Advances in development of tuberculosis vaccines and preventive drug therapies: current pipeline, evidence, and access
Abstract
Tuberculosis remains the leading cause of death from a single infectious agent globally. The WHO Global Tuberculosis Report 2025 indicates that progress towards the WHO End TB Strategy targets remains off track despite modest declines in incidence and mortality. In 2024, an estimated 10·7 million people developed tuberculosis and 1·23 million died from the disease. In this Series paper, we examine evidence published between Jan 6, 2020, and Jan 6, 2026, to provide an updated overview of tuberculosis vaccines and tuberculosis preventive treatment (TPT). As of June 4, 2026, 18 tuberculosis vaccine candidates are in active clinical development, including six in phase 3 (M72/AS01E, MTBVAC, VPM1002, GamTBvac, Immuvac [MIP], and BCG revaccination trials), representing the most diverse and advanced pipeline since the introduction of BCG in 1921. Platforms include live-attenuated mycobacterial vaccines (eg, MTBVAC), recombinant BCG-derived approaches (eg, VPM1002), protein-adjuvant subunit vaccines (eg, M72/AS01E), viral-vectored candidates (eg, AdHu5Ag85A, ChAdOx1.85A, and TB/FLU-04L), and inactivated whole-cell strategies (eg, DAR-901, RUTI, and Immuvac [MIP]). However, only a few candidates have progressed to late-stage efficacy evaluation. Short-course rifamycin-containing TPT regimens-1 month of daily isoniazid plus rifapentine, 3 months of once-weekly isoniazid plus rifapentine, 3 months of daily isoniazid plus rifampicin, and 4 months of daily rifampicin-show non-inferior…
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