[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]


                                                                      ?

                 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              TODD TIAHRT, Kansas
 ROSA L. DeLAURO, Connecticut         DENNIS R. REHBERG, Montana
 JESSE L. JACKSON, Jr., Illinois      RODNEY ALEXANDER, Louisiana
 PATRICK J. KENNEDY, Rhode Island     JO BONNER, Alabama
 LUCILLE ROYBAL-ALLARD, California    TOM COLE, Oklahoma
 BARBARA LEE, California
 MICHAEL HONDA, California
 BETTY McCOLLUM, Minnesota
 TIM RYAN, Ohio
 JAMES P. MORAN, Virginia           

 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
                                                                      ?

                                  COMMITTEE ON APPROPRIATIONS

                   DAVID R. OBEY, Wisconsin, Chairman

 JOHN P. MURTHA, Pennsylvania             JERRY LEWIS, California
 NORMAN D. DICKS, Washington              C. W. BILL YOUNG, Florida
 ALAN B. MOLLOHAN, West Virginia          HAROLD ROGERS, Kentucky
 MARCY KAPTUR, Ohio                       FRANK R. WOLF, Virginia
 PETER J. VISCLOSKY, Indiana              JACK KINGSTON, Georgia
 NITA M. LOWEY, New York                  RODNEY P. FRELINGHUYSEN, New 
 JOSE E. SERRANO, New York                Jersey
 ROSA L. DeLAURO, Connecticut             TODD TIAHRT, Kansas
 JAMES P. MORAN, Virginia                 ZACH WAMP, Tennessee
 JOHN W. OLVER, Massachusetts             TOM LATHAM, Iowa
 ED PASTOR, Arizona                       ROBERT B. ADERHOLT, Alabama
 DAVID E. PRICE, North Carolina           JO ANN EMERSON, Missouri
 CHET EDWARDS, Texas                      KAY GRANGER, Texas
 PATRICK J. KENNEDY, Rhode Island         MICHAEL K. SIMPSON, Idaho
 MAURICE D. HINCHEY, New York             JOHN ABNEY CULBERSON, Texas
 LUCILLE ROYBAL-ALLARD, California        MARK STEVEN KIRK, Illinois
 SAM FARR, California                     ANDER CRENSHAW, Florida
 JESSE L. JACKSON, Jr., Illinois          DENNIS R. REHBERG, Montana
 CAROLYN C. KILPATRICK, Michigan          JOHN R. CARTER, Texas
 ALLEN BOYD, Florida                      RODNEY ALEXANDER, Louisiana
 CHAKA FATTAH, Pennsylvania               KEN CALVERT, California
 STEVEN R. ROTHMAN, New Jersey            JO BONNER, Alabama
 SANFORD D. BISHOP, Jr., Georgia          STEVEN C. LaTOURETTE, Ohio
 MARION BERRY, Arkansas                   TOM COLE, Oklahoma
 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        

                 Beverly Pheto, Clerk and Staff Director

                                  (ii)

 
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.
    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 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 3\1/2\ 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 Government 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.

                           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.
    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 as we can and also communicating rapidly 
and openly with the Congress and the public.
    Thank you.
    [The statement of Dr. Frieden follows:]



    
                           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.
    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:]



    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 vis-a-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 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 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:]



    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 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, 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:]



    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. 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.
    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:]



    
    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 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 left-hand 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 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.

                           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 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.
    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 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?
    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 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.

                 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.

                          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?
    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, 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 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.
    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.
    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 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 infrastructure? 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.

                       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 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.
    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 [email protected].

    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) 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 cell-based. 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 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 egg-based 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.

                         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 cell-based 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 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.
    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 estimates 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. So we are in a very, 
very fragile situation in terms of vaccine supply. 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, vaccine 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 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 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 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 all-hazards 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.

                            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 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 foreign-owned 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.
    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 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.]