Moderna announced that Health Canada has approved the use of Moderna's mRNA COVID-19 vaccine, Spikevax, in a two-dose series of 50 µg 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.

"Health Canada was the first regulator to fully approve our COVID-19 vaccine, and we are pleased they have taken this important step to expand this authorization to children aged 6 to11 years," said Stéphane Bancel, Chief Executive Officer of Moderna. "I want to thank the Government of Canada for their partnership and the trust this decision shows in the effectiveness and safety of our vaccine in this important patient population."

Moderna's vaccine was investigated in the ongoing Phase 2/3 "KidCOVE" study, a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of Spikevax (mRNA-1273) given to healthy children 28 days apart. Data submitted to Health Canada from over 4,000 children demonstrated that vaccination of children aged 6 to11 years with a 50 μg 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 μg doses of mRNA-1273 was also demonstrated, and vaccination was generally well tolerated.

Recently, the Therapeutic Goods Administration in Australia and the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) authorized Moderna's mRNA COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 to 11 years.