Pfizer/BioNTech's Omicron JN.1-optimized COVID-19 vaccine recommended by CHMP

Pfizer/BioNTech's Omicron JN.1-optimized COVID-19 vaccine recommended by CHMP

Pfizer/BioNTech's Omicron JN.1-optimised monovalent COVID-19 vaccine has been recommended by the Human Medicines Committee of the European Medicines Agency (EMA) for individuals aged six months and older.

The recommendation by the Committee for Medicinal Products for Human Use (CHMP) was based on positive outcomes and real-world evidence supporting the safety and efficacy of Comirnaty vaccines.

Furthermore, the results showed that the JN.1-optimized vaccine generated significantly better responses against multiple Omicron JN.1 sub-lineages, including KP.2, KP.3, as well as other currently prevalent sub-lineages, compared to the companies' Omicron XBB.1.5-optimized monovalent COVID-19 vaccine.

The adaptation of Comirnaty JN.1 is in line with the recommendation of the World Health Organization's Technical Advisory Group and EMA's Emergency Task Force (ETF) to update COVID-19 vaccines to target the SARS-CoV-2 variant JN.1.

Different from the XBB family, JN.1 is currently the most widely circulating variant worldwide, growing faster than other variants and being either more infectious or better at evading the immune system.

The ETF stated that “evidence indicates that targeting JN.1 would help maintain the effectiveness of vaccines as SARS-CoV-2 continues to evolve” and urged companies developing new COVID-19 vaccines to “discuss strategies to alter the composition of their vaccines” to target JN.1.

The European Commission will review the CHMP’s recommendation and is expected to make a final decision shortly.

If successful, the updated vaccine will be available to be shipped to EU Member States immediately, with companies already manufacturing Comirnaty JN.1 to ensure supply readiness ahead of the upcoming COVID-19 vaccination season.

The companies have also submitted an application to the US Food and Drug Administration for approval of the Omicron KP.2-optimized monovalent COVID-19 vaccine for individuals six months of age and older.

The recommendation comes after the companies announced that the Medicines and Healthcare products Regulatory Agency in February approved a change to the licence of their Comirnaty Omicron XBB.1.5-optimised COVID-19 vaccine, which has received approval from the UK regulator in September 2023 for use in individuals aged six months and older.

In addition, the companies announced positive results from an ongoing Phase 1/2 study of their mRNA-based combination vaccine for influenza and COVID-19 and outlined plans to enter late-stage development in October 2023.

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