Failure to meet commitments for TB research is not inevitable; the global COVID-19 response may show us the way.
It is just over a year since the World Health Organization (WHO) officially declared the COVID-19 outbreak a pandemic. As the world scrambled to stave off the throes of the crisis with global lockdowns, rerouting of health care resources, and unparalleled investment in the research and development (R&D) of COVID-19 health technologies, another respiratory disease, tuberculosis (TB), fell to the wayside.
In a field already plagued by chronic underfunding, a complex pathogen profile, and widespread complacency, we are now way off target to even approach the WHO goal to end TB by 2035. In just one year, the COVID-19 pandemic has turned back the clock on the global TB response by up to 12 years. TB diagnosis and treatment fell dramatically in many high-TB burden countries, and resurgences in TB cases are now feared. TB vaccines trials were equally affected.
“The COVID-19 pandemic severely impacted many TB vaccine trials and stretched already limited resources,” said Marisa Russell, associate director, Clinical Operations, IAVI. “We cannot afford more delays. We need everyone, from those with political and economic power to those in our most vulnerable communities, to join forces to help us complete this critical work.”
We won’t end TB without new vaccines. First administered in 1921, the Bacille Calmette-Guérin (BCG) vaccine has remained the only available TB vaccine for a century yet offers little to no protection in adults. TB vaccine research is now at a critical juncture. Promising results from a Phase IIb trial of the M72 TB vaccine candidate in 2019 showed the candidate to be 50% effective in preventing TB disease in people already infected with TB. Now licensed to the Bill & Melinda Gates Medical Research Institute, its continued development is anticipated. Elsewhere, the MTBVAC and VPM1002 TB vaccine candidates are entering Phase IIb and Phase III clinical trials, respectively.
The COVID-19 response has shown us that with concerted political, economic, and scientific will, it is possible to develop a vaccine in unprecedented timeframes. Yet despite TB being one of the world’s deadliest infectious diseases, killing 1.4 million people in 2019, TB R&D has been under-resourced for decades — amounting to an annual US$1.3 billion shortfall. At the 2018 United Nations High-Level Meeting to End TB, global leaders reaffirmed existing commitments to the Sustainable Development Goals (SDGs) and WHO’s End TB Strategy. New commitments included a call to mobilize at least $2 billion annually for TB research. These commitments are yet to be fulfilled — but failure to do so is not inevitable.
“SARS-CoV-2 has had a severe impact on TB control and research alike,” said Dereck Tait, senior medical director, IAVI. “If we address TB research with the same political will, public-private partnerships, and funding opportunities that drove the rapid development of SARS-CoV-2 vaccines, we may still achieve the End TB Strategy goals.”
Leveraging the expertise of organizations and individuals who are already paving the way in TB R&D will be key to this end. The Product Development Partnership (PDP) model is a case in point. The Keeping The Promise report, published in January this year, showcases the role of PDPs in developing new products for people suffering from diseases and health threats underserved by traditional markets. These efforts include Pretomanid to treat drug-resistant TB; the first to be developed and registered by a not-for-profit organization, TB Alliance.
TB is a social justice issue, with over 90% of TB cases occurring in developing and emerging economies. It wreaks enormous socio-economicburden on patients, families, and communities, and poses grave risk to health workers who put their lives on the line with often limited resources. Amid the ongoing pandemic, TB endemic communities face a double burden. Dr. Uvistra Naidoo knows this all too well. A TB pediatrician, scientist, advocate, and survivor, Uvi is currently recovering from his second bout of COVID-19. Earlier this year he sadly lost his father, a fellow physician to whom he credits the success of his three-year treatment from multi-drug resistant TB, to COVID-19. He notes a severe lack of caring in the world’s response to TB but sees COVID-19 as an opportunity to advocate one core value that must underpin any global health response — empathy.
“Eradicating TB is achievable but only if it’s approached with the same commitment, empathy, and integrity that the world has shown for COVID-19,” said Uvi, adding, “It’s high time that we cohesively prioritize political, scientific, and community leadership to end this preventable and curable disease, once and for all. It’s the world I live in hope for.”
But the TB R&D field must also look inward. In such a resource-constrained environment it pays to review inefficiencies; financial, operational, or otherwise. We must optimize the existing and forthcoming prevention and therapeutic technologies at our fingertips and ensure that no individual or family is burdened with catastrophic expenses due to what is a preventable and curable disease. The Global Strategy for TB Research and Innovation adopted by WHO member states at the 73rd World Health Assembly in August last year echoes this call, highlighting four major areas for action: creating an enabling environment for TB R&D, increasing investment, optimizing data sharing, and promoting equitable access to the benefits of R&D.
“Greater synergy among stakeholders, from researchers to funders and policymakers, is imperative if we want to make up for time we’ve lost during the pandemic,” said Tait. “This will require more efficient coordination between and within TB R&D sectors.”
Eradicating TB was never going to be an easy path. It’s time we take heed from the COVID-19 response. It’s time for more funding for TB research. It’s time to end the suffering caused by TB. The clock is ticking.