Pfizer and BioNTech Get CHMP Nod for Omicron JN.1-adapted COVID-19 Vaccine in EU

Pfizer Inc. and BioNTech SE have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the marketing authorization for their Omicron JN.1-adapted monovalent COVID-19 vaccine, known as COMIRNATY® JN.1. This vaccine is aimed at active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals aged six months and older.

The decision from the CHMP follows guidance from both the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition and the EMA's Emergency Task Force (ETF). These organizations have recommended updating COVID-19 vaccines to target the SARS-CoV-2 variant JN.1, which is anticipated to be relevant for the 2024-2025 vaccination campaign. The ETF noted that evidence suggests targeting the JN.1 variant would help maintain the efficacy of the vaccines as the SARS-CoV-2 virus continues to evolve.

The European Commission (EC) will review the CHMP's recommendation and is expected to make a final decision soon. Once the EC provides authorization, Pfizer and BioNTech will be prepared to ship doses of the updated vaccine to EU member states immediately. The companies have been manufacturing the JN.1-adapted monovalent COVID-19 vaccine in anticipation of a potential rise in demand during the upcoming fall and winter seasons.

The recommendation by the CHMP is based on an extensive body of clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the COVID-19 vaccines developed by Pfizer and BioNTech. The application also included manufacturing and pre-clinical data demonstrating that the JN.1-adapted vaccine generates a significantly improved immune response against various Omicron JN.1 sublineages compared to the previously used Omicron XBB.1.5-adapted monovalent vaccine.

In parallel, Pfizer and BioNTech have started rolling applications with the U.S. Food and Drug Administration (FDA) for the approval of their Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals aged six months and older, following recent FDA recommendations. The companies will continue to monitor the evolving COVID-19 landscape and make necessary preparations to meet global public health needs.

The COVID-19 vaccines by Pfizer and BioNTech, including COMIRNATY®, are based on BioNTech's proprietary mRNA technology. These vaccines have been co-developed by the two companies, with BioNTech holding marketing authorizations in the United States, European Union, United Kingdom, and other countries. BioNTech is also the holder of emergency use authorizations or their equivalents in various regions, including jointly with Pfizer in the United States.

The updated vaccine is part of the companies’ ongoing efforts to adapt their immunization strategies in response to the continually evolving virus. The rapid development and adaptation of these vaccines are crucial as they seek to maintain high levels of protection against new variants.

In summary, the CHMP's recommendation for the Omicron JN.1-adapted monovalent COVID-19 vaccine marks a significant step toward addressing the ongoing challenges of the COVID-19 pandemic. With the decision from the European Commission pending, Pfizer and BioNTech are poised to begin distributing the updated vaccines as soon as authorization is granted, ensuring that EU member states have timely access to these crucial immunizations. The companies' proactive approach in manufacturing and preparing for the distribution underscores their commitment to public health and readiness to tackle future waves of COVID-19.

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