By IDSE News Staff
The FDA’s Vaccines and Related Biological Products Advisory Committee 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.
The advisory committee reviewed information on the circulation of SARS-CoV-2 virus variants, current vaccine effectiveness, human immunogenicity data about 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.
The manufacturers of the licensed and authorized COVID-19 vaccines for the United States will be monovalent JN.1 vaccines to more closely match currently circulating SARS-CoV-2 viruses, and should be available for fall 2024.
The agency will continue to monitor the safety and effectiveness of the COVID-19 vaccines, as well as circulating variants.
In related news, Moderna applied to the FDA to review its Spikevax 2024-2025 formula, which targets the JN.1 variant.
The submission is based on FDA guidance, which aligns with recommendations from the World Health Organization Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency’s Emergency Task Force on the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen composition.
