Moderna COVID vaccine gets full FDA approval

The U.S. FDA has granted full approval for Moderna's COVID-19 vaccine after finding it meets the agency’s standards for safety, efficacy and manufacturing quality. The vaccine has been approved for the prevention of COVID-19 in adults 18 years old and older.

Moderna’s vaccine will be marketed under the name Spikevax and is the second vaccine to receive full FDA nod. Pfizer-BioNTech’s Comirnaty received FDA approval back on August 23.

Until now, Spikevax had been approved by the FDA under an emergency use authorization, first granted in December 2020, with more than 204 million doses administered across the U.S. The approval marks a big step for the biotech company based in Cambridge, Massachusetts.

“This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.,” said Stéphane Bancel, CEO of Moderna. The vaccine will remain available under EUA as a booster shot and in the two-dose regimen. The EUA authorization also allows patients to mix and match the Moderna booster with vaccines received for the primary dose. 

“While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated,” said Janet Woodcock, acting FDA commissioner.

Spikevax is not currently approved for use in people under the age of 18. In June, Moderna applied for an extension of its EUA to cover children aged 12-17 but the decision was delayed by the FDA to evaluate the risk of myocarditis. Currently, the Pfizer-BioNTech vaccine is authorized for children aged five to 15 under EUA and full FDA approval for individuals 16 years old and up.