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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)

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.

Feasibility of novel adult tuberculosis vaccination in South Africa: a cost-effectiveness and budget impact analysis

We conducted expert interviews to identify plausible vaccination implementation strategies for the novel M72/AS01E vaccine candidate. The strategies were defined in terms of target population, coverage, vaccination schedule and delivery mode. We modelled these strategies to estimate long-term resource requirements and health benefits arising from vaccination over 2025–2050.

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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