Opinion: We won’t get the innovation needed to end TB without more R&D

After being vaccinated for tuberculosis as an infant in the Kenyan county of Nakuru, Carol Mburu assumed she was protected against the world’s deadliest infectious disease. However, her TB diagnosis at the age of 22 confirmed the Bacille Calmette-Guérin, or BCG, vaccine’s ineffectiveness in protecting her beyond childhood. The BCG vaccine — the only vaccine against TB — was introduced in 1921 and is one of the most widely administered vaccines in the world. But given its limited effectiveness, and the continued burden of TB globally, the century-old vaccine and stories like Mburu’s remind us of the urgent need to fund the development of new tools to address this disease that has been affecting humans for over 9,000 years. While immunizations are one of the greatest public health achievements in human history, and the BCG vaccine has undoubtedly saved millions, we know vaccines are not a silver bullet. Addressing TB will require innovation across the range of care needs, from prevention to diagnosis to treatment. Unfortunately, chronic underfunding of research and development for TB has left significant gaps throughout the care cascade, resulting in 1.6 million deaths in 2021 alone. With the second United Nations High-Level Meeting on TB taking place this September, advocates are calling on member states to use this moment to recommitment to TB elimination and prioritize research and development to achieve the global goal of ending this disease. Outdated tools Compounded with waning vaccine protection, access to diagnostic tools to test for TB can be a matter of life or death. In Mburu’s case, she was fortunate to receive a diagnosis as a young adult. Globally, however, diagnosis is the weakest link in the TB continuum of care, with a large global gap between the estimated number of people who fall ill with TB and the number of people diagnosed. In 2021, an estimated 4.2 million people did not receive a diagnosis and, therefore, did not receive the care they needed. High cost, low sensitivity, and limited accessibility of tests are impeding access to diagnostic tools and presenting significant barriers to TB elimination — because we cannot end TB if we cannot find TB. The complexity and fragility of the TB care cascade does not end with a diagnosis. Current treatment options present many additional issues. Treatment regimens used in the majority of the world today are complicated and often toxic, lasting up to two years. Complex regimens and severe side effects can lead to misuse or poor treatment adherence, which can result in the development of drug-resistant strains. Options to invest in The rise of drug-resistance, intensified by the disruptive impact of the COVID-19 pandemic on TB programs, is a daunting reminder of the consequences that follow the poor management of epidemics. In order to meet global TB elimination targets and save millions, innovation across TB prevention, diagnosis, and treatment must be prioritized. Fortunately, work is already underway to improve the tools we have to address the TB epidemic. These innovations are injecting a renewed sense of optimism into the TB movement. • Prevention: No infectious disease has ever been eradicated in the absence of an effective vaccine and TB will be no exception. The development of a new TB vaccine could be a real game-changer, as it is projected to be the single most effective intervention in bringing the world closer to TB elimination. Currently there are 16 candidates in the TB vaccine pipeline. Meeting the Sustainable Development Goal target of eliminating TB by 2030 will require prioritizing the development and deployment of new safe, effective, and affordable vaccines. • Diagnosis: Ensuring that people with TB are not missed by health systems will require equitable access to affordable diagnostic tools. Leveraging investments from the COVID-19 pandemic and investing in more accessible tests will be game-changers for TB detection. Ongoing development of new tools, like point-of-care and self-testing technologies to decentralize care along with tongue swabs and urine-based tests to simplify sample collection, will bring diagnostics to lower levels of the health care system, helping to meet patients where they are. • Treatment: Ending TB will require shorter, more straightforward, and more effective treatment regimens. Fortunately, such innovations are coming to fruition, with the development of new, safer, and shorter TB treatments, such as the research non-profit TB Alliance’s BPaL regimen. The three-drug, all-oral, six-month regimen has shown a treatment success rate of about 90% in clinical trials for drug-resistant TB. The shorter duration, lower pill burden, and higher efficacy of this new treatment can help ease the burden on health systems, while improving treatment outcomes and quality of life for individuals with drug-resistant TB. Call for commitment While the science to develop new TB tools is there, this progress is threatened by the severe funding shortfall for TB R&D. In 2018, at the first United Nations High-Level Meeting on TB, member states committed to expanding funding for TB R&D to $2 billion annually by ensuring that all countries contribute their “fair share.” Every year since this commitment was made, the world has failed to meet the target. Donor countries, such as the United States and Canada, have never fulfilled their goals, despite being key contributors to global health. To make matters worse, the annual funding needed for TB R&D has more than doubled due to years of underfinancing as well as the impacts of the COVID-19 pandemic on TB programming. The Stop TB Partnership’s Global Plan to End TB 2023-2030 calls on funders to contribute $5 billion annually for TB R&D. In 2021, only $1 billion was raised. Global leaders have an opportunity to reaffirm their commitment to ending TB through their meaningful participation at the U.N. HLM on TB this September. Civil society organizations, affected communities around the world, and TB survivors like Mburu are calling on heads of state to back their words with real action by meeting the updated “fair share” target of allocating 0.15% of their total R&D expenditure to TB and championing the development of new tools to prevent, diagnose, and treat TB. This funding will complement existing contributions by donor countries to global TB elimination, by improving the tools employed by multilaterals organizations like The Global Fund to Fight AIDS, Tuberculosis and Malaria. With the funding and political will to promote scientific development, game-changing innovations will bring us closer to a world where no one suffers from TB. Visit the Talking TB series for more coverage on how we can eliminate tuberculosis by 2030. The time for a paradigm shift and a renewed focus on funding, research, and global solutions is now. Join the conversation by using the hashtag #TalkingTB.