FDA advisory c'tee recommends expanded indication for FluMist

US drugmaker MedImmune, which is being acquired by AstraZeneca (Marketletter April 30), says that the US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee has voted in favor of expanding the population for use of FluMist (influenza virus vaccine live, intranasal) to include children under five years of age. The committee decided that the data demonstrate the efficacy of the agent in children six to 59 months of age, and also voted in favor of the risk-benefit profile in children 12 to 59 months of age without a history of wheeze, as well as in children 24 to 59 months of age regardless of wheeze history. FluMist is currently approved for healthy children and adolescents five to 17 years of age and healthy adults aged between 18 to 49 years. The FDA is expected to respond to the firm's supplemental Biologics License Application requesting an expanded indication in children below five years of age by May 28.