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Data indicate that the 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, induces a strong immune response against contemporary circulating and emerging lineages
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More than five billion doses of the Pfizer-BioNTech COVID-19 vaccines distributed globally
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Vaccine demonstrates a favorable safety and efficacy profile
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Shipping will begin soon to ensure rapid access of this season’s vaccine
July 29, 2026 --NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Commission (EC) has granted marketing authorization for the companies’ 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the Emergency Task Force (ETF) of the European Medicines Agency (EMA) to update COVID-19 vaccines to target the XFG variant of the JN.1 lineage for the 2026-2027 season. The ETF stated that “the evidence suggests that targeting XFG would provide the best protection against COVID-19.”1
The marketing authorization is valid in all 27 European Union (“EU”) Member States, as well as Iceland, Liechtenstein and Norway. Pfizer and BioNTech have already initiated manufacturing of the monovalent XFG-adapted COVID-19 vaccine at risk to ensure supply readiness in anticipation of the respiratory disease season, when the demand for COVID-19 vaccination is expected to increase. EU Member States as well as Norway, will be supplied either via the EC contract or according to individual country government policies.
The EC approval follows the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation from July 23, 2026 based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical and real-world data supporting the safety and efficacy of the Pfizer and BioNTech COVID-19 vaccine as well as manufacturing/quality and non-clinical data showing that the monovalent XFG-adapted COVID-19 vaccine generated strong immune responses against currently circulating SARS-CoV-2 lineages, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1 and other contemporary lineages.2
The companies have also submitted data for the updated COVID-19 vaccine to regulatory authorities around the world. The companies are continuing to monitor the evolving epidemiology of COVID-19 in preparation to meet global public health needs.
The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for the Pfizer-BioNTech COVID-19 vaccine and its adapted vaccines in the United States, the EU, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in other countries.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us.
About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.
1.ETF. ETF recommends updating COVID-19 vaccines to target XFG variant. Updated May 29, 2026. Accessed June 25, 2026. https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-xfg-variant
2.Vaccines and Related Biological Products Advisory Committee. Meeting Presentation - 2026-2027 COVID-19 Vaccine Formula: Pfizer/BioNTech Supportive Data. May 28, 2026. Accessed June 25, 2026. https://www.fda.gov/media/192765/download