Vials containing the Moderna COVID-19 vaccine. [Image from Wikipedia]
Moderna (Nasdaq:MRNA) announced today that it submitted for full FDA approval of its mRNA COVID-19 vaccine for individuals 18 years of age and older.
Cambridge, Mass.-based Moderna initiated the rolling submission process with the FDA for a Biologics License Application (BLA) to license its mRNA COVID-19 vaccine, according to a news release. The move mirrors Pfizer and BioNTech, who last month initiated the process for a BLA for their COVID-19 vaccine.
The company said it will continue to submit data to the FDA in support of the BLA on a rolling basis with a request for priority review. Once the submission is complete, the FDA will notify Moderna when it is formally accepted for review.
Moderna’s two-dose COVID-19 vaccine is currently available under the FDA’s emergency use authorization (EUA), which it garnered in December 2020. The company noted that the CDC’s data as of today confirms that more than 124 million doses of Moderna’s COVID-19 vaccine have been administered in the U.S. so far.
“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” Moderna CEO Stéphane Bancel said in the release. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”