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February 27, 2013: Vaccines and Related Biological Products Advisory Committee Final Agenda

FOOD AND DRUG ADMINISTRATION
Center for Biologics Evaluation and Research
132nd Meeting of the Vaccines and Related Biological Products Advisory Committee
NIH Fishers Lane Conference Center
Terrace Level, Rooms 508-510, 5635 Fishers Lane
Rockville, Maryland
February 27, 2013

AGENDA

Open Session
8:30 a.m.

Call to Order and Opening Remarks
Conflict of Interest Statement

Robert Daum, M.D., Chair
Donald Jehn, M.S., FDA

Topic 1:
Strain Selection for the Influenza Virus Vaccine for the 2013-2014 Influenza Season
8:45 Introduction Jerry Weir, Ph.D.
Director
Division of Viral Products
OVRR/CBER/FDA
8:55 U.S. Surveillance: Influenza Activity Update:
2012-13 Season
Lyn Finelli, DrPH, MS
Lead, Influenza Surveillance and
Outbreak Response Team
Influenza Division, NCIRD
CDC
9:15 World Surveillance/Virus Characterization Nancy Cox, Ph.D.
Director, Influenza Division
Director, WHO Collaborating Center
For Surveillance, Epidemiology &
Control of Influenza,
National Center for Immunization &
Respiratory Diseases, CDC
10:00 Break  
10:15 DoD Vaccine Effectiveness Report CDR Michael J. Cooper
USPHS MEDCOM
Armed Forces Health Surveillance
Center
10:35 Vaccine Responses Zhiping Ye, M.D., Ph.D.
Senior Investigator
Division of Viral Products
OVRR/CBER/FDA
10:55 Availability of Vaccine Viruses & ReagentsĀ 

Manju Joshi, Ph.D.
Lead Biologist
Division of Biological Standards &
Quality Control, OCBQ/CBER/FDA

11:15 Comments from Manufacturers Kathleen Coelingh, Ph.D.
Senior Director,
Medical and Scientific Affairs
MedImmune
11:35 Lunch  
12:35 pm Open Public Hearing  
1:35 Committee Discussion and Recommendations  
2:45 Adjournment