Health Canada Approves Use of Pfizer-BioNTech COVID-19 Vaccine for Canadians 12 and Over

On May 5, 2021, Health Canada approved the use of Pfizer-BioNTech mRNA vaccine in children ages 12 to 15, after initially authorizing its use for individuals 16 and older. This would be the first COVID-19 vaccine authorized for use in children in Canada.

Health Canada approval was based on topline results from a Phase 3 clinical trial in the United States which involved 2,260 adolescents from 12 to 15 years old. The trial demonstrated the vaccine is 100% effective in preventing SARS-CoV-2 infection in this age group beginning 1 week after the second dose. The vaccine was well tolerated among trial participants and there were no major safety concerns identified.


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