MEDIMMUNE SUBMITS SBLA FOR FLU VACCINE

MedImmune has submitted a supplemental biologics license application (sBLA) to the FDA for approval to use CAIV-T (cold adapted influenza vaccine, trivalent) in preventing influenza in healthy individuals 5 to 49 years of age. CAIV-T is MedImmune's investigational, refrigerator-stable formulation of FluMist, a frozen vaccine approved to prevent influenza in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. Included in the sBLA are data from a recently completed pivotal Phase III study comparing the immunogenicity of FluMist and CAIV-T, as well as additional preclinical and clinical data supporting the comparability of the two formulations.

FluMist is indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. In studies of people between the ages of 5 and 49 years, runny nose was the most commonly reported side-effect. Other common side-effects included various cold-like symptoms, such as headache, cough, sore throat, tiredness/weakness, irritability, and muscle aches.