NEW YORK and MAINZ, Germany, July 29, 2026
Pfizer Inc. and BioNTech SE announced that the European Commission (EC) has granted marketing authorization for their 2026–2027 XFG-adapted COVID-19 vaccine, providing active immunization against SARS-CoV-2 for individuals 6 months of age and older. The updated monovalent mRNA vaccine targets the XFG variant of the JN.1 lineage, following recommendations from the European Medicines Agency (EMA) Emergency Task Force (ETF). The authorization covers all 27 European Union Member States, as well as Iceland, Liechtenstein, and Norway, with vaccine shipments expected to begin immediately to support the upcoming respiratory virus season. The approval reinforces the companies’ continued leadership in COVID-19 vaccination, with more than five billion doses of Pfizer-BioNTech COVID-19 vaccines distributed globally.
XFG-Adapted Vaccine Demonstrates Strong Protection Against Emerging Variants
The European Commission’s approval follows the EMA Committee for Medicinal Products for Human Use (CHMP) recommendation issued on July 23, 2026, supported by an extensive package of clinical, non-clinical, manufacturing, quality, and real-world evidence. Data demonstrated that the 2026–2027 XFG-adapted vaccine generated strong immune responses against currently circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1, and several other emerging lineages. The updated vaccine also maintained a favorable safety and efficacy profile, supporting its continued use across pediatric and adult populations. The EMA Emergency Task Force concluded that targeting the XFG variant would provide the best available protection against COVID-19 during the 2026–2027 vaccination season.
Manufacturing Underway to Support Seasonal Vaccine Demand
To ensure timely vaccine availability, Pfizer and BioNTech initiated at-risk manufacturing of the updated vaccine ahead of regulatory approval. Distribution will begin shortly through the European Commission procurement contract and country-specific government purchasing programs, ensuring rapid access before seasonal respiratory infections increase. The companies also confirmed that regulatory submissions for the XFG-adapted vaccine have been filed with health authorities worldwide as they continue monitoring the evolving epidemiology of COVID-19 and emerging variants. The vaccine remains based on BioNTech’s proprietary mRNA platform, which has been used globally since the initial launch of the Pfizer-BioNTech COVID-19 vaccine.
Advertisement
Strengthening Global COVID-19 Preparedness
The latest authorization highlights the ongoing commitment of Pfizer and BioNTech to maintaining vaccine effectiveness against evolving SARS-CoV-2 variants through rapid strain adaptation and regulatory collaboration. By updating the vaccine composition to match the XFG variant, the companies aim to provide improved protection during the 2026–2027 respiratory disease season while supporting public health efforts across Europe. With billions of doses already supplied globally and continued investment in mRNA vaccine innovation, Pfizer and BioNTech remain focused on ensuring long-term preparedness against COVID-19 and future viral evolution.
Source: Pfizer press release
