Advisory Committees
2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
Material is organized by meeting date, with more recent meeting first.
December 15, 2009
On November 18, 2009, the committee will discuss and make recommendations on the safety and effectiveness of a Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), BLA125324, and will hear an update on FDA’s Influenza A (H1N1) 2009 monovalent vaccine activities; Post-marketing surveillance. On November 19, 2009, the committee will discuss and make recommendations on the safety and effectiveness of an Influenza Vaccine, Purified Recombinant Influenza Hemagglutinin, BLA STN125285.
November 18-19 2009
On November 18, 2009, the committee will discuss and make recommendations on the safety and effectiveness of a Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), BLA125324, and will hear an update on FDA’s Influenza A (H1N1) 2009 monovalent vaccine activities; Post-marketing surveillance. On November 19, 2009, the committee will discuss and make recommendations on the safety and effectiveness of an Influenza Vaccine, Purified Recombinant Influenza Hemagglutinin, BLA STN125285.
September 9, 2009
On September 9, 2009, in the morning, the committee will discuss and make recommendations on the safety and effectiveness in females of a vaccine against Human Papillomavirus manufactured by GlaxoSmithKline. In the afternoon the committee will discuss and make recommendations on the safety and effectiveness of vaccinating males with Gardasil, a vaccine against Human Papillomavirus manufactured by Merck
July 23, 2009
On July 23, 2009, the Committee will discuss clinical trials to support use of vaccines against the 2009 H1N1 influenza virus.
February 18-19, 2009
On February 18, 2009, in the morning, the committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2009 - 2010 influenza season , and in the afternoon will discuss the utility of adding a second B strain to current seasonal influenza vaccines. On February 19, 2009, the committee will discuss the conducting of clinical studies of pandemic influenza vaccine in the pediatric population in the absence of an influenza pandemic.
- Announcement
- Briefing Document (PDF - 72KB)
- Briefing Information (PDF - 9KB)
- Draft Agenda (PDF - 11KB)
- Draft Agenda Day 1 (PDF - 10KB)
- Draft Agenda Day 2 (PDF - 16KB)
- Eratta (PDF - 7KB)
- Minutes (PDF - 30KB)
- Presentations
- The Rationale for Initiating Pediatric Clinical Development of GlaxoSmithKline Biologicals’ Candidate H5N1 Vaccine Produced in Quebec. (PDF - 685KB)
- Temporary Voting and Non-Voting Members (PDF - 10KB)
- Temporary Voting and Non-Voting Members (PDF - 10KB)
- Transcripts
