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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).

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

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.

Prep4TBVax

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

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

Evaluating vaccination strategies for tuberculosis in endemic and non-endemic settings

We propose a continuous age-structured model for the epidemiology of tuberculosis with pre- and post-exposure vaccination. We use uncertainty and sensitivity analysis to make predictions about the efficacy of different vaccination strategies in a non-endemic setting (United States) and an endemic setting (Cambodia). In particular, we determine optimal age groups to target for pre-exposure and post-exposure vaccination in both settings.

Measuring indirect transmission-reducing effects in tuberculosis vaccine efficacy trials: why and how?

Tuberculosis is the leading bacterial cause of death globally. In 2021, 10·6 million people developed symptomatic tuberculosis and 1·6 million died. Seven promising vaccine candidates that aim to prevent tuberculosis disease in adolescents and adults are currently in late-stage clinical trials. Conventional phase 3 trials provide information on the direct protection conferred against infection or disease in vaccinated individuals, but they tell us little about possible indirect (ie, transmission-reducing) effects that afford protection to unvaccinated individuals. As a result, proposed phase 3 trial designs will not provide key information about the overall effect of introducing a vaccine programme. Information on the potential for indirect effects can be crucial for policy makers deciding whether and how to introduce tuberculosis vaccines into immunisation programmes. We describe the rationale for measuring indirect effects, in addition to direct effects, of tuberculosis vaccine candidates in pivotal trials and lay out several options for incorporating their measurement into phase 3 trial designs
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