Moderna applies to expand COVID-19 vaccine authorization to adolescents

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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​).

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