(The Canadian Press)

By Justin Goulet

Health Canada approves Pfizer’s COVID-19 vaccine

Dec 9, 2020 | 9:39 AM

OTTAWA, ON – Canada has reached a significant milestone in the fight against COVID-19 this morning.

On Wednesday, Health Canada approved the Pfizer-BioNTech vaccine. This comes after the company submitted its vaccine on October 9 and Health Canada conducted a thorough, independent review of the evidence presented.

The health agency has issued a document related to this decision, which can be viewed here. Included is a high-level summary of the evidence that Health Canada reviewed to support the authorization of the vaccine.

More details will be made available in the next few 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,” reads a release from CNW Group.

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“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 authorization require Pfizer-BioNTech to continue providing information to Health Canada on the safety, efficacy and quality of the vaccine to ensure its benefits 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,” reads the release.

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.