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
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 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.