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TB vaccine development: monitoring international patent filings to anticipate access challenges

2025-2026

Maps international patent filings for two late-stage TB vaccine candidates, MTBVAC and M72/AS01E, as well as the QS-21 adjuvant used in M72/AS01E

Part of Change 2.0

2024-2027

Hypothetical vaccines

Actionable market intelligence, including vaccine demand forecast/scenarios, generated to strategically guide manufacturers and partners in their planning for introduction in high burden countries. The objectives include: 1. Strategic assessment of appropriate market-shaping interventions, 2.Stakeholder and decision process mapping , 3.Demand dynamics understanding and realistic market forecast development, 4. Commercialization strategy support for lead candidate(s).

Facing up to reality? What to do if M72/AS01E doses are limited

M72/AS01e

The Ph3 trial for the vaccine candidate M72/AS01E is underway, and, assuming a positive result, could be licensed by 2030. Modelling suggested a large potential impact from introducing M72/AS01E but assumed an unconstrained dose supply. However, at least initially, it is likely that M72/AS01E will be supply-constrained. We estimated the effect of decisions surrounding the allocation of constrained doses on the potential global impact of M72/AS01E

Cost and Cost Effectiveness of Novel Tuberculosis Vaccines in Low-and Middle-income Countries: A Systematic Review of Modelling Studies

Hypothetical vaccines, M72/AS01e

This review addressed the costs and cost-effectiveness of novel tuberculosis (TB) vaccines compared to the current standard of care (BCG) in various settings and for different age groups in LMICs

Age-targeted tuberculosis vaccination in China and implications for vaccine development: a modelling study.

2019

Hypothetical vaccines

We modelled the potential impact of new tuberculosis vaccines in China targeting adolescents (15–19 years) or older adults (60–64 years) with varying vaccine characteristics to inform strategic vaccine development.

Potential impact of tuberculosis vaccines in China, South Africa, and India

2020

BCG revaccination, M72/AS01e

To inform vaccine development decision making, we modeled the impact of hypothetical tuberculosis vaccines in three high-burden countries.

The epidemiologic impact and cost-effectiveness of new tuberculosis vaccines on multidrug resistant tuberculosis in India and China

2021

Hypothetical vaccines

We investigated the epidemiologic impact, cost-effectiveness, and budget impact of hypothetical novel prophylactic prevention of disease TB vaccines on RR/MDR-TB in China and India.

Mixed vaccination strategy for the control of tuberculosis: A case study in China

2017

Hypothetical vaccines

This study first presents a mathematical model of TB transmission considering BCG vaccination compartment to investigate the transmission dynamics nowadays

Affordability of adult tuberculosis vaccination in India and China: A dynamic transmission model-based analysis

2021

M72/AS01e

To estimate the total disability adjusted life years (DALYs) averted by the vaccination programme, we simulated a 50% efficacy vaccine providing 10-years of protection in post-infection populations between 2027 and 2050 in India and China using a dynamic transmission model of M. tuberculosis.

Bridging the gap: evaluating high TB burden country data needs to support the potential introduction of TB vaccines for adolescents and adults: a workshop report

2024

A workshop to asked high TB burden country experts about what epidemiological, impact, feasibility and acceptability data they anticipated they would need to guide TB vaccine introduction.