FDA delays decision on Moderna coronavirus vaccine for adolescents to evaluate myocarditis risk, company says

The Food and Drug Administration is delaying a decision on whether to make Moderna’s coronavirus vaccine available to adolescents because the agency needs more time to evaluate if the shot increases the risk of a rare cardiac side effect, the company said Sunday.

Moderna, a Cambridge, Mass., biotechnology company, said in a news release that the FDA indicated it will take until at least January to complete the review of Moderna’s application for use in 12-to-17-year-olds. The agency told the vaccine maker Friday evening it needed more time to analyze emerging international data on the risk of myocarditis, an inflammation of the heart muscle that in rare instances occurs after vaccination.