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54–386 PDF 2009

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

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html

http://www.house.gov/reform

(II)

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

EDOLPHUS TOWNS, New York, Chairman

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

JIM COOPER, Tennessee

GERALD E. CONNOLLY, Virginia

MIKE QUIGLEY, Illinois

MARCY KAPTUR, Ohio

ELEANOR HOLMES NORTON, District of

Columbia

PATRICK J. KENNEDY, Rhode Island

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

——— ———

DARRELL E. ISSA, California

DAN BURTON, Indiana

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

JOHN J. DUNCAN, JR., Tennessee

MICHAEL R. TURNER, Ohio

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

BRIAN P. BILBRAY, California

JIM JORDAN, Ohio

JEFF FLAKE, Arizona

JEFF FORTENBERRY, Nebraska

JASON CHAFFETZ, Utah

AARON SCHOCK, Illinois

BLAINE LUETKEMEYER, Missouri

——— ———

RON STROMAN, Staff Director

MICHAEL MCCARTHY, Deputy Staff Director

CARLA HULTBERG, Chief Clerk

LARRY BRADY, Minority Staff Director

(III)

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

(1)

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

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ity? 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:]

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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:]

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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

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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:]

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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 medVerDate 11-MAY-2000 09:55 Feb 18, 2010 Jkt 000000 PO 00000 Frm 00021 Fmt 6633 Sfmt 6633 U:\DOCS\54386.TXT KATIE PsN: KATIE
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ical 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

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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 severalfold.

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:]

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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

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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 welltolerated, 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:]

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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.

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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.

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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:]

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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

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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

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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

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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.

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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 vacVerDate 11-MAY-2000 09:55 Feb 18, 2010 Jkt 000000 PO 00000 Frm 00068 Fmt 6633 Sfmt 6633 U:\DOCS\54386.TXT KATIE PsN: KATIE
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cinated. 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.

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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.’’

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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

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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

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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.

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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 percentplus 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

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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

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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

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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.

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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.

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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

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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.

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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

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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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