World TB Day 2024 – Yes! We Can End TB!

March 22, 2024

Statement of Jeanne Marrazzo, M.D., M.P.H., Lakshmi Ramachandra, Ph.D., and Peter Kim, M.D.
National Institute of Allergy and Infectious Diseases
National Institutes of Health

In observance of World Tuberculosis Day (Sunday, March 24) the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, joins our partners in reaffirming our commitment to ending the tuberculosis (TB) pandemic while honoring the lives lost to TB disease. This year's observance reprises the 2023 theme of "Yes! We Can End TB!" as a nod to the strong momentum of the TB response in many high-burden countries, bolstered by the dedication of TB stakeholders worldwide. On this day, NIAID celebrates the leadership of those affected by TB, their communities, and civil society.

Tuberculosis is a disease caused by the bacterium Mycobacterium tuberculosis. As many as two billion people worldwide live with latent M. tuberculosis infections,which have a 5-10% chance of developing into active disease over a person's lifetime. The World Health Organization estimates that 10.6 million people developed active TB in 2022, of whom 1.3 million were children, and 1.3 million people died from the disease. In the United States, the Centers for Disease Control and Prevention estimates that up to 13 million people are living with latent M. tuberculosis, and that 8,331 people developed active TB in 2022, representing a 5.9% increase over 2021 numbers and the second consecutive year of increasing TB incidence. There were 602 TB-related deaths in the United States in 2021, the most recent year for which data are available. TB affects the entire world, but more than 95% of TB deaths occur in low- and middle-income countries. Drug-resistant TB accounts for about one in three of all antimicrobial resistance-related deaths globally.

NIAID supports basic, preclinical, translational, and clinical research to advance the development of TB vaccines, diagnostics, therapeutics. To guide this work, this week NIAID released its 2024 Strategic Plan for Tuberculosis Research, an update to the first plan issued in 2018. The updated plan has four strategic priorities: improving fundamental TB knowledge; advancing research to improve TB diagnosis; accelerating research to improve TB vaccine development; and, supporting research to advance strategies to treat and prevent TB. As with the 2018 iteration, NIAID will implement this plan by leveraging current resources and global collaborations, including existing NIAID-supported clinical trials networks. These efforts will continue to build on the advances we celebrate today.

Improved diagnostics will help providers offer appropriate TB treatment during a person's health care visit. NIAID continues to support the evaluation of promising early-stage TB diagnostics and strategies through the Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) consortium. Studies are conducted in the context of existing clinical practice in TB high-burden countries including populations particularly difficult to diagnose, such as children and people with HIV. The FEND for TB consortium shares findings with developers and policymakers to facilitate improvement of technologies and inform clinical best practices. This work also includes research on artificial intelligence in TB diagnosis, and testing simpler sample collection, such as oral swabs, urine, breath, stool and blood. NIAID is working with many partners to evaluate TB biomarkers. Several novel technologies are also in development to enhance identification of TB drug resistance to help guide treatment decisions.

Current TB therapy requires many months of treatment with complicated medication regimens that tend to cause side effects, often leading to incomplete treatment and poor outcomes. Multidrug-resistant (MDR) and extremely-drug resistant (XDR) strains of TB that do not respond to the current standard of care are becoming more common worldwide. New antibiotic drug classes and combination regimens are urgently needed to expand therapeutic options.

NIAID scientists contributed to important advances in drug development this year. In collaboration with industry partners, scientists in the Tuberculosis Research Section of NIAID's Laboratory of Clinical Immunology & Microbiology (LCIM) found that a first-in-class agent called ganfeborole was safe and had strong activity against TB, making it a candidate for further clinical development. NIAID scientists previously have shown that the antibiotic linezolid is highly effective in treating XDR-TB, but with side effects that limit its use in less resistant forms of TB. LCIM is now in collaboration with an industry partner to conduct an early phase clinical study of an agent in the same antibiotic class as linezolid that may offer a more tolerable option for people with drug-susceptible TB. NIAID has helped the Global Alliance for TB Drug Development with preclinical research supporting two drug candidates in the same antibiotic class as bedaquiline that entered clinical evaluations in the past year.

Ongoing NIAID-supported TB therapeutics studies are examining drug combinations to enhance treatment and preventdevelopment of MDR-TB. One study is examining a shortened regimen for tuberculous meningitis, a form of TB that affects the membranes surrounding the brain and spinal cord and is fatal 25-50% of the time. Studies are expected to launch in the coming year to evaluate other novel TB medicines and drug combinations, as well as further clinical evaluation of a therapeutic vaccine that showed promising outcomes in an early stage study last year. On the preclinical side, NIAID will soon award funding for the Consortium for Design of TB Drug Regimens. This program will support identification of efficacious combination regimens for future clinical testing.

The Bacille Calmette-Guerin (BCG) vaccine protects infants and young children against disseminated TB disease and death, but does not provide long-lasting protection for adults. NIAID investments in TB vaccine-related research have led to the advancement of several vaccine candidates. Early development of the H107e/CAF®10b vaccine candidate by the Statens Serum Institut in Denmark was supported by NIAID's Partnership program and is now being tested in an early phase trial with funding from the Bill & Melinda Gates Foundation. NIAID also supports studies of other two vaccine candidates to assess their safety and ability to generate an immune response. One study is currently enrolling and will evaluate MTBVAC, developed by Biofabri. The other study, expected to start this year, will evaluate VPM1002, developed by Serum Institute of India.

Basic science and epidemiology underpin TB research efforts that lead to clinical advances and guide research priorities. Over the past year, NIAID-supported researchers uncovered additional molecular mechanisms of antibiotic resistance in M. tuberculosis. Scientists at the NIAID Vaccine Research Center discovered that TB-specific immune cells in the airway correlated with protection against TB infection in animal studies of the BCG vaccine, an insight that helps guide future research on BCG and other TB vaccine strategies. The NIAID Immune Mechanisms of Protection Against Mycobacterium tuberculosis Centers (IMPAc-TB) published new findings on the role that innate immunity could play in TB prevention. This year marks the 10^th anniversary of NIAID's TB Portals program, which makes TB epidemiology data openly available for research and educational purposes around the world. The portal recently added new sites in Mexico, Kyrgyzstan, and South Africa this year. In light of the shared health determinants and frequent co-occurrence of HIV and TB, NIAID supports TB research in people with and without HIV across its portfolio to ensure new interventions will serve the diverse population affected by TB.

Looking ahead, NIAID will continue to promote a global, multidisciplinary approach to TB research, drawing on expertise from fields within and outside the TB community to bring cutting-edge approaches to complex scientific challenges. NIAID is committed to a robust effort in TB science to develop rapid, easily deployable diagnostics, better treatment regimens for all forms of TB, and effective vaccine and prevention strategies-all required to end TB.

NIAID's efforts in TB science are made possible by the contributions of many, including scientists, civil society, funding partners, and the study participants without whom research would not be possible. We express our deep gratitude to all who help advance TB research.

Jeanne Marrazzo, M.D., M.P.H. is Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health. Lakshmi Ramachandra, Ph.D., is Chief, Tuberculosis and Other Mycobacterial Diseases Section, Division of Microbiology and Infectious Diseases, NIAID. Peter Kim, M.D., is Director, Therapeutics Research Program, Division of AIDS, NIAID.

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