CHMP Recommends Pfizer/BioNTech's KP.2 COVID-19 Vaccine

Pfizer and BioNTech have received a recommendation from the European Medicines Agency’s human medicines committee for their updated COVID-19 vaccine targeting the KP.2 strain, a derivative of JN.1. This recommendation is applicable for individuals aged six months and older. This development follows the European Commission's approval of the JN.1-adapted COVID-19 vaccine for the same age group just two months prior.

This vaccine adaptation aligns with recent guidelines from the World Health Organization’s Technical Advisory Group on COVID-19 Vaccine Composition. The group recommended that vaccines for the years 2024 and 2025 should focus on the JN.1 family of Omicron subvariants.

The European Union regulator is now set to review the latest recommendation from the Committee for Medicinal Products for Human Use (CHMP). If approved, doses of the KP.2 vaccine will be distributed to member states that have placed orders for this formulation.

The CHMP’s recommendation is supported by non-clinical data indicating that the KP.2-adapted vaccine elicits a significantly enhanced immune response against several circulating Omicron JN.1 sublineages, such as KP.2, LB.1, KP.3, and KP.3.1.1. This represents an improvement over the previously adapted Omicron XBB.1.5 vaccine by Pfizer and BioNTech.

Supporting evidence for the safety and efficacy of prior COVID-19 vaccine formulas developed by Pfizer and BioNTech also played a crucial role in informing the decision. Last month, the KP.2-adapted vaccine received approval from the US Food and Drug Administration (FDA) for individuals aged 12 and above and was granted emergency use authorization for children aged six months to 11 years. Additionally, in July, the Medicines and Healthcare products Regulatory Agency approved four versions of the JN.1-adapted COVID-19 vaccine.

Pfizer and BioNTech have expressed their commitment to continuously monitor the evolving epidemiology of COVID-19 and are prepared to develop modified vaccine formulations as needed.

Beyond their current COVID-19 vaccines, Pfizer and BioNTech are also investigating a combined vaccine approach that targets both influenza and COVID-19. This dual-purpose vaccine aims to mitigate the impact of both viruses while simplifying the vaccination process for healthcare providers and recipients. This combined vaccine could potentially streamline immunization practices, making it easier to administer and manage.

In conclusion, the recommendation for the KP.2-adapted COVID-19 vaccine marks a significant step in the ongoing efforts to address the evolving challenges posed by the COVID-19 pandemic. With regulatory reviews pending and new vaccine strategies under evaluation, Pfizer and BioNTech remain at the forefront of developing effective solutions to combat COVID-19 and other respiratory illnesses.