Health Canada last Thursday authorized the use of Moderna’s Spikevax vaccine against COVID-19 in children six months to five years old. This is the first COVID-19 vaccine authorized in Canada for this age group, marking an important milestone in Canada’s response to COVID-19.
With this authorization, approximately 1.7 million children are now eligible for the COVID-19 vaccination.
Health Canada received a request from Moderna to extend the indication for the Spikevax vaccine on April 29. Health Canada initially authorized the use of the vaccine in people 18 years and older on December 23, 2020, then in children 12 to 17 years old on August 27, 2021 and in children six to 11 years old on March 17, 2022.
After a rigorous and independent scientific review of the evidence, Health Canada has determined that the benefits of this vaccine for children 6 months to 5 years of age outweigh the risks.
The authorization consists of a primary series of two doses of 25 micrograms each, the second dose to be administered four weeks after the first. For comparison, this dose is half the dose allowed for children aged six to 11 and a quarter of the dose allowed for people over 12 years old.
The clinical trial showed that the immune response to the Spikevax vaccine in children aged six months to five years was comparable to that seen in 18 to 25 year olds in a previous study. Efficacy was assessed when Omicron was the predominant variant of COVID-19 circulating in the United States and Canada.
It should be noted that Health Canada has imposed conditions on the authorization requiring Moderna to continue to provide information on the safety and effectiveness 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 the risks, as well as to detect any potential new safety signals. in any age group. (A.B.)
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