Next-generation TB vaccines, expected to become available from 2029, could deliver major health and economic gains, helping to save an estimated 7.3 million lives, generate up to $135 billion in economic benefits for low-and middle-income countries by 2050, and support efforts to combat antimicrobial resistance, Gavi, the Vaccines Alliance said.
Nevertheless, in its early market shaping roadmap (EMSR) for novel TB Vaccines, published , Gavi, the Vaccine Alliance (Gavi) warns that action is required now to prepare governments and vaccine manufacturers for the vaccines’ arrival.
According to the roadmap, demand for the vaccines among low-income countries and middle-income countries could reach, on average, 85 million vaccination courses per year, with greater demand in the early years as high-burden countries seek to expand protection across multiple age groups in high-risk areas.
In particular, Gavi says action must be taken now to ensure that countries with the highest disease burden are able to access vaccines in sufficient quantities.
Sania Nishtar, the Gavi chief executive officer (CEO) said: “Novel TB vaccines could be the next blockbuster immunisation tool, however they will only realise their potential if we can ensure sufficient, predictable and affordable supply for those countries that need them most.”
According to new analysis on the potential impact of the new tuberculosis (TB) vaccines, which are expected to become available from 2029, the economic benefits highlight the potential for the new TB vaccines to become one of the most impactful new immunisation tools in decades, representing a breakthrough technology in fighting the world’s deadliest infectious disease.
Tuberculosis (TB) is common in parts of Asia, Africa, and Latin America, with the World Health Organization (WHO) tracking eight countries as high-burden countries that account for the majority of cases globally.
Top high-burden countries include India (25% of global cases), Indonesia (10%), The Philippines (6.8%), China (6.5%), Pakistan (6.3%), Nigeria (4.8%), Democratic Republic of the Congo (3.9%), and Bangladesh (3.6%).
A regional breakdown shows most new infections occur in three main WHO regions: South-East Asia (34% of global burden), Western Pacific (27%), and Africa (25%).
Nishtar, the Gavi, the Vaccine Alliance chief executive, said further that, “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.”
Roadmap to a powerful new tool
2024 saw 10.7 million tuberculosis cases and 1.2 million tuberculosis deaths globally. The burden falls overwhelmingly on low- and middle-income countries, with Gavi-supported countries accounting for an estimated 77 percent of all deaths.
The one vaccine currently licensed, the Bacille Calmette-Guérin (BCG) vaccine, is over 100 years old, and while it is effective in protecting infants and young children against severe forms of the disease, its protection wanes, highlighting the need for new tools to prevent manifestation of the disease among adolescents and adults.
New vaccines aim to fill that gap. Designed to prevent infectious pulmonary TB disease among adolescents and adults, they would be a major addition in the fight against TB. Combined with other prevention measures, they could accelerate progress against one of the world’s deadliest diseases.
With the first of these new promising candidate vaccines potentially securing regulatory approval by the end of this decade, Gavi’s Roadmap has identified a series of risks that could hold back rapid rollout once licensure is secured.
These include policy risks, including the possibility that recommendations could be limited to the highest-risk groups because of gaps in evidence; risks that could limit uptake by countries, such as inadequate global and domestic financing, and supply risks, driven, for example, by this demand uncertainty holding back manufacturer capacity investments for late-stage candidates.
To overcome these risks, Gavi highlights three well-defined objectives that, drawing on its market-shaping and innovative financing expertise, it will pursue to help ensure new vaccines reach low-income and middle-income countries that need them the most, as fast and equitably as possible.These are:
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 rollout once vaccines come available. Through the WHO TB vaccine accelerator’s finance & access working group, Gavi will continue working with partners in its co-lead capacity, to support these efforts with the ultimate goal of bringing these new TB vaccines as rapidly as possible to the people who need them most.
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 percent efficacy against TB disease irrespective of previous exposure, with immunity waning exponentially over 10 years.
