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Canada approves Pfizer COVID-19 vaccine

Last Updated Dec 9, 2020 at 12:18 pm PST

Summary

Pfizer's COVID-19 vaccine has been given approval by Health Canada

Canada is set to receive initial shipments of Pfizer's COVID-19 vaccine within days

Vaccination programs across Canada could begin within days of receiving shipments of the drug

OTTAWA (NEWS 1130) – A COVID-19 vaccine has been approved for use in Canada.

Health Canada has given Pfizer’s drug the green light, with initial vaccine doses expected to arrive in this country within days.¬†Vaccination campaigns are also expected to begin around the same time.

“This is a critical milestone in our fight against COVID-19 and in our efforts to provide every Canadian with access to a vaccine. Canadians can have confidence in our rigorous review process and that the vaccine was only authorized after a thorough assessment,” says Dr. Supriya Sharma, chief medical advisor at Health Canada.

The approval comes with terms and conditions. The vaccine is only approved for use in people 16 years and older, officials say, adding they are still awaiting results for further clinical trials on children before approving its use for younger people.

The department is also requiring the manufacturer to continue providing more information to Health Canada on the safety, efficacy, and quality of the vaccine.

“…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,” a statement from Health Canada reads.

It says it will be publishing “a number of documents” related to its decision to approve the vaccine, “including a high-level summary of the evidence that Health Canada reviewed to support the authorization of the vaccine.”

Canada has approved the vaccine before many of its allies, including the U.S. It is the third country to approve the Pfizer shot, after the U.K. and Bahrain.

A timeline for vaccinating Canadians shows the federal government expects to have enough doses for everyone by the end of September.

Monitoring the situation

Canada’s approval of Pfizer’s COVID-19 vaccine comes a day after the U.K. began its inoculation campaign. British regulators warned on Wednesday that people with a history of serious allergic reactions shouldn’t receive the Pfizer-BioNTech shot as they investigate two adverse reactions possibly related to it.

Sharma says Health Canada is aware of the warnings out of the U.K., and is assuring Canadians the agency is working to get more information.

She adds Health Canada will not hesitate to take action if there are safety concerns.

“The people that had the allergic reactions in the U.K. had a history of other severe allergic reactions. They both carried adrenaline, epinephrine shots with them. At this point in time, we’re not changing our recommendations, but what we’re doing is we’re looking at that information and should we need to broaden it to be extended to people with other severe allergic reactions — such as foods or other medications — then we’ll make those recommendations and we’ll do it before the first person gets the vaccine,” she explains.

Currently, Health Canada is only advising people with allergies to the ingredients in the Pfizer vaccine to avoid it.

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Canada secured a deal with Pfizer to receive up to 249,000 initial doses of the vaccine by the end of this month — earlier than anticipated. The government had originally planned to begin receiving vaccines in early January.

The initial round of vaccines will be divided among the provinces on a per-capita basis, Prime Minister Justin Trudeau previously said.

The federal government has bought 20 million doses of Pfizer and German partner BioNTech’s vaccine — which requires people receive two shots each — with the option to buy 56 million more. Four million doses are expected to arrive in Canada by March.