Posted by Michael Wonder on 02 Nov 2021
Moderna provides update on timing of U.S. emergency use authorisation of its COVID-19 vaccine for adolescents
31 October 2021 - Moderna today provided an update that the U.S. FDA has notified the Company that it will require additional time to complete its assessment of Moderna’s emergency use authorisation request for the use of the Moderna COVID-19 vaccine (mRNA-1273) at the 100 µg dose level in adolescents 12 to 17 years of age.
On Friday evening, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination.
The FDA notified Moderna that this review may not be completed before January 2022.
