Tuberculosis (TB) remains one of the world’s deadliest infectious diseases, causing more than 10 million new cases and over one million deaths annually, with the greatest burden borne by low- and middle-income countries (LMICs). Although the Bacille Calmette\u2013Gu\u00e9rin (BCG) vaccine has protected infants against severe TB for more than a century, its effectiveness in preventing adolescent and adult pulmonary TB is limited.<\/p>\n\n\n\n
As of 2025, at least 16 novel TB vaccine candidates are in clinical development pipeline, including six in Phase III trials, making vaccine introduction increasingly feasible. However, ensuring equitable access will depend not only on scientific success but also on sustainable financing and coordinated market preparation.<\/p>\n\n\n\n
The WHO TB Vaccine Accelerator’s Financing and Access Working Group projects that global demand will substantially exceed supply during the early years following vaccine introduction. Under optimistic assumptions, vaccines could begin reaching markets around 2030, yet large-scale catch-up vaccination of adolescents and adults is expected to dominate demand throughout the 2030s. Even under favorable manufacturing scenarios, production capacity is unlikely to meet projected needs before the late 2030s, creating significant supply shortages that will require transparent allocation frameworks and prioritization of high-risk populations.<\/p>\n\n\n\n
From the supply perspective, manufacturers identified major barriers to scaling production, including insufficient financing for late-stage clinical trials, uncertain long-term demand, and limited incentives for expanding manufacturing capacity. Procurement stakeholders similarly noted that no dedicated global financing mechanism currently exists for novel TB vaccines. Estimated procurement costs of US$5.2\u20137.8 billion between 2030 and 2040 will require a combination of domestic investment, donor support, and innovative financing mechanisms. Meanwhile, high-burden countries are actively planning introduction strategies, but most remain unable to commit domestic funding until stronger evidence on vaccine effectiveness, cost-effectiveness, health impact, and affordability becomes available.<\/p>\n\n\n\n
To address these challenges, the WHO working group proposes a comprehensive strategy centered on six priorities: establishing global catalytic instruments to guarantee demand which will boost supply and drive down price; accelerating generation of country-specific evidence to inform policy and budgeting; ensuring the clarity on domestic and external funding through blended financing models; strengthening coordination between supply and demand to align manufacturing, procurement, and country readiness; improving market transparency for key access information, e.g. non-commercial information on pricing, production, and market access and distribution plans; and promoting licensing and technology transfer to at least one manufacturer in each high-burden region. Together, these measures aim to improve affordability, strengthen supply resilience, and support equitable vaccine distribution.<\/p>\n\n\n\n
For countries such as China, early preparation will be critical to ensure timely introduction once new TB vaccines become available. Developing robust evidence on disease burden, health and economic impact, financing options, and implementation readiness, while integrating vaccination into existing TB control and immunization systems, will facilitate evidence-based policy decisions and accelerate equitable access. As WHO emphasizes, combining scientific innovation with strategic financing and global collaboration offers an unprecedented opportunity to transform TB prevention and move closer to ending the global TB epidemic.<\/p>\n\n\n\n