Canada Backs Pfizer Virus Vaccine, Day Before FDA Meeting

By Adam Lidgett
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Law360 (December 9, 2020, 3:27 PM EST) -- Canada handed Pfizer and its German partner BioNTech emergency approval Wednesday for a COVID-19 vaccine, marking the third country to greenlight the companies' treatment.

Canada will be able to get between 20 million and 76 million doses through 2021, the companies said. The United Kingdom gave emergency approval to the treatment last week, and Bahrain has also granted approval, the companies said.

And while the United States has yet to give approval, the U.S. Food and Drug Administration is scheduled to meet with the Vaccines and Related Biological Products Advisory Committee on Thursday to consider a request by Pfizer and BioNTech for emergency approval.

"Today's decision from Health Canada is a historic moment in our collective fight against the COVID-19 pandemic and is a major step towards returning to normalcy in Canada," Pfizer Canada President Cole Pinnow said in a statement.

Health Canada said Wednesday in a separate announcement that the treatment "meets the department's stringent safety, efficacy and quality requirements for use in Canada." The department added that while the vaccine at this point is for anyone over the age of 16, there are still studies being done to see if the vaccine can be used on those under 16.

"Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place," Health Canada said.

Pfizer and BioNTech said last week that they inked a deal with the United Kingdom for 40 million doses to be delivered in the U.K. this year and next year. While the vaccines will be sent out in stages, Pfizer and BioNTech "will take immediate action to begin the delivery of vaccine doses," the companies said at the time.

When the companies announced they were seeking approval from the FDA, they said that if their vaccine is approved in the U.S., they expect to be able to produce 50 million doses by the end of the year and up to 1.3 billion doses next year. The companies will be ready to distribute the first doses within hours of government approval, they said at the time.

Moderna has also requested emergency approval from the FDA, asking the regulator to sign off on its COVID-19 vaccine that the drugmaker claims is 100% effective at preventing severe cases and 94% effective at preventing infection.

The U.K.-based pharmaceutical giant AstraZeneca said it is seeking approval in multiple countries around the world for one of its coronavirus vaccine candidates that achieved 90% effectiveness.

--Editing by Orlando Lorenzo.

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