- The FDA needs more time to complete its assessment of Moderna's Covid-19 vaccine for 12-to-17-year-olds before granting emergency use authorization, the drugmaker said in a statement Sunday.
- The review may not be completed until January 2022.
Moderna said the Food and Drug Administration will need more time to complete its assessment of the biotech company's Covid-19 vaccine for children ages 12 to 17.
The agency is looking specifically at the risk of myocarditis in kids, Moderna said in a statement Sunday, and the review may not be completed before January 2022. Myocarditis is the inflammation of the heart 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 said.
Moderna also said it will delay filing a request for emergency use authorization for a smaller dose of the vaccine for younger kids ages 6 to 11 while the FDA completes its review.
Moderna said on May 25 its Covid vaccine was 100% effective in a study of 12-to-17-year-olds. The company then applied to expand the emergency use of its vaccine for adolescents in June.