Moderna mentioned 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 danger of myocarditis in youngsters, Moderna mentioned in a press release Sunday, and the overview might not be accomplished earlier than January 2022. Myocarditis is the irritation of the guts muscle.
“The corporate is totally dedicated to working carefully with the FDA to assist their overview and is grateful to the FDA for his or her diligence,” Moderna mentioned.
Moderna additionally mentioned it would 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 overview.
Moderna mentioned on May 25 its Covid vaccine was 100% efficient in a examine of 12-to-17-year-olds. The corporate then utilized to broaden the emergency use of its vaccine for adolescents in June.
