The BNT162b2 vaccine has been granted authorisation under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19.
Canada is now the third country to have approved the mRNA vaccine. Earlier this month, the UK granted it a temporary emergency use authorisation (EUA) and last week, Bahrain followed suit by approving the vaccine.
Pfizer and BioNTech have committed to supply at least 20 million doses and a maximum of 76 million doses of the BNT162b2 vaccine to Canada in 2021.
Pfizer Canada president Cole Pinnow said: “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.”
According to Health Canada, the mRNA vaccine is initially indicated for use in people, aged 16 years or older.
Pfizer and BioNTech are carrying out additional clinical trials on children of all age groups. Health Canada stated that it could revise the indication in the future to include children should the data from the trials support it.
The approval from Health Canada comes nearly two months after Pfizer’s rolling submission to the regulator.
Health Canada’s approval is based on the data from a phase 2/3 clinical trial, which started enrolling in July this year and had taken in nearly 44,000 people across nearly 150 sites in various countries.
Health Canada stated: “Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems 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.
“The terms and conditions of the Pfizer-BioNTech vaccine authorisation 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.”
BioNTech holds the regulatory approval in the country, while Pfizer Canada will have the commercialisation rights.
Based on BioNTech’s mRNA technology, the BNT162b2 vaccine has been designed to encode an optimised SARS-CoV-2 full-length spike glycoprotein, which is a target of virus neutralising antibodies.