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Pfizer/BioNTech coronavirus vaccine gets a nod in Canada
Published in The Saudi Gazette on 09 - 12 - 2020

Canada's health department on Wednesday gave emergency approval to a coronavirus vaccine for its own country, a day before the United States' Food and Drug Administration is due to meet about whether to do the same.
Health Canada determined the Pfizer/BioNTech vaccine for COVID-19 meets the department's safety, efficacy and quality requirements for use in Canada, the department said on Wednesday. The decision comes a week after the United Kingdom approved the vaccine there.
The nation's first coronavirus vaccine green light comes under a new interim order system that allows for accelerated approval very similar to the US Food and Drug Administration's emergency use authorizations.
Further details from Health Canada are expected to be announced later Wednesday, but Canadian Prime Minister Justin Trudeau said this week that Canada would receive an initial shipment of 249,000 doses by the end of the year and expected Canada's first vaccinations to occur sometime next week.
Meanwhile, in the United States, an official said coronavirus vaccines would be distributed to vulnerable populations within days of any decision to authorize them.
The FDA will meet on Thursday to discuss whether to grant emergency use authorization (EUA) for the Pfizer/BioNTech vaccine candidate in the US. A decision could come within days of that meeting, officials say.
The meeting comes as coronavirus hospitalizations in the US and average daily cases are at an all-time high.
After any EUA is made, "we will start to have shots in arms within 96 hours" of that decision, Gen. Gustave Perna, chief operating officer of the federal government's Operation Warp Speed vaccine initiative, said Tuesday. "That's what I believe with all my heart."
The FDA also intends to deliberate on a separate vaccine candidate, from Moderna, on Dec. 17, according to CNN. — Agencies


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