Health Canada authorises COVID 19 vaccine Spikevax in young children 6 months to 5 years.

Until now, children under 5 were the only age group not yet eligible in Canada for vaccination against COVID-19. The two-dose primary series of Spikevax for children in this age group is completed in one month, the same primary dosing schedule as adults, adolescents, and children over 5 years of age.

Interim results from the Phase II/III KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6-month to 5 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile. The antibody titers in the pre-specified 6 month to 23 month and 2 years to 5 years of age sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study. Preliminary efficacy analysis on PCR-confirmed cases collected during the Omicron wave showed similar efficacy estimates against Omicron in the 6-month to 5 years of age group to those in adults after two doses of mRNA-1273.

The KidCOVE 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. The ClinicalTrials.gov identifier is NCT04796896. The KidCOVE study included eight trial sites across Canada. A total of 414 Canadian children under the age of 5 were included in the KidCOVE trials.

Health Canada previously 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 six years of age and older in March 2022.