U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

For sale by the Superintendent of Documents, U.S. Government Printing Office

Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800

Fax: (202) 512–2250 Mail: Stop SSOP, Washington, DC 20402–0001

96–948 PDF 2004

THE NATION’S FLU SHOT SHORTAGE: HOW IT

HAPPENED AND WHERE WE GO FROM HERE?

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

OCTOBER 8, 2004

Serial No. 108–231

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

DOUG OSE, California

RON LEWIS, Kentucky

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

TIM MURPHY, Pennsylvania

MICHAEL R. TURNER, Ohio

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

KATHERINE HARRIS, Florida

MICHAEL C. BURGESS, Texas

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

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

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

BETTY MCCOLLUM, Minnesota

———

BERNARD SANDERS, Vermont

(Independent)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

(III)

C O N T E N T S

Page

Hearing held on October 8, 2004 ............................................................................ 1

Statement of:

Gerberding, Dr. Julie L., Director, Centers for Disease Control and Prevention; Dr. Anthony S. Fauci, Director, National Institute of Allergy

and Infectious Diseases; and Dr. Lester M. Crawford, Acting Commissioner, Food and Drug Administration ....................................................... 16

Grant, Christine, vice president for public policy and government affairs,

Aventis Pasteur, Inc., accompanied by David Johnson; James Young,

president, research and development, Medimmune, Inc.; and Robert

Stroube, State health commissioner, Virginia Department of Health ...... 51

Letters, statements, etc., submitted for the record by:

Davis, Chairman , a Representative in Congress from the State of Virginia:

Letters dated October 7 and 8, 2004 ....................................................... 80

Prepared statement of ............................................................................... 4

Prepared statement of Mr. Pien ............................................................... 46

Fauci, Dr. Anthony S., Director, National Institute of Allergy and Infectious Diseases, information concerning various charts .............................. 20

Grant, Christine, vice president for public policy and government affairs,

Aventis Pasteur, Inc., prepared statement of ............................................. 54

Stroube, Robert, State health commissioner, Virginia Department of

Health, prepared statement of ..................................................................... 76

Waxman, Hon. Henry A., a Representative in Congress from the State

of California, prepared statement of ........................................................... 8

Young, James, president, research and development, Medimmune, Inc.,

prepared statement of ................................................................................... 63

(1)

THE NATION’S FLU SHOT SHORTAGE: HOW IT

HAPPENED AND WHERE WE GO FROM HERE?

FRIDAY, OCTOBER 8, 2004

HOUSE OF REPRESENTATIVES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 10:05 a.m., in room

2154, Rayburn House Office Building, Hon. Tom Davis (chairman

of the committee) presiding.

Present: Representatives Davis, Burton, Mica, Souder,

Blackburn, Tiberi, Burgess, Waxman, Kanjorski, Cummings,

Kucinich, Tierney, Watson, Van Hollen, Ruppersberger, Norton,

Cooper, and McCollum.

Also present: Representative DeFazio.

Staff present: Melissa Wojciak, staff director; David Marin, deputy staff director; Keith Ausbrook, chief counsel; Ellen Brown, legislative director and senior policy counsel; Jennifer Savavian, chief

counsel for oversight and investigations; Anne Marie Turner, counsel; Drew Crockett, deputy director of communications; John

Cuaderes, senior professional staff member; Susie Schulte, professional staff member; Teresa Austin, chief clerk; Robin Butler, financial administrator; Allyson Blandford, office manager; Corinne

Zaccagnini, chief information officer; Todd Greenwood, staff assistant; Phil Barnett, minority staff director; Kristin Amerling, minority deputy chief counsel; Karen Lightfoot, minority communications

director/senior policy advisor; Anna Laitin, minority communications and policy advisor; Sarah Despres and Rosalind Parker, minority counsels; Josh Sharfstein, minority professional staff member; Earley Green, minority chief clerk; and Jean Gosa and Teresa

Coufal, minority assistant clerks.

Chairman TOM DAVIS. Good morning. A quorum being present,

the Committee on Government Reform will come to order. I want

to welcome everybody to today’s oversight hearing regarding recent

developments in the U.S. influenza vaccine supply.

As many of you know, a major flu vaccine manufacturer announced on Tuesday it would be unable to deliver any of its flu vaccine to the United States. British regulators suspended the manufacture’s license, and held up the doses destined for the United

States because at least some of the supply was contaminated.

The loss of the Chiron flu vaccine poses a serious challenge to

the U.S. vaccines supply for the upcoming flu season. Chiron was

to export between 46 to 48 million flu shots this year to the United

States, almost half of our Nation’s supply.

2

The Department of Health and Human Services had planned for

a vaccine supply of about 100 million doses this season, after a demand of about 87 million doses last flu season.

Today we will examine the contributing factors that led to the severe flu vaccine shortage, the public health implications of the vaccine shortage, and the U.S. Government and vaccine manufacturers

plan to address this problem. Our government witnesses are here

today to reassure and inform the public.

The public health implications of this development are potentially enormous. Every year approximately 36,000 die and 200,000

people are hospitalized due to complications from influenza. With

a significant shortage of vaccines, the number of people who die

from or are hospitalized for influenza could increase drastically this

year.

The Center for Disease Control and Prevention issued interim

recommendations for influenza vaccinations on October 5, 2004.

They give priority for vaccination with Fluzone the primary vaccine

that remains available to the high risk population.

And nasal spray is another alternative, but there will be, at

most, 2 million doses ready for distribution this year. As a result

of the shortage, millions of healthy people and even many in the

high risk population will have to forego vaccination. We have been

telling people for years now that the flu is not something to take

lightly. It is no wonder that phones at hospitals, clinics, and doctor’s offices have been ringing off the hook this week.

Vaccination clinics with shuttered doors do not inspire confidence

or trust. People want to know how this happened. They want to

know what it means for them and their families. They want to

know how are we going to make sure that it doesn’t happen again.

In the short term, coordination and cooperation between Federal,

State and local public health providers will be crucial. It will be

more important than ever to identify individuals who fall within

the high risk population, and ensure that they receive priority.

We will collectively have to grapple with the public’s understandable frustration and feelings of helplessness. Preparing for the annual flu season highlights the importance of strong cooperation between different health agencies and private sector companies at all

levels.

However, this year’s vaccine shortage starkly underscores the

need to ensure that adequate production capabilities exist. We are

not here today to point fingers, but we go into today’s hearing already concluding that the current system is flawed.

In a committee hearing we held last February, witnesses discussed the possibility of a similar situation unfolding. The committee was concerned that Chiron did not have a manufacturing plant

located within the United States. It was theorized that should a flu

pandemic occur, the UK could nationalize Chiron’s vaccine supply,

resulting in the loss of half of the U.S. flu vaccine supply.

With only a few vaccine manufacturers producing flu vaccines

every year, we concluded then, and we reiterate today, we need to

consider what can be done to strengthen the market and increase

production capabilities.

The current vaccine shortage begs the question: Do we need new

mechanisms, new incentives to guarantee that an adequate number

3

of safe and effective flu vaccines are produced and delivered annually?

Questions continue to mount, and hopefully today some will be

answered. Why did both Chiron and U.S. officials anticipate that

only 4 to 8 million doses would be lost? Why did they not know before Tuesday that a license suspension was possible? Are any of the

Chiron doses salvageable?

Our witnesses today will discuss the factors contributing to the

flu vaccine shortage, how the Government and vaccine manufacturers will respond to and manage this crisis, and the steps that must

be taken to be prepared for next year’s flu season.

I know we all share the same goal at the end of the day, a public

health system prepared to deal with the annual influenza season.

We have a great selection of witnesses today, and I would like to

thank all of them for appearing before the committee, and I look

forward to your testimony. I now yield to Mr. Waxman for an opening statement.

[The prepared statement of Chairman Tom Davis follows:]

4

5

6

Mr. WAXMAN. Thank you.

Chairman TOM DAVIS. Let me just start—I know Mr. DeFazio is

here from another committee. I would ask unanimous consent that

he would be allowed to participate. Without objection, so ordered.

Mr. WAXMAN. Well, thank you, Chairman Davis, for calling this

hearing on a critical flu vaccine shortage facing the United States.

Three days ago, one of the two major companies providing vaccines

in this country announced it would not ship any flu vaccines this

year.

Just weeks before the start of the flu season, it appears we have

lost half of our vaccine supply. As a result, an estimated 40 million

Americans who would otherwise have been protected against the

flu will not. One key question is how this all could have happened?

In late August, the flu vaccine manufacturer, Chiron, which has

a manufacturing facility in Great Britain announced that there

were potential contamination problems with several million doses

of the vaccine. The company began working with the Food and

Drug Administration and British regulators to identify the problem, and to ensure the safety of the remaining lot of vaccines.

While the company was assuring the public that the problem was

under control, and while FDA was reviewing the company’s investigation, British regulators sent a team of inspectors that shut the

plant down.

The British Government immediately announced that it had already purchased a back-up supply of vaccine, it nearly completely

offset its reliance on Chiron. In the United States, public health officials appeared to have been taken completely by surprise. After

the public announcement, senior FDA officials flew to Britain to determine whether any of Chiron’s vaccines could be usable this year.

A second key question is, what can be done to ensure that the

highest risk individuals are vaccinated? The CDC responded instantly to the crisis by issuing new flu vaccine recommendations

with priorities for vaccination. But following those recommendations will be an enormous challenge. Some hospitals, clinics, doctors offices and State public health departments are scheduled to

receive their full order from Aventis, the only major flu vaccine

supplier left this year.

Other hospitals, clinics, doctors offices, and public health departments are left entirely without the vaccine. It is important to discuss what role the public sector can play in overcoming these disparities. While this hearing will, by necessity, focus on the current

situation, I hope we can also find time to discuss a third key question, how can we shore up our fragile public health care system?

For 5 years we have seen a series of experts reports calling attention to major deficits in vaccine supply for both children and

adults. In February, our committee heard testimony about the urgent need to improve flu vaccine supply and planning. And just last

week, the Government Accountability Office testified before the

Senate that ‘‘there is no mechanism in place to ensure distribution

of flu vaccine to high risk individuals before others when the vaccines is in short supply.’’

This raises the question of what more can be done to better prepare for possible vaccine delays and shortages in the future? It is

long past time for Congress to pay attention to these calls for acVerDate 11-MAY-2000 12:20 Dec 07, 2004 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 D:\DOCS\96948.TXT HGOVREF1 PsN: HGOVREF1
7

tion. In May, Chairman Davis and I asked the Appropriations

Committee to restore cuts and enhance public health funding in

the President’s budget. Even this minimal request was not granted.

I am very pleased that our Nation’s leading public health officials

and other distinguished witnesses have taken the time to testify

this morning. We are all indebted to your efforts and eager to hear

your testimony. Thank you.

Chairman TOM DAVIS. Thank you very much.

[The prepared statement of Hon. Henry A. Waxman follows:]

8

9

10

11

12

Chairman TOM DAVIS. Any other opening statements?

Mr. Mica.

Mr. MICA. Thank you, Mr. Chairman. I have taken a personal interest in this since I came to Congress. It is nice to talk about some

of the effects of, say, vaccine or vaccination that went bad. My

uncle, who has passed away, probably partly from a broken heart,

he had two children who were vaccinated and they had adverse reaction.

And both of them went into convulsions. And at the time they

didn’t know, but both of them were brain damaged. Both of them

are still alive, but they require constant care, and none of them

have lived normal lives. So it is something that our family has

dealt with. My brother, when he came to Congress, Dan Mica,

worked on the Vaccine Compensation Fund, I think, with Mr. Waxman and Mr. Burton and others who were here.

And I took an interest and have tried several times to amend the

fund so that it would be more effective. And, unfortunately, some

folks walked away from revising that. But, how did we get here,

with the United States basically relying on vaccines, flu vaccines

and other vaccines, to other country’s manufacturing?

The number of vaccine manufacturers in the United States has

dropped from 20 to only 3 in the past 15 years, largely as a result

of lawsuits filed on behalf of supposed victims. Now, everyone

has—can have an adverse reaction. I have some of my pills here

that I take. Some people actually can have an adverse reaction to

aspirin. And some people actually can die from these, and do die

from these.

But, one of the major problems is that we haven’t dealt with the

liability question. So we forced the manufacturer overseas or some

place else for the large part. You know, they blame the insurance

industry, but the insurance industry won’t even cover liability in

these cases. We blame the drug manufacturers. And they won’t

manufacture here. Doesn’t somebody get it?

Go on the Web and look at—try to get a little information on vaccines. Pull up the Web. And this is offensive. The first thing that

comes up is a law firm, vaccine injury. Sue. Sue. Sue. So what the

hell do you get? Nothing.

So we have senior citizens and others put at risk, young and others, because this Congress and others won’t change the law. I will

tell you, it really—it is really sad that—and if it was just medicine,

we are outsourcing the whole production of manufacturing. I come

from the business sector. Most of the business people here in Congress don’t have a clue as to how business operates. But it actually

operates by making a profit and being able to exist without lawsuits, overly regulated and without oppressive taxation.

So we have run them all off, whether it is—you know, we don’t

even produce any ladders in the United States. Vaccines and ladders. Why? Because of the field day we have created for trial attorneys. So I am pretty bitter about it. This should have been changed

a long time ago. We should have changed the liability laws, and we

should have changed the vaccine compensation fund so that it

works, and it does provide compensation.

Mr. Chairman, I yield back the balance of my time.

13

Chairman TOM DAVIS. Thank you. Any other Members wish to

make opening statements.

Ms. Watson.

Ms. WATSON. Thank you, Mr. Chairman, for conveying this hearing so quickly. This is a very disturbing development. And it is

very essential to have sufficient doses of flu vaccine available for

millions of Americans that are at risk for complications due to the

flu.

The number of anticipated doses falls far short of the CDC’s goal

of vaccinating at least 85 million people this year. The CDC guidelines to ration the vaccine to high risk adults, children between 6

and 23 months of age, health care workers and the elderly is an

appropriate response.

I have concerns about what this means for our national bioterror

response system. Yes, I know it is somewhat of a separate issue,

but it can get—or we can get so caught off guard with distributing

flu vaccines, and are we at risk for similar problems with emergency distributions of antibiotics or vaccines, or anthrax or small

pox? I hope the witnesses can address this point.

In dealing with this crisis, we must make sure mercury, listed

as Thimerasol in vaccines is removed from the dosages of young

children. On September 28, 2004, our Governor in California, Governor Arnold Schwarzenegger signed a bill sharply restrict the

mercury content in vaccines for women and babies.

Mercury is a known neurotoxic substance. Mercury inhibits brain

function among other detrimental effects. Children between the

ages of 6 and 23 months should not be subject to a substance that

we would close down and—that we would close down a high school

for 1 week after spilling a few of the grams.

Manufacturers in the last few years have voluntarily eliminated

Thimerosal or reduced it to trace elements. The only exception is

Aventis Pasteur, who is the sole supplier of flu innoculations for

children under 2 years old. Vaccination is an important health policy for our society. And we have the ability to vaccinate without

mercury used as a preservative.

In signing the message, Governor Schwarzenegger noted that the

U.S. Food and Drug Administration and the American Academy of

Pediatrics recommended the removal of Thimerosal from childhood

vaccines in 1999. So we have a combination of issues here, Mr.

Chairman, and we must get to the bottom.

I feel that here in our own country, we must support the research on inoculations and vaccinations and the elements that

make these potent medicines, and we must see, as a policy body,

that we contribute the necessary resources so that we can develop

our own vaccinations without the harmful ingredients that we feel

are present at the current time. Thank you so much.

Chairman TOM DAVIS. Ms. Watson, thank you very much.

Dr. Burgess, did you have any comment.

Mr. BURGESS. Thank you, Mr. Chairman. I will be very brief, because I do want to hear what our witnesses have to say this morning. And I do thank you for conveying this hearing. I thank the

witnesses for coming together so quickly.

Mr. Mica made the plea about reforming liability as it reflects

our vaccine manufacture in this country, and I just couldn’t agree

14

more. I think his point was extremely important. We forget in this

country, the success of vaccine preventable disease. We don’t see

diseases any longer that in my father’s and grandfather’s generation used to affect hundreds of thousands of children and adults in

this country.

When I graduated from medical school in 1977, the year before,

we all gathered around a hospital room in Houston because there

was a child with diphtheria, and no one had seen diphtheria for so

long, and everyone wanted to make sure that this class of medical

students at least saw one case of diphtheria before they graduated.

It is a tremendous success story that you all have, and a story

that is not often told. We get distracted by words such as

outsourcing and Thimerosal. I urge this panel, though, to come to

some conclusion about what we can do to alert the liability structure in this country so that we are not driving these manufacturing

jobs offshore, and so that we are not tarnishing the good reputation

that what vaccines have done for this country and what life—how

much better life is without vaccine preventible diseases in our

midst.

Thank you, Mr. Chairman.

Chairman TOM DAVIS. Thank you very much. Any other Members wish to make opening statements? Ms. Norton.

Ms. NORTON. First, Mr. Chairman, I know we are near the end

of this term, but I want to thank you and commend you for not letting us go home without looking into this matter, because I think

all over the country there is a serious concern about—we see it in

our own region, the region you and I live in, about entire parts of

the region whose supply comes from this particular provider, and

therefore who have no supply.

First, I want to say it is—I regard this as kind of a test or trial

run. Ms. Watson spoke about bioterrorism. It ought to tell us that

the failure to have a back-up plan for vaccines or medicines that

can mean the lives of the American people simply must be allowed

to happen again. It seems to me that it is much more serious when

it happens with regard to the flu vaccine, because it is more likely

that flu will take tens of thousands of lives whereas a bioterrorism

attack would probably be contained maybe even to a small facility,

who knows?

So I certainly hope this is a shot across our bow. For years there

have been difficulties of one kind or the other with respect to the

flu vaccine. I simply want to raise two points. One is the point of

science. I look at the science. I will be interested to know when—

how what we have done in the development of this science, where

we identify the virus, apparently it has to be identified pretty late,

here it was identified in the late winter or early spring.

But then we grow the strains in chicken eggs. The first thing

that occurs to a nonscientist to me is by now shouldn’t we have

some alternative environment that allows us to grow the strains

more quickly, especially this country, which has done, I must say,

things that seem to me to be far more miraculous than what I have

just asked.

Second, the notion of such a major provider, such a major provider of an insensible vaccine being offshore. Now, if there are liVerDate 11-MAY-2000 12:20 Dec 07, 2004 Jkt 000000 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 D:\DOCS\96948.TXT HGOVREF1 PsN: HGOVREF1
15

ability concerns, we need to bring those out. I think there may be

other concerns as well.

But, there has been a lot of talk about jobs offshore, or

outsourcing, the economic concerns that outsourcing raises. But,

there has been almost no concern, no talk about what happens

when you outsource a major medicine or vaccine that is indispensable to the American people. And I think that this crisis forces us

to face it.

We raise it at the end of the session. I think it gives us time to

follow it through and see whether we have made any movement as

the new session begins. A third concern is how in the world this

plant, this operation, passed FDA inspection in 2003, and yet the

British have to shut down the place. I don’t understand the difference between the regulators in both places. And my fourth concern is apparently the total absence of a back-up plan. Everybody

knows that tens of thousands of people will die without the vaccine.

Everybody knows that half the supply was offshore, and here we

are sitting here wondering what are we going to do with no backup

plan? This is inexcusable and I think we have to begin to bring forward something that, one, gives us an explanation, and two gives

us a road map to a solution in the future.

Chairman TOM DAVIS. Thank you. Any other Members wish to

make opening statements? We will proceed then to our panel. I am

very pleased to have a distinguished panel. We have Dr. Julie

Gerberding, the Director of the CDC. Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases, and

Dr. Lester Crawford, Acting Commissioner of the Food and Drug

Administration here to discuss efforts being taken at the Federal

level to respond to the flu vaccine shortage.

They will also describe coordination efforts with State and local

authorities to manage this crisis. As you know, it is our committee’s policy that we swear you in. So if you just rise with me and

raise your right hands.

[Witnesses sworn.]

Chairman TOM DAVIS. Thank you very much. I think you know

the rules. There will be a light on in front of you. It will be green

when you start. When it turns orange that means you are at the

4 minute mark. Red, it is your 5 minute mark.

We want you to make sure you say everything you want to say,

but your entire written testimony is in the record, and we have

read that and the questions will be based on that.

So we are just very pleased and honored that you could make

time to be here with us today. This is an important and serious crisis. And we know you are working on it.

Dr. Gerberding, we will start with you. And thanks for being

with us.

16

STATEMENTS OF DR. JULIE L. GERBERDING, DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION; DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES; AND DR. LESTER M.

CRAWFORD, ACTING COMMISSIONER, FOOD AND DRUG ADMINISTRATION

Dr. GERBERDING. Thank you, Chairman Davis, Mr. Waxman, and

the committee. We are very happy to be here to give you an update

on the current flu situation.

On Tuesday morning, I was unhappily awakened by the CEO of

Chiron to notify me that we were losing 50 percent of our flu supply this year, just as I was preparing to testify in front of a different House committee. So this has been certainly the top challenge that the CDC is facing this week.

While we were disappointed to learn this news, we were not entirely unprepared. We have been concerned about vaccine shortages

for years. We knew in August that there may be a delay in shipping some doses from this manufacturer, and we are looking at

avian influenza throughout Western Asia.

So the Department has been aggressive in developing the pandemic flu plan. Secretary Thompson and the administration requested for fiscal years 2004 and 2005 $100 million to expand our

vaccine supply capability and modernize our vaccine supply capability, Congress provided $50 million this year, and we hope you

will support the full $100 million in fiscal year 2005.

We also have initiated, for the first time ever, a stockpile for flu

vaccines for children. We have 21⁄2 million doses in that stockpile.

We are procuring at least 2 million more doses from Aventis. We

also have a stockpile of antiviral treatment, and are hoping to expand that stockpile eminently.

Within hours of the announcement, the Secretary conferred with

all of the vaccine manufacturer CEOs, and the Secretary announced the new recommendations from the immunization advisory committee. These advisory recommendations had actually

been developed by the CDC as a back-up plan for vaccine preparedness when we learned that we may have a shortage this year. So

we had undertaken a contingency planning effort at the CDC just

in case we ended up in this situation.

Within hours, we also had a press conference, we communicated

to our health alert system to more than 90,000 clinicians and 88

partner organizations who resubmitted the information to their

membership, so we were able to reach hundred of thousands of clinicians in just a matter of minutes, in part because of the investments bioterrorism preparedness.

Within the first 48 hours, the FDA was dispatched to the UK,

as you have already mentioned. We have had several more press

briefings, conducted media tours, stood up our clinician hotline and

done everything we can to try to communicate the priorities for immunization under this new constraint supply situation.

Let me just describe the next steps that we will be taking. First

and foremost, we will continue our traditional efforts to monitor flu

activity in the United States, so that we know where the hot spots

are emerging and we can use that as part of our prioritization efforts. In addition, we are working with the State and local health

17

officers through ASHTO and NASHO to assess the current supply

of vaccine in individual counties as well as the estimated demand

for vaccines in those counties.

Third, I am working with my colleagues at the CDC and the Department with the CEO of Aventis Pasteur to develop a distribution plan for the doses of vaccine that have not yet been distributed. I must say that we have had absolutely extraordinary cooperation from Aventis Pasteur as well as Chiron, who has let us

know who their high priority recipients are, the people that they

had contracted with who were serving the highest priority populations.

Unfortunately, for the flu vaccine, the government only procures

about 10 percent of the total supply, so we have very little independent capacity to modify distribution, and this voluntary effort

is something that we are very grateful for.

We are also, as I mentioned, taking steps to expand the stockpile, and also to expand our capacity to treat and prophalax people

with antiretroviral—with antiviral therapy. And, finally, we are

asking Americans and clinicians across the country to collaborate

with us in this effort. This is really a tough time. There are going

to be many frustrated people. Not all people who need flu vaccines

are going to be able to get it.

And we are going to have to work together to do the very best

we can to match the supply that we do have with the demand

among the people who are the most vulnerable to the serious complications of flu.

And I really thank you, but I also hope that this committee and

Congress would regard this as a call to action. The situation has

gone on far too long. We continue to have a completely fragile vaccine production capability in this country, and it is getting more

and more fragile every year. So we need to work together in a bipartisan way with the administration and Congress and really take

the appropriate steps to protect all Americans who are at risk for

vaccine preventable diseases. Thank you.

Chairman TOM DAVIS. Thank you very much.

Dr. Fauci.

Dr. FAUCI. Thank you, Mr. Chairman, for calling this hearing.

And, Mr. Chairman, members of the committee, thank you for giving me the opportunity to testify before you today. I am going to

spend a few minutes talking about the role of the research component of the Department of Health and Human Services, in this case

the NIH, in the vaccine development process, but also in addressing some of the problematic issues that we face today with the recent events that have occurred over the past couple of days.

If you look over at these posters, this is just a schematic diagram

of the role of the research endeavor in influenza vaccine development. All of the way to the left is where the academic and NIH

community generally concentrates their effort in concept development and early basic research that feeds into and informs the production and development of vaccines that are done in very strong

partnership with industry.

So of all of the endeavors that we engage upon, industry, academic, and government collaboration is not only important, it is essential to the ultimate endeavor. So what I am going to talk about

18

is some of the research endeavors that have occurred and how

hopefully this will help us getting to where we want to go.

To give you an idea of the depth of the commitment to vaccine

research, this is the budget of my institute, the Infectious Diseases

Institute, which in 2004 was $4.3 billion. As can you see, a full 27

percent of all of our resources are directed at vaccine research to

the tune of about $1.2 billion. What do we do with that? This poster designates schematically some of the issues that we address directly. We do a bit, a little bit of surveillance in epidemiology. The

bulk of this is done extraordinarily well by the CDC.

We fundamentally concentrate on basic research, and the research capacity, to allow us to get to the end game of where we are

going, which in this case is diagnostics, therapeutics and vaccines.

Just a moment on therapeutics, because we are not specifically

talking about that at this hearing, but it is an important component of the armamentarium, the development of new and better

drugs to be used as antivirals in influenza.

But the question that was asked by at least a couple of Members

of the question, particularly Ms. Norton when she asked about

what we can do about going from the antiquated techniques that

we have, there are two among several, but two very important components in vaccine development. One of them is isolating the virus

that you are going to be dealing with, providing a seed virus for

a pilot lot to start the production.

That was generally done in a way that was reliable, but in some

respects unpredictable. If you look at the blue virus, that is a tried

and true virus that we use all of the time in developing vaccines.

If this were the virus in question, that we were looking to make

a vaccine against, you put these together, and you hope that over

a period of time, weeks or possibly months, but hopefully weeks,

it would reassort and recombine to give you the genes expressed of

what you want in this one with the other genes here.

New techniques developed by NIH grantees called reverse genetics allows us now to take the unpredictability out of this, by genetic

manipulation, taking the genes directly from one of these viruses,

and taking the genes directly here, put them a carrier component

called a plasmid, and directly inserting them into the cell line that

you want to make that seed virus in.

That is one thing that will take away some of the unpredictability. Importantly, the production has relied, and I think with

good results over the years, on egg-based culture systems to grow

the virus to make the vaccine. The difficulty with that is that it

takes a lot of startup time. Chickens to eggs, eggs are there, you

inject the virus in, you make it grow. And it really is cyclic. It is

not something that generally grows year round.

We need to gradually move away from that, improve the efficiency of a cell-based culture in which you have more direct control

over. If we had that as the major component of influenza, we would

have much more flexibility, speed and dependability.

In fact, on this next slide, this shows the potential advantages

of where we want to go with cell culture-based influenza vaccine.

It is faster production, it allows a rapid response to the discovery

of new and evolving flu strains. It requires less manufacturing

space, and this is important, it circumvents possible problems that

19

are presented by highly virulent flu strains such as those that are

lethal to chicken embryos and it is tolerated by people with egg allergies.

And on this final poster, it shows what we have been doing in

the enormous increase over the past couple of years in our influenza research funding, particularly gauged not only at the possibility of the evolution of pandemic flu, but also understanding, as we

have heard Dr. Berberding allude to, the fragility of the system

that we and many components of the Department would like to address.

And hopefully the research component of this will contribute to

the speed, the flexibility and the dependability of the process of influenza vaccine development, to allow us to respond better and to

anticipate problems such as we are facing today. Thank you, Mr.

Chairman.

[The information referred to follows:]

20

21

22

23

24

25

26

27

28

Chairman TOM DAVIS. Thank you very much.

Dr. Crawford.

Dr. CRAWFORD. Thank you very much, Mr. Chairman. I want to

assure the members of the committee and the American public that

the FDA is very serious about its vaccine safety responsibilities.

Influenza vaccine is unique in that the active vaccine ingredients

change almost every year, which as a result, present new manufacturing challenges. These viruses are continually evolving or mutating, and the recommendations for which viruses to include in the

vaccine are based on the surveillance data provided from laboratories worldwide.

Early each year, public health experts evaluate the data to determine the strains of virus to include in the influenza virus vaccine

administered in the fall. For this reason, it is impossible to stockpile influenza vaccine for use in future years, when there may be

a shortage due to manufacturing issues.

The FDA works closely with manufacturers to facilitate the rapid

production of influenza vaccine each year. As soon as the strains

are recommended, manufacturers begin to grow the virus strains in

fertile hen’s eggs. These seed strains used by each manufacturer

are tested by FDA’s Center for Biologics Evaluation and Research

[CBER], to ensure that they are the same as the recommended

strains and to assure the safety and effectiveness of the vaccines.

Then, manufacturers submit the results of their testing along

with sample vials from each lot for lot release by CBER. Lot release consists of a review by CBER of the manufacturer’s test results for each bulk lot of the vaccine.

Finally, manufacturers and CBER perform additional testing

prior to distribution to assure the safety and efficacy of these products. FDA inspected Chiron’s manufacturing facility in 1999, 2001,

and 2003. As is the case with most FDA inspections, FDA investigators identified compliance issues at each inspection.

Chiron’s corrective measures in response to these deficiencies

were reviewed by FDA and found to be adequate. On August 25,

2004, the company informed FDA that they had discovered bacterial contamination in eight lots of the final vaccine product, and

that Chiron was thoroughly investigating the problem. Chiron was

holding all vaccine lots during its investigation, and did not release

any of the product.

Throughout September, FDA, CDC and Chiron had weekly conference calls to discuss the status of the investigation. Chiron informed the FDA that they had identified the cause of the contamination, and it was limited to specific lots.

The company indicated to FDA that there was no evidence that

any other lots were affected. But, nonetheless, they were retesting

all final lots. Chiron later informed FDA that results of the testing

were negative. The company indicated that they were going to submit their final report on the investigation this week, and a call was

scheduled for Tuesday.

The FDA had no knowledge of the British decision to suspend

the firm’s UK license to manufacture flu vaccine prior to being informed by the relevant agency from the UK this week.

Dr. Jessie Goodwin, director of CBER and a team of senior scientific and compliance officials, met with FDA’s counterpart yesterVerDate 11-MAY-2000 12:20 Dec 07, 2004 Jkt 000000 PO 00000 Frm 00032 Fmt 6633 Sfmt 6633 D:\DOCS\96948.TXT HGOVREF1 PsN: HGOVREF1
29

day in the UK to gain further understanding of their action. Today,

they are meeting with Chiron officials onsite in England and will

begin an inspection of the company’s manufacturing facility over

the weekend. During that inspection they will be joined by two senior inspection officials from the UK.

Clearly, the loss of this vaccine poses a serious challenge. However, it is important to remember that we have faced influenza

shortages in the past. We work with our HHS colleagues, health

officials and manufacturers on how to best use the limited supply.

For example, Aventis Pasteur has indicated to the FDA that they

will provide an additional 1 million doses, increasing their total

number of available doses to 55.4 million.

Nonetheless, this is still well below last year’s supply of 87 million doses. We are encouraging people to take advantage of the

MedImmune FluMist vaccine. FluMist is recommended for healthy

individuals, 5 to 49 years of age, and therefore provides an option

for those who would not receive vaccine under CDC’s priority vaccine guidelines.

MedImmune anticipates having 1 to 2 million doses of FluMist

available this year. Now, in the future, we must create more efficient ways to produce flu vaccine so we can better deal with shortages or unexpected problems.

Each of the past two budgets, the Department has requested $100 million to shift vaccine development to new cell-culture technologies, as well as to provide for year-round availability of eggs for

egg-based vaccines. We received 50 million in the fiscal year 2004

budget for this activity, and urge Congress to fully fund $100 million request in the fiscal year 2005 budget.

FDA has also been investing its energy and resources in important initiatives such as the current good manufacturing practices

for the 21st century, known as the CGMP Initiative, and the Critical Path Initiative.

These activities will also help increase the availability of vaccines

and other medical products. It is imperative that we invest in the

more efficient, reliable and modern method for producing influenza

vaccines. With adequate supply and widespread immunization, the

morbidity and mortality from influenza can be markedly reduced.

Once again, I thank you for having me here today. I look forward

to the rest of the hearing.

Chairman TOM DAVIS. Well, thank you all very much. We may

be expecting votes in the 11 o’clock timeframe, which gives us

about 25 minutes, about 5 rounds here. I am going start, Dr.

Gerberding.

Virginia, Maryland and the District of Columbia were all heavily

dependent on Chiron to supply vaccines for the public sector. Is the

CDC exploring the option of acquiring the undelivered Aventis

Fluzone doses, which I think is about 20 million, and then distributing it to States that contracted solely with Chiron?

Dr. GERBERDING. Thank you. The CDC is working with Aventis

to look at the undistributed doses of vaccine. Of those, certain

doses are considered to be very high priority, for example, those

needed for force protection or for populations that we know are extremely high risk, and so Aventis will be certainly honoring their

contracts in that regard.

30

A small number of doses have not been sold. CDC is hoping to

purchase those. We will work with Aventis to ensure that they are

used in the highest priority areas. Then there are doses in the middle, some of which go to high priority populations such as nursing

homes. We are also working with Chiron, because we have gotten

the information about where the unmet high priority contacts are.

Right now, it appears that we will be able to honor all public sector requests for vaccine purchase. I don’t want to commit to that

today, but it looks very promising. And we will be announcing the

overall supply plan soon, after we are sure that we have accounted

for the parts of the geographic distribution that are most vulnerable right now.

This is not going to be perfect. And we are still going to have to

rely on prioritization. When we issued the guidelines this week, we

were very careful to refer to them as interim guidelines, knowing

as we got more information about where the demand is, where the

supply is, and where the flu is, we may have to even make those

recommendations more or less stringent.

Chairman TOM DAVIS. The priorities right now, would be as you

would rank them. Seniors? HIV?

Dr. GERBERDING. People who are 65 years of age and older, are

at the very highest risk for hospitalization and death due to flu. So

they are the highest priority. Children between the ages of 6

months and 23 months are also a high priority, because they have

a disproportionate hospitalization rate, and are at some risk of

death.

Anybody with an underlying medical condition is at risk, so they

are included in the prioritization risk. And then there are people

who are caretakers of individuals in those other groups. So because

they might spread flu to somebody else, they are included in the

priority list right now.

Most of those people are well, and some of them certainly could

qualify for FluMist. So we would like to emphasize the comment

about using FluMist for those people who are otherwise healthy

and between the ages of 5 and 49.

Chairman TOM DAVIS. Dr. Fauci, I have heard someone suggest

that, because of the shortage, the possibility of diluting the vaccine

doses in order to double the supply. Is that a possibility, or would

there be a need or clinical trials beforehand?

Dr. FAUCI. Well, that is based on a study that was performed

through NIH funding at six institutions throughout the country

from the 2000–2001 vaccine trivalent vaccine. What it did was look

at 1,000 individuals and give half of them a half a dose and the

other half a full dose. And it was found that although the full dose

gave more of a measurable response that you would correlate with

protection, there was not substantial different, suggesting that in

time of dire need, you might be able to do that.

These data are available. The NIH, as of a couple of days ago,

submitted it to the FDA, and it is something that at least needs

to be considered. There is certainly no decision or no promise that

we can be able to do that. But, depending upon how things unfold,

it is something that we will at least have on the table to look at.

31

And this importantly could only be used in individuals who are

the healthy adults, because the study was done in that group of individuals.

Chairman TOM DAVIS. Dr. Crawford, I understand FDA currently

has a team of scientists and researchers in Liverpool meeting with

Chiron. We appreciate your proactivity there. Do you think any of

the Chiron Fluviron doses are salvageable? And legally what can

you do, because I understand there are already some doses in the

United States?

Dr. CRAWFORD. It is not possible to say if any of them are salvageable at this point. The inspection of the facility itself and the

examinations that would be attendant upon that sort of conclusion

will begin tomorrow.

The meetings with the Chiron officials are going well, as they did

with the MHRA people yesterday. But, I have to present to you a

pessimistic point of view of whether or not we can clear any of

these. As you know they are contaminated with a bacterium, in the

gram negative range, and it is not clear to me whether or not we

can or not. I would like to be able to say that there is some optimism. There is the possibility that we will consider this on a riskbased evaluation.

Chairman TOM DAVIS. My time is up, but just before I ask—I

want to just ask one last question. What steps are we taking with

Chiron to make sure that they are going to be able to produce vaccines next year? Because right now they are under suspension.

Dr. CRAWFORD. Yes. We are meeting with the MHRA, and they

have pledged to work with us. That is the regulatory counterpart

in the UK. And so I think together they are on the ground, and

we are also on the ground. And I think we can work with them to

bring them forward.

Frankly, we will have to provide some technical service, as we

often do, to vaccine manufacturers. And I would be optimistic about

that prospect. What I am concerned about, is that these kinds of

events often result in a further consolidation of the industry, the

lack of competition in that industry is something that we have testified about before. But that worries me a great deal.

Chairman TOM DAVIS. Thank you.

Mr. Waxman.

Mr. WAXMAN. Thank you, Mr. Chairman. Evidently in August,

we had some idea that there was a contamination possible to the

supply from Chiron that was the vaccine that was being produced

in Great Britain. And the British knew about it. And they went out

and made arrangements immediately to make sure they had a full

supply for their needs.

Obviously their needs are less than ours, and, second, they have

other companies they can go to other than the two that we have

to rely on.

Dr. Gerberding, our system is so fragile, and contingency planning is so important. What happened in August when you first

heard about the possible shortage? What actions did CDC take?

Dr. GERBERDING. The initial contingency plan was to assume the

worse case scenario, that we wouldn’t get vaccine from Chiron, and

then identify what is the most restricted number of people who

must get vaccines. And that is about 50 million people, based not

32

only on the numbers in the high risk groups but also on patterns

of requests for vaccination that we have observed in previous years.

So, for example, in 2002, through our national health interview

survey, we recognized that of the people who should have been receiving vaccines, what proportion actually were vaccinated. And we

could extrapolate that into the current year, and make a guess at

how many people were likely to request vaccines if these patterns

held up.

That was about 50 million people, give or take several million,

depending on the demand and the severity of the flu season. So

that was the first step. It is also very important to remember that

by August, vaccine was already under contract. We only have access to about 10 percent of the total supply, and we have procured

what we could for the stockpile, with the $40 million appropriation

that we had to do that. So we had no flexibility to go to a different

manufacturer and buy vaccine, because they had already sold it.

Mr. WAXMAN. Now, Chiron—I mean, Aventis, which is now the

only company that is supplying this vaccine, has its own contracts.

They have contracts with clinics, but they also have contracts with

the private sector.

Do you know, and more importantly, do the State and local people that run the vaccine programs know to whom they are selling

the vaccine, to whom they have already delivered it, and whether

there can be some redirection either of the existing supply that has

already been distributed or that part of the supply that has yet to

be distributed so that you can make a determination that the

prioritization schedule is going to be met?

Dr. GERBERDING. The vaccine manufacturers consider that information proprietary and we have no legal authorization to demand

it. However, we have been able to develop an arrangement with

Aventis Pasteur where we are getting that information to the county level, which I think is a very reasonable approach, so that the

county health officers or the local health officers, the State health

officers can see how, for our population, we have a very large imbalance or we are doing OK or no shortages are reported.

We are hoping that will help us map out the patterns that we

need to address with the reallocation of the remaining doses. And

I think it is commendable that we are even talking about a manufacturer being willing to deflect some doses of vaccine from people

who are expecting to receive it, to meet the highest priority demand.

So this is voluntary, it is very difficult, there is no mapping of

vaccine supply authority in this country. But, we will do the best

we can.

Mr. WAXMAN. Is there any mapping or knowledge within the

county of who has the vaccine and who does not?

Dr. GERBERDING. The county health officials, as well as State

health officials, have been surveying their members. The first survey to come out of the National Association of City and County

Health Officers indicates that all of the jurisdictions are making an

attempt to map availability within their jurisdiction, and they are

certainly able to know what they have in the public sector.

But some private sector participants are not willing to disclose

the amount of vaccine they have. We sense that there is probably

33

some hoarding going on, and people are waiting to make sure that

their patients or their customers are served first.

Mr. WAXMAN. You could ask Aventis to give you that information. They don’t have to, but you could ask for it, couldn’t you?

Dr. GERBERDING. We have asked for it. And the one caveat is

that some of the vaccine is purchased, for example, by a large drugstore, and then they redistribute it across the United States. So we

don’t have a one-to-one mapping of exactly where the doses of vaccine are.

Mr. WAXMAN. Dr. Crawford, in August Chiron announced several

million doses of its flu vaccine might have been contaminated by

bacteria. The British regulators immediately sent out an inspection

team to review the manufacturing standards at the facility. FDA

did not.

Was FDA aware that this extensive review by British regulators

was going on? And why did FDA not conduct its own investigation

of the facility, and is there a communication between the British

equivalent of the FDA with you so that you know what they are

up to and you can communicate freely and respond?

Dr. CRAWFORD. Actually, when those conclusions were reached

we did have inspectors in the plant from the United States. They

were in Liverpool at the time on August 25. And they did review

the records. It looked like at that point, the maximum number of

lots that might be turned down were something less than 10 percent.

We arranged, in cooperation with the Centers for Disease Control

a weekly conference call to see what progress they were making.

The United Kingdom did the same thing. And so what happened

is, is that we obviously hoped for the best. It was too late on August 25 to start a new cycle of vaccine production, because that is

a 6-month enterprise as we mentioned earlier.

But we hoped for the best. We gave them all we could in terms

of help, as did the British. And I think it is fair to say that our

final conference call with them where we would reached a go-or-nogo decision was on the same day that the British announced, the

time differential made us a few hours behind. I was in a meeting

in Geneva with one of the officials of the MHRA who told me about

this situation very early in the morning. And also revealed that

they would be—they would have 20 percent less vaccine in England

than they had anticipated needing.

Their level of vaccination is not as great as ours, so they didn’t

have quite as much of an impact.

Mr. WAXMAN. Can I just ask you one question, Mr. Chairman if

you permit? Could you contrast the FDA review with the British

review? They seemed to be much more involved than FDA. You

were looking at the records, but they were already inspecting the

plant. Is that a fair statement?

Dr. CRAWFORD. No. Actually we were in the plant on August 25.

So I think it was about the same thing.

Mr. WAXMAN. Thank you. Thank you, Mr. Chairman.

Mr. SOUDER [presiding]. Dr. Burgess.

Mr. BURGESS. Yes, Dr. Crawford. Following the same line of

questioning that Mr. Waxman was taking. Was there some evidence that the British equivalent of the FDA had that was more

34

compelling than the evidence that you had, because it does seem

that their decision was different? You have to wonder if the data

that was presented to both was consistent.

Dr. CRAWFORD. The decision day, which was Tuesday of this

week, was the same for the British as it was for the United States.

They did have a meeting on Friday when they considered options.

But their final decision was not announced until Tuesday after

further meeting on Monday afternoon and into the night. So I

would say the availability of information was the same to the two

governments.

Mr. BURGESS. The data presented was the same and the conclusion reached was identical with the two agencies.

Dr. CRAWFORD. Yes.

Mr. BURGESS. Are you at liberty to tell us what bacteria is involved in the contamination?

Dr. CRAWFORD. It’s called serratia marcesens.

Mr. BURGESS. Dr. Gerberding, we saw headlines about the shortage of the flu vaccine and how it affected some of the youngest patients in this country. There was a contingency in place for this

year if there was a similar bad actor from the flu standpoint where

there was a run on the vaccine as we saw last year, is that correct?

Dr. GERBERDING. Yes, sir. We actually had expected a record

number of doses of flu vaccine to be produced this year, in part to

allow more surge than we had last year and in part because we

had added the recommendation for children between the ages of 6

and 23 months to be immunized. Last year, 87 million doses of vaccine were administered—83 million doses were administered. This

year, we had anticipated 100 million. Even with the loss of the 6

to 8 million doses from Chiron, based on their projections, we still

anticipated we would have more vaccine than last year.

But, nevertheless, I am a pragmatic South Dakotan, and I always prepare for the worst-case scenario, and when you know that

some doses are contaminated, even though all testimony—the CEO

of Chiron was here a week ago testifying they expected full delivery

in October. He met with the Secretary and expected full delivery

in October. So we were prepared for the delay, but in the background we had a backup plan in case the worst case happened, and

indeed it did.

Mr. BURGESS. Do you think that preparation that you undertook

last year, perhaps it is fair to say that is going to blunt some of

the potential trouble that is going to accrue from the loss of the

British vaccine?

Dr. GERBERDING. It is very helpful that Aventis’ production was

higher this year than last year for several reasons. They tried to

make more, but also the vaccine yield was very good. So we were

able to get a few more doses from Aventis Pasteur than they had

initially projected several months ago.

The opposite issue is that FluMist, which went unsold last year,

only made 1.5 million doses instead of the 4.5 million doses. So we

lost the opportunity to use the nasal vaccine for the healthy people

who aren’t on the priority list this year under the shortage condition.

So, again, flu is always unpredictable, but the demand for flu

vaccine is equally unpredictable. What we need is a robust surge

35

capacity so that when demand exceeds supply we have some place

to go to fill in the gaps.

Mr. BURGESS. Do you feel you have the pieces in place to make

certain that the healthier members of the community understand

that they need to use the internasal FluMist?

Dr. GERBERDING. We are engaged in full communication at CDC,

so we are reaching out directly to consumers in those age groups.

We are reaching out to employers across the business community.

I have been interacting with the National Business Group on

Health, and they have blasted out information to their memberships. We are working with stakeholder groups from our employee

sector through NIOSH and other parts of CDC, and we are engaged—several CDC people are doing radio tours, and we are setting a satellite uplink up so that we can blast out through those

mechanisms. There have been several press briefings already, and

we will continue to try to use that menu for outreach.

Our next emphasis will be on translating this information into

all relevant information so that people in all communities will have

it. We are setting up an 800 number so that people who cannot find

vaccine will have a place to call or people who are confused about

whether they need vaccine or not have a place to call to get that

information from the CDC. We will be mapping those calls by district and by county, and then we will use that information as helpful input to the local health officials to recognize supply and demand mismatches in their community.

So these activities are all ongoing, a lot of effort made to communicate. But with any public health situation of this magnitude and

as challenging as this one is, you can never communicate enough.

So we will continue to look for every opportunity to try to shape

people’s decision in a way that allows us to get the people who need

the vaccine the most get vaccinated.

Mr. BURGESS. Dr. Fauci, you mentioned the funding difference

between the 100 million that would help you go to a cell culture

for technology. If you got that funding today from this Congress,

that $60 million shortfall was made up, how quickly could we expect to see the end result?

Dr. FAUCI. I think we would be able to implement it almost immediately.

There are two components to that additional amount that the

Department had asked for. One is to provide a guaranteed yearround availability of eggs for egg-based culture and the other is to

push the envelope on the development of the cell-based culture.

Since research is already ongoing on the cell-based culture, not

only through our grantees and contractors but the companies themselves are starting to phase some of that in, the money as it becomes available will literally hit the ground running in making this

happen.

Chairman TOM DAVIS [presiding]. The gentleman’s time has expired. Mr. Kanjorski.

Mr. KANJORSKI. Thank you, Mr. Chairman.

Just being a total layman, it seems to me that you are testifying

that we are involved in a crapshoot with vaccines. If there had

been contamination at Aventis, we would be without a vaccine in

the country and have no capacity to produce it. And I can underVerDate 11-MAY-2000 12:20 Dec 07, 2004 Jkt 000000 PO 00000 Frm 00039 Fmt 6633 Sfmt 6633 D:\DOCS\96948.TXT HGOVREF1 PsN: HGOVREF1
36

stand that, but I can’t figure out that there is a definite plan until

you get the new technology in place, but it will take probably 5 to

7 years. This shortage could happen this year or the following year,

and there is no methodology in place other than that you have a

great informative thing after the occurrence to notify people who

can’t get the vaccine.

My question is, what do we have to protect that next year this

won’t happen and what can we do or what role should the government play with the private sector to try and insulate? I am not

hearing whether we should have duplicate manufacturing facilities,

separate manufacturing facilities, onsite, constant inspection and

when critical decisions will be made if there’s a contamination

problem. And this is just a contamination problem. It could have

been a terrorist problem.

Dr. GERBERDING. You are absolutely right, that we are vulnerable to failures in the manufacturing process. We have known this

for more than a decade. In the years 2000 to 2003 we saw this

problem come up over and over again with childhood immunizations, and we need more manufacturing capability and we need

more manufacturers of these vaccines.

Mr. KANJORSKI. Doctor, aren’t we involved in a terrorism war, or

am I missing something in the last 3 years? I seem to hear you testifying like we are in any age that we could have been in the 1980’s

and 1990’s and that vaccines and responding to bacteriological

problems should be one of our highest priorities. Can you tell me

what Department of Homeland Security and this government has

done in the last 3 years to make sure that this eventuality that has

now occurred shouldn’t have occurred or we should have had a

backup plan?

Dr. GERBERDING. I agree with you completely. We have been trying to make a strong case for the fact that influenza is a public

health threat and it deserves macroinvestments.

Mr. KANJORSKI. That is a given. We are talking about something

that probably half a million people may die that wouldn’t have died

if they had vaccine. Is that probable?

Dr. GERBERDING. In an average year, 36,000 people die from influenza. We can’t predict whether this year will be a severe flu season or a mild season.

Mr. KANJORSKI. And then we can say that because, with half the

dosage, the likelihood we may suffer 18,000 additional deaths or at

least 5,000. We are going to have people really die and as many

or more people than died in the World Trade Center.

Dr. GERBERDING. Every year, even with an adequate vaccine supply, people die from flu because we don’t get everybody.

Mr. KANJORSKI. Doctor, are any more people likely to die in the

United States because of this contamination than otherwise

wouldn’t have died if we had adequate vaccination capacity?

Dr. GERBERDING. I don’t know, but I’m worried about it.

Mr. KANJORSKI. You have no professional opinion that you can

project, the likelihood? Because maybe we shouldn’t spend anything in vaccination. If we can use half the production and we don’t

need the whole, then we obviously don’t need that protection out

there. There must be some mathematical scale that this is a lifedeath issue.

37

Dr. GERBERDING. I agree with you completely, and we cannot——

Mr. KANJORSKI. I’m not condemning your organization or the others at the table, other than we are 3 years into the war on terrorism and it doesn’t sound right to me. I’m not condemning your

agencies, your asking for money and preparation. I have visited

these manufacturing facilities, and they have called my attention

to the fact that they don’t know what will happen to this country

in a pandemic and how we are going to respond to it. Have you

presented to the Congress and to the President a plan to meet terrorism and pandemics and have we responded to it?

Dr. GERBERDING. As we said, we requested resources to scale up

the surge capacity for vaccine from Congress last year. Secretary

Thompson and the administration requested $100 million; Congress appropriated $50 million. We have asked for the opportunity

to expand the vaccine stockpile so we could purchase a reserve. We

are making progress toward achieving that, but we haven’t had the

full appropriation to accomplish that yet.

Mr. KANJORSKI. So this Congress has failed to respond to the

agencies of the executive department of this government that

would have been a response to homeland security because we do

not have the capacity potentially to meet the biological protections

against biological warfare, is that correct?

Dr. GERBERDING. We requested $100 million, and we received $50. We are hoping Congress will support the full $100 million in

fiscal year 2005.

Chairman TOM DAVIS. Mr. Souder.

Mr. SOUDER. Thank you, Mr. Chairman.

First, I would like to add my voice to the many others that Dr.

Gerberding—I hope next time the network does a TV show they

give you full credit. Your agency deserves full credit for the work

that you do.

Based on conversations I have heard here, I want to ask you a

couple of questions. My colleague from Indiana, Senator Bayh, introduced legislation a year ago that sounds to me like it attempts

to address some of the things you raised. One of the things that

Dr. Crawford raised was a seeming lack of competition in the marketplace. One of the things there would be to encourage through

investment credit more people to get into the business. Do you

think that would help at all? What do you think is the biggest

stumbling block?

And I would appreciate a further comment on that, because—and

let me add this, and we will start with Dr. Crawford and move

through. A second part of the legislation deals with trying to make

sure that the government buys—or if the market doesn’t meet, the

government will back up and purchase a larger supply so we have

a backup supply.

It is not without precedent. I remember working as a staffer with

MRE companies, because we have these pulses in Ready-to-Eat

meals at wartime. So part of the goal had been to keep two or three

of these companies in business so that when we had a policy we

had the capability to do that.

How do you feel about what impact on the market that would

have if we had a backup guarantee if the production rate were

higher? One question is, can we get more people into an investment

38

credit; and, second, would having some backup guarantee for the

high-risk population that guaranteed that if they produced it, like

FluMist did—and my question along the same lines, FluMist is

going to testify, who manufacture that, in the next panel that they

had to cut back because the market didn’t do it and they’re restricted in the areas that the government backs up and we are losing manufacturers. What, if it isn’t those two things that I mentioned earlier, would you do to try to get more manufacturers in

the business?

Dr. CRAWFORD. What we are trying to do—as you know, we don’t

have funding for like startup companies and that sort of thing. We

basically regulate them. We are the bad news for them, rather than

the good news. What we are trying to do is improve our process so

that we create a favorable regulatory environment for more companies to get involved.

I mentioned the good manufacturing practices, which we have

just announced after a 2-year study; and what this will do would

make it—it would be a newer approach to manufacture. It would

be less onerous, more scientific, more systematic. And over time,

along with the new research initiative that we are working with

the National Institutes of Health on called the critical path, we believe it will make it a more predictable climate for vaccine manufacturers but one that produces better products with more certainty

of success.

In the lots that we have now, I mentioned earlier that 8 of 100

were originally considered to be defective. As we go through our examination tomorrow, this will actually be a test case. We don’t

know how many or if any are badly contaminated until we do the

inspection. But certainly a better regulatory environment where it

is more modernized, if we take a newer approach at it, would help;

and that is what we’re committed to.

Mr. SOUDER. I agree that the regulatory environment in all kinds

of things is a deterrent, and certainly all the manufacturers say

that to some degree. We have only been able to move that slightly.

I hope we continue to move that and keep people’s health safe.

The question is also is there a tipping point here where a small

investment or even a medium investment tax credit would, say, impact these new technologies or if we, in effect, backed up some of

the purchases for pulse components. Dr. Fauci.

Dr. FAUCI. You bring up an important point that has many ramifications for what has been said thus far today as we keep referring

to the fragility of the vaccine development industry. I think it boils

down to things that we in the Department at all three of our agencies have been facing, and that is a real lack of a climate of

incentivization to get companies involved. People say, how come

you only had two companies involved for the vaccine for influenza?

Those were the only two companies licensed in this country to

make it and distribute it. It isn’t as if we had 15 companies, and

we decided on 2, and I think that sometimes gets misunderstood.

If you look at the climate of how we look at vaccine development,

it’s very risky business for a company to get involved, risky because

of the profit margin, risky because you are dealing with biologics

and they are much more difficult to predict the success of it. And

there’s the issue of the use of vaccine which is used once or twice

39

or three times in a person’s lifetime, as opposed to the other possibility of the same company developing a blockbuster drug that

someone would use everyday of their lives for the rest of their lives

that they could make millions at.

What we are trying to do is to do everything from regulatory incentives to research by pushing the envelope more to take away

some of the risks by the approaches that I showed in my opening

statement about perfecting things like the reversed genetics or perfecting things like the use of cell culture base. And then, finally,

it is the issue of pricing and how our culture views how much one

is willing to pay for a vaccine.

This morning, in preparation for the hearing, I got on the phone

in my office very early and I called up a pharmacy in Bethesda and

I asked about the relative prices of things, because we talk about

it a lot. And I asked them what would be the retail price of a year’s

supply of Lipitor, which is a blockbuster, cholesterol-lowering drug.

$1,608. What would be the yearly cost of 50 milligrams of Viagra?

$3,500 a year per person. What is the cost of the Aventis Pasteur

vaccine? $7 to $10.

You are talking about the idea of any company wanting to go toward something that has a major profit margin. We need to help

with incentives. We could do it researchwise or regulatorywise, but

it is a rather broad, generic issue. We hope, working with the committee, we will be able to find solutions to that.

Mr. SOUDER. Could I see if Dr. Gerberding has anything to add?

Dr. GERBERDING. In the short run, before we are able to scale up

and using some of the tools you described, that the backup plan of

the government purchasing additional doses of vaccine is one that

we are already doing on a small scale; and it is conceivable that,

by expanding that, manufacturers would be incentivized to make

as much vaccine as they could. The downside of that is that taxpayers would have to be prepared that, most years, we would

throw vaccine away and it would be a waste of tax dollars. So there

is a tradeoff with flu vaccine because we have to get a new vaccine

preparation every year.

Chairman TOM DAVIS. Ms. Watson.

Ms. WATSON. Pass.

Chairman TOM DAVIS. Mr. Tierney.

Mr. TIERNEY. Dr. Crawford, does the Food and Drug Administration pretty much agree with the determination made by the British

health authorities?

Dr. CRAWFORD. I can’t answer that until we get through our inspection. We are looking through the lots and hoping for the best,

but there is an air of pessimism, so probably we will.

Mr. TIERNEY. Is anything being done about the prospect of price

gouging?

Dr. GERBERDING. We are concerned about price gouging. The first

step is to identify where it’s happening, and the second step is to

alert the State and local health officials that it’s happening in their

jurisdiction and also the FTC who has the regulatory responsibility

to evaluate and take the appropriate steps. I think it is tragic. We

know in any market where there’s a shortage of product that there

is a tendency to raise the price, these unfair price increases; and

they really add insult to injury.

40

Mr. TIERNEY. Are you satisfied that our officials are actually

working on this issue, giving the proper notice to people?

Dr. GERBERDING. I don’t have an answer on that today, just 48

hours into this, but we will be looking for it and also make our hotline available if there are reports of this so people can alert us and

we can pass the information onto the appropriate response agencies.

Mr. TIERNEY. Dr. Fauci, you should have slept over last night.

You were here yesterday on the West Nile virus.

Doctor, with respect to our research, MedImmune says they are

developing vaccines for—and giving it for free to government inspectors or researchers, but they obviously charge others who create a profit from it for that. Do we need to address our patent laws

at all to make sure that enough people have access to the reverse

genetics processes or anything or is it fine the way it is?

Dr. FAUCI. I think what you are referring to is what is going on

is a dispute about the pattern of the reverse genetics. I’m not sure

we need to address the patent laws on that. We need to clarify

pretty quickly what the patent issues are involved there so we can

get the ball rolling on this, but I don’t think this is a generic patent

law problem.

Mr. TIERNEY. A moment ago you were talking about the different

prices that you get for different prescription drugs. The fact of the

matter is, it’s not the government that is keeping the price of the

flu vaccine low, is it? We don’t set the price and keep it low?

Dr. FAUCI. Actually not. But one of the issues we face—what I

was referring to was not that it’s the government or industry.

Mr. TIERNEY. It’s a market situation.

Dr. FAUCI. Culture of people feeling and maybe in some respects,

appropriately so.

Mr. TIERNEY. It is the market. Because if people made more of

a demand for it, the price could be raised higher. It it’s raised higher, they’re afraid people won’t buy it at the higher price.

Dr. FAUCI. Also, the third party payers wouldn’t necessarily pay

it. That’s an important issue.

Mr. TIERNEY. One of the things—I think Dr. Gregory Poland

from the Mayo Clinic gave the options. We either have to subsidize

or give incentives to manufacturers to get them into the business,

or the government has to own or operate either themselves or to

a contractor a plant to produce the vaccine. Seems to lay out some

of the options that you say we went from regulation to doing it

yourself.

But as long as we leave it entirely without a regulation to the

industry, we get the lower prices, we get less demand, and we get

two manufacturers instead of more, and it creates a problem. Anybody in any of these agencies before us right now debating this

issue as a policy matter, whether the government ought to have a

contractor get in there and somehow subsidize them to create this

or get in the business themselves or regulate the price, is that discussion going on?

Dr. GERBERDING. That discussion is ongoing and has been going

on for some time. Just on Monday, the National Vaccine Advisory

Committee, who has responsibility for advising the Department

and the government on those issues, issued some statements that

41

recommended that we look at those options that you just mentioned. There is not a long list of options, and we need to bite the

bullet here and come up with a plan.

Mr. TIERNEY. This is absolute free market aspect when it comes

to health care. It doesn’t always seem to fit the same model as if

you’re selling widgets. Health care is a different item here, and we

get that right across the spectrum of health care issues. I know

that everybody is paranoid of the word regulation or any government involvement, but we expect the government to step forward

for our safety and protection. I hope that debate accelerates. I

think Congress ought to be involved in this debate, and there ought

to be further hearings on this away from the ideology as to what

is a practical matter of how we take care of health concerns, and

that may mean a little less of absolute free market and more intervention here to make sure we have this product available.

Chairman TOM DAVIS. Mr. Mica.

Mr. MICA. I remember previous hearings on the subject of the

cost of some of these vaccines. I remember someone holding up a

vaccine vial, and in that testimony they said that the cost of the

vaccine itself was less than $1 or around $1, but—I don’t remember—if you can get insurance, the cost was like about $20 some.

I don’t know if that’s still the case. Is that a typical ratio, Dr.

Fauci? I think you were talking about some of the costs.

Dr. FAUCI. I’m not actually sure, and I would hesitate to make

any statement about the relative costs of the liability insurance

that they would have to pay.

Mr. MICA. Are they having trouble getting it, manufacturers? I

heard you cite some incentives. Isn’t that one of the major problems, the most significant problem to manufacturers in the United

States?

Dr. FAUCI. I best leave that for the companies to answer. But I

know when you are dealing with childhood vaccines we do have a

childhood vaccine fund for compensation. But not in the adult.

Mr. MICA. Right now, we are looking at blaming sort of the bureaucrats, and you all haven’t paid enough attention to this, and

there probably will be horrible things like price gouging because

the supply is down. You had a responsibility. And it was kind of

interesting, someone said you had to fly—who flew over to check

it?

Dr. FAUCI. The FDA.

Mr. MICA. So we had to fly to Europe to check the supply. I’m

sure it is much more beneficial to manufacture this outside the

United States and keep an eye on it. I understand you have an annual inspection?

Dr. CRAWFORD. Depending on what the risk is expected to be, it

can be as little as every 2 years.

Mr. MICA. How many did we have here at the site that went

bad? Can you supply a record of your visit for the committee?

Dr. CRAWFORD. Absolutely.

Mr. MICA. This is a research and development budget for the Na- tional Institute here, and it says vaccine research. We supply $1.18

billion in research. Mr. Sanders and I several years ago went over

and met some of the drug manufacturers trying to figure out why—

what was happening in the marketplace. At that time, they told us

42

there was no R&D in Europe, that it was all being done in the

United States for most drug development and vaccines. Is that still

the case?

Dr. CRAWFORD. For pharmaceuticals?

Mr. MICA. Yes.

Dr. CRAWFORD. Sixty-three percent of the profit, it is reported,

from pharmaceuticals worldwide is gained through U.S. sales. So

quite naturally——

Mr. MICA. We were told, quite frankly, that there is no R&D

going on or very limited. Almost all of it comes from the United

States. The U.S. taxpayers are financing R&D in vaccines and

other pharmaceuticals, and then we are outsourcing because you

can’t manufacture in the United States because you get your butt

sued. And you also certify or do you approve the drugs? The FDA

approves those vaccines, right?

Dr. CRAWFORD. Yes, we do.

Mr. MICA. You know, I think it’s time we looked at some system

where we took responsibility and there would be plenty of drugs

available at low costs if we limited the liability, if we set up some

funds for decent compensation for victims, whether it is a pharmaceutical or a vaccine. Wouldn’t that be a better solution, Dr. Fauci?

Dr. FAUCI. I think the idea of compensation is something that

needs to be——

Mr. MICA. We have done some of it with children’s immunization.

We produce it.

Our responsibility is to have an agency like the FDA to say that

this is a good drug. Now we force the manufacturing outside. We

are paying for the R&D. It would behoove us to manufacture in the

United States and have better control and we are certifying it

whether it is manufactured in the United States or outside that it

is good. So shouldn’t we have some of that responsibility, FDA?

Dr. CRAWFORD. Yes, we should.

Chairman TOM DAVIS. The gentleman’s time has expired.

Ms. Norton, you will be the last questioner.

Ms. NORTON. Look, having been caught without a backup plan

already, I’m really compelled to ask what is the backup plan in

case the volunteer sharing doesn’t work out?

Now the most generous people in the world are health care people, so I’m sure everybody is doing what you’d expect them to do.

What are you empowered to do if, in fact, your, quote, backup volunteer plan proves as insufficient as having no backup plan for half

of the supplies which now are unavailable, what are you empowered to do? What would you do if in fact people begin to make their

own assessments, particularly since the private sector controls

most of the supply?

Dr. GERBERDING. Thank you. That’s an important distinction between childhood vaccines for routine prevention of vaccine-preventible diseases and influenza where we have such a small proportion

of the market share in the governmental control. CDC has no authority to regulate distribution of vaccine or to regulate the manner

in which vaccine is supplied. We rely on our best technical advice.

We rely on altruism, as you have described.

We have experience with this in 2000, 2001, where we had a

similar vaccine shortage. We found that, overall, there was adherVerDate 11-MAY-2000 12:20 Dec 07, 2004 Jkt 000000 PO 00000 Frm 00046 Fmt 6633 Sfmt 6633 D:\DOCS\96948.TXT HGOVREF1 PsN: HGOVREF1
43

ence to the recommendations. In fact, we ended up in many areas

with excess doses of vaccine because people complied so carefully

with the recommendations.

What we are talking about here is a very fine line between what

we have and who needs it the most. I just don’t think it’s a matter

of doses, but it’s a matter of where are those doses, and we have

no authority to redistribute the vaccine.

Ms. NORTON. I don’t want to take the entire time. Are you prepared to come back during the lame duck session and get some authority to do something now that you know full well that the private sector could turn you down and could decide on its own where

the supplies go?

Dr. GERBERDING. We would be delighted to work on with Congress on solutions. Our colleagues at the FDA, who is the regulatory agency, has a role to play in this as well, but we would be

willing to look at all possible solutions.

Ms. NORTON. I’m asking you and Mr. Crawford to, in fact, be prepared now that there is no backup plan, now that we cannot in our

economy force the private sector to do things with respect to supplies in their hands, to be back here when we come here to tell us

what it is we need to do. We can’t just sit here saying we don’t

have the authority, there’s nothing we can do about it.

In order to let other Members ask questions, I’m going to forego

the rest of my questions.

Chairman TOM DAVIS. We have 3 minutes left to vote.

Mr. Cooper.

Mr. COOPER. Following up on my colleague’s line of questioning,

could this Congress save lives by passing a law making sure that

only high-priority recipients got the vaccine—seniors, infants, people with chronic diseases, health care workers? Would that save

lives in this country?

Dr. CRAWFORD. I should defer that to Dr. Gerberding. Basically,

you are saying that you would codify their recommendations,

CDC’s recommendations?

Mr. COOPER. With the force of law behind the voluntary guidelines that Dr. Gerberding has mentioned, would that save lives in

this country? Because, in response to Mr. Kanjorski earlier, it

seemed like the normal casualty rate that we could face with influenza could go up substantially this year as a result of this manufacturing shortage. You only have voluntary guidelines at your disposal and you’re not empowered to do more? Would you be able to

save lives if you had that extra legal authority?

Dr. CRAWFORD. I’m not prepared to answer that. I think she expected good compliance based on past years, but I better defer to

Dr. Gerberding.

Dr. GERBERDING. I don’t have an answer for you either. This is

a work in progress. In past years, we have been able to have a good

match between what we expect and how people adhere to those recommendations. Whether we would have more benefit from codifying it or more mess from codifying it, I can’t really tell you right

now. I think enforcement of that would be a very difficult challenge

to patch together on short notice, but we will look at that as an

option and, as the Congresswoman suggested, come back with a set

44

of options that we could discuss with the committee during the

next session.

Chairman TOM DAVIS. Thank you very much.

I’m going to dismiss this panel with our thanks. We will take a

recess to go vote and be back in 15 minutes.

[Recess.]

Chairman TOM DAVIS. The committee will come to order.

The gentleman from Indiana is recognized.

Mr. BURTON. Mr. Chairman, you really are fast with that gavel,

and I love it.

I’m sorry, Mr. Chairman, I wasn’t here earlier today when the

hearing started—and this is on a related subject. I got my flu shot

this morning, and I guess a lot of Americans so far haven’t been

able to do it because of the shortage. But the concern that I have,

part of the contents of the vaccination that people are getting.

There is a substance called thermarisol, which is about 50 percent

ethyl mercury in the flu vaccine, and most adult vaccines have

mercury in it.

Governor Schwarzenegger of California recently signed a bill in

California which prohibits children up to age 3 from getting a vaccination that contains thermarisol; and the reason for that is because the mercury in vaccines—and we have had hearings on this

over the last 4, 5 years—the mercury in vaccines is seen by many

scientists around the world as a major contributing factor to neurological disorders such as autism in children and Alzheimer’s in

adults.

Now we are getting it out of most of the children’s vaccines. It’s

in about three or four of the children’s vaccines today. In California, they are going to get it out of all of them, which is a giant step

in the right direction, and I congratulate the legislature out there

and the Governor for doing that.

We need to get mercury out of all vaccinations. Mercury is toxic

to the human body, to the human neurological system. It is in the

flu vaccine and in most of the adult vaccines. It needs to be removed. You can go to single-shot vials without having mercury in

them; and, Mr. Chairman, it would be great for the American people and the world if we removed that.

Mercury toxicity is a major ecological problem for the whole

world. It is in our water, in our fish. We are being told not to eat

fish in many cases because there is mercury in them, and we continue to put it in vaccines that’s injected in our children and

adults.

We used to have 1 in 10,000 children that were autistic. It is now

1 in 166 according to CDC. We used to have Alzheimer’s that was

recognized quite frequently, but now it has become an epidemic. So

we need to get these toxic substances out of our vaccines. I think

the pharmaceutical industry has done a great job for the people of

this country and for the world, but there are certain things that

can be cleaned up. One of them is getting the mercury out of the

vaccines.

Mr. Chairman, I thank you very much for yielding to me; and

this is another shot across the bow, the pharmaceutical industry,

to get the mercury out of all vaccines for the good of humanity.

45

Chairman TOM DAVIS. Thank you very much, and you have been

consistent in your position on this.

We move to our next panel, and I thank our witnesses for appearing. They are the three flu vaccine manufacturers to discuss

vaccine production capacities to respond to shortage crisis.

We will hear from Christine Grant of Aventis Pasteur, manufacturer of Fluzone, the vaccine. Dr. David Johnson accompanies Ms.

Grant, and he is available to respond to questions.

We also have Dr. James Young from MedImmune, which manufactures the nasal spray vaccine, FluMist.

Unfortunately, a representative from Chiron is unable to attend

this hearing, but the company has submitted written testimony for

the hearing record. I ask unanimous consent that Chiron’s testimony be included in the official hearing language. And without objection, so ordered.

[The prepared statement of Mr. Pien follows:]

46

47

48

49

50

51

Chairman TOM DAVIS. We also have a visitor to this committee

who I have known for many years, Dr. Robert Stroube. He is the

Virginia State Health Commissioner. He is no stranger to this committee either. He’s here to provide an assessment of State and local

public health departments’ ability to respond adequately to the vaccine shortage threat.

We swear all witnesses before you testify. So if you would rise

and raise your right hands.

[Witnesses sworn.]

Chairman TOM DAVIS. Ms. Grant, we’ll start with you; and we’ll

move straight on down. I can’t thank you enough for being with us

and being patient, but we’ll try to get through questions as quickly

as we can.

STATEMENTS OF CHRISTINE GRANT, VICE PRESIDENT FOR

PUBLIC POLICY AND GOVERNMENT AFFAIRS, AVENTIS PASTEUR, INC., ACCOMPANIED BY DAVID JOHNSON; JAMES

YOUNG, PRESIDENT, RESEARCH AND DEVELOPMENT,

MEDIMMUNE, INC.; AND ROBERT STROUBE, STATE HEALTH

COMMISSIONER, VIRGINIA DEPARTMENT OF HEALTH

Ms. GRANT. Good morning, Chairman Davis and members of the

committee. Thank you for the opportunity to testify today on behalf

of Aventis Pasteur.

During the past 10 years, Aventis Pasteur has been a reliable

supply of influenza vaccine for the United States, consistently increasing our annual production. This year, we expect to produce

55.4 million doses, 33 million of which have already been distributed.

I’m here to communicate our company’s pledge to continue to do

everything we can to manage this influenza season consistent with

the recommendations of Federal and State health authorities. Vaccines have proven to be the most cost-effective, preventive intervention in human history; and all of our employees are passionate

about the contributions they make to lifesaving work.

Aventis Pasteur is the world’s largest vaccine company with

nearly 9,000 employees. The company’s global experience has been

utilized to manage influenza epidemics over many decades. Vaccine

has been produced at the Swiftwater, PA, location for over 100

years and influenza vaccine produced there for more than 30 years.

Today, we produce approximately one-half of the U.S. influenza

vaccine supply. Although there have been years where disruption

and shortages have ensued in the influenza vaccine marketplace,

Aventis Pasteur has been able to deliver vaccine to our customers

on a timely basis during influenza season.

As I previously stated, Aventis Pasteur intends to achieve its

plan to produce approximately 55.4 million doses of Fluzone for the

United States this season. Customers had already placed orders for

more than 52 million of those doses prior to Chiron’s announcement. This included approximately 4.5 million doses for the CDC,

including the late season strategic reserve, which the CDC

proactively and wisely planned. It is important to note that over 85

percent of all influenza vaccine is administered by the private

health care sector.

52

So since hearing the announcement 3 days ago, we have worked

with the CDC and the FDA to determine whether we can manufacture additional doses later this year. Any additional doses available

from going back into production, however, would not be available

until February or March; and such a decision would have implications for the amount of vaccine which can be produced for next

2005–2006 season.

Mr. Chairman, as we have heard today, the supply shortage has

caused many policymakers to ask: Why are there so few vaccine

manufacturers in the United States and what needs to be done to

encourage vaccine manufacturers?

Over the last several years, we testified before Congress about

the urgent need for Federal policymakers to do more to cherish and

promote vaccine companies; and we suggest five recommendations

to achieve this goal.

First, demand for vaccine drives supply. We need to work together to steadily increase annual reliable demand to achieve

Healthy People 2010 goals. This will give companies confidence to

continue to reinvest and thus increase supply.

Second, annualize the funding for CDC’s strategic influenza vaccine reserve, which was only budgeted for two seasons yet is proving to be a very wise investment.

Third, liability exposure chills interest in this field. We are

pleased to acknowledge the House of Representatives passage of

the JOBS bill just late last night, which included the Influenza

Vaccine Excise Tax; and we strongly encourage the Senate and

White House to take quick action on the bill. This will ensure that

influenza vaccine is now covered under the Vaccine Injury Compensation Program.

Fourth, we encourage the committee and Congress to begin now

to plan to address special vaccine liability issues that will occur

when there is an influenza pandemic.

Fifth, we encourage the committee to help resolve inconsistencies

between SEC accounting guidelines for routine pediatric stockpiles

and CDC’s desire to implement such stockpiles, for which Congress

has already authorized the appropriated funding.

We are aware that vaccine companies have left the U.S. market

in the last decade. This included two companies that produced influenza vaccine. It’s important to remember that, even if a new

company were to plan a new facility today, it would require a minimum of 5 to 7 years to build, validate, license, manufacture and

deliver vaccine to the marketplace. This is due to the inherent complexity of building reliable production facilities that meet necessary

health and safety standards.

Aventis Pasteur has been a leader in introducing innovative technology. We have learned through experience it takes years to develop and incorporate new processes into routine manufacturing.

For example, we are working on the promising technology known

as cell culture, but we caution it is going to take years to transition

this technique from research to full-scale production. Additionally,

the technique will not substantially reduce the total production

time.

Mr. Chairman, we share the committee’s concern and frustration

with this year’s supply problem. However, government authorities

53

and the private sector have worked well together in the past to

manage difficult situations to ensure optimal immunization rates;

and we want to commend HHS, the CDC and the FDA’s leadership

for their immediate and decisive action to address what is inherently the unpredictable nature of vaccine production. In less than

12 hours, as you heard, the CDC’s Advisory Committee on Immunization Practices issued interim recommendations to prioritize influenza immunization for high-risk populations.

The National Flu Summit, a public-private partnership of the

CDC, professional associations, public health authorities and companies such as ours, has already discussed how best to implement

those recommendations; and influenza professionals are recommending that health care providers who actually see patients

are best equipped to determine who is at high risk.

In summary, Aventis Pasteur pledges to continue to do everything we can do to manage this season consistent with the recommendation of Federal and State health authorities; and we commend Congress for your prompt interest to address this issue during your busiest week of your session.

Chairman TOM DAVIS. Thank you very much.

[The prepared statement of Ms. Grant follows:]

54

55

56

57

58

59

Chairman TOM DAVIS. Dr. Young, thanks for being with us.

Dr. YOUNG. Good afternoon, Mr. Chairman. Certainly a pleasure

for me to be here this afternoon to address the committee on this

very important topic, and I commend you on inviting members of

the manufacturing community here to provide their perspective.

My name is Dr. Jim Young. I’m president of research and development at MedImmune, a biotech company headquartered in Gaithersburg, MD. As you may know, MedImmune is new to the influenza vaccine business, having introduced a new type of flu vaccine

this past year called FluMist, approved by the FDA for use in helping individuals 5 to 49 years old. Unlike the other flu vaccines

which are injected into the muscle, this vaccine is simply sprayed

into the nose to protect against influenza.

MedImmune currently has the manufacturing capacity to

produce 20 million doses of FluMist. This year, however, we produced only 2 million doses of bulk vaccine and before this week’s

events had planned on filling and finishing only 1.1 million of those

doses, which we did. That finished material, I’m pleased to report,

was released for distribution by the FDA yesterday.

I’m sure you are sitting there thinking, with the capacity to

produce 20 million doses of this innovative vaccine, why did we

only fill 1 million doses? Quite simply, because, one, the product

was approved with a very narrow label indication by the FDA; two,

it has been faced with significant confusion and misinformation

propagated in the marketplace; three, has not had strong support

from the recommending authorities; and, four, was launched into

a climate of overwhelming complacency and with a lack of awareness on the part of the public as to the severe illness and death

that is associated with influenza.

It is these factors that account for an insufficient demand to justify increased production of FluMist.

Nearly 8 months ago, I sat before this committee testifying that

close to 4 million of the 5 million FluMist doses manufactured last

season would be destroyed at the end of the 2003–2004 influenza

season, a season in which there was a vaccine shortage and 152

children died from flu. Thirty-nine of those children actually were

eligible to receive FluMist and could have received the vaccine but

didn’t. The fact of the matter is that there were 4 million lost vaccination opportunities with product that we had available that

went unused.

Consequently, as a result of last season’s experience and based

upon FluMist’s existing licensure for the restricted population of

healthy individuals 5 to 49 years, MedImmune planned very limited production this season, somewhere between 1 and 2 million

doses. This was a substantial about-face from original intent when

we decided to enter the influenza vaccine business nearly 3 years

ago with the desire to increase the number of influenza manufacturers in the United States and worked to fulfill the stated goals

of public health officials to expand the number of U.S. citizens receiving influenza vaccination.

However, in response to the vaccine shortage announced this

week, we are committed to filling the remaining bulk material we

have in inventory actually starting today and expect to produce up

to 1 million additional doses of FluMist for distribution. Under norVerDate 11-MAY-2000 12:20 Dec 07, 2004 Jkt 000000 PO 00000 Frm 00063 Fmt 6633 Sfmt 6633 D:\DOCS\96948.TXT HGOVREF1 PsN: HGOVREF1
60

mal circumstances, getting these additional lots of FluMist approved and released by the FDA would likely take well into December. However, we are in communication with the FDA and hopeful

that, with their assistance, the timing of this release can be expedited.

As they did during the flu crisis last season, the FDA has also

indicated that it may be willing to consider waiving other logistical

and distribution requirements, including the need for a freezebox

to store vaccine in frost-free freezers, in order to broaden the distribution of these additional doses. None of these expedited procedures will, of course, pose any added risk to the consumer or to the

quality of the product. By producing up to 2 million doses for the

healthy population between 5 and 49, we are freeing up 2 million

doses of the injectable vaccine for use in the highest risk population, which could potentially save hundreds of lives.

After our initial very disappointing and sobering experience as a

flu vaccine manufacturer, we spent several months earlier this year

evaluating whether we should remain in the influenza vaccine

business or whether we should cut our losses and get out after

dealing with the costly and overwhelmingly difficult regulatory

landscape to bring this new and effective vaccine to the market.

Our partner with FluMist last year, Wyeth, a former manufacturer

of the inactivated flu vaccine, also went through this same internal

debate. In April, Wyeth opted to exit while MedImmune decided to

stay in the business.

MedImmune’s decision to stay in the flu business was based on

a continuing belief that influenza is an extremely important disease and that FluMist is an important new addition in prevention,

warranting our investment to become a meaningful contributor to

the vaccine production in this country. Since taking over complete

control of the future of FluMist, we have cut the price of the product from $46 a dose last year to a price as low as $16 a dose this

year for the private market and negotiated even lower prices for

government purchases. We are working with the CDC, VA and

DOD, providing them the option to purchase a significant proportion of the additional product we are now working to deliver to the

marketplace.

While we are here today because of an imminent and serious vaccine shortage, I want to emphasize the problem is much larger and

transcends well beyond the season. As Speaker of the House Dennis Hastert stated on Wednesday, ‘‘there are only a handful of vaccine manufacturers left in the world. We know that our current

production capabilities would not be able to handle a massive surge

for vaccine products caused by a flu crisis. We need to take steps

to address this situation before it becomes an even bigger problem.’’

Bigger? How much bigger does this problem need to become?

How many more hearings, analyses, consultants, discussions and

testimonies must there be before any action is taken? Already,

King Pharmaceuticals, Wyeth, Parke-Davis and Merck have pulled

out of the influenza vaccine business over the past few years. Why

are they exiting? Two reasons.

First to participate in the influenza vaccine business requires

enormous investment in clinical development, manufacturing facilities and regulatory requirements; and the return on the investment

61

is abysmal, given the low price received for the vaccine. On our

part, MedImmune has invested $1 billion to bring FluMist to the

market with what is a very narrow label and expects to invest $200

million more in an attempt to expand the indication to a broader

U.S. population, an amount that you saw this morning from Dr.

Fauci’s presentation, which is greater than the NIH is expected to

spend on FluMist over the next 3 years.

Second, the demand for influenza vaccine is inconsistent, such

that when manufacturers increase capacity in anticipation of

broader demand, interest often wanes and unused product is wasted. Demand is strongly influenced by policies set by the Federal authorities. Current influenza vaccine recommendations primarily

target high-risk individuals. However, the burden of the influenza

virus illness is significant in healthy persons who fall outside of

these targeted age groups as well and in otherwise healthy

unvaccinated school-aged children who serve as vectors for transmission of influenza to their families and to high-risk individuals

with whom they have contact.

The vast majority of stakeholders in influenza prevention are

reaching the same conclusion, that the recommended population for

influenza vaccination must be expanded greatly, a movement that

we all endorse. A universal recommendation that all Americans receive annual flu vaccine will drive the demand for routine annual

vaccination and the development of sufficient infrastructure to develop the vaccine, which will in turn provide the impetus on the

part of vaccine manufacturers to increase their production. This

will ensure the capacity needed to produce even larger quantities

of vaccine in the event of the emergence of a new pandemic strain.

Ironically, it is a situation like the one we are now faced with,

where we are telling healthy individuals not to get vaccinated,

which runs counter to the message public health authorities need

to send to expand demand. History tells us that it will take several

years before many healthy individuals again seek vaccination for

flu.

What is it that MedImmune specifically recommend that the

Federal Government do?

First, we believe that regulatory authorities should look at the

available scientific and clinical data pertaining to FluMist and reconsider a broader role FluMist could play potentially within the

context of public health given the benefits that we have demonstrated in clinical studies of this vaccine. This is particularly relevant to the 50 to 64-year-old high-risk group that will otherwise

go unprotected this year.

Second, the government needs to find ways to incentivize companies to build manufacturing facilities in the United States. There

is an increasing trend for U.S.-based companies to build manufacturing plants offshore in order to gain access to a well-trained pool

of potential workers as well as significant tax advantages. With

this trend comes the increased risk of the type of event we are currently experiencing. Companies will face regulatory decisions that

may prevent product from entering the United States or, worse yet,

in the event of a catastrophic event or the emergence of a new pandemic strain, the host country may embargo vaccine for use in its

own borders.

62

Third, logistical and accounting issues need to be sorted out so

that the Federal Government can stockpile additional product or

even bulk vaccine, a relatively inexpensive step in the manufacturing process. Bulk material could be stored for up to 2 years or until

a new influenza strain is introduced and could be filled at a defined

schedule as needed.

Finally, the Federal Government should provide incentives for

manufacturers to develop innovative production methods that could

expand the capacity. They should make potential new vaccine

strains available to the manufacturer sooner and eliminate the

need for the FDA release for flu vaccine lots. All of these would result in earlier and greater product availability.

In conclusion, I would like to reiterate that MedImmune has

manufacturing capacity to produce 20 million doses of influenza

vaccine; and with the addition of our new $75 million state-of-theart manufacturing facility currently being validated and modest

changes in the works at our current facility, we will soon be able

to produce 40 to 50 million doses of vaccine. In order to make production at these levels a viable option, we need the Federal Government to create sufficient support and demand to reduce regulatory hurdles and to place a far higher value upon influenza vaccination for all Americans.

Thank you for this opportunity to speak to you today.

Chairman TOM DAVIS. Thank you very much.

[The prepared statement of Dr. Young follows:]

63

64

65

66

67

68

69

70

71

72

73

Chairman TOM DAVIS. Dr. Stroube.

Dr. STROUBE. Mr. Chairman, distinguished members of the committee, my name is Robert Stroube; and I’m the State health commissioner for the Commonwealth of Virginia and honored to be testifying before you today. I would like to thank the Chair and the

committee for holding this hearing regarding the recent developments concerning the U.S. influenza vaccine supply.

The recent flu vaccine shortage is creating a serious challenge for

public health. The present system of vaccine production and distribution is incapable of effectively responding to the current demand for the vaccine, let alone a large-scale flu outbreak or pandemic. It is imperative the Federal Government take steps now to

improve our current flu vaccine production and distribution system.

In Virginia, the health department ordered about 110,000 doses

of flu vaccine from Chiron, which we will not receive. This is almost all the flu vaccine that we typically provide to adults through

119 local health departments. Not having this vaccine will mean

that many people, especially those at high risk for flu complications, will not be able to count on their local health department for

a flu shot this year.

At this time, we expect only to receive about 11,000 doses of

adult flu vaccine, but this is a drop in the bucket compared with

the amount of flu vaccine that is needed for those people in our

communities who are most vulnerable to serious complications

from the flu. Any flu vaccine available from our local health departments will be provided to those people in the high-risk priority

groups recommended by the Advisory Committee on Immunization

Practices this past Tuesday.

The flu vaccine shortage hopefully will not impact the more than

the 115,000 doses of flu vaccine we have ordered from Aventis for

children in the Vaccines for Children program. This program is for

underinsured children, Native American children and those on

Medicaid. But the health department provides only a very small

proportion of the flu vaccine that is provided to the public. Most

vaccines are provided by the private sector.

The biggest difficulty is determining how much flu vaccine is

available in the private sector within our State and how to advise

the at-risk population on where to find any available vaccine. We

do not have a way of tracking flu vaccine availability in the private

sector. We do not have any legal authority to redirect flu vaccine

in the private sector.

We are making every effort to encourage the medical community

to follow the ACIP recommendations and prioritize the available

supply for people in the priority groups identified. We have distributed information from the CDC to the health care community

through our Health Alert Network. Over 54,000 health care providers were notified by e-mail or faxed Tuesday night and Wednesday.

In addition to our outreach to the medical community, we distributed a Statewide press release urging the prioritization of available

flu vaccine, we have conducted numerous media interviews, and we

have taken hundreds of phone calls from citizens. We are providing

people the best information we have available regarding this developing situation.

74

This serious situation is compounded by the fact that we have

gone to great lengths over the past few years to educate the people

about the importance of getting their flu shot each year. We have

not only encouraged people in the high-risk groups to get their flu

shot, but more and more it has been encouraged for all people.

We had just launched our Statewide education efforts for this

year—prior to receiving the unexpected news from Chiron. Our

education efforts have now been undermined again due to this situation. For example, we had to cancel our annual ‘‘vaccinate and

vote’’ campaign, which targets the vaccination of high-risk individuals on Election Day.

Six upcoming smallpox vaccination dispensing exercises for a bioterrorism preparedness program are now on hold because we were

going to use flu vaccine to get volunteers to participate in these exercises.

This current situation follows similar problems we had last year

when we ran out of flu vaccine at the height of the season. Last

year, VDH, the Virginia Health Department, administered more

than 160,000 of flu vaccine to the public, which is more than double the number of flu shots that we typically provide.

When we ran out of the flu vaccine last year, many high-risk patients went without vaccine, parents could not get young children

vaccinated, and health care providers could not vaccinate their

staff. Attempting to prioritize vaccine to high-risk patients was a

local health department nightmare. In some cases, security was

needed to maintain control of demanding patients.

Now Virginia and other States are faced with the difficulties of

prioritizing a limited supply of flu vaccine again, even more limited

than last year. We anticipate that many people will go

unvaccinated this year.

As you know, only three companies are licensed in the United

States to produce the vaccine. Chiron was expected to provide

about half of the vaccine supply. Aventis is the other company that

produced the flu vaccine for injection. The third company produces

the live attenuated nasal flu vaccine, which is not targeted for the

high-risk patients.

As I stated earlier this year when I testified before this committee, Congress needs to support the development a of a more reliable

vaccine production and distribution process. The current year-long

process is incapable of meeting increasing vaccine demands or

timely adjustments to vaccine formulation. The Nation’s influenza

program must include a comprehensive and critical look at all aspects of the system, including production and distribution of vaccine.

The current situation over the past few years caused concern regarding our ability to address an influenza pandemic in the United

States. Virginia has a pandemic flu response plan, but that plan

cannot be effectively carried out without having an adequate supply of vaccines and antiviral medications. We must rely on the Federal Government to assure this.

In Virginia alone, we estimate that during an influenza pandemic there could be more 1.3 million outpatient visits, over 28,000

hospitalizations and over 6,200 deaths in a 12- week period. The

75

thought of these statistics alone are enough to make improving the

flu vaccine production and distribution system a high priority.

Given the estimated 36,000 people that die each year in the

United States due to flu, I believe addressing the flu vaccine production and distribution problem should be a high priority for Congress. Government must support improvements of the vaccine production process and consider ways to ensuring that enough flu vaccine is available.

Thank you for the opportunity to speak to you, and I will be glad

to answer questions.

[The prepared statement of Dr. Stroube follows:]

76

77

78

79

Chairman TOM DAVIS. Well, thank you all.

I would ask unanimous consent to put in the record a letter from

a Mr. Victor Schwartz talking about his concerns about product liability issues for a national vaccine strategy.

And Mr. Waxman wanted to put in the record a letter to Secretary Thompson signed by Evan Bayh and Rahm Emanuel.

Without objection, those will go into the record.

[The information referred to follows:]

80

81

82

83

84

Chairman TOM DAVIS. Let me start the questioning.

Dr. Young, on MedImmune, it just was called to my attention in

terms of what NIH was telling some of their employees about the

FluMist for some of their health care workers. For healthy people

who don’t fall into those vulnerable areas, FluMist is about all we

are going to be able to get this year. What level of protection does

that give, and if you are a health care worker or a vulnerable population, why isn’t this used for them? Can you explain that?

Dr. YOUNG. Currently, because of the body of data we have from

our clinical trials, supports the use in healthy 5 to 49 year olds.

That is where the FDA approved it. We have done numerous studies in younger populations, older populations——

Chairman TOM DAVIS. Your 5 to 49-year-olds. Vulnerable population is 65 and over?

Dr. YOUNG. Absolutely.

Chairman TOM DAVIS. That leaves me out. What do you do if you

are 55?

Dr. YOUNG. Although we have done studies——

Chairman TOM DAVIS. If you are a 55-year-old healthy guy where

does that put you?

Dr. YOUNG. You know, I ask the same question. I am 51 years

old, and I ask why should I not be able to receive FluMist when

my 49-year-old peer can. I certainly don’t believe that I am at any

worse risk to receiving——

Chairman TOM DAVIS. This was just in clinical trials.

Dr. YOUNG. That is right.

Chairman TOM DAVIS. There is no evidence that it doesn’t work.

It is just that is where it has been——

Dr. YOUNG. Well, in fact, we have—our original clinical trial was

in adults up to age 64. It is an interesting situation where, when

we went to the Vaccine Advisory Panel of the FDA the first time,

4 years ago, they actually recommended approval for all adults up

to age 64. In the meantime, 2 years later, 50 to 64-year-olds had

become a recommended population for the vaccine. When the committee was asked again, should this be approved now for 50 to 64-

year-olds, we were in a double jeopardy situation, and they said,

well, we think it is safe, but we can’t be sure that the efficacy has

been demonstrated sufficiently to recommend approval.

We had actually gotten the reverse message from the FDA on

that. They thought that we needed more efficacy data when, in

fact, there is no—all of the evidence from the clinical trails suggests it is just as efficacious in that segment as in the lower population, adult population segment.

So I think we need to relook at that, particularly in a situation

where last year we were recommending that 50 to 64-year-olds are

a high risk population and yet now we are saying that they

shouldn’t get it, when in fact we may have a vaccine that could be

useful in that population.

Chairman TOM DAVIS. Now, based on last year’s sale, you produced a smaller supply of flu vaccines this year, is that right?

Dr. YOUNG. That is correct.

Chairman TOM DAVIS. Does the vaccine shortage this season—

will that affect your decision next year? And is there any way you

can cook up a larger batch this year or it is too late?

85

Dr. YOUNG. As I mentioned in my testimony, we actually had

some additional unfilled product in inventory in freezers, which we

are now thawing out and re—and filling to provide potentially another million doses of vaccine. But we can’t ramp up de novo new

additional supplies beyond that.

Whether it will influence us to produce more vaccine remains to

be seen. We still have a lot of questions in the marketplace, a lot

of confusion.

Just this morning you heard Dr. Gerberding report about the revised recommendations that came out 2 days ago suggesting that

healthy health care workers and those who care for young, young

children should be encouraged to use FluMist. While she was testifying to that, the NIH put out a memo to their employees saying

they should not, in their hospitals, should not receive FluMist. So

again adding to the confusion that the agencies are putting out different mixed messages out there to the constituencies.

Chairman TOM DAVIS. OK. Thank you.

Ms. Grant, you mentioned in your testimony that demand drives

supply. What can the government do to help ensure that the demand for the annual flu vaccine is predictable? We do that for

farmers. I mean, vaccine is pretty important.

Ms. GRANT. Well, I am going to start with a nonfinancial incentive first. That is to make sure that we are all pulling in the same

direction in looking at the groups that aren’t getting immunized.

Only 67 percent of the seniors are getting immunized today, and

yet we all know that is a recommendation. So that we can work

with our agencies that care for Medicare patients, only 37 percent

of our health care professionals in a year are getting immunized.

They, obviously, are role models as well as needing to protect themselves. So we need to pull together to make clear year after year

that we aren’t anywhere near meeting the Healthy People 2010.

I think the other issue, a financial incentive that needs to continue to be discussed and reviewed, is you heard about the strategic stockpile this year. Certainly that has turned out to be a wise

investment that CDC thought of planning for, having a few million

extra doses; and that is something which I would encourage your

committee to continue to look on favorably.

Now a little of a good thing goes a long way, and then we have

to balance to make sure what the appropriate sizing of such an annual strategic stockpile would be so we don’t risk throwing away

excessive doses. But those two approaches would help drive demand, which will drive supply.

Chairman TOM DAVIS. Thank you.

Mr. Kanjorski.

Mr. KANJORSKI. Thank you, Mr. Chairman.

Mr. Chairman, I have the great honor and privilege of being the

Member of Congress representing Aventis in the Poconos in Pennsylvania. I have had the occasion to be at the plant on numerous

occasions where 1,700 of some of the most highly qualified people

are working day and night to provide protection not only for the

influenza but other necessary vaccines.

My impression, having been there and met with the officials of

that organizations is that their first mission is to meet the needs

of the American population and the world population to fight infecVerDate 11-MAY-2000 12:20 Dec 07, 2004 Jkt 000000 PO 00000 Frm 00089 Fmt 6633 Sfmt 6633 D:\DOCS\96948.TXT HGOVREF1 PsN: HGOVREF1
86

tious diseases such as influenza. It seems to me they have the capacity to do so.

They are frustrated, if I may say, that government has not participated in the best way to get that done. We talk about it. We

have hearings on it. I think, as the Secretary referred and the

other gentleman on the panel, that nothing seems to be accomplished.

It seems that the Congress has hearings when we find out a disaster such as this occurs, but after that we all go home. I dare say

we won’t have another hearing on vaccinations or vaccines until

the next terrorist attack or other such pandemic occurs in the

world, and we will all come in here, rub our hands, and say why

didn’t we all prepare for this, when all of the three witnesses today

that are appearing at this panel, and the three earlier witnesses,

are telling us out that there are things we can do to make sure

that we smooth out the line for demand, that we anticipate future

needs, that we anticipate pandemics and that we prepare to meet

those challenges at relatively small cost.

I think I heard the figure of $100 million for a plant, and I think

I have heard in the past maybe $1 billion of investment and other

incentives to this industry would really bring us up to high speed

to prepare for whatever we need at the highest technical response

that science can give us and industry can give us.

I did a little calculation, and that was part of my antagonism toward the first panel. I am sure they are capable and doing the best

they can. But what you are talking about, if it were $1 billion, it

would cost us only 2 days of the cost of the Iraq war; and we are

talking about the risk of 300 million Americans and 6 billion people

in the world.

When you will look at the numbers in any regard and the lead

time necessary to meet these challenges, the expenditures of 2 days

of the Iraq war or a week of the Iraq war is miniscule. That money

I think could be made available by the Congress, and probably

there is a full intent to do so, except we have pretty terrible communication between the executive branch with a plan, the Congress with a response of priority, and then the people that are

going to do the work, the private sector in this country and all

around the world, that seem to be left out except when they run

into a problem or we have a problem. Then we have this tremendous partnership that joins for these few days to soothe the American population so that everybody can go home and think that we

are prepared. We are neither prepared for a world influenza epidemic, and we are certainly not prepared for a biological attack.

So, with all of this criticism, Mr. Chairman, it is not without a

suggestion. I have enjoyed all of my visits to Aventis. I think they

would entertain either this full committee or a representative portion of this committee to come up to the great Poconos Mountain

areas for a day or two, show you what they do, show you what the

industry does, show you the lack of coordination and cooperation

between government and the industry and our various regulatory

authorities and that we can walk away in 24 or 48 hours with an

actual knowledge of what has to be done by this Congress and the

executive branch of this government to really put a coordinated reVerDate 11-MAY-2000 12:20 Dec 07, 2004 Jkt 000000 PO 00000 Frm 00090 Fmt 6633 Sfmt 6633 D:\DOCS\96948.TXT HGOVREF1 PsN: HGOVREF1
87

sponse to the challenge of viral and bacterial infections in the

United States. I highly recommend it.

Now I know I have a few minutes left.

Chairman TOM DAVIS. I will ask the staff to look at the that, too.

Mr. KANJORSKI. It is my invitation. Come on up there. You will

enjoy it.

Chairman TOM DAVIS. It will certainly be better for me than the

last time that I was in your district.

Mr. KANJORSKI. I agree with you, Mr. Chairman.

Mr. Chairman, Ms. Grant represents Aventis here. I just want

to throw the question: What do you think the government has to

do to help your company and other companies meet these challenges, not only of influenza but biological attack? What do we

have to do? And lay it out and be candid with us.

Ms. GRANT. Well, thank you, Mr. Congressman; and we are

equally honored to have you and your capable staff representing

our employees and our district. So I thank you.

I would say we certainly welcome the committee’s visit to the

great State of Pennsylvania and the wonderful Poconos. You might

want to consider doing it before the snow sets in, but—or after—

but we would love to have you up there.

Congressman, I had mentioned five recommendations; and I will

just reiterate two at this point.

First of all, it is the kind—a little kind of thing that I mentioned.

And that is, for some reason, there are SEC accounting guidelines

that just popped up in the last year or so which suddenly have created inconsistencies with the language that CDC has been using

quite successfully with our and other companies for many decades

to build strategic stockpiles. So it is like the old adage of, but for

the nail in the horse’s shoe, the battle was lost. So this little thing,

which seems certainly within the purview of this committee, to perhaps talk about getting those two agencies together to see if we

can’t work that out.

The second issue, the very important issue you mentioned, planning for pandemic. CDC, through the National Vaccine Program

Office, has just put out a draft plan for pandemic. We would

strongly encourage this committee to think about the need to prepare now for the inevitable vaccine liability concerns and exposure

that are going to emerge when any company in the world is asked

to prepare a pandemic vaccine that by its very nature will not have

had years of clinical trails and experiences.

What we are saying is we need to bring that issue to your attention. We need to work with you to make sure that we balance compensation and liability concerns so you are not disappointed when

the companies point out that they just can’t get in the business of

working on the pandemic vaccine when we are in the middle of the

pandemic.

So those are two of the five that I bring to your attention.

Chairman TOM DAVIS. Thank you very much, and thank you for

what your company is doing.

Mr. Cooper, thanks for your patience.

Mr. COOPER. If we focus on the short-term concerns for a second.

The earlier panel discussed the possibility of being able to halve

the dose so that twice as many people could receive the vaccine or

88

the FluMist. What are the practical obstacles to making that happen, assuming that you got FDA approval for that?

Ms. GRANT. I am sorry, sir. As Dr. Fauci said, that is certainly

something that—I am not sure it is a short-term solution. Because

here we are in the midst of a season where we are already being

advised by the public health authorities not to go the route of immunizing healthy individuals; and, as you heard, the trials done to

date have been on healthy individuals. So while I believe my medical colleagues would suggest that there may be some promise in

looking at that, it is probably too late this year to really think that

is going to solve our problem.

I would be happy to ask my colleague, Dr. Johnson, to comment

if he wishes.

Dr. YOUNG. If I can make a comment to that. I think the biggest

concern is that there is concern now that the injectable vaccine

doesn’t work as well in the elderly as their immune system starts

to decline with age. So the thought of halving a dose in a population which is currently thought to be suboptimally responding to

the vaccine——

Mr. COOPER. So your product is for the healthy, 5 to 49, and

could you halve the dose there?

Dr. YOUNG. Actually, half the dose would still fall in the specification for the vaccine.

Mr. COOPER. So you could do it?

Dr. YOUNG. The problem is that then you would have to adjust

the shelf life to make it a much shorter half life so it doesn’t fall

below that spec over time. So unless the vaccine is used very quickly, that would be a problem.

Mr. COOPER. But FluMist could probably do it, if you got FDA

approval?

Dr. YOUNG. Unfortunately, there is not a lot of data that supports being able to do that.

Mr. COOPER. I said if you got FDA approval.

Dr. YOUNG. Certainly.

Mr. COOPER. Second question. A number of jurisdictions across

the country unfortunately ordered only from Chiron. What do we

tell those jurisdictions that basically have no flu vaccine at all right

now?

Ms. GRANT. As Dr. Gerberding said, literally Tuesday morning,

as Blackberries were being worked at another hearing and the impact of this announcement became known, our company began to

work with her staff to being to understand which States, particularly the public health sector, although it only buys about 10 percent of the vaccine, is and is not—does and does not have access.

As you heard, and I would like to reiterate, what we are working

on together is to figure out where there is lack of coverage and

then do the best we can. As she said, it won’t be perfect, but the

pledge is to try to make sure that we are able to provide some vaccines to all public health sectors.

Mr. COOPER. Let me put in a word for Nashville, TN, because it

is my understanding that none of our hospitals in our city were

able to get any vaccines. So it would be helpful there.

Third, for Aventis. When you sell the vaccine to a distributor, are

there any safeguards against price gouging in the contract?

89

Ms. GRANT. OK. Well, in the case of a distributor, by their very

nature, they intend to sell it on. So as far as our contract goes, we

do not, per se, have controls over the price they charge.

I will say, however, Congressman, that as both an attorney and

as a former health commissioner, I am well aware of the price—

I think we should all be aware of the price-gouging laws that exist

in every State and certainly our company would find that—any

kind of price-gouging behavior absolutely outrageous and would encourage, if we hear from any customer or patient, to contact their

local authorities to find out what their remedies are.

Mr. COOPER. How would you define price gouging? As a doubling

of the price? What would it be?

Ms. GRANT. That is an interesting question. I really haven’t

thought about it to begin to volunteer a standard. But that might

be one of those things that we would know when we see it.

Mr. COOPER. I think we are going to have a hard time reporting

it unless we give them an idea of what the standard would be. If

they don’t know what they are going to report, you know, what is—

what does the average vaccine sell for?

Ms. GRANT. Well, I will just say that our company has made very

clear—our prices are known. It would be visible.

Mr. COOPER. What is the price?

Ms. GRANT. As was suggested, in general, it varies by the customer class and the type of vaccine. In general, this year it is between $8 and $10; and then the pediatric vaccine, the list price is

about $12 a dose.

Mr. COOPER. So if customers were to see, $20, $25, that would

be a doubling of the price; and that might count as gouging.

Ms. GRANT. A customer certainly might want to ask questions

about that.

Mr. COOPER. There are a lot of other long-term concerns.

I appreciate everyone’s testimony. I think you have given this

panel and Congress a lot to think about; and hopefully we will be

able to respond not only to this sort of problem but also a possibly

larger problem, should bird flu or things like that come to the fore.

Thank you very much.

Chairman TOM DAVIS. Thank you.

Mr. Van Hollen, thanks for your patience.

Mr. VAN HOLLEN. Thank you, Mr. Chairman. I also want to

thank all of the witnesses for their testimony; and, Dr. Young,

thank you for your testimony.

MedImmune is in my congressional district, Mr. Chairman, right

here in Gaithersburg. So I think when we are planning that trip,

Mr. Chairman, I just want to—we should make sure we stop in

Gaithersburg, which is, of course, very close by here. I am sure

that the company would be happy to have the committee visit.

Let me ask you, Dr. Young, or anybody else, but you in your testimony talked about the fact that there were a number of children

last year who died of the flu who would have been eligible to receive FluMist. You were here I think for the testimony of Dr.

Gerberding, and she was very reluctant to answer the question:

What will be the direct health effect of this shortage that we are

facing now in terms of the numbers of deaths and the number of

90

people hospitalized? And her answer was we can never predict the

severity of the flu season and flu strain.

I understand that in terms of absolute numbers. But in terms of

percentages, you know, given a particular flu season and the severity of that, do you have any estimate as to what this crisis is going

to mean in terms of additional lives lost in this country?

Dr. YOUNG. I think it is very hard to come to a precise number,

and it all depends on how well the available supplies of vaccine are

deployed to the highest risk individuals.

Clearly, if we can continue to administer the available vaccine in

that highest-risk elderly population, then clearly we can avoid a

fair number of deaths, much like previous years.

Mr. VAN HOLLEN. Right.

Now, I guess the question—maybe this was asked earlier. But

Aventis has obviously got contracts with certain providers already;

and some of those, I assume, were providers who were going to be

providing the product to people in the healthier range who would

be eligible for FluMist. I guess the question is whether or not there

is any discussions under way where we would redirect the Aventis

product, which has been cleared for the broad age group, to the

people at most severe risk and allow FluMist to be directed to

those in the healthier age range.

Ms. GRANT. Well, I hope I gave the right figure about 33 million

of our vaccine doses have already been distributed; and they certainly were, I am sure, sold to customers caring for all different

populations.

You heard Dr. Gerberding say that, as we speak, our people are

working with her people to figure out, certainly at the county level,

where vaccine is. So I think we are always open—I mean, that will

be, of course, a matter among the health providers at that level.

The sheer scale—it would be unwise to promise too much because

the sheer scale of the difference between the vaccine that we have

produced and what under the best of circumstances can be available from FluMist won’t solve the problem. But we will work together through CDC.

Mr. VAN HOLLEN. Let me ask you. You mentioned Dr.

Gerberding and the fact that you are in discussions with some of

your—the people you provided the product to and trying to figure

out where it is and how we can get it to the most at need and risk

populations. Has there been any reluctance on the part of Aventis

to provide that information to public health officials at the county

and State levels?

Ms. GRANT. I wouldn’t characterize—I think the cooperation has

been terrific. As I understand and in personally talking with her

and in personally talking with our CEO who has been working

with her, we are trying to do everything the best we can.

We are suggesting that there are some ways—just last year

when we faced the late season surge demand and there was sort

of the first instinct to, well, let’s know where all of the vaccine is,

having worked in the field for some 30 years our people knew that

a lot of that vaccine had already been distributed. So that probably

the first instinct should be let’s ask people what they still have.

Rather than trying to set up an enormously elaborate information

system, sending things out, wondering why we are not hearing

91

back, just go out to people generally and say, if you have vaccine,

please contact your local health officers. And that was actually

rather successful.

So I don’t think it is a question of reluctance. I think it is question of talking through practically what are you likely to get in the

way of the best response to solve the problem. And that is as I understand where we are.

Mr. VAN HOLLEN. Good. Now I understand that with respect to

the FluMist, because of the whole range of issues you discussed in

your testimony, you didn’t plan to produce more this year; and

given the production times, it is just not feasible to do more than

an additional million doses. Is that——

Dr. YOUNG. That is absolutely correct.

Mr. VAN HOLLEN. Dr. Fauci testified about some very, very important and good long-term options, but as we discussed the shortterm options, I think your testimony is pretty clear. It is not so

much in terms of our ability to generate more vaccine. It is a question of just using what we have and redistributing it.

Dr. YOUNG. Oh, yeah. If you look at the long-term planning that

goes into supply requirements, it is years of planning. We have

long-term 3-year, 4-year contracts with the egg producers to make

sure that we have adequate supplies of substrate we need to grow

the vaccine. Once we finish our campaign and stop making vaccine,

the egg supply dries up; and, consequently, we can’t go back and

manufacture more product in a rapid response mode. So we have

to really understand up front where the demand is going to be in

order to ensure that we have adequate supplies on hand.

Mr. VAN HOLLEN. All right. Let me just ask one more.

In previous years, as I understand it, individuals in the 50 to 65-

year range were also defined to be at high risk, is that right?

Dr. YOUNG. That is correct.

Mr. VAN HOLLEN. So when we get the list now of who is a highrisk group, it is really not based on a health decision. It is saying,

here is the doses we have available, these are the people most at

risk, but that those other individuals in this other age category, in

terms of health analysis, they continue to be at risk as much this

year as they were last year, right?

Dr. YOUNG. Absolutely. It is basically a triage system to say,

with limited supply, who can we prioritize and ensure that we have

the least—the greatest benefit for the amount of vaccine we have.

And that is—it is a very difficult decision to have to say to someone, last year, you—we told you to get the vaccine. This year, we

are telling you not to get the vaccine.

Mr. VAN HOLLEN. Thank you very much.

Chairman TOM DAVIS. OK. Any other questions?

Mr. VAN HOLLEN. No.

Chairman TOM DAVIS. Thank you all very much.

I know Ms. Blackburn is on her way over, so I am going to ask

a couple of other questions as well.

Dr. Stroube, let me ask you: For those individuals who don’t fall

into the high-risk priority group for the flu vaccine, what precautions can they take to reduce their risks of contracting the flu?

Dr. STROUBE. Well, what we put out in—I was trying to find my

press release so I can tell you exactly what we are telling people.

92

It is, basically, wash your hands if you have—anytime you think

about it, anytime you have been with somebody or if you have a

runny nose, to keep from spreading, to use good hygiene, to avoid—

if you are sick with the flu, going in nursing homes, around people

who are ill. Those are the type of recommendations we are making.

Chairman TOM DAVIS. Now, washing the hands, that is not—how

does washing the hands help? Because your hand comes in contact

with your face and everything else?

Dr. STROUBE. You rub your mouth and eyes, and then you have

picked it up on your hands and you are transmitting it back to

yourself.

Chairman TOM DAVIS. So washing your hands frequently would

be one thing.

Dr. STROUBE. That is one thing. That is a traditional public

health message for all kinds of things. But that is one of the things

that we are stressing.

Chairman TOM DAVIS. What are we trying to do in Virginia since

the British supply is now canceled for us? Are we going to try to

work with the Center for Disease Control and Aventis and try to

get some of that released for our vulnerable population?

Dr. STROUBE. Well, yesterday we had a video conferencing with

all of our health directors all across the State and their staffs; and

we are trying to find out what is going on from southwest Virginia,

northern Virginia, the whole place, and come up with some consistent policies for the State. So we put a freeze yesterday on the vaccine we did have until we can sort out where it is and make sure

it is equitably distributed.

Some of our local health departments got vaccine directly. Others

didn’t. So we want to try to do that. We want to come up with some

knowledge of where the most needs are.

Yesterday, we were overcome, overwhelmed with nursing homes

calling in and said they were relying on getting the vaccine from

Chiron and don’t have it. So we have to sort out who has vaccine,

who needs it, and then figure out how we can match that up. And

some will need persuasion, hopefully moving some of the vaccine

that people have and using their good will to let us take it to other

places on it.

We were actually hoping that we would be able to do more with

the halving of the doses, but that doesn’t look like it is going to be

viable.

Chairman TOM DAVIS. How do private doctors get it? Do they get

from the State or contract individually?

Dr. STROUBE. In Virginia, they contract directly with the distributors on it.

Chairman TOM DAVIS. Are you coordinating with them, too, to

see what they have available, what doctors might——

Dr. STROUBE. Exactly. We sent out—like I was saying, 54,000 emails and faxes went out late Tuesday, early Wednesday to all of

the health care providers. We have a law in Virginia now that requires that to provide their e-mail and fax to us, and we have that

in a data base. We sent it out urging them to work with us, and

we will be following up on that, trying to—at a local level, that will

be passed off to our districts.

93

Chairman TOM DAVIS. Thanks. Let us know how we can help.

Obviously, you learn from what has happened this year, and we

just want—we don’t want a reoccurrence, but we have to get

through this year as well.

Mrs. Blackburn.

Mrs. BLACKBURN. Thank you, Mr. Chairman; and I want to

thank our panel for being here, all of the witnesses that have participated today.

In my State, in Tennessee, this is something that is important

to us; and we are, of course, concerned about our supply, just as

everyone else is. We have two suppliers, Chiron and—does about

a third of the supply, and then Aventis does about two-thirds of the

supply.

My question, Ms. Grant, is to you. You mentioned in your testimony, in your written statement, that demand drives the supply

and what can the government do to help ensure that the demand

for the annual flu vaccine is more predictable each year? Because

one of the things that concerns me, and this is the reason that I

asked the question of you, is it seems that so many times, regardless if we are looking at public health policy or we are looking at

operational policy for governmental entities, whether it is the Federal, State or local entity, we are more reactive than proactive; and

we fail to plan. We think in short-term segments and not long-term

segments.

We know that you all have said—more than one of you have said

in your written statements in your testimony that it takes from 5

to 7 years for a new company seeking to locate in the United States

to be able to provide that vaccine. So, you know, I want you to, if

you will, talk for just a moment about process and what we can do

to do a better job with the predictable nature of what we would

need each year.

Ms. GRANT. Well, as I mentioned in a couple of the recommendations, that it is very, very important that we all speak with the

same language consistently, that despite the occasional setback, as

we clearly are going to face this year which is frustrating to all of

us, that we have to all agree that we are going to pull together to

continue to recommend to the various risk groups the importance

of being immunized.

And it is interesting, in Tennessee, I know that they are taking

very seriously something that wasn’t taken seriously a couple of

years ago, and that is the importance of using standing orders

when people are admitted to hospitals or nursing homes to make

it very easy and routine. That is a process. It is a simple thing, in

a sense. It is not so simple to execute it, but it is a simple thing

to ensure that every single patient who is a resident of a nursing

home or hospital year in year out is offered influenza vaccine.

There are millions of those patients, and that would have a profound affect on a certainty that demand—if all hospitals in all

States we knew would do that, we would know how much more

vaccine is likely to be utilized.

We talked about the health care workers, only 37 percent. If we

had a common understanding that health care workers are ready,

willing and able to—and interested in protecting themselves and

their patients by being immunized.

94

So there are many individual things that we can do.

I mentioned the strategic reserve. Again, while the strategic reserve is not the total solution, the predictability of the government

working with us collectively to think about what is the appropriate

amount to guarantee that the government sector is interested in

buying—we are not looking for that to be the total solution. It is

a private market. It is working reasonably well. But those are a

couple of very important things that we can start talking about.

Mrs. BLACKBURN. Thank you.

Dr. Young, I would like to hear from you and then Ms. Grant

talking about, with a company who wants to locate, wants to create

a flu vaccine and the 5 to 7-year window of time—which I think

really is pretty optimistic if you are looking at it. But knowing the

demand for vaccine is not going to be decreasing, it is going to increase, talk for a moment, if you will, about what you think that

we should be looking at to shorten that window of time to create

some efficiencies within what is a very heavily bureaucratic system

which makes it very difficult for anyone who is doing R&D work

or creating a vaccine to walk through that process. I would love to

hear your thoughts on that.

Dr. YOUNG. It is a very complex issue, to say the least. Clearly,

the vaccine business—the entire pharmaceutical business is highly

regulated, as it well should be, to protect the safety of the public

who receives these vaccines and drugs. So, clearly, very stringent

standards have been established for current good manufacturing

practices; and it is quite clear that it takes significant investments

to meet those standards to design, construct, validate. We have to

demonstrate that the process works reproducibly within certain parameters, time in and time out, to assure the quality of the product.

It is particularly significant when you start talking about biological products like this. It is not like chemical processes that are very

easy to control and maintain strict control over the parameters of

production. It is the manufacturing of biological products that become very labor intensive and testing intensive to ensure the high

quality of that product.

So, unfortunately, there aren’t really any easy shortcuts building

a plant, designing a plant, and then validating and operating that

plant. We have to put in some very strict standards to ensure the

reproducibility, the safety and the potency of that product time in

and time out; and, unfortunately, there aren’t just any shortcuts to

doing that.

Mrs. BLACKBURN. Ms. Grant.

Ms. GRANT. I would say certainly, as a company, we are used to

planning 5, 10 years out. So while it is a long timeframe, the most

important thing I would say for the government and this committee

to think about right now are two or three things not to do. To tell

our management and our shareholders in the world that we should

continue to increase our capacity, which we want to do at Aventis,

we have to make sure that the government is not going to chill our

interests. So two things I would not do.

I would not think about what is sometimes described as the

GOCO, or the government-operated facility. That is not what we

95

are looking for in the way of competition. We are looking for

healthy private sector competition, and we will welcome that.

I think the second issue is the notion that we are sort of skirting

around today, some of the taking issues. We would like to say that

the first order of business is to really work collaboratively with the

public sector to make sure that we get through tough situations

and seasons without sort of jumping to more Draconian solutions.

It is always very welcome to have Congress work with State officials on environmental issues to make sure that, while we never

compromise safety or other standards, that, nevertheless, that

things—we work together and know that we want to get there in

the next few years and work out those issues.

Mrs. BLACKBURN. Thank you. Thank you, Mr. Chairman.

Chairman TOM DAVIS. Thank you very much.

Just a couple of last questions and we will let you go.

Ms. Grant, it is already October. Soon you are going to begin the

process of developing and producing a new flu vaccine for next

year. What does this do to avoid the shortages next year and the

contingency plans, and we are not even sure that Chiron will be

producing next year at this point. How do you factor that in?

Ms. GRANT. Well, certainly everyone in our company is very concerned about that type of issue; and I can only finish by repeating

the pledge that we are taking into account all of the information

in the environment, just as this year. We are seeing how we can

optimize, maximize our production capability. This will certainly

influence, as we hear more from the government over the next

month or so, what we can do. We do have a certain maximum capacity. We are scraping up against that. But we are going to do everything possible to make sure we maximize.

Chairman TOM DAVIS. Easy for me to say, but then all of a sudden, if everybody else gets in the business and you are stuck holding 40 million shots, then it hits you financially. So isn’t that part

of the equation?

Ms. GRANT. It is a factor. And I just would say that is why we

have to work together to make sure that we continue to increase

the demand so that we always feel comfortable our ability to sell

increased supply is justified by seeing the demand will be there.

Chairman TOM DAVIS. Well, we appreciate what you are doing.

I am glad you are here. You are our saviors this year.

And, Dr. Young, that goes for your company as well. Same answer that I just talked about in terms of capacity for next year.

Dr. YOUNG. Absolutely. I mean, I think we have to look at the

overall situation. Clearly, if more vaccine were available and the

recommending bodies would be more proactive in trying to promote

the use of the vaccine—just like this year. They have cut back on

vaccine when it is—the recommendations in terms of who should

get it, to prioritize who gets the vaccine in the event there is excess

vaccine, they ought to be going in the other direction and saying,

look, we have extra vaccine. We ought to be using it more broadly

in kids. Only 10 percent of kids get vaccinated now. We ought to

be pushing that in that event in order to spur more demand.

Chairman TOM DAVIS. 36,000 deaths, that is a lot of people that

could have probably been—any of those been vaccinated? I mean,

96

these are the people who don’t get vaccinated for the most part,

right?

Ms. GRANT. It certainly is an issue. We knew last year that most

of the children, sadly, the pediatric cases that resulted in death

had not been vaccinated. So the public needs to understand that

it is a very serious disease in the elderly and the young children

and make sure they are immunized.

Chairman TOM DAVIS. Guys like me and Dr. Young, I guess we

just keep washing our hands.

But thank you very much, both of you, for what you are doing.

Dr. Stroube, thank you for your leadership at the State level. Let’s

work with you every way we can in the Commonwealth.

With that, the hearing is adjourned.

[Whereupon, at 1:35 p.m., the committee was adjourned.]

[Additional information submitted for the hearing record follows:]

97

98

99

100

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

117

118

119

120

121

122

123

124

125

126

127

128

129

130

131

132

133

134

135

136

137

138

Æ