Canada Approves Comirnaty COVID-19 Vaccine

Pfizer Canada ULC and BioNTech SE announced that Health Canada had granted Approval for COMIRNATY® to prevent COVID-19 in individuals 12 years of age and older.

The vaccine was initially authorized for use in Canada under an Interim Order Authorization on December 9, 2020, and has been referred to as the Pfizer-BioNTech COVID-19 Vaccine.

The formulation for Pfizer-BioNTech COVID-19 Vaccine is the same formulation as COMIRNATY, and they are considered interchangeable by Health Canada.

“Based on the longer-term follow-up data that we submitted, today’s decision by Health Canada affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” said Fabien Paquette, Vaccines Lead, Pfizer Canada, in a press statement issued on September 16, 2021.

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in Canada, the United States, the European Union, and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies.