Food and Drug Administration, Center for Biologics Evaluation and
Research
Vaccines and Related Biological Products Advisory Committee Meeting
May 16 - 17, 2007
DRAFT 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