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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)

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)

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

Prep4TBVax

2023-2025
M72/AS01e, MTBVAC
Planned
New TB vaccines are likely to be crucial in addressing the ongoing TB pandemic. With multiple promising vaccine candidates in the pipeline and the earliest availability of a candidate expected by 2028, it is of outmost importance that once available, the vaccine can be implemented rapidly and effectively. Limited research has looked at the delivery strategies available to provide a new TB vaccine to beneficiaries and therefore, this study assesses the acceptability and feasibility of delivery strategies for the vaccine candidates M72/AS01e and MTBVAC in Ethiopia, Nigeria, and Tajikistan.

Potential implications of reduced tuberculosis vaccine efficacy in those with undernutrition on overall vaccine impact in India

Hypothetical vaccine
Ongoing
Nutritional status is a leading risk factor for tuberculosis (TB). In India up to half of all TB episodes are attributed to undernutrition. Given the impact of nutrition on the immune system, vaccine characteristics such as efficacy and duration of protection could vary depending on nutritional status. Therefore, previous vaccine impact estimates may be overestimated. We re estimated vaccine impact in India with reduced efficacy with undernutrition
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