Vaccines and Related Biological Products Advisory Committee
February 27 & 28, 2007 Meeting
Date and Time:
The meeting will be held on February 27, 2007 from 8:00 a.m. to 5:30 p.m. and on February 28, 2007 from 8:00 a.m. to 4:15 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 February 27, 2007, in the morning session, the committee will hear presentations and make recommendations on the safety and effectiveness of an H5N1 inactivated influenza vaccine manufactured by Sanofi Pasteur. In the afternoon, the committee will hear presentations and have discussions on clinical development of influenza vaccines for pre-pandemic uses. On February 28, 2007, in the morning, the committee will hear presentations and make recommendations on strain selections for the influenza virus vaccine for the 2007 - 2008 season. In the afternoon, the committee will hear presentations and have discussions on circulating lineages of influenza type B virus.
Oral Presentations:
Oral presentations from the public will be scheduled between approximately 10:45 a.m. to 11:15 a.m. and 2:45 p.m. to 3:15 p.m. on February 27, 2007 and from approximately 10:40 a.m. to 11:10 a.m. and 2:50 p.m. to 3:20 p.m. on February 28, 2007. Those desiring to make formal oral presentations should notify the contact person on or before February 5, 2007.