Moderna stated the Meals and Drug Administration will want extra time to finish its evaluation of the biotech firm’s Covid-19 vaccine for kids ages 12 to 17.
The company is wanting particularly on the threat of myocarditis in youngsters, Moderna stated in a press release Sunday, and the evaluation might not be accomplished earlier than January 2022. Myocarditis is the irritation of the guts muscle.
“The corporate is absolutely dedicated to working intently with the FDA to assist their evaluation and is grateful to the FDA for his or her 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 evaluation.
Moderna stated on Could 25 its Covid vaccine was 100% efficient in a research of 12-to-17-year-olds. The corporate then utilized to broaden the emergency use of its vaccine for adolescents in June.
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