FDA official announcements

FDA Advises COVID-19 Vaccine Update to Target KP.2 Strain for 2024-2025, If Feasible

Jun 14, 2024, 02:19 PM

The U.S. Food and Drug Administration (FDA) has advised COVID-19 vaccine manufacturers to update their vaccines to target the KP.2 strain, if feasible, for the 2024-2025 season. This decision follows recommendations from FDA advisers who noted the continued evolution of the SARS-CoV-2 virus. The KP.2 strain is a descendant of the highly contagious JN.1 variant that circulated widely in the U.S. during the previous winter. While the FDA initially directed manufacturers to update to a JN.1 formulation, it has now reversed this decision to better match the circulating strains. Novavax has indicated it will not be able to produce a KP.2 vaccine in time for the fall and will instead distribute a JN.1 vaccine, which it had already been producing. Peter Marks from the FDA played a significant role in this decision, and Novavax intends to have doses in the U.S. for distribution by mid-July.