Moderna Initiates Rolling Submission of Biologics License Application for its COVID-19 Vaccine

Moderna announced on June 1, 2021 that it has initiated a rolling submission process with FDA for a biologics license application (BLA) for its messenger RNA (mRNA) COVID-19 vaccine for individuals 18 years of age and older.

The company will continue to submit data to FDA on a rolling basis to support the BLA over the next few weeks with a request for priority review, Moderna said in a company press release. When the submission is completed, FDA will notify the company when the vaccine is formally accepted for review.

Currently, the vaccine is available in the United States under an emergency use authorization granted by FDA on December 18, 2020.

“We are pleased to announce this important step in the US regulatory process for a BLA of our COVID-19 vaccine,” said Stéphane Bancel, CEO of Moderna, in the press release. “We look forward to working with [FDA] and will continue to submit data from our Phase III study and complete the rolling submission.”

Source: Moderna