Pfizer filed a submission to Health Canada Monday asking the health regulator to approve its COVID-19 vaccine for children ages five to 11.
Currently, COVID-19 vaccines in Canada are only approved for use on individuals aged 12 and up.
The submission is based on data from Pfizer’s Phase 2/3 trial where more than 2,000 participants under 12 used smaller doses than adults, the pharmaceutical company said in a news release.
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Pfizer is the first company to request approval for the use of its COVID-19 vaccine on children younger than 12. In Canada, the shot is now called Comirnaty after federal health officials announced a name change for all three COVID-19 vaccines in September.
“Health Canada will only authorize the use of Comirnaty if the independent and thorough scientific review of all the data included in the submission showed that the benefits of the vaccine outweighed the potential risks in this age group,” the health regulator said.
Health Canada has not set a date for when it will issue a decision, but it approved the same shot for teens a few weeks after receiving the application.