Health Canada has authorized the use of the Pfizer COVID-19 vaccine in kids aged five to 11.
The Pfizer-BioNTech Comirnaty COVID-19 vaccine has become the first of its kind to be authorized for kids in Canada and marks “a major milestone in Canada’s fight against COVID-19,” says Health Canada’s Friday morning news release.
Health Canada received an authorization application from Pfizer in October. The vaccine was authorized for use in people 16 years of age and older on December 9, 2020, and subsequently authorized for children 12 to 15 on May 5, 2021.
The federal health agency says the vaccine was authorized after a “thorough and independent scientific review of the evidence.” Health Canada has determined that the “benefits of this vaccine for children between five and 11 years of age outweigh the risks.”
The agency 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 those 12 years of age and older.
Clinical trials showed that the immune response in kids aged five to 11 years 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 the five to 11 age group, and “no serious side effects were identified.”
Health Canada has placed terms and conditions requiring Pfizer-BioNTech to continue providing information to the agency on the safety and efficacy of the vaccine in this younger age group. The agency says it 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 monitor the safety of this vaccine closely and will take action if any safety concerns are identified.