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FDA Approves FluMist for Young Children

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By: Tim Wright

Editor-in-Chief, Contract Pharma

MedImmune, Inc. received approval from the FDA for the expanded use of FluMist (Influenza Virus Vaccine Live, Intranasal) in children two to five years of age. FluMist is now approved for active immunization for the prevention of influenza A and B viruses in individuals two to 49 years of age. The company expects to ship FluMist with the expanded label in the next few days.

FluMist is different from the flu shot in that it uses live, attenuated — or weakened — viruses within the vaccine to help stimulate an immune response that is designed to closely resemble the body’s natural response to a flu infection.

In a study that included more than 4,000 children between the ages of two and five years of age during the 2004-2005 flu season, there was a 54% reduction in cases of flu in children who received FluMist compared with those who received the traditional flu shot (4.5% vs. 9.8%, respectively). In the study, FluMist demonstrated a reduction in flu rates compared to the inactivated vaccine against strains that were both matched and mismatched to the vaccine.

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