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Canada approved the Pfizer-BioNTech coronavirus vaccine for use, the government announced on Wednesday. 

“Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place,” Health Canada, the country’s department of health, said in a statement. 

The vaccine was approved for use in the UK on Dec. 2, and the first doses were administered on Tuesday. 

In the US, Pfizer has submitted findings from its late-stage trial to the FDA for review, but authorization is still pending.

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Canada approved Pfizer and BioNTech’s coronavirus vaccine for use, the country’s health department announced on Wednesday. The UK made a similar decision earlier this month, but the vaccine is still awaiting authorization for emergency use in the US. 

“It’s a momentous day for Canada,” said Dr. Supriya Sharma, Canada’s chief medical advisor, on Wednesday.

The vaccine, made by US drugmaker Pfizer and German biotech firm BioNTech, is 95% effective at preventing COVID-19, according to the company’s Phase 3 trials. Pfizer predicts it will produce up to 50 million vaccine doses for global distribution by the end of 2020, and up to 1.3 billion doses in 2021.

Initial supplies of the vaccine will be limited, with more coming in spring of 2021, Canadian officials announced in a press conference Wednesday. The country should receive up to 249,000 doses of Pfizer’s vaccine by the end of December, health officials said. And 14 sites across the country will be ready to receive vaccines next week, health officials added.

“Canada reached a critical milestone in its fight against COVID-19 with the authorization of the first COVID-19 vaccine,” the country’s health department said in a statement. “Health Canada has determined that the Pfizer-BioNTech vaccine meets the Department’s stringent safety, efficacy and quality requirements for use in Canada.”

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Canadian health officials highlighted that although the vaccine was approved through an interim order aimed at streamlining the vaccine process, that Canadians should “feel comfortable” taking the shot, and that health officials, as well as Pfizer, will be monitoring closely for any adverse effects in the coming months.

Canada is also reviewing three other experimental vaccines, and has placed seven pre-orders for vaccines, including Pfizer’s, according to Canadian health officials and the Duke Global Innovation and Health Center. 

When asked how Canada’s health department “beat the FDA” to approval, Dr. Sharma said, “We’re not in a race against any other regulator….we got the last piece of information late last night… and that’s what we are announcing today.”

Read more: How the pharma giant Pfizer teamed up with a little-known biotech to develop an effective coronavirus vaccine in record time

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