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BusinessModerna says FDA needs more time to review its vaccine for teens

Moderna says FDA needs more time to review its vaccine for teens

Moderna stated the Food and Drug Administration will want more time to full its evaluation of the biotech firm’s Covid-19 vaccine for youngsters ages 12 to 17.

The company is trying particularly on the danger of myocarditis in youngsters, Moderna stated in an announcement Sunday, and the review will not be accomplished earlier than January 2022. Myocarditis is the irritation of the guts muscle.

“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 stated.

Moderna additionally stated it can delay submitting a request for emergency use authorization for a smaller dose of the vaccine for youthful youngsters ages 6 to 11 whereas the FDA completes its review.

Moderna stated on May 25 its Covid vaccine was 100% efficient in a examine of 12-to-17-year-olds. The firm then utilized to broaden the emergency use of its vaccine for adolescents in June.

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