November 16-17, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Summary Minutes
Food and Drug Administration
Center for Biologics Evaluation and Review
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
November 16 – 17, 2010
Silver Spring Hilton, Silver Spring, MD
Dr. Jack Stapleton, Chair +
Dr. Jose Romero ##
Dr. Pablo Sanchez
Dr. Frank DeStefano
Dr. Vicky DeBold *
Dr. Margaret Rennels **
Dr. Peter Gilbert #
Dr. Ambrose Cheung
Dr. Anna Durbin
Dr. Gregory Gray #
Dr. Gary Schoolnik #
Dr. Carol Tacket
Dr. Norman Baylor
Dr. Wellington Sun
Dr. Jay Slater
Dr. Drusilla Burns
Dr. Lewis Schrager
Dr. Jeffrey Roberts
Temporary Voting Members
Dr. Patricia Ferrieri +
Dr. Bruce Gellin
Dr. Emil Gotschlich +
Dr. C. Rick Lyons +
Dr. Pamela McInnes
Dr. Larry Moulton
Dr. Melinda Wharton
Dr. Cathy Eng ++
Dr. Michael Greene ++
Dr. Lauri Markowitz ++
Dr. Theodore Tsai ** ++
Dr. Elizabeth Unger ++
Dr. Ed Nuzum
Dr. Conrad Quinn
Dr. Joel Palefsky
Dr. Patrick Brill-Edwards
Dr. Elizabeth Garner
Committee Management Specialist
* Consumer Representative
** Industry Representative
+ Attended November 16 only
# Did not attend
## Acting Chair November 17
++ Attended November 17 only
These summary minutes for the November 16-17, 2010 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on 12/9/2010.
I certify that I participated in the November 16-17, 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.
/// original signed ///
Jose Romero, M.D.
Acting Chair, Nov 17, 2010
The Chair, Dr. Jack Stapleton, called the Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 9:00 a.m. EST on November 16, 2010. The Committee discussed the pathway to licensure for Protective Antigen-based Anthrax Vaccine. Presentations were provided by CBER, NIAID and CDC. There was a closed session to allow firms to discuss confidential studies related to the topic.
An Open Public Hearing was announced. There was one written statement submitted to the Committee. No public comment was offered.
At 8:30 am on November 17, 2010 the meeting reconvened under the direction of the acting Chair, Dr. Jose Romero. Retirement plaques for Drs. Stapleton, Romero and Sanchez were presented by Dr. Norman Baylor, OVRR, FDA. The Committee discussed the effectiveness of vaccinating males and females with Gardasil by Merck & Co. for the prevention of anal dysplasia and anal cancer. Presentations were provided by CBER and Merck & Co.
An Open Public Hearing was announced. There were seven written statements submitted to the Committee and there were three oral presentations from the public.
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 World Wide Web at:
Proceedings were adjourned at approximately 12:15 pm on November 17, 2010.
On November 16, 2010, after opening administrative remarks, the committee discussed pathways to licensure for protective antigen-based anthrax vaccines for a post-exposure prophylaxis indication using the animal rule. The following discussion point was presented to the Committee:
- Please discuss whether CBER’s proposed strategy would adequately bridge animal protection data to humans to support a post-exposure prophylaxis indication for a Protective Antigen-based anthrax vaccine.
Post-exposure prophylaxis (PEP) indication: For the prevention of disease caused by residual B. anthracis spores in exposed individuals who received a full course of antibiotics. The proposed CBER strategy is the following:
- GUP (general use prophylaxis) studies: used to estimate protective antibody levels in animals and extrapolate animal protection to humans via an antibody bridge.
- PEP (post-exposure prophylaxis) studies: proof-of-concept that the vaccine can protect in a post-exposure setting in which an individual has been exposed (supportive only).
- Passive immunization studies: proof-of-concept that antibodies generated by PA-based vaccines provide protection against exposure (supportive only).
The Committee was asked to discuss and comment on this proposed strategy. There were no votes. The Committee felt as a whole that the proposed strategy was scientifically sound considering that it is not ethically possible to have human studies.
On November 17, 2010 the meeting was entirely open to the public. After opening remarks and presentation of service plaques for the retiring committee members, the Committee discussed the effectiveness of vaccinating males and females with Gardasil by Merck & Co. for the prevention of anal dysplasia and anal cancer. After an introduction of the topic by CBER, Dr. Joel Palefsky provided a detailed presentation of the pathophysiology and epidemiology of anal HPV (human papilloma virus) infection, AIN (anal intraepithelial neoplasia) and anal cancer. Dr. Palefsky noted the biological similarity between anal and cervical cancer and the similarity between males and females in HPV-related anal disease. Then Dr. Brill-Edwards from Merck & Co. discussed the current status of Gardasil and the proposed additional indication. Dr. Garner from Merck & Co. discussed the role of HPV in anal cancer in men and women, the burden of anal cancer in men and women, high-grade anal intraephithelial neoplasia (AIN 2/3) as the precursor of anal cancer, AIN study design and results, postlicensure surveillance and longer term studies. Dr. Garner concluded with the rationale for an anal cancer indication in males and females.
There were two discussion topics for the Committee to comment on:
- the strength of the data to support an indication for the prevention of AIN and anal cancer in males, and
- the scientific rationale for extrapolating efficacy in the prevention of AIN and anal cancer to females.
The Committee, as a whole, felt that the data did support an indication for the prevention of AIN and anal cancer in males and that the rationale for extrapolating efficacy to females was sufficient. Several members noted their concerns regarding safety of the product, but it was recognized that the population for whom Gardasil is indicated would not change should the additional indication for prevention of AIN and anal cancer be approved.
On November 16, 2010, there were closed sessions of this meeting on either side of the lunch break in order for the Committee to hear confidential studies of two different firms.