Pfizer Canada and BioNTech SE were granted Authorization by Health Canada under Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2). The distribution of the vaccine in Canada will be prioritized 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 commercialization rights.

Health Canada’s decision is based on data that was filed through the rolling submission regulatory pathway, and includes data from the Phase 2/3 clinical trial, which began recruiting in late-July 2020, and enrolled approximately 44,000 people across approximately 150 sites in multiple countries.

Pfizer Canada and BioNTech will supply the Government of Canada a minimum of 20 million doses (and up to 76 million doses) of the vaccine through 2021.

Pfizer and BioNTech continue to work in collaboration 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. The companies are taking a phased approach to quickly scale, manufacture and distribute large quantities of the vaccine.

BioNTech will hold the regulatory approvals in the UK and Canada, and, if granted, in the U.S., the EU and other countries. Pfizer will have marketing and distribution rights worldwide with the exception of China, Germany and Turkey.