Pfizer-BioNTech COVID-19 Vaccine COMIRNATY Receives Full Health Canada Approval for Individuals 12 Years and Older
KIRKLAND, QC & MAINZ, Germany, Sept. 16, 2021 /CNW/ - 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.
"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. "While a significant number of eligible Canadians are fully vaccinated, there is still much work to be done as infection and hospitalization rates continue to rise across the country, primarily among unvaccinated populations."
"Today's full approval is a testament to the vaccine's efficacy and safety profile," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "Our companies have shipped more than 1.4 billion doses worldwide, and we will continue to work tirelessly to broaden the access to our vaccine and to be prepared for potential emerging escape variants."
COMIRNATY, which is based on BioNTech's proprietary mRNA technology, was developed by both 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. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
About Pfizer Canada
For further information
SOURCE Pfizer Canada Inc.