Moderna says the FDA wants extra time to assessment its teenage vaccine
Moderna said it would take more time for the Food and Drug Administration to complete its assessment of the biotech company’s Covid-19 vaccine for children ages 12-17.
The agency is specifically studying the risk of developing myocarditis in children, Moderna said in a statement on Sunday, and the review may not complete until January 2022. Myocarditis is the inflammation of the heart muscle.
“The company is determined to work closely with the FDA in support of its review and is grateful to the FDA for their diligence,” said Moderna.
Moderna also said it will delay filing an emergency approval application for a smaller dose of the vaccine for younger children ages 6-11 while the FDA completes its review.
Moderna said on May 25 that its Covid vaccine was 100% effective in a study of 12 to 17 year olds. The company then applied in June to expand the emergency use of its vaccine to teenagers.
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