CHMP Recommends Pfizer/BioNTech’s Omicron JN.1-Adapted COVID-19 Vaccine

Pfizer/BioNTech's Omicron JN.1-adapted monovalent COVID-19 vaccine has received a recommendation from the European Medicines Agency’s (EMA) human medicine committee for use in individuals aged six months and older. This recommendation by the Committee for Medicinal Products for Human Use (CHMP) is founded on positive outcomes and real-world evidence validating the safety and efficacy of the Comirnaty vaccines.

The data revealed that the JN.1-adapted vaccine elicited a notably enhanced immune response against various Omicron JN.1 sublineages, such as KP.2 and KP.3, as well as other currently circulating sublineages. This performance was significantly better compared to the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.

The decision to adapt Comirnaty JN.1 aligns with recommendations from the World Health Organization’s Technical Advisory Group and the EMA’s Emergency Task Force (ETF), which advised updating COVID-19 vaccines to target the SARS-CoV-2 variant JN.1. JN.1, differing from the XBB family, is currently the most prevalent variant globally. It is spreading more rapidly compared to other variants and exhibits either higher transmissibility or better immune evasion capabilities.

The ETF emphasized that targeting JN.1 would help maintain the vaccines' efficacy as SARS-CoV-2 continues to evolve. They also encouraged companies developing new COVID-19 vaccines to discuss strategies for modifying their vaccine composition to target JN.1 specifically.

The European Commission will review the CHMP’s recommendation and is expected to make a final decision soon. If the decision is favorable, the updated vaccine will be ready for immediate shipment to EU member states. Pfizer/BioNTech have already commenced manufacturing Comirnaty JN.1 to ensure supply readiness for the upcoming COVID-19 vaccination season.

Furthermore, the companies have also submitted applications to the US Food and Drug Administration for the approval of their Omicron KP.2-adapted monovalent COVID-19 vaccine for individuals aged six months and older.

The recommendation comes after the companies announced that the Medicines and Healthcare products Regulatory Agency had approved a license change for their Comirnaty Omicron XBB.1.5-adapted COVID-19 vaccine in February, following the UK regulator’s approval in September 2023 for use in individuals aged six months and older.

Additionally, Pfizer/BioNTech reported positive outcomes from an ongoing phase 1/2 study of their mRNA-based combination vaccine for influenza and COVID-19 in October 2023. They also detailed plans to advance to late-stage development for this combination vaccine.