Moderna applies for full FDA approval of its COVID-19 vaccine

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

“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application of our COVID-19 vaccine,” said Stéphane Bancel, Moderna CEO. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

Moderna said that 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, FDA will notify the company when it is formally accepted for review.

The Moderna COVID-19 vaccine currently is available in the United States under an Emergency Use Authorization, which was granted on Dec. 18, 2020. As of today, according to the Centers for Disease Control and Prevention, more than 124 million doses of the Moderna COVID-19 vaccine have been administered in the United States.