Another season, another updated formula, another authorization for babies on up. The COVID vaccine calendar just keeps rolling.
The European Commission granted marketing authorization on July 29 2026.
The formula is the companies’ 2026-2027 COVID-19 vaccine adapted to the XFG variant.
Authorization covers active immunization to prevent COVID-19 caused by SARS-CoV-2.
It applies to individuals 6 months of age and older.
The decision follows the EMA Emergency Task Force recommendation to target XFG of the JN.1 lineage.
The ETF stated targeting XFG would provide the best protection against COVID-19.
Authorization is valid across all 27 EU member states plus Iceland, Liechtenstein and Norway.
Pfizer and BioNTech had already started manufacturing the monovalent XFG-adapted vaccine at risk.
Shipping is expected to begin soon ahead of the respiratory season.
More than five billion doses of the Pfizer-BioNTech COVID-19 vaccines have been distributed globally to date.
The companies cite clinical, non-clinical and real-world data supporting safety and immune response against circulating lineages.
Pfizer press release: https://www.pfizer.com/news/press-release/press-release-detail/european-commission-authorizes-pfizer-and-biontech-xfg
Yahoo Finance coverage: https://finance.yahoo.com/healthcare/articles/european-commission-authorizes-pfizer-biontech-203000882.html
The Pharma Letter: https://www.thepharmaletter.com/biotech-news/ec-authorizes-pfizer-and-biontech-xfg-adapted-covid-19-vaccine