Moderna initiates application for full FDA vaccine approval

Moderna, who plans on revving up its vaccine supply to up to 3 billion doses by next year, has officially begun a biologics license application (BLA) with FDA for approval of its two-dose mRNA shot to prevent Covid-19 in people 18 years of age and older.

The vaccine was granted emergency use authorization (EUA) back in December 2020.

As noted by Stéphane Bancel, Moderna’s CEO, the company will continue to submit Phase III data to support the BLA 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 Moderna of when it is formally accepted for review.

Two other manufacturers of the vaccine, Pfizer and BioNTech, initiated the rolling process last month.