Food and Drug Administration
Center for Biologics
Evaluation and Research
SUMMARY MINUTES
VACCINES AND RELATED
BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
Meeting # 94: February 20, 2003
Committee
Members
Dr.
David Stephens, Chair
+Dr.
Michael Decker
Dr.
Pamela Diaz
Dr.
Judith Goldberg
Dr.
Sam Katz
Dr.
David Markovitz
Dr.
Gary Overturf
Dr.
Peter Palese
Dr.
Julie Parsonnet
Dr.
Ruth Karron
Dr.
Walter Royal, III
Dr.
Rich Whitley
Dr.
Audrey Manley
Dr.
Roland Levandowski
Dr.
Zhiping Ye
DOD Presenter
Ms.
Linda Canas
CDC
Presenters
Dr.
Nancy Cox
Dr.
Kathryn Carbone
Consultants
Dr.
Robert Couch
Dr.
Nancy Cox
Col.
Benedict Diniega
Dr.
Walter Dowdle
*Ms.
Barbara Loe Fisher
Dr.
Bruce Gellin
Dr.
Pamela McInnes
Dr.
Martin Myers
Executive
Secretary
Dr.
Jody Sachs
These summary minutes for the February 20, 2003 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on ______________________.
I
certify that I participated in the February 20, 2003 Meeting of the Vaccines
and Related Biological Products Advisory Committee and that these minutes
accurately reflect what transpired.
_____________________________ ______________________________
Jody
Sachs, D.P.M. David Stephens, M.D.
Executive
Secretary Chair
The Chair, Dr. David
Stephens, called the 94th Meeting of the Vaccines and Related Biological
Products Advisory Committee to order at 8:30 a.m. EST on February 20,
2003. The meeting addressed the review
and discussed
the selection
of strains to be included in the influenza virus vaccine for the 2003-2004
Season and the
intramural research program of the Laboratory of Bacterial Polysaccharides
(LBP), Office of Vaccines Research and Review (OVRR).
The Meeting was held at the Holiday Inn,
8120 Wisconsin Ave., Bethesda, Maryland 20814.
An Open Public Hearing session was announced. No public comment was offered.
Following is a summary of the discussion. Additional information and specific details may be obtained from the transcript of the meeting. The transcript may be viewed on the World Wide Web at: http://www.fda.gov/ohrms/dockets/ac/cber02.htm#Vaccines%20and%20Related%20Biological.
A copy of the agenda is attached.
Proceedings
were adjourned at approximately 3:40 p.m. EST on February 20, 2003.
Open Session
Strain Selection for Influenza Virus Vaccine for the 2003-2004
Season
The panel heard presentations on strains of circulating influenza virus. After discussion, the committee made the following recommendations for the influenza virus strains to be included in vaccine for use during the 2003-2004 Season in the United States.
Based
on information about the appearance and epidemiology of new influenza virus
variants, responses to current vaccines and the availability of strains and
reagents needed for manufacturing, the committee recommended a trivalent
formulation.
·
The
committee recommended that for the influenza A H1N1 component, A/New
Caledonia/20/99, should be retained.
·
Based
on current information, the committee decided to defer the influenza A H3N2
component, in order to review new information obtained in the next few weeks
suggesting that another strain might be a better match with naturally
circulating viruses.
·
The
committee recommended retaining the current
B/Hong Kong/330/01-like virus strains (B/Hong Kong/330/01 and B/Hong Kong/1434/2002.)
·
The
committee strongly recommended that data be obtained from a pediatric population
to study pediatric immunogenicity and efficacy of the
influenza vaccine, as this group is relatively unprimed
and may display a distinct pattern of susceptibility to the circulating strains
compared to the adult population.
·
The
2003-2004 vaccine recommendation from the committee would be to continue with a
trivalent vaccine consisting of:
1) H1N1,
A/New Caledonia/20/99,
2) B/Hong Kong/330/2001-like virus strain,
3) postponing the H3N2 component
selection until further information can be collected and reviewed.
Session 2 –
OPEN Session
Laboratory of Bacterial Polysaccharides
An overview of the Division of Bacterial, Parasitic, & Allergenic
Products was presented by Dr. Richard Walker, FDA, CBER, DBPAP, OVRR, followed
by a presentation of laboratory research activities and accomplishments by the
Laboratory of Bacterial Polysaccharides (LBP),
by Dr. Carl Frasch, Laboratory Chief.
Session 2 – CLOSED Session
After discussion, the
members voted unanimously to accept the Site Visit Report as written.