Moderna completes submission for full FDA approval of COVID-19 vaccine

Moderna announced on Wednesday it has completed its submission to the US Food and Drug Administration for full approval of its COVID-19 vaccine for people age 18 and older, and Pfizer and BioNTech announced they have begun submitting data for full FDA approval of a third dose of their vaccine.

Moderna said it has requested priority review from the FDA. The company began submitting data for its Biologics License Application, or BLA, to the FDA in June.

“This BLA submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company’s history,” Moderna CEO Stéphane Bancel said in a statement.

The Moderna vaccine is currently available under emergency use authorization for people age 18 and older in the United States. Moderna has also filed with the FDA for an emergency use authorization for its vaccine in people age 12 and older.

Moderna’s vaccine would be the second one approved by the FDA. On Monday, the FDA approved the Pfizer/BioNTech vaccine for people age 16 an older, opening the door to more vaccine mandates.

Even with priority review, the approval process typically takes months; the FDA moved resources around in order to be able to approve the Pfizer/BioNTech vaccine in less time.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Monday that the agency worked around the clock to conduct its own analyses and inspect facilities, completing all the same work it would for any approval.

“It’s actually 97 days since Pfizer completed the role of its BLA and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude,” Marks said Monday.