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MedImmune refrigerated FluMist clears FDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

MedImmune is planning its own February thaw as it gears up to stop producing the frozen formulation of its intranasal influenza vaccine FluMist in favor of the newly-approved refrigerator-stable formulation when manufacturing begins next month, the company says. MedImmune announced FDA approval of the new FluMist formulation, also known as CAIV-T (cold adapted influenza vaccine, trivalent), for "healthy children and adults 5 years to 49 years of age" on Jan. 8. An indication for use in children ages 1 to 5 years has an estimated late-May user fee goal. MedImmune expects to manufacture 7 to 10 million doses of the new formulation, which is easier to distribute and store, for the 2007/2008 flu season - two to three times the 3 million doses of frozen FluMist manufactured for the 2006/2007 season. The fridge formulation will also be priced at a slight discount to the older version. FDA issued a "complete response" letter for refrigerated FluMist in July (1Pharmaceutical Approvals Monthly August 2006, p. 32); MedImmune responded Aug. 11, 2006 with additional information on bridging studies for both versions...
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