Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

Wednesday, December 14 - 15, 2005

Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD 20814

AGENDA

Day 1

Open Session

9:00 a.m. Call to Order and Opening Remarks Gary D. Overturf, M.D., Chair

9:05 Presentation of Appreciation Plaques to Norman W. Baylor, Ph.D., FDA

Retiring Members

9:10 Administrative Matters Christine Walsh, R.N., FDA

Safety and Efficacy of Rotavirus Vaccine Manufactured by Merck

9:20 a.m. FDA Brief Introduction Rosemary Tiernan, M.D., M.P.H., FDA

Presentation of Questions

9:30 Sponsor Presentation Mark Bagarazzi, M.D./

Penny Heaton, M.D., M.P.H.

Merck Research Laboratories

10:30 Break

10:45 FDA Presentation Rosemary Tiernan, M.D., M.P.H., FDA

Hector Izurieta, M.D., M.P.H., FDA

11:45 Lunch

1:15 p.m. Open Public Hearing

1:45 FDA Presentation of Questions Rosemary Tiernan, M.D., M.P.H., FDA

2:00 Committee Discussion of FDA Questions

Committee Recommendations

4:30 p.m. Adjourn for the day

Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

Wednesday, December 14 - 15, 2005

Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD 20814

AGENDA

Day 2

Open Session

9:00 a.m. Call to Order and Opening Remarks Gary D. Overturf, M.D., Chair

9:05 Administrative Matters Christine Walsh, R.N., FDA

Safety and Efficacy of ZOSTAVAX (Zoster Vaccine Live [Oka/Merck] ) Manufactured by Merck

9:20 a.m. FDA Brief Introduction Patricia Rohan, M.D., FDA

Presentation of Questions

9:30 Sponsor Presentation David Gutsch, M.D./

Jeffrey Silber, M.D.

Merck Research Laboratories

10:45 Break

11:00 FDA Presentation Patricia Rohan, M.D., FDA

12 noon Lunch

1:30 p.m. Open Public Hearing

2:00 FDA Presentation of Questions Patricia Rohan, M.D., FDA

2:15 Committee Discussion of FDA Questions

Committee Recommendations

4:30 p.m. Adjourn meeting