Breakthroughs Blog: Tuberculosis

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last week, the Bill & Melinda Gates Foundation and Wellcome Trust announced that they will jointly invest more than $500 million in phase 3 trials for the GSK-developed M72/AS01E tuberculosis (TB) vaccine, which could become the first new tuberculosis vaccine in 100 years. 2018 phase 2b trials showed that the vaccine was 50 percent effective, but after GSK pulled out because they did not see a commercial market for the vaccine, the company passed the license to the Bill & Melinda Gates Medical Research Institute in 2020. The phase 3 trials will involve 26,000 people in Africa and Southeast Asia, hopefully confirming the vaccine’s viability as TB cases and deaths rise around the world.A new initiative led by Gavi, the World Health Organization, and the Coalition for Epidemic Preparedness Innovations will work to stockpile experimental vaccines for infectious diseases with epidemic potential to improve preparedness for future outbreaks. This global virtual pooled inventory will initially focus on Marburg and the Sudan strain of Ebola, for which there are no existing vaccines or proven treatments. Last year’s outbreaks in Africa of these two hemorrhagic fevers saw aborted attempts to move forward clinical trials for vaccines, losing crucial opportunities to gather essential data on potential tools and highlighting the need for this kind of stockpiling, preparation, and partnership.The Medicines Patent Pool recently announced sublicensing agreements with seven manufacturers to produce and distribute generic versions of Shionogi’s COVID-19 antiviral treatment in low- and middle-income countries, improving availability and equitable access in these countries, even after the end of the Public Health Emergency of International Concern. The oral antiviral, Ensitrelvir, is currently only approved in Japan, although it is being considered in the United States and all 117 countries in the agreements. Medicines Patent Pool previously signed sublicensing agreements with Pfizer in 2021 to manufacture and distribute its treatment, Paxlovid, in 95 low- and middle-income countries.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Data from late-stage trials showed that Pfizer’s experimental antibiotic drug combination was well-tolerated and effective in treating complicated infections caused by drug-resistant bacteria. The combination, which includes the experimental mix aztreonam-avibactam, existing generic drug metronidazole, and two older antibiotics: meropenem and colistin, is aimed at treating complicated intra-abdominal infections and some types of hospital-acquired pneumonia caused by gram-negative bacteria. The study underscores that innovative, novel antibiotics continue to be an important goal in the face of the rising global threat of antimicrobial resistance.Last week, the US Food and Drug Administration (FDA) approved Pfizer’s Abrysvo vaccine for respiratory syncytial virus (RSV) following strong results from a phase 3 trial, making it the second vaccine to protect older adults from RSV approved in recent months. Both vaccines will not be available until the US Centers for Disease Control and Prevention recommends them, which the agency is expected to do soon. Experts have highlighted the great potential for both vaccines to drastically reduce the number of infections and hospitalizations in adults that result from the virus every year.A new study showed the success of implementing shorter treatment regimens for drug-resistant tuberculosis (TB) in a small cohort in the United States. The six-month, all-oral bedaquiline, pretomanid, and linezolid (BPaL) regimen for rifampin-resistant TB was implemented in 70 patients in 2019, shortly after FDA approval of the regimen. The promising results lend support to the early implementation of new TB treatments and highlight the promise of further innovation to reduce the burden of TB, especially drug-resistant TB, in the United States and around the world.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.Last week, Indian drug company Cipla confirmed that a generic version of the HIV prophylaxis long-acting cabotegravir (CAB-LA) will be manufactured at its plants in South Africa for the first time, which could potentially offer millions of people at risk of HIV infection in Africa access to the groundbreaking drug. CAB-LA is a two-monthly jab that is easier to take regularly and has also been found to work better than the daily HIV prevention pill, which is currently available for free in South Africa and several other countries on the continent. The introduction of generic manufacturers into the market for HIV drugs has the potential to dramatically reduce medicine prices, which are often out of reach for low- and middle-income countries, even at prices discounted by the manufacturers that hold the original patents.IAVI and Zendal Group’s subsidiary Biofabri have signed an expanded deal to develop MTBVAC, the only live, attenuated mycobacterium tuberculosis (TB) vaccine in the pipeline. The developers are targeting the vaccine for use in adults and adolescents and are aiming for the candidate to be more effective and potentially longer lasting than the bacillus Calmette-Guérin, or BCG, vaccine that is currently in use to prevent TB in newborns. IAVI is planning to commence a trial for the MTBVAC in 2024 after sufficient funding is secured. The deal also includes support for advancing MTBVAC for infants following Biofabri commencing a phase 3 trial of MTBVAC in neonates last year.Last week, the US National Institutes of Health announced that they are beginning to enroll patients in an early-stage clinical trial testing an mRNA universal flu vaccine that is aimed at protecting against a wide variety of strains of the flu and providing long-term immunity. The shot, designed by researchers at the National Institute of Allergy and Infectious Diseases, will test whether the shot is safe and produces an immune response in 50 healthy adult volunteers. If proved to be safe and effective, a universal flu vaccine could eliminate the need for scientists and vaccine manufacturers to predict the dominant flu strain and produce shots in advance of prime flu season, as well as reduce the risk of illness and hospitalization, particularly when the shots available are not well matched to the dominant circulating strains.

Prior to COVID-19, tuberculosis (TB)—another airborne disease—was the world’s leading global infectious disease killer, claiming the lives of around 1.5 million people annually. Insufficient and inadequate tools and treatments, and growing drug resistance, have challenged global efforts to bring the TB epidemic to an end, and more recently, disruptions from COVID-19 have reversed years of TB progress. In 2020, global TB deaths increased for the first time in more than a decade, and about 1 million fewer people were tested and treated for TB compared to 2019. The number of new cases and deaths increased further in 2021. At the same time, global funding for TB diagnostic, treatment, and prevention services fell by $500 million from 2019 to 2020, and total funding for TB research and development dropped by $33 million.Scientists hope the tide can be turned as new technologies and innovations advance to market—but to achieve that, more investment is urgently needed to boost resources and reverse setbacks.In recognition of World TB Day, test your knowledge of innovations to end TB with GHTC’s quiz below: