CAMBRIDGE, Mass. — The U.S. Food and Drug Administration has told Moderna it needs more time to assess the company's emergency use authorization (EUA) request for its COVID-19 vaccine for kids 12-17.
The FDA says there are recent international analyses of the risk of myocarditis after vaccination, and more time is needed to evaluate this. An increased risk of myocarditis has been described for COVID-19 vaccines, including the Moderna COVID-19 vaccine, particularly in young men and following the second dose. The U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have stated that myocarditis following vaccination with mRNA vaccines has been rare and generally mild.
Moderna says its global safety database does not suggest an increased risk of myocarditis in those under 18, but the company doesn't have access to data from recent international analyses.
The review may not be completed until January 2022.
"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 news release.
Moderna is also delaying filing an EUA request for a vaccine dose for kids 6-11 while the FDA completes its review of the vaccine for those 12-17.