FDA panel recommends updated COVID-19 vaccines targeting XBB.1.5 subvariant

The FDA’s Vaccines and Related Biological Products Advisory Committee met on June 15, 2023, to discuss and make recommendations for SARS-CoV-2 strain(s) for updated COVID-19 vaccines for use in the United States beginning in the fall of 2023. For the 2023-2024 formulation of the COVID-19 vaccines for use in the U.S. beginning in the fall 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. Following discussion of the evidence, the committee expressed a preference for XBB.1.5. 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 generated by new candidate vaccines expressing or containing updated spike components, and preliminary human immunogenicity data generated by one XBB.1.5 candidate vaccine. Based on the totality of the evidence, FDA has advised manufacturers who will be updating their COVID-19 vaccines, that they should develop vaccines with a monovalent XBB 1.5 composition. Publicly traded companies in the COVID-19 vaccine space include Moderna (MRNA), BioNTech (BNTX), Pfizer (PFE), Inovio (INO), AstraZeneca (AZN), Novavax (NVAX), and Johnson & Johnson (JNJ).