Moderna initiates rolling BLA for COVID-19 vaccine

By The Science Advisory Board staff writers

Moderna has started the rolling submission process with the U.S. Food and Drug Administration (FDA) for a biologics license application (BLA) for the use of its messenger RNA COVID-19 vaccine in individuals ages 18 years and older.

The vaccine is currently available in the U.S. under an emergency use authorization (EUA) granted by the FDA on December 18, 2020. The BLA is supported by analyses from phase III clinical results, and Moderna will continue to submit data to the FDA to support the BLA on a rolling basis from the phase III trial over the coming weeks with a request for a priority review from the agency.


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