February 22, 2010: Meeting of the Vaccines and Related Biological Products Advisory Committee Summary Minutes

February 22, 2010
Bethesda Mariott, Pooks Hill
Bethesda, MD

Committee Members
Dr. Jack Stapleton, Chair
Dr. Vicky Debold *
Dr. Frank DeStefano
Dr. Peter Gilbert
Dr. Margaret Rennels **
Dr. Jose Romero
Dr. Pablo Sanchez

FDA Participants
Dr. Norman Baylor
Dr. Jerry Weir
Dr. Zhiping Ye
Dr. Rajesh Gupta

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. Anthony Fiore
Dr. Kevin Russell
Tony Colegate
Dr. Robin Robinson

Temporary Non-Voting Member
Dr. Nancy Cox

Acting Designated Federal Official
Dr. William Freas

Committee Management Specialist
Denise Royster

* Consumer Representative
** Industry Representative

These summary minutes for the February 22, 2010 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on March 22, 2011.

I certify that I or either reviewed the meeting transcripts or participated in the February 22, 2010 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 /// Jack Stapleton, M.D. Chair

The Chair, Dr. Jack Stapleton, called the Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 8:30 a.m. EST on February 22, 2010. After administrative remarks, presentations were provided by CBER, CDC, HHS, DoD and Industry. The Committee then discussed and made recommendations on the selection of strains to be included in the influenza virus vaccine for the 2010-2011 influenza season.

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 Web Site. Proceedings were adjourned at approximately 12:35 pm on February 22, 2010.

Open Session

On February 22, 2010, the committee discussed and made recommendations on the selection of strains to be included in the influenza virus vaccine for the 2010-2011 influenza season. The following discussion point was presented to the Committee:

1) Which influenza strains should be recommended for the antigenic composition of the 2010-2011 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 2010-2011 influenza vaccines. The Committee was asked to vote on (1) whether to retain current vaccine strain A/Brisbane/59/2007 (H1N1)-like virus or to replace the current vaccine strain with a pandemic A (H1N1) vaccine virus A/California/7/2009 – like virus. The Committee voted a unanimously (12 votes) not to retain the current strain, but to replace the current vaccine strain with the pandemic A (H1N1) vaccine virus; (2) whether to retain current vaccine strain A/Brisbane/10/2007 (H3N2) – like virus or to replace current vaccine stain with the Southern Hemisphere vaccine virus A/Perth/16/2009 (H3N2) – like virus. Several members of the Committee discussed the antigenic used in the prediction of the most suitable virus stain selection. The Committee voted unanimously (12 votes) not to retain the current strain, but to replace the current strain with the Southern Hemisphere vaccine virus; (3) whether to retain current B/Brisbane/60/2008-like (B/Victoria lineage) or to replace current vaccine strain with alternative vaccine strain (B/Yamagata lineage). Prior to the vote, the Committee discussed that besides antigenic mapping, HI data and pre and post infection human serology results need to be considered in the strain selection. It was also stressed that a timely decision in order to start production is more important than trying to evaluate other B stains. The Committee voted unanimously (12 votes) to retain the current B/Brisbane/60/2008 – like virus (B/Victoria lineage).