The CHMP has granted positive opinion to Omicron JN.1-adapted COVID-19 vaccine, Comirnaty JN.1, for subjects ≥6mos. of age, following the WHO & EMA recommendations to update vaccines for the 2024-2025 campaign targeting the SARS-CoV-2 variant JN.1
The opinion was supported by safety & efficacy data from clinical, non-clinical & RWE studies of COVID-19 vaccines, demonstrating enhanced response against various Omicron JN.1 variants such as KP.2, KP.3 & others vs the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine
Both companies are initiating rolling applications with the US FDA, seeking approval for their Omicron KP.2-adapted COVID-19 vaccines for individuals (≥6mos.)
Ref: Pfizer | Image: Pfizer
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