February 22, 2010: Meeting of the Vaccines and Related Biological Products Advisory Committee Presentation Agenda

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

February 22, 2010

Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda MD AGENDA

Open Session
8:30 a.m.	Call to Order and Opening Remarks	Jack Stapleton, M.D., Chair
8:35	Administrative Matters	Christine Walsh, R.N., FDA

Topic 1: Strain Selection for the Influenza Virus Vaccine for the 2010 - 2011 Season
8:45 a.m.	Introduction	Jerr Weir, Ph.D., FDA
9:00	DHHS Response to the 2009 HINI Influenza	Robin Robinson, Ph.D., BARDA Pandemic
9: 15	U.S. Surveilance	Anthony Fiore, M.D., M.P.H., CDC
9:30	World Surveillance/Strain Characterization	Nancy Cox, Ph.D., CDC
10:15	Vaccine Effectiveness Report Kevin Russell, M.D., DOD .10:30 Vaccine Responses	Zhiping Ye, M.D., Ph.D., FDA
10:50	Availability of Strains and Reagents	Rajesh Gupta, Ph.D., FDA
11:00	Break
11:15	Comments from Manufacturers	Tony Colegate, Novartis
11:35	Open Public Hearing
12:35 p.m.	Strain Selection Options/ Committee Discussion and Recommendations	Jerry Weir, Ph.D., FDA
1:45	Adjourn Meeting