On Jun. 1, 2021, Moderna announced that it had initiated the rolling submission process with the U.S. Food and Drug Administration 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 continued 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.