FDA Advisory Panel Recommends Updated COVID Vaccine Variant for 2025-2026

Washington, D.C. — Advisers to the Food and Drug Administration (FDA) met Thursday to recommend changes to the COVID-19 vaccines for the 2025-2026 season. The committee unanimously suggested that vaccine manufacturers target the JN.1 variant and its related strains for the upcoming fall and winter vaccines.

The recommendation is based on data presented by Moderna, Pfizer/BioNTech, and Novavax, showing that vaccines aligned with the JN.1 variant effectively protect against circulating strains, including the LP.8.1 variant.

During the all-day meeting, the advisory group discussed the uncertainty of which JN.1 subvariant would be dominant by fall. FDA officials will work with the companies to finalize the vaccine formulation.

This recommendation also coincides with the FDA’s announcement of a new framework for COVID vaccines that could limit access to certain populations. Under the new plan, vaccine availability may be restricted to people age 65 and older and younger individuals with health conditions that put them at high risk for severe illness.

Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, emphasized that the new requirements aim to provide better information to the public and restore trust in vaccines. He noted this approach aligns the U.S. vaccine strategy with those used in other high-income countries.

Experts remain divided about the implications of these changes. Some are concerned that limiting vaccine access could hinder efforts to vaccinate children and those wishing to minimize the risk of mild illness. Others argue that updated vaccines should reflect the dominant circulating strains, which could enhance public health.

As the FDA deliberates on these recommendations and adjustments, many in the health community continue to stress the importance of addressing COVID-19, which remains a significant health threat despite years of vaccination efforts.