FDA Backs Covid JN.1-Lineage for Next Boosters

FDA says it is advising Covid-19 vaccine makers to formulate their products to match the currently circulating JN.1-lineage and preferentially using the LP.8.1 Covid strain for booster shots beginning in the fall (2025-2026). The recommendation followed a 5/22 Vaccines and Related Biological Products Advisory Committee meeting that recommended the JN.1-lineage-based formulation.

During this meeting, panel members were provided manufacturing timelines, and they “reviewed the available data on the circulation of SARS-CoV-2 virus variants, current vaccine effectiveness, human immunogenicity data of current vaccines against recently circulating virus variants, the antigenic characterization of circulating virus variants, animal immunogenicity data on new candidate vaccines expressing or containing updated spike components, and human immunogenicity data on the COVID-19 vaccines (2024-2025 Formula),” according to an agency notice.