US FDA advisers to weigh composition of COVID vaccines for 2025-2026
By Christy Santhosh and Puyaan Singh
(Reuters) -The U.S. Food and Drug Administration's advisory panel is set to vote on Thursday to recommend whether COVID-19 vaccines for the 2025-2026 immunization campaign should target strains of the virus descending from the JN.1 variant.
According to the Centers for Disease Control and Prevention, the LP.8.1 strain - a subvariant of the previously recommended JN.1 strain - accounted for 70% of total cases in the U.S. over a two-week period ended May 10.
While the LP.8.1 is the predominant circulating strain, other virus subvariants, including LF.7 and XFG, have also been increasingly detected in recent weeks, FDA documents showed earlier this week.
Public health experts say that there is no certainty on which strains are going to be dominant. The strain selection process is "intelligent guesswork," Sten Vermund, dean of the University of South Florida College of Public Health, told Reuters ahead of the advisory committee meeting.
Top U.S. vaccine regulator Vinay Prasad and FDA Commissioner Marty Makary, both of whom have been critical of U.S. COVID vaccine policies, said the benefit of repeated annual shots for healthy adults remains uncertain after several years of the virus circulation and vaccine availability.
Earlier this week, the FDA said it plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65.
"You would need a huge clinical trial that is very costly and you wouldn't finish it in time for the COVID virus season," Vermund told Reuters.
FDA's Prasad said he was open to hearing the thoughts of the vaccine advisory panel on the new policy.
Analysts have said the new clinical trials are reasonable and may help alleviate investor concerns regarding vaccine manufacturers as they maintain the existing framework for older adults and at-risk individuals, who are typically the ones seeking vaccinations.
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