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MedImmune Resolves FDA Observations Regarding Manufacturing Process for FluMist(R)
Date:9/7/2007

FluMist Expected to Be Available Soon for 2007-2008 Season

GAITHERSBURG, Md., Sept. 7 /PRNewswire/ -- MedImmune announced today that it has resolved the observations made by the U.S. Food and Drug Administration (FDA) during an annual inspection of the company's influenza vaccine manufacturing facility in Speke, United Kingdom. The agency's observations led to the issuance of a Warning Letter on May 24, 2007, which has now been resolved. The UK facility is the bulk manufacturing site for FluMist(R) (Influenza Virus Vaccine Live, Intranasal). MedImmune will continue to work with the FDA on the implementation and ongoing execution of all quality and compliance commitments.

MedImmune 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. MedImmune can now also take the necessary regulatory steps to seek the FDA's final approval of the company's supplemental biologics licensing application requesting expansion of the vaccine's indication to include children below 5 years of age.

About FluMist

FluMist is currently indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. There are risks associated with all vaccines, including FluMist. As with any vaccine, FluMist does not protect 100 percent of individuals vaccinated and may not protect against viral strains not contained in the vaccine.

Under no circumstances should FluMist be administered as an injection (i.e. parenterally). FluMist is contraindicated in persons with hypersensitivity to any component of the vaccine, including eggs; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a history of Guillain-Barre syndrome; and in individuals with known or suspected immune def
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SOURCE MedImmune
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