FDA Says Monovalent XBB-lineage COVID-19 Vaccine is Warranted

The U.S. Food and Drug Administration (FDA) today published a Briefing Document regarding the selection of strain(s) to be included in the Periodic Updated COVID-19 Vaccines for the 2023-2024 vaccination campaign.

The FDA confirmed that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in an open session on June 15, 2023, to discuss and recommend COVID-19 vaccine selection.

As noted in section 3.2, XBB sublineages accounted for about 95% of the circulating virus variants in the U.S. by early June 2023.

The FDA wrote the totality of available evidence suggests that a monovalent XBB-lineage vaccine is warranted.

And given the current state of naturally acquired, vaccine-induced, and hybrid (combined natural infection in the setting of at least one COVID-19 vaccination) immunity in the U.S. population, FDA suggested that each of the authorized bivalent vaccines moves to a single dose for most individuals, with additional doses for the very young, those 65 years and older, and individuals with certain kinds of immunocompromise.