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

 

Members Not Present

Dr. Rich Whitley

Dr. Audrey Manley

 

FDA Presenters

Dr. Roland Levandowski

Dr. Zhiping Ye

 

DOD Presenter

Ms. Linda Canas


CDC Presenters

Dr. Nancy Cox

 

FDA Participants

Dr. Karen Midthun

Dr. Norman Baylor

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.