Canada becomes third country to authorize Pfizer and BioNTech COVID-19 vaccine

KIRKLAND, QC and MAINZ, Germany, Dec. 9, 2020 /CNW/ – Pfizer Canada and BioNTech SE today announced that Health Canada has granted Authorization under Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2). This comes after the vaccine is being rolled out in the U.K. and approved to be distributed in Bahrain.

Health Canada received Pfizer’s submission on October 9, 2020 and 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.

The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the National Advisory Committee on Immunizations (NACI). BioNTech will hold the regulatory approval in Canada, while Pfizer Canada will have the commercialization rights.

Health Canada released a statement saying the terms and conditions of the Pfizer-BioNTech vaccine authorization require the manufacturer to continue providing information to Health Canada on the safety, efficacy and quality of the vaccine to ensure the benefits of the vaccine continue to be demonstrated through market use.

The initial indication of the vaccine is for use in people 16 years of age or older. Pfizer-BioNTech are running further clinical trials on children of all age groups and the indication could be revised in the future to include children if the data from these studies support it.

The vaccine was authorized under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. This process allowed Health Canada to assess information submitted by the manufacturer as it became available during the product development process, while maintaining Canada’s high standards.

Health Canada assures that Canadians can feel confident that the review process was rigorous and that strong monitoring systems are 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.

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. I’d like to acknowledge the tremendous efforts of Pfizer and BioNTech colleagues around the world who have contributed to the development of this vaccine,” says Cole Pinnow, President, Pfizer Canada. “We commend Health Canada for its careful and thorough assessment of our COVID-19 vaccine and timely action to help protect Canadians.”  

“It is encouraging to see that our mRNA vaccine is now authorized in Canada. Following the U.K. and Bahrain, it is the third country to approve use of our vaccine within a week,” said Sean Marett, BioNTech’s Chief Business and Chief Commercial Officer. “Together with our partner Pfizer, we are ready to ship the vaccines to Canada as soon as we receive the green light from the regulatory authority to start with the distribution.”

Health Canada’s decision is based on data that was filed through the rolling submission regulatory pathway and includes data from the Phase 2/3 clinical trial, which began recruiting in late-July 2020, and enrolled approximately 44,000 people across approximately 150 sites in multiple countries.

Pfizer Canada and BioNTech will supply the Government of Canada a minimum of 20 million doses (and up to 76 million doses) of the vaccine through 2021.

lead photo Major General Dany Fortin, head of vaccine distribution effort

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