Pfizer and BioNTech Achieve Health Canada Authorization for Their Vaccine to Combat COVID-19

IndustryPRwire — Pfizer Canada and BioNTech SE announced 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.

Cole Pinnow, President, Pfizer Canada Commented “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, We commend Health Canada for its careful and thorough assessment of our COVID-19 vaccine and timely action to help protect Canadians.”  

Sean Marett, BioNTech’s Chief Business and Chief Commercial Officer Commented “It is encouraging to see that our mRNA vaccine is now authorized in Canada. Following U.K. and Bahrain, it is the third country to approve use of our vaccine within a week, 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.

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