Vaccines and Related Biological Products Advisory Committee
May 16-17, 2007
Date and Time:
The meeting will be held on May 16, 2007 from 8:30 a.m. to 4:45 p.m. and on May 17, 2007 from 9:00 a.m. to 3:30 p.m.
Location:
Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry Parkway, Gaithersburg, MD 20877, 301-977-8900.
Contact Persons:
Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting.
Agenda:
On May 16, 2007, in the morning session, the committee will hear presentations and make recommendations on the safety and effectiveness of influenza virus vaccine live (FluMist) in a pediatric population less than 59 months of age, manufactured by MedImmune Vaccines, Inc. In the afternoon, the committee will hear an update on the influenza strain selection for the 2007 to 2008 influenza season. The committee will also hear an overview of the function of the Laboratory of Bacterial Polysaccharides and the Laboratory of Enteric & Sexually Transmitted Diseases, Division of Bacterial Parasitic and Allergenic Products, Office of Vaccines Research and Review, CBER and in closed session will discuss the report of the November 29, 2006 Laboratory Site Visit . On May 17, 2007, the committee will hear presentations and make recommendations on the safety and immunogenicity of a live vaccinia virus smallpox vaccine (ACAM2000) manufactured by Acambis, Inc.
Oral Presentations:
Oral presentations from the public will be scheduled between approximately 11:25 a.m. to 11:55 a.m. and 3:35 p.m. to 4:05 p.m. on May 16, 2007 and between approximately 12:45 p.m. to 1:15 p.m. on May 17, 2007. Those desiring to make formal oral presentations should have notified the contact person on or before April 24, 2007.
Closed Committee Deliberations:
On May 16, 2007 from 4:05 p.m. to 4:45 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss the review of internal research programs in the Office of Bacterial Parasitic and Allergenic Products, Office of Vaccines Research and Review, CBER.