Moderna, Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older. Spikevax is the trade name authorized by the European Medicines Agency (EMA) for the Moderna COVID-19 vaccine.
Following the CHMP’s positive opinion, the European Commission will consider authorizing the use of the Moderna COVID-19 Vaccine in adolescents ages 12 years of age and older.
Safety data continue to accrue, and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term efficacy and safety.
The Company will revise the age range to capture adolescent data in its ongoing and planned post-authorization studies. Moderna has submitted data from the Phase 2/3 study to a peer-reviewed publication. These data have also been submitted to health authorities around the world and the Company expects authorizations for adolescents in the coming weeks.
Moderna is also conducting a Phase 2/3 study, called the KidCOVE study, of mRNA-1273 in children ages 6 months to less than 12 years.
