November 19, 2021 | Ottawa, ON | Health Canada
Today, Health Canada authorized the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine in children 5 to 11 years of age. This is the first COVID-19 vaccine authorized in Canada for use in this age group and marks a major milestone in Canada’s fight against COVID-19.
Health Canada received an application from Pfizer-BioNTech to expand the indication of Comirnaty on October 18, 2021. The vaccine was initially authorized for use in people 16 years of age and older on December 9, 2020, and subsequently authorized for children 12 to 15 years of age on May 5, 2021.
After a thorough and independent scientific review of the evidence, the Department has determined that the benefits of this vaccine for children between 5 and 11 years of age outweigh the risks. Health Canada has authorized a two-dose regimen of 10 micrograms to be administered three weeks apart, which is a lower dose than the 30 micrograms two-dose regimen authorized for people 12 years of age and older.
The clinical trial showed that the immune response in children 5 to 11 years of age was comparable to the immune response in people 16 to 25 years of age. The vaccine was 90.7% effective at preventing COVID-19 in children 5 to 11 years of age and no serious side effects were identified.
Health Canada has placed terms and conditions requiring Pfizer-BioNTech to continue providing information to Health Canada on the safety and efficacy 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 any risks, as well as to detect any potential new safety signals in any age group.
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.