Food and Drug Administration
Center for Biologics Evaluation and Review
DRAFT SUMMARY MINUTES
135th VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
FDA White Oak Campus, Bldg. 31, Great Room
Silver Spring, Maryland
|February 28, 2014|
Dr. Robert Daum, M.D. Chair
Dr. Janet Englund, M.D.
Dr. Karen Kotloff, M.D.
Dr. Sarah Long, M.D.
Dr. Patrick Moore, M.D. M.PH.
Dr. Mark Sawyer, M.D.
Dr. Gillian Air , Ph.D.
Dr. Edgar Marcuse, M.D. M.PH.
Dr. Stephanie Christner, D.O. *
Dr. Michael Hudgens, Ph. D.
Dr. Pedro Piedra, M.D. +
Dr. Marion Gruber, Ph.D.
Dr. Jerry Weir, Ph.D.
Dr. Zhiping Ye, M.D., Ph.D.
Dr. Manju Joshi, Ph.D.
Dr. Carolyn Wilson, Ph.D.
|Temporary Voting Members|
Dr. Bruce Gellin, M.D.
Dr. Pamela McInnes, D.D.S, M.Sc.
Dr. Melinda Wharton, M.D. M.PH. (by phone)
Dr. Jack Bennink, Ph.D.
Dr. Roland Levandowski, M.D.
Dr. Scott Stanek, D.O., M. PH.
Dr. Michael Cooper, Ph.D. (DoD)
Dr. Nancy Cox, Ph.D. (CDC)
Dr. Lisa Grohskopf, M.D. (CDC)
Dr. Sam Lee, Ph.D. (Sanofi Pasteur)
|Temporary Non-Voting Member|
Dr. Nancy Cox, Ph.D.
Dr. Theodore Tsai, M.D.
|Designated Federal Official|
Prabhakara Atreya, Ph.D.
|Committee Management Specialist|
|* Consumer Representative|
+ Did not attend
These summary minutes for the February 28, 2014 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on March 31, 2014
I certify that I participated in the February 28, 2014 Meeting of the Vaccines and Related Biological Products Advisory Committee and that these minutes accurately reflect what transpired.
|Prabhakara Atreya, Ph.D. |
Designated Federal Official
|Robert Daum, M.D.|
The 135th Meeting of the Vaccines and Related Biological Products Advisory Committee was called to order at 8:00 a.m. EST on February 28, 2014 by the Chair, Dr. Robert Daum. The Designated Federal Officer read a statement into the public record that it was determined that the Committee discussion on Topic I presented no potential for a conflict of interest.
Topic I Open Session:
The Committee Members and FDA participants were introduced after which the meeting Topic I began, which addressed the August 28, 2013 site visit of the intramural research programs of the Laboratory of the Respiratory Viral Diseases (LRVD), Division of Viral Products (DVP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER).
In the Open Session, the committee heard presentations of on the following:
- Overview of the Regulatory Science Research and Site Visit Process at CBER and OVRR’s research programs
- Overview of the Research in the Division of Viral Products and
- Overview and summary of individual research programs in the Laboratory of Respiratory Viral Diseases
Time was allotted during the meeting for public comment. No individuals from the public requested time at the meeting to address the Committee. The public was welcome to attend the open session of the Topic I meeting.
Topic I Closed Session:
Dr. Daum, who also served as the Chair for the site visit conducted on August 28, 2013, presented the Site Visit report to the committee. Following a detailed discussion of the site visit report, the Committee voted unanimously (10 Yes, 0 Abstain, 0 No) to accept this report as submitted by the site visit team without further modifications.
TOPIC II Open Session
Topic II began after the conflict of interest statement was read by the DFO into the public record. The Committee was then briefed on the strain selection options for the influenza virus vaccine for the 2014-2015 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. Finally industry perspective comments on Flu Vaccine manufacturing were presented.
An Open Public Hearing was announced. There was one public comment from Ms. Barabra Loe Fisher, a spokesperson from the National Vaccine Information Center (NVIC). The Committee then proceeded with discussion and subsequent votes on influenza strain selection for trivalent and quadrivalent influenza vaccines for 2014-2015 influenza season.
Following is a summary of the discussion and recommendations. 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 2014 Vaccines and Related Biological Products Advisory Committee meetings main page.
The Committee (10 regular members plus 6 temporary voting members, total 16) was asked to vote on the strain composition for 2014-2015 trivalent influenza vaccines:
- Influenza A (H1N1)
- Recommend an A/California/7/2009 (H1N1)-like virus (current vaccine strain)
- Influenza A (H3N2)
- Recommend an A/Texas/50/2012 (H3N2)-like Virus (Current Vaccine Strain)
- Influenza B
- Recommend a B/Massachusetts/2/2012-like virus (B/Yamagata lineage) (current vaccine strain)
The Committee voted unanimously (16 Yes, 0 Abstention, 0 No) to retain the current strain A/California/7/2009 (H1N1)-like virus.
The Committee voted unanimously (16 Yes, 0 Abstention, 0 No) to retain the current strain A/Texas/50/2012 (H3N2)-like Virus.
The Committee voted unanimously (16 Yes, 0 Abstention, 0 No) to retain the current strain B/Massachusetts/2/2012-like virus (B/Yamagata lineage).
The Committee was also asked to vote on the strain selection for the 2nd influenza B strain for a quadrivalent influenza vaccine.
- Influenza B
- Recommend inclusion of a B/Brisbane/60/2008-like virus (B/Victoria lineage) (recent vaccine strain and current quadrivalent vaccine recommended strain)
The Committee unanimously voted (16 Yes, 0 Abstention, 0 No) to include recent vaccine strain B/Brisbane/60/2008 – like virus (B/Victoria lineage).
The meeting was adjourned at 3:20 p.m.