FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND
RESEARCH
DRAFT AGENDA (revised 2/9/04)
Sheraton Four-Points Hotel, 8400
Wisconsin Ave., Bethesda, Maryland
8:30 a.m. Call to Order Dr. Gary Overturf, Chair
8:35 Administrative Matters Dr. Bill Freas
8:40 Presentation of Plaques to Retiring Members Dr. Karen Midthun
8:50 OPEN
Session
Strain
Selection for Influenza Virus Vaccine for the 2004-2005 Season
8:50 Introduction Dr.
Roland Levandowski, FDA
9:50 Vaccine Effectiveness Dr. Carolyn Bridges, CDC
Col. James Neville, DOD
Dr. Antoine Flahault, INSERM, Paris
11:20 Break
11:30 U.S.
Surveillance Ann Moen, CDC
12:00
p.m. Lunch
1:00 Open
Public Hearing
1:30 World
Surveillance and Strain Characterization Dr.
Nancy Cox, CDC
Strain
Characterization
2:00 Additional
Reports Linda Canas, DOD
Dr. Maria Zambon, HPA, UK
3:00
Break
3:30 Vaccine Responses Dr.
Roland Levandowski, FDA
4:00 Availability of Strains and Reagents
Dr. Zhiping Ye, FDA
4:15 Comments from Manufacturers
5:00 Update on H5 Dr.
Nancy Cox, CDC
Dr. Phil Minor,
NIBSC
NIH Speaker (TBA)
7:00 p.m. Adjourn
AGENDA (Continued)
VACCINES AND RELATED BIOLOGICAL
PRODUCTS ADVISORY COMMITTEE
Second Day
Thursday,
February 19, 2004
8:30
a.m. Call to Order
8:35 Announcements
OPEN Session
Strain
Selection for Influenza Virus Vaccine for the 2004-2005 Season
8:45 Open Public Hearing
9:15 Options
for Strain Selection Dr. Roland Levandowski, FDA
9:35 Committee Discussion and
Recommendations
10:45 Break
11:00
Mammalian Tissue Culture Used in Vaccine Preparation
FDA Perspective Dr. Zhiping Ye, FDA
NIBSC Perspective Dr.
Phil Minor, NIBSC
1:00 p.m. Adjourn