Canada has reached a critical milestone in its fight against COVID-19 today with the authorization of the first COVID-19 vaccine.
Health Canada received Pfizer’s submission on October 9, 2020 and after a thorough, independent review of the evidence, it 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.
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 terms and conditions of the Pfizer-BioNTech vaccine authorization require the manufacturer 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.
The initial indication of the vaccine is for use in people 16 years of age or older.
For more details on the official announcement, please click here.
Meanwhile, U.K. regulators are saying that people who have a “significant history” of allergic reactions shouldn’t receive the new Pfizer-BioNTech vaccine.
They are investigating two adverse reactions that occurred on the first day of its mass vaccination program.
Speaking in Ottawa, Dr. Supriya Sharma, a Health Canada senior medical advisor, explains Canada's authorization of Pfizer #COVID19 vaccine via "interim order pathway" & notes that Canada's approval covers multiple lots & manufacturing sites, making it broader than U.K.'s #cdnpoli pic.twitter.com/d66WBuJCpr
— CPAC (@CPAC_TV) December 9, 2020
Health Canada has authorized Pfizer-BioNTech’s #COVID19 vaccine. After a thorough and independent review of the evidence. Health Canada has determined that the vaccine meets its stringent safety, efficacy and quality requirements. https://t.co/mhFcspCpTi#COVIDvaccines pic.twitter.com/q6xkC27z6i
— Health Canada and PHAC (@GovCanHealth) December 9, 2020
This is very exciting news and a great step forward in our fight against #COVID19. We are ready to deliver the vaccine to Ontarians as soon as it's available, beginning with our most vulnerable populations and those who care for them. https://t.co/eFIjylIvxx
— Christine Elliott (@celliottability) December 9, 2020
This is phenomenal news for all Canadians as we take the next step toward ending this pandemic. As soon as vaccines arrive on Ontario soil, we will be ready to deliver and administer them.
Friends, the light at the end of the tunnel grows brighter.https://t.co/AcC5AJLg7j
— Doug Ford (@fordnation) December 9, 2020