Tuberculosis (TB) is the world’s deadliest infectious disease; it claimed 1.23 million lives in 2024. A pair of promising vaccines are in late-stage development, but there is no guarantee that they will be accessible to all who need them if they are approved. In fact, The World Health Organization’s TB Vaccines Accelerator Finance & Access Working Group has highlighted the need to anticipate barriers, bottlenecks, and market dynamics that could impact timely, equitable, and sustainable access to novel TB vaccines.
Frontiers in Public Health recently published research identifying potential challenges to accessing these vaccines. This important research, which increases the transparency of patent applications on TB vaccine candidates, covers international and national patent filings on MTBVAC and M72/AS01E, and a key adjuvant component (QS-21). It was funded by ITPC-Global, as part of the Make Medicines Affordable strategic focus area, and co-authored by researchers from diverse field of expertise and Mike Frick, Co-Director of Treatment Action Group’s tuberculosis program.
The researchers searched for patent applications on for MTBVAC, M72/A01E and QS-21 filed through the Patent Cooperation Treaty (PCT) system until March 2025, focusing on 30 countries with the highest burdens of TB. They developed a patent landscape, finding six PCT applications for MTBVAC, twenty-two for M72/AS01E, and twenty-one for QS-21. Notably, more applications were filed in middle-income countries which have the capacity to manufacture vaccines.
The authors underscore the importance of monitoring patent landscapes as part of TB vaccine readiness efforts, and stress the importance of public-health approaches to intellectual property, including the use of TRIPS flexibilities, to support affordable and sustainable access once effective vaccines become available.