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January 31, 2022

Moderna's COVID-19 vaccine fully approved by FDA

A review of scientific data confirmed the benefits of the two-dose vaccine series outweigh its risks

The U.S. Food and Drug Administration granted full approval to Moderna's COVID-19 vaccine Monday, a little more than one year after the vaccine was made available under an emergency use authorization. 

The FDA only grants full approval after it has had enough time to gather sufficient evidence that the benefits of a vaccine outweigh its risks, and that it can be manufactured safely and with consistent quality. 

Full licensure will allow Moderna's vaccine to stay on the market once the public health emergency has ended. It is now being sold under the brand name Spikevax.

Acting FDA Commissioner Dr. Janet Woodcock said that "for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated."

The full approval is for the primary, two-dose vaccination series among people ages 18 and older. The booster dose remains available under emergency use authorization.

More than 200 million doses of the vaccine have been administered in the United States since it was first authorized in December 2020, according to the U.S. Centers for Disease Control and Prevention's COVID Data Tracker.

"The totality of real-world data and the full (license) for Spikevax in the United States reaffirms the importance of vaccination against this virus," Moderna CEO Stéphane Bancel said. "This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S."

The FDA decision was based on data from Moderna's Phase 3 trial, which found the vaccine was safe and highly effective about six months after the second dose. The agency also reviewed manufacturing and facilities data required for licensure. 

According to the FDA, Moderna will need to conduct post-marketing studies to further evaluate the risks of myocarditis and pericarditis following vaccination.

The Moderna vaccine is the second COVID-19 vaccine to receive full approval. Pfizer's vaccine, marketed under the brand name Comirnaty, received approval in August for use in people ages 16 and older.

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