Moderna Seeks Vaccination Authorization for Adolescents in Canada and the USA
Moderna, Inc. announced that it has submitted for authorization of its COVID-19 vaccine in adolescents with Health Canada. The Company also plans to submit for an emergency use authorization with the U.S. Food and Drug Administration (FDA) to expand the authorized use of its vaccine to adolescents.
“We are pleased to announce that we have submitted for authorization of our COVID-19 vaccine for use in adolescents with Health Canada,” said Stéphane Bancel, CEO of Moderna.
“We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents. We have filed for conditional marketing approval with the European Medicines Agency, and we will file for an Emergency Use Authorization with the U.S. FDA and regulatory agencies around the world for this important younger age population."
In May 2021, the Company announced that the Phase 2/3 TeenCOVE study of Moderna’s COVID-19 vaccine in adolescents met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination.
On December 18, 2020, the U.S. FDA issued authorization enabling the COVID-19 Vaccine Moderna to be distributed in the USA for use in individuals 18 years of age and older. As of June 7, 2021, the COVID‑19 Vaccine Moderna has not been Approved or licensed by the FDA.