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FluMist warning letter

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Manufacturing deficiencies at MedImmune's Liverpool, U.K. manufacturing facility for the live intranasal flu vaccine FluMist are not expected to affect the availability of the influenza vaccine for the 2007-2008 flu season, according to FDA. The agency issued a warning letter to MedImmune May 24, citing the company for several significant deviations from current good manufacturing practice in the manufacture of FluMist bulk monovalent lots stemming from an inspection between March 21 and March 27. MedImmune said it expects to have 7 million doses of FluMist available for the 2007-2008 influenza season. The deficiencies will delay approval of MedImmune's sBLA for FluMist seeking to extend the age indication for the vaccine. FDA issued a "complete response" letter for the sBLA May 25, pending resolution of the outstanding issues...

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