FluMist is currently approved in the US to prevent influenza in individuals five to 49 years of age. MedImmune is seeking to gain approval for the refrigerator-stable formulation of the drug, CAIV-T, in children 12 months to 59 months of age who do not have a history of wheezing or asthma.
The supplemental biologics license application (sBLA) consists of data from more than 30,000 subjects in 15 clinical studies, including MedImmune’s pivotal phase III trial involving approximately 8,500 children between six and 59 months of age. In this trial, efficacy of the vaccine was established across all age groups of children.
Specifically, children vaccinated with CAIV-T had 55% fewer overall confirmed cases of influenza compared to the injectable vaccine. The study also showed that CAIV-T vaccination resulted in 89% fewer cases of matched H1N1 strains and 79% fewer cases of circulating mismatched H3N2 strains as compared to the flu shot.