U.S. FDA Reviews COVID-19 Vaccines for 2025-2026

The U.S. FDA published the Briefing Document for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on May 22, 2025. VRBPAC has met multiple times since 2022 to discuss and make recommendations on selecting the strain compositions for COVID-19 vaccines.

Today's meeting agenda focused on selecting the 2025-2026 Formula for COVID-19 Vaccines.

As noted in the Document, while current circulating SARS-CoV-2 variants have derived from the JN.1 variant that appeared in late 2023, the JN.1 virus lineage continues to evolve.

The LP.8.1 subvariant has now become the predominant circulating strain, but other virus subvariants including LF.7 and XFG have also been increasingly detected in the U.S. in the recent weeks.

Because of the continuing antigenic drift between JN.1 and KP.2, which were used in the 2024-2025 vaccine, and the currently circulating subvariants in the Asia Pacific countries, a review and discussion regarding the need for a strain composition update for COVID-19 vaccines is warranted.

In an article published in the New England Journal of Medicine on May 20, 2025, FDA Commissioner Dr. Martin Makary and Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, stated that these changes align the U.S. with the practices of many other countries.

'The FDA's new COVID-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science. The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.'

'These clinical trials will inform future directions for the FDA, but more importantly, they will provide information that health care providers and the American people desperately crave.'

The complete FDA Briefing Document is available at this link.