MedImmune's sBLA for production of seasonal influenza vaccines approved by FDA

By Lisa Kerner

Charlotte, N.C., July 6 - The Food and Drug Administration approved MedImmune, Inc.'s supplemental Biologics License Application to use reverse genetics technology in the production of seasonal influenza vaccines, including FluMist (Influenza Virus Vaccine Live, Intranasal) and the refrigerator-stable formulation, CAIV-T (cold adapted intranasal vaccine - trivalent).

"For producing pandemic influenza vaccine seeds, reverse genetics has the added benefit of allowing scientists to remove potentially pathogenic portions of the virus, thereby creating a safer production process for the vaccines," vice president of research and development George W. Kemble said in a company news release.

MedImmune's live, attenuated vaccine technology, which also used reverse genetics technology, is being used in a National Institutes of Health phase 1 study of an intranasal H5N1 influenza vaccine candidate.

The company recently received a $170 million contract from the U.S. Health and Human Services Department to expedite the development of cell culture-based production of its influenza vaccine.

MedImmune, based in Gaithersburg, Md., is focused on the areas of infectious diseases, cancer and inflammatory diseases.

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