Moderna: FDA needs more time to review its vaccine for teens


(NBC) – Moderna’s push to get its COVID-19 vaccine approved for teens is on hold for now.

The company says the Food and Drug Administration needs more time to study the vaccine for children ages 12 to 17. The review may not be done before January.

Moderna says the agency wants more time to study the risk of myocarditis, which is the inflammation of the heart muscle, in children.

The company says it will also delay filing a request for emergency use authorization for a smaller dose for younger children ages 6 to 11 while the FDA does its study.

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