FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

January 30 , 2002

Holiday Inn, 8120 Wisconsin Ave., Bethesda, Maryland

Draft AGENDA as of 1/22/02

Wednesday, January 30

9:00 AM Call to Order, Introductions, Administrative Matters Dr. Robert Daum

9:15 Presentation of Plaques to Retiring VRBPAC Members Dr. Kathryn Zoon, FDA

9:30 Open Public Hearing

9:45 Session 1 OPEN Session

Strain Selection for Influenza Virus Vaccine for the 2002-2003 Season

9:45 Introduction Dr. Roland Levandowski, FDA

10:00 U.S. Surveillance Dr. Keiji Fukuda, CDC

10:20 World Surveillance and Strain Characterization Dr. Nancy Cox, CDC

10:40 Molecular Characterization of Strains Dr. Alexander Klimov, CDC

11:00 Break

11:30 Additional Surveillance Reports Ms. Linda Canas, DOD

11:45 Vaccine Responses Dr. Roland Levandowski, FDA

12:05 Availability of Strains and Reagents Dr. Zhiping Ye, FDA

12:15 Lunch

1:15 Comments from Manufacturers Dr. Slusaw, PhRMA

2:00 Options for Strain Selection Dr. Roland Levandowski, FDA

2:15 Committee Discussion and Recommendations

3:30 Open Public Hearing

4:15 Adjournment