FDAMA) of 1997, FDA conducted a comprehensive review of the use of thimerosal in childhood vaccines and 

found no evidence of harm from the use of thimerosal as a vaccine preservative, 

other than local hypersensitivity (allergic) reactions (Ball et al. 2001). Furthermore, 

a number of studies were conducted to address public concerns about a potential association of thimerosal in vaccines and neurodevelopmental disorders, including autism. These studies were independently conducted by different investigators using 

various designs in different samples and countries, (e.g., Sweden, Denmark, United 

States, United Kingdom and Canada), and all have consistently provided evidence 

of no association between thimerosal-containing vaccines and autism, despite the 

fact that different methods were used and different populations were examined. In 

2004, the IOM’s Immunization Safety Review committee concluded that this body 

of evidence favors rejection of a causal relationship between thimerosal-containing 

vaccines and autism. Since then, additional studies conducted in 2006, 2007 and 

2008 provide further support that thimerosal exposure of children from vaccines is 

not associated with neurodevelopmental disorders. Three leading federal agencies 

(CDC, FDA, and NIH) have reviewed the published research on thimerosal and 

found it to be a safe product to use in vaccines. Three independent organizations 

[the National Academy of Sciences’ Institute of Medicine, Advisory Committee on 

Immunization Practices (ACIP), and the American Academy of Pediatrics (AAP)] reviewed the published research and also found thimerosal to be a safe product to use 

in vaccines. Thus, the available evidence supports the scientific conclusion that currently licensed vaccines containing thimerosal preservative, including some formulations of H1N1 vaccine, are safe. 

The one I would like to hear from you right now is the Congress 

has allocated about $6.8 billion over the last few years for pandemic preparedness. And hearing your testimony today, there 

seems to be a lot of barriers and glitches along the way. I understand the fill and finish issue, where there is a lot of time delay 

there. I guess I want to get away from using the egg to the cellbased. And I think someone mentioned, maybe you, Dr. Fauci, you 

mentioned about using molecular level science and site-based—I 

forgot the rest of the phrase that you used. 

Could you expand a little bit more on that and why you think 

that that might be more efficient and what we are faced against 

when we look at production of eggs and using the egg approach, 

which is archaic by some of your words versus the current technology that we have in front of us? 

Dr. FAUCI. That is an excellent question. I would be happy to answer it as succinctly as I can. 

We right now overwhelmingly have an egg-based technology, 

which has the vicissitudes that we mentioned. One of them is the 

growth, you can get contamination, et cetera. The plan is to move 

to a much more reliable cell-based technology, which still requires 

the growth of the virus, and does not eliminate all the fragility of 

the system. The end game for us is the investment which we are 

making and the ability to scale up in the arena of molecular techniques. 

Let me give you one example of a molecular technique that is 

probably the more advanced of a group of about five or six that are 

being pursued, everything from the fundamental basic research at 

the NIH up through and including the partnership with the companies to get it, and that is instead of relying on the whole virus to 

grow, the part of the virus that is the immunogenic part that you 

want the body to make an immune response against is a thing 

called hemagglutinin NRH. You can take the gene of that and you 


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can insert it in a virus that happens to infect insects. It is called 

a baculovirus, which you grow in insect cells. You can have a great 

deal of control of the amount you do, the growth you do. So what 

comes out is not the whole virus, but just the purified protein that 

you want. 

The NIH was involved in the phase two trials with the company. 

The company has now done phase three trials for efficacy, and are 

in the process of applying to the FDA for licensure. That is the 

good news. The challenge ahead is how do you get that technology 

to be scaled up enough to essentially replace completely the fragile 

technology. 

So what we are going to be seeing, Mr. Honda, over the next few 

years, and it is going to take years, because that is the nature of 

the process, as fast as you go, is a gradual transition from eggbased to egg-based together with cell-based, to cell-based to advanced molecular technology. 

The ultimate end game for all of us, and where we are aiming 

our research at the NIH, is to get what is called a universal vaccine. A universal influenza vaccine is a vaccine that would induce 

a response to a component of influenza that does not change from 

season to season and that does not change whether you have a 

pandemic strain or a seasonal strain. And that, if you can do it, 

that would be the end game. 

You mentioned that, Ms. DeLauro, the end game, because then 

you could make as much as you want and you could store it, you 

do not have to change from season to season, and you could inject 

people, get them immunized, and immune and protected, and then 

perhaps every few years thereafter do it again. That is the plan. 

That is going to take years. 

VIRUS MUTABILITY

Mr. HONDA. It seems like with that approach the mutability of 

the virus can be approached much quicker. You have a baseline 

from which to work. 

Dr. FAUCI. You could even bypass it. Because influenza A, which 

is the one that is usually the culprit, is influenza A. It could be a 

pandemic, it could be a seasonal, it could be an H3N2, an H1N1, 

it is still influenza A. There are parts of that virus that the body 

does not seem to make an immune response that stays constant 

even as the virus changes. 

What we are doing now is identifying those parts we call cryptic 

components to put in a form that when you vaccinate somebody 

they will make a response that will protect you against any influenza. That is where we are aiming. But that is not going to be 

easy, but it is doable. 

Mr. HONDA. This feels like something where a company is trying 

to protect their patent, and just changing the site of each item 

gives it an opportunity to create another patent. It is not like that 

or something. 

Dr. FAUCI. No, it is not. 

Mr. OBEY. The gentleman’s time has expired. 

Dr. FAUCI. That may be a problem, but that is not this problem. 

Mr. OBEY. The gentleman’s time has expired. Mr. Cole. 


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VACCINE MANUFACTURERS

Mr. COLE. Thank you very much, Mr. Chairman. I apologize for 

missing some of your presentation. I had other engagements. So I 

beg your pardon. I may cover some ground that you already covered, so forgive me if I do. 

As I went the through the material and listened to some of the 

testimony, one of the things that struck me, perhaps not accurately, and Dr. Lurie or anybody can take the question, was how 

much of the product that we need is dependent upon foreign manufacturing? So one, is that a correct problem? Two, what are the reasons why so much production is elsewhere as opposed to here, if 

that is indeed a challenge? 

Dr. LURIE. Sure. Right now there is one manufacturer that manufactures entirely within the United States, a second manufacturer 

that does partially. And there are—everybody is more able to fill 

and finish the vaccine but not make the antigen within the United 

States. That is an historic problem that had to do with investment 

in the vaccine infrastructure, the profitability of making flu vaccine. Flu vaccine historically has not been very profitable. When 

this problem was recognized several years ago, a couple things happened. We took very aggressive actions to get manufacturers licensed even to sell vaccine in the United States, and then aggressive actions to rebuild the manufacturing infrastructure within the 

United States precisely because we do not want to be dependent on 

a situation where everything we need to protect the public is manufactured elsewhere. 

Mr. COLE. Are there specific things that Congress should be 

doing to sort of assist you in making sure that we do not have that 

kind of challenge going forward? 

Dr. LURIE. Well, we need to continue to invest in manufacturing 

capacity in the United States. We have started to do that with the 

cell-based facility that is going to open or begin startup next year 

and is having an opening this fall. But that will only get us for cellbased maybe only half of where we project we need to go to be prepared. 

So we need to continue to invest in that large scale manufacturing capacity in the United States, but with our eye on the end 

game so that when we have the new science we are then not another 5 years behind with scaling up that manufacturing capacity. 

So that is going to be a continuous process for a while, and it is 

going to take some substantial investment. 

Mr. COLE. Let me ask the second question. Obviously, all this I 

know you more than anybody else are somewhat disappointed that 

we put out information that we were not able to fulfill in terms of 

commitments. When along the process did you begin to have the 

sense that we were going to come short? And what, if anything, differently should we have done in terms of trying to lower the expectations? I think that is one of the challenges that you have today, 

that you all have. 

Dr. LURIE. Well, I think it is fair to say that there are a variety 

of points along the way where we got information that our amount 

of vaccine was going to be lower than we initially anticipated. At 

every step of the way we looked at that information, communicated 


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it as quickly as possible to our State and local partners and to the 

American public. 

So we tried to be, and I think we have been, really transparent 

about the communication. And there have been multiple points 

along the way where different things went wrong. You know, 

whether it was about virus growth, or whether it was about problems with filling lines or other sorts of things. 

So each step along the way we have tried really hard to communicate that to the American public. And you walk a really fine line, 

I will say, between needing to be really transparent and satisfying 

everybody’s needs for projections and ending up with a set of projections where you really fall short. And that has been the challenge. 

Mr. COLE. Believe me, I am not trying to be critical. The complexity here just from the hearing here is evident. I just wanted to 

see if there was something we should have done differently, with 

the expectations being a real one. We all live with it, and I think 

it has caused a problem. 

Let me ask one last question. I am sure just like the military, 

after you go through an exercise like you are still in the midst of, 

you do a lessons learned and what would we do different. One, 

what is the timeline for that? And two, is that something that appropriately could be shared with this committee? Because I think 

we would all like to see what the process is as you go back and 

reevaluate. 

Dr. LURIE. I expect that at all levels we will be doing a lot of 

that. We have already begun doing some of that within my office. 

And I think really across Federal, State, and local levels we need 

to do that because we need to be better prepared for the next time. 

And we are always asking ourselves what could we do better? 

What could we do faster? What did we learn from? And in fact, you 

know, our ability to respond to this is really because of lessons 

learned from other kinds of events. So that is already underway. 

Mr. COLE. So will that be in a document that is publicly available so folks can have a look at? 

Dr. LURIE. I think we intend to be fully transparent with all of 

this. 

Mr. COLE. Thank you very much. Thank you, Mr. Chairman. 

DELAY IN VACCINE AVAILABILITY

Mr. OBEY. Let me make a few observations and ask a few questions. First of all, I have forgotten whose testimony it was that indicated that we lost about 15,000 public health personnel in States 

around the country. I would like to simply point out that that occurred despite the fact that we put billions of dollars in the stimulus package into efforts to stabilize State budgets. And as a result, 

that package this year has filled about 40 percent of the States’ 

budget holes. The problem is that next year the remaining funds 

in that stimulus package will only fill about 20 percent of State 

budget holes so we are going to have a problem at the State level 

in terms of budgets twice as bad as the one we had this year. And 

if we do not do something about that, we are going to lose a whole 

lot more people, not just public health personnel. One observation. 


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Let me ask a question. Will the delay in this vaccine result in 

a delay in the regular seasonal vaccine’s availability? 

Dr. FRIEDEN. No, we do not think so, although the other way 

around is the case. There were delays in growing this year’s seasonal flu vaccine which delayed somewhat the start of production 

of this vaccine. 

Mr. OBEY. All right. You have all been very reluctant to make 

any further predictions about how many doses you are going to 

have and when. Let me ask what might appear to be a cynical 

question: are we going to have an appreciable amount of this vaccine delivered after the second round of the flu hitting people is 

over? 

Dr. FRIEDEN. I think there is no question that currently we are 

continuing to see virus activity, the number of people getting sick 

increased in many States, although it has already begun to decrease in other States, particularly in the Southeast. So it is likely 

that the current wave of infections will peak, crest, and begin to 

decline before there are ample supplies. Whether there will be another wave of H1N1 between now and May, when flu season ends, 

or whether we will get a different strain of influenza, only time will 

tell. 

Mr. OBEY. It appears that we have relied upon the estimates of 

manufacturers in order to determine what our expectations were in 

terms of the availability of vaccines. 

Have you been able to develop in any way a process which would 

enable you to make judgments that are independent of the estimates of the manufacturers with regard to that question? 

Dr. FRIEDEN. We really are dependent on the production facilities 

to tell us what they can produce. Dr. Lurie may want to describe 

that more. 

Dr. LURIE. No, I would agree with that. And we are very dependent, as you have heard, about what those yields are to do anything. 

And in fact even with making projections early, making assumptions the yield would be lower even than they told us, we still got 

into this bind. Once that stuff is made, as I said, we are tracking 

lot by lot every step of the process. So from there on we are developing more comfort, but not complete comfort. 

VACCINE PRODUCTION

Mr. OBEY. Are you satisfied that the manufacturers notified you 

immediately after they got their first inkling that things were 

going to be developing more slowly than they expected? 

Dr. LURIE. You know, we have had communication with the manufacturers every week, and I would say there has been a really 

good exchange of information throughout this process. 

Mr. OBEY. So the answer would be—— 

Dr. LURIE. I mean obviously nobody knows what they do not 

know, but I think that this has been a really good collaboration and 

that there has been a very good exchange of information. 

N95 RESPIRATOR PRODUCTION AND USE

Mr. OBEY. Okay. Let me ask about respirators. According to HHS 

documents, as of June 2009, 102 million N95 respirators were purchased for the Federal stockpile. The Bureau of Labor Statistics esVerDate Nov 24 2008 03:58 Dec 19, 2009 Jkt 053853 PO 00000 Frm 00106 Fmt 6602 Sfmt 6602 E:\HR\OC\A853.XXX A853

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timates that there are just under 14 million U.S. workers employed 

in the health care industry. Of those 102 million respirators apparently provide only seven N95s per health care worker. Considering 

that OSHA estimates that an average of four N5s are used per 8- 

hour shift, would not this number seem shockingly low? What is 

the rationale for stockpiling that low number of N95s? Why not 

more? 

Dr. FRIEDEN. The global production capacity for N95s cannot 

keep up with the demand that would be used to comply with the 

CDC recommendations for use of N95s for health care workers caring for people who might have H1N1 influenza. The stockpile is 

meant to address not just influenza, but a whole range of infectious 

disease conditions that might benefit from respirator protection 

through N95s. 

Mr. OBEY. If the global capacity is inadequate, what can we do 

about that? 

Dr. FRIEDEN. In the guidelines that CDC issued, we outlined a 

series of steps which health care facilities can take to preserve and 

limit the use of N95s so that the highest risk procedures and the 

highest risk situations we have N95s—— 

Mr. OBEY. What can we do to boost the capacity for production? 

Dr. FRIEDEN. It is only recently that CDC has recommended use 

of N95s for health care workers caring for patients who may have 

H1N1 influenza. This has big implications for supply and for the 

market. And I think as we get through this flu season we need to 

look at what the stockpile should or should not have. 

VACCINE SCIENCE AND DELIVERY

Mr. OBEY. Look, just one last point, I am not especially known 

around here for being patient, and yet I have been hearing this 

stuff for five years. I just want to quote a couple statements from 

hearing transcripts in 2004 and 2005. 

In October of 2004, Dr. Gerberding in her opening statement 

said, ‘‘we need to prepare for pandemic influenza; a time bomb is 

ticking.’’ 

I then asked her a number of questions. I asked, ‘‘Is there something the government can do to help regularize the annual vaccine 

supply that we have? For instance, should or could the government 

simply guarantee a specific level of market to manufacturers in 

order to make certain that there is enough incentive for producers 

to produce it year after year?’’ 

And I went on to say, ‘‘it seems to me that if this is a crisis, I 

do not understand why we cannot bring the lead countries of the 

world together, the governments and industry people, find out what 

it would take to develop. If it is physical facilities that are necessary, fine. I understand you cannot do it instantly. But there 

must be some way to compress the timeframe if we regard this as 

an emergency rather than merely an interesting problem.’’ 

In response, Dr. Gerberding said, ‘‘I have to be frank here. Our 

capacity to develop and produce vaccines for any infectious disease 

is extremely fragile in this country. We do not have excess production capacity for any one of the vaccines, let alone influenza. The 

entire global production of flu vaccine is 290 million doses a year. 

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ply. I think we need to work with the committee to identify ways 

that we can motivate and expand our overall vaccine production capability. This is a catastrophe waiting to happen. We are at a crisis 

point here.’’ 

In April of 2005, I said the following: ‘‘This ought to be a high 

priority. My problem is I do not really think our government is 

treating it as a high priority.’’ And I said, ‘‘I would simply say that 

the numbers that are being cited demonstrate our existing program 

is totally inadequate and not doing the job.’’ 

Dr. Gerberding responded, ‘‘So I think this is a real opportunity 

for us to collaborate and really identify, you know, in five years 

where do we want to be and how are we going to get there and how 

fast can we get there?’’ 

Now, that was five years ago. And so I mean I heard you, Doctor, 

say earlier that we needed to do more to increase our investments 

in producing modern vaccine technology and we needed to do more 

to regularize demand. 

We have been hearing that for five years. I know you are new 

on the watch, but what does it take by way of resources that this 

committee could provide over the next four years so that we are not 

flap-jawing and yapping at each other using the same talking 

points that we have heard for five years? What do we do? How 

much do we need? 

If there is something we can do, ask us for it. Tell us what we 

need. I mean we are spending lots of money on lots of other stuff 

in this budget that is much less important than this. This flu may 

wind up being not merely as severe as we feared, but by God sometime in our lifetime that ain’t going to be the story. 

So what do we finally have to do so that we do not chew the 

same cud year after year after year? 

Dr. FRIEDEN. Thank you, Mr. Chairman, for your question. I 

think that is the essential question that all of us have to address. 

And it starts with vaccine science, the basic science that Dr. Fauci 

and NIH does, the applied science that BARDA and Dr. Lurie’s 

unit does, and the delivery systems that CDC and State and local 

health departments provide. And all of those are, as you said I believe in your opening statement, are pipelines that are rusty. And 

we need to strengthen them and we need to recognize also that 

some of the basic science is a question of what is possible. It may 

or may not work out, but with more investment it is more likely 

to work out. 

Mr. OBEY. Let me say I understand that. I mean nothing has 

bugged me more in the over 30 years I have been on this subcommittee than to listen to people say, well, if we can send a man 

to the moon we ought to be able to cure cancer. Well, one was a 

rather simple engineering problem in comparison to dealing with 

the multiple kinds of cancers that are out there. So it is a whole 

lot more complicated. 

But having said that, if we were to make this a top priority, 

what would we do? What would our budgets look like? What is a 

reasonable scientific expectation if we do A, B, and C, and what are 

A, B, and C? That is what we are asking. 

Dr. FRIEDEN. I can address the delivery system reasonably well. 

But with additional resources for epidemiology, lab capacity, vacVerDate Nov 24 2008 03:58 Dec 19, 2009 Jkt 053853 PO 00000 Frm 00108 Fmt 6602 Sfmt 6602 E:\HR\OC\A853.XXX A853

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cine delivery at Federal, state, and local levels, we can ensure that 

we can get vaccine out. 

FIVE-YEAR STRATEGIC PLAN

Mr. OBEY. Does our government have a five-year plan to try to 

accomplish that? I do not want to sound like the Soviet Union with 

its five-year plans, but have we ever or will we ever have a multiple-year plan to try to get there? And if so, what would it look 

like? 

Dr. LURIE. So we had a pandemic plan. Our office is in year 

three of a five-year strategic plan. I think to Mr. Lewis’s point, one 

of the lessons learned here is pretty quickly to take a look at that 

plan, where we are in our five-year strategic plan, where the 

science is, and come back quickly to put together a new five-year 

strategic plan and work closely with you to see if we can make 

progress in implementing it. 

Dr. FAUCI. Same thing, Mr. Chairman. You know we have been 

working with each other on this for a long time. And I was there 

when you were reading all of that testimony. But from the NIH 

standpoint, as you well said when you were saying it somewhat facetiously, with science it is very, very difficult to predict, because 

science is discovery, it is not engineering. But we do have a 

plan—— 

NIH APPROPRIATION

Mr. OBEY. No, I was saying the trip to the moon was engineering. 

Dr. FAUCI. Yes, and I mean, right, science is discovery and the 

trip to the Moon is engineering. And discovery requires the kind of 

basic science input that we have and that you generously supported. In 2003 our budget for influenza was $50 million. It is now 

$260 million at a time when the NIH budget was flat. So we have 

reprioritized for this emergency. Even though all science feeds 

upon each other, we have made a significant investment in that despite, as you well know better than anybody in the world, the flatness of the NIH budget. 

Mr. OBEY. You wanted to respond? 

Dr. WILLIAMSON. Yeah. Mr. Chairman, I think speaking with my 

local colleagues from the rusty end of the spigot where we are trying to deliver the vaccine, one of the challenges we face, and we 

need to be very clear, were it not for the funding that you have provided to the States and through the States to the locals for emergency response, and recently through the public health emergency 

response dollars, we would not be here having this conversation because there would in many States be almost no infrastructure with 

which to respond. 

So the first thing I would ask, and I do not know the number, 

but the first thing we need to do is to accept that there is some 

minimum level of infrastructure support that is going to be necessary at the Federal level all the time because State budgets have 

these fluctuations. 

And the other message that I think goes with that is whether or 

not the epidemiologist is tracking influenza today, they certainly 


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may be tracking a food-borne outbreak tomorrow. So there certainly is that cross-utilization. 

I can speak from Alabama’s perspective here, we need almost a 

Hill-Burton or interstate highway project across the country to replace some of our public health laboratory infrastructure. Now 

some of the States, like Virginia, have done wonderful jobs in 

building new labs. But many of us, my State, for example, we are 

dealing with a lab that was built in the 1970s. And that is fine. 

They do great work there. But it was designed at a time when public health was not changing, the work they were doing was fairly 

constant, and it was designed to meet that timeline. It is a $40 million investment for the State. We cannot do that. 

So we need that sort of bricks and mortar capacity construction 

going forward. 

Mr. FULTON. I would like to speak to both your question and Ms. 

DeLauro’s point about the shortfalls. The health care reform bill in 

its wellness package, at a billion dollars a year for infrastructure 

in local public health and in State public health, will be critical to 

our continuing to have the capacity to be on the ground when these 

types events occur. 

I do not want money just to hire people to sit around and wait 

for a flu event. I need the people to be health educators and visiting nurses and clinic staff. And that piece in the health care reform bill is critical, and hopefully it is not one of the things that 

gets tossed out at the end, much like happened with the stimulus 

money in the negotiations in the first stimulus bill. 

Mr. JACKSON. Mr. Chairman? One quick question. I hope this is 

not too far off the direction of H1N1. But it occurs to me that while 

these are dedicated health professionals dealing with a profound 

problem in the system, and there are problems that we are discovering in the system, I am wondering if this is the same infrastructure that we would rely upon if this were a man-made biological 

event? Would we be calling essentially these professionals to tell us 

that the preparations are inadequate? 

Mr. FULTON. Yes. The preparedness is the same. It is the same. 

Mr. JACKSON. So if this were a man-made biological event, we 

would be going through the exact same contracting that you are 

looking for to determine private sector influenza or vaccine-producing entities to distribute to the American people, that we would 

have trucks lined up alongside these entities trying to distribute 

them to distribution centers throughout the country. 

And it just appears to me that the inadequacy of a—I do not 

want to say that our response is inadequate because I think that 

in your testimony, each of you have shown us that we are doing 

the best we can given the lateness of the mutating nature of this 

particular event. But, my concern is if this were a man-made biological event, either through a terrorist event or something created 

in the laboratory that we wish we did not discover, would we be 

relying upon the same infrastructure to address the distribution? 

Mr. Chairman, thank you. 

DISTRIBUTION INFRASTRUCTURE

Mr. FULTON. Well, at the local level, yes. We are trained on a variety of different responses. It could be a hurricane, it could be a 


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tornado, which happens in our neck of the woods, it could be an 

outbreak of tuberculosis, it could be an anthrax attack. We have 

practiced and have been trained in a wide variety of those types 

of events. And it would be the same workforce that is now deployed 

for H1N1 that would be deployed to provide the services for things 

like another terrorist event. 

Dr. WILLIAMSON. And that is certainly true at the State level. 

For example, in our case we are using a platform to monitor bed 

availability in influenza-like illness that we actually designed to 

monitor bed availability during hurricanes, and used it during 

Katrina to route patients from our southern part of the State further north so that patients coming from Mississippi and Louisiana 

would be able to be hospitalized more closely. 

So in that sense, absolutely, it is the same epidemiologists who 

are going to be tracking, whether it is anthrax or whether it is 

H1N1, it is the same laboratory doing different tests perhaps, but 

it is the same laboratory and same laboratory capacity or lack 

thereof that we are dependent on. 

Dr. LURIE. Yes. Go ahead. 

Dr. FAUCI. Mr. Jackson, you remember we had this conversation 

at one of our appropriations hearings, and in fact they are exactly 

the same technologies that we are trying to develop. And I can only 

speak from the research standpoint, not from in the trenches in the 

community. But from the research standpoint, we make indistinguishable a man-made biological event and a naturally occurring 

one. And in fact, in all of our biodefense plans we actually merged 

those two and call it such and such for biodefense and emerging 

infectious diseases. 

Nature, in my mind, is the most effective and the worst and the 

most dangerous bioterrorist. And how you respond to it from the 

standpoint of the development of vaccine platforms is indistinguishable from what we would do to try and isolate an agent that someone deliberately released, how we would characterize it, and how 

we would try to make a vaccine. 

So the answer to your question, which is a very good question, 

is absolutely yes, we would be doing the same thing from a fundamental research and clinical trials standpoint. 

Dr. LURIE. And I would very much concur with my colleague. 

Our preparedness planning, we try to make all hazards, you know, 

whether it is natural or man made, whether it is a weather event 

or a pandemic. Many of the things you have to do to respond are 

the same. And at the same time, we are working hard to do the 

advanced development, to have flexible large-scale manufacturing 

capacity so that when we need to produce a new kind of countermeasure, regardless of what it is, we will be able to do it. But we 

are still dependent on where we are with the same infrastructure, 

the same technologies, the same workforce, all of those kinds of 

things. 

From the public health perspective, I also want to say if you 

want to be able to respond to an emergency like this you have got 

to be able do it day to day. And one of the concerns is the more 

we whittle away at this infrastructure, whether it is at the local 

level or the State level or the Federal level, the less we will be able 


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to do that, back to Ms. DeLauro’s point about really needing a huge 

infrastructure project for this country. 

ALL HAZARDS APPROACH

Dr. FRIEDEN. Absolutely. It is the same system. In fact, at the 

CDC it is granting mechanisms that are used for preparedness and 

response to terrorism that have been used to funnel money or provide money to States and localities. It shows the wisdom of the allhazards approach, the dual-use approach. You want people who are 

addressing problems today to get in the practice of doing that both 

so that you can have them well practiced, and also so that if you 

do not have an emergency or it takes a couple of years, you are 

making excellent use of that money and those resources to protect 

people’s health day in and day out. 

Dr. LURIE. I think it is also important to point out that many of 

the investments that we have made in preparedness really have 

benefits in day-to-day public health practice. And I do not want us 

to lose sight of that. So it is not just if nothing happens. 

Even if I look at the use of incident command in public health, 

so many health departments around the country now use this for 

routine outbreak investigation. And they tell you that it goes better 

and faster. And you can find example after example after example 

of where this investment pays off. There is just not enough of it. 

Mr. OBEY. Mr. Tiahrt, do you have any wrap-up questions? 

N95 RESPIRATORS

Mr. TIAHRT. I have a couple questions. First of all, is there any 

scientific evidence that an N95 respirator is more effective than a 

common surgical mask? 

Dr. FRIEDEN. This is an area of considerable debate and discussion. CDC and the Department of Labor, OSHA, requested that the 

National Academy of Sciences’, Institute of Medicine undertake an 

independent and rapid review looking at that specific question, and 

without reference to feasibility or cost. 

The Institute of Medicine, or IOM, did that review and recommended two things. First, the use of N95 masks, given the level 

of uncertainty with theoretical reasons that would suggest that 

they may be superior, and second, they are conducting additional 

research. 

Mr. TIAHRT. Theoretically, they look better or they are more 

highly tech and so, but we really do not know. We could use common surgical masks at least as a backstop, correct? 

Dr. FRIEDEN. In our guidance—— 

Mr. TIAHRT. We do not know what percentage it is whether or 

worse than an N95 or if it is the same. 

Dr. FRIEDEN. In our guidance we give outlines of what can be 

done if there is a shortage of N95s. 

Mr. TIAHRT. But we do not have any scientific evidence that says 

an N95 is superior. Correct? 

Dr. FRIEDEN. I would agree with that. 


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VACCINE DEMANDS

Mr. TIAHRT. Okay. Now what is the need? How many of these 

vaccines do we need? 

Dr. FRIEDEN. Masks? 

Mr. TIAHRT. No, no, I am switching to vaccines. We have a problem of getting vaccines. I listened to the whole hearing. I just do 

not know how many we need. How many do we need? 

Dr. FRIEDEN. We would like to have enough vaccines so that everyone who wants to be vaccinated—— 

VACCINE SUPPLY

Mr. TIAHRT. What is enough? Is that one million? Is that 100 

million? Is that 300 million? 

Dr. FRIEDEN. It would depend on demand. We want there to be 

enough for everyone who wants to be vaccinated to be vaccinated. 

Mr. TIAHRT. So we do not have a goal? What is our goal? We do 

not know the demand, but we have a goal, I would assume. We are 

building some, we are buying to some level. What is that level? 159 

million in the priority groups? 

Dr. FAUCI. In the five priority groups. 

Dr. FRIEDEN. But we know that many people—— 

Dr. FAUCI. Will not want it. 

Dr. FRIEDEN [continuing]. Will not want it. 

Mr. TIAHRT. So 159 million is what we need. 

Dr. FAUCI. If everybody in the priority group wanted a vaccine, 

that would be 159 million. 

Mr. TIAHRT. And how many do we have on hand today? 

Dr. FRIEDEN. 32.3 million. 

Mr. TIAHRT. 32.3. So we need 127 million theoretically. 

Dr. FRIEDEN. In the best of situations, we get about a third of 

people who are under 65 and about two-thirds of people who are 

over 65 to get vaccinated against seasonal flu each year. 

Mr. TIAHRT. So what do I take away from the 127 million that 

we need? How much do I take away because of that? Do I take 

away all of it? It is not all of it, is it? We do need something, right? 

Dr. LURIE. So maybe I can come at this from the other perspective. When we started this, we said that we would buy or put in 

orders for enough bulk vaccine to get ultimately to about 250 million doses if we needed it. Now, all of that does not have to get 

made and not all of it needs to get filled and finished. 

Mr. TIAHRT. So it is not 250 million or it is 250 million? 

Dr. LURIE. No, we have had a staged approach. That was when 

we thought we were going to need two doses for everybody. 

Mr. TIAHRT. Now it is less because we do not need two doses for 

everybody. 

Dr. LURIE. Right. So where we always want to be is ahead of ourselves when the production catches up, and the antigen that is in 

big vats, and figuring out how much we need to fill and finish and 

put in vials based on the demand, and always have enough, eventually, and that the goal is to always have enough to meet that demand. 

We also want to be in a situation where we are good stewards 

of society’s resources. And so the best way to do that is to hold a 


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bunch of those in that bulk form, not in vials, until we can anticipate that demand and we are going to need it. Because then that 

can be turned back into seasonal vaccine. 

Mr. TIAHRT. I guess it is a little confusing. We know we have a 

demand, but we do not know how big the demand is, so we do not 

know how many to put in vials versus bulk. So what are we working towards? 

Dr. LURIE. So far, we are putting as much in vials as we can 

until we get a signal that demand is really starting to drop off. 

VACCINE MANUFACTURING

Mr. TIAHRT. I can see why this has—I mean reporters are having 

trouble not saying that this is a crisis. It is like we cannot define 

where we are going particularly, and so we do not know if we are 

there. 

Dr. FRIEDEN. I think as Dr. Lurie said, we are telling the manufacturers to make as much vaccine as they can safely as quickly as 

they can. 

Mr. TIAHRT. But we have five manufacturers, one in America, 

none of them owned by American companies. Some of them are in 

Australia, owned by Australian companies that have diverted their 

supply. 

Can you see the reason why people are a little bit uncertain 

about this? None of these are controlled by American manufacturers. In fact, the one manufacturer in America is actually owned by 

a French company. What if the French said, gee, we got to have 

that stuff, ship it over here. We are left with what for a fallback? 

I mean we have made it so difficult for an American company to 

own American pharmaceutical manufacturing capability for this 

vaccine that we have pushed it all over shore, either in ownership 

or in physical location. 

So I can understand why people are very upset. And it is not just 

the fact that we have not thrown enough government money at 

this. We spent lots of money. It is the fact we have got a structure 

in place created by our Federal Government that makes it onerous 

for people to manufacture or have a facility that manufactures this 

capability in America. 

Dr. LURIE. Certainly the structure and all the incentives that 

have been in place over decades have led us to the situation that 

we are in. We are all confronting the problem. 

Mr. TIAHRT. Yeah. It is just like we are worried about the alligators. We forgot we started out to drain the swamp. I do not think 

we are after the real problem here. We are responding to an emergency again. And Mr. Obey made this. But I think there are some 

underlying structural problems in our economy that have put us in 

this situation and forced manufacturing overseas or to a foreignowned entity. And I think until we get to the root cause of that, 

we are just going to be in this problem 5 years from now and 10 

years from now and 15 years from now. We will be dependent on 

somebody else as a society, we will be dependent on some foreign 

entity or foreign government to say, okay, you guys can have some 

now. 


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Do you see any other way about it? I mean a French-owned company is the only geographically-based in America manufacturer. Is 

that not correct? 

Dr. LURIE. That is correct. But let me also, just so people do not 

have the misconception that the French Government can, you 

know, suddenly decide—— 

Mr. TIAHRT. That is what the Australian Government did. 

Dr. LURIE. That is because it was being manufactured in Australia. 

Mr. TIAHRT. So you are saying that if the French Government 

did tell them you got to send it over here we could stop it at the 

border? 

Dr. LURIE. There is something called the Defense Protection Act 

that would ensure that that vaccine would stay in this country. 

And part of the reason that we really need to have the manufacturing capacity in this country is so that we can use those mechanisms to ensure that we have vaccine when we need it. 

Mr. TIAHRT. I can see why people are concerned, Mr. Chairman. 

We do not have the ability do what we need to do. 

Mr. OBEY. I would simply say that four and five years ago, when 

we were talking about this problem, we focused with Secretary 

Leavitt on the issue of what role the Federal Government could 

play in regularizing production by assuring manufacturers that if 

they did locate in this country and if they did produce that they 

would have a purchaser of last resort so that they knew that they 

would not be stuck with millions of doses if there was no demand 

in any given year. And it seems to me until we work out that kind 

of an arrangement, we are going to be stuck. 

So to me it is the same question we raised with Secretary Leavitt 

four years ago. When are we going to get with it and try to set up 

that kind of an arrangement? 

Any comment? You are going to duck it now? 

Mr. TIAHRT. In the one facility, when we asked them to manufacture stuff for us, do we waive any liability on their part? I was just 

watching TV last night and there was another ad saying if you 

have been harmed by this drug, call this number. And there is a 

lot of advertising going on about how we can get to these drug 

manufacturers and sue the pants off them. So when we ask people 

to do something like this, which is, you know, rather vague whether on how many doses are needed and what the side effects are, 

we just kind of go on percentages, and more than 50 percent, it is 

not risk free. So do we give them any liability waivers for this or 

do we just—we do? 

Dr. LURIE. Yes. So these manufacturers—— 

Mr. TIAHRT. So if we give them liability waivers it makes it easier for us to make things in America. Is that what we are saying? 

Dr. LURIE. This is something called the PREP Act that provides 

liability coverage other than willful misconduct for manufacturers 

all the way through to the people who put the shot in the arm. 

Mr. TIAHRT. So we protect them liability-wise. And that is a good 

thing. Otherwise we would not have the manufacturing here? 

Dr. LURIE. There are a lot of reasons we do not have manufacturing here. That has certainly been a big obstacle. If we did not 


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have the PREP Act in place, I am not sure we would have vaccine 

right now at all. 

Mr. TIAHRT. Good point. Very good point. I think that goes to the 

underlying causes of why we are in this situation. We have forced 

manufacturing overseas because of liability, because of a tax structure, because of a regulatory structure that is onerous, because of 

our inability to be energy independent. And then we wonder how 

we get in these situations. We say, well, we did not throw enough 

money at it. 

No, we put a structure in place over the last generation that has 

systematically forced jobs overseas. Now, to cover for it we are 

going to give these guys liability protection. But that is just one of 

probably 8 different or 12 different things that have caused people 

to make the conscious decision as stockholders to not invest in 

America, because it is just too costly. It is just too difficult. It is 

just too hard. 

So instead, they move their production to Australia or someplace 

else. And not knowing the complete history, I can tell you the 

structure problems, but I cannot tell you the complete history. But 

that is the bottom line is we have done this as a government. We 

have made it so onerous for them to make stuff here in America 

that now in order to keep what we got and to get the vaccines we 

have we have to waive the liability requirements. 

One of many infrastructure problems that we need to correct, 

and that is the job of Congress to correct, not you guys. 

I appreciate what you do, and thanks for coming and testifying. 

And you know, we are dependent on you. Godspeed. Thank you, 

Mr. Chairman. 

Mr. OBEY. Let me simply point out that in the last supplemental, 

I believe, we also provided a process under which a government 

could set up a compensation system to assist anyone who had been 

injured by those vaccines. So I think we have taken significant actions to try to deal with that problem. 

Did she leave? I guess Ms. Roybal-Allard has gone. And she 

wanted to ask two questions. I will put them in the record, if there 

is a record. That is right, there is not a record. This is a briefing. 

Old habits die hard. 

Well, thank you all for coming. I appreciate it. It has been very 

useful. 

Dr. FRIEDEN. Thank you. 

[Whereupon, the subcommittee was adjourned.] 


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