The extended timeline is so the FDA can look into reports of a rare side effect — myocarditis, or the inflammation of the heart muscle — in those who’ve gotten the shot. Moderna said the FDA informed the company of the delay on Friday.
“The safety of vaccine recipients is of paramount importance to 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.
The government’s review of Moderna’s application for an emergency use authorization of its coronavirus vaccine in adolescents may not be completed before January, the company said. Moderna requested the FDA’s authorization for use in adolescents in June.
The FDA is reviewing “recent international analyses” of the possible side effect, according to Moderna.