Pfizer Canada ULC and BioNTech SE today announced that Health Canada has granted full approval (Notice of Compliance or NOC) 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 authorization permitted essential rollout of vaccine doses across Canada to help provide protection during the COVID-19 pandemic, based on preclinical and clinical data, including initial data from the Phase 3 clinical trial.
Although the vaccine’s brand name will be COMIRNATY following this approval, Canada will continue to receive vials of the vaccine labeled as 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 to provide the COVID-19 vaccination series. Given the current ongoing pandemic, a gradual transition to new labeling with the COMIRNATY brand name will occur at a later date.
For this full approval (Notice of Compliance; “NOC”) of the New Drug Submission (NDS), Pfizer and BioNTech submitted a comprehensive data package that included longer-term follow-up data from the Phase 3 trial, where the vaccine’s efficacy and safety profile were observed up to six months after the second dose. The NDS package also included the manufacturing and facilities data required for licensure.