FDA Panel Recommends Monovalent JN.1 COVID Vaccine for Fall, Limits Use to High-Risk Groups

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) has unanimously recommended that COVID-19 vaccines for the 2025-2026 respiratory virus season continue to target the JN.1 lineage of SARS-CoV-2, despite the dominant circulating strain in the U.S. being the LP.8.1 subvariant descended from JN.1. While some committee members favored updating vaccines to specifically target the newer LP.8.1 variant, others advocated for maintaining the broader JN.1 target, noting that last year's vaccines still offer protection. This cautious approach aligns with recommendations from global health organizations like the WHO and the European Medicines Agency, which also support JN.1 while acknowledging LP.8.1 as a suitable alternative. The meeting occurred amid new FDA guidelines that will limit COVID-19 vaccine availability primarily to seniors and high-risk individuals, requiring additional placebo-controlled trials for vaccines intended for healthy younger populations, which complicated deliberations around strain updates. Committee members expressed concerns about balancing the need for updated vaccines with practical considerations of vaccine accessibility and production timelines. The FDA typically follows the advisory committee's recommendations, but the new risk-based vaccination framework represents a significant shift in COVID-19 vaccine policy moving forward.