www.fdanews.com/articles/203082-moderna-seeks-emergency-authorization-in-eu-canada-for-covid-19-vaccine-in-adolescents
Moderna Seeks Emergency Authorization in EU, Canada for COVID-19 Vaccine in Adolescents
June 8, 2021
Moderna has filed for updated emergency authorizations of its COVID-19 vaccine with regulators in the EU and Canada for adolescents aged 12 to 17 years.
The submissions were supported by a U.S. phase 2/3 study in which the two-dose vaccine demonstrated 100 percent efficacy in almost 2,500 adolescents.
The company also plans to file for revised emergency authorizations from the FDA and other global regulators.