May 26 (Reuters) - Advisers to the U.S. Food and Drug Administration will discuss whether COVID-19 vaccines should be updated to target the latest circulating XFG subvariant for the 2026-27 immunization campaign, according to documents filed on Tuesday.
While the COVID variants continue to be derived from the JN.1 virus variant, new subvariants such as NB.1.8.1 and XFG have emerged since May last year, the agency said.
The World Health Organization recommended earlier this month that vaccine manufacturers
target the monovalent LP.8.1 strain or other currently circulating variants such as XFG or NB.1.8.1.
The FDA advisory panel is set to vote on the updated formulation for COVID shots on Thursday.
The agency had toughened requirements for COVID vaccine use under former FDA Commissioner Marty Makary and vaccine chief Vinay Prasad, including measures like asking for large, placebo-controlled trials in the 50-to-64 age group for it to be included in recommendations.
The U.S. Centers for Disease Control and Prevention had last year removed its broad recommendation for the shots, calling for consultation with a healthcare provider first.
The FDA had recommended that COVID shots for the 2025-26 period target LP.8.1 - a subvariant of the JN.1 strain.
CDC data showed the XFG subvariant was estimated to account for a majority of cases in the United States over a four-week period up to April 11.
Three COVID shots have been authorized for use in the U.S.: Moderna and Pfizer-BioNTech's messenger-RNA-based vaccines, as well as Novavax's protein-based shot that takes longer to manufacture.
Novavax licensed its COVID vaccine to French drugmaker Sanofi in 2024 in a deal worth at least $1.2 billion. Sanofi, along with Pfizer and Moderna, is set to make a presentation to the advisory committee.
The vaccine manufacturers have indicated that they are prepared to produce an XFG vaccine for the 2026-27 vaccination season, the FDA said.
(Reporting by Mariam Sunny in Bengaluru; Editing by Pooja Desai)
