On September 16, 2021, Health Canada granted full approval (Notice of Compliance or NOC) for COMIRNATY™. The vaccine was initially authorized for use in Canada under an Interim Order Authorization on December 9, 2020 under the name Pfizer-BioNTech COVID-19 Vaccine.
COMIRNATY™ and the Pfizer-BioNTech COVID-19 Vaccine have the same formulation, and are considered interchangeable by Health Canada. For additional information, please refer to the Health Canada approved Product Monograph for COMIRNATY™.
Although the vaccine’s brand name is now COMIRNATY™, Canada will continue to receive vials of the vaccine labeled as Pfizer-BioNTech COVID-19 Vaccine and a transition to new labeling in Canada with the COMIRNATY™ name will occur at a later date. This approval has no impact on any vials of the Pfizer-BioNTech COVID-19 Vaccine currently in Canada and these are usable until their expiry date. As a reminder, vials of Pfizer-BioNTech COVID-19 Vaccine with an expiry date of August 2021 through February 2022 printed on the label may remain in use for 3 months beyond the printed date as long as all approved storage conditions have been maintained.
Product Monograph (download PDF, 2544KB)
Patient Information (download PDF,106KB)
September 9, 2022 Health Product Risk Communication (download PDF, 550KB)
May 9, 2022 Health Product Risk Communication (download PDF, 1217KB)
November 19, 2021 Health Product Risk Communication (download PDF, 753KB)
Canadian regulations limit the scope of information we are permitted to give on prescription drugs via the Internet or other means. Please consult a qualified health professional for more detailed information.
Please contact Pfizer Canada Medical Information at 1 800 463-6001 with any comments or inquiries.
If you would like to report an adverse event related to Pfizer's COVID-19 vaccine, we encourage you to visit our designated safety web portal, where you can efficiently and seamlessly report your experience with the Pfizer Covid-19 vaccine. You can access this web portal at www.pfizersafetyreporting.com
If you encounter technical difficulties in viewing our product information please contact Pfizer.ca