Thursday, July 06, 2006

Medimmune Gets FDA Clearance for New Flu Vaccine Production Process GAITHERSBURG, Md. -- Biopharmaceutical company MedImmune Inc. said Thursday the U.S. Food and Drug Administration cleared its application to create new flu vaccines using a new method.

The supplemental biologics license application sought permission to use reverse genetics technology to build new vaccine strains. The process involves assembling genes coded specifically for a virus strain, and has been touted as faster and more efficient than conventional methods.

MedImmune said it will use the technique to produce seasonal influenza vaccines for its FluMist product line and others. The benefit in producing vaccines for a pandemic influenza, the company said in a statement, is the speed and ability to remove pathogenic, or harmful, portions of the virus during production.

The company has already started using the technique in a Phase I clinical trial the National Institutes of Health, for work on a intranasal avian flu vaccine.

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