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.
Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) announced Thursday August 27, 2026 FDA approval of the supplemental Biologics License Application for their 2026-2027 XFG-adapted Comirnaty (COVID-19 mRNA vaccine) for adults ages 65 and older and for individuals 5-64 with at least one underlying condition that puts them at high risk for severe COVID-19 outcomes. The XFG-adapted formula was designed to elicit strong immune responses against XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1, and other contemporary lineages. Shipping to distribution centers began immediately after approval. The XFG-adapted authorization for the 2026-2027 respiratory season provides continuity with Pfizer-BioNTech's annual mRNA vaccine cadence and, indirectly, reinforces the manufacturing and lipid-nanoparticle infrastructure that Moderna is now leaning on for the intismeran neoantigen peptide-encoding cancer vaccine program.
Pfizer (NYSE: PFE) reported Q2 2026 earnings Tuesday August 4, 2026 with revenue of $15 billion and adjusted diluted EPS of $0.77, beating analyst expectations. The company raised the midpoint of its full-year 2026 revenue guidance to $60.5-62.5 billion, up from a previous $59.5-62.5 billion range. The guidance update reflected approximately $1.5 billion in upside from non-COVID products, partially offset by a reduction in the company's forecast for COVID-19 treatments (Paxlovid and Comirnaty) now pegged at approximately $4 billion for the year. Adjusted R&D expenses increased 12% operationally to $2.7 billion, driven by increased spending on oncology and obesity product candidates. CEO Albert Bourla said in the earnings call that the obesity program is advancing with substantial momentum and that the oncology portfolio remains a source of strength. Shares rose approximately 1.86% to $25.50 following the announcement. Pfizer's obesity program includes danuglipron (oral GLP-1) and multiple next-generation candidates advanced through the Metsera acquisition; the Metsera monthly-injectable ultra-long-acting GLP-1 candidate produced up to 11% weight loss over 28 weeks in Phase 2b data reported earlier in 2026.