By Christy Santhosh
May 28 (Reuters) – The U.S. FDA’s advisory panel will vote on Thursday on whether COVID-19 vaccines for the 2026-2027 immunization campaign should target the dominant XFG variant, after staff members raised concerns about limited data on currently circulating strains.
The Food and Drug Administration’s Vaccine and Related Biological Products Advisory Committee will convene with no membership changes by Robert F. Kennedy Jr., a sign of procedural normalcy after a series of vaccine policy shake-ups under the health secretary.
Since the last recommendation a year ago, vaccine regulation has been in a state of limbo after a court put a stay on decisions made by the CDC’s advisory panel to drop recommendations for childhood vaccines, including the COVID shot, saying that Kennedy had not properly appointed the panel.
Four COVID shots have been approved for use in the U.S.: Moderna’s mNEXSPIKE and Spikevax, Pfizer-BioNTech’s, Comirnaty – all three mRNA-based vaccines – as well as Novavax-Sanofi’s protein-based shot that takes longer to manufacture.
In briefing documents published before the meeting, which started at 8:30 a.m ET, Moderna said it is prepared to supply the recommended COVID vaccine composition by mid-August.
Pfizer and BioNTech said they are ready to supply the updated COVID vaccine formula upon approval, while Sanofi said it is manufacturing XFG-targeting COVID shots for the 2026-207 season.
In briefing documents released earlier this week, the FDA said assessing the evolution of COVID-19 has become increasingly difficult as virologic surveillance, sequencing volumes and timely data sharing from state and local public health departments have declined.
The Centers for Disease Control and Prevention’s COVID dashboard reflects the gap, with weekly data currently unavailable due to low sequencing submissions. The most recent update, now a month old, showed XFG strains accounted for more than half of U.S. cases over the four weeks ended April 11.
Reduced sequencing reflects both the 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 had recommended COVID shots target LP.8.1 — a subvariant of the JN.1 strain.
While COVID variants continue to be derived from the JN.1 strain, other subvariants such as NB.1.8.1 have emerged since May last year, according to the FDA’s briefing documents.
Earlier this month, the World Health Organization recommended vaccine manufacturers to target the monovalent LP.8.1 strain or other currently circulating variants such as XFG or NB.1.8.1.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shilpi Majumdar and Devika Syamnath)
Comments