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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