The FDA announced it will delay its decision on whether children ages 12 to 17 should receive the Moderna COVID-19 vaccine to determine if the shot increases the risk of a rare side effect that impacts kids’ hearts, the agency said Sunday.
The announcement comes just three days after the FDA authorized Pfizer-BioNTech’s COVID-19 vaccine for children between ages five and 11.
Moderna, based in Cambridge, Massachusetts, was told the federal agency would need until at least January 2022 before the FDA can finish its review, according to the Washington Post.
The company also added that it will delay its request for FDA authorization of its COVID vaccine for children 6 to 11 years old, the paper reported.
The agency informed Moderna on Friday night that it would require the extra time to further examine ongoing and emerging data – from international sources – on the risks of myocarditis, which is an inflammation of the heart muscle that in rare cases occurs after vaccination.
The announcement comes after several countries, from Nordic nations to Japan, voiced concerns that the Moderna vaccine increased the risk of myocarditis in men ages 18 to 30.