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Update from the Office of Vaccines Research and Review, CBER/FDA

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. FDA licensed a new combination vaccine containing DTaP, hepatitis B, and IPV in 12/02 Marketed as Pediarix â„¢ by GSK

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Update from the Office of Vaccines Research and Review, CBER/FDA

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

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

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

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

  5. VRBPAC Update • BLA for FluMist, MedImmune’s live, influenza virus vaccine discussed at Dec. 2002 VRBPAC • Majority of the committee voted that the data were adequate to support safety and effectiveness in healthy individuals 5-49 years of age • Review ongoing • Next VRBPAC meeting Feb. 20, 2003 to discuss the influenza virus strains to be included in 2003-2004 vaccine formulation

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