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 1/22/02Wednesday, 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, FDA9:30 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, CDC10:20 World Surveillance and Strain Characterization
Dr. Nancy Cox, CDC10:40 Molecular Characterization of Strains Dr. Alexander Klimov, CDC
11:00
Break11:30 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, FDA12:15
Lunch1:15 Comments from Manufacturers Dr. Slusaw, PhRMA
2:00 Options for Strain Selection
Dr. Roland Levandowski, FDA2:15 Committee Discussion and Recommendations
3:30 Open Public Hearing
4:15 Adjournment