PFE · News · 20260827N

Comirnaty Regulatory Approval

PFIZER INC · 2026-08-27 · Importance 47 · Surprise 60 · In source text

The U.S. Food and Drug Administration approved Pfizer and BioNTech’s supplemental Biologics License Application for the 2026–2027 COMIRNATY XFG-adapted COVID-19 vaccine on August 27, 2026. The vaccine targets the XFG variant in accordance with FDA guidance and is authorized for adults aged 65 and older and people aged 5 through 64 with at least one underlying condition creating a high risk of severe COVID-19 outcomes. Shipping began immediately for distribution through U.S. pharmacies, hospitals, and clinics for the fall 2026 season.

Key facts

• On August 27, 2026 the U.S. Food and Drug Administration approved the supplemental Biologics License Application (sBLA) for Pfizer and BioNTech's 2026-2027 COVID-19 vaccine formula targeting the XFG variant. source
• Pfizer and BioNTech stated that shipping for this season's COVID-19 vaccine will begin immediately and the vaccine will be available in pharmacies, hospitals, and clinics across the U.S. in the coming days. source
• The FDA approval covers use in adults ages 65 years and older. source
• The FDA approval also covers individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. source
• Pfizer and BioNTech said the FDA selection of the XFG variant is based on guidance as the preferred composition of COVID-19 vaccines for use in the U.S. beginning in fall 2026. source
• Pfizer and BioNTech said the 2026-2027 COVID-19 vaccine formula targets the XFG variant in line with FDA guidance to more closely match contemporary circulating variants. source
• Reuters reported that the U.S. Food and Drug Administration approved Pfizer-BioNTech's updated COVID vaccine for the 2026-27 season. source
• The approved product name is COMIRNATY® XFG; COVID-19 Vaccine, mRNA. source

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