FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on May 22, 2025, to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States beginning in the fall of 2025.
The committee unanimously voted to recommend a monovalent JN.1-lineage vaccine composition. Following the vote, the committee discussed considerations for the selection of JN.1 and/or a specific JN.1-lineage strain for COVID-19 vaccines (2025-2026 Formula).
During this meeting, the advisory committee was informed of the manufacturing timelines, they reviewed the available data on the circulation of SARS-CoV-2 virus variants, current vaccine effectiveness, human immunogenicity data of current vaccines against recently circulating virus variants, the antigenic characterization of circulating virus variants, animal immunogenicity data on new candidate vaccines expressing or containing updated spike components, and human immunogenicity data on the COVID-19 vaccines (2024-2025 Formula).
Based on the totality of the evidence, FDA has advised the manufacturers of the approved COVID-19 vaccines that to more closely match currently circulating SARS-CoV-2 viruses, the COVID-19 vaccines for use in the United States beginning in fall 2025 should be monovalent JN.1-lineage-based COVID-19 vaccines (2025-2026 Formula), preferentially using the LP.8.1 strain.
FDA will continue to monitor the safety and effectiveness of the COVID-19 vaccines and the evolution of the SARS-CoV-2 virus.
