http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3663t1.rtf

FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND
RESEARCH

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

FRIDAY
NOVEMBER 3, 2000

PRESENT:

ROBERT S. DAUM, M.D.         Acting Chair (recused)
DIANE E. GRIFFIN, M.D., Ph.D.   Acting Chair
PAMELA S. DIAZ, M.D.             Member
MARY K. ESTES, Ph.D.             Member
WALTER L. FAGGETT, M.D.         Member
BARBARA LOE FISHER               Member
THOMAS R. FLEMING                Invited Participant
JUDITH D. GOLDBERG, Sc.D.       Member
ALICE S. HUANG, Ph.D.           Member
ERIK HEWLETT, M.D.               Invited Participant
SAMUEL L. KATZ, M.D.             Member
STEVE KOHL, M.D.                 Member
JOHN LIVENGOOD, M.D.             Invited Participant
MARTIN MYERS, M.D.               Invited Participant
AUDREY F. MANLEY, M.D., M.P.H.  Member
DAVID S. STEPHENS, M.D.         Member

And now I will go ahead and read the conflict of interest statement. The
following announcement addresses conflict of interest issues associated with
the meeting of the Vaccines and Biological Products Advisory Committee on
November 3, 2000, for the discussion of the safety and efficacy of CPDT
Adsorbed, the Diphtheria Tetanus Acellular Pertussis Vaccine sponsored by
Aventis Pasteur Limited of Toronto, Canada.
Of the committee members, Drs. Kim and Snyder could not be with us today. 
However, the Director of the Center for Biologics Evaluation and Research
has appointed Drs. Thomas Fleming, Erik Hewlett, John Livengood and Martin
Myers as temporary voting members for the discussion.
To determine if any conflicts of interest existed, the Agency reviewed the
submitted agenda and all financial interests reported by the meeting
participants. As a result of this review, the following disclosures were
made.  In accordance with 18 U.S.C. 208, Dr. Goldberg, Kohl, Fleming and
Hewlett have been granted waivers which permit them to participate in the
committee discussion and to vote.  In accordance with the Food and Drug
Administration Modernization Act of 1997, Section 505, Drs. Estes, Goldberg,
Kohl, Stephens, Fleming and Hewlett have been granted waivers which permit
them to participate fully in the committee discussions. Dr. Robert Daum has
recused himself from the discussion on CPDT Adsorbed.
Drs. Estes, Faggett, Griffin, Katz and Stephens have associations with
firms that could be affected by the committee discussions. However, in
accordance with 18 U.S.C. 208 and Section 2635.502 of the Standards of
Conduct, it has been determined that waivers or appearance determinations
are not warranted for this discussion.



They discuss the number of infant deaths that occurred during the vaccine
trials.

Christine
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