Pfizer/BioNTech’s Omicron JN.1-adapted COVID-19 vaccine recommended by CHMP
01 Jul 2024
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Source: PMLiVE
Pfizer/BioNTech’s Omicron JN.1-adapted monovalent COVID-19 vaccine has been recommended by the European Medicines Agency’s (EMA) human medicine committee for individuals aged six months and older.
The Committee for Medicinal Products for Human Use (CHMP) recommendation was based on positive results and real-world evidence supporting the safety and efficacy of the Comirnaty vaccines.
In addition, results showed that the JN.1-adapted vaccine generated a substantially improved response against several Omicron JN.1 sublineages, including KP.2, KP.3, as well as other currently circulating sublineages, in comparison to the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccineCOVID-19 vaccine.
The adaptation of Comirnaty JN.1 follows the recommendation from the World Health Organization’s Technical Advisory Group and the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccinesCOVID-19 vaccines to target the SARS-CoV-2 variant JN.1.
Differing from the XBB family, JN.1 is currently the most widely circulating variant worldwide, which continues to grow quickly compared to other variants and is either more transmissible or better at evading the immune system.
The ETF said that the “evidence indicates that targeting JN.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve” and urged companies developing new COVID-19 vaccinesCOVID-19 vaccines “to discuss strategies for changing the composition of their vaccines” to target JN.1.
The European Commission will review the CHMP’s recommendation and is anticipated to make a final decision soon.
If successful, the updated vaccine will be available to ship immediately to EU member states, with the companies’ already manufacturing Comirnaty JN.1 to ensure supply readiness ahead of the upcoming COVID-19 vaccination season.
The companies have also submitted applications with the US Food and Drug Administration for the approval of their Omicron KP.2-adapted monovalent COVID-19 vaccineCOVID-19 vaccine for individuals aged six months and older.
The recommendation follows the companies’ announcement that the Medicines and Healthcare products Regulatory Agency approved a change to the licence of their Comirnaty Omicron XBB.1.5-adapted COVID-19 vaccineCOVID-19 vaccine in February, following approval from the UK regulator in September 2023, for use in individuals aged six months and older.
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