The FDA's review of the Moderna vaccine for teens could take until January 2022

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The Food and Drug Administration needs more time to complete its assessment of Moderna's COVID-19 vaccine for use for 12- to 17-year-olds, the drugmaker said Sunday. The review could take until January 2022 to complete.

Moderna said in May that its vaccine was 100 percent effective in a study of 12- to 17-year-olds. The FDA is now specifically reviewing the risk of myocarditis, an inflammation of the heart muscle. Moderna will wait to file a request for emergency authorization for a smaller dose of its vaccine for children ages 6 to 11 until the FDA completes the review for the teenage group.

The FDA expanded Pfizer's COVID-19 emergency use to include adolescents ages 12 through 15 back in May. On Friday, the FDA further approved Pfizer's COVID-19 vaccine for emergency use authorization for children ages 5 to 11.

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Jeva Lange
Jeva Lange

Jeva Lange was the executive editor at TheWeek.com. She formerly served as The Week's deputy editor and culture critic. She is also a contributor to Screen Slate, and her writing has appeared in The New York Daily News, The Awl, Vice, and Gothamist, among other publications. Jeva lives in New York City. Follow her on Twitter.