Modelling the health and economic impacts of M72/AS01 _E vaccination and BCG-revaccination: estimates for South Africa

Abstract Background Tuberculosis remains a major public health problem in South Africa, with an estimated 300,000 cases and 55,000 deaths in 2021. New tuberculosis vaccines could play an important role in reducing this burden. Phase IIb trials have suggested efficacy of the M72/AS01 E vaccine candidate and BCG-revaccination. The potential population impact of these vaccines is unknown. Methods We used an age-stratified transmission model of tuberculosis, calibrated to epidemiological data from South Africa, to estimate the potential health and economic impact of M72/AS01 E vaccination and BCG-revaccination. We simulated vaccination scenarios over the period 2025–2050 with a range of product characteristics and delivery strategies. We calculated reductions in tuberculosis cases and deaths and costs and cost-effectiveness from health-system and societal perspectives. Results M72/AS01 E vaccination may have a larger impact than BCG-revaccination, averting approximately 80% more cases and deaths by 2050. Both vaccines were found to be cost-effective (compared to no new vaccine) across a range of vaccine characteristics and delivery strategies. The impact of M72/AS01 E is dependent on the assumed efficacy of the vaccine in uninfected individuals. Extending BCG-revaccination to HIV-infected individuals on ART had minimal effect on the health impact, but increased costs by approximately 70%. Conclusions Our results show that M72/AS01 E vaccination or BCG-revaccination could be cost-effective in South Africa. However, there is considerable uncertainty in the estimated impact and costs due to uncertainty in vaccine characteristics and the choice of delivery strategy.