Pfizer-BioNTech COVID-19 vaccine authorized for use in children 12 to 15 years of age
Today, Health Canada authorized the use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age. This is the first COVID-19 vaccine authorized in Canada for use in children and marks a significant milestone in Canada's fight against the COVID-19 pandemic.
Health Canada received an application to expand the indication of Pfizer-BioNTech's COVID-19 vaccine on April 16, 2021. The vaccine was initially authorized for use in people 16 years of age and older on December 9, 2020.
After completing a thorough and independent scientific review of the evidence, the Department has determined that this 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 this authorization requiring Pfizer-BioNTech to continue providing information to Health Canada on the safety, efficacy and quality of the vaccine in this younger age group to ensure its benefits continue to be demonstrated once it is on the market.
In keeping with the Department's commitment to openness and transparency, Health Canada 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.
SOURCE Health Canada