Pfizer Canada and BioNTech announced on Thursday, September 17, 2026 that Health Canada authorized the XFG variant-adapted Comirnaty vaccine for active immunization against COVID-19 in people aged 6 months and older. The authorization was based on the cumulative clinical, non-clinical, and real-world data the companies had already submitted. The companies said the vaccine will be available through various distribution channels in the coming days and weeks, and Pfizer Canada said it has enough inventory to meet its contractual commitments.
Moderna (NASDAQ: MRNA) announced Friday August 28, 2026 that the UK Medicines and Healthcare products Regulatory Agency (MHRA) authorized its updated Spikevax XFG-adapted COVID-19 mRNA vaccine for adults and children aged six months and older, priced for the autumn NHS vaccination program covering adults 65 and older, care home residents, health and social care workers, and clinically vulnerable groups. For the first time in the UK, the updated Spikevax vaccine will also be available to purchase privately for those not eligible for the NHS Autumn vaccination program, distributed through high street pharmacies, occupational health providers, and private healthcare companies. The authorization mirrors the FDA supplemental BLA approval that Pfizer-BioNTech received Wednesday August 27 for Comirnaty XFG, and lands as the roughly $2 billion August 27 Moderna convertible notes raise gears the company for cancer vaccine expansion.
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.
An Icahn School of Medicine at Mount Sinai team reported in Nature Biotechnology on April 29 that hepatocytes actively dampen the immune response to standard mRNA vaccines and that engineering vaccines to avoid hepatocyte expression sharply boosts efficacy. In mice with lymphoma, an mRNA vaccine engineered to silence hepatocyte expression cut tumor burden by more than 50% versus a conventional mRNA vaccine, driven by a stronger killer T-cell response. The finding inverts a longstanding assumption that liver expression is helpful and supplies a generalizable design principle for mRNA cancer vaccines, infectious-disease vaccines, and gene-editing payloads.
Nearly half of participants in a Phase 1 trial of BioNTech/Genentech's personalized mRNA neoantigen vaccine autogene cevumeran remain alive up to six years after treatment, with T-cell responses showing no signs of waning. Eight of 16 patients produced durable CD8+ T cells targeting tumor neoantigens after nine doses, with the immune memory still detectable at six-year follow-up. A Phase 2 trial is underway.