OTTAWA, ON – Thanks to advances in science and technology, and an unprecedented level of global cooperation, Canada reached a critical milestone Wednesaday (Dec. 9) in its fight against COVID-19 with the authorization of the first vaccine.
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.
As part of its continued commitment to openness and transparency, Health Canada is publishing a number of documents related to this decision, including a high-level summary of the evidence that Health Canada reviewed to support the authorization of the vaccine. More detailed information will be available in the coming weeks, including a detailed scientific summary and the full clinical trial data package.
Health Canada says in a news release that Canadians can feel confident that the review process was rigorous and that it has 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 initial indication of the vaccine is for use in people 16 years of age or older.
Pfizer-BioNTech are running further clinical trials on children of all age groups and the indication could be revised in the future to include children if the data from these studies support it.
(Government of Canada News Release)