MedImmune's FluMist submitted to FDA for approval in younger children

By Elaine Rigoli

Tampa, Fla., July 31 - MedImmune, Inc. has submitted to the Food and Drug Administration a supplemental Biologics License Application for use of CAIV-T (cold adapted influenza vaccine, trivalent) in children 12 months to 59 months of age who do not have a history of wheezing or asthma.

CAIV-T is the refrigerator-stable formulation of FluMist, a frozen vaccine approved in the United States to prevent influenza in individuals five to 49 years of age, according to a news release.

"This is a very satisfying moment for MedImmune as it represents the culmination of multi-year clinical, manufacturing and regulatory efforts to improve the profile of our influenza vaccine. Pending FDA review and approval, we believe that our live, attenuated influenza vaccine will be an important new vaccine for many children currently recommended for annual influenza vaccination by the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices," executive vice president and chief medical officer Edward M. Connor Jr., said in the release.

The supplemental BLA consists of data from more than 30,000 subjects in 15 clinical studies, including MedImmune's pivotal phase 3 trial involving about 8,500 children between six months and 59 months of age. In this trial, efficacy of the vaccine was established across all age groups of children, the release said.

MedImmune is a pharmaceutical company with headquarters in Gaithersburg, Md.

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