Kirkland, July 25, 2022 – Today, Pfizer Canada and BioNTech filed a New Drug Submission (NDS) with Health Canada for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 sub-lineage, to be administered as a booster dose in individuals 12 years of age and older. This application follows guidance from Health Canada to work towards the introduction of an Omicron-adapted bivalent vaccine candidate to address the continued evolution of SARS-CoV-2. The safety and efficacy of this NDS is still under investigation and market authorization has not yet been obtained.
In Canada, the Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY, is currently approved for use in individuals aged 5 and older. Canadians may find more information about the vaccine at www.pfizerbiontechvaccine.ca. Canadian Health Care Professionals can visit www.cvdvaccine.ca for more information.
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.
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Corporate Affairs Canada