On Mar. 17, 2022, Moderna announced that Health Canada had approved the use of Moderna’s mRNA COVID-19 vaccine, SPIKEVAXﾙ, in a two-dose series of 50 ﾵg per dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 to11 years. The announcement follows the recent authorization of the Company’s COVID-19 vaccine in the same age group in both Australia and the European Union.

Data submitted to Health Canada from over 4,000 children demonstrated that vaccination of children aged 6 to11 years with a 50 ﾵg mRNA-1273 primary series is associated with non-inferior anti-SARS-CoV-2 neutralizing antibody responses when compared to that in individuals 18 to 25 years old from the Phase 3 COVE study. Positive direct efficacy of two 50 ﾵg doses of mRNA-1273 was also demonstrated, and vaccination was generally well tolerated.