Health Canada authorisation is based on Pfizer and BioNTech’s regulatory application, filed under the rolling submission regulatory pathway
Health Canada authorises first Covid-19 vaccine. (Credit: Pete Linforth from Pixabay.)
Pfizer and BioNTech have secured the Health Canada authorisation under Interim Order for the emergency use of their mRNA-based Covid-19 vaccine BNT162b2.
Health Canada said that the Pfizer-BioNTech vaccine has met its safety, efficacy and quality requirements for use in Canada.
The distribution of the vaccine in Canada is planned to be prioritised based on the populations identified by the National Advisory Committee on Immunizations (NACI).
BioNTech will hold the regulatory approvals in the UK and Canada, along with the US, the EU and other countries, if approved, while Pfizer holds the global marketing and distribution rights, except in China, Germany and Turkey.
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.”
Health Canada authorisation is based on data from the Phase 2/3 study of BNT162b2
Health Canada’s decision is based on Pfizer and BioNTech’s regulatory application filed on 9 October 2020, under the rolling submission regulatory pathway.
The submission includes data from the Phase 2/3 clinical trial, which enrolled around 44,000 people across nearly 150 sites in different countries, from late-July 2020.
Pfizer Canada and BioNTech have agreed with the Government of Canada to supply a minimum of 20 million doses of the vaccine, with an option to increase it up to 76 million doses, through 2021.
The companies said that they are working together with governments and health authorities around the world to help ensure BNT162b2 can reach those most in need as quickly as possible, subject to country authorization or approval.
Also, they are following a phased approach to rapidly scale, manufacture and distribute large quantities of the vaccine at high quality, complementing the mRNA manufacturing expertise that BioNTech has gained over almost a decade.
BioNTech chief business and chief commercial officer Sean Marett said: “It is encouraging to see that our mRNA vaccine is now authorized in Canada. Following UK 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.”
Recently, the mRNA-based Covid-19 vaccine BNT162b2 has been authorised by the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) for emergency use.