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# FDA Backs New Covid Vaccine with XBB Variant
- URL: https://www.fdaweb.com/fda-backs-new-covid-vaccine-with-xbb-variant/
- Published: 2023-06-12T12:00:00.000Z
- Updated: 2026-09-14T18:38:34.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154664

FDA reviewers are recommending that the Covid-19 vaccination program for the 2023-2024 season contain a monovalent vaccine comprising the XBB-lineage variant, which is currently the predominant strain in the U.S. In a just-posted [briefing document](https://www.fda.gov/media/169378/download?ref=fdaweb.com) released in advance of a 6/15 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, the reviewers say that the “current sublineages under consideration include XBB.1.5, XBB.1.16, or XBB.2.3… Other factors to inform decision making to be discussed at the VRBPAC meeting include virus surveillance and genomic analyses, antigenic characterization of viruses, human serology studies from current vaccines, and manufacturing timelines.”

FDA says that in addition to considering the Covid-19 vaccine strain composition for the upcoming vaccination period, panel members will be asked to discuss the “available data on the circulation of SARS- CoV-2 virus variants, current vaccine effectiveness and clinical immunogenicity data of current vaccines against recently circulating viruses, the antigenic characterization of circulating virus variants, and pre-clinical immunogenicity data generated by new candidate vaccines expressing or containing updated spike components.”