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. TB Alliance has launched a new pan-phase 2 clinical trial to evaluate the safety and efficacy of replacing bedaquiline with a new experimental compound, TBAJ-876, in the organization’s three-drug BPaL regimen. The new regimen, composed of novel compounds with minimal pre-existing resistance, could provide a method to treat all patients with active tuberculosis (TB), including drug-sensitive and drug-resistant TB, with a universal treatment that is shorter, simpler, and more people-friendly than current regimens. Results from the preclinical and phase 2 studies showed that TBAJ-876, compared to bedaquiline, eliminated TB bacteria faster and was potentially safer. The study aims to enroll 300 participants with drug-sensitive TB at 21 trial sites in Georgia, the Philippines, South Africa, Tanzania, and Uganda.  Last week, the Bill & Melinda Gates Foundation announced a $23.6 million grant to US-based life science company Micron Biomedical to fund the first-ever mass production of needle-free vaccine technology. The technology, which uses dissolvable microneedles attached to the skin via a patch-like device, has the potential to boost the uptake of a variety of injectables, particularly in low-income countries, because it is simpler to transport and easier to administer. Specifically, the funding will support the development of a manufacturing facility that can make around 10 million doses annually for large clinical trials and hopefully wider use, subject to approval from regulatory authorities.A phase 3 clinical trial in South Africa found that a widely available oral antibiotic, levofloxacin, was safe and substantially reduced the risk of children and adults developing multidrug-resistant tuberculosis (MDR-TB). The trial is the first high-quality study to look at a preventive treatment for MDR-TB in children—there are currently no preventive MDR-TB treatments for adults or children. The researchers hope the new results will lead to updated guidelines from the World Health Organization that will lead to the rapid scale-up of levofloxacin because the drug is already widely available and relatively affordable, with child-friendly formulations already available through procurement agencies.  

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 Thursday, the US Food and Drug Administration (FDA) announced its approval of the first vaccine to prevent the disease caused by the chikungunya virus. The Ixchiq vaccine, developed by Valenva, is approved for adults at increased risk of exposure to the virus. It was previously granted fast-track and breakthrough therapy designations from FDA. Chikungunya is a chronic and debilitating disease that has no specific treatment, which has become an increasing global threat due to climate change. FDA is requiring that Valneva perform a post-market study to continue to monitor the vaccine’s safety and side effects.With support from Medicines for Malaria Venture (MMV), Kenyan manufacturer Universal Corporation Ltd has received prequalification from the World Health Organization (WHO) for sulfadoxine-pyrimethamine plus amodiaquine (SPAQ), an antimalarial drug used to prevent seasonal malaria in children during peak transmission periods. This approval, which makes UCL only the sixth African pharmaceutical company to have a product WHO-prequalified, will allow Africa to reduce reliance on imported generic versions of the drug from India and China. In the face of a myriad of barriers to quality local drug production and a persistently high burden of malaria cases and deaths, the approval will also make it easier for other African companies to enter the market and attract major buyers, as well as ensure the accessibility and availability of the drug where it is most needed and free up national resources to dedicate to other aspects of the malaria response.A new study found that more than half of tuberculosis (TB) patients in South Africa receiving treatment with a bedaquiline-containing regimen had isolates resistant to the drug, which was introduced in South Africa in 2012 and has recently become part of all standard drug-resistant TB regimens globally. The study is one of the first to report individual-level bedaquiline resistance gain over time among patients in a setting with a bedaquiline-containing regimen as the standard treatment. The results highlight the need for drug-susceptibility testing capacity to accompany the scale-up of new drugs like bedaquiline to monitor the emergence of drug resistance.

At GHTC, we get to read stories every day about incredible innovations in global health. Most of the technologies we see are inventive, some are revolutionary, and a few are so unusual, one might think they were ripped from the pages of a science fiction novel. Now, we’re testing how well you know these global health technologies with our annual Halloween game: the TRICK or TREATment quiz.For each question, we will present a description of a global health technology. Choose TREATment if you believe this innovation exists. Choose TRICK if you think we are trying to pull one over on you and, instead, the product is still in development or is just a figment of our imagination. 

With thousands of delegates dashing from one meeting to another in the frenetic New York streets, it was clear that the United Nations General Assembly (UNGA) was back in full swing this year. Given the three High-Level Meetings (HLMs) on global health, including pandemic preparedness, prevention, and response (PPPR); universal health coverage (UHC); and tuberculosis (TB), this was already set to be a major opportunity to reset coming out of the worst of the COVID-19 pandemic. Yet despite high ambitions, this year’s forum fell short of expectations, with many key issues, such as new agreements for sharing medical countermeasures (MCMs), accountability and enforcement mechanisms, or new funding commitments, being either punted to other forums or ignored. Innovation did feature strongly in all three HLMs, and despite the general disappointment, the research community was able to notch a few wins.A milestone in global pandemic preparednessThe UNGA HLM on PPPR marked a historic moment with the adoption of a political declaration. While nonbinding, this declaration carries significant symbolic weight, underscoring the global recognition that pandemic threats transcend mere health emergencies; they are existential threats that must be addressed with a whole-of-society approach. However, it was clear in the lead-up that the ambition had been severely curtailed and much of the text of the political declaration watered down. The meeting saw minimal participation from heads of state and inadequate representation from civil society. Many countries chose to focus on their past accomplishments in PPPR without articulating clear next steps or new commitments.Funding (or lack thereof) was another key theme of the week. The declaration emphasizes the importance of supporting sustainable and alternative financing mechanisms, as well as strengthening the capacity for innovation and production of MCMs. Specifically, it highlights the need to assist low- and middle-income countries (LMICs) by bolstering local production, technology transfer, and voluntary licensing. Support for the Pandemic Fund is noted, acknowledging the need for $10 billion to make the mechanism successful. Despite these encouraging commitments, the adopted declaration does not include specific new financial pledges for the Pandemic Fund nor targets that ensure the realization of the 100 Days Mission Plus, an initiative that would seek to develop and distribute MCMs within 100 days of an outbreak. Some were also hoping to see the declaration lay out some key principles or targets for a potential MCMs platform to succeed the Access to COVID-19 Tools Accelerator, which coordinated and oversaw the rollout of COVID-19 technologies to low-income countries. But while leaders emphasized the importance of achieving equitable access to essential tools in their statements, disappointingly, there was no mention of a platform in the final declaration text, and the idea was hardly mentioned by member states during debate. Instead, it was clear from the statements leaders made at the meeting that they are eyeing the ongoing processes in Geneva on a pandemic accord and reforms to the International Health Regulations (IHR) to resolve many of these issues—further increasing the stakes for the outcomes of these processes, which need to be aligned with each other and with the declaration.Lack of progress on UHC implementationThe UHC meeting began with the adoption of a nonbinding political declaration by member states. During the meeting, issues of equity and access took center stage. Various countries emphasized the importance of ensuring that health care and health products are accessible to all, regardless of income, and advocated for gender-inclusive health interventions.The role of R&D in achieving UHC emerged as another central theme. Many countries highlighted the need for local and regional production of vaccines, diagnostics, medicines, and other health technologies. Several member states stressed the importance of technology transfer to LMICs and the removal of barriers posed by intellectual property rights. Collaboration and innovation were identified as key drivers of improved global health outcomes. In alignment with the sentiments coming out of the previous day’s PPPR HLM, this reflects a growing recognition of the importance of regional and domestic capacity for health care production and innovation.The spotlight on R&D in the broader UHC context is an exciting step in the right direction, but like the PPPR HLM, the UHC discussions lacked targeted commitments. Member states focused on identifying gaps and areas of needed improvement, such as localized manufacturing of health technologies and increased investments, but largely failed to pledge new financing and other concrete commitments to fill these gaps.  TB commitments finally include tangible targetsThe week culminated with the TB HLM adopting a political declaration, setting forth targets and commitments for tackling TB. In the document, governments pledged to mobilize at least $22 billion annually by 2027, with a more substantial commitment of $35 billion annually by 2030 for TB prevention and treatment. Additionally, there was a commitment to mobilize an additional $5 billion a year by 2027 for TB research and innovation. These commitments are ambitious, especially given that governments have delivered less than half of the $13 billion they had committed to raise by 2022 during the 2018 HLM. Similarly, only half of the $2 billion pledged annually for TB R&D has materialized.While many in the TB community celebrated the adoption of the declaration, it is important to note that the document does not go as far as some advocates would have liked, particularly on equity and inclusiveness provisions, and others have expressed disappointment about the lack of engagement from heads of state. That said, the ambitious funding targets set forth in the declaration hold the potential to make a significant impact if they are met with concrete actions, accountability, and global leadership. Now, the challenge lies in holding governments accountable for their commitments by putting in place robust monitoring mechanisms to track progress.So where do we go from here? With all three political declarations adopted at the HLMs, the General Assembly must formally ratify them in the coming week, and there could still be fights ahead, as several member states lodged objections ahead of the summit. The UNGA HLMs shed light on the global community's priorities on PPPR, UHC, and TB but also gave insight on the lack of concrete commitments from member states. Heads of state were disappointingly underrepresented in all three. Statements from ministers were verbose on gaps and needs but short on commitments and implementation.Zooming out to the broader ecosystem, it is reassuring to see alignment between multilateral bodies, such as the G7’s promise to foster innovative technologies for TB and other diseases, acknowledging the need for advancements in this critical area. In fact, one of the major concrete announcements of the week was the government of Japan launching its Impact Investment Initiative for Global Health (Triple I for GH), a new G7 initiative that seeks to align private and nonprofit stakeholders around best practices for impact investment in global health. Finally, the G20 also reaffirmed its commitment to combat TB and other diseases and to support the interim MCMs platform under development by WHO.While the HLMs were significant milestones, the true test lies in the implementation of commitments. With the political declarations being nonbinding, it is now up to other multilateral bodies to pick up the baton and ensure targets are established, commitments are made, and leaders deliver on implementation. Looking ahead, the deliberations around the pandemic accord will next take center stage through the intergovernmental negotiating body on the pandemic accord, with the process set to conclude by next year. Several member states hope this will serve as a vehicle to advance discussions on the development and access to MCMs. Similarly, IHR reforms offer a chance to advance key elements of the PPPR agenda, such as data sharing and other core capacities.  The G7 and G20 will also need to play a bigger role in financing all these ambitions.The HLMs ultimately served as a good reset moment to reemphasize the importance of these global health priorities, but it is now up to other forums and national governments to work collaboratively to translate pledges into action.