Coronavirus: Canada approves Pfizer, BioNTech COVID-19 vaccine for use

Health officials in Canada on Wednesday authorized the use of a COVID-19 vaccine developed by U.S. pharmaceutical company Pfizer and German biotechnology company BioNTech, making Canada the second western country to approve the vaccine.

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The decision came weeks after Pfizer submitted an application for regulatory review of its COVID-19 vaccine.

“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,” officials said in a statement.

“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.”

>> Related: UK approves Pfizer COVID-19 vaccine for emergency use

The authorization applies to people 16 years of age or older, officials said. Pfizer and BioNTech are running clinical trials to determine whether the vaccine is safe in younger children.

Earlier this week, Canadian health officials said the country expected to get up to 249,000 doses of the Pfizer/BioNTech COVID-19 vaccine this month, contingent on the government’s approval of the drug. In all, the country has secured up to 76 million doses of the vaccine, officials said.

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The United Kingdom became the first western country to approve of a COVID-19 vaccine. Health workers began inoculating people with the drug developed by Pfizer and BioNTech on Tuesday.

Regulators in the U.S. plan to debate the scientific research backing the Pfizer/BioNTech vaccine Thursday. In a 53-page analysis released by the U.S. Food and Drug Administration ahead of the meeting, officials signaled they would move to approve of the historic drug.

>> Related: FDA sees ‘no specific safety concerns’ for Pfizer, BioNTech vaccine, analysis shows

Officials with Pfizer and BioNTech previously said the companies’ drug was shown to be 95% effective in its clinical trial. Data released Tuesday showed that, in a trial involving 36,600 participants, eight people who were given the vaccine developed COVID-19 while 162 people who were given a placebo got the virus.

Officials say they expect the first vaccine doses to be delivered nationwide by Dec. 15, if the FDA authorizes emergency use of the drug.

>> Related: First shipments of Pfizer vaccine could be delivered by Dec. 15

Last week, biotechnology company Moderna asked the FDA to approve of emergency use of its COVID-19 vaccine. The company previously announced that a clinical trial found the drug to be 94% effective.

Experts are scheduled to meet Dec. 15 to review the company’s data.

>> Related: Moderna says new results show vaccine 94% effective; company seeking emergency OK

The U.S. continues to lead the world in COVID-19 cases, with more than 15.1 million reported as of Wednesday, according to a tally from Johns Hopkins University. More than 286,000 people in the U.S. have died of the viral infection.

Worldwide, more than 68.4 million cases of COVID-19 have been reported since the virus was first detected in December 2019, resulting in over 1.5 million deaths.

Cox Media Group