The U.S. FDA's advisory panel will meet and vote on Thursday on whether COVID-19 vaccines for the 2026-2027 immunization campaign should target the dominant XFG variant, after staff raised concerns about limited data on circulating strains.
The FDA's Vaccine and Related Biological Products Advisory Committee convenes with no membership changes by Robert F. Kennedy Jr., a sign of procedural normalcy after vaccine policy shake-ups.
Since last year's recommendation, vaccine regulation has been in limbo after a court stayed CDC advisory panel decisions to drop childhood vaccine recommendations, including COVID shots, citing improper appointment by Kennedy.
The FDA said assessing COVID-19 evolution has become increasingly difficult as virologic surveillance, sequencing volumes, and data sharing from state and local health departments have declined.
The CDC's COVID dashboard reflects the gap, with weekly data unavailable due to low sequencing submissions. The latest update, a month old, showed XFG strains accounted for over half of U.S. cases in the four weeks ending April 11.
Reduced sequencing reflects both loss of government surveillance staff and reduced academic funding, said Jill Roberts, associate professor at the University of South Florida College of Public Health.
For the 2025-26 season, the FDA recommended COVID shots target LP.8.1, a subvariant of JN.1.
While variants continue to derive from JN.1, other subvariants like NB.1.8.1 emerged since last May, per FDA briefing documents.
Earlier this month, the WHO recommended vaccine manufacturers target monovalent LP.8.1 or other circulating variants like XFG or NB.1.8.1.
Four COVID shots are approved in the U.S.: Moderna's mNEXSPIKE and Spikevax, Pfizer-BioNTech's Comirnaty (three mRNA-based), and Novavax-Sanofi's protein-based shot, which takes longer to manufacture.
