FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND
RESEARCH
VACCINES AND RELATED BIOLOGICAL
PRODUCTS ADVISORY COMMITTEE
Holiday Inn, 8120 Wisconsin Ave.,
Bethesda, Maryland
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. Nancy Cox, CDC
9:15 World
Surveillance and Strain Characterization Dr. Nancy Cox, CDC
9:35 Molecular
Characterization of Strains Dr. Nancy Cox, 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