US pharma giant Pfizer and German biotech company BioNTech have bagged Health Canada approval for their BNT162b2 Covid-19 vaccine.
The BNT162b2 vaccine has been authorized to be used in Canada under the regulator’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19.
Canada has now joined the UK and Bahrain in approving the mRNA vaccine for preventing Covid-19.
The country will get anywhere between 20 million and 76 million doses of the BNT162b2 vaccine in 2021, as per an agreement signed by Pfizer and BioNTech with the Canadian government in August.
BioNTech will hold the Canadian regulatory approval for the BNT162b2 Covid-19 vaccine, while Pfizer’s Canadian subsidiary will have the commercialization rights.
Built on BioNTech’s mRNA technology, the BNT162b2 vaccine is said to encode an optimized SARS-CoV-2 full-length spike glycoprotein, which is a target of virus neutralizing antibodies.
Cole Pinnow – President of Pfizer Canada 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.”
Health Canada stated that the BNT162b2 mRNA vaccine can be given to people, aged 16 years or older. The indication could be expanded to cover children of all age groups once Pfizer and BioNTech produce data to support it through their ongoing clinical trials.
It can be noted that Pfizer and BioNTech initiated a rolling submission in early October with Health Canada, seeking its approval for the BNT162b2 Covid-19 vaccine candidate.
Health Canada authorized the mRNA vaccine based on the findings of a phase 2/3 clinical trial, which began enrolling volunteers in late-July. Eventually, the trial enrolled close to 44,000 people at around 150 sites in multiple 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 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.”