Moderna applies to FDA for full licensure of its COVID-19 vaccine

June 3, 2021

Moderna announced that it has initiated the rolling submission process with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older.

Moderna said it will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks with a request for a priority review. Once the rolling BLA submission is complete, the FDA will notify Moderna when it is formally accepted for review.

The Moderna COVID-19 Vaccine is currently available in the United States under an emergency use authorization (EUA), which was granted on December 18, 2020. According to the U.S. Centers for Disease Control and Prevention (CDC), more than 124 million doses of the Moderna COVID-19 Vaccine have been administered in the United States.

The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center.

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