MEDIMMUNE PUBLISHES STUDY OF FLUMIST VS. FLU SHOT

According to pivotal Phase III research published in the Feb. 15 issue of New England Journal of Medicine, children under 5 immunized with MedImmune's FluMist (influenza virus vaccine live, intranasal) reported 55 percent fewer cases of influenza compared with children who received the flu shot. FluMist also demonstrated protection against influenza strains that were both matched and mismatched to the vaccine. The study of 8,475 children, 6 months to 5 years of age, was conducted at 249 sites in the U.S., Europe, Asia and the Middle East.

The study used the recently approved refrigerated formulation of FluMist. MedImmune conducted this pediatric study during the 2004-2005 influenza season and submitted results in July 2006 to the FDA as the basis of a pending request to expand the age indication for FluMist to include children as young as 1 who do not have a history of wheezing or asthma. FluMist is currently indicated for healthy children and adolescents 5 to 17 years old and healthy adults 18 to 49 years old.

In the trial, children were randomly assigned to receive either FluMist or the flu shot. In the double-blind trial, each study participant received one of the actual vaccines along with a saline injection or placebo intranasal spray. As is recommended for this age group, children who had not been previously vaccinated were given a second dose of vaccine along with an additional placebo 28 to 42 days after the first dose. Throughout the flu season, nasal swabs were obtained from children reporting any flu-like illness to culture for possible influenza as defined by the study protocol.

Overall, there were 185 fewer cases of culture-confirmed influenza in the group receiving FluMist compared with those receiving the shot. FluMist demonstrated protection against influenza A viruses well-matched to those in the vaccine, as well as those mismatched to the vaccine virus.

Generally, both vaccines were well tolerated. However, FluMist was associated with a statistically significant greater number of hospitalizations for any cause.