Moderna’s Covid-19 vaccine receives full FDA approval

By Naomi Thomas and Ben Tinker, CNN

Moderna’s Covid-19 vaccine has received full approval from the US Food and Drug Administration, according to news releases from the FDA and Moderna.

The vaccine, named Spikevax, is now approved for use in people ages 18 and older. It is not approved or authorized for use in younger individuals. There’s no difference between the approved vaccine and the vaccine previously available through emergency use authorization.

Moderna’s is the second Covid-19 vaccine to receive full approval from the FDA. Pfizer’s Covid-19 vaccine, Comirnaty, was approved for use in people age 16 and older in August. The Pfizer vaccine is also authorized for use in individuals ages 5 to 15.

Moderna said the FDA based its decision to give full approval on scientific evidence shared by Moderna in its submission package to the agency, which included six month follow up data from a Phase 3 clinical trial study as well as FDA-required manufacturing and facilities data.

“This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.,” Moderna CEO Stéphane Bancel said in the release. “The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved. We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic.”

Dr. Janet Woodcock, the FDA’s acting commissioner, called the approval a “significant step” in the fight against Covid-19.

“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Woodcock said in a statement. “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.”

The two-dose vaccine has been available in the US under FDA emergency use authorization since December 18, 2020. Since then, more than 204 million doses of Moderna’s Covid-19 vaccine have been administered in the US, accounting for about 38% of all doses administered, according to data from the US Centers for Disease Control and Prevention.

Nearly 75 million people have completed their initial series with the Moderna vaccine, and about 38.5 million people have gotten a Moderna booster shot.

Makers of Covid-19 vaccines originally applied for emergency use authorizations because the authorization process takes less time than what’s required for full approval.

Emergency use authorization is what its name suggests — a medical product, such as a vaccine, that gets special FDA authorization to be used during an emergency. When the health emergency is over, “then any EUA(s) issued based on that declaration will no longer remain in effect,” according to the FDA.

A booster dose of the vaccine at a 50mg dose is currently available under EUA for those 18 years and older. A third 100mg dose of the vaccine is authorized for use in immunocompromised adults.

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CNN’s John Bonifield and Deidre McPhillips contributed to this report.