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Availability

Availability refers to sufficient, sustainable and timely supply of new TB vaccines for adults and adolescents. This includes having demand assessed for different population groups, defining policy and evidence needs, and having procurement plans in plans. This follows from the WHO global framework for country introduction of new adolescent and adult TB vaccines (https://www.who.int/publications/m/item/who-global-framework-to-prepare-for-country-introduction-of-new-tb-vaccines-for-adults-and-adolescents)

Global TB vaccine R&D roadmap

2022
Completed
The purpose of the Global roadmap for research and development (R&D) of tuberculosis (TB) vaccines is to provide global stakeholders – researchers, funders, industry, regulatory authorities, policy decision-makers and civil society – with actionable priorities to guide their activities. The roadmap primarily focuses on developing and delivering affordable and effective vaccines for use in low- and middle income countries with a high incidence of TB, in line with the World Health Organisation (WHO) goals outlined below. However, such vaccines may also be useful to protect high-risk populations or groups in high-income/low incidence countries. The roadmap integrates and aligns strategic planning and innovation towards a shared vision with associated short-, medium- and long-term priorities for global TB vaccine development. The roadmap covers the entire R&D chain, with an emphasis on late-stage development and implementation.

Facing up to reality? What to do if M72/AS01E doses are limited

M72/AS01e
Ongoing
The Ph3 trial for the vaccine candidate M72/AS01E is underway, and, assuming a positive result, could be licensed by 2030. Modelling suggested a large potential impact from introducing M72/AS01E but assumed an unconstrained dose supply. However, at least initially, it is likely that M72/AS01E will be supply-constrained. We estimated the effect of decisions surrounding the allocation of constrained doses on the potential global impact of M72/AS01E

Advancing evidence-informed in-country decision-making for new TB vaccine introduction: A responsive and integrated vaccine modelling approach from India

hypothetical
Ongoing
As new TB vaccines move into late-stage development, it is imperative for high-burden countries like India to ensure timely and effective evidence-generation to inform decision-making and accelerate vaccine development and introduction. To enable this, an in-country vaccine mathematical modelling effort has been initiated in India.

Part of Change 2.0

2024-2027
Hypothetical vaccines
Planned
Actionable market intelligence, including vaccine demand forecast/scenarios, generated to strategically guide manufacturers and partners in their planning for introduction in high burden countries. The objectives include: 1. Strategic assessment of appropriate market-shaping interventions, 2.Stakeholder and decision process mapping , 3.Demand dynamics understanding and realistic market forecast development, 4. Commercialization strategy support for lead candidate(s).

IAVI

Ongoing
1. Understand likely use cases, delivery strategies, target populations, and drivers of preference and adoption; 2. Project demand; 3. Evaluate potential willingness to pay and budget impact; 4. Explore innovative financing mechanisms;

TBVacMod

Ongoing
Estimate the health impact of introducing a prevention of disease vaccine for adult and adolescents in moderate to high TB burden countries. Explore different vaccine introduction scenarios based on input from country stakeholders, including national TB program and immunization program officials, on priority groups for vaccination and likely vaccine coverage. The project's key questions include: 1) who are the priority groups in different countries and what is expected level of vaccine coverage in those groups 2) how will vaccine impact differ in different introduction scenarios (vary age, priority group, coverage)

Tuberculosis Vaccine Accelerator Council

Ongoing
In January 2023, WHO’s Director-General announced plans to establish a TB vaccine accelerator Council to facilitate the development, testing, authorization, and use of new TB vaccines, drawing on lessons learned from the response to the COVID-19 pandemic. The establishment meeting of the Council took place on 20 September 2023, on the occasion of the 78th session of the United Nations General Assembly, in the lead up to the Second United Nations High-level Meeting on TB.The Council is anticipated to work in multiple ways. These includeidentifying needs for, and types of innovative sustainable financial solutions, as well as partnerships between the public, private and philanthropic sectors that can expedite the translation of science into TB vaccines, and ensure their equitable access once available; identifying market solutions to incentivize TB vaccine development, and to ensure that the R&D ecosystem is positioned to rapidly manufacture and distribute vaccines equitably and at scale, once they are available; and advocating with decision makers in the public, private, philanthropy and other relevant sectors to strengthen commitment and concerted action to develop and expand access to novel effective TB vaccines, including through political platforms such as the African Union, ASEAN, BRICS, G20, G7 and others.

Scoping Community Interventions to Support New TB Vaccine Introduction: From Grassroots Partnerships to Global Policymaking

2024-2025
Planned
To assess the role of communities and civil society in shaping TB vaccine introduction policies, implementation and equitable access. Aim 1: Map the structures, networks, and major players active in TB civil society and overlay these with the policy pipeline for new TB vaccines. Aim 1: Map the structures, networks, and major players active in TB civil society and overlay these with the policy pipeline for new TB vaccines. Aim 2: work with members of the regional community advisory boards (rCABs) established with support from the USAID-funded SMART4TB project to produce country policy portraits illustrating how TB and immunization policy is made in selected countries and the points where community and civil society actors can intervene. Aim 3: work with the rCAB in the Eastern Europe and Central Asia (EECA) region to explore interventions by community and civil society to ensure equitable access to new TB vaccines. All three Aims will be completed in relation to the ECVP and the Global Framework for Country Introduction of New TB Vaccines.

Preparing the landscape for TB vaccines: South Africa’s strategic planning

Ongoing
The South African TB Think Tank is a national collaboration of TB stakeholders, including researchers, policymakers, clinicians, and civil society. Chaired by the Chief Director of the National TB Programme (NTP), members consolidate TB research through several technical task teams, providing evidenced-based policy recommendations to the Department of Health. To support the national TB vaccine initiative, the TB Think Tank provided recommendations for the recently released NTP Strategic Plan, 2023-28
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