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February 27, 2013: Vaccines and Related Biological Products Advisory Committee Meeting Summary Minutes

SUMMARY MINUTES
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

February 27, 2013
NIH Fishers Lane Conference Center
Terrace Level, Room 508-510, 5635 Fishers Lane
Rockville, MD

Committee Members FDA Participants
Dr. Robert Daum, Chair
Dr. Ambrose Cheung
Dr. Anna Durbin
Dr. Gregory Gray
Dr. Gary Schoolnik
Dr. Carol Tacket
Dr. Gillian Air
Dr. Edgar Marcuse
Dr. Kent Kester
Dr. Michael Hudgens
Dr. Pedro Piedra +
Dr. Marion Gruber
Dr. Jerry Weir
Dr. Zhiping Ye
Dr. Manju Joshi
   
Temporary Voting Members
Dr. Bruce Gellin
Dr. Pamela McInnes
Dr. Melinda Wharton
Dr. Vicky Debold*
Dr. Theodore Eickhoff
Dr. Roland Levandowski
Dr. Scott Stanek 
Speakers
Dr. Michael Cooper (DoD)
Dr. Nancy Cox (CDC)
Dr. Lyn Finelli (CDC)
Kathleen Coelingh (MedImmune)
   
Temporary Non-Voting Member
Dr. Nancy Cox
Industry Representative
Dr. Theodore Tsai
   
Designated Federal Official
Donald Jehn, M.S.
Committee Management Specialist
Denise Royster
 
* Acting Consumer Representative
+ Did not attend

These summary minutes for the February 27, 2013 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on March 12, 2013.

I certify that I participated in the February 27, 2013 Meeting of the Vaccines and Related Biological Products Advisory Committee and that these minutes accurately reflect what transpired.

/// original signed ///
Donald Jehn, M.S.
Designated Federal Official
/// original signed ///
Robert Daum, M.D.
Chair

The Chair, Dr. Robert Daum, called the Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 8:30 a.m. EST on February 27, 2013.  Following administrative remarks and reading of the conflict of interest statement, the meeting topic began.

During the meeting topic, the Committee received presentations by FDA, CDC, DoD and manufacturers on seasonal influenza strains for subsequent selection. 

An Open Public Hearing was announced.  There was one public comment from Beverly Taylor, a spokesperson from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).  The Committee then proceeded with discussion and subsequent votes on influenza strain selection for trivalent and quadrivalent influenza vaccine for 2013-2014 influenza season.

Following is a summary of the discussion.  Additional information and specific details may be obtained for the transcript and the webcast of the meeting.  The transcript may be viewed on the World Wide Web at the 2013 Meeting Materials, Vaccines and Related Biological Products Advisory Committee page.

Open Session
After opening administrative remarks on February 27, 2013, the Committee was briefed on the strain selection for the influenza virus vaccine for the 2013-2014 influenza season.  The topic was introduced by FDA, followed by presentations on U.S. and world surveillance by CDC.  Vaccine effectiveness reports were provided by CDC and DoD, and FDA provided presentations on vaccine responses and availability of vaccine viruses and reagents. 

The Committee was asked to vote on options for strain composition for 2013-2014 trivalent influenza vaccines:

  • Influenza A (H1N1)
    • Retain current vaccine strain A/California/7/2009 (H1N1)-like virus
    • Replace current vaccine strain with an alternative candidate vaccine virus
  • Influenza A (H3N2)
    • Replace current vaccine strain A/Victoria/361/2011 (H3N2) - like virus with an A(H3N2) virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011
    • Retain the current vaccine strain
    • Replace current vaccine strain with an alternative candidate vaccine virus
  • Influenza B
    • Replace current vaccine strain with a B/Massachusetts/2/2012-like virus (B/Yamagata lineage)
    • Retain current B/Wisconsin/1/2010 - like virus (B/Yamagata lineage)
    • Replace current vaccine strain with an alternative candidate vaccine virus from the B/Victoria lineage

The Committee voted unanimously (17 votes) to retain current strain A/California/7/2009 (H1N1)-like virus.

The Committee voted 16 Yes, 1 Abstention, 0 No to replace current vaccine strain A/Victoria/361/2011 (H3N2) - like virus with an A(H3N2) virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011

The Committee voted unanimously (17 votes) to replace the current vaccine strain with a B/Massachusetts/2/2012-like virus (B/Yamagata lineage). 

The Committee was asked to vote on options for strain selection for the 2nd influenza B strain for a quadrivalent influenza vaccine.

  • Influenza B
    • Include recent vaccine strain B/Brisbane/60/2008-like virus (B/Victoria lineage)
    • Include an alternate candidate vaccine virus of the B/Victoria lineage

The Committee voted 16 Yes, 1 Abstention, 0 No to include recent vaccine strain B/Brisbane/60/2008 – like virus (B/Victoria lineage).

The meeting was adjourned at 2:15 p.m.