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SUMMARY
The Vaccine and Related Biological Products
Advisory Committee meeting was called to order by the Chair, Dr. Gary Overturf,
on February 18, 2004 at 8:30 a.m. EST.
Dr. Roland Levandowski, FDA discussed last year’s selection of the
components of the influenza vaccine and the constraints, importance and
deadlines for selection of this year’s vaccine components. Subsequent presentations included vaccine
effectiveness, U.S. and world
surveillance of influenza activity, strain characterization, vaccine responses,
availability of strains, comments from manufacturers, and an update on
influenza A(H5N1) activity in Asia. An
Open Public Hearing was announced. No public
comment was offered. The Chair
adjourned the first day of the meeting at 6:10 p.m. EST.
The Chair called the second day of the
meeting to order at 8:30 a.m. EST. An
Open Public Hearing was announced. No
public comment was offered. The panel heard
an overview of their options for strain selection of the components of next
season’s influenza vaccine. After
discussion, the committee made the following recommendations for the influenza
virus strains to be included in vaccine for use during the 2004-2005 season in
the United States. Based on information
about the appearance and epidemiology of new influenza virus strains, responses
to current vaccines, and the availability of new candidate strains for manufacturing,
the committee recommended:
·
The
Committee unanimously recommended (17 votes in favor, 0 against, and 0
abstained) retaining the 2003-2004 influenza A H1N1 component, New Caledonia
20/99, for the 2004-2005 season.
·
The
Committee unanimously recommended (17
votes in favor, 0 against, and 0 abstained) changing the influenza A H3N2
component of the influenza vaccine to the A/Fujian-like strain for the
2004-2005 season.
·
The Committee recommended (16 votes in favor of a change or
provisional change, 1 vote to defer and 0 abstained) a change of the 2003-2004
influenza B component to a Yamagata lineage, B/Shanghai – like strain for the
2004-2005 season with a provision to meet via teleconference on March 17, 2004,
review any further data gathered in the interim period, and make their decision
final at that time if no new information would contradict the
recommendation.
The panel heard presentations from both the
FDA and National Institute for Biological Standards and Control (NIBSC) UK and
had discussions on the use of mammalian cell lines for the use in preparation
of reference influenza viruses.
This completed the committee discussion and
recommendations and the meeting was adjourned at 12:20 p.m. EST