December 9, 2020 -- Health Canada has granted authorization under an interim order for the emergency use of Pfizer-BioNTech's messenger RNA COVID-19 vaccine, BNT162b2.
The distribution of the vaccine in Canada will be prioritized according to the populations identified by the National Advisory Committee on Immunizations. BioNTech will hold the regulatory approval in Canada, while Pfizer Canada will have commercialization rights.
Health Canada's decision is based on data filed through a rolling submission regulatory pathway and included data from phase II/III clinical trials which began in July 2020 and has enrolled approximately 44,000 people globally.
Pfizer Canada and BioNTech will supply the Canadian government a minimum of 20 million doses and up to 76 million doses of the vaccine through 2021.