Food and Drug Administration

Center for Biologics Evaluation and Research

Vaccines and Related Biological Products Advisory Committee Meeting

February 18 - 19, 2009

Hilton Washington DC/Silver Spring

8727 Colesville Road, Silver Spring, MD

AGENDA

 

Day 1 – February 18, 2009

 

Open Session

 

8:30 a.m.         Call to Order and Opening Remarks              John Modlin, M.D., Chair

8:35                 Administrative Matters                                   Christine Walsh, R.N., FDA

8:40                 Presentation of Retirement Plaque                 Norman Baylor, Ph.D., FDA

 

Topic 1: Strain Selection for the Influenza Virus Vaccine for the 2009 – 2010 Influenza Season

 

8:45 a.m.         Introduction                                                    Jerry Weir, Ph.D., FDA

 

9:00                 U.S. Influenza Activity and Surveillance       Joseph Bresee, M.D., CDC

                                                                                               

9:15                 World Surveillance/Strain Characterization    Alexander Klimov, Ph.D., Sc.D, CDC

                                                                                                .

10:15               DOD Vaccine Effectiveness Report              Major Thomas F. Gibbons/

                                                                                                Lieutenant Colonel Victor H. MacIntosh,     

10:45               Break

 

11:00               Vaccine Responses                                         Zhiping Ye, M.D., Ph.D., FDA

 

11:20               Availability of Strains and Reagents              Rajesh Gupta, Ph.D., FDA

 

11:35               Comments from Manufacturers                      Raymond Fitch, Sanofi Pasteur

 

12:00 p.m.       Lunch

 

1:15                 Open Public Hearing

 

1:45                 Strain Selection Options/                                Jerry Weir, Ph.D., FDA

Committee Discussion & Recommendations

 

3:00                 Break

 

 

 

Food and Drug Administration

Center for Biologics Evaluation and Research

Vaccines and Related Biological Products Advisory Committee Meeting

 

Agenda con’t

 

 

Topic 2: Discuss Utility of Adding a Second Influenza Type B Strain to Current Seasonal Influenza Vaccines

 

3:15 p.m.         VRBPAC 2008 Summary of Issues/              Rakesh Pandey, Ph.D., FDA                           

Vaccine Development Issues                                          

                                                                                               

3:35                 Update on Influenza Type B Surveillance      Anthony Fiore, M.D., M.P.H., CDC/

                                                                                                Carrie Reed, DSc, M.P.H., CDC

 

4:15                 Committee Discussion

 

5:30 p.m.         Adjourn for the Day