On Feb. 17, 2023, Moderna announced that Health Canada had authorized the use of its Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.214 (SpikevaxBivalent Original/Omicron) in children and adolescents 6 to 17 years of age. The authorizations are based on a 25 ﾵg booster dose for children ages 6 to 11 years old and a 50 ﾵg booster dose for adolescents 12 to 17 years old, each following a completed primary series of any of the authorized COVID-19 vaccines or a previous booster.

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 November 20222, 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.