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Today, Health Canada authorized the use of the Moderna Spikevax COVID-19 vaccine in children 6 months to 5 years of age. This is the first COVID-19 vaccine authorized in Canada for use in this age group and marks a milestone in Canada’s response to COVID-19. As a result of this authorization, approximately 1.7 million children are now eligible for vaccination against COVID-19.
Vaccination is one of the most effective ways to protect our families, communities and ourselves against COVID-19. Evidence indicates that the vaccines used in Canada are very effective at preventing severe illness, hospitalization and death from COVID-19.
Health Canada received an application from Moderna to expand the indication of Spikevax on April 29, 2022. Health Canada initially authorized the vaccine for use in people 18 years of age and older on December 23, 2020, and subsequently authorized for children 12 to 17 years of age on August 27, 2021, and children 6 to 11 years of age on March 17, 2022.
After a thorough and independent scientific review of the evidence, Health Canada has determined that the benefits of this vaccine for children between 6 months and 5 years of age outweigh the potential risks. Health Canada has authorized a two-dose primary series of 25 micrograms each, with the second dose to be administered 4 weeks after the first dose. This is half the dose authorized for children 6 to 11 years of age and one quarter of the dose authorized for people over 12 years of age.
The clinical trial showed that the immune response to Spikevax in children 6 months to 5 years of age was comparable to that seen in people 18 to 25 years of age from a previous study. Efficacy was assessed when Omicron was the predominant variant of COVID-19 circulating in the U.S. and Canada. The vaccine was well tolerated and no safety signals were identified from the trial.
Health Canada has placed terms and conditions on the authorization requiring Moderna to continue providing information to Health Canada on the safety and efficacy of the vaccine in this younger age group. This will provide the Department with more data from ongoing studies and real-world use to ensure that the benefits of the vaccine continue to outweigh any risks, as well as to detect any potential new safety signals in any age group.
In keeping with Health Canada’s commitment to openness and transparency, the Department is publishing multiple documents related to this decision, including a high-level summary of the evidence it reviewed.
Health Canada and the Public Health Agency of Canada will continue to closely monitor the safety of this vaccine, and will take action if any safety concerns are identified.