FDA Panel to Vote on COVID-19 Vaccine Strain for 2025-2026

UNITED STATES – The U.S. Food and Drug Administration’s (FDA) advisory panel is scheduled to vote on Thursday to determine which COVID-19 strain should be targeted in vaccines for the 2025-2026 immunisation campaign, as new variants continue to evolve and spread.

The discussion centres around whether to focus on strains descended from the JN.1 variant, which includes the rapidly spreading LP.8.1 subvariant. According to data from the Centres for Disease Control and Prevention (CDC), LP.8.1 accounted for 70% of COVID-19 cases in the U.S. during the two weeks ending May 10.

Although LP.8.1 is currently the dominant strain, other subvariants like LF.7 and XFG have also been increasingly detected, adding complexity to the decision-making process.

Experts acknowledge the uncertainty in selecting the appropriate strain. “The strain selection process is intelligent guesswork,” said Sten Vermund, dean of the University of South Florida College of Public Health, in comments to Reuters. Public health officials face the challenge of anticipating which variants will dominate in the coming months.

Meanwhile, FDA Commissioner Marty Makary and top vaccine official Vinay Prasad, both of whom have expressed scepticism about repeated annual vaccinations for healthy adults, noted that the long-term benefits of such a strategy remain unclear after several years of virus circulation and vaccine deployment.

Adding another layer to the evolving vaccine strategy, the FDA announced plans this week to require new clinical trials for COVID-19 booster approvals for healthy individuals under the age of 65. The move is seen as an effort to ensure efficacy and safety, though experts caution that such trials may be costly and time-consuming.

“You would need a huge clinical trial that is very costly, and you wouldn’t finish it in time for the COVID-19 season,” Vermund noted.

Despite the challenges, some analysts believe the new requirement for clinical trials could offer reassurance to investors and the public, while preserving vaccine availability for older adults and those at higher risk.