Food And Drug
Administration
Center For
Biologics Evaluation And Research
Vaccines And Related
Biological Products Advisory Committee Meeting
DRAFT AGENDA
Day 1 – February 20, 2008
8:30 a.m. Call to Order and Opening Remarks John Modlin, M.D., Acting Chair
8:35 Administrative
Matters Christine Walsh, R.N., FDA
Topic 1: Safety and Efficacy of Rotavirus Vaccine Manufactured by GSK
Biologicals
8:50 a.m. FDA Brief Introduction Steven Rosenthal, M.D., FDA
Presentation of Questions
9:00 Sponsor Presentation GlaxoSmithKline Biologicals
10:30 Break
10:45 FDA Presentation Steven Rosenthal, M.D., FDA
11:45 Lunch
4:00 p.m. Adjourn for the day
Food And Drug
Administration
Center For
Biologics Evaluation And Research
Vaccines And Related
Biological Products Advisory Committee Meeting
DRAFT AGENDA
Day 2 – February 21, 2008
Open Session
8:30 a.m. Call to Order and Opening Remarks John Modlin, M.D.,
Acting Chair
8:35 Administrative Matters Christine Walsh, R.N.,
FDA
Topic 2: Strain Selection
for the Influenza Virus Vaccine for the 2008 – 2009 Season
8:45 a.m. Introduction Jerry
Weir, Ph.D., FDA
9:00
9:15 World Surveillance/Strain Characterization Nancy Cox, Ph.D., CDC
10:00 Vaccine Effectiveness Report Angela
Owens/Thomas Gibbons,
Major,
USAF, BSC, Ph.D.
.
10:15 Vaccine Responses Zhiping
Ye, M.D., Ph.D., FDA
10:35 Availability of Strains and Reagents Rajesh Gupta, Ph.D.,
FDA
10:45 Break
11:00 Comments from Manufacturers Tony Colegate
11:20 Open Public
Hearing
11:50 Strain Selection Options/ Jerry Weir, Ph.D., FDA
Committee Discussion and
Recommendations
1:00 Lunch
Topic 3: Clinical
Development of Influenza Vaccines for Pandemic and Pre-Pandemic Uses
2:00 p.m. Summary of FDA/NIH/WHO December 2007 Hana Golding Ph.D., FDA
Workshop: Immune Correlates of Protection Against
Influenza
A Viruses in Support of Pandemic Vaccine
Development
2:10 Update on H5N1 Surveillance Nancy Cox Ph.D., CDC
2:30 Pandemic and Pre-pandemic Influenza Joseph Toerner, M.D., M.P.H., FDA
Vaccine
Development Issues
2: 45 Open
Public Hearing
3:15 Committee
Discussion
4:30 p.m. Adjourn
meeting