Pharma Focus Asia

Pfizer and BioNTech Receive Positive CHMP Recommendation for EU Approval of Omicron JN.1-adapted COVID-19 Vaccine

Friday, June 28, 2024

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for their Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1). This vaccine aims to provide active immunization against COVID-19 caused by SARS-CoV-2 for individuals aged 6 months and older. The recommendation 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 to target the SARS-CoV-2 variant JN.1 for the 2024-2025 vaccination campaign. The ETF stated that targeting JN.1 would help maintain vaccine effectiveness as SARS-CoV-2 continues to evolve.

The European Commission (EC) will review the CHMP’s recommendation and is expected to make a final decision soon. Upon approval by the EC, the updated vaccine will be ready for shipment to EU member states. Pfizer and BioNTech have been producing the Omicron JN.1-adapted vaccine in advance to ensure supply readiness for the anticipated increase in demand during the fall and winter seasons.

The CHMP’s recommendation is based on extensive clinical, non-clinical, and real-world evidence that supports the safety and efficacy of Pfizer and BioNTech’s COVID-19 vaccines. The application included manufacturing and pre-clinical data showing that the JN.1-adapted vaccine generates a significantly improved immune response against multiple Omicron JN.1 sublineages, including KP.2, KP.3, and other currently circulating variants, compared to the companies’ previous Omicron XBB.1.5-adapted vaccine.

Pfizer and BioNTech are also starting rolling applications with the U.S. Food and Drug Administration (FDA) to seek approval for their Omicron KP.2-adapted vaccine for individuals aged 6 months and older, in accordance with recent FDA recommendations. The companies will continue to monitor the evolving epidemiology of COVID-19 and prepare to meet global public health needs.

COMIRNATY® COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were jointly developed by both companies. BioNTech holds the Marketing Authorization for COMIRNATY® and its adapted vaccines (COMIRNATY® Original/Omicron BA.4/5; COMIRNATY® Omicron XBB.1.5) in the United States, the European Union, the United Kingdom, and other countries, and holds emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)* is FDA authorized under Emergency Use Authorization (EUA) to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 6 months through 11 years.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the FDA but has been authorized for emergency use under an EUA to prevent COVID-19 in individuals aged 6 months through 11 years. The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization is revoked sooner.

At Pfizer, we use science and global resources to deliver therapies that significantly improve lives. We are committed to setting the standard for quality, safety, and value in healthcare product development, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures for the most feared diseases. As a leading biopharmaceutical company, we collaborate with healthcare providers, governments, and communities to support and expand access to reliable, affordable healthcare worldwide.



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