Food and Drug Administration, Center for
Biologics Evaluation and Research
Vaccines
and Related Biological Products Advisory Committee Meeting
May 16, 2007
AGENDA
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
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 Alexander Klimov, Ph.D., 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
Polysaccharides
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