Moderna has 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.
Stéphane Bancel, Chief Executive Officer of Moderna, said: “We look forward to working with the FDA and will continue to submit data from our Phase III study and complete the rolling submission.”
Moderna 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.
According to the US Centers for Disease Control and Prevention (CDC), more than 124 million doses of the Moderna Covid-19 vaccine have been administered in the US as of June 1, 2021.
