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Tackling Tuberculosis in India: A New Hope

India fights TB with innovative vaccine strategies amid growing health challenges.

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India faces a significant health issue with tuberculosis (TB), which remains the highest burden globally. In 2021, the country reported approximately 2.9 million TB cases and 506,000 deaths, accounting for around 30% of the world's total. The situation worsened due to the COVID-19 pandemic, which disrupted TB diagnosis and treatment, leading to more deaths than seen in the previous years. Delays in detecting and treating TB patients have raised concerns that the burden of the disease may increase further.

Government Efforts to Control TB

The Indian government has prioritized TB control through its National Strategic Plan to End Tuberculosis (2020-2025). The plan, implemented by the National Tuberculosis Elimination Programme, aims to reduce the spread of TB, prevent new cases, and tackle factors affecting health. Despite setbacks from the COVID-19 pandemic, the program achieved advancements such as increasing testing capabilities and introducing simultaneous screening for TB and COVID-19.

One crucial aspect of the plan includes the development of new vaccines for TB. Organizations worldwide, including the World Health Organization (WHO), emphasize the need for effective vaccines to combat the disease. A study commissioned by the WHO argued for ongoing investment in TB vaccine research. Currently, there are 16 vaccine Candidates at different stages of testing, targeting various age groups and aspects of the disease.

Current Vaccine Candidates

Recent trials have shown promising results for one vaccine candidate, M72/AS01E, which demonstrated an Efficacy of about 49.7% in preventing TB disease in adolescents and adults. However, it still requires further testing in larger trials before it can be approved for public use. There was also a separate trial of the Bacillus Calmette–Guérin (BCG) vaccine, which showed a 45.4% efficacy in preventing sustained infection among uninfected adolescents.

Both vaccines could have significant impacts if widely implemented. Each offers different levels of effectiveness and potential benefits, making the choice of Vaccination strategy crucial.

Forecasting the Impact of Vaccination

To understand how these vaccines might affect TB cases and deaths in India, researchers created a model simulating the infection dynamics of TB in the country, considering various factors such as vaccination, treatment access, and age distribution. This model utilized population data and previous TB prevalence surveys to project future scenarios up to 2050.

Using this model, researchers analyzed the potential outcomes of introducing M72/AS01E and BCG-revaccination. For M72/AS01E, if introduced routinely to 15-year-olds and as part of a campaign for those aged 16-34, it could avert around 12.7 million cases and 2 million deaths from 2030 to 2050. Increasing its efficacy to 70% would magnify these benefits, although delays in rollout could lead to significantly higher cases and deaths.

On the other hand, the BCG-revaccination strategy, with its 45% efficacy, could prevent around 9 million cases and 1.5 million deaths if introduced to 10-year-olds and through campaigns for older adolescents.

Cost-Effectiveness of the Vaccines

When considering the financial implications, both vaccine scenarios were shown to be Cost-effective compared to a baseline scenario with no new vaccines. The estimated costs involved, including diagnosis, treatment, and vaccination, were weighed against the benefits of preventing TB cases and deaths.

For the M72/AS01E scenario, the estimated costs from the health system perspective reached about $5.3 billion, with a similar figure from a societal perspective. The costs and benefits were assessed using key economic thresholds, confirming that this scenario was cost-effective across various measures.

In comparison, the BCG-revaccination scenario showed lower costs, around $653 million, making it financially viable at all pricing thresholds evaluated.

The Need for Innovative Solutions

Given that TB poses a significant challenge, it is crucial to explore multiple vaccine candidates rather than focusing on one or two. Vaccines already in development, while promising, may not perform as expected. Thus, maintaining a diverse range of options will increase the chances of successfully reducing TB cases.

Research has shown that both M72/AS01E and BCG-revaccination have the potential to significantly lessen the TB burden in India over the years. They are both projected to be cost-effective, but the uncertainty surrounding their efficacy and delivery must be acknowledged. It’s important not to solely rely on one or two candidates, as outcomes may vary.

The different characteristics of each vaccine candidate could lead to varying health impacts. The M72/AS01E vaccine, for instance, targets older individuals who are at higher risk for TB, potentially leading to more substantial public health benefits.

Future Considerations

Some limitations arise from this analysis, particularly in the assumptions made regarding vaccine characteristics and the projected effects of interventions. The delivery strategies chosen may not reflect future plans in India, and the impact of various targeting approaches needs further investigation.

In conclusion, addressing the ongoing challenge of tuberculosis in India requires an informed, multi-faceted approach to vaccination. While effective vaccines like M72/AS01E and BCG-revaccination appear promising, ongoing research and investment in a variety of vaccine candidates are critical for achieving long-term success in eliminating TB. Continuous evaluation will be essential to ensure effective delivery and maximize health benefits across different regions.

Original Source

Title: New tuberculosis vaccines in India: Modelling the potential health and economic impacts of adolescent/adult vaccination with M72/AS01E and BCG-revaccination

Abstract: BackgroundIndia had an estimated 2.9 million tuberculosis cases and 506 thousand deaths in 2021. Novel vaccines effective in adolescents and adults could reduce this burden. M72/AS01E and BCG-revaccination have recently completed Phase IIb trials and estimates of their population-level impact are needed. We estimated the potential health and economic impact of M72/AS01E and BCG-revaccination in India and investigated the impact of variation in vaccine characteristics and delivery strategies. MethodsWe developed an age-stratified compartmental tuberculosis transmission model for India calibrated to country-specific epidemiology. We projected baseline epidemiology to 2050 assuming no-new-vaccine introduction, and M72/AS01E and BCG-revaccination scenarios over 2025-2050 exploring uncertainty in product characteristics (vaccine efficacy, mechanism of effect, infection status required for vaccine efficacy, duration of protection) and implementation (achieved vaccine coverage and ages targeted). We estimated reductions in tuberculosis cases and deaths by each scenario compared to no-new-vaccine introduction, as well as costs and cost-effectiveness from health-system and societal perspectives. ResultsM72/AS01E scenarios were predicted to avert 40% more tuberculosis cases and deaths by 2050 compared to BCG-revaccination scenarios. Cost-effectiveness ratios for M72/AS01E vaccines were around seven times higher than BCG-revaccination, but nearly all scenarios were cost-effective. The estimated average incremental cost was US$190 million for M72/AS01E and US$23 million for BCG-revaccination per year. Sources of uncertainty included whether M72/AS01E was efficacious in uninfected individuals at vaccination, and if BCG-revaccination could prevent disease. ConclusionsM72/AS01E and BCG-revaccination could be impactful and cost-effective in India. However, there is great uncertainty in impact, especially given unknowns surrounding mechanism of effect and infection status required for vaccine efficacy. Greater investment in vaccine development and delivery is needed to resolve these unknowns in vaccine product characteristics.

Authors: Rebecca A Clark, C. K. Weerasuriya, A. Portnoy, C. Mukandavire, M. Quaife, R. Bakker, D. Scarponi, R. C. Harris, K. Rade, S. K. Mattoo, D. Tumu, N. A. Menzies, R. G. White

Last Update: 2023-07-10 00:00:00

Language: English

Source URL: https://www.medrxiv.org/content/10.1101/2023.02.24.23286406

Source PDF: https://www.medrxiv.org/content/10.1101/2023.02.24.23286406.full.pdf

Licence: https://creativecommons.org/licenses/by/4.0/

Changes: This summary was created with assistance from AI and may have inaccuracies. For accurate information, please refer to the original source documents linked here.

Thank you to medrxiv for use of its open access interoperability.

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