Health Canada approved the Pfizer-BioNTech COVID-19 vaccine for use, it announced on Wednesday, adding that it granted authorization under Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2).
According to Pfizer, 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).”
We are proud to announce that Health Canada has granted Authorization under Interim Order for the emergency use of Pfizer and BioNTech’s COVID-19 vaccine. This is a historic step forward in our efforts to reduce the number of Canadians suffering from this devastating virus. pic.twitter.com/ZdttETMtFP
— Pfizer Canada (@PfizerCA) December 9, 2020
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, in a statement.
“We commend Health Canada for its careful and thorough assessment of our COVID-19 vaccine and timely action to help protect Canadians.”
Pfizer notes that Health Canada’s decision is based on 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.
“It is encouraging to see that our mRNA vaccine is now authorized in Canada,” 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.”
According to the Government of Canada, Health Canada approved the vaccine after a “thorough, independent review of the evidence.”
“As part of its continued commitment to openness and transparency, Health Canada is publishing a number of documents related to this decision, including a high-level summary of the evidence that Health Canada reviewed to support the authorization of the vaccine,” the federal government said.
More detailed information will be available in the coming weeks, including a detailed scientific summary and the full clinical trial data package.
The federal government also noted that 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.”
Earlier this week, Prime Minister Justin Trudeau announced that Canada would be receiving up to 249,000 doses of Pfizer’s vaccine candidate this month.
Trudeau noted that because the vaccine needs to be stored at -70°C, the distribution of it would be “a logistical challenge.”
Canadian health officials have said they will procure up to 194 million doses of COVID-19 vaccines, with the option to purchase an additional 220 million. The first three million will be available some time in the first quarter of 2021.