Pfizer-BioNTech Comirnaty® is registered as a new drug and has a new brand name that most people have not seen or heard before but it is the same vaccine that Canadians have been using throughout the COVID-19 pandemic.
Comirnaty is based on BioNTech’s proprietary mRNA technology but was developed by both BioNTech and Pfizer and authorized for essential rollout on December 9, 2020 under the more familiar name Pfizer-BioNTech COVID-19 Vaccine.
Pfizer issued a press release today confirming that “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.”
Pfizer says that health care providers will continue to receive vaccine vials labelled “Pfizer-BioNTech COVID-19 Vaccine” while they gradually transition over to the new labelling, which at some point will say “Comirnaty.”
Pfizer and BioNTech renamed the vaccine in their application for approval to Health Canada for use of the vaccine on young people between 12 and 15 years old.
The approval means that Pfizer and BioNTech met the federal drug regulations in Canada for the import, sale, advertising and use of their COVID-19 vaccine product.
Their submission package to Health Canada contained longer-term follow-up information from research and testing, in which “the vaccine’s efficacy and safety profile were observed up to six months after the second dose.”
The companies plan to pursue regulatory approvals in the United States, the European Union and the United Kingdom as well as in other countries where the vaccine was granted approval for emergency use during the COVID-19 pandemic.