Moderna announced on Thursday that Health Canada had authorized the use of Moderna’s mRNA Covid-19 vaccine, SPIKEVAX™, in children aged 6 to 11 years.
Health Canada has approved the use of Moderna’s COVID-19 vaccine in children ages 6 to 11 years, in a two-dose series of 50 µg per dose for active immunization using SPIKEVAX.
Australia and the European Union recently approved Moderna’s Covid-19 vaccine in the same age group.
“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,” Bancel added.
More from their news release:
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.
The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). Over 400 children in Canada were randomized into the study and the ClinicalTrials.gov identifier is NCT04796896.
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.
Health Canada has approved the use of Moderna’s mRNA COVID-19 vaccine, SPIKEVAX (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older.
Moderna is currently available for people 18 years and older in the United States and still waiting for U.S. regulators for its approval to vaccinate children ages 12-17 years using SPIKEVAX.