VANCOUVER (NEWS 1130) – Moderna has formally asked Health Canada to approve its COVID-19 vaccine for use in adolescents.
Pfizer-BioNTech’s shot is currently the only one approved for use in children 12 to 18 years old.
“We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents,” said Stéphane Bancel, CEO of Moderna. “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. We remain committed to doing our part to help end the COVID-19 pandemic.”
Moderna, which is behind one of two mRNA vaccines currently approved for use in Canada, announced last month that its late-stage “TeenCOVE” study “met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination.”
It says no cases of COVID-19 were reported during the study in participants who received two doses of the vaccine.
“The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% when using the same case definition as in the Phase 3 COVE study in adults,” the biotechnology company added.
The study involved 3,732 participants between the ages of 12 and 18 in the U.S. Moderna says its vaccine was “generally well tolerated” and that no significant concerns have been identified so far.