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Health Canada's statement approving Pfizer-BioNTech COVID-19 vaccine

FILE PHOTO: A phial of the Pfizer/BioNTech COVID-19 vaccine jab after being administered is seen at a vaccination centre, on the first day of the largest immunisation programme in the British history, in Cardiff, Wales, Britain December 8, 2020. Ben Birchall/Pool via REUTERS

(Reuters) - Health Canada on Wednesday approved the COVID-19 vaccine from Pfizer Inc and BioNTech SE, clearing the way for shots to be delivered and administered across the country.

Here is the full text of Health Canada’s announcement:

“Thanks to advances in science and technology, and an unprecedented level of global cooperation, today, Canada reached a critical milestone in its fight against COVID-19 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, 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.

“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. 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.

“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. This process allowed Health Canada to assess information submitted by the manufacturer as it became available during the product development process, while maintaining Canada’s high standards.”

Reporting by Denny Thomas, editing by Steve Scherer

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