TB vaccine development: monitoring international patent filings to anticipate access challenges
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
Philippines
Part of Change 2.0
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).
The potential health and economic impact of introducing the vaccine candidate VPM1002 to prevent tuberculosis disease in low- and middle-income countries
This study estimates the potential health and economic impact of introducing the TB vaccine candidate VPM1002 in 79 low- and middle- income countries. It models routine vaccination and vaccination campaigns, estimating TB cases and deaths averted and the cost-effectiveness of different introduction scenarios. It provides evidence for decisions about the potential future introduction and scale-up of VPM1002
Facing up to reality? What to do if M72/AS01E doses are limited
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
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
New tuberculosis vaccines are in late-stage trials, but how confident is the public in high burden countries in vaccines?
With tuberculosis (TB) vaccine candidates in late-stage trials, it is important to prepare for implementation to avoid delays upon licensure. General confidence in vaccines has been identified as an anticipated barrier to introducing new TB vaccines. In the absence of detailed TB specific vaccine acceptability and confidence data, we analysed currently available vaccine confidence data in countries appearing on one of the World Health Organization (WHO) high burden lists to investigate vaccine confidence in countries with a high TB burden
Epidemiologic study to assess the IGRA positivity in populations with a high TB
Tuberculosis (TB) vaccine efficacy trials evaluating prevention of disease must be feasible in size and duration and would ideally take place at clinical trial sites that enroll from communities with the highest incidence rates. In preparation for the Phase 3 trial of the investigational M72/AS01E-4 vaccine, we conducted a multi-country study, using interferon gamma release assay (IGRA) positivity as a proxy for expected incidence of TB. In addition to the above objects, the results from this study could help in in new vaccine introduction to identfy TB hotspot areas.
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
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.
Modelling the global burden of drug-resistant tuberculosis avertable by a post-exposure vaccine
Using mathematical models, we seek to estimate the potential impact of a post-exposure TB vaccine, having 50% efficacy in reducing active disease, on global rifampicin-resistant (RR-) TB burden.
Meeting the 2030 End TB goals in the wake of COVID-19: a modelling study of countries in the USAID TB portfolio.
From 2023 onwards we modelled a combination of interventions acting at different stages of the care cascade, including improved diagnostics; reducing the patient care seeking delay; and the rollout of a disease-preventing vaccine from 2025 onwards.