Health Canada has announced the authorization of Pfizer-BioNTech’s COVID-19 vaccine for adolescents between 12 and 15 years of age.
It is the first COVID-19 vaccine authorized in Canada for children and marks a “significant milestone in Canada’s fight against the COVID-19 pandemic,” says a press release from the federal health agency.
Health Canada received an application to expand the indication of the Pfizer-BioNTech vaccine in April. The vaccine was initially authorized for use in people 16 years of age and older on December 9, 2020.
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Health Canada says it completed a “thorough and independent scientific review” of the evidence and consequences before the department determined that the vaccine is “safe and effective at preventing COVID-19 when used in children between 12 and 15 years of age.”
Health Canada has placed terms and conditions on an authorization requiring Pfizer-BioNTech to continue providing information to Health Canada on the safety, efficacy, and quality of the vaccine in the younger age group to ensure its “benefits continue to be demonstrated once it is on the market.”
Health Canada says it 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.