PEDIATRIC STUDY SHOWS 55 PERCENT FEWER FLU CASES WITH FLUMIST VS. SHOT

Children under 5 immunized with FluMist had 55 percent fewer cases of influenza compared with children who received the flu shot, according to a recent study. FluMist manufacturer MedImmune said it hopes these results will support expansion of the age indication for FluMist to include children as young as 1.

The study, published in the Feb. 15 issue of the New England Journal of Medicine, also said FluMist protected children against flu strains that were both matched and mismatched to the vaccine. The Phase III trial examined 8,475 children, 6 months to 59 months old, and was conducted at 249 sites in the U.S., Europe, Asia and the Middle East.

MedImmune conducted the pediatric study during the 20042005 influenza season and submitted the results to the FDA in July 2006 as the basis for a request to expand FluMist's indication to children as young as 1 with no history of wheezing or asthma. FluMist is currently indicated for healthy children and adolescents 5 to 17 years of age and healthy adults 18 to 49.

The company's primary objective in the study was to determine how FluMist would perform against the flu shot in young children, and "to assess the comparative safety outcomes to help us determine for whom FluMist might be most beneficial in the pediatric population," Edward Connor, MedImmune's executive vice president and chief medical officer, said.

The study used the refrigerated formulation of FluMist, which the FDA approved Jan. 5.