Pfizer and BioNTech win FDA approval for XFG-adapted COVID vaccine
US pharma major Pfizer (NYSE: PFE) and German biotech firm BioNTech (Nasdaq: BNTX) have secured US Food and Drug Administration (FDA) clearance for the 2026-2027 formula of their COVID-19 vaccine Comirnaty (COVID-19 vaccine, mRNA), reworked to target the XFG variant. Shipping began immediately after the August 27 approval.
The supplemental Biologics License Application covers adults aged 65 and over, along with people aged five through 64 who have at least one underlying condition placing them at high risk of severe outcomes. That mirrors the narrowed eligibility the agency applied to last season's shots rather than a broad population recommendation.
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