Pfizer and BioNTech’s updated COVID-19 vaccine targeting the KP.2 strain, a descendant of JN.1, has been recommended by the European Medicines Agency’s human medicines committee for use in individuals aged six months and older.
The recommendation comes just two months after the European Commission approved the companies’ JN.1-adapted COVID-19 vaccine for the same age population.
The adaptations follows recent guidance from the World Health Organization’s Technical Advisory Group on COVID-19 Vaccine Composition, which recommended that vaccines for 2024/2025 should target the JN.1 family of Omicron subvariants.
The EU regulator will now review the Committee for Medicinal Products for Human Use’s (CHMP) latest recommendation and, if approved, doses of the KP.2 vaccine will ship to member states that have ordered the formulation.
The recommendation was based on non-clinical data showing that the KP.2-adapted vaccine generates a substantially improved response against multiple currently circulating Omicron JN.1 sublineages, including KP.2, LB.1, KP.3 and KP.3.1.1, compared with the companies’ Omicron XBB.1.5-adapted vaccine.
Clinical and real-world evidence supporting the safety and efficacy of prior formulas of the COVID-19 vaccines by Pfizer and BioNTech also helped inform the decision.
The KP.2-adapted vaccine was approved by the US Food and Drug Administration last month for use in individuals aged 12 years and older, and was granted emergency use authorisation for those aged six months to 11 years.
The Medicines and Healthcare products Regulatory Agency also approved four forms of the JN.1-adapted COVID-19 vaccine in July.
The companies said in their most recent announcement that they will “continue to monitor the evolving epidemiology of COVID-19 and remain prepared to develop modified vaccine formulas”.
In addition to their COVID-19 formulas, the partners are evaluating a combined vaccine approach for influenza and COVID-19. It is hoped that the vaccine could alleviate the impact of both COVID-19 and flu while offering a combined administration, potentially simplifying immunisation practices for healthcare providers and patients.