Posted by Michael Wonder on 01 Jun 2021
Moderna announces initiation of rolling submission of biologics license application with US FDA for the Moderna COVID-19 vaccine
1 June 2021 - Moderna today announced that it has initiated the rolling submission process with the U.S. FDA 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.
Moderna will continue to submit data to support the biologics license application to the FDA on a rolling basis over the coming weeks with a request for a priority review.
