Advisory Committees
2010 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
Material is organized by meeting date, with more recent meeting first.
November 16-17, 2010: Vaccines and Related Biological Products Advisory Committee Meeting
On November 16, 2010, the committee will meet in open session to review and discuss the pathway to licensure for protective antigen-based anthrax vaccines for a post-exposure prophylaxis indication using the animal rule. On November 17, 2010, the committee will meet in open session to review and discuss the effectiveness of vaccinating males and females with Gardasil manufactured by Merck
- Announcement
- Briefing Document: Anal cancer indication for Gardasil (PDF - 295KB)
- Briefing Document: Supplemental Biologics Licensing Application for Use in Anal Cancer Prevention (PDF - 2.2MB)
- Briefing Document: Pathway to Licensure for Protective Antigen-based Anthrax Vaccines for a Post-exposure Prophylaxis Indication Using the Animal Rule (PDF - 655KB)
- Draft Agenda
- Presentations
- Roster (PDF - 37KB)
- Summary Minutes
- Transcripts
- Waivers for Conflicts of Interest
Septmber 21, 2010: Vaccines and Related Biological Products Advisory Committee Meeting
On September 21, 2010, the committee will meet in open session to hear updates on the research programs of the Laboratory of Respiratory
May 7, 2010: Vaccines and Related Biological Products Advisory Committee Meeting
On May 7, 2010, in the morning, the committee will review and discuss available data regarding the unexpected finding of DNA originating from porcine circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline and indicated for the prevention of rotavirus gastroenteritis in infants.
- Announcement
- Background Material
Porcine Circovirus and Rotavirus Vaccines - Briefing Document: Background information regarding the discovery of porcine circovirus 1 (PCV1) DNA sequences in GlaxoSmithKline’s (GSK) rotavirus vaccine (Rotarix®) and the development and use of advanced analytical methods in the characterization of cell substrates
- Briefing Document Member Roster (PDF - 22KB)
- Briefing Document Consultant and Participant Roster (PDF - 18KB)
- Draft Agenda (PDF - 17KB)
- Final Agenda
- Temporary Voting Members and Non Voting Temporary Voting Member
- Transcript (PDF - 353KB)
- Presentations
- Summary Minutes
- Waivers for Conflicts of Interest
- Webcast
February 22, 2010: Vaccines and Related Biological Products Advisory Committee Meeting
On February 22, 2010, the committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2010-2011 influenza season.
- Announcement
- Draft Agenda (PDF - 15KB)
- Influenza Vaccine Responses (PDF - 268KB)
Persons with disabilities having problems accessing this PDF file may call 301-827-0314 for assistance. - Member Roster (PDF - 32KB)
- Presentation Agenda
- Presentations
- Questions Document
- Summary Minutes
- Transcripts (PDF - 193KB)
- Waivers for Conflicts of Interest
