Pfizer and BioNTech's updated Covid-19 vaccine, which targets 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-optimised COVID-19 vaccine for the same age group population.
This adaptation follows recent guidance from the World Health Organisation’s Technical Advisory Group on COVID-19 Vaccine Composition, which recommended that vaccines for 2024/2025 should target the JN.1 family of Omicron sub-variants.
The EU regulator will now review the latest recommendation from the Committee for Medicinal Products for Human Use (CHMP) and, if approved, doses of the KP.2 vaccine will be shipped to member states that have ordered this formulation.
This recommendation was based on non-clinical data showing that the KP.2-optimized vaccine produces significantly better responses against several currently prevalent Omicron JN.1 sub-lineages, including KP.2, LB.1, KP.3, and KP.3.1.1, compared to the companies' Omicron XBB.1.5-optimized vaccine.
Clinical and real-world evidence supporting the safety and efficacy of prior formulations of COVID-19 vaccines produced by Pfizer and BioNTech also helped sway the decision.
The Kp.2-optimized vaccine was approved last month by the US Food and Drug Administration for use in individuals aged 12 years and older, and granted emergency use authorization for people six months through 11 years of age.
The Medicines and Healthcare products Regulatory Agency also approved four variants 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 formula, the partners are evaluating a combined vaccine approach for influenza and COVID-19. The hope is that this vaccine could reduce the impact of both COVID-19 and flu as well as offer combined administration, simplifying vaccination practices for healthcare providers and patients.