Updated COVID-19 Vaccines for Use in the United States Beginning in Fa – FDA.gov

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 5, 2024, to discuss and make recommendations on the selection of the 2024-2025 Formula for COVID-19 vaccines for use in the United States beginning in the fall of 2024.

The committee unanimously voted to recommend a monovalent JN.1-lineage vaccine composition. Following the vote, the committee discussed considerations for the selection of a specific JN.1 lineage SARS-CoV-2 strain (e.g., JN.1 or KP.2) and expressed a strong preference for JN.1.

During this meeting, the advisory committee was informed of the manufacturing timelines, and they reviewed the available data. These data included information 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 preliminary human immunogenicity data on JN.1 candidate vaccines.

Based on the totality of the evidence, FDA has advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines for use in the United States beginning in fall 2024 should be monovalent JN.1 vaccines to more closely match currently circulating SARS-CoV-2 viruses.

FDA will continue to monitor the safety and effectiveness of the COVID-19 vaccines and the evolution of the SARS-CoV-2 virus.

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Updated COVID-19 Vaccines for Use in the United States Beginning in Fa - FDA.gov