Food and Drug Administration, Center for Biologics Evaluation and Research

Vaccines and Related Biological Products Advisory Committee Meeting

May 16 - 17, 2007

Hilton Hotel, Washington DC North/Gaithersburg

620 Perry Parkway, Gaithersburg, MD 20877



Day 1 – May 16, 2007

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 Effectiveness of FluMist™ in a Pediatric Population Less Than 59 Months of Age 


8:45 a.m.         Introduction/Background                               Douglas Pratt, M.D., FDA


8:55                 MedImmune Presentation                               MedImmune  


9:55                 Questions/Clarifications


10:05               Break


10:15               FDA Presentation                                           Therese Cvetkovich, M.D., FDA

                                                                                                Melisse Baylor, M.D., FDA

                                                                                                Sang Ahnn, Ph.D., FDA


11:15               Questions/Clarifications


11:25               Open Public Hearing


11:55               Committee Discussion and Recommendations


1:15 p.m.         Lunch


Committee Update: Influenza Strain Selection for the 2007 – 2008 Influenza Season


2:30 p.m.         Influenza Strain Selection Update                  CDC


Topic 2:  Overview of Laboratory of Bacterial Polysaccharides/Laboratory of Enteric & Sexually Transmitted Diseases, Division of Bacterial Parasitic & Allergenic Products, Office of Vaccines Research and Review, CBER


2:45 p.m.         Overview of Laboratory of Bacterial                         Willie Vann, Ph.D., FDA



3:05                 Questions/Clarifications


3:10                 Overview of Laboratory of Enteric &            Dennis Kopecko, Ph.D., FDA

                            Sexually Transmitted Diseases


3:30                 Questions/Clarifications


3:35                 Open Public Hearing


4:05                 Closed Session


4:45                 Adjourn for day