Geneva, 14 September 2026 – New tuberculosis (TB) vaccines, expected to become available from 2029, could help save up to an estimated 7.3 million lives between 2030 and 2050, unlocking up to US$ 135 billion in economic benefits across low- and middle-income countries, according to a new analysis of their potential impact. These benefits highlight the potential for new TB vaccines to become one of the most impactful immunisation tools in decades, representing a breakthrough in the fight against the world’s deadliest infectious disease.
Nevertheless, in its Early Market Shaping Roadmap for novel TB Vaccines, published today, Gavi, the Vaccine Alliance, warns that immediate action is required to prepare governments and vaccine manufacturers for the vaccines’ arrival. According to the Roadmap, demand for these vaccines in low- and middle-income countries could average 86 million vaccination courses per year, with even greater initial demand as high-burden countries seek to expand protection across multiple age groups in high-risk areas.
“Novel TB vaccines could be the next blockbuster immunisation tool, however they will only realise their potential if we are able to ensure sufficient, predictable, and affordable supply for those countries with the highest disease burden,” said Dr. Sania Nishtar, CEO of Gavi, the Vaccine Alliance. “To help countries secure the doses they need, we are beginning to work with partners now to lay the groundwork for timely access when these vaccines become available.”
Roadmap to a powerful new tool
In 2024, global health systems recorded 10.7 million tuberculosis cases and 1.2 million deaths. The burden falls overwhelmingly on low- and middle-income countries, with Gavi-supported nations accounting for an estimated 77% of all deaths. The only currently licensed vaccine, the Bacille Calmette-Guérin (BCG), is over a century old. While it effectively protects infants and young children against severe forms of the disease, its protection wanes over time, highlighting the urgent need for new tools to prevent the disease among adolescents and adults.
Next-generation vaccines aim to fill this critical gap. Designed to prevent infectious pulmonary TB among adolescents and adults, they represent a major advancement in the global fight against tuberculosis. Combined with other prevention measures, these vaccines could significantly accelerate progress against one of the world’s deadliest infectious diseases.
With the first of these promising candidate vaccines potentially securing regulatory approval by the end of this decade, Gavi’s Roadmap has identified a series of risks that could hinder rapid rollout once licensure is secured. These include policy risks, such as recommendations being limited to high-risk groups due to evidence gaps; uptake risks, like inadequate global and domestic financing; and supply risks driven by demand uncertainty holding back manufacturer capacity investments for late-stage candidates.
To overcome these challenges, Gavi highlights three core objectives. Drawing on its market-shaping and innovative financing expertise, the alliance will pursue these goals to ensure new vaccines reach low- and middle-income countries that need them most, quickly and equitably:
- Objective 1: Ensure sufficient, timely, affordable, and sustainable supply of novel TB vaccines to meet demand.
- Objective 2: Support widespread uptake that maximises health impact through routine immunisation and targeted catch-up campaigns.
- Objective 3: Encourage a competitive and geographically diverse pipeline of novel TB vaccine candidates, ensuring products meet country preferences.
Alongside this work, several high-burden countries—including some hosting vaccine trials—are already laying the groundwork for vaccine rollout. Through the WHO TB Vaccine Accelerator’s Finance & Access working group, Gavi will continue collaborating with partners in its co-lead capacity to support these efforts, aiming to bring these new TB vaccines as rapidly as possible to the people who need them most.
1. Preliminary modelling by the London School of Hygiene & Tropical Medicine (LSHTM), based on a vaccination scenario targeting high-risk populations and adolescents through routine immunisation, alongside targeted catch-up campaigns in those populations and high-burden settings. Assumes 50% efficacy against TB disease irrespective of previous exposure, with immunity waning exponentially over 10 years.
