FDA Approves MedImmune's Refrigerated Formulation of FluMist

January 24, 2007
BioPharm International Editors

The FDA has approved MedImmune's (Gaithersburg, MD, www.medimmune.com) new refrigerated formulation of FluMist (influenza virus vaccine live, intranasal), which is used to help prevent influenza in healthy children and adults from 5 to 49 years of age.

The FDA has approved MedImmune’s (Gaithersburg, MD, www.medimmune.com) new refrigerated formulation of FluMist (influenza virus vaccine live, intranasal), which is used to help prevent influenza in healthy children and adults from 5 to 49 years of age.

FluMist has been marketed in a frozen formulation since its original FDA approval in 2003, and millions of doses have been distributed and administered. The newly approved formulation of FluMist, known in clinical studies as CAIV-T (cold adapted influenza vaccine-trivalent), will be available for the 2007–2008 influenza season. Both formulations are free of preservatives, including thimerosal.

Pending the FDA's approval of an expanded age indication, MedImmune plans to increase production of its new formulation of FluMist for the 2007–2008 season. The company anticipates shipping its first doses in 2007, in time for physicians to start vaccinating patients as early as August.

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