Canada’s health regulator approves Pfizer’s COVID-19 vaccine

Coronavirus Vaccine

A woman holds a small bottle labeled with a “Coronavirus COVID-19 Vaccine” sticker and a medical syringe in front of displayed Pfizer logo in this illustration taken, October 30, 2020. (REUTERS/Dado Ruvic/File Photo)

TORONTO (NewsNation Now) — Canada’s health regulator on Wednesday approved the COVID-19 vaccine from Pfizer and its German partner BioNTech, clearing the way for shots to be delivered and administered across the country.

Health Canada posted on its website that the country’s first coronavirus vaccine has been authorized.

The agency conducted a “thorough, independent review” after receiving Pfizer’s submission for vaccine approval in October.

The nation’s first coronavirus vaccine green light comes under a new interim order system that allows for accelerated approval very similar to the U.S. Food and Drug Administration’s emergency use authorizations.

“Health Canada has determined that the Pfizer-BioNTech vaccine meets the Department’s stringent safety, efficacy and quality requirements for use in Canada,” the regulator said in its statement.

Canadian officials have said that under their procurement deal with Pfizer, doses would not be shipped to Canada until the vaccine won Health Canada approval.

Canada is set to receive up to 249,000 doses this month and 4 million doses of the vaccine by March.

The Canadian government has purchased 20 million doses of that vaccine, which requires people to receive two doses each, and it has the option to buy 56 million more.

The U.K. was first to approve the Pfizer vaccine, and its first doses were administered on Tuesday.

Pfizer is responsible for shipping its vaccine, which requires ultra-cold storage, to warehouses across Canada.

For the most part, provincial and territorial health systems will administer the shot, for free, across the country. They will have final say over how to use scarce early supplies in their jurisdictions.

According to preliminary guidance published by the federal government in early November, vulnerable people and those who look after them are high priority, including long-term care residents and some health care workers.

Canada has ordered more shots per capita than any other country.

Health Canada is also reviewing three other vaccine candidates, including one from Moderna.

READ HEALTH CANADA’S FULL 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.”

health canada

The Associated Press and Reuters contributed to this report.

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