February 25, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Agenda

AGENDA

Food and Drug Administration
Center for Biologics Evaluation and Research
Vaccines and Related Biological Products Advisory Committee
125th Meeting

February 25, 2011

DoubleTree Hotel Bethesda and Executive Meeting Center
8120 Wisconsin Ave., Bethesda, MD 20814

Topic:  Strain Selection for the Influenza Virus Vaccine for the 2011-2012 Season

8:30 a.m.	Call to Order	Jose Romero, M.D.,Chair
8:35	Administrative Remarks	Don Jehn, M.S., FDA
8:45	Introduction	Jerry Weir, Ph.D., FDA
8:55	U.S. Surveillance	Lisa Grohskopf, M.D., CDC
9:15	World Surveillance/Virus Characterization	Nancy Cox, Ph.D., CDC
10:00	DoD Vaccine Effectiveness Report	Kevin Russell, M.D., DOD
10:20	Break
10:35	Vaccine Responses	Zhiping Ye, M.D., Ph.D., FDA
10:55	Availability of Vaccine Viruses & Reagents	William McCormick, Ph.D., FDA
11:10	Comments from Manufacturers	Samson Lee, Ph.D., Sanofi Pasteur
11:30	Update on H5N1 and H9N2 Surveillance and Virus Characterization	Nancy Cox, Ph.D., CDC
11:50	Open Public Hearing
12:50 p.m.	Committee Discussion and Recommendations
1:50	Update on Febrile Seizure Signal after Influenza Vaccine	David Martin, M.D., FDA
2:05	Meeting Adjournment