Food and Drug
Administration
Center for
Biologics Evaluation and Research
Vaccines and Related
Biological Products Advisory Committee Meeting
Hilton
AGENDA
Day 1 – February 18, 2009
Open Session
8:30 a.m. Call
to Order and Opening Remarks John
Modlin, M.D., Chair
8:35 Administrative
Matters Christine
Walsh, R.N., FDA
8:40 Presentation
of Retirement Plaque Norman
Baylor, Ph.D., FDA
Topic 1: Strain Selection for the Influenza Virus Vaccine
for the 2009 – 2010 Influenza Season
8:45 a.m. Introduction Jerry
Weir, Ph.D., FDA
9:00
9:15 World
Surveillance/Strain Characterization Alexander
Klimov, Ph.D., Sc.D, CDC
.
10:15 DOD
Vaccine Effectiveness Report Major
Thomas F. Gibbons/
Lieutenant
Colonel Victor H. MacIntosh,
10:45 Break
11:00 Vaccine
Responses Zhiping Ye, M.D., Ph.D.,
FDA
11:20 Availability
of Strains and Reagents Rajesh Gupta, Ph.D., FDA
11:35 Comments from Manufacturers Raymond Fitch, Sanofi
Pasteur
12:00 p.m. Lunch
1:15 Open Public Hearing
1:45 Strain
Selection Options/ Jerry
Weir, Ph.D., FDA
Committee Discussion & Recommendations
3:00 Break
Food and Drug
Administration
Center for
Biologics Evaluation and Research
Vaccines and Related
Biological Products Advisory Committee Meeting
Agenda con’t
Topic 2: Discuss Utility of Adding a Second Influenza Type
B Strain to Current Seasonal Influenza Vaccines
3:15 p.m. VRBPAC
2008 Summary of Issues/ Rakesh
Pandey, Ph.D., FDA
Vaccine Development Issues
3:35 Update on Influenza Type B Surveillance
Anthony Fiore, M.D., M.P.H., CDC/
Carrie
Reed, DSc, M.P.H., CDC
4:15 Committee Discussion
5:30
p.m. Adjourn for the Day