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Moderna says FDA needs more time to review COVID vaccine in 12-to-17-year olds

Moderna says FDA needs more time to review COVID vaccine in 12-to-17-year olds

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Moderna Inc. MRNA, -0.78% said it would delay filing a request with the U.S. Food and Drug Administration to emergency use authorization of its COVID-19 vaccine at the 50 µg dose level in children ages 6 to 11, to give the regulator time to complete its review of an earlier submission for use in adolescents 12 to 17 years of age. The company announced the news in a Sunday release, in which it said the FDA had informed it that it needed more time to complete its assessment of the request for the 100 µg dose level in 12-to-17-year-olds.

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