Coronavirus
The FDA Delays Reviewing the Moderna Vaccine for Adolescents as It Looks Into Heart Risks
The Food and Drug Administration’s review for an emergency use authorization of Moderna’s COVID-19 vaccine for adolescents as young as 12 years old is being delayed as the agency takes a deeper look into a possible rare heart risk, Moderna said on Sunday.
The review of the possible heart risk, a heart muscle inflammation called myocarditis, may push back approval until early 2022, the agency warned Moderna.
“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 a statement on Sunday.
