June 1, 2021
Moderna Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for the Moderna COVID-19 Vaccine
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jun. 1, 2021– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it 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.
“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,” said Stéphane Bancel, Chief Executive Officer of Moderna. “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 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 is currently available in the U.S. under an Emergency Use Authorization (EUA), which was granted on December 18, 2020. As of today, according to the U.S. Centers for Disease Control and Prevention (CDC), more than 124 million doses of the Moderna COVID-19 Vaccine have been administered in the U.S.