The FDA had requested clarification and additional information on the data previously submitted by MedImmune in its supplemental biologics license application (sBLA). In this sBLA, MedImmune is seeking approval to switch formulations from frozen FluMist, currently approved in healthy individuals five to 49 years of age, to the refrigerator-stable CAIV-T (cold adapted influenza vaccine, trivalent) formulation, for the same population.
“We believe that our responses adequately address the FDA’s questions as contained in the letter,” commented Linda Peters, senior vice president of regulatory affairs at MedImmune. “Pending FDA review and approval, we remain on track with our plans to launch thimerosal-free, refrigerator-stable CAIV-T in time for the 2007-2008 influenza season.”
MedImmune submitted a separate sBLA to the FDA on July 28, 2006 for the use of CAIV-T in children 12 months to 59 months of age who do not have a history of wheezing or asthma. This supplement included data from MedImmune’s pivotal phase III trial involving approximately 8,500 children between six months and 59 months of age. In this trial, efficacy of the vaccine was observed across all age groups of children in the study.
Children vaccinated with CAIV-T had 55% fewer overall confirmed cases of influenza compared to recipients of 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.