On Jun. 16, 2023, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee announced recommendations for SARS-CoV-2 strain(s) for updated COVID-19 vaccines for use in the United States beginning in the fall of 2023.

The 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.

This recommendation incorporates advisory committee input and is based on the totality of the available evidence to select the vaccine composition that the FDA anticipates will best protect public health. The agency anticipates the timely submission of the data and filings to support FDA action on updated COVID-19 vaccines, in order to make vaccines available this fall that meet our standards for safety, effectiveness and quality.