CAMBRIDGE, Mass. — Moderna officials said Sunday that the Food and Drug Administration is delaying a decision on approving an emergency use authorization of the company’s 100 µg vaccine for teens aged 12 to 17, stating that the FDA needs more time to complete its assessment.
In a news release, Moderna said that it was informed by the FDA that the agency needed more time to evaluate recent international analyses of risks for myocarditis after vaccination.
Such a review may not be completed until January 2022, Moderna said in its release.
“The company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence,” Moderna said in a statement.
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Moderna officials added that the company will delay filing a request for a EUA of mRNA-1273 at the 50 µg dose level for children ages 6 to 11 while the FDA completes its review of the company’s adolescent EUA request.
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