FDA's Aviron FluMist analysis

FDA and AVIR on Wednesday released safety and efficacy analysis on AVIR's FluMist influenza vaccine that will be considered Thursday and Friday by the Vaccines and Related Biological Products Advisory Committee. The company has submitted safety and efficacy data from studies of 4,653 healthy adults and 1,602 healthy children. According to the FDA's analysis, the overall estimated efficacy in preventing laboratory-documented influenza in healthy adults was 85% compared to placebo, which is statistically similar to the 71% efficacy of a licensed influenza vaccine. In healthy children, two doses of FluMist were 93.4% effective in preventing culture-confirmed influenza and one dose was 88.8% effective. The briefing documents are available at http://www.fda.gov/ohrms/dockets/ac/01/briefing/3769b1.htm.

Aviron is requesting an indication for active immunization for the prevention of influenza in children, adolescents and adults 1-64 years of age. In children and adolescents, the company wants labeling indicating that the product reduces influenza and influenza-associated illnesses including otitis media, lower respiratory illness and febrile illness. ...