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The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 15, 2023 to discuss and make recommendations for updated COVID-19 vaccines for use in the United States in autumn of 2023. The committee unanimously voted that the vaccine composition be updated to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant.
At the meeting, VRBPAC reviewed available data on the circulation of various 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 generated by new candidate vaccines expression or containing updated spike components, and preliminary human immunogenicity data generated by one XBB.1.5 vaccine candidate. The committee was also informed of current manufacturing timelines.
Based on the provided evidence, FDA ultimately advised manufacturers planning to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition. FDA plans to continue monitoring the safety and effectiveness of the COVID-19 vaccines and the evolution of the SARS-CoV-2 virus.