The FDA has notified Moderna that it will need additional time to complete its evaluation of Moderna’s EUA request for the use of the company’s COVID-19 vaccine at the 100-µg dose level in adolescents between 12 and 17 years.
The United States Food and Drug Administration (FDA) has notified Moderna that the agency requires additional time to evaluate current international analyses about possible risk of myocarditisfollowing vaccination in adolescents aged 12 to 17. According to a company press release, the FDA review may not be completed before January 2022.
“The safety of vaccine recipients is of paramount importance,” said the press release. “[Moderna] is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their dilligence.”1
An increased risk of myocarditis has been associated with COVID-19 vaccines in adolescent and pediatric populations, specifically in young boys, following the second dose. However, the and the World Health Organization have found that myocarditis following mRNA vaccination “rare and generally mild.”
Approximately 1.5 million adolescents have received the Moderna COVID-19 vaccine. Currently, the rate of myocarditis reported Moderna’s global safety database in those younger than 18 does not show an increased risk of myocarditisDue to the delay in review of the adolescent request, Moderna plans to delay filing an EUA requests for mRNA-1273 at the 50 -µg dose for children between ages 6 and 11 years of age.
1. Moderna provides update on timing of U.S. emergency use authorization of its COVID-19 vaccine for adolescents. News Release. Moderna. October 31, 2021. Accessed November 2, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-provides-update-timing-us-emergency-use-authorization