MEDIMMUNE REPLIES TO COMPLETE RESPONSE LETTER FOR FLUMIST

MedImmune has submitted its response to the complete response letter sent by the FDA for CAIV-T (cold-adapted influenza vaccine, trivalent). The FDA had requested clarification and additional information on the data previously submitted by MedImmune in its supplemental biologics license application (sBLA). MedImmune is seeking approval to switch formulations from frozen FluMist (influenza virus vaccine live, intranasal), currently approved in healthy individuals 5 to 49 years of age, to the refrigerator-stable CAIV-T formulation, for the same population.

MedImmune submitted an sBLA on July 28 for the use of CAIV-T in children over 12 who do not have a history of wheezing or asthma. This supplement included data from the company's Phase III trial involving approximately 8,500 children between 6 months and 5 years of age.