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FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
Date:9/19/2007

u infections can exceed 30 percent in school-age children. Each year, up to 60 million Americans get the flu, according the U.S. Centers for Disease Control and Prevention (CDC). Resulting complications cause more than 200,000 hospitalizations and approximately 36,000 deaths in the U.S. annually.

Protection Against Matched and Mismatched Strains of Flu

FluMist has demonstrated in clinical trials that it helps provide protection against flu strains both matched and mismatched to those used in the vaccine. Mismatched strains are circulating strains that are different from those included in manufacturing the season's flu vaccines. According to CDC data, vaccine mismatch has occurred to varying degrees in five of the last 11 flu seasons, most recently during the 2005-2006 season.

About FluMist

FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life- threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

Do not administer FluMist to children less than two years of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children less than five years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing.

If Guillain-Barre syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential ben
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SOURCE MedImmune, Inc.
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