BioNTech and Pfizer XFG-Adapted Comirnaty (2026-2027 Season COVID-19 mRNA Vaccine) Receives Health Canada Authorization for Ages 6 Months and Older; Distribution to Commence Within Weeks
BioNTech SE (NASDAQ: BNTX) and Pfizer (NYSE: PFE) announced Thursday September 17, 2026 (syndicated Friday September 18) that Health Canada authorized their XFG-adapted Comirnaty (COVID-19 mRNA vaccine) for the 2026-2027 respiratory season in individuals aged 6 months and older. XFG (an LP.8.1 descendant Omicron subvariant lineage) was designated by WHO's Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) in April 2026 as the preferred variant for 2026-2027 seasonal vaccine composition, and multiple regulators (FDA, EMA, MHRA) have already authorized XFG-adapted formulations. Distribution across Canadian provinces and territories is expected to commence within days to weeks pending CDA/CADTH reimbursement pathways. Health Canada's authorization follows the June 2026 approvals of the equivalent updated Moderna Spikevax and Novavax Nuvaxovid XFG-adapted formulations. Comirnaty remains BioNTech's flagship product; 2025 global revenue was approximately €4.2 billion.