Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

February 20 - 21, 2008

Hilton Hotel, Washington DC North/Gaithersburg

620 Perry Parkway, Gaithersburg, MD 20877

DRAFT AGENDA

 

 

Day 1 February 20, 2008

Open Session

 

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

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

 

Topic 1: Safety and Efficacy of Rotavirus Vaccine Manufactured by GSK Biologicals

 

8:50 a.m. FDA Brief Introduction Steven Rosenthal, M.D., FDA

Presentation of Questions

 

9:00 Sponsor Presentation GlaxoSmithKline Biologicals

 

10:30 Break

 

10:45 FDA Presentation Steven Rosenthal, M.D., FDA

11:45 Lunch

 

1:00 p.m. Open Public Hearing

 

1:30 FDA Presentation of Questions Steven Rosenthal, M.D., FDA

 

1:40 Committee Discussion of FDA Questions/

Committee Recommendations

 

4:00 p.m. Adjourn for the day

 

 

 

 

 

 

 

 

 

Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

February 20 - 21, 2008

Hilton Hotel, Washington DC North/Gaithersburg

620 Perry Parkway, Gaithersburg, MD 20877

DRAFT AGENDA

 

 

Day 2 February 21, 2008

 

Open Session

 

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

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

 

Topic 2: Strain Selection for the Influenza Virus Vaccine for the 2008 2009 Season

 

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

 

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

 

9:15 World Surveillance/Strain Characterization Nancy Cox, Ph.D., CDC

10:00 Vaccine Effectiveness Report Angela Owens/Thomas Gibbons,

Major, USAF, BSC, Ph.D.

.

10:15 Vaccine Responses Zhiping Ye, M.D., Ph.D., FDA

 

10:35 Availability of Strains and Reagents Rajesh Gupta, Ph.D., FDA

 

10:45 Break

11:00 Comments from Manufacturers Tony Colegate

11:20 Open Public Hearing

 

11:50 Strain Selection Options/ Jerry Weir, Ph.D., FDA

Committee Discussion and Recommendations

 

1:00 Lunch

 

Topic 3: Clinical Development of Influenza Vaccines for Pandemic and Pre-Pandemic Uses

 

2:00 p.m. Summary of FDA/NIH/WHO December 2007 Hana Golding Ph.D., FDA

Workshop: Immune Correlates of Protection Against

Influenza A Viruses in Support of Pandemic Vaccine

Development

 

2:10 Update on H5N1 Surveillance Nancy Cox Ph.D., CDC

 

2:30 Pandemic and Pre-pandemic Influenza Joseph Toerner, M.D., M.P.H., FDA

Vaccine Development Issues

 

2: 45 Open Public Hearing

 

3:15 Committee Discussion

 

4:30 p.m. Adjourn meeting