Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron JN.1-Adapted COVID-19 Vaccine in the EU

Pfizer and BioNTech have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for their Omicron JN.1-adapted COVID-19 vaccine, the companies announced on Thursday. This updated vaccine, branded as COMIRNATY® JN.1, is tailored to target the Omicron JN.1 lineage of SARS-CoV-2 and is recommended for individuals aged six months and older.

The CHMP’s recommendation is based on pre-clinical and epidemiological data demonstrating that the JN.1-adapted monovalent vaccine generates an improved immune response against multiple JN.1 sublineages. This move aligns with the recommendations from the World Health Organization (WHO) and the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the JN.1 variant for the 2024-2025 vaccination campaign. According to the ETF, targeting JN.1 will help maintain the effectiveness of the vaccines as the virus continues to evolve.

The European Commission (EC) will review the CHMP’s recommendation and is expected to make a final decision soon. Once authorised by the EC, Pfizer and BioNTech will be ready to ship doses to applicable EU member states immediately. The companies have been manufacturing the vaccine in anticipation of increased demand during the fall and winter seasons.

The CHMP’s positive opinion is backed by comprehensive clinical, non-clinical, and real-world evidence supporting the safety and efficacy of Pfizer and BioNTech’s COVID-19 vaccines. Manufacturing and pre-clinical data show that the JN.1-adapted vaccine offers a substantially improved response against multiple Omicron JN.1 sublineages, including KP.2 and KP.3, compared to the previous Omicron XBB.1.5-adapted vaccine.

In addition to the progress in the European Union, Pfizer and BioNTech are initiating rolling applications with the U.S. Food and Drug Administration (FDA) for their Omicron KP.2-adapted monovalent COVID-19 vaccines, following recent FDA recommendations.

Pfizer and BioNTech’s COVID-19 vaccines are based on BioNTech’s proprietary mRNA technology. BioNTech holds the Marketing Authorization for COMIRNATY® and its adapted vaccines in multiple regions, including the United States and the European Union.

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