Moderna announced on Sunday that the US Food and Drug Administration has requested more time to finish its review of the company's COVID-19 vaccination for teenagers aged 12 to 17 years.
Moderna said in a statement that the FDA notified them that the evaluation may not be finished before January 2022, which could delay the issuance of an emergency use authorization (EUA) for that age range.
Based on interactions with the agency, Moderna CEO Stephane Bancel believes the vaccine will be approved for people aged 12 to 17 in the coming weeks.
The FDA needed the extra time to analyze recent international evaluations of the danger of a form of heart inflammation called myocarditis following vaccination, a rare side effect that has mostly afflicted young boys, according to the US biotech company.
Moderna said it is reviewing additional external assessments on the elevated risk of myocarditis in those under the age of 18 as they become available.
In June, Moderna submitted an application to the FDA seeking approval of its shot for children aged 12 to 17.
After the FDA and the Centers for Disease Control and Prevention certified the COVID-19 vaccine from Pfizer and partner BioNTech in May, Americans of those ages are eligible for it.
Moderna has also announced that it will postpone filing an EUA for a half-strength 50 microgram dose of the vaccine for children aged 6 to 11 until the FDA has completed its examination of the 12-17 submission.