U. S. Department of health & human services




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U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES

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PUBLIC HEALTH SERVICE

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FOOD AND DRUG ADMINISTRATION

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CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

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VACCINES AND RELATED BIOLOGICAL PRODUCTS

ADVISORY COMMITTEE

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Tuesday, 14 September 1999

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The meeting took place in Versailles Rooms

I and II, Holiday Inn, Wisconsin Avenue, Bethesda,

Maryland, at 1:00 p.m., Harry B. Greenberg, M.D.,

Chair, presiding.


PRESENT:

HARRY B. GREENBERG, M.D., Chair

NANCY CHERRY, Executive Secretary

ADAORA ADIMORA, M.D., Member

ROBERT S. DAUM, M.D., Member

KATHRYN M. EDWARDS, M.D., Member

MARY K. ESTES, Ph.D., Member

WALTER L. FAGGETT, M.D., Member

BARBARA LOE FISHER, Member

DIANE E. GRIFFIN, M.D., Ph.D., Member

ALICE S. HUANG, Ph.D., Member

KWANG SIK KIM, M.D., Member

DIXIE E. SNIDER, JR., M.D., MPH, Member

DAVID S. STEPHENS, M.D., Member

ROBERT BREIMAN, M.D., Invited Participant

L. PATRICIA FERRIERI, M.D., Invited Participant

DAVID KARZON, M.D., Invited Participant

I N D E X

Page No.

Call to Order, Introductions, Administrative 4

Matters, HARRY GREENBERG, Chair


Session 1: Update on Thimerosal   Open Session 9

DR. WILLIAM EGAN, FDA


Session 2: Update on Cell Substrate Workshop   27

Open Session   DR. ANDREW LEWIS, FDA


Session 3: Update on RotaShield   Open Session 46

DR. KATHRYN CARBONE, FDA


Session 4: Briefing on Selected Individual

Research Programs   Open Session


Introduction   DR. THOMAS HOFFMAN, FDA 71


Laboratory of Parasitic Biology and 74

Biochemistry   DR. RICHARD KENNEY, FDA


Laboratory of Biophysics   85

DR. RICHARD PASTOR, FDA


Open Public Hearing 94



P R O C E E D I N G S

1:00 p.m.

CHAIR GREENBERG: Could people in the back

please take their seats? Peter Paradiso, sit down.

Okay. Id like to welcome you all to the

Vaccine and Related Biological Products Advisory

Committee. My name is Harry Greenberg, and after the

welcome Id like the members of the committee to

briefly introduce themselves and their affiliation,

and we can start over here.

Rob?

DOCTOR DAUM: Im Robert Daum from the

University of Chicago.

DOCTOR EDWARDS: Im Kathy Edwards from

Vanderbilt University, Nashville, Tennessee.

DOCTOR ADIMORA: Ada Adimora, University of

North Carolina at Chapel Hill.

DOCTOR KIM: Kwang Sik Kim from Childrens

Hospital in Los Angeles.

DOCTOR GRIFFIN: Diane Griffin from Johns

Hopkins School of Public Health.

DOCTOR SNIDER: Dixie Snider, Associate

Director for Science at the Centers for Disease

Control and Prevention.

DOCTOR STEPHENS: David Stephens, Emory

University, Atlanta.

MS. FISHER: Barbara Loe Fisher, National

Vaccine Information Center in Vienna, Virginia.

DOCTOR ESTES: Mary Estes, Baylor College

of Medicine, Houston.

CHAIR GREENBERG: Harry Greenberg, Stanford

University and the Palo Alto VA Hospital.

DOCTOR KARZON: David Karzon at Vanderbilt

Medical School.

DOCTOR HUANG: Alice Huang, California

Institute of Technology.

DOCTOR FERRIERI: Patricia Ferrieri,

University of Minnesota Medical School, Minneapolis.

CHAIR GREENBERG: Okay, thank you.

We have a couple of new members of the

panel. Welcome.

And, without further ado Id like Nancy

Cherry to read the COI statement.

EXECUTIVE SECRETARY CHERRY: Good morning.

Let me add my welcome to all of you. We havent had

a meeting for a while, but particularly also to our

new members, Doctor Walter Faggett who isnt at his

place yet, Ms. Barbara Fisher over here on the corner,

Doctor Diane Griffin and Doctor David Stephens. Their

terms of office began in February, but since we

havent met face to face since then this is their

first meeting.

Two of our members, Doctor Steve Kohl and

Doctor Dianne Finkelstein, are unable to attend this

meeting, but the Director of the Center for Biologics

Evaluation and Research has appointed Doctors Robert

Breiman, Theodore Eickhoff, Patricia Ferrieri and

David Karzon as temporary voting members for Sessions

I through V and Session VII. Doctor Eickhoff will not

be able to join us until tomorrow.

The committee management specialist for

this meeting is Ms. Denise Royster, and you probably

saw her at the table or here in the room. Shes

assisted today by Ms. Rosanna Harvey, who we borrowed

from another committee.

And now, may I have a drum roll, what

youve been waiting for, the conflict of interest

statement.

The following announcement addresses

conflict of interest issues associated with this

meeting of the Vaccines and Related Biological

Products Advisory Committee on September 14 15, 1999.

To determine if any conflicts of interest existed, the

agency reviewed the submitted agenda and all financial

interests reported by the committee participants.

In accordance with 18 USC 208, the

following individuals have been granted waivers that

permit them to participate in the committee

discussions: Doctors Edwards, Greenberg, Griffin and

Ferrieri. Doctor Greenberg has recused himself from

the discussion on RotaShield, and Doctor Mary Estes

has received a limited waiver permitting her to

participate in that same discussion by sharing her

expertise. Should the need for votes arise during

that session, Doctor Estes will be unable to vote.

Several participants disclosed a potential

conflict of interest, which was deemed by FDA as not

requiring a waiver, but does suggest an appearance of

a conflict of interest. A written appearance

determination under 2635.502 of the Standards of

Ethical Conduct has been granted to permit Doctors

Daum, Finkelstein and Stephens to participate in the

committee discussions.

With regard to FDAs invited guests, and

this is tomorrow, the agency has determined that the

services of Doctor George Carlone is essential for the

discussion of meningococcal conjugate vaccines.

Doctor Carlone reported that as a part of his federal

government duties he is involved in a CRADA for

pneumococcal protein vaccine, supported by a firm that

could be affected by the discussion.

In the event that the discussions involve

specific products or firms not on the agenda, and for

which FDAs participants have a financial interest,

the participants are aware of the need to exclude

themselves from the discussions and their exclusion

will be noted for the public record.

With respect to all other meeting

participants, we ask in the interest of fairness that

you address any current or previous financial

involvement with any firm whose product you wish to

comment on.

Copies of all waivers and appearance

determinations addressed in this announcement are

available by written request under the Freedom of

Information Act.

And, I have one other little announcement.

Some of you may need to move your microphones just a

little closer. I think it will help our

transcription.

CHAIR GREENBERG: Thank you, Nancy.

We have an interesting and full agenda for

this afternoon, so Id like to, without further ado,

move on, and Doctor Bill Egan from FDA is going to

update the panel and the audience on the issue of

Thimerosal and its inclusion in various vaccines.

Bill  all the speakers should realize we

have a strict time limit, and Id ask you to end your

talk before it.

DOCTOR EGAN: Good afternoon.

Over the past several months, there has

been a significant amount of activity related to

Thimerosal as a preservative in vaccines. During the

next few minutes, I hope to provide you with an

overview of these activities and a sense of where we

are headed.

Let me first provide a little background

about preservatives and Thimerosal, and I should first

mention that most of the data and the listings that

are in my talk were compiled by Doctor Leslie Ball,

Doctor Doug Pratt and Doctor Robert Ball.

By way of background, let me mention that

a preservative must be present in multi dose, multi 

entry vials. This requirement was placed into the

Public Health Service regulations in 1968. There

were, and there still are, good reasons for this

requirement, for a preservative in these multi entry

vials.

The regulations, our Code of Federal

Regulations, also state that a preservative should not

be toxic to the recipient, and it should not denature

the product.

A definition of a preservative, however,

is not provide in the Code of Federal Regulations. A

definition, however, is found in the United States
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