EDCTP and AIGHD launched a Global Roadmap for Tuberculosis Vaccine Development

EDCTP and AIGHD have launched a Global TB Vaccine R&D Roadmap. It identifies priorities for the development and implementation of new TB vaccines with the aim to coordinate and accelerate global action. The project was carried out in close collaboration with the World Health Organization.

Tuberculosis (TB) is still one of the most fatal infectious diseases worldwide and the globe is in desperate need of an effective vaccine to stop the current deadly course of TB. With more than 1.4 million deaths a year, TB is a major global public health challenge, especially in low- and middle-income countries. Ambitious global TB control goals have been established, but it is widely recognised that these will not be achieved without safe and effective vaccines. Despite the huge global burden of disease, there is little commercial incentive to develop new TB vaccines – no new vaccine has been introduced since BCG in the 1920s. Addressing the need for new vaccines will require coordinated cross-sectoral partnerships and a focus on “end-to-end” development, from early-stage discovery research through to programmatic implementation.

Dr Michael Makanga, Executive Director, EDCTP: “Our enduring commitment to actively contribute to a concerted global R&D effort that will ultimately end TB is the main drive for investing in this very consultative new global TB vaccine roadmap. This launch is timely to leverage recent advances and new opportunities arising from lessons learnt from other diseases such as COVID-19”

Prof. Frank Cobelens, Chair, Executive Board, AIGHD: “This roadmap reflects a collective analysis by end-users, implementers, regulators, funders, manufacturers, and researchers of the barriers in TB vaccine R&D and the actions we need to take to overcome them. It lists concrete steps that we strongly hope will be taken by each of these actors. For COVID-19, collective effort has brought tremendous acceleration of vaccine development. Let’s show we can do this for TB as well”.

The project timeline was set out in three consecutive phases of consultations to achieve a collaborative result. First, a small group of approximately 20 stakeholders ranging from pharmaceutical developers to NGOs and National Institutes of Health was selected and interviewed. The interviews constituted the base for the second round of consultation: a consent workshop. It has been a year since stakeholders in the fight to end TB convened in Amsterdam in the workshop to discuss elements, challenges, and objectives of the Global Roadmap. AIGHD organized the meeting on March 3-4, 2020 together with the WHO and EDCTP. Following the workshop, a draft version of the Roadmap was reviewed thoroughly by involved partners: WHO, EDCTP, AIGHD, and the advisory board of the project, which was appointed by AIGHD and includes pharmaceutical companies and TB experts. Following this third phase, a last public consultation round transpired where researchers, funders, industry, regulatory and policy decision-makers, as well as individuals around the globe had the opportunity to contribute to its final version. The consultation period was from December 27, 2020, to February 15, 2021, and yielded some useful insights from stakeholders of the Norwegian University of Life Sciences, International AIDS Vaccine Initiative (IAVI), University of Zaragoza (Spain), University of Dschang (Cameroon) and Universidade Federal De Minas Gerais (Brazil). The decision to have a public consultation round follows in the footsteps of the European Commission that has started the European Health Emergency Preparedness and Response Authority (HERA) in the face of COVID-19. The initiative went through a public consultation round to prepare a document for better EU preparedness and response to serious cross-border health threats like COVID-19.

“Inclusivity and transparency are key when aiming to tackle global health threats like TB. Therefore, we also chose to go through a public consultation round,” Explains Remko van Leeuwen, co-investigator for the Roadmap project.

The final version of the Roadmap was presented by AIGHD at the Virtual Global Forum on TB Vaccines during a special session with more than 250 participants. Development of the Global TB Vaccine R&D Roadmap was supported by EDCTP through a grant to AIGHD. The Roadmap is funded by the EDCTP2 programme under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

Watch a video on the process of creating the TB Vaccine Roadmap.