07 Mar Recent publication in The Lancet Infectious Disease urges next steps for TB Vaccine R&D Roadmap

AIGHD Director, Prof. Frank Cobelens, and colleagues publish review in the Lancet Infectious Disease insisting on the acceleration of research and development for a vaccine against Tuberculosis.

For centuries, tuberculosis (TB) has infected 10 million people annually and been the leading cause of death around the globe, making it the world’s most infectious killer. That is, until the Covid-19 pandemic. The coronavirus pandemic has caused significant health, social and economic impacts over the past two years. This includes impacts on the access to TB diagnostics and treatment services. With additional attention and resources dedicated to the current pandemic, it is estimated that there has been an increase of 100,000 TB deaths in 2020. While Covid-19 deaths have surpassed TB deaths in most recent years, deaths from TB will return to the most infectious killer once the pandemic is over. Therefore, it is imperative that we focus attention on solutions to combat TB. One of these tools is a new, effective, and affordable vaccine that will eliminate TB globally. This is urgently needed, particularly for use in adults and adolescents in low- and middle-income countries.

Since 2019, AIGHD has been deeply involved in creating a Roadmap for the research and development of a TB vaccine. Along with the European & Developing Countries Clinical Trials Partnership (EDCTP), AIGHD launched the Global TB Vaccine R&D Roadmap, which identifies priorities for the development and implementation of new TB vaccines with the aim of coordinating and accelerating global action. This process has been highly consultative intended to provide a shared set of priorities to guide the activities with input from researchers, stakeholders, vaccine manufacturers, funders, regulators, and other organizations focused on vaccine research and development including GAVI and the Global Fund. Additionally, this consultation mechanism has taken into account lessons learned from Covid-19 vaccine development.

With the consultative process now complete, AIGHD director, Prof. Frank Cobelens and colleagues have published a paper in The Lancet Infectious Disease illustrating the need to accelerate R&D, engage funders, and advocate for TB new vaccines. It is now the time to include global agencies, industry, regulatory authorities, national decision-makers and communities to join forces and invest in tuberculosis vaccine research and development, raise awareness of the need for and possibilities presented by new tuberculosis vaccines, and mobilize community support for tuberculosis vaccination.

Thus far, the R&D project has been carried out in close collaboration with the World Health Organization (WHO). The next step in this process will be executed by the WHO, with involvement of AIGHD, with the creation of an implementation roadmap. This roadmap will focus on implementation and policy rather than research and development and will include next steps for regulators, the process of commercialization and manufacturing of the vaccines, and global recommendations for the rollout of a new TB vaccine. These two documents will work together not only in identifying critical research, but also by driving policy, generating increased funding, and encouraging advocacy work within the field of TB vaccines.

The research and development roadmap set research priorities for the clinical development of a new TB vaccine by bringing together the views of a broad range of stakeholders. The call for acceleration towards achieving a new vaccine requires more funding, more effective use of existing resources, and stronger engagement among stakeholders at the political, commercial, public health, and community levels. The swiftness with which a Covid-19 vaccine was developed and distributed is a shining example that should be the rule rather than the exception moving forward.