Moderna gets Health Canada authorization for Omicron-targeting bivalent COVID booster vaccine for 6 to 17 years old

"The authorization of a booster dose of mRNA-1273.214 in children and adolescents is a critical step to broaden protection against the Omicron family of variants, and the emergence of new variants of concern in Canada," said Stéphane Bancel, Chief Executive Officer of Moderna. "This decision highlights the effectiveness and safety of our vaccine in this important age group."

The pediatric and adolescent authorization is based on clinical trial booster data for Moderna's original vaccine, Spikevax, which was administered to over a thousand participants in each cohort. The application described data from a 25 μg booster dose administered to children ages 6 to 11 years old and a 50 μg booster dose for adolescents 12 to 17 years old, following a completed primary series of the Moderna COVID-19 vaccine. In addition, the application included clinical trial data from a Phase 2/3 studying mRNA-1273.214.

"We are pleased with Health Canada's authorization of our bivalent booster for children and adolescents and our continued collaboration to provide boosters to help protect all Canadians from current and future COVID-19 variants of concern, especially as this virus continues to circulate across the country and around the world," said Shehzad Iqbal, Country Medical Director of Moderna Canada.

In November 2022, Moderna announced that its bivalent Omicron-targeting booster candidates (mRNA-1273.214 and mRNA-1273.222) trigger a superior antibody response compared to a booster dose of mRNA-1273, the Company's prototype vaccine, against Omicron (BA.4/BA.5) in Phase 2/3 clinical trials. Both bivalent vaccines also met non-inferiority immunogenicity criteria to the original strain.