Food and Drug Administration, Center for Biologics Evaluation and Research
Vaccines and Related Biological Products Advisory Committee Meeting
July 23, 2009
Hilton Hotel, Washington DC North/Gaithersburg
Montgomery Ballroom
620 Perry Parkway, Gaithersburg, MD 20877
DRAFT AGENDA
Open Session
Discussion of clinical trials to support use of vaccines against the 2009 H1N1 influenza virus
8:00 a.m. Call to Order and Opening Remarks John Modlin, M.D., Chair
8:05 Conflict of Interest Statement Christine Walsh, R.N., FDA
8:15 FDA Introduction Norman Baylor, Ph.D., FDA
8:20 Epidemiology of Newly Emerged Anthony Fiore, M.D., MPH, CDC
H1N1 Influenza Virus/Strain Selection Nancy Cox, Ph.D., CDC
8:50 Overview of DHHS Procurement of H1N1 Robin Robinson, Ph.D., DHHS
Influenza Vaccines & Adjuvants
9:05 Questions/Clarifications
9:15 Manufacturing Considerations Jerry Weir, Ph.D., FDA
9:30 FDA Regulatory Approaches & Activities Wellington Sun, M.D., FDA
to Support Use of H1N1 Vaccine
9:45 Overview of Clinical Studies by NIAID/NIH Linda Lambert, Ph.D., NIH
10:00 Questions/Clarifications
10:10 Break
10:30 Post Marketing Safety Monitoring Hector Izurieta, M.D., MPH, FDA
During an Influenza Pandemic/Post
Marketing Collection of Effectiveness Data
11:00 Questions/Clarifications
11:10 Manufacturers Comments on Clinical Trials Vaccine Manufacturers:
with H1N1 Vaccine Novartis, Sanofi Pasteur,
CSL Ltd., MedImmune,
GlaxoSmithKline
12:00 p.m. Lunch
1:00 Open Public Hearing
2:00 Presentation of Issues to be Discussed Wellington Sun, M.D., FDA
2:05 Committee Discussion
4:00 Adjourn Meeting