The European Commission granted marketing authorization for Pfizer and BioNTech's 2026-2027 COVID-19 vaccine targeting the XFG variant, covering individuals aged 6 months and older across all 27 EU member states plus Iceland, Liechtenstein and Norway. The approval follows an EMA Emergency Task Force recommendation and CHMP endorsement, with more than 5 billion doses of the companies' COVID-19 vaccines distributed globally to date.
The European Commission authorized Pfizer and BioNTech's XFG-adapted COVID-19 vaccine for the 2026-2027 season, covering all 27 EU member states.
"The evidence suggests that targeting XFG would provide the best protection against COVID-19," the EMA's Emergency Task Force said in its May 29 recommendation.
The approval follows the CHMP recommendation from July 23, based on clinical, non-clinical and real-world data showing the monovalent XFG-adapted vaccine generated strong immune responses against circulating lineages including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1. More than 5 billion doses of the Pfizer-BioNTech COVID-19 vaccines have been distributed globally.
The authorization ensures supply readiness ahead of the respiratory disease season, when demand for COVID-19 vaccination is expected to rise. Pfizer and BioNTech have already initiated manufacturing at risk, with shipping set to begin soon.
The marketing authorization is valid in all 27 EU member states as well as Iceland, Liechtenstein and Norway. EU member states and Norway will be supplied either via the EC contract or according to individual country government policies. The companies have also submitted data for the updated vaccine to regulatory authorities around the world and continue monitoring COVID-19 epidemiology to meet global public health needs.
The vaccine is based on BioNTech's proprietary mRNA technology. BioNTech holds the marketing authorization for the Pfizer-BioNTech COVID-19 vaccine and its adapted versions in the US, the EU, the UK and other countries.
The approval secures a continued revenue stream for both companies heading into the 2026-2027 respiratory season, reinforcing their position in the COVID-19 vaccine market. Investors will watch uptake rates and government ordering volumes as the season approaches.
This article is for informational purposes only and does not constitute investment advice.
