The potential health and economic impact of introducing the vaccine candidate VPM1002 to prevent tuberculosis disease in low- and middle-income countries: a modelling study

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ABSTRACT Background The tuberculosis (TB) vaccine candidate VPM1002 did not prove efficacy in the recent Phase III trial and is in discussion with the Indian regulator. However, low efficacy TB vaccines may still have public health value. We estimated the potential health and economic impact of introducing VPM1002 in low- and middle-income countries (LMICs). Methods We calibrated compartmental TB dynamic models to epidemiologic and demographic data for 79 individual LMICs. We assumed the vaccine would be introduced between 2027-2047, delivered routinely and annually to the age six cohort and delivered in two 10-yearly campaigns for older ages, be efficacious for 3 years, have efficacy of 16.9% (95% confidence interval = -13.3 to 39.1%), and prevent TB disease. We estimated the cumulative symptomatic TB episodes and TB-associated deaths averted by 2050, and cost-effectiveness from health-system and societal perspectives. Results Results suggest, across 79 LMICs, there may be 6.7 (95% uncertainty interval = -4.0 to 14.9) million symptomatic TB episodes averted, and 0.7 (-0.4 to 1.5) million TB-associated deaths averted overall over 2027-2050. At an assumed vaccine cost of 0.75 USD per dose, VPM1002 vaccination may be cost-effective compared to no vaccination in 15 of 79 modelled LMICs (19%), assuming a threshold of 1-times per-capita gross domestic product from the health system perspective, and may be cost-effective in 28 out of 79 countries (35%) and dominant in 14 countries (18%) from the societal perspective. Conclusions The VPM1002 Phase III trial did not prove efficacy, therefore results could be due to chance. However, if the true vaccine efficacy was consistent with the observed point estimate, then overall rollout in LMICs may avert a portion of symptomatic TB cases and TB-associated deaths, and in some countries could be cost-effective/saving. Although potentially infeasible, it would be useful to obtain more precise estimates of VPM1002 efficacy through larger Phase III/IV studies.

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