Pfizer and BioNTech Granted Favorable CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine in the European Union

Today, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of their Omicron JN.1-adapted monovalent COVID-19 vaccine, COMIRNATY® JN.1, for active immunization against COVID-19 caused by SARS-CoV-2 in individuals aged 6 months and older. This adaptation follows guidance from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency’s Emergency Task Force (ETF) to update vaccines targeting the SARS-CoV-2 variant JN.1 for the 2024-2025 vaccination campaign. The ETF highlighted that focusing on JN.1 is crucial to sustaining vaccine efficacy amidst ongoing viral evolution.

Pending review by the European Commission (EC), which is expected to render a final decision shortly, the updated vaccine could swiftly become available for distribution across applicable EU member states. Pfizer and BioNTech have proactively manufactured the Omicron JN.1-adapted monovalent COVID-19 vaccine to ensure readiness ahead of the upcoming fall and winter seasons, anticipating increased demand for vaccination.

The CHMP’s positive recommendation stems from comprehensive evaluations of prior clinical, non-clinical, and real-world data affirming the safety and effectiveness of Pfizer and BioNTech’s COVID-19 vaccines. The submission included data demonstrating enhanced immune responses against multiple Omicron JN.1 sublineages, including KP.2, KP.3, and other prevalent variants, compared to the companies’ earlier Omicron XBB.1.5-adapted monovalent vaccine.

Concurrently, Pfizer and BioNTech have initiated rolling applications with the U.S. Food and Drug Administration (FDA), aligning with recent FDA guidance, to seek approval for their Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals aged 6 months and older. The companies remain vigilant in monitoring COVID-19 epidemiology and are prepared to meet global health demands accordingly.

Pfizer-BioNTech’s COVID-19 vaccines, including COMIRNATY®, leverage BioNTech’s mRNA technology and have been developed collaboratively. BioNTech holds the Marketing Authorization for COMIRNATY® and its adapted versions (COMIRNATY® Original/Omicron BA.4/5; COMIRNATY® Omicron XBB.1.5) in various jurisdictions, alongside emergency use authorizations jointly with Pfizer.

For full prescribing and safety information regarding COMIRNATY® and related vaccines, individuals are advised to consult healthcare providers or visit Pfizer’s official resources for detailed guidance on indications, authorized use, and safety considerations.

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