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February 25, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Summary Minutes

SUMMARY MINUTES
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

February 25, 2011
DoubleTree Hotel Bethesda and Executive Meeting Center
Bethesda, MD

Committee Members
Dr. Jose Romero, Chair +
Dr. Vicky Debold *
Dr. Frank DeStefano
Dr. Ambrose Cheung
Dr. Anna Durbin
Dr. Peter Gilbert
Dr. Gregory Gray
Dr. Margaret Rennels **
Dr. Gary Schoolnik
Dr. Carol Tacket

FDA Participants
Dr. Norman Baylor
Dr. Jerry Weir
Dr. Zhiping Ye
Dr. William McCormick
Dr. David Martin

Temporary Voting Members
Dr. Gillian Air
Dr. Theodore Eickhoff
Dr. Bruce Gellin
Dr. Wayne Hachey
Dr. Roland Levandowski
Dr. Pamela McInnes
Dr. Melinda Wharton

Speakers
Dr. Nancy Cox
Dr. Kevin Russell
Dr. Lisa Grohskopf
Dr. Samson Lee

Temporary Non-Voting Member
Dr. Nancy Cox

Designated Federal Official
Donald Jehn, M.S.

Committee Management Specialist
Denise Royster

* Consumer Representative
** Industry Representative

These summary minutes for the February 25, 2011 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on March 4, 2011.

I certify that I participated in the February 25, 2011 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

/// orginal signed ///
Jose Romero, M.D.
Chair

The Chair, Dr. Jose Romero, called the Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 8:30 a.m. EST on February 25, 2011. After administrative remarks, presentations were provided by CBER, CDC, DoD and Industry. An update on H3N2, H1N1, B influenza virus as well as swine and avian origin influenza virus Surveillance and Virus Characterization was provided by the CDC. The Committee then discussed and made recommendations on the selection of strains to be included in the influenza virus vaccine for the 2011-2012 influenza season. An additional update on Febrile Seizure Signal after the 2010-2011 Influenza Vaccine was provided by FDA prior to closure of the meeting.

An Open Public Hearing was announced. There was one public comment 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 FDA website. Proceedings were adjourned at approximately 1:15 pm on February 25, 2011.

Open Session

On February 25, 2011, the committee discussed and made recommendations on the selection of strains to be included in the influenza virus vaccine for the 2011-2012 influenza season. The following discussion point was presented to the Committee:

  1. Which influenza strains should be recommended for the antigenic composition of the 2011-2012 influenza virus vaccine in the U.S.? Data to be considered included the epidemiology of circulating influenza virus, the antigenic characteristics of influenza virus strains currently circulating in human populations, the serologic responses to circulating influenza viruses of persons immunized with current influenza virus vaccines, and manufacturing considerations including the availability of suitable vaccine candidate strains.

Based on WHO recommendations, the Committee was given three options for strain composition for 2011-2012 influenza vaccines. The Committee was asked to vote on (1) whether to retain current vaccine strain A/California/7/2009 (H1N1)-like virus or to replace the current vaccine strain with an alternative vaccine virus. The Committee voted 15 Yes to retain with 1 abstention; (2) whether to retain current vaccine strain A/Perth/16/2009 (H3N2)-like virus or to replace current vaccine stain with an alternative vaccine virus. The Committee voted a unanimous 16 Yes; (3) whether to retain current B/Brisbane/60/2008-like (B/Victoria lineage) or to replace current vaccine strain with alternative vaccine strain. Prior to a vote on (3), the Committee discussed issues related to B strain/Yamagata lineage to be part of a quadrivalent vaccine or given as a separate vaccine to children in addition to the seasonal flu trivalent vaccine. Industry indicated that clinical trials are underway for a quadrivalent vaccine, however, licensure of these vaccines in time for the 2011-2012 influenza season is not anticipated. The Committee voted on (3) with a unanimous Yes.