RegulatoryJul 29, 2026, 04:33 PM
BioNTech & Pfizer Get EC Approval for 2026-27 XFG COVID-19 Vaccine
AI Summary
BioNTech and Pfizer announced that the European Commission (EC) has granted marketing authorization for their 2026-2027 COVID-19 vaccine formula. This updated vaccine targets the XFG variant and is approved for active immunization in individuals 6 months of age and older across the EU, Iceland, Liechtenstein, and Norway. The companies have already begun at-risk manufacturing to ensure supply readiness for the upcoming respiratory disease season, with data indicating a strong immune response against contemporary circulating and emerging lineages.
Key Highlights
- EC granted marketing authorization for 2026-2027 COVID-19 vaccine targeting XFG variant.
- Vaccine approved for individuals 6 months of age and older in EU, Iceland, Liechtenstein, and Norway.
- Authorization based on EMA's ETF recommendation to target XFG variant of JN.1 lineage.
- Pfizer and BioNTech initiated at-risk manufacturing to ensure supply readiness.
- Data shows strong immune responses against XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1, and other lineages.
- Over five billion doses of Pfizer-BioNTech COVID-19 vaccines distributed globally.
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