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Assessing the readiness of communities and civil society to contribute to new TB vaccine policy making and implementation

2024-2026
Hypothetical vaccines
Three-part study to assess the readiness of community and civil society to contribute to TB vaccine policymaking and implementation at national, regional, and global levels, and the investments funders should make to strengthen community capacity and engagement. 1) No Vaccines Without Us: A Global Landscape Analysis of Civil Society Engagement in TB Vaccine Preparedness is based on a global survey of 125 civil society organizations active in the TB response in 42 countries. 2) Country Policy Portraits, written by local activists, illustrate how vaccine policy is made in seven countries — Bangladesh, Kazakhstan, Kenya, Malawi, Mongolia, South Africa, and Vietnam — and propose reforms to strengthen the representation of community partners in national immunization decision making. 3) TB Vaccine Access in “4D”: A Roadmap Charting Civil Society Actions for Equitable Access outlines a series of actions civil society can take to assure access to new TB vaccines along four dimensions: development, delivery, demand, and data.

Global TB vaccine R&D roadmap

2022
The purpose of the Global roadmap for research and development (R&D) of tuberculosis (TB) vaccines is to provide global stakeholders – researchers, funders, industry, regulatory authorities, policy decision-makers and civil society – with actionable priorities to guide their activities. The roadmap primarily focuses on developing and delivering affordable and effective vaccines for use in low- and middle income countries with a high incidence of TB, in line with the World Health Organisation (WHO) goals outlined below. However, such vaccines may also be useful to protect high-risk populations or groups in high-income/low incidence countries. The roadmap integrates and aligns strategic planning and innovation towards a shared vision with associated short-, medium- and long-term priorities for global TB vaccine development. The roadmap covers the entire R&D chain, with an emphasis on late-stage development and implementation.

Measuring indirect transmission-reducing effects in tuberculosis vaccine efficacy trials: why and how?

2023
Hypothetical vaccines
Tuberculosis is the leading bacterial cause of death globally. In 2021, 10·6 million people developed symptomatic tuberculosis and 1·6 million died. Seven promising vaccine candidates that aim to prevent tuberculosis disease in adolescents and adults are currently in late-stage clinical trials. Conventional phase 3 trials provide information on the direct protection conferred against infection or disease in vaccinated individuals, but they tell us little about possible indirect (ie, transmission-reducing) effects that afford protection to unvaccinated individuals. As a result, proposed phase 3 trial designs will not provide key information about the overall effect of introducing a vaccine programme. Information on the potential for indirect effects can be crucial for policy makers deciding whether and how to introduce tuberculosis vaccines into immunisation programmes. We describe the rationale for measuring indirect effects, in addition to direct effects, of tuberculosis vaccine candidates in pivotal trials and lay out several options for incorporating their measurement into phase 3 trial designs

An effective vaccine is only the first step: the need to create and sustain demand for TB vaccines

2023
Understanding public willingness to receive new TB vaccines, as well as defining how to address any barriers to acceptance, will be key to ensuring that the promise of these vaccines can be fully realized. Although we can learn from previous vaccine intro ductions, it is imperative we close key research gaps specific to new TB vaccines. This will inform the development of interventions to generate and sustain high demand for TB vaccines in communities that stand to benefit the most

Global TB vaccine partnership

2011-2023
The Global Tuberculosis Vaccine Partnership (GTBVP) is a forum for key stakeholders in TB vaccine R&D to identify and address barriers impeding TB vaccine R&D and to discuss R&D priorities in order to help inform funding decisions
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