Today, Dec. 9, Health Canada approved the Pfizer-BioNTech vaccine for COVID-19.  

In a release, they say, “Health Canada received Pfizer's submission on October 9, 2020 and after a thorough, independent review of the evidence, Health Canada has determined that the Pfizer-BioNTech vaccine meets the Department's stringent safety, efficacy and quality requirements for use in Canada.” 

There are documents available online that includes a summary of the evidence they reviewed to support the authorization of the vaccine. Health Canada says more information will be available in the coming weeks, including a detailed scientific summary and the full clinical trial data package.

“Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place. Health Canada and the Public Health Agency of Canada will closely monitor the safety of the vaccine once it is on the market and will not hesitate to take action if any safety concerns are identified.” 

The manufacturer is required to continue providing information to Health Canada on the safety, efficacy and quality of the vaccine to ensure the benefits of the vaccine continue to be demonstrated through market use. 

Currently, the vaccine is for use in people 16-years-old and up. Pfizer-BioNTech are running further clinical trials on children of all age groups, and this may be revised.  

The vaccine was authorized under Health Canada's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.