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

Sure, here’s a rewritten version of the article:

Today, Pfizer and BioNTech 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 recommendation aims to actively immunize individuals aged 6 months and older against COVID-19 caused by SARS-CoV-2.

The decision to adapt the vaccine to target the JN.1 variant aligns with recommendations from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency’s Emergency Task Force (ETF) for the 2024-2025 vaccination campaign. The ETF emphasized that targeting JN.1 is crucial for maintaining vaccine effectiveness amid evolving SARS-CoV-2 variants.

Pending the European Commission’s (EC) final decision, the updated vaccine is poised for immediate distribution across EU member states. Pfizer and BioNTech have proactively manufactured the Omicron JN.1-adapted vaccine to meet anticipated demand during the upcoming fall and winter seasons.

The CHMP’s recommendation stems from comprehensive evaluations of clinical, non-clinical, and real-world data supporting the safety and efficacy of Pfizer and BioNTech’s COVID-19 vaccines. The application included evidence demonstrating improved response against multiple Omicron JN.1 sublineages compared to previous vaccine adaptations.

In parallel, Pfizer and BioNTech have initiated rolling applications with the U.S. Food and Drug Administration (FDA) following recent FDA guidance, seeking approval for their Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals aged 6 months and older. Both companies pledge ongoing vigilance in monitoring COVID-19 epidemiology and readiness to address global public health needs.

Pfizer and BioNTech’s COMIRNATY® vaccines, developed using BioNTech’s mRNA technology, hold marketing authorizations and emergency use approvals across multiple jurisdictions. For further details, including safety information and regulatory updates, please refer to the official announcements and regulatory documents available through relevant health authorities.

This revised version focuses on the essential details of the announcement while maintaining clarity and relevance to the target audience.

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