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. 2024 May 16:31:100424.
doi: 10.1016/j.lansea.2024.100424. eCollection 2024 Dec.

Estimating the potential health and economic impacts of new tuberculosis vaccines under varying delivery strategies in Delhi and Gujarat, India: a modelling study

Rebecca A Clark  1   2   3   4 , Allison Portnoy  5   6 , Chathika K Weerasuriya  1   2   3 , Tom Sumner  1   2   3 , Roel Bakker  1   2   3   7 , Rebecca C Harris  1   2   3   8 , Kirankumar Rade  9   10 , Sanjay Kumar Mattoo  11 , Dheeraj Tumu  9   11 , Nicolas A Menzies  6   12 , Richard G White  1   2   3   4
Affiliations

Estimating the potential health and economic impacts of new tuberculosis vaccines under varying delivery strategies in Delhi and Gujarat, India: a modelling study

Rebecca A Clark et al. Lancet Reg Health Southeast Asia. .

Abstract

Background: India has the largest tuberculosis burden, but the all-age prevalence in 2021 ranged from 747/100,000 in Delhi to 137/100,000 in Gujarat. No modelling studies have compared the potential impact of new tuberculosis vaccines in regions with differing disease and infection prevalence.

Methods: We used modelling to simulate hypothetical scenarios of introducing M72/AS01E (with 50% efficacy to prevent disease) and BCG-revaccination (with 45% efficacy to prevent infection) in Delhi and Gujarat.

Findings: The hypothetical M72/AS01E scenario could avert 16.0% of cases and 14.4% of deaths in Delhi, and 8.5% of cases and 7.6% of deaths in Gujarat between 2025 and 2050. The hypothetical BCG-revaccination scenario could avert 8.8% of cases and 8.3% of deaths in Delhi, and 5.1% of cases and 4.8% of deaths in Gujarat between 2025 and 2050.

Interpretation: Additional trials for both vaccines are underway, which will provide further evidence on the vaccine efficacy and narrow the range of uncertainty on the estimates.

Funding: Bill & Melinda Gates Foundation (INV-001754).

Keywords: Cost-effectiveness; Health economics; India; Mathematical modelling; Subnational; Tuberculosis; Vaccines.

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Conflict of interest statement

RCH reports employment by Sanofi Pasteur, unrelated to tuberculosis and outside the submitted work. NAM received consulting fees from The Global Fund to Fight AIDS, Tuberculosis and Malaria, and WHO, and reports funding to their institution from the U.S. Centers for Disease Control and Prevention, the Bill & Melinda Gates Foundation, NIH, and U.S. Council of State and Territorial Epidemiologists. RGW is also funded for other work by the Wellcome Trust (218261/Z/19/Z), NIH (1R01AI147321-01), EDCTP (RIA208D-2505 B), UK MRC (CCF 17-7779 via SET Bloomsbury), ESRC (ES/P008011/1), BMGF (OPP1084276, OPP1135288 & INV-001754), and WHO. All other authors declare no conflicts of interest.

Figures

Fig. 1
Fig. 1
Cumulative cases and deaths averted between 2025 and 2050 for Policy Scenarios for both vaccines and regions. The top of each bar represents the median cumulative number of cases or deaths averted for each scenario, and the bounds represent 95% uncertainty intervals. Cumulative cases and deaths averted were compared to the predicted number of cases and deaths that would occur between 2025 and 2050 with the Status Quo no-new-vaccine baseline: 4.1 (3.7–4.4) million cases and 533 (349-761) thousand deaths in Delhi, and 2.2 (2.0–2.5) million cases and 210 (100–325) thousand deaths in Gujarat.
Fig. 2
Fig. 2
Competing choice cost-effectiveness analysis for Delhi and Gujarat Policy Scenarios for both vaccine products.
Fig. 3
Fig. 3
Comparison of ICERs for select Vaccine Characteristic and Coverage Scenarios. The cost-effectiveness thresholds are indicated as follows: solid line = 1 times GDP per capita (US$1928), dashed line = country-level upper bound (US$443), and dotted line = country-level lower bound (US$328). The Basecase M72/AS01E scenario assumes a 50% efficacy POD vaccine efficacious with any infection status at the time of vaccination, with 10 years duration of protection reaching 80% coverage for 15-year-olds and 70% coverage for those aged 16–34. Each M72/AS01E scenario is delivered routinely to those aged 15 and as a campaign for those aged 16–34. The Basecase BCG-revaccination scenario assumes a 45% efficacy POI vaccine efficacious with no current infection at the time of vaccination, with 10 years duration of protection and reaching 80% coverage. Each BCG-revaccination scenario is delivered routinely to those aged 10 and as a campaign for those aged 11–18. The scenarios on the figure are labelled with the difference in product characteristics for that scenario compared to the Basecase.
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