FDA Grants Full Approval To Moderna’s COVID-19 Vaccine

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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.

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“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.