FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
AGENDA 
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
February 18 & 19, 2004
Sheraton Four-Points Hotel, 8400 Wisconsin Ave., Bethesda, Maryland

Wednesday, February 18, 2004

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			Dr. Greg Slusaw, Aventis Pasteur

 5:00 	Update on H5  						Dr. Nancy Cox, CDC
									Dr. Phil Minor, NIBSC
									Dr. Linda Lambert, NIAID
 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		Use of Mammalian Tissue Culture for Reference Strain Isolation
		 
			FDA Perspective 				Dr. Zhiping Ye, FDA
NIBSC Perspective 				Dr. Phil Minor, NIBSC

 1:00  p.m.	Adjourn