Moderna Applies for Full U.S. Approval for Its COVID-19 Vaccine

Moderna has begun its bid for full U.S. approval for its COVID-19 vaccine in the hopes of advancing it beyond Emergency Use Authorization (EUA) status. If regulators grant the request, it will allow the company to market the vaccine directly to consumers and would mark Moderna’s first approved product for the coronavirus.

The company announced on June 1 that it had filed its 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.

Moderna’s vaccine is one of three — along with Pfizer/BioNTech’s and Johnson & Johnson’s — that have EUAs in the U.S., which last only as long as the public state of emergency lasts.

Pfizer and BioNTech filed a BLA application May 7 (DID, May 10). If both vaccines get full approval in the U.S., it may help quell lingering questions among the public about the safety of the two vaccines, which have together made dramatic progress in curbing the COVID-19 pandemic in the U.S. since getting their EUAs in December 2020.

Moderna’s vaccine has been found to be more than 90 percent effective at protecting against COVID-19 and more than 95 percent effective against severe disease up to six months after the second dose. The Moderna vaccine involves two doses given four weeks apart.

An EUA gives conditional approval based on two months of safety data. A request for full approval requires at least six months of data. Moderna said that it 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.

Since getting its EUA on Dec. 18, 2020, more than 124 million doses of the Moderna COVID-19 vaccine have been administered in the U.S., according to the Centers for Disease Control and Prevention.

Moderna is expected to soon ask the FDA to expand the emergency use of its vaccine for adolescents as young as age 17. The company announced in recent weeks that its vaccine was found to be 100 percent effective in its study of kids aged 12 to 17. — Suz Redfearn