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


 
     THE ADMINISTRATION'S FLU VACCINE PROGRAM: HEALTH, SAFETY AND 
                              DISTRIBUTION 

=======================================================================

                                HEARING

                               before the

                         COMMITTEE ON OVERSIGHT
                         AND GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                           SEPTEMBER 29, 2009

                               __________

                           Serial No. 111-31

                               __________

Printed for the use of the Committee on Oversight and Government Reform


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              COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

                   EDOLPHUS TOWNS, New York, Chairman
PAUL E. KANJORSKI, Pennsylvania      DARRELL E. ISSA, California
CAROLYN B. MALONEY, New York         DAN BURTON, Indiana
ELIJAH E. CUMMINGS, Maryland         JOHN L. MICA, Florida
DENNIS J. KUCINICH, Ohio             MARK E. SOUDER, Indiana
JOHN F. TIERNEY, Massachusetts       JOHN J. DUNCAN, Jr., Tennessee
WM. LACY CLAY, Missouri              MICHAEL R. TURNER, Ohio
DIANE E. WATSON, California          LYNN A. WESTMORELAND, Georgia
STEPHEN F. LYNCH, Massachusetts      PATRICK T. McHENRY, North Carolina
JIM COOPER, Tennessee                BRIAN P. BILBRAY, California
GERALD E. CONNOLLY, Virginia         JIM JORDAN, Ohio
MIKE QUIGLEY, Illinois               JEFF FLAKE, Arizona
MARCY KAPTUR, Ohio                   JEFF FORTENBERRY, Nebraska
ELEANOR HOLMES NORTON, District of   JASON CHAFFETZ, Utah
    Columbia                         AARON SCHOCK, Illinois
PATRICK J. KENNEDY, Rhode Island     BLAINE LUETKEMEYER, Missouri
DANNY K. DAVIS, Illinois             ------ ------
CHRIS VAN HOLLEN, Maryland
HENRY CUELLAR, Texas
PAUL W. HODES, New Hampshire
CHRISTOPHER S. MURPHY, Connecticut
PETER WELCH, Vermont
BILL FOSTER, Illinois
JACKIE SPEIER, California
STEVE DRIEHAUS, Ohio
------ ------

                      Ron Stroman, Staff Director
                Michael McCarthy, Deputy Staff Director
                      Carla Hultberg, Chief Clerk
                  Larry Brady, Minority Staff Director




















                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on September 29, 2009...............................     1
Statement of:
    Frieden, Thomas R., M.D., Director, Centers for Disease 
      Control and Prevention; Anthony S. Fauci, M.D., Director, 
      National Institute of Allergy and Infectious Diseases, 
      National Institutes of Health; and Jesse Goodman, M.D., 
      Acting Chief Scientist and Deputy Commissioner for 
      Scientific Administration and Medical Programs, Food and 
      Drug Administration........................................    18
        Fauci, Anthony S., M.D...................................    30
        Frieden, Thomas R., M.D..................................    18
        Goodman, Jesse, M.D......................................    46
Letters, statements, etc., submitted for the record by:
    Connolly, Hon. Gerald E., a Representative in Congress from 
      the State of Virginia, prepared statement of...............    79
    Cummings, Hon. Elijah E., a Representative in Congress from 
      the State of Maryland, prepared statement of...............    11
    Fauci, Anthony S., M.D., Director, National Institute of 
      Allergy and Infectious Diseases, National Institutes of 
      Health, prepared statement of..............................    32
    Frieden, Thomas R., M.D., Director, Centers for Disease 
      Control and Prevention, prepared statement of..............    20
    Goodman, Jesse, M.D., Acting Chief Scientist and Deputy 
      Commissioner for Scientific Administration and Medical 
      Programs, Food and Drug Administration, prepared statement 
      of.........................................................    49
    Issa, Hon. Darrell E., a Representative in Congress from the 
      State of California, prepared statement of.................     7
    Towns, Hon. Edolphus, a Representative in Congress from the 
      State of New York, prepared statement of...................     3


     THE ADMINISTRATION'S FLU VACCINE PROGRAM: HEALTH, SAFETY AND 
                              DISTRIBUTION

                              ----------                              


                      TUESDAY, SEPTEMBER 29, 2009

                          House of Representatives,
              Committee on Oversight and Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 2:05 p.m., in 
room 2154, Rayburn House Office Building, Hon. Edolphus Towns 
(chairman of the committee) presiding.
    Present: Representatives Towns, Cummings, Kucinich, Clay, 
Watson, Connolly, Quigley, Van Hollen, and Issa.
    Staff present: Kevin Barstow, investigative counsel; Jean 
Gosa, clerk; Velginy Hernandez, press assistant; Adam Hodge, 
deputy press secretary, Carla Hultberg, chief clerk; Marc 
Johnson, assistant clerk; Chris Knauer, senior investigator/
professional staff member; Mike McCarthy, deputy staff 
director; Julie Rones, counsel; Christopher Sanders, 
professional staff member; Leneal Scott, IT Specialist; Ron 
Stroman, staff director; Lawrence Brady, minority staff 
director; Jennifer Safavian, minority chief counsel for 
oversight and investigations; Adam Fromm, minority chief clerk 
and Member liaison; Ashley Callen, minority counsel; and Molly 
Boyl, minority professional staff member.
    Chairman Towns. The committee will come to order. Let me 
begin by thanking you for being here today. This past March, a 
novel strain of H1N1 influenza [swine flu], was reported in 
Mexico. Several people died, and the virus spread quickly. Just 
3 months later, in June, the World Health Organization declared 
this strain of swine flu to be a pandemic, the first global 
pandemic declared since 1968.
    According to the CDC, by the end of August, this new virus 
had spread throughout the United States resulting in more than 
9,000 hospitalizations and over 600 deaths. At first, some 
scientists feared that this could be a pandemic disaster on the 
scale of the Hong Kong flu of 1968; or, worse, the Spanish flu 
of 1918. At this point, however, it appears to pose much less 
of a threat. Nevertheless, there is great uncertainty about the 
course of this flu. It is this very uncertainty that I think 
concerns people most.
    If there is any good news, it is that so far this flu 
strain has not caused the number of deaths that some had 
feared. But why? What did the experts see then that they are 
not seeing today? And what does this foretell regarding how 
this virus may behave? Although dangerous mutations have not 
yet occurred, is this still a possibility? What do the experts 
expect and what do the best assessments now suggest?
    Public Health officials believe that vaccination is the 
best means to protect against this flu. We understand that a 
vaccine has been approved and is in production. But ever since 
the swine flu vaccine fiasco of the late 1970's, people have 
been cautious.
    Today we want to discuss questions that I believe the 
public has about the benefits and risk of the new vaccine. We 
want to understand whether it is necessary, whether it is 
available, who will get it, and when will they get it. The more 
information that can be made available regarding these 
questions, the better the public and other key stakeholders can 
assess both the risk and the benefits of receiving this 
important vaccine.
    With the swine flu virus spreading rapidly, hundreds of 
thousands of health-care workers, many in my State of New York, 
are now being required to get flu shots. Concerns have been 
raised about mandatory immunizations. In fact, there is a 
protest underway right now in Albany, NY, which highlights the 
concerns that some have regarding mandatory vaccinations. I 
want to carefully examine these concerns today with our 
witnesses.
    In addition, the Chamber of Commerce estimates that during 
a normal year, the U.S. economy loses an average of $10 billion 
as a result of the flu. It could be double that this year, and 
many businesses that are not adequately prepared may not be 
able to function given the number of workers that could be 
absent.
    Fortunately, we have the three leading experts on these 
issues with us today and we are happy to have them. I welcome 
all of you and look forward to your testimony.
    [The prepared statement of Hon. Edolphus Towns follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Towns. I will now yield to the ranking member, Mr. 
Darrell Issa of the State of California, for his opening 
statement.
    Mr. Issa. Thank you, Mr. Chairman. Thank you for holding 
this always timely hearing.
    Today we will examine the H1N1 pandemic flu, and many will 
say we're not examining it for the first time, and that is 
true. As a matter of fact, we are not examining it and other 
causes of pandemic outbreaks for the last time or the second-
last time or perhaps the thousandth last time.
    It is very clear that the flu--the flu virus can mutate as 
it migrates; it has, in all the years since the many outbreaks, 
including the so-called Spanish flu that was so devastating to 
our soldiers from Fort Riley, Kansas, two generations ago.
    Unlike then, we understand now that there are steps that 
must be taken. Today, we'll hear not just about the virus and 
not just about vaccines, but about a series of steps that must 
be taken now and in the future in preparation for an effective 
response.
    If we have an effective vaccine today, we have it for 
today. Tomorrow is yet another day, and those vaccines that 
worked yesterday, likely, do not respond next year. Moreover, 
this committee has previously talked about and heard witnesses 
on the annual flu shots people receive and the questions about 
that.
    This committee was very, very involved, and properly so, in 
the provisions of the Public Readiness and Emergency 
Preparation Act [PREP] Act, which, in fact, went a long way 
toward creating an environment in which our government could 
encourage the development of these vaccines, at great cost, 
without the liability of being beyond economic advice of their 
counsel. We must continue to do so. We must work on a 
bipartisan basis to recognize that, for example, the Veterans 
Administration, which plans to make available more than 3 
million H1N1 doses this year, does so to Federal workers and 
veterans without fear of lawsuit, because in fact they have a 
liability exemption. But that's not true of the broader market.
    So as we talk about the requirements we have--and the 
chairman is talking about protest against these vaccines--we 
must bear in mind that there will always be two schools: those 
who will rightfully sue us or threaten us if we don't respond 
and we don't prepare and we don't have vaccine, and those who 
will respond and protest and sue if we do.
    Mr. Chairman, I hope that this committee will, in fact, 
dedicate itself as the premier oversight committee of the 
Congress to do this on an annual basis, because as much as 
people may say, ``well, we've heard about it before,'' the flu 
of next year is not the flu of this year, the pandemic of this 
year may pale in comparison to the pandemic of next year. And 
as we as a Congress support the efforts of various 
organizations, both public and private, to implement an 
international strategy to make us invulnerable as possible, we 
have to realize that nothing changes faster than the flu.
    With that, I yield back and look forward to the hearing.
    Chairman Towns. Thank you very much.
    [The prepared statement of Hon. Darrell E. Issa follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Towns. Any other Members seeking recognition? The 
gentleman from Maryland, Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman. Mr. 
Chairman, I certainly thank you for holding this hearing today 
on the administration's flu vaccine program. The H1N1 virus has 
been taking the world by storm since April 2009. The U.S. 
Secretary of Health and Human Services,Kathleen Sebelius, 
renewed the declaration that a public health emergency exists 
nationwide involving this virus.
    As the government prepares for the 2009 flu season, we must 
take every measure to ensure that all Americans, but especially 
populations of concern including children and the elderly, are 
well prepared for the increased spread of H1N1.
    At least 46 U.S. children, under the age of 18, have died 
from the H1N1 swine flu infection since April. H1N1 flu is a 
new virus, so people may have little or no immunity, which 
means that the virus may spread more easily from person to 
person.
    In my State of Maryland, we are on a widespread activity 
alert, meaning that outbreaks of the flu or flu-like illnesses 
have been reported in at least half of the regions in the 
State, and there is recent evidence of lab-confirmed influenza 
in the affected regions. In fact, H1N1 is now the predominant 
strain of flu in the State of Maryland.
    Currently, Maryland has had eight deaths and over 170 
hospitalizations due to H1N1. So, I'm curious to learn from our 
witnesses how the administration will address the areas that 
have been hit the hardest. And we have 135 days left in the flu 
season, and vaccinations are expected to be available within a 
few weeks. Education around the importance of the seasonal flu 
vaccine has helped millions of Americans see the importance and 
value of receiving this treatment. However, with something as 
common as a flu shot, people are still resistant. People are 
afraid of potential side effects. They are concerned they will 
actually get the flu from the inoculation. And there are those 
who just do not believe that the flu shot will be effective.
    Last year in a RAND Internet-based survey of some 4,000 
U.S. residents results showed that 46 percent of adults for 
whom flu vaccination is strongly recommended, meaning those 
with underlying conditions, those over 50, those in close 
contact with infants, the ill, Mr. Chairman, and the elderly 
had no intention of getting the vaccine. Similarly those 
especially vulnerable to flu are not getting the vaccine 
either.
    In that study, it was reported that 52 percent of people 
with asthma had no intention of getting the flu vaccine. With 
the current state of apathy toward the seasonal flu 
vaccinations, I am worried that there will be the same or even 
a worse case of apathy toward the H1N1 vaccine.
    As I close, since the initial outbreak earlier this spring, 
the media has put a strong emphasis on H1N1 virus and the need 
for children to get vaccinated. However, there are some 
concerns about whether all of the hype is really necessary.
    The Centers for Disease Control and Prevention estimates 
that an average of 36,000 people die from seasonal flu each 
year, while the CDC's own data shows that so far there have 
been fewer than 1,000 H1N1 deaths. Certainly, I know that this 
hearing will shed light on this subject. And one thing we need 
to keep in mind, Mr. Chairman, is that it is better that we be 
cautious and err on the side of caution in making sure that our 
people are protected, no matter what their reluctance might be.
    If we have a safe vaccine, which I do believe we have, we 
need to make sure that we do everything in our power to 
convince the public that it is important that they take 
advantage of it.
    And with that, Mr. Chairman, I thank you and I yield back.
    Chairman Towns. I would like to thank the gentleman from 
Maryland for his statement.
    [The prepared statement of Hon. Elijah E. Cummings 
follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Chairman Towns. And I now yield 5 minutes to the gentleman 
from Ohio, Mr. Kucinich.
    Mr. Kucinich. Thank you very much, Mr. Chairman. I want to 
welcome our witnesses.
    This is an opportunity for still another civics lesson 
through this committee, and that is that we have public health 
officials here who are once again demonstrating the primacy of 
the government's role in matters of public health; that we have 
here, oh, yes, a government-run flu vaccine program. Why? 
Because the government has the resources and the ability to 
distribute in the public interest and to protect the public 
health, medical means and materials, in this case, flu 
vaccines, that can be important to protecting the health of the 
people of the United States. This is one of the purposes of the 
government.
    At this very time, Mr. Chairman, a Senate committee is 
meeting on a public option for health care. And I want to 
connect the two, because the fact of the matter is with tens of 
millions of Americans without access to primary care, if you 
don't have access to primary care and you get the flu, the 
effects of the flu can be much more damaging. You don't have to 
be a doctor to understand that. You also may be more medically 
compromised than other people and therefore even more 
vulnerable to being able to contract an influenza.
    So we have to use this opportunity to explore cause and 
effect here as well, because what we have to do with the 
influenza issue here--swine flu is one thing and the more 
generalized type of flu another--but we also have to realize 
this occurrence in the context of a health-care system which 
is, in itself, a weakened system. And we reflect that it is 
Congress' responsibility to strengthen it.
    So, I want to thank Dr. Frieden, Dr.Fauci and Dr. Goodman 
for their presence here today. We look forward to your 
testimony as to how we can prepare the American people for this 
influenza season. But we also have to understand that there are 
things happening in health care in America which make our 
constituents even more vulnerable to every manner of flu and 
the generalized pandemic that can ensue, not just this season, 
but any season. And to look at the underlying question here is 
one of the things Congress will certainly be involved in in the 
next few months.
    Mr. Chairman, with that I yield back. Thank you.
    Chairman Towns. I thank the gentleman from Ohio for his 
statement. I yield to the gentleman from Illinois, Mr. Quigley.
    Mr. Quigley. Waive.
    Chairman Towns. He waives.
    Let me introduce our witnesses today. Dr. Thomas R. 
Frieden, good to see you. Director of the Centers for Disease 
Control and Prevention. Dr. Frieden has been trained in 
internal medicine, infectious diseases, public health and 
epidemiology. Before being named the Director of the CDC in 
June 2009, Dr. Frieden was the commissioner of the New York 
City Department of Health and Mental Hygiene.
    Dr. Fauci, Dr. Anthony S. Fauci, Director of the National 
Institute of Allergy and Infectious Diseases, at the National 
Institutes of Health. Dr. Fauci, a native of Brooklyn, NY, 
advises the White House and the Department of Health and Human 
Services on medical and public health preparedness against 
emerging infectious disease, such as pandemic influenza.
    Our next witness is Dr. Jesse Goodman, the Food and Drug 
Administration Acting Chief Scientist and Deputy Commissioner 
for Scientific and Medical Programs. Previously, Dr. Goodman, 
an infectious disease expert, was the Director of FDA's Center 
for Biologics, Evaluation and Research.
    Gentlemen, it is a longstanding policy that we swear all of 
our witnesses in, and so if you would stand and raise your 
right hands.
    [Witnesses sworn.]
    Chairman Towns. You may be seated. Let the record reflect 
they answered in the affirmative.
    Dr. Frieden, we will start with you and come right down the 
line, OK? And let me just say that we have 5 minutes. When you 
start, the light is green and then as you move forward it 
becomes yellow, which is saying you have 1 minute to summarize. 
And then after that it becomes red. Red all over the United 
States means stop. OK, you may proceed.

 STATEMENTS OF THOMAS R. FRIEDEN, M.D., DIRECTOR, CENTERS FOR 
    DISEASE CONTROL AND PREVENTION; ANTHONY S. FAUCI, M.D., 
    DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS 
  DISEASES, NATIONAL INSTITUTES OF HEALTH; AND JESSE GOODMAN, 
   M.D., ACTING CHIEF SCIENTIST AND DEPUTY COMMISSIONER FOR 
 SCIENTIFIC ADMINISTRATION AND MEDICAL PROGRAMS, FOOD AND DRUG 
                         ADMINISTRATION

              STATEMENT OF THOMAS R. FRIEDEN, M.D.

    Dr. Frieden. Thank you very much. Members of Congress----
    Voice. Turn your mic on.
    Dr. Frieden. Thank you very much, Mr. Chairman, Ranking 
Member Issa, and members of the committee. In the spring, I was 
New York City health commissioner and we had hundreds of 
thousands of cases of H1N1 influenza. At that time, we didn't 
have as clear an understanding as we do today of the level of 
illness it causes. We had health-care settings that had a great 
deal of difficulty dealing with the large number of patients 
coming in. We had intense media interest. And tragically, we 
had some people who became very severely ill, and some people 
who died. So, H1N1 influenza is something that we have to take 
extremely seriously. And what I would like to do is update you 
briefly on the situation and our response.
    As of today, H1N1 really never went away from the spring 
until now. It continued to spread over the summer, in summer 
camps and elsewhere. And when schools came back into session 
and kids went to college, we saw large numbers of cases.
    Influenza is now widespread across the United States and, 
in fact, this is unchartered territory for an influenza season. 
We've had already many millions of cases and we will have many 
millions of cases more.
    So far, there has been no change in the pattern of illness, 
so the level of illness with H1N1 is no more severe than 
seasonal influenza. And intensive laboratory studies have shown 
no change in how deadly the virus is and no significant change 
in the genetic makeup of the virus. That's good news, because 
it indicates that so far, it doesn't seem that it will become 
more deadly in the immediate future. And so far, it seems like 
the vaccine, which Dr. Fauci will speak about more, will be an 
excellent match against the specific virus that's spreading 
now.
    However, influenza is probably the most unpredictable of 
all infectious diseases. There are many variables, and only 
time will tell what will happen, whether it will become 
something that becomes more deadly is something we just don't 
know until the time comes. Therefore, the role of the CDC, much 
of which is made possible because of the support of the 
Congress over several years, is several-fold.
    We currently have more than 1,500 staff working on H1N1 
response. The activities include the identification and 
characterization of the virus, identifying a candidate strain, 
monitoring the spread of disease in the United States, and 
globally, and responding through communications with the 
public; guidelines for schools, businesses, health-care 
providers, and a vaccination campaign.
    The vaccination campaign is an unprecedented effort. It's a 
public-private partnership, with substantial amount of vaccines 
coming available in the weeks to come. Production is rolling 
and our choice was to let it buildup in warehouses then send it 
out; or what we decided to do is send it out as soon as it 
becomes available off the production line and its safety and 
potency has been verified. That means that over the next 
several weeks, there will be some vaccine in the system, but 
there will also be some roughness as it gets distributed.
    Eventually, there will be vaccine for all who want to be 
vaccinated. The priority of people who are at higher risk of 
becoming severely ill, pregnant women, those with underlying 
conditions, school children, contacts of people under the age 
of 6. The vaccine will be free in public settings and in 
private settings. There will be no cost of the vaccine, 
although some settings will charge an administration fee. There 
will be up to 90,000 providers across the country providing 
vaccine, and the challenges are significant.
    This is a shared responsibility of the Federal, State and 
local governments of the health-care system, of individuals, of 
businesses, and, of the manufacturers who are partners in this 
process.
    Progress has been possible because of the ongoing 
investment by Congress. We are working hard with our partners 
in HHS, under the leadership of Secretary Sebelius, and the 
U.S. government generally, and State, local tribal governments, 
as well as health-care providers; and we are committed to 
regular open communications with the public and the Congress. 
It's an evolving situation. We're committed to staying open and 
answering your questions. Thank you.
    Chairman Towns. Thank you very much.
    [The prepared statement of Dr. Frieden follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Towns. Dr. Fauci.

              STATEMENT OF ANTHONY S. FAUCI, M.D.

    Dr. Fauci. Mr. Chairman, members of the committee, thank 
you for giving me the opportunity to review for you, the role 
of the National Institutes of Health, their research endeavor, 
and the preparedness and response to the 2009 H1N1 influenza 
pandemic, particularly in the arena of the development and 
testing of vaccines against this new virus.
    The National Institute of Allergy and Infectious Diseases 
has been involved in basic and clinical research related to 
seasonal influenza for several decades. And we have the 
responsibility for the development of rapid diagnostics for the 
flu, the development and testing of antiviral drugs, the 
understanding of how the influenza viruses evolve, how they 
mutate, how they transmit, what immune responses are induced. 
And, importantly, we are deeply involved in the development of 
the testing of vaccines to prevent seasonal and pandemic 
influenza.
    This latter effort is a collaborative process among several 
agencies of the Federal Government, particularly the sister 
agencies represented here in the Department of Health and Human 
Services, in partnership with the pharmaceutical companies that 
actually manufacture the vaccines.
    As schematically shown on the first poster over there on 
the right, the development of an influenza vaccine is a step-
wise process, starting with the isolation of the virus up to 
and including the actual development of the new vaccine for 
distribution. In this regard, the 2009 H1N1 pandemic influenza 
virus was first isolated by the CDC and made available to a 
number of parties, including us at the NIH, for purposes of 
studying its characteristics. Pharmaceutical companies, with 
which we have longstanding relationships in the development of 
influenza vaccines, were given what we called ``seed'' or 
reference viruses for the purpose of developing pilot lots for 
the NIH to test in clinical trials.
    Historically, our Institute has set up a network of vaccine 
and treatment evaluation units throughout the country. These 
groups have extensive experience in the conduct of vaccine 
trials and were called upon, again, to answer several important 
questions that would inform how we would use the H1N1 vaccines 
in this country and worldwide.
    The important information gained from these clinical trials 
involve safety, even though we have safety data from decades of 
experience with seasonal vaccines made in the same manner. Also 
immunogenicity; or, simply put, does the vaccine elicit a 
response that will be predictive of protection against this 
virus? For example, what is the correct dosage and the number 
of doses? If we require the use of an enhancing substance 
called an ``adjuvant'' to amplify the response in spare doses, 
would this be safe and effective.
    Also, we need to know about the effectiveness of vaccine in 
special populations, such as the elderly, children and pregnant 
women.
    As shown in the next poster, we have several ongoing trials 
that have already provided extremely valuable information for 
the implementation of our vaccination program. I can report 
today some good news regarding these clinical trials. For 
example, it was unclear at first whether this vaccine would 
induce a protective response at all. And if so, would it 
require an unreasonable dosage and/ or a number of doses to 
achieve this effect? We now know that a single dose of the 
standard 15 micrograms of vaccine in adults and the elderly, 
without the need of an adjuvant, is, not only well-tolerated, 
but induces a robust immune response in a high percentage of 
recipients.
    This is a very important finding and has important 
implications for the supply of vaccine, as well as, for 
effectiveness in protecting our citizens, as well as, people 
throughout the world against the pandemic influenza.
    In addition, we found that, very similar to the seasonal 
flu vaccines, one dose of the 2009 H1N1 vaccine induces a 
robust response in children 10 to 17 years old, indicating that 
they will require only one dose, while younger children will 
likely require two doses, which is quite similar to the case 
with seasonal flu vaccine.
    Current studies are ongoing in pregnant women, and we hope 
to have preliminary data within a few weeks. In addition, we 
are planning to conduct vaccine trials in individuals who might 
have particular difficulty with the H1N1 virus, such as 
asthmatics and individuals with HIV infection.
    In summary, the NIH research effort, in the development and 
testing of the 2009 H1N1 vaccine, is an important part of the 
collaborative effort among the sister agencies of the 
Department of Health and Human Services, and we look forward to 
continuing this effort as we face the challenges ahead of us 
this fall and winter.
    Thank you very much, and I would be happy to answer 
questions later.
    Chairman Towns. Thank you very much, Dr. Fauci.
    [The prepared statement of Dr. Fauci follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Towns. Dr. Goodman.

                STATEMENT OF JESSE GOODMAN, M.D.

    Dr. Goodman. Mr. Chairman and members of the committee, I 
very much appreciate the opportunity to be here today and 
describe FDA's role in this public health response. This 
ongoing collaborative response is the product of hard work and 
continuing investment made possible by Congress's support for 
preparedness activities in the Department of Health and Human 
Services.
    When the H1N1 virus emerged in the spring, we immediately 
established an incident-command system to speed and coordinate 
our response. This allowed us to work hand in hand with HHS and 
my partners at the table here to rapidly mobilize what has been 
an emergency public health response. And this included not just 
the vaccine enterprise that we began at that time, but allowing 
emergency use authorization for antivirals for ill children 
under 1-year old, deploying a new diagnostics, so both the 
public health and health-care system could accurately diagnose 
this infection.
    The very good news is that the initial doses of licensed 
vaccines will be available very, very soon and that full-scale 
production is continuing. And these vaccines are made in 
exactly the same manner as the 100-plus million doses of 
seasonal vaccine that are made and used safely every year to 
help protect American people.
    Well, immediately after this virus was detected--and as you 
saw on Dr. Fauci's chart--we all began working together to 
generate all the tools, including the virus reference strains' 
reagents necessary to manufacture the virus. And we worked with 
our colleagues at NIH to design and mobilize those clinical 
studies, as well as, with the manufacturers that you've heard 
about.
    Fortunately, this occurs on a background--and it's been 
mentioned here--of substantial investment that has helped us 
prepare better. We engaged for several years in an effort to 
strengthen influenza in public health system preparedness. And 
this has truly helped in this response.
    In the last 5 years, we've been able to virtually double 
the number of U.S. licensed manufacturers of vaccine and also 
their production capacity. And some examples of some of these 
activities, undertaken by us in conjunction with the Assistant 
Secretary for Preparedness and Response and the Biomedical 
Advance Research and Development Authority under that office, 
have included having resources as mundane as chickens--having a 
large flock of chickens available year round, not to mention 
the roosters, to help produce large numbers of eggs. And this, 
in fact, was called into play in this very response.
    In addition, in May, we approved a new facility for a U.S.-
based manufacturer that markedly increased the ability to 
produce vaccine.
    Well, as a result of some of the work you've heard about, 
on September 15th, FDA approved what we called ``supplements'' 
to the licenses of four U.S.-licensed manufacturers of vaccines 
made to protect against the pandemic influenza ``A'' strain. 
This approval is consistent with how strain changes are 
approved each and every year for identically manufactured, 
licensed seasonal flu vaccines.
    FDA is very experienced with the development and production 
of these vaccines which were produced, as I said, by identical 
license processes; and have an extensive track record of safety 
and effectiveness in the United States.
    And as Dr. Fauci mentioned, and as with the currently 
licensed seasonal flu vaccines, none of these vaccines contain 
an adjuvant, because none was needed.
    Well, given the lack of measured background, immunity to 
the 2009 virus circulating, as Dr. Fauci mentioned, clinical 
studies were undertaken so that we could be as informed as 
possible on how to use these vaccines. And as you have heard, 
the data available, to date, are very positive and show that 
again, like seasonal vaccines, a normal 15-microgram dose 
induces a great immune response that's likely to be protective 
both in healthy adults and older children. And the vaccine has 
been very well-tolerated.
    I want to stress that these pandemic vaccines are subject 
to the same stringent manufacturing and quality oversight 
that's in place for licensed seasonal influenza vaccine. Make 
no mistake, we've worked very hard to get vaccine available as 
quickly as feasible, but no corners have been cut in this 
process. Each facility is inspected annually for compliance 
with good manufacturing practices. Extensive in-process 
controls and product testing are required at multiple stages of 
manufacturing. And each lot of vaccine must be reviewed and 
tested by the manufacturer, and results and samples of every 
lot provided to FDA. No lot of vaccine could be used until 
testing is completed and it's released by the manufacturer and 
FDA.
    I'm a bit over my time, but I do want to mention something 
about safety and safety monitoring, since this is very 
important to everyone. We expect the potential side effects for 
the H1N1 vaccines to be mild and to be similar to those that 
follow the use of seasonal vaccines. Following a flu shot--
which, in answer to the chairman's comment, you cannot get flu 
from the flu shot, the flu shot is a killed virus that has been 
purified to get the component of the virus that can help 
protect you. The most common side effect of a flu shot is 
soreness at the site of immunization. Some individuals may 
develop mild fever, body aches or fatigue that typically just 
last a few days.
    From the nasal spray vaccine, which is a live, weakened 
virus that similarly cannot cause flu in an individual, side 
effects may include runny nose, nasal congestion, sore throat 
and fever. Although these kinds of mild reactions are to be 
expected, unexpected adverse events are a potential risk of any 
medical product, even those associated with such a long and 
excellent record of safety.
    It is important to realize that every day in the United 
States, some previously healthy people will have serious and 
unexpected medical events, regardless of whether or not they 
have received a vaccine or any medical product. These are what 
we call ``background rates,'' or cases of a disease that we 
would expect to see whether somebody receives a vaccine or not. 
It's important to realize that when a large number of people 
are going to get a product in a short period of time, we're 
going to see many people who, by chance alone, may experience 
serious events which coincide with the time period following 
immunization.
    It will be challenging, but very important, to keep aware 
of this, and to distinguish such events from those that are 
expected to occur coincidentally from somewhere, or an 
unexpected event that could occur from immunization.
    Therefore, we are working with multiple partners, in 
particular CDC and HHS, to not only do the rigorous vaccine 
safety monitoring that we do every year and with every vaccine, 
but with this vaccine to expand that monitoring, including 
numerous other partners of Federal agencies--the Department of 
Defense, Veterans Affairs, Centers for Medicare and Medicaid 
Services, our international partners, our State and local 
partners, and many others. So we're going to have a very 
augmented safety surveillance system in place.
    While we are gratified that this vaccine will soon be 
available, there are many opportunities to further develop the 
science and capacity that we need to enhance our preparedness. 
And I particularly appreciated Mr. Issa's comments that this a 
continued--that while this is an event this year, it is 
continuing work to be prepared for this and similar other 
events that's going to keep our public-health system and our 
people best protected.
    We clearly need more capacity, both in the United States 
and globally, to produce vaccines. Major investments by NIH at 
the basic science end, by HHS in advanced development on newer 
kinds of flu vaccines, are already kicking in. Cell-culture-
based vaccines, recombinant vaccines, will provide us with 
increased capability. With your support, in FDA's laboratories, 
we are working on methods that will speed the evaluation and 
testing of the vaccine so it can help make vaccines available 
sooner.
    Vaccines, though, are only part of the picture here. So 
while people tend to focus on them, we need to keep clear that 
there are lots of other opportunities. We need to take the 
opportunity to promote the development of new antivirals, rapid 
diagnostics' and enhanced safety surveillance, and a variety of 
public health tools. All of this will better prepare us to 
respond to the future threats that we know will also occur.
    So, in conclusion, we are fully committed to and engaged in 
protecting public health during this very challenging time. 
Working together with our partners, we have made important 
progress in providing vaccines and other tools to help safely 
protect our population.
    Again, I thank you for the opportunity to be here today, 
and we welcome your questions.
    Chairman Towns. Thank you very much.
    [The prepared statement of Dr. Goodman follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Towns. Let me thank all three of you for your 
testimony.
    Let me begin by asking you, Dr. Frieden and Dr. Fauci, 
should the American public be more frightened about the H1N1 
influenza than the seasonal influenza?
    Dr. Frieden. H1N1 influenza is what we have spreading 
widely in the United States today. And so that's what is the 
dominant strain. But the bottom line is that anyone who has a 
mild illness should know that for most people, neither testing 
nor treatment will be indicated. If, however, you are severely 
ill, you have difficulty breathing, or if you have an 
underlying condition, such as diabetes, or heart disease or 
lung disease, children with certain neuromuscular problems that 
make it harder for them to breathe, or women who are pregnant, 
then it would be quite important, if you have fever, flu-like 
symptoms, to get to see your doctor and get treated promptly, 
because that can make a big difference.
    And over the coming weeks, vaccine will become available 
and it is recommended that people get vaccinated. Seasonal flu 
kills approximately 36,000 people each year in our estimates. 
Although the pandemic influenza, or H1N1 influenza, is not 
affecting the same age groups, it is making many millions of 
people sick. Vaccine is our best tool, and until vaccine is 
available, and even afterwards, there are some simple things 
that people can do to protect themselves, their families and 
their community.
    Stay home if you're sick, it doesn't do yourself or others 
around you a favor to go out if you've got a fever or are 
coughing and could make others sick as well. Cover your cough--
cover your mouth when you cough or sneeze, and wash your hands 
frequently. These three simple steps can make a big difference 
in how rapidly and widely flu spreads in a community.
    Up until now, we see that H1N1 is spreading more widely 
than seasonal flu generally does and in somewhat different age 
groups: more young people affected, fewer older people 
affected, and the level of severity is no more than seasonal 
flu, but we also don't see it as being less than seasonal flu.
    Chairman Towns. Dr. Fauci.
    Dr. Fauci. Yes, I just--to reiterate, we should take all 
influenza seriously, both seasonal flu as well as the situation 
we are facing now with H1N1 pandemic influenza. As Dr. Frieden 
mentioned, the burden of disease in seasonal flu is 36,000 
people each year die, and 92 percent of them are elderly 
individuals. And the majority of those--when I say ``elderly,'' 
I mean older than 65--and the majority of them are 80 and 
older. So that is an important burden of disease in that age 
group.
    The difference, as you've heard from all of us with regard 
to H1N1, although it doesn't appear to be more severe in 
general in the big picture than a seasonal flu, it has a 
propensity to infect younger individuals in greater quantities. 
And a certain percentage of them, unfortunately, would go on--a 
very small percentage, but nonetheless any death in a young 
person is a tragedy. And under these circumstances we're trying 
to avoid people getting infected by vaccination. And you know 
the target groups include pregnant women and younger 
individuals who are more vulnerable to what we call the 
complications of influenza, and that's the reason why we want 
to stress the importance of people within those priority groups 
of getting vaccinated.
    So, you asked should we be worried and concerned? I would 
say that we should pay attention to it and follow the 
guidelines of the Centers for Disease Control and Prevention.
    Chairman Towns. This is to you, Dr. Goodman. This vaccine, 
how can we be assured of its safety and its effectiveness?
    Dr. Goodman. Well, the good news is we were able to get 
vaccines made that are completely made in the identical way, in 
the same licensed FDA overseeing manufacturing facilities with 
all the same testing as the seasonal flu vaccines we use in 
over 100 million people every year. So these are very tried and 
true vaccines. The safety record of them has been outstanding 
over many years.
    In terms of their effectiveness, there are circumstances, 
such as when the flu virus is different in the vaccine than 
what's out there, where the vaccine is sometimes not as 
effective as we like.
    In this case, we believe that the vaccine is likely to be 
highly effective. We won't know until it's used, but that's our 
belief, based on the best science. And the reason for this is 
No. 1, as Dr. Fauci has said, it induces a really strong and 
good immune response in the people who have been getting it. It 
is an immune response that typically correlates with protection 
against the virus and protection against some of the serious 
complications, like ending up in a hospital or worse.
    The other reason is that, as Dr. Frieden said, all of our 
surveillance shows that up to now this virus hasn't changed. So 
the virus and the vaccine strain used to make the vaccine is 
virtually identical to what's circulating out there. And under 
those circumstances, we expect vaccine to be effective.
    Chairman Towns. Thank you very much. My time has expired.
    I yield 5 minutes to the gentleman from California, 
Congressman Issa.
    Mr. Issa. Thank you, Mr. Chairman.
    I think all the witnesses did spend some time talking from 
terms of safety, perhaps because there has been so much 
additional concern for this new vaccine.
    Let me go through a couple of quick questions and I'm going 
to try to be as accurate as I can in who answers them. But the 
idea that health-care professionals, first responders, and 
hospital personnel would be required to mandatorily receive 
these shots, can somebody make the case for that, because there 
seems to be a very specific pushback from that industry of 
people who find the odds versus the side effects unacceptable?
    Dr. Frieden. The first thing I would make clear is that 
there is no Federal mandate for any individual to get 
vaccinated.
    Mr. Issa. OK. So the Washington Post, ``Mandatory Flu Shots 
Hit Resistance'' is premature?
    Dr. Frieden. There is no Federal mandate.
    Mr. Issa. OK.
    Dr. Frieden. At least one jurisdiction has mandated that 
unless there is a religious exemption or a medical exemption, 
such as an allergy to eggs, that health-care workers be 
vaccinated.
    Mr. Issa. Since all of you are at this level, can you make 
a case for whether the State has a compelling interest for that 
one State versus the other? In other words, if the State is 
right, then why aren't we doing it from this dais? And if the 
State is wrong, then are the people being adversely forced to 
do something that is probably outside the need of government?
    Dr. Frieden. This is something that has been debated for 
some time, even before pandemic influenza came along this time 
around. In fact, the mandate that the State of New York 
implemented was prior to the emergence of H1N1 influenza and 
unrelated to it.
    The argument is a simple one and an important one. The 
evidence is clear that many patients become ill because they 
get infected with influenza from health-care workers. 
Furthermore, health-care workers are themselves at risk of 
contracting influenza at their workplaces and of bringing it 
home to their families. There are other vaccinations such as 
measles, which are required of health-care workers, and other 
annual programs such as testing for tuberculosis infection, 
which are required of health-care workers. Our sense is that 
this particular season, in the midst of a pandemic, is not the 
time at the Federal level where we would start a new mandate 
along those lines, but the important point to make is we really 
do want health-care workers to get vaccinated for their own 
protection, the protection of their families, and the 
protection of their fellow workers.
    Mr. Issa. So to view the cliff notes in my short 5 minutes, 
you are not prepared to support it at this time but you are not 
ruling out supporting it at a national level?
    Dr. Frieden. Not this year.
    Mr. Issa. OK. And I'm going to leave all of you a copy of 
H.R. 1478, which is from the gentleman from New York, Mr. 
Hinchey, and I just would like you to followup. It's a bill 
that would make the Armed Forces and ultimately all 
government--the goal is to make all government entities liable 
for litigation for their actions; in other words, open them up 
to malpractice suits and the like.
    And I would like you to respond on specifically, relative 
to your agencies which enjoy liability limitation as government 
entities over and above all over narrow ones, how it would 
impact your agencies if you were fully able to be sued by the 
public, by class action lawsuits for any and all things which 
you decide to do.
    And I'm doing this for a reason, at a time of--first of 
all, because I'm on the dais and it is my 5 minutes. But 
second, because at a time in which we're talking about health 
care--and Mr. Kucinich talking so boldly about your public 
option--there's a number of pieces of legislation coming 
through that would open up the government option to litigation. 
And I'd like each of you to give me your view of how you are 
able to do your job without having to worry about, excessively, 
the fact that you might be sued for anything that goes wrong. 
And if you could respond in writing, because I realize that's 
far more than you might be able to do.
    Last question. The H1N1 vaccine is for a different group 
than the flu virus vaccination, as a whole. Could you give us 
your breakdown of, in an ideal world, if you only had 10 
million or 12 million or 15 million doses, who should get it 
first? And I say this because we're dealing with seniors versus 
non-seniors, children who have been reported actually having a 
lower incident or problem, and this unusual bulge called 
``Middle America,'' healthy young people who seem to be at the 
highest risk, and how that plays for our consideration of 
dollars and the public message.
    Dr. Frieden. We're confident that eventually there will be 
enough vaccine for everyone to receive it who wants to receive 
it, in terms of H1N1 influenza. Each year for seasonal flu, we 
vaccinate about 100 million people. There is also going to be 
enough seasonal flu vaccine around, and anyone who wants 
seasonal flu vaccine can receive it, really.
    For the H1N1 vaccine, there are five key priority groups. 
This doesn't mean that we deny it to other people, but we 
prioritize these groups: pregnant women, people with underlying 
conditions, health-care workers, people who are contacts of 
people, infants under the age of 6 months, who cannot 
themselves be vaccinated, and then children and young adults 6 
months to 24 years.
    Mr. Issa. OK, Mr. Chairman, I think others may want to 
respond, but I do want to thank you and mention that in this 
case, since there is a controversy, I intend on getting one of 
these shots if for no other reason than to show that I believe 
that it's safe and effective. If anyone else wants to respond.
    Thank you, Mr. Chairman.
    Chairman Towns. Thank you very, very much.
    At this time, I yield 5 minutes to the gentleman from 
Maryland, Mr. Cummings.
    Mr. Cummings. Thank you very much. And thank you, 
gentlemen, for your excellent testimony.
    Dr. Fauci, one of the things that I'm very concerned about 
is the elderly. We have in my district probably 100 senior 
houses with at least 400 or 500 elderly. And I'm just 
wondering--they are locked into a situation, they don't have 
isolation and things of that nature. I was with two groups of 
elderly people yesterday, and they expressed some concerns 
about the vaccine. And I'm just wondering, how--what is your 
advice to that population? You have some people who--like one 
gentleman said, he said, I'm stuck in my ways and I'm not 
sticking a needle in my arm.'' And I mean, that's what he said. 
And so I'm just--how do you deal with that population?
    Dr. Fauci. Well, what we try to do is to explain to them in 
a way that's clear, that they can understand, the risk at their 
age of getting--let's start with seasonal influenza first, 
because seasonal influenza is available right now. And since 
the elderly are the ones that suffer most from serious 
consequences, I mentioned a while ago, just a moment ago, 
36,000 deaths each year, 92 percent of which are in individuals 
65 years of age or older. I would encourage them to get this 
vaccine as soon as they can, even though they may have 
skepticism about vaccine.
    Whenever you make a decision about an intervention versus 
what it might do for you, you do what is called the ``risk-
benefit'' analysis. And I think if you look at the risk of the 
vaccine that has decades of a good track record for safety, and 
the risk of an elderly individual who gets influenza coming up 
with serious complications which might trigger a very difficult 
clinical course for them, in my mind and in the mind of people 
who do this every day, it overwhelmingly weighs toward getting 
vaccinated if you are an elderly individual.
    If you are thinking about H1N1, as Dr. Frieden just 
mentioned, there are five target groups. Of those target 
groups, since the elderly individuals greater than 65, if you 
look at what's happened over the spring and in the summer and 
in the southern hemisphere over the year, the individuals who 
are in that elderly group do not appear to be particularly 
susceptible to the H1N1. That doesn't mean that they shouldn't 
get it. We just would like to get the people who are in the 
five target groups vaccinated first, and then virtually anyone 
can get vaccinated.
    And as we all mentioned, we feel confident that we will 
have enough vaccine at the end of the day for everyone.
    Mr. Cummings. The other population was the HIV population.
    Dr. Fauci. Right.
    Mr. Cummings. As you know, being from Maryland, that 50 
percent of all our HIV cases are in Baltimore. Ninety percent 
of them are African American.
    Dr. Fauci. Right.
    Mr. Cummings. And you talk about trials still being 
conducted, and I know you're not--you don't have a magic ball, 
but do you predict that they are going to--I mean that it will 
be safe for people with--suffering from HIV?
    Dr. Fauci. Yes, I have little doubt that there would be any 
difference in the safety profile, Mr. Cummings, between the 
H1--excuse me, the HIV-infected individuals and uninfected 
individuals. The issue when you're immunosuppressed--which is 
what HIV does, it diminishes your ability to respond 
immunologically--that they may not have as robust a response to 
the vaccine, but they can still get considerable benefit of it. 
And since they are an immune-compromised group, even without 
clinical trials, I would like to see them get vaccinated as 
part of the group that's particularly susceptible for getting 
complications from it.
    Mr. Cummings. Thinking back on some comments of Mr. 
Kucinich and Mr. Issa, are you concerned that our health system 
will be able to appropriately--or any of you can answer this, 
address these issues? I mean, we've got a lot of people, of 
course, with no insurance. We have folks underinsured. We have 
people who don't have as much access as others do to sufficient 
health care. Is this a concern of yours? Is there a certain 
point where you can see us getting sort of overloaded with 
regard to these cases? It seems like it takes--you get to a 
certain point with the disease, and it seems it takes some 
intensive medical care.
    And I was just wondering, where are we on that and what do 
you predict? And if such should take place, what plans do you 
have ready to go into operation? I don't want us to have 
another Katrina-type situation where we say that we're ready 
for something, and then when the time comes, there is--we say 
wait for the rubber to meet the road, and then we discover 
there is no road.
    Dr. Fauci. There will be challenges for sure, particularly 
when you have widespread outbreaks in various regions of the 
country, as we are seeing even right now in certain regions of 
the country. Tom.
    Dr. Freiden. I think that the reality is that our health-
care system doesn't currently have a good information system 
that would allow us, for example, to call back everyone who 
needs to be vaccinated. It doesn't have good coordination that 
would allow us to share information and share resources within 
areas in most parts of the country, and it doesn't emphasize 
prevention. So we have vaccination practices that aren't as 
good as we would like in some groups of doctors, for example, 
obstetricians, as we try to get pregnant women vaccinated. So I 
think the challenges that we face in health care, and I think 
everyone can identify many of those, are going to be played out 
in this.
    Also the response is going to be a State-specific response. 
So States that are better prepared to operate a vaccination 
program, or which have more resources for surge, will be better 
prepared to deal with it.
    Health and Human Services, with support of the Congress, 
has provided more than $3 billion in hospital preparedness over 
the past 7 years for additional ventilators, for exercises, for 
surge planning and preparations, and I think we are much better 
off with those preparations that have occurred so far.
    But the challenges are real. The virus is potentially 
spreading rapidly. We do want to encourage people who are not 
severely ill and don't have underlying conditions not to go to 
emergency departments, because we have seen in parts of the 
country where that happens, that can make it very difficult for 
the emergency departments to manage. It is a shared 
responsibility between many different parties.
    Chairman Towns. The gentleman's time has expired, but we 
will have another round.
    The gentleman from Ohio.
    Mr. Kucinich. You know, that is precisely the point, 
though. We have a primary health-care system which is not 
widely available to all Americans, with 47 million Americans 
without any insurance and emergency rooms generally ending up 
as the place where people go to get care, at least those 47 
million people.
    So you may say that we spent $3 billion to try to improve 
the surge capacity of America's hospitals. But so many of 
America's hospitals right now are locked into a system where 
they are actually rewarded for turning people out of a hospital 
bed in a few days, whereas if people are hit with H1N1, they 
are quite likely to require hospitalization.
    I just want to go back to the point that I made, Mr. 
Chairman, which I appreciate my colleague Mr. Cummings 
reiterating, and that is we cannot forget the broader context 
of health care in America, where people are actually in a 
weakened state because of this for-profit system, because they 
don't have access to health care until they get really sick and 
then the costs go through the roof. So let's politicize this 
moment, because this is one of those moments where we need to 
look at the bigger picture at the same time we are looking at 
H1N1.
    I also want to ask Dr. Freiden, we are talking about H1N1 
vaccine here. Let's for a second go to the seasonal flu 
vaccine. We lose about 36,000 people every year because of 
seasonal flu. The CDC Web site says that the initial 
distribution of vaccine every year at the beginning of the 
season is critical to protect those who are most vulnerable, 
such as the elderly, that Mr. Cummings is mentioning.
    Now I am hearing from one our staffers, who is a physician, 
Dr. Lopez in our Cleveland office, says that in Cleveland, 
chain pharmacies will have an ample supply of the flu vaccine, 
while doctors are still waiting for shipment that they would 
want to give to their patients.
    Have you heard about anything like this and is this a 
nationwide problem?
    Dr. Freiden. In terms of the seasonal flu vaccine, there 
will be something on the order of 114 million doses available 
this year. There have already been more than 50 million doses 
distributed throughout the country. And while there may be some 
focal areas with shortages, there is going to be plenty of 
seasonal flu vaccine for anyone who wants it.
    The seasonal flu vaccination program is 90 percent through 
the private and voluntary sector, and not through the 
government sector. The H1N1 response will be ordered a little 
differently to try to ensure that there is access and 
efficiency to the system.
    In this, the seasonal flu vaccine, whoever orders first 
gets first, so there sometimes are focal shortages in different 
areas. But the big picture is, at least for this year for 
seasonal flu vaccine, there is plenty available.
    Mr. Kucinich. We are hearing from doctors who say they 
ordered it and drugstore chains are getting it ahead of the 
doctors. Do you know how it happens?
    Dr. Freiden. It has to do with when it is ordered. So the 
earlier in the season that a provider or pharmacy orders, the 
earlier they are likely to get it. As we have the H1N1 system, 
we are not using that system. We are using a different system 
which will give the State health department or the State 
government the authority to authorize where within the State it 
would go, and provide equity across the State and the country 
in terms of availability, as well as, to try to get it out to 
places that don't usually vaccinate for H1N1, such as schools.
    Mr. Kucinich. Who is paying for that vaccine, the seasonal 
vaccine?
    Dr. Freiden. The seasonal vaccine is paid for as the 
health-care system generally pays for things, a mix of payers. 
For H1N1, it is entirely paid for by the Federal Government.
    Mr. Kucinich. So when it comes to the seasonal flu vaccine, 
if it goes to the drugstores first, or the chain stores, is it 
possible that people could end up paying more for that than if 
they just went directly to their doctors?
    Dr. Freiden. It would depend on the original charges, 
doctors versus other providers.
    Mr. Kucinich. I really think you should look into this 
thing where doctors who deal with patients on a regular basis 
are having difficulty getting flu vaccine, and the chain 
drugstores somehow are getting in ahead of the doctors. That 
doesn't seem logical and it doesn't seem fair.
    Now, the CDC Web site says, ``Influenza vaccine production 
and distribution are primarily private sector endeavors. The 
Department of Health and Human Services and CDC do not have 
authority to control influenza vaccine distribution nor the 
resources to manage such an effort.''
    Can you please clarify who in the private sector controls 
who gets the vaccines first?
    Dr. Freiden. The CDC provides guidance and some resources 
for planning. Ultimately, it is a decision of each doctor, each 
medical provider, each patient, of whether or not to order the 
vaccine and whether or not to give it or receive it.
    Mr. Kucinich. Who in the private sector controls who gets 
the vaccine first? You didn't answer the question.
    Dr. Freiden. It depends on when it is ordered. So the 
earlier orders get filled first, in general.
    Mr. Kucinich. Thank you, Mr. Chairman.
    Chairman Towns. Thank you very much.
    I now yield 5 minutes to the gentlewoman from California, 
Congresswoman Diane Watson.
    Ms. Watson. Thank you, Mr. Chairman, for holding this most 
significant and critical hearing. I just have to followup on 
something that my colleague Mr. Kucinich said.
    You know, this has to be a teaching moment as well, because 
I just saw a television advertisement saying we don't want 
government to run health care.
    What would happen if this particular flu spreads across, as 
it is doing now, and if government wasn't there? We are indeed 
the safety net.
    Let me get into what I was prepared to say. As a result of 
the Nation's economic conditions and ensuing budget crisis, my 
State, the State of California, has had to make millions of 
dollars in cuts to our State and our local health departments 
and programs.
    Is there any fear that the economic crisis that States such 
as California--and there are others too--are facing will have 
an effect on pandemic preparedness, or their ability to 
effectively and efficiently distribute the H1N1 vaccine?
    And thank you so much, experts, for using ``H1N1.'' We are 
trying to teach our constituents that it is not the swine flu. 
So thank you for reinforcing H1N1.
    Can you respond?
    Dr. Freiden. Yes. We are quite concerned about the State 
and local public health departments. We have seen decades of 
under investment in public health and the public health 
infrastructure that has been exacerbated over the past couple 
of years with the economic crisis, so we are seeing layoffs, 
attrition, furloughs, freezes, in terms of hiring. This makes 
it even more challenging to implement the vaccination and 
overall response program.
    We have provided now, or are in the process of providing 
now, nearly $1.5 billion to State and local governments for 
preparation, planning and vaccine administration. We are 
providing the vaccine free of charge, along with needles and 
alcohol and disposable equipment that would be needed with it. 
We are providing technical assistance and guidance.
    I think we will inevitably see some variability in the 
separate States, with some better prepared and some less well 
prepared. The CDC has staff on the ground, in the field, in 
virtually every State in the country, and we provide whatever 
assistance we can. But again, it is a shared responsibility, 
and the State government does have responsibilities, as does 
the local governments, as does the Federal Government.
    Ms. Watson. My concern is that being the largest State in 
the Union, and California being the first State that is a 
majority of minorities, and most of our immigrants come across 
the Pacific and not always over our southern border, and people 
are coming already infected, or not having 1 day of health 
care, so it hits our State with a greater wallop than a lot of 
others because of the demographics.
    During the initial H1N1 outbreak in the spring, it is 
important to note that there are probably a lot of people who 
actually contracted the H1N1 virus but never got it 
specifically diagnosed, and that relates to what I just told 
you about the demographics, believing it to be the usual 
seasonal flu virus.
    Do those people who have unknowingly had the H1N1 flu have 
the potential of any extra risk or complications when getting 
vaccinated?
    Dr. Freiden. For most people with average flu, there is no 
reason to be tested or treated. So the fact that they weren't 
is not going to harm them. However, anyone who is severely ill, 
or has underlying conditions, should be promptly attended to, 
to reduce the risk of severe illness. So most people who had 
the flu in the spring won't know whether it was H1N1 or not. We 
recommend that they all get vaccinated. And there is no reason 
to suspect that the vaccine would be risky or riskier for 
people who have had the infection before.
    Dr. Fauci.
    Dr. Fauci. Actually not at all. I agree completely with Dr. 
Freiden. If you have gotten H1N1, for example, in the spring in 
school, we'll say, and then we come back now and you want to 
vaccinate a child--first of all, the vast majority of times, 
you won't definitively know that you had H1N1, though you could 
assume that if it was rampant in the community. But there is no 
evidence scientifically at all that suggests if you then get 
vaccinated with a vaccine against H1N1, you are at any greater 
risk for toxicity or any adverse event.
    Ms. Watson. Thank you very much.
    Chairman Towns. Thank you very much.
    I now yield 5 minutes to the gentleman from Virginia, Mr. 
Connolly.
    Mr. Connolly. Thank you, Mr. Chairman, and thank you for 
holding this hearing on a subject that is so important to the 
American public and to American public health. And welcome to 
the panel.
    In 1917, the original influenza strain that struck in 
Kansas was mild, not severe, eerily similar to the way you 
described this strain, and involved initially in the town it 
hit no fatalities; is that not correct?
    Dr. Freiden. The best available evidence is that the first 
wave or waves of the pandemic in 1917 to 1919 were mild, 
followed by more serious waves.
    Mr. Connolly. As I understand it, what changed, what 
allowed the strain to become lethal, was it jumped into 
mustering camps? It just so happened that the United States was 
now mustering large groups, concentrated groups in overcrowded 
conditions, of young men who were being trained to go to the 
trenches in France in World War I. And when the influenza 
strain went from that Kansas town to the nearby military camp, 
it transmuted into something far more lethal that led to many 
deaths and then spread around the country.
    Is that true?
    Dr. Freiden. There are a lot of different theories about 
what happened in 1918-1919. It is clear that crowded conditions 
such as barracks are breeding grounds for influenza, as well 
as, other infectious diseases. There are some theories that it 
was actually demobilizing individuals coming back to to the 
United States that may have brought the flu.
    Why there was apparently a mild spring wave followed by a 
severe fall wave is, as far as I know, not definitively known. 
Perhaps Dr. Fauci would like to comment further.
    Dr. Fauci. No, it really is all theory and hypothesis. Of 
note, which people don't fully appreciate, is that the virus 
that was in that early spring wave, as they call it, that virus 
has never been isolated or identified.
    The virus that hit like a vengeance in the late summer and 
fall of 1918, that virus has been dug up and sequenced, and we 
know what that virus is. We have no idea what the relationship 
between that virus is and the virus from the spring, because we 
have never had any isolates that have been molecularly 
analyzed. So it really is just a big theory.
    Mr. Connolly. So, Dr. Fauci, they could have been actually 
two different strains?
    Dr. Fauci. It absolutely could be two.
    Mr. Connolly. Now, you touched on the fact that you have 
sort of five targeted groups for vaccination for H1N1, and I 
was heartened to hear you say that the recognition included in 
there that actually it seems to affect the over 65 population 
less severely than some of the others. That was the 
characteristics of the pandemic of 1918 as well, was it not, 
that actually the most affected group in terms of severity and 
lethality was actually the sort of 15 to 5, when young people's 
immune system was at the peak performance, but it kind of went 
into hyperdrive and overreacted to the introduction of this, 
and a lot of young people turned out to be more vulnerable. Is 
that correct?
    Dr. Fauci. It is a very interesting question. There are two 
aspects to what you said. If you have a 65- or 70-year-old 
person who is less susceptible to getting infected in the first 
place, it is likely that person during the experience in their 
lives, decades and decades before, came into contact with a 
virus that had some degree of similarity, which provided for 
them a background type of immune response so that they were 
able to avoid infection with the particular virus.
    In fact, this may be exactly what is going on right now 
with elderly individuals who seem less prone to get infected 
with H1N1 because of prior experiences that they have had 
during their years either of previous exposures to viruses, or 
even previous vaccinations that they may have had. That is one 
issue.
    The other issue, which dates back to the hypothesis from 
1918, is that young people who do get infected have such a 
vigorous inflammatory immunological response, that it is 
conceivable, though not completely proven but not an 
unreasonable hypothesis, that the actual response to the virus 
in a vigorous, healthy young person allows for a greater damage 
to the lung tissue and an outpouring of inflammatory cells. So 
there are two issues going on; there is prior exposure, and the 
strength of your immune response.
    Mr. Connolly. Certainly the accounts from 1918 are legion 
of precisely that: young people healthy in the morning and dead 
by night.
    Dr. Fauci. Right.
    Mr. Connolly. Let me just ask a final question. This has 
implications for, if you will, triage and the distribution of 
vaccines should it be in short supply. A few years ago, for 
example, we had a scarcity of flu vaccine, as you will recall. 
Automatically the protocol was, all right, whatever supply we 
have is targeted for the most vulnerable, people over 65 and 
very young.
    In this particular case, that would be the wrong model, 
would it not?
    Dr. Freiden. Right. And that is exactly what we are most 
concerned about and exactly what we are doing, which is to 
prioritize to the groups that would be at highest risk of 
severe illness, and also to monitor very intensively. So every 
day, samples are sent to CDC and we analyze the data to see 
whether we see any change in the level of severity or in the 
genetic pattern of the virus that would suggest that it could 
become more deadly. And the good news is that up until now, we 
have not seen any significant change in the pattern of the 
virus, nor in the pattern of illness in people.
    Mr. Connolly. I thank the Chair.
    Chairman Towns. Thank you very much.
    I now yield 5 minutes to the gentleman from Maryland, 
Congressman Van Hollen.
    Mr. Van Hollen. Thank you, Mr. Chairman. I also want to 
thank all of the witnesses for their testimony.
    I want to pick up on the question of Mr. Connolly. First, 
to get some of the facts in terms of the age distribution of 
the impact of this disease, because that does seem to be very 
different than the kind of flus that we have been used to 
addressing.
    With respect to the 593 deaths so far from this H1N1, 
first, is that the number that you have? Is that correct; 593 
deaths in the United States?
    Dr. Freiden. We continue to count deaths each week, so the 
number continues to increase.
    Mr. Van Hollen. What is the age distribution? Dr. Fauci 
said with respect to seasonal flu, as I understood it, about 92 
percent-plus deaths were in the 65-plus age range, with a lot 
of those being in the 80-plus.
    With respect to the deaths so far from H1N1, what is the 
age distribution?
    Dr. Freiden. We have seen very few deaths in people over 
the age of 65, there have been about 50-plus deaths in children 
over the age of 18, and the bulk have been in that young-to-
middle age group. About two-thirds to 70 percent have been 
among individuals who have underlying medical conditions, such 
as diabetes or lung disease, asthma or other problems.
    The level--the hospitalizations have followed a similar 
pattern, although slightly different in terms of people with 
asthma maybe being hospitalized more, but less likely to die, 
people with diabetes or underlying conditions more likely to 
unfortunately, tragically, die.
    Mr. Van Hollen. So based on those figures, it sounds like 
almost the reverse of the normal seasonal flu in terms of age 
impact?
    Dr. Freiden. It is the reverse of most flu seasons. There 
are different types of flu, and the ``H1,'' that particular 
type of flu characteristically does affect younger people more 
than older people, even if it is not the pandemic strain.
    Mr. Van Hollen. Right. Now, if our theory that one of the 
reasons elderly people aren't as severely impacted is because 
they have had earlier seasonal flus or they have had earlier 
vaccines that may have helped them, it does suggest that this 
strain is very different than the strains we have been seeing 
for a very long period of time. Because otherwise, I assume, 
that is why young people are feeling it.
    Dr. Fauci. Well, it is very different, but there is some 
strong suggestion that individuals who are elderly have 
percentages as high as--30-35 percent of them have antibodies 
that actually would cross-react with this flu, even though we 
have never seen in our history anything like this in the sense 
of an identical virus like this.
    There have been other H1N1's. There have been people that 
have gotten vaccinated against the swine flu in 1976. There are 
people who were exposed to H1N1 years and years ago.
    It is highly likely that those individuals do have some 
degree of subliminal background immunity, that when they see 
this virus they mount a reasonably good immune response. 
Whereas the youngsters, children, adolescents, people in their 
twenties, that doesn't seem to be the case. It spreads very 
widely through them.
    Mr. Van Hollen. Just in terms of the rate of transmission 
right now, how does it compare to the seasonal flu?
    Dr. Freiden. There a fair amount of data, some of it 
conflicting, about that. What we do know is we don't see the 
kind of explosive outbreaks in schools and colleges in most flu 
seasons that we are seeing now. In New York City we had one 
school that had over 1,000 kids that had H1N1. We just don't 
see that. So certainly in some populations, the younger adults 
and children, it seems to spread quite readily sometimes. But 
the overall rate of spread is not entirely clear.
    Mr. Van Hollen. Just following up on that and getting to 
the question of the adequacy of our State and local public 
health response, I hope that although the distribution happens 
at the local and State level with the support that you are 
providing at the Federal level, I hope that you will monitor 
very closely the local impacts and in some ways hold people 
accountable.
    As you said, there is going to be some variability, but it 
seems to me we have a responsibility at the Federal level to 
make it clear where we do not think that the local response is 
adequate. I hope that all of you will agree that is a 
responsibility of the Federal Government.
    Sometimes it is not easy, you are going to have to be 
calling out shortcomings in terms of the local response. But in 
the interest of the public health, it seems to me we should 
have some kind of grading system or some kind of way to 
identify who is responding adequately, and who is not, 
especially with respect to schools where you have a lot of 
young people obviously gathered, and this is a strain of the 
flu that has a very severe impact potentially on young people.
    Dr. Freiden. We will certainly do everything we can to 
support States and localities to respond effectively and to 
provide whatever support is possible. I think that there will 
be attention to the areas that are not vaccinating large 
numbers or where vaccine is more difficult to obtain.
    There are going to be real challenges, particularly in the 
next few weeks as the vaccine program just begins to roll out, 
including to places that don't usually vaccinate, such as 
schools.
    Mr. Van Hollen. Thank you.
    Chairman Towns. The gentleman's time has expired. We will 
have a second round. I thank all of the witnesses.
    You know that vaccinations often bring fear to many groups, 
and the ability to spread false information is also prevalent. 
What information have you come across regarding this flu strain 
or this vaccine that you believe is false or confusing? Do you 
wish to clear that up today?
    I received a call earlier today from farmers saying, 
``please stop referring to this as the `swine flu' because 
people think they get it from pork.'' So I think that these are 
things that I would like for you to clear up. This is an 
opportunity for you to do so, because we want to make certain 
that accurate information is getting out there. We have the 
experts here. We want to make certain that people know exactly 
what is going on.
    The other thing people are saying, and I find this one very 
interesting, is that if you want to avoid it, don't live in the 
South. Go to a cold area and you don't have to worry about it. 
So I guess if you went to Niagara Falls, it would not be a 
problem, according to what information is being passed out 
there by people.
    I would like for you to take this opportunity to clear this 
up, so people will know exactly what we are dealing with here. 
Because, as you know, there's some people when it comes to 
vaccinations, anything of that sort, they just don't want to 
participate.
    So right down the line.
    Dr. Freiden. I will start, and then my colleagues I am sure 
will add to it.
    First, in terms of the spread, it is very different in 
different parts of the country and it will change from time to 
time. Currently it is more prominent in some States than 
others, but it is widespread across the United States. There is 
more in the south of the United States, possibly because 
schools went back into session sooner.
    There are at least three common myths about flu which are 
important to confront.
    First, you cannot get the flu from a flu shot. It is not 
possible. It is killed vaccine and there is no way you can get 
the flu from it. You can get a sore arm, but you can't get the 
flu from a flu shot. That is perhaps one of the more common 
misconceptions.
    The second, which is common and problematic, is that flu is 
not necessarily a mild illness. It is not the common cold. It 
can knock you flat on your back and make you quite sick for a 
while. You can miss school, work, and if you are unfortunate or 
have an underlying condition, it can put you in the hospital or 
even kill you. So flu needs to be taken seriously.
    You can't get the flu from a flu shot, and the flu shot is 
highly protective against what can be, and is for many people, 
a moderate illness that is unpleasant.
    Third, in the public settings for the H1N1 vaccination 
program which will start in a few weeks, the public settings, 
immunization clinics, schools, vaccine administration and the 
vaccine itself will be free to the person being vaccinated. 
They may bill your insurance company or Medicaid, but no one 
will have to pay for it out-of-pocket in the public sector 
vaccine clinics.
    It may be that the private sector sometimes has copayments, 
and we have encouraged them to waive those for H1N1 
vaccination, and many insurers have agreed to do that. But at 
least for the public sector it will be free, and the vaccine 
itself will be free everywhere. There may be some 
administration fees in the private sector.
    Dr. Fauci. Just to add another one to Dr. Freiden's, is we 
have heard, and I am sure you have, Mr. Chairman, about some 
people who feel that maybe it is a good idea to actually 
deliberately expose yourself to get infected.
    You have heard about flu parties, people getting people 
together like you have these chicken-pox parties. That is 
really a bad idea. It is a bad idea because, like Dr. Freiden 
said, influenza can be a very bad disease. Even at its best, 
sometimes it makes you very uncomfortable and puts you out of 
sorts, if not out of school and out of work. And also, even 
though there is a very small percentage of people who go on to 
real serious complications, you can't predict who that is going 
to be. So the idea about getting infected deliberately is a 
real bad idea.
    What is a real good idea, is to get vaccinated.
    Dr. Goodman. I think one very important myth here is that 
somehow vaccines in general, and in particular this vaccine, 
may be unsafe for pregnant women. I think it is very important 
to realize that pregnant women have been among the groups most 
overrepresented in having serious outcomes for themselves and 
their offspring with this flu.
    These vaccines, although there aren't a lot of formal 
studies in pregnant women, have been safely used every year in 
hundreds of thousands of pregnant women and studies that have 
been performed about their use have not shown any increases in 
adverse outcomes for the moms or their babies.
    So there is not a known risk to pregnant women. We 
certainly continue to collect more data. There is certainly a 
known risk to pregnant women and their babies from getting this 
flu.
    Chairman Towns. Just very quickly, because my time has 
expired, I know that it is not a Federal policy, but as you 
know, some States are requiring that public health workers 
receive vaccination. Let me ask you, are you monitoring this? 
Because I think that is something that really needs to be 
looked at and to see whether or not there is any value to this. 
So, are you monitoring it?
    Dr. Freiden. There are a lot of important studies, and they 
are ongoing, that we continue to track, that identify what are 
the risks to patients if the health-care workers who provide 
their care don't get vaccinated. And perhaps the experience 
from the jurisdictions that are doing this will be helpful in 
trying to understand that further.
    Chairman Towns. OK. The gentleman from California.
    Mr. Issa. Thank you, Mr. Chairman.
    I will reiterate a question for emphasis here. Pregnant 
women are among the most vulnerable. They are the ones that 
have the most natural reluctance to take any and all substances 
that are not grown in the ground, cutoff and freshly cleaned.
    How is it when I hear the list of who should get it first, 
that isn't first? Why isn't that the group that most of you 
need to make sure are first heard? Because they have a 
reluctance, even if they are only among the top, shouldn't they 
be the first that you say, pregnant women or those who expect 
may become pregnant, shouldn't that be the first group, with 
their high immune--and particularly with H1N1 they are likely 
to fight more aggressively the disease?
    Dr. Freiden. We don't distinguish among those five priority 
groups. All of them are equally high priority. And for each of 
them we have----
    Mr. Issa. That is like going to school and A through F 
being equal. I know there is a subtle difference between a 91 
and a 59, but it made all the difference in the world when I 
was going to school.
    Dr. Freiden. For each of them it is important that we reach 
out, so we work with the American College of Obstetrics and 
Gynecology to help get vaccine out and promote vaccination for 
pregnant women. We are working with magazines, mothers' 
magazines, net resources and others.
    For each of those groups I think there is a special effort. 
There is a special effort to try to reach out to them most 
appropriately. The bulk of the people who have severe illness 
and death from H1N1 are not pregnant women, but pregnant women 
are at six or eightfold increase risk of severe and negative 
outcomes. So we do want to really prioritize vaccination in 
this and other groups, although we do understand that there is 
reluctance and will be.
    Dr. Fauci. Besides, it would be logistically really a 
problem to have you're first, you're second, you're third, 
because if you have distribution centers that are actually 
giving vaccines, and someone is among those five target groups 
that we have all mentioned during this testimony, that if a 
pregnant woman walks in and says I want to get vaccinated, she 
will get vaccinated, because not only is she among the five 
target groups, she is even among the five priority groups 
within the target groups.
    Mr. Issa. And within that, is there a difference in 
trimester? Has there been any study showing that level of 
vulnerability just before delivery versus early gestation?
    Dr. Fauci. Of when you could have it? No. There is no 
difference at all.
    Mr. Issa. Just all pregnant women.
    Let me do one followup question. Since the former chairman 
of this committee isn't here and since he has been an outspoken 
critic of the side effects, real and/or alleged, of heavy 
metals in vaccines, can you discuss the level of--you would 
know the right term for the small amount of metal that is sort 
of part of the carrier in many vaccines, as to both today's flu 
vaccines and obviously the H1N1, and particularly as to the 
claim that autism can often be caused by that, and other birth 
defects?
    Dr. Freiden. I think we will all comment briefly. 
Thimerosal is what you are referring to. The amount of 
Thimerosal in vaccines has fallen substantially in recent 
years. We will have a substantial amount of Thimerosal-free 
vaccine in this H1N1 program.
    Mr. Issa. A substantial amount. Some yes, some no. So a 
patient can say I want metal-free or Thimerosal-free?
    Dr. Freiden. Thimerosal is used as a preservative in 
multidose vials. In single-dose vials it is not necessary, by 
and large. There have been a series of scientific studies that 
have not linked Thimerosal with autism. Autism is a very 
serious problem, and it is a tragic problem for the parents who 
have to deal with it, often. But we need to continue to make 
efforts to identify the causes and ways of preventing it.
    There is good data that suggests or indicates that there is 
no link between vaccine and autism. However, because we want to 
accommodate the concerns of people who believe there may be, 
and we want as many people to get vaccinated as possible, we 
have made a Thimerosal-free vaccine available, to the extent 
possible. Since you have to have a preservative in a multidose 
vial, it is not possible to eliminate it completely.
    Mr. Issa. So those who might otherwise not get a shot 
should ask for a single dose, Thimerosal-free dose, and it 
should be reasonably available on request?
    Dr. Freiden. Yes.
    Mr. Issa. Yes, sir? Yes, Doctor?
    Dr. Fauci. I would just add to that while there is an 
effort, as Dr. Freiden said, to get as much preservative-free 
vaccine as possible, I think that particularly for people in 
risk groups, if there is--you make your own choice, but given 
that there is no known risk and that the scientific community, 
including the Institute of Medicine in 2004, found there was no 
connection between Thimerosal and autism, that people should 
consider carefully the idea of not getting vaccinated because 
of this concern.
    Mr. Issa. In closing, Doctors, I asked the question, one, 
because one Member not here at the dais is terribly supportive 
of the theory that there is still a connection. And I don't 
want to say that he is wrong, because I am not qualified. But I 
think for everyone that will look at this hearing, being aware 
that if you have a young child or a pregnant woman who has that 
concern, that there is a way to get us past that concern. And 
understand that if you are a Member of Congress, you get hit 
every day or every month by somebody who wants the fluorine out 
of the water too; that in fact there is an interest group 
against almost anything you can name. And if it spreads into a 
portion of society that would not protect themselves, then I 
think that is where we have the interest for the question.
    I appreciate your understanding. And I thank you, Mr. 
Chairman, for giving us this opportunity. I yield back.
    Chairman Towns. I yield to the gentleman from Maryland, 
Congressman Cummings.
    Mr. Cummings. Thank you, Mr. Chairman. I want us to put a 
microscope for a moment on the first category of people at high 
risk, between 25 through 64, who are at a high risk for 
complications of H1N1 infection because of chronic disorders 
that compromise the immune system.
    You are on C-SPAN here. Why don't you tell us exactly what 
those diseases are? Because, one, the reason why I am saying 
that is we have 26.6 million people in the United States with 
diabetes who probably, unless a doctor tells them that they are 
high risk, they may not know it. We have people who are on 
chemo with cancer. And, of course, chemo, you are the doctor, I 
never spent 1 day in medical school, but I do know that chemo 
can compromise the immune system; is that right?
    Dr. Freiden. Yes.
    Mr. Cummings. Of course, we have already talked about AIDS. 
I want you all to tell the American people--see, if I got 8 
percent of the population that has diabetes and doesn't even 
know that they are at high risk, I want to make sure that the 
other folks, using this wonderful opportunity we have here, we 
need to let them know that they are at high risk right now.
    Could you tell us what those diseases are that we are most 
concerned about?
    Dr. Freiden. Anyone who, as you say, has diabetes; anyone 
who has a chronic heart condition, such as congestive heart 
failure; anyone with a chronic lung condition that would make 
it harder for them to breathe, such as emphysema or asthma; 
anyone who has immune compromise, such as being on cancer 
chemotherapy or someone with HIV; anyone with a neuromuscular 
disorder; someone who has trouble breathing on their on; 
myasthenia gravis or other problems that cause a weakening of 
the musculature; people with underlying health conditions which 
give them less reserve to call upon if they have become 
infected with influenza are more likely to end up in the 
hospital and more likely to die.
    That is why these groups are so important to be vaccinated 
when vaccine becomes available, and if someone in one of these 
groups becomes sick with fever, with cough, it is so important 
that they get treated promptly; ideally, within 48 hours.
    Mr. Cummings. And how are we getting that word out? Are we 
telling doctors that? I am telling you. I am sure there are 
people watching this right now saying, wait a minute. Diabetes? 
The reason why I am so concerned about that is because there is 
so much diabetes in my district, and, I am sure, a lot of 
districts. When you say somebody who is in that top category, 
when you said diabetes, it automatically jumps out at me.
    But go ahead, Dr. Fauci.
    Dr. Fauci. We are trying, and we appreciate the opportunity 
to say what Dr. Freiden just said at a hearing like this that 
is on C-SPAN. That is one way of getting it out.
    Virtually every day we talk about this. The CDC has a--and 
I can say this because I am not from the CDC--has a beautiful 
Web site that you click open and they just list them all. And 
we keep talking about it, from Secretary Sebelius herself, down 
to the people doing the clinical trials in the trenches. This 
is something we constantly talk about.
    But I agree with you; we have to keep shouting it from the 
hills so people understand that, because a lot of people who 
are in the risk categories don't really fully appreciate that 
they are. I think you mentioned one of the most important ones, 
the diabetics.
    Mr. Cummings. Probably, you know, if diabetics are 8 
percent, and then when we put in all the other people that you 
all just mentioned, we may be talking about 25 percent of the 
population. Is that an unreasonable figure? Is it?
    Dr. Fauci. No, that is close.
    Mr. Cummings. That is just in the the first category.
    In your testimony, I think it was you, Dr. Fauci, you said 
that--and correct me if I am wrong--that currently the H1N1 
vaccine does not contain adjuvants which would increase the 
potency of vaccines, but you are testing them as well. We 
include adjuvants in our seasonal flu shots; is that right?
    Dr. Fauci. No.
    Mr. Cummings. We don't?
    Dr. Fauci. No.
    Mr. Cummings. OK. There is a rumor that we will run out of 
this vaccine as soon as we produce it. That is not true either?
    Dr. Fauci. That is not the right rumor. That is a rumor, it 
is not correct. We fully expect that we will have enough 
vaccine of the H1N1 2009 for all who want or need it, and we 
certainly will have enough of the seasonal influenza vaccine, 
based on the history of uptake of seasonal flu vaccine. So we 
feel confident that we will have enough for everyone who wants 
and needs it, without the use of adjuvants.
    Mr. Cummings. I go back to what I said a little bit 
earlier. I do believe that sometimes--it is not your office--I 
will be very brief, Mr. Chairman--that we operate, sadly, in a 
culture of mediocrity in our country, and I will never forget 
Katrina as long as I live.
    I just want to make sure, going back to my friend and 
colleague from Maryland, what Mr. Van Hollen said. I just want 
to make sure that we hold our entire, all of our agencies, 
accountable. I know that may be difficult to do. But I agree 
with him, we cannot have another situation where we think we 
have everything under control and we don't.
    Thank you very much, Mr. Chairman.
    Chairman Towns. Thank you very much. Let me just ask one 
question, because I think, Dr. Fauci, you sort of mentioned it. 
Who has the best and most current information for the public in 
terms of Web site, videos, Twitter, whatever? Who has that? I 
think we need to put that on the record and let people hear it.
    Dr. Fauci. I go to the CDC Web site every day. They are a 
fountain of information. I would recommend that if anyone wants 
to know anything about the kinds of things we are talking about 
right now, it is very, very easy. It is flu.gov, F-L-U dot G-O-
V. Just click on that and it is there. You could just search 
anything you want that has to do with flu, all of the things we 
are talking about, risk categories, vaccines, etc.
    Chairman Towns. Because I think that is important. We are 
trying to make certain that people have accurate information, 
and that is what this is all about.
    So I want to thank the witnesses again for being here 
today. Of course, we want to get this information out. I would 
also like to thank you for the work that you are doing on this 
issue as well. I am certain that the American people will thank 
you, also.
    Let me thank you again for the time that you have spent 
here with the committee, answering all the questions that we 
have raised.
    So at this point in time, without any further questions or 
objections, the committee stands adjourned.
    [Whereupon, at 3:45 p.m., the committee was adjourned.]
    [The prepared statement of Hon. Gerald E. Connolly and 
additional information submitted for the hearing record 
follow:]

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