Canada’s health regulator has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).
Pfizer submitted documentation related to the BNT162b2 vaccine to Canadian regulators on Oct. 9, 2020.
“Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place,” Health Canada explained in a statement. The agency also stressed it would carefully monitor the safety of the vaccine and “will not hesitate to take action if any safety concerns are identified.”
Health Canada also has released data about the vaccine, its mode of action and potential side effects on its website. The agency plans on publishing further documents, including the full clinical trial package related to the vaccine, in the coming weeks.
Last week, the U.K. and Bahrain became the first countries to allow the distribution of the vaccine.
The Pfizer-BioNTech vaccine may soon be available in the U.S. The Vaccines and Related Biological Products Advisory Committee, an advisory panel to FDA, will meet tomorrow to discuss Emergency Use Authorization (EUA) of the vaccine.
President Trump has pressed the FDA to make the vaccine available. “We’re very hopeful that the FDA will authorize the Pfizer vaccine within days,” he said at yesterday’s Operation Warp Speed briefing.
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