Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

February 20 - 21, 2008

Hilton Hotel, Washington DC North/Gaithersburg

620 Perry Parkway, Gaithersburg, MD 20877

DRAFT AGENDA

 

 

Day 1 – February 20, 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 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

 

1:00 p.m.         Open Public Hearing

 

1:30                 FDA Presentation of Questions                         Steven Rosenthal, M.D., FDA

 

1:40                 Committee Discussion of FDA Questions/

                        Committee Recommendations

 

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

February 20 - 21, 2008

Hilton Hotel, Washington DC North/Gaithersburg

620 Perry Parkway, Gaithersburg, MD 20877

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                 U.S. Surveillance                                                        Joseph Bresee, M.D., CDC

 

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