Moderna says FDA has delayed approval of its COVID-19 vaccine for teens
Feds are taking a deeper look into a possible rare heart inflammation known as myocarditis.
Moderna said Sunday that federal regulators have delayed emergency use approval for its COVID-19 vaccine for teenagers so the government can further study a rare heart reaction.
The Food and Drug Administration's review of the heart muscle inflammation known as myocarditis may push back approval until early 2022, the regulators told the drug company.
“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 in its announcement.
Moderna also said it plans to delay its request for emergency use authorization of the COVID-19 vaccine for children aged 6 to 11 until the extended review is completed for adolescents 12 and older.
The Centers for Disease Control and Prevention say rare cases of myocarditis have occurred, most commonly among male adolescents a few days after getting the second dose of the COVID-19 vaccine.