Moderna COVID vaccine SPIKEVAX gets nod in Canada for children aged 6 months to 5 years

"Since the pandemic began, we have worked with a deep sense of responsibility to deliver on the promise of mRNA science for Canadians," said Patricia Gauthier, President and General Manager, Moderna Canada. "This decision from Health Canada confirms the effectiveness and safety of Moderna's vaccine in this final and important age group. With this announcement, parents and caregivers now have an option to protect these very young children, a group at high risk of infection and where additional health prevention measures like wearing masks may not always be feasible."

Positive interim results from the Phase 2/3 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 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.