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)
Availability
TBVacMod
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
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
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
Cost and Cost Effectiveness of Novel Tuberculosis Vaccines in Low-and Middle-income Countries: A Systematic Review of Modelling Studies
This review addressed the costs and cost-effectiveness of novel tuberculosis (TB) vaccines compared to the current standard of care (BCG) in various settings and for different age groups in LMICs
Advancing evidence-informed in-country decision-making for new TB vaccine introduction: A responsive and integrated vaccine modelling approach from India
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
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).
Potential implications of reduced tuberculosis vaccine efficacy in those with undernutrition on overall vaccine impact in India
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
Evolution of Tuberculosis Vaccine Modelling studies: Insights from studies in India
Focusing on India, we performed a scoping review to identify and evaluate studies that have used mathematical modeling to assess the epidemiological and economic
impact of TB vaccine introduction in India
The implications of using different time horizons when evaluating investment to prevent infectious disease
A lifetime time horizon is conventional for cost-effectiveness analysis, but not routine for transmission-dynamic modeling, given uncertainty in future epidemiological dynamics and high computation costs. We demonstrate implications of alternative analytic time horizons with a case
study of novel tuberculosis (TB) vaccine introduction