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81–863 PDF 2003

S. HRG. 107–691

LOSING MOMENTUM: ARE CHILDHOOD VACCINE

SUPPLIES ADEQUATE?

HEARING

BEFORE THE

SUBCOMMITTEE ON PUBLIC HEALTH

OF THE

COMMITTEE ON HEALTH, EDUCATION,

LABOR, AND PENSIONS

UNITED STATES SENATE

ONE HUNDRED SEVENTH CONGRESS

SECOND SESSION

ON

EXAMINING THE ADEQUACY OF CHILDHOOD VACCINE SUPPLIES, FOCUSING ON THE EXTENT THAT RECENT SHORTAGES HAVE AFFECTED

IMMUNIZATION POLICY AND PROGRAMS, WHAT FACTORS HAVE CONTRIBUTED TO RECENT SHORTAGES, AND WHAT STRATEGIES ARE

FEDERAL AGENCIES CONSIDERING TO HELP MITIGATE THE DISRUPTIONS IN SUPPLY

SEPTEMBER 17, 2002

Printed for the use of the Committee on Health, Education, Labor, and Pensions

(

COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

EDWARD M. KENNEDY, Massachusetts, Chairman

CHRISTOPHER J. DODD, Connecticut

TOM HARKIN, Iowa

BARBARA A. MIKULSKI, Maryland

JAMES M. JEFFORDS (I), Vermont

JEFF BINGAMAN, New Mexico

PAUL D. WELLSTONE, Minnesota

PATTY MURRAY, Washington

JACK REED, Rhode Island

JOHN EDWARDS, North Carolina

HILLARY RODHAM CLINTON, New York

JUDD GREGG, New Hampshire

BILL FRIST, Tennessee

MICHAEL B. ENZI, Wyoming

TIM HUTCHINSON, Arkansas

JOHN W. WARNER, Virginia

CHRISTOPHER S. BOND, Missouri

PAT ROBERTS, Kansas

SUSAN M. COLLINS, Maine

JEFF SESSIONS, Alabama

MIKE DeWINE, Ohio

J. MICHAEL MYERS, Staff Director and Chief Counsel

TOWNSEND LANGE MCNITT, Minority Staff Director

SUBCOMMITTEE ON PUBLIC HEALTH

EDWARD M. KENNEDY, Chairman

TOM HARKIN, Iowa

BARBARA A. MIKULSKI, Maryland

JAMES M. JEFFORDS, Vermont

JEFF BINGAMAN, New Mexico

PAUL D. WELLSTONE, Minnesota

JACK REED, Rhode Island

JOHN EDWARDS, North Carolina

HILLARY RODHAM CLINTON, New York

BILL FRIST, Tennessee

JUDD GREGG, New Hampshire

MICHAEL B. ENZI, Wyoming

TIM HUTCHINSON, Arkansas

PAT ROBERTS, Kansas

SUSAN M. COLLINS, Maine

JEFF SESSIONS, Alabama

CHRISTOPHER S. BOND, Missouri

DAVID NEXON, Staff Director

DEAN A. ROSEN, Minority Staff Director

(II)

CONTENTS

STATEMENTS

TTUESDAY, SEPTEMBER 17, 2003

Page

Reed, Hon. Jack, a U.S. Senator from the State of Rhode Island ....................... 1

Heinrich, Janet, Director, Health Care-Public Health Issues, U.S. General

Accounting Office, Washington, DC .................................................................... 2

Doran, Timothy F., M.D., Chairman of Pediatrics, Greater Baltimore Medical

Center, Baltimore, MD, on behalf of the American Academy of Pediatrics;

and Wayne F. Pisano, Executive Vice President, Aventis Pasteur North

America, Swiftwater, PA ..................................................................................... 9

ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:

Janet Heinrich .................................................................................................. 18

Timothy F. Doran, M.D. ................................................................................... 30

Wayne Pisano ................................................................................................... 37

(III)

(1)

LOSING MOMENTUM: ARE CHILDHOOD

VACCINE SUPPLIES ADEQUATE?

TUESDAY, SEPTEMBER 17, 2002

U.S. SENATE,

SUBCOMMITTEE ON PUBLIC HEALTH,

OF THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND

PENSIONS,

Washington, DC.

The subcommittee met, pursuant to notice, at 2:34 p.m., in room

SD–430, Dirksen Senate Office Building, Senator Reed, presiding.

Present: Senators Reed and Murray.

OPENING STATEMENT OF SENATOR REED

Senator REED [presiding]. Let me call the hearing to order.

Good afternoon. Today’s hearing will examine a critical issue for

the health of our Nation—the stability and adequacy of our childhood vaccine supply.

Indeed, shortages of 8 of the 11 recommended childhood vaccines

have plagued our health care system for the past 12 to 18 months

and have affected every segment of our society. We will hear today

that too many children are going without timely vaccinations. Physicians have been forced to turn away young patients. State and

local public health officials have been left scrambling for vaccine

supplies, and school departments have had to waive immunization

requirements for entry, leaving young children vulnerable to potentially devastating, yet entirely preventable, diseases such as measles, rubella, and even chicken pox.

Last year, I had the opportunity to chair a hearing of the HELP

Committee that explored some of these issues. Since then, several

members of this committee and others concerned about the critical

shortage of vaccines commissioned a report by the General Accounting Office to get a better handle on the root causes for the recent shortage.

It is clear from this report that we have a system that cannot

guarantee an adequate supply of vaccines from year to year and is

unprepared to handle a potential outbreak of many routine childhood diseases. We are putting our children in danger. Congress,

the administration, medical providers and manufacturers must

work together to ensure an adequate and reliable supply of vaccines.

Vaccines are one of the greatest public health accomplishments

of the 20th century, reducing once common diseases by 95 to 99

percent. Yet the campaign to protect our Nation’s children from the

2

ravages of these contagions has in many ways been the victim of

its own success. Today, most parents have never heard of these diseases, except when they bring their children in for well-baby visits,

and providers have limited experience actually treating them in the

practice setting.

In addition, significant consolidation in the vaccine manufacturing industry over the past two decades has resulted in a decline in

the number of producers in the market. Over a dozen manufacturers existed prior to 1980. Today, only four manufacturers produce

almost all of the routine childhood vaccines on the United States

market.

The GAO report outlines the factors that contributed to the recent shortages and paints a disturbing picture for the future of our

vaccine supply. We are clearly at a point where swift action must

be taken to preserve and strengthen our immunization system.

I am particularly concerned that the recent vaccine supply disruptions will inevitably have a negative impact on vaccine coverage

rates in this country. The public health community must remain

vigilant in tracking this data so that the appropriate response can

be taken to protect public health.

We simply cannot allow decades of tremendous progress in reducing vaccine-preventable diseases to become undone.

In addition to Jan Heinrich of the GAO, also testifying before the

subcommittee today are Dr. Timothy Doran, a physician from Baltimore and a member of the American Academy of Pediatrics, and

Wayne Pisano, of Aventis Pasteur, one of the four remaining vaccine manufacturers in the United States market.

I look forward to hearing each of your perspectives on the recent

vaccine shortages and your reactions to the findings and recommendations articulated by the GAO.

I would like to thank all of our witnesses for taking the time to

be here today to discuss this important issue, one which affects

each and every one of us.

Now, as my colleagues arrive, I will recognize them, but Ms.

Heinrich, please go ahead.

STATEMENT OF JANET HEINRICH, DIRECTOR, HEALTH CAREPUBLIC HEALTH ISSUES, U.S. GENERAL ACCOUNTING OFFICE, WASHINGTON, DC

Ms. HEINRICH. Mr. Chairman, we are pleased to be here this

afternoon to discuss findings from a report which we are releasing

today that you and several others in Congress requested on the recent incidents of vaccine shortages.

Immunizations, as you said, are considered one of the leading

public health achievements of the 20th century. Immunization programs have eradicated polio and smallpox in the United States and

much of the world and reduced the number of deaths from several

childhood diseases, such as measles, to near zero.

A consistent supply of many different vaccines is needed to support this effort. The Centers for Disease Control and Prevention

recommends that routine immunizations be given against 11 childhood diseases, four of which were added to the schedule in the last

10 years.

3

The recent incidents of vaccine shortages began in the fall of

2000 when supplies of the tetanus and diphtheria booster fell

short. As you can see on this chart, supplies of other vaccines also

declined, and by fall 2001, CDC reported shortages of five vaccines

that protect against eight childhood diseases.

Recent reports suggest that most supplies are now beginning to

return to normal.

In response to these shortages, State immunization programs rationed the amount of vaccines distributed to providers and recommended deferred immunizations for some children so that available supply could be directed to those at highest risk. Many States

also suspended immunization requirements, allowing children to

attend day care and school with fewer of the previously recommended vaccinations.

No single reason explains the recent shortages. Rather, multiple

factors coincided that affected both the supply and the demand for

vaccines. We identified four key factors—problems in the manufacturing process due to several factors, including changes to assure

compliance with good manufacturing practices; the removal of thimerosal from vaccines; manufacturers’ sudden decision to discontinue production; and unanticipated demand for new product.

Manufacturing and production problems such as slowdowns or

plant maintenance activities taking a bit longer than expected contributed to the shortage of several vaccines. Changes over the last

several years in FDA inspection practices may have resulted in the

identification of more or different instances of manufacturers’ noncompliance with good manufacturing practices. These inspection

program changes were not well-communicated by FDA to manufacturers.

As a precautionary measure, in July of 1999, the American Academy of Pediatrics and the U.S. Public Health Service issued a joint

statement advising that thimerosal, a mercury compound used as

a preservative in vaccines, be eliminated or reduced as soon as possible. Efforts to remove thimerosal affected the production of several vaccines and contributed in particular to the shortages of

DTaP. Removing the preservative was complex, and for some manufacturers just not possible.

Another major factor in the shortage of DTaP and tetanus toxoid

was the decision of one manufacturer to discontinue production of

all products containing tetanus toxoid. This company experienced

difficulties removing thimerosal from its vaccine and also in responding to a consent decree requiring significant upgrades in its

facilities involved in producing tetanus toxoid. The manufacturer

had produced approximately one-quarter of the tetanus toxoid and

about one-quarter to one-third of all DTaP distributed in the

United States.

A new pneumococcal conjugate vaccine was added to the recommended schedule in January of 2001 and was accompanied by

an extensive education campaign by the company prior to its availability. The company was only able to provide about half the needed doses during the first part of 2002, and the demand continues

to outstrip the supply.

While the recent shortages have been largely resolved, the vaccine supply remains vulnerable to disruptions that could occur in

4

the future. Although there may be some excess manufacturing capacity, the production of vaccines is a lengthy process and prevents

the quick production of more vaccine when disruptions occur.

The limited number of manufacturers poses another problem.

Five of the eight childhood vaccines have only one company producing the vaccine for the U.S. market. Several new formulations

under development, once approved by FDA, could reduce the number of sole source vaccines.

In conclusion, Federal efforts to strengthen the vaccine supply

have taken on greater urgency with the recent incidents of shortages. The Federal role in the supply and demand of vaccines is extensive, including the development of the schedule, the purchase of

over 50 percent of the childhood vaccines administered in the

United States each year, and the regulatory oversight to ensure

safety, efficacy, and compliance with good manufacturing practices.

Several strategies for strengthening the supply are being put forward. While many of these hold promise, ensuring an adequate

supply for the future poses continuing challenges.

Mr. Chairman, this concludes my remarks, and I am happy to

answer any questions.

[The prepared statement of Ms. Heinrich may be found in additional material.]

Senator REED. Thank you very much.

I should point out that not only being director of the health care

group at the U.S. General Accounting Office, Dr. Heinrich has an

extensive resume—she is a graduate of the University of Michigan

School of Nursing and a master’s of public health from Johns Hopkins University. This experience is quite evident not only in your

report but in your presentation. So thank you very much, Dr.

Heinrich.

Let me ask a question or two. One of the aspects of the GAO report is the indication that vaccine stockpiles are considered to be

a potential short-term strategy that could help mitigate crises. The

report also goes on to note that supply at least the CDC has the

authority under the National Vaccine Program as well as the Vaccines for Children Program to stockpile. Yet, only two vaccines are

currently stockpiled, and we are uncertain as to how many doses

are there—they are the MMR and the IPV.

To me, this underscores the very basic issue, of how do we urge

HHS to develop a strategy uniting all the disparate elements—

CDC, FDA, manufacturers, health care providers—to deal with not

only the stockpile issue but also the other issues we discussed.

HHS—and you might comment—is in the best position to put this

strategy in place. Without this strategy, we will continue to deal

with some symptoms of the issues but not the whole, systemic

cause of the vaccine shortages.

Could you elaborate, Dr. Heinrich?

Ms. HEINRICH. The National Vaccine Policy Office is charged

with coordination of all the different elements of the Department

of Health and Human Services that are involved in policies related

to vaccines, both in terms of the supply, demand, and the regulatory safety issues.

They are also charged with including the other important stakeholders, that being States as well as the manufacturers.

5

I think there are questions about how effective the National Vaccine Program Office has been able to be. They have recently moved

the office from CDC to the office of the Assistant Secretary for

Health, but we know that there has been limited funding, for example, in the past.

Certainly in terms of stockpiling, we say in our report that the

authority that CDC has to stockpile is clear for the program for

vaccines for children. That program has eligibility requirements, so

it does not cover all children, so there is a need, we feel, for clarification of the authority that CDC has to stockpile.

In terms of your question on overall strategy, we feel that that

is absolutely critical, and we then outline many components of that

strategy that have to be thought about, everything from how much

and in what form it is stored, who stores it. Currently, the two vaccines that are stockpiled are stored by the manufacturer, and that

vaccine is rotated through their ongoing inventory so there is always an updated supply. So do not think of it as just sitting on a

shelf; it is vaccine that is in constant rotation.

But if a stockpile is going to be effective, there has to be that

strategic perspective that you note.

Senator REED. And just for the record, your view would be that

HHS is the appropriate agency to develop this strategic approach?

Ms. HEINRICH. Yes, certainly, we do think it is HHS, because

other than, for example, the Department of Defense, which has

other needs, it is the Department of Health and Human Services

that is responsible.

Senator REED. Again, I appreciate your insights and comments,

and if there are other things that you feel the Congress should do—

and from your response to questions, to clarify some of the authority of CDC and ensure that the Office of Vaccine Policy is funded

and robustly supported are the two principal recommendations—is

that correct?

Ms. HEINRICH. Those certainly are important. We also make recommendations that focus on the role of the Food and Drug Administration because, as we have said, those vaccines that are in the

review process have the potential to alleviate some of the stress in

the system in terms of having other manufacturers supplying some

of the recommended vaccines for children.

The FDA does have procedures that they could use to expedite

the review of these vaccines. It is their current policy that vaccines

that are currently used in the market do not qualify for this expedited review, and we are suggesting that they look at that policy

because they could in fact find that when we have supplies that are

fragile, that is enough rationale for the expedited review of those

vaccines that could add available products for children’s vaccines.

Senator REED. Thank you.

I understand that several of the childhood vaccines are pricecapped under Federal purchase contracts. Did you find that these

price caps played a direct role in causing any of the recent shortages?

Ms. HEINRICH. We certainly did not find that they played a direct

role, and that is because some of the vaccines that are capped were

not in short supply. Some of the more recent vaccines that cost

6

more and are not under caps were in short supply. The only vaccine that is at the cap that was in short supply was MMR.

Senator REED. Thank you.

The report also talks about the Vaccine Injury Compensation

Program, and offers some recommendations to streamline it to

make it more effective. However, I would note on page 8 of your

testimony that the working group did not conclude that this program was a cause of any of the shortages. Is that accurate?

Ms. HEINRICH. Certainly in the data that we obtained, we did not

hear people saying that this shortage that we have just experienced

was directly linked to the problems and concerns about vaccine liability. However, we certainly did hear from manufacturers that it

is a growing problem, and we certainly did check into the Vaccine

Injury Compensation Program to see what claims they have received, and we did find out that there are over 800 claims that

have been added to the Vaccine Injury Compensation program,

many of them related to the thimerosal and removal of thimerosal

issues.

Senator REED. Let me ask you a final question before I recognize

Senator Murray for her opening comments any questions.

Among the several areas of concern is the manufacturing capacity. I think you have commented on the FDA’s role in ensuring that

capacity. Is there a consideration for some type of Governmentowned or operated company? I know some of these private companies have very checkered histories, but have you considered that at

all in your review?

Ms. HEINRICH. Certainly when we were talking with people and

collecting data, we asked them what they thought of the proposal

for a Government-owned program and also checked with an organization in Massachusetts that is a Government-sponsored manufacturer of DTaP and tetanus, as a matter of fact. Our conclusion is

that, one, not too many people that we were talking with advocated

this, but second, the Government-owned facility would be under the

same regulatory processes and procedures that the private sector

is and would have the same challenges in meeting those good manufacturing practices.

We also heard that having a Government-owned facility, certainly where there are viable products in the market, would be a

rather chilling effect to the private sector.

Senator REED. Thank you very much, Dr. Heinrich.

Senator Murray?

Senator MURRAY. Mr. Chairman, thank you very much for having this really important hearing. I appreciate it, and I certainly

appreciate Ms. Heinrich’s testimony and her being here today as

well.

There has been a lot of speculation about the delays and shortages, and I think this report gives us a much better basis for understanding what the scope of the problem was and what happened, and I think it is not because of one specific thing, but a

number of things happened that together over the last 3 years created this problem, and I hope that all of us will look at ways that

we can provide a better infrastructure in the future so we do not

have these kinds of delays.

7

In my State, I was hearing from a lot of different sectors, certainly from schools, which require immunizations before they allow

kids to come in, and kids were coming in and saying, ‘‘I cannot get

them’’; obviously, from pediatricians and public health officials,

who were really concerned because they were not getting their supplies on time; and lots of other people.

So I am glad that we are now hearing that there is no shortage

particularly right now, although in my State, we are still hearing

that there is a problem with some of the catch-up kids who did not

get their immunizations on time and are now trying to go back and

get them and get back in line, and I think that is going to cause

us some problems for a while that we need to address.

So Mr. Chairman, I really appreciate this opportunity, and I just

have a few questions that I wanted to ask Ms. Heinrich while she

is here today.

Your report indicates that vaccine shortages have peaked, and

most supplies are returning to normal. I wanted to know how you

documented that. Do you collect data from State and local health

officials? Are they private providers or physicians’ offices? How do

you calculate that?

Ms. HEINRICH. Certainly the work that we did and reflected in

the report was on our survey of States. In terms of there being a

supply that is available now, we obtained that information from

the Centers for Disease Control and Prevention.

It should be noted that although CDC is saying that overall,

there are adequate supplies, they footnote that there is not enough

for aggressive catch-up campaigns as you suggested. It is also very

clear that the pneumococcal conjugate, the PVC, is still in short

supply.

Senator MURRAY. The reason I ask is because I am still hearing

from some parts of my State that there is a shortage, so I am just

wondering who CDC is asking in order to get the information back

to you that the problem has been solved.

Ms. HEINRICH. They would be in contact with those State immunization programs. And I think that to understand what the private sector is experiencing, we would need to go to organizations

such as the American Academy of Pediatrics.

Senator MURRAY. Did you do that in your report?

Ms. HEINRICH. We did not.

Senator MURRAY. OK. In reviewing the data on the impact of the

shortages, did you find any particular increases in the reported

cases of some of the childhood illnesses, like measles?

Ms. HEINRICH. We actually looked very aggressively to see if

there would be any evidence of increased infectious diseases as a

result of the delay in children obtaining these immunizations. We

could not find any evidence.

On the other hand, there will always be a lag time in terms of

the reporting of those infectious diseases, so we may not know

about this for another period of time, even up to a year.

Senator MURRAY. The other question I have is why there are

such discrepancies in the number of vaccines in short supply and

why some States and local public health offices experienced longer

and more supply distractions. It appears in your report that 52 of

the programs experienced shortages of two or more vaccines, but 31

8

of the programs reported shortages of five or more vaccines, and

nine programs had shortages of one or more vaccines for 12 months

or longer. Is that a matter of population? Are there other factors

that contribute to these kinds of discrepancies that you report?

Ms. HEINRICH. Each State has its own immunization program

and its own policies and procedures and its own ability to buy and

stockpile vaccines. So part of what you are seeing is that each

State is unique in terms of what stockpiles they might have had.

What happens is that CDC gives grants to States under their

317 Program. The States can then purchase vaccines through that

program and through State moneys, as a matter of fact, if they so

choose. Then, it really is again up to the State policy in terms of

whom they distribute that to, who participates in their program.

Oftentimes, you will have private sector as well as public sector

providers involved.

Senator MURRAY. I appreciate your input on that. Thank you.

Thank you, Mr. Chairman.

Senator REED. Thank you very much, Senator Murray.

Again, Dr. Heinrich, thank you so much for your testimony and

for your excellent report.

Ms. HEINRICH. Thank you.

Senator REED. Let me now call the second panel to the witness

table.

We are joined today by Dr. Timothy F. Doran. Dr. Doran lives

in Baltimore, MD. He has been a practicing pediatrician for nearly

20 years, and has chaired the Department of Pediatrics at the

Greater Baltimore Medical Center in Baltimore since 1999. Dr.

Doran received his Bachelor of Arts degree from Harvard College,

in Cambridge, MA, and his medical degree from Tufts University

School of Medicine in Boston. He completed his pediatric residency

at Montefiore Hospital and Medical Center, the Bronx, NY, and

was chief resident at the Albert Einstein School of Medicine’s Department of Pediatrics at Montefiore.

Dr. Doran served as president of the Maryland Chapter of the

American Academy of Pediatrics from 1996 to 1998 and was honored as Pediatrician of the Year by the Maryland Chapter in 1998.

Dr. Doran is the current chairman of the AAP’s National Nominating Committee.

In addition to his work at the State and national levels for the

American Academy of Pediatrics, Dr. Doran has held numerous

board and committee positions advocating for underserved populations of children, including victims of sexual abuse and children

with disabilities and other special health care needs.

Dr. Doran is married and has two children.

I want to thank you for being here. Dr. Doran also grew up in

North Attleboro, MA, which is almost as good as being in Rhode

Island, and his father worked in Rhode Island, so that makes up

for it. We welcome you particularly, Dr. Doran.

Wayne F. Pisano, our next witness, is the executive vice president for Aventis Pasteur North America. He has overall responsibility for both the United States and Canadian businesses. Additionally, he serves as the head of the global market process team

and chairs several North American executive committees.

9

Mr. Pisano joined Aventis Pasteur in 1997 as vice president of

marketing and was promoted to senior vice president of marketing

and sales during April of 1998. Mr. Pisano has played a strategic

role in resolving vaccine supply issues and recommending approaches to prevent recurrences.

Mr. Pisano holds a bachelor’s degree in biology from St. John

Fisher College and a master’s degree in marketing from the University of Dayton.

Thank you both for joining us. Let me ask Dr. Doran if he would

proceed. Your testimony will be made a part of the record by unanimous consent. If you would like to abbreviate it or summarize,

that would be accepted and appreciated.

Dr. Doran?

STATEMENTS OF DR. TIMOTHY F. DORAN, CHAIRMAN OF PEDIATRICS, GREATER BALTIMORE MEDICAL CENTER, BALTIMORE, MD, ON BEHALF OF THE AMERICAN ACADEMY OF PEDIATRICS; AND WAYNE F. PISANO, EXECUTIVE VICE PRESIDENT, AVENTIS PASTEUR NORTH AMERICA, SWIFTWATER,

PA

Dr. DORAN. Thank you, Senator.

Good afternoon, Mr. Chairman and Senator Murray. As you mentioned, I am Dr. Tim Doran, a practicing pediatrician and chairman

of pediatrics at Greater Baltimore Medical Center, a community

hospital in Baltimore, MD.

On behalf of the American Academy of Pediatrics, I thank you

for the opportunity to testify today about the current shortage of

childhood vaccines.

My practice consists of about 1,800 children from predominantly

middle-class families. In the past, however, I practiced in many different locales, from a poor island in the West Indies to inner-city

Baltimore.

In the 20 years that I have been practicing, I have never experienced the severe shortage of required immunizations as I have in

the past year.

This afternoon, I want to address three key points. First, I will

describe the consequences of the vaccine shortage to patients and

their families. Second, I will tell you about the administrative impact on pediatric practices. And finally, I will summarize the American Academy of Pediatrics’ recommendations to address this problem.

The heart and soul of a pediatrician’s job is disease prevention.

The predictable delivery of safe and effective vaccines is central to

our goal of keeping children healthy. In recent months, my practice

has seen shortages in several routinely-administered vaccines, as

you have heard, reflecting a national trend. In fact, just last week,

I again ran out of the new pneumococcal vaccine, Prevnar. This

vaccine protects children from life-threatening meningitis, pneumonia, and blood infections.

A pediatrician from New Mexico reported that his high-risk population of American Indian infants is also currently out of this vaccine. This is especially troublesome because this past spring, he diagnosed a 4-1/2-month-old Navajo infant with a case of pneumoVerDate 11-MAY-2000 13:14 Mar 14, 2003 Jkt 000000 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 81863 SLABOR2 PsN: SLABOR2
10

coccal meningitis—a vaccine-preventable and potentially fatal

childhood illness.

The parents of my patients have been understandably anxious

when they learn that a vaccine is unavailable. They know that

there is a small but finite chance that their child might become ill

with an otherwise easily preventable illness because of a delayed

or missed vaccine.

Because of media coverage of anti-vaccine groups, I spend a significant amount of time with many parents, reassuring them that

our vaccines are safe and beneficial. I cannot help but wonder how

my credibility and that of my colleagues suffers when I then have

to explain that these important vaccines are not available for their

child.

In addition to the major risks to patients and worry to parents,

the vaccine shortage has had an administrative impact on my practice as well. We must now create a system of callback lists to reach

those most in need of missed vaccines when they become available.

Our experience has been that these systems are not very reliable

or effective. Even if my relatively affluent practice, the level of

compliance with these callbacks is far from perfect and clearly inferior to immunizing at routine checkups.

I have also had to explore creative and time-consuming alternative methods to procure the full supply of vaccine that my practice needs. It is another reminder to me of the lack of a coordinated

distribution system that has led to spotty supplies.

At the same time as the shortages of 8 of the 11 required vaccines occurred, one vaccine for older adolescents and adults to prevent Lyme disease was pulled from the market because it was unprofitable. Although this was not a required immunization, its disappearance reminds pediatricians that vaccine decisions can sometimes be driven more by economics than by public health considerations.

The bottom line is that the public requires a secure supply of all

the recommended pediatric vaccines, vaccines that save children’s

lives and are the most cost-beneficial medical intervention in history.

We must safeguard our children from preventable interruptions

in vaccine delivery. This should never happen again in this country.

One immediate step is necessary. The Federal Government

should provide and adequately fund the creation of stockpiles, as

mentioned, for all recommended vaccines, stockpiles of sufficient

size to ensure that significant and unexpected interruptions in

manufacturing do not result in shortages for children.

The GAO report recognizes and the Academy supports the importance of this stockpile for childhood vaccines, including the development of a comprehensive strategic plan to implement the vaccine

stockpile.

Another crucial step is to preserve and strengthen the liability

protection for consumers, manufacturers, and physicians through

the Vaccine Injury Compensation Program. The VICP has become

an integral part of maintaining the vaccine market. Enacted in the

late 1980’s with the support and guidance of the American Academy of Pediatrics, the VICP has helped to stabilize what was then

11

and appears again to be a fragile vaccine market. We reiterate our

strong support that claims for vaccine-related injury or death must

be filed first with the VICP. We appreciate the efforts by Dr. Frist

and others to craft modifications as necessary to ensure that the

VICP is working to its full potential.

The American Academy of Pediatrics participates in the work of

the National Vaccine Advisory Commission. The recommendations

of NVAC, coupled with some of the other GAO recommendations,

create an excellent starting point to address a system that must be

fixed.

Universal immunization is a fundamental public health measure

that has profoundly improved the health of our Nation. It would be

tragic to let this hard-won advance slip away. The health of our

children depends on it.

Thank you for your time and attention.

Senator REED. Thank you very much, Doctor.

[The prepared statement of Dr. Doran may be found in additional

material.]

Senator REED. Mr. Pisano?

Mr. PISANO. Mr. Chairman, Senator Murray, good afternoon.

I am Wayne Pisano. I am the executive vice president for Aventis

Pasteur North America, and I would like to thank the committee

for providing us this opportunity to offer input on issues that are

so vital to the health of our Nation.

Aventis Pasteur is one of the leading developers and manufacturers of vaccines, with U.S. headquarters in Swiftwater, PA. Vaccines

have been produced at Swiftwater, PA since 1897.

Aventis Pasteur is one of four global vaccine companies supplying pediatric vaccines in the United States. Many people are surprised that the industry is so small, but that is a direct result of

the 1980’s liability crisis that drove many companies out of the

market.

We have in this country a unique and amazing vaccine enterprise that has resulted in freedom from disease for millions of children. Many physicians would be treating some tens of thousands

of cases of rubella, diphtheria, pertussis, and other potential killers

if not for our successful efforts. Vaccines in the hands of a robust,

cooperative public and private health delivery system have made

these diseases historical artifacts.

The country is now emerging from an 18-month period during

which there were a number of vaccine shortages. Today I am

pleased to report that there is ample tetanus vaccine for all needs,

and there is ample pertussis vaccine. It is our understanding that

supplies of varicella and MMR vaccine are returning to normal.

In the face of numerous factors, the fact that the private sector

can and has responded to supply issues demonstrates its underlying strength and vitality. Having said that, we need to establish a

national policy addressing how best to prevent or minimize the

likelihood of recurrences. Our company offered a series of recommendations earlier this year. This hearing offers an excellent

opportunity to discuss these with this committee.

While my full testimony provides a more comprehensive look at

the vaccine enterprise, including the underlying causes of the reVerDate 11-MAY-2000 13:14 Mar 14, 2003 Jkt 000000 PO 00000 Frm 00015 Fmt 6633 Sfmt 6633 81863 SLABOR2 PsN: SLABOR2
12

cent shortages as well as the additional threats in the future, the

basics can be succinctly stated.

First, vaccines are extremely difficult to produce. I said there

were only for global manufacturers of pediatric vaccines in the

United States, and some of these are single-source providers. If one

of the manufacturers unexpectedly experiences production difficulties or leaves the market, it can cause supply disruption.

Second, the lengthy and costly process of new product development combined with time-consuming production cycles adds up to

a complex regulatory process that discourages new entrants.

Third, despite their undisputed value, vaccines historically have

been extremely low or commodity-priced. Federal programs that

cap vaccine prices may produce short-term savings for the Government but ultimately contribute to the supply problem. If return on

a manufacturer’s investment is unacceptably low, that business

cannot survive.

Fourth, as some members of this committee will recall, the liability crisis of the 1980’s drove many manufacturers out of the market. We are today facing liability problems that dwarf what we saw

two decades ago, which potentially pose a threat for future supplies.

I would like to talk about what can be done to improve the immunization enterprise, effectively presenting a vaccine supply

agenda for your consideration.

We have offered a number of legislative and policy proposals during the past year that we believe will provide a tune-up for the system and a coherent approach for the long-term stability. These proposals are consistent with both the GAO report and the draft recommendations now under review by Secretary Thompson’s National Vaccine Advisory Committee.

First, it is time to seriously consider building a strategic vaccine

reserve by creating stockpiles for use if supplies are disrupted. Had

this been the case when one company recently discontinued tetanus

vaccine production, a shortage would have been unlikely.

Second, manufacturers should voluntarily pledge to provide advance notice if they plan to cease production. Several months ago,

Aventis Pasteur publicly pledged to give at least 6 months of notification before discontinuing any production. We believe that this

pledge, as with other good business practices, need not be legislated. We understand that a bipartisan group of Senators on this

committee is attempting to shape an appropriate advance notice

provision. We look forward to working with you on this issue.

Third, we urge you to reform the Vaccine Injury Compensation

Program in two ways. It can and needs to be made more familyfriendly, and second, we need to reaffirm the original intent of the

Vaccine Injury Compensation Program so that all vaccine claims

initially proceed through the program.

My full testimony outlines in some depth the creative ways in

which the law you enacted in the 1980’s is being circumvented. In

an industry with total U.S. revenues of $2.5 to $3 billion, Aventis

Pasteur alone faces over 100 lawsuits, with more being filed every

week, that seek far beyond this amount in damages. Tease cases

should be moved back to the Vaccine Injury Compensation Program

as Congress intended.

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We support Senator Frist’s bill, S. 2053, which accomplishes the

twin goal of making the program more family-friendly for claimants

while bringing such claims back within the Vaccine Injury Compensation Program. We are now spending millions of dollars defending against these suits, suits in which we believe we will ultimately prevail but at an enormous cost to the viability of the industry and to the immunization enterprise.

Frankly, the liability issue dwarfs all others as a threat to the

stability of the vaccine supply, and we urge you to pass this bill

before you adjourn.

Fourth, FDA funding in the area of vaccine testing research

needs to be increased. Budget cuts in recent years threatened

FDA’s competency in this important area. With CBER currently

undergoing organizational changes, the time is right for restoration

of these resources.

There are also a number of nonlegislative actions that can have

real and lasting impact on vaccine supply. For example, we have

urged that the CDC be encouraged to act on confidential information in ways that can provide for managing and stimulating alternative supply to minimize shortages. We believe that the CDC can

act under its current authority as a confidential facilitator of critical supply information with the manufacturer’s permission.

Other nonlegislative initiatives include adequate reimbursement

to providers for immunization services. This is also outlined in my

written testimony.

Several proposals in Congress would actually undermine incentives for manufacturers to produce vaccines. Whether called the

National Vaccine Authority, a GOCO or a GOGO, each of these

proposals results in the Federal Government getting into the business of manufacturing vaccines. We do not believe that any of these

approaches would be constructive measures for addressing supply

issues.

The vaccine enterprise in this country is a remarkable success

story. I do not believe that it is fragile at its core, but it clearly

has several areas that can be strengthened.

Thank you for your attention and your commitment to the immunization system in this country.

[The prepared statement of Mr. Pisano may be found in additional material.]

Senator REED. Thank you very much, Mr. Pisano, for your testimony. Thank you both for excellent testimony.

Let me proceed to questions. Dr. Doran, the GAO report suggests

that there are a number of vaccines under development which

could mitigate potential shortages in the future, but often, these

new vaccines are very expensive—the PCV, the pneumococcal vaccine, is an example of a rather expense vaccine.

Do you anticipate the cost of these new vaccines as a potential

barrier to access to immunization?

Dr. DORAN. The barrier certainly comes in terms of the number

of vaccines given versus the cost, and obviously, most pediatricians

will opt for whatever is the most convenient and most effective vaccine strategy, and most pediatricians will abide by the ACIP and

the CDC recommendations, and the financing is not generally the

major consideration.

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The liability issues are serious. Influenza vaccine is now on the

docket in terms of 24-month-olds. It is not currently covered under

the VICP, so pediatricians from a personal liability standpoint have

some trepidation going forward unless there is clear coverage from

the liability standpoint.

Senator REED. Thank you.

Let me follow up with another question on an issue that you alluded to in your testimony. There is the administrative disruption

of calling children back and determining who has missed a vaccination. I fear it might lead to what is really a lost generation of children who have missed their routine vaccine, they have moved, or

you cannot get them back, and we now have a cohort of

unvaccinated children because of these shortages.

How are you and your colleagues trying to manage to avoid that

lost generation?

Dr. DORAN. The majority of the immunizations that we give are

in the first 2 years of life. There are a number of regular, routine

visits, and any pediatrician or family practitioner or someone delivering health care to children should be checking their vaccination

records. In terms of losing them over years, I do not anticipate that

that would be a problem. The fear for pediatricians is if you have

missed the first couple of doses, and the child comes down with a

preventable illness.

But the problem is there, and I think we will just have to see

how much of a problem from those lost vaccinations over this period of time, how effective we are at recapturing those children. My

anticipation is that there is adequate room in terms of the periodicity schedule of when children come to see physicians that it can be

rectified. However, I think your point is well-taken.

Senator REED. Thank you very much.

Mr. Pisano, you and Dr. Doran and the GAO conclude that there

is merit in some kind of stockpiling, but the GAO report identifies

some key questions, and I wonder how industry can help answer

questions like, for example, what quantity to stockpile, the form

and storage of stockpiled vaccines, insuring that vaccine quantities

are in addition to normal supplies.

Can you give us a response to these questions? I know you are

speaking in behalf of your company, but could you give an indication of potential industry response and also, obviously, ongoing cooperation on this matter?

Mr. PISANO. I think the current guidelines recommend a 6-month

stockpile for the VFC program. This is what CDC has authorized

to do and obviously, as has been pointed out, we are not quite

there.

We would actually recommend that NVPO form working groups

with CDC, FDA, and the vaccine manufacturers to address each individual vaccine. In some cases, we have multiple manufacturers;

in some cases, we have single manufacturers; in some cases, we

have second vaccines in the development process such that there

will be a second manufacturer in the future. I think each vaccine

ought to be looked at individually to determine how much vaccine

should be in a safety reserve, who should do that in terms of which

manufacturer or multiple manufacturers. And in fact, there are

other vaccines that potentially could actually be kept at bulk level

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and not into finished goods, and you may have a longer shelf life

than I think was earlier recognized. There is a shelf life, and the

current stockpile shave to be rotated because of the expiration date

on the production lots.

Senator REED. Thank you, Mr. Pisano.

Aventis Pasteur has publicly stated its support for a notification

requirement. Let me commend you for that. I think that is a sensible approach. And the GAO report indicates that no manufacturer

would object to a 6-month notice requirement similar to what they

do now for other drugs.

What kind of notification requirement do you think all the manufacturers could agree on, and what would it look like in practice?

Would it be 6 months? Would it be longer? Could you give us any

indication?

Mr. PISANO. It is difficult for me to speak on behalf of the other

manufacturers, and I think that is something that it would be

worthwhile hearing from them on. Aventis Pasteur believes that a

minimum of 6 months would be necessary. We also see that linked

into the stockpile, so there is basically a safety reserve there.

In terms of the need to legislate versus volunteering pledges, I

think that is something that the committee needs to discuss further.

Senator REED. Good.

Both of you and the GAO report have concluded that two of the

major responses to this shortage would be a notice requirement to

at least let the market and all the providers know if a manufacturer is going off line, and also some type of stockpile.

Is there another major recommendation that you would add to

those two?

I will ask you, Mr. Pisano, and then you, Dr. Doran.

Mr. PISANO. I think it is important for the CDC to be able to

share confidential information as well as work collaboratively with

the FDA. There are times when the Government policymakers

know that there is a potential problem or a problem occurring with

one manufacturer. If they have the ability to notify the other manufacturers at that time, we can adjust manufacturing production

schedules.

I think a good example of that was 2 years ago with influenza,

when one manufacturer left the marketplace, and another was experiencing significant difficulties in manufacturing. Had CDC notified the other manufacturers, we could have adjusted production

schedules. It would not have totally eliminated the problem, but it

would have basically reduced the magnitude that this country experienced.

So we need the CDC to share this information in the best interest of the immunization enterprise.

Senator REED. Thank you, Mr. Pisano.

Dr. Doran?

Dr. DORAN. The additional items that I would include would be

the liability issues that we discussed, but also the administration

fee for providers. It was proposed to reduce the administration fee

for pediatricians to a level where they would actually be losing

money with each vaccination. That is in discussion right now, is my

understanding, with CMS and stakeholders in that, and they are

16

hopefully arriving at a suitable solution to that, but the original

proposal was to make the administration fee so low as to be prohibitive to providers.

I spend a tremendous amount of time with parents explaining

about the issues of MMR and autism, of thimerosal. It is an enormous undertaking in terms of my time. So the administration fee

needs to be commensurate with the time and effort and syringes

and storage and all those other factors. So that is something that

needs to be on the radar screen as well.

Senator REED. I know there are some who propose or suggest

that to support the reduction that many times, nurses administer

these vaccines. But your point would be that that is in cooperation

with the physician who spends other time explaining and counseling; is that fair?

Dr. DORAN. Senator Reed, I have many lawyer parents, and they

do not want a 20-second answer on the relationship of MMR and

autism. These are discussions that can be prolonged, and you cannot walk out of the room and say, ‘‘I cannot answer that. You just

have to get your vaccine.’’

So these are serious matters and would impact; if the reductions

were made, I would predict they would have a serious adverse impact on the whole immunization program.

Senator REED. Let me ask a final question. I think this has been

an excellent hearing, beginning with an excellent report from GAO

which was very substantive and very thorough. Both of your testimony has been on point and very helpful. I will give you an opportunity to look ahead into the future. What do you believe is the

greatest challenge to the vaccination program, either something

that we have discussed or that we might not have touched on?

Mr. Pisano?

Mr. PISANO. I think the liability issues that we are facing going

forward really dwarf anything we have ever faced before. I think

it is critical that the Vaccine Compensation Program be strengthened, be made more family-friendly. Clearly, there are enough complaints from parents that it is problematic getting through the system and needs to be reexamined. And we need to make sure that

when problems occur, the parents and the claimants go through

the Vaccine Injury Compensation program, as Congress intended.

So I think that strengthening those two components is absolutely

critical for keeping manufacturers in the market and also for encouraging other manufacturers to come back into the marketplace.

Senator REED. Dr. Doran?

Dr. DORAN. Senator Reed, on the issue of the NVPO or whatever

agency has central responsibility, I think there needs to be a very

strong center based at a Federal level that can coordinate this and

tease out these problems and bring solutions to the table that we

can all agree on.

Senator REED. Thank you both very much, gentlemen.

I would like to thank all the witnesses. Again, we began with a

very substantive and very thoughtful report by the GAO, and I

want to thank Dr. Heinrich for her excellent testimony.

Thank you, Dr. Doran and Mr. Pisano, for your insights. I am encouraged, actually, that HHS seems to be agreeing with the GAO’s

recommendations and beginning to implement them. But as you

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just pointed out, Dr. Doran, we need a strategy, not just good will

and good wishes, and I hope they can develop that strategy quickly.

I hope also that we can move forward on the issue of stockpiling,

which seems to be a consensus position of all the witnesses this

afternoon. We must play a more active role in Congress to ensure

this is done, because we have had hearings before, and we have

looked at these issues, and we have a wonderful report, but reports

and hearings do not vaccine children. Consistent, concerted efforts

to get them vaccinated, working with providers, manufacturers and

the administration will get it done, and we have to get it done.

There has been an impact of these shortages. School entry criteria have been changed. You and your colleagues are working to

bring children back into your offices and make sure they have vaccinations that they did not get on time, which comes with a cost.

I will be watching closely to ensure that we do not have a lost generation, that we do not have significant numbers of children who

have missed their opportunity and did not get a second chance.

That would be detrimental to them and also to the public health.

We have made great progress through immunization because of

this partnership between the industry, between the Government,

and between the medical profession, and we want to continue that

partnership and that progress. As I said, one of the great marquis

accomplishments of the 20th century has been the vaccination and

immunization programs of the United States and of the world. We

want to maintain that for the benefit of our children and our

grandchildren and generations to come.

Thank you all for an excellent hearing. I will now call the hearing adjourned.

[Additional material follows.]

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[Whereupon, at 3:28 p.m., the committee was adjourned.]

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