Canadian Manufacturing

Pfizer and BioNTech receive Health Canada Authorization for COVID-19 vaccine

The companies will supply a minimum of 20 million doses to Canada through 2021

December 9, 2020  by CM Staff

Fact Sheet – Scaling Up to Supply a COVID-19 Vaccine

KIRKLAND and MAINZ — Pfizer Canada and BioNTech SE announced on Dec. 9 that Health Canada has granted Authorization under Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2). 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.

“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.

“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.”

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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.