European Investor
28 Aug 2026, 16:36
Pfizer and BioNTech Win FDA Approval for Updated XFG COVID-19 Vaccine
Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) received U.S. FDA approval for their updated 2026–2027 COMIRNATY COVID-19 vaccine targeting the XFG variant.
The updated vaccine is approved for adults aged 65 and older and for people aged 5 to 64 who have at least one underlying condition that increases their risk of severe COVID-19. The XFG formulation follows FDA guidance aimed at more closely matching currently circulating variants.
According to the companies, supporting data showed strong immune responses against several circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1. Pfizer and BioNTech said shipments will begin immediately, with the vaccine expected to reach U.S. pharmacies, hospitals and clinics within days.
The approval is commercially positive for both companies because it keeps their COVID-19 vaccine franchise positioned for the upcoming U.S. vaccination season. However, the financial impact will ultimately depend on vaccination rates and demand for updated COVID-19 shots.
Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) received U.S. FDA approval for their updated 2026–2027 COMIRNATY COVID-19 vaccine targeting the XFG variant.
The updated vaccine is approved for adults aged 65 and older and for people aged 5 to 64 who have at least one underlying condition that increases their risk of severe COVID-19. The XFG formulation follows FDA guidance aimed at more closely matching currently circulating variants.
According to the companies, supporting data showed strong immune responses against several circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1. Pfizer and BioNTech said shipments will begin immediately, with the vaccine expected to reach U.S. pharmacies, hospitals and clinics within days.
The approval is commercially positive for both companies because it keeps their COVID-19 vaccine franchise positioned for the upcoming U.S. vaccination season. However, the financial impact will ultimately depend on vaccination rates and demand for updated COVID-19 shots.
