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U.S. Department of Health and Human Services

Advisory Committees

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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 RemarksJack Stapleton, M.D., Chair

8:35

Administrative MattersChristine Walsh, R.N., FDA
Topic 1: Strain Selection for the Influenza Virus Vaccine for the 2010 - 2011 Season

8:45 a.m.

IntroductionJerr Weir, Ph.D., FDA

9:00

DHHS Response to the 2009 HINI InfluenzaRobin Robinson, Ph.D., BARDA Pandemic

9: 15

U.S. SurveilanceAnthony Fiore, M.D., M.P.H., CDC

9:30

World Surveillance/Strain CharacterizationNancy Cox, Ph.D., CDC

10:15

Vaccine Effectiveness Report Kevin Russell, M.D., DOD .10:30 Vaccine ResponsesZhiping Ye, M.D., Ph.D., FDA

10:50

Availability of Strains and ReagentsRajesh Gupta, Ph.D., FDA

11:00

Break 

11:15

Comments from ManufacturersTony Colegate, Novartis

11:35

Open Public Hearing 

12:35 p.m.

Strain Selection Options/ Committee Discussion and RecommendationsJerry Weir, Ph.D., FDA
1:45Adjourn Meeting