Food and Drug Administration, Center for Biologics Evaluation and Research

Vaccines and Related Biological Products Advisory Committee Meeting

May 16 - 17, 2007

Hilton Hotel, Washington DC North/Gaithersburg

620 Perry Parkway, Gaithersburg, MD 20877

AGENDA

 

Day 2 May 17, 2007

Open Session

9:00 a.m. Call to Order Ruth A. Karron, M.D., Chair

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

 

Topic 3: Safety and Immunogenicity of Live Vaccinia Virus Smallpox Vaccine, Percutaneous Scarification, ACAM2000 Manufactured by Acambis, Inc.

 

9:15 a.m. Introduction/Background Michael Merchlinsky, Ph.D., FDA

9:25 DHHS's Smallpox Program Gerald Parker, D.V.M., Ph.D., M.S., DHHS

 

9:40 DOD Presentation LTC Stephen M. Ford, DOD

 

10:00 Acambis, Inc. Presentation David Wonnacott, Ph.D.

John M. Neff, M.D.

Thomas P. Monath, M.D.

Jason W. Mason, M.D.

Michael Watson, M.D., Ph.D.

11:00 Clarifications/Questions

 

11: 15 Break

 

11:30 FDA Presentation Steven Rosenthal, M.D., FDA

Michael Merchlinsky, Ph.D., FDA

12:30 Clarifications/Questions

 

12:45 p.m. Open Public Hearing

1:15 Lunch

 

2:30 Committee Discussion and Recommendations

 

3:30 p.m. Adjourn Meeting