Gavi, the Vaccine Alliance, has published a roadmap calling for early preparations to support the rollout of novel tuberculosis vaccines that could become available from 2029.

New analysis cited by Gavi estimates that the vaccines could help prevent enough disease to save up to 7.3 million lives between 2030 and 2050. The same analysis projects up to US$135 billion in economic benefits across low- and middle-income countries.

Gavi’s Early Market Shaping Roadmap identifies policy, country uptake, financing and supply challenges that could slow the introduction of the vaccines after regulatory approval. The alliance said work must begin before availability is confirmed to help countries obtain doses in sufficient quantities and at affordable prices.

Demand could reach 85 million courses annually

According to the roadmap, demand among low-income and middle-income countries could average 85 million vaccination courses each year, with requirements potentially higher during the first years of availability.

Several high-burden countries, including some involved in vaccine trials, are already laying the groundwork for possible national rollouts. Gavi said it would continue working with partners through the WHO TB Vaccine Accelerator’s Finance & Access working group.

“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, Gavi’s chief executive officer.

She added: “In order to help countries secure doses in the volumes they need, we are beginning to work with partners now to lay the groundwork for timely access when these vaccines become available.”

New tools aimed at adolescents and adults

Tuberculosis is described as the world’s deadliest infectious disease. In 2024, an estimated 10.7 million people developed TB worldwide and 1.2 million died from the disease. Gavi-supported countries accounted for an estimated 77% of global TB deaths that year.

The only currently licensed TB vaccine mentioned in the roadmap is BCG, which is more than 100 years old. It protects infants and young children against severe forms of TB, but its protection wanes. The novel vaccines under consideration are intended to prevent infectious pulmonary TB among adolescents and adults.

Preliminary modelling by the London School of Hygiene & Tropical Medicine examined routine vaccination for adolescents and other high-risk groups, targeted catch-up campaigns and use in high-burden settings. The modelling assumed 50% efficacy against TB disease and immunity that wanes exponentially over 10 years.

Gavi said the projected health and economic gains depend on successful vaccine development, regulatory approval, financing and uptake. The estimates are based on analysis and modelling rather than results from an established rollout, while uncertainty over future demand could also affect manufacturers’ willingness to invest in production capacity.