U.S. FDA Vaccine Committee Meets Tomorrow

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in an open session on June 5, 2024, to discuss and recommend selecting the 2024- 2025 Formula for COVID-19 vaccines.

VRBPAC has met multiple times since 2022 to discuss the selection of the Formula for COVID-19 vaccines. The U.S. FDA Briefing Document and Agenda for this new meeting were recently posted online. 

The FDA has approved two COVID-19 vaccines for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 and older. In addition, the FDA currently authorizes three vaccines for use in the U.S. under emergency use authorization.

The U.S. COVID-19 emergency declaration was withdrawn on May 11, 2023.

Available data suggest that the current formula of COVID-19 vaccines should be updated for the anticipated 2024–2025 respiratory virus season in the U.S.

Based on the review of virus epidemiology data indicating the recent dominance of the JN.1 sublineage and data from post-monovalent XBB.1.5 human sera indicating a drop in neutralizing antibody responses against JN.1, the World Health Organization Technical Advisory Group on COVID-19 Vaccine Composition recommended that a monovalent JN.1 lineage component be included in the composition of COVID-19 vaccines (2024-2025 Formula).

This recommendation was made on April 26, 2024, before the dominance of the KP.2 sublineage in the U.S.

Initial neutralization data of various vaccine candidates are now available for both the JN.1 and KP.2 sublineages and will be presented along with current SARS-CoV-2 epidemiologic data for VRBPAC’s consideration.

To digitally attend this meeting, visit this YouTube link tomorrow: https://youtube.com/live/weaKQiFk_98