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



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