Moderna says FDA wants extra time to assessment its vaccine for teenagers

Moderna mentioned the Meals and Drug Administration will want extra time to finish 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 mentioned in a press release Sunday, and the assessment might not be accomplished earlier than January 2022. Myocarditis is the irritation of the center muscle.

“The corporate is totally dedicated to working carefully with the FDA to help their assessment and is grateful to the FDA for his or her diligence,” Moderna mentioned.

Moderna additionally mentioned it is going to 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 assessment.

Moderna mentioned on Could 25 its Covid vaccine was 100% efficient in a research of 12-to-17-year-olds. The corporate then utilized to increase the emergency use of its vaccine for adolescents in June.

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