FDA Delays Decision On Moderna Vaccine For Adolescents

The agency says it wants to further study the risk of myocarditis, or the inflammation of the heart muscle, in children.

U.S. regulators are delaying their decision on Moderna's COVID-19 vaccine for 12-to-17-year-olds while they study the rare risk of heart inflammation, the company said Sunday.

The FDA told the company Friday evening that its review could last until January, Moderna said.

The company also said it will delay filing a request for emergency-use authorization of a lower dose of the vaccine for 6-to-11-year-olds.