Moderna applies to expand COVID-19 vaccine authorization to adolescents
An application for the use of the vaccine in adolescents has already been submitted to Health Canada.
In the EU, the mRNA vaccine is authorized for people aged 18+ (as is the case in the US and other markets), having been granted a Conditional Marketing Authorization in January.
In May, Moderna published results from a Phase 2/3 TeenCOVE study in adolescents which met its primary immunogenicity endpoint. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine. The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% (using the same case definition as in the Phase 3 COVE study in adults).
In addition, a vaccine efficacy of 93% in seronegative participants was observed starting 14 days after the first dose using the secondary Centers for Disease Control and Prevention (CDC) case definition of COVID-19, which tested for milder disease.
The study enrolled a total of 3,732 participants aged 12-18 years old in the US. The vaccine was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adults. All participants will be monitored for 12 months after their second injection to assess long-term protection and safety.
Fellow mRNA vaccine producers Pfizer/BioNTech have already received authorization for their vaccine in adolescents in the EU and US, also taking the minimum age down to 12 years old. It is down to Member States to decide when to open vaccination to younger age groups (France, for example, plans to open vaccination to adolescents on June 15).
