Update from the Office of Vaccines Research and Review, CBER/FDA NVAC Meeting Washington, D.C. February 4-5, 2003

New Approvals since October 2002 NVAC Meeting l FDA licensed a new combination vaccine containing DTaP, hepatitis B, and IPV in 12/02 l Marketed as Pediarix™ by GSK l DTaP and hepatitis B components from GSK previously licensed, but not the IPV l Indicated for active immunization against diphtheria, tetanus, pertussis, hepatitis B, and polio types 1-3 in infants born to HB-sAg negative mothers

New Approvals since October 2002 (cont.) l Pediarix™ recommended for administration at 2, 4, and 6 months of age l Induced immune responses comparable to those induced by separately administered licensed vaccines l Most frequent adverse reactions: injection site reactions, fever, and fussiness l Fever occurred more frequently after administration of Pediarix™, compared with separately administered vaccines

New Approvals since October 2002 (cont.) l October 2002: supplement to Wyeth’s BLA for Dryvax smallpox vaccine approved n Provides for 100-dose kit with new source of diluent and needles l January 2003: supplement to Aventis Pasteur Inc.’s BLA for DT vaccine approved n Provides for trace-thimerosal formulation

VRBPAC Update l BLA for FluMist, MedImmune’s live, influenza virus vaccine discussed at Dec VRBPAC n Majority of the committee voted that the data were adequate to support safety and effectiveness in healthy individuals 5-49 years of age n Review ongoing l Next VRBPAC meeting Feb. 20, 2003 to discuss the influenza virus strains to be included in vaccine formulation