FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

 

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

 

February 20, 2003

Holiday Inn, 8120 Wisconsin Ave., Bethesda, Maryland

 

 

Thursday, February 20, 2003

 

8:30 AM Call to Order Dr. David Stephens, Chair

 

8:35 Administrative Matters Dr. Jody Sachs, FDA

 

8:40 Session 1 OPEN Session

Strain Selection for Influenza Virus Vaccine for the 2003-2004 Season

 

8:40 Introduction Dr. Roland Levandowski, FDA 8:55 U.S. Surveillance Dr. Keiji Fukuda, CDC

9:15 World Surveillance and Strain Characterization Dr. Nancy Cox, CDC

9:35 Molecular Characterization of Strains Dr. Alexander Klimov, CDC

 

10:00 Break

 

10:20 Additional Surveillance Reports Linda Canas, DOD

10:35 Vaccine Responses Dr. Roland Levandowski, FDA

10:55 Availability of Strains and Reagents Dr. Zhiping Ye, FDA

11:10 Comments from Manufacturers Dr. Sam Lee, Aventis

11:30 Options for Strain Selection Dr. Roland Levandowski, FDA

 

12:00 PM Lunch

 

1:00 Open Public Hearing

1:30 Committee Discussion and Recommendations

 

2:30 Session 2 OPEN Session

Laboratory of Bacterial Polysaccharides

2:30 Overview of Division of Bacterial, Parasitic, & Allergenic Products

Dr. Richard Walker, FDA

2:40 Overview of Laboratory of Bacterial Polysaccharides Dr. Carl Frasch, FDA

2:50 Open Public Hearing

 

3:20 Session 2 CLOSED Session

 

4:30 Adjournment