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news.MedImmune has said that it has resolved the FDA's concerns made during an annual inspection of the company's influenza vaccine manufacturing facility in Speke, UK.
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The agency’s observations led to the issuance of a warning letter on May 24, 2007. The UK facility is the bulk manufacturing site for FluMist (influenza virus vaccine live, intranasal).
MedImmune said that it will continue to work with the FDA on the implementation and ongoing execution of all quality and compliance commitments.
The company is currently working with the FDA on the standard annual lot release process so that shipping of FluMist to customers can soon begin for the upcoming influenza season.
It also plans to acquire the FDA’s final approval of its supplemental biologics licensing application requesting expansion of the vaccine’s indication to include children below five years of age.
FluMist is currently indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, five to 17 years of age, and healthy adults, 18 to 49 years of age.
On January 5, 2007, the FDA approved MedImmune’s supplemental biologics license application for a refrigerated version of FluMist, which is being manufactured for the 2007-2008 influenza season.