Health Canada authorises emergency use of Pfizer’s COVID-19 vaccine
Posted: 10 December 2020 | Hannah Balfour (European Pharmaceutical Review) | No comments yet
Canada becomes the third country to approve Pfizer and BioNTech’s mRNA COVID-19 vaccine BNT162b2 for emergency use – after UK and Bahrain.
Health Canada has authorised the emergency use of BNT162b2, Pfizer and BioNTech SE’s mRNA COVID-19 vaccine, under Interim Order. The companies have agreed to supply the Government of Canada with a minimum of 20 million doses (and up to 76 million doses) of the vaccine through 2021.
According to the companies, distribution of the vaccine in Canada will be prioritised 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 commercialisation 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,” said Cole Pinnow, President, Pfizer Canada. “We commend Health Canada for its careful and thorough assessment of our COVID-19 vaccine and timely action to help protect Canadians.”
“It is encouraging to see that our mRNA vaccine is now authorised in Canada. Following UK and Bahrain, it is the third country to approve use of our vaccine within a week,” 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.”
The authorisation was based on data filed through the rolling submission regulatory pathway. It includes data from the Phase II/III clinical trial, which began recruiting in late-July 2020, and enrolled approximately 44,000 people across approximately 150 sites in multiple countries.
