FDA Presenters

Dr. Roland Levandowski

CDC Presenters

Dr. Nancy Cox

FDA Participants

Dr. Karen Midthun

Dr. William Egan

Dr. Norman Baylor

Consultants

Dr. Nancy Cox

Col. Benedict Diniega

Dr. Walter Dowdle

Dr. Theodore Eickhoff

*Ms. Barbara Loe Fisher

Dr. Bruce Gellin

Dr. Pamela McInnes

Dr. Martin Myers

Executive Secretary

Dr. Jody Sachs

These summary minutes for the March 18, 2003 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on ______________________.

I certify that I participated in the March 18, 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 95th Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 10:30 a.m. EST on March 18, 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.

The Meeting was held at Food and Drug Administration, 5515 Security Lane, Conference Room A on the 11th Floor, Suite 1113, Rockville, Maryland 20814 by teleconference.

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/cber03.html#VaccinesandRelatedBiological

A copy of the agenda is attached.

Proceedings were adjourned at approximately 12:00 p.m. EST on March 18, 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 new strains and reagents needed for manufacturing, the committee recommended retaining a trivalent formulation.

· The committee recommended that the influenza A H3N2 component, A/Panama/2007/99 (an A/Moscow/10/99-like strain), should be retained in view of the fact that it has not yet been possible to isolate for manufacturing purposes a suitable virus representative of a group of antigenically divergent influenza A H3N2 viruses that have been increasing in prevalence during 2003. However, committee members expressed concern that vaccines may provide less effective protection if the emerging group of viruses continues to spread.

· The committee strongly urged that alternative methods of recovering influenza viruses be considered in manufacturing and that new strains continue to be investigated for changing the influenza strain components next year.

The Committee recommended in February:

· Retaining the influenza A H1N1 component, A/New Caledonia/20/99,

· Retaining the current B/Hong Kong/330/2001-like virus strain.

In Summary:

· 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) H3N2, A/Panama/2007/99 (an A/Moscow/10/99-like virus),

3) B/Hong Kong/330/2001-like virus strain.