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.PANTHER, a newly launched pan-African platform for emergency research and preparedness, aims to address the lack of clinical trials carried out on the continent, despite it facing a disproportionate amount of the global disease burden. The researchers behind the initiative see the platform as a way to ensure essential data is captured in clinical trials during active outbreaks of existing or newly emerging diseases, especially following the recent Marburg and Sudan ebolavirus outbreaks. PANTHER hopes to prepare around 80 percent of the groundwork for trials before an outbreak by targeting at-risk spots, creating a network of researchers and health care providers, and proactively engaging funders so that when an outbreak is identified, this foundation can be quickly leveraged to adapt trials to local contexts and specific disease characteristics.Last week, researchers announced promising results from a phase 1 clinical trial, supported by the US National Institutes of Health, looking at a temperature-stable tuberculosis (TB) vaccine that can be freeze-dried and safely stored at higher temperatures for months. The shot, given to 45 healthy adults in the study, was found safe, well-tolerated, and elicited measurable responses in the body. If further testing of the vaccine proves successful, the shot could be a clear alternative to the bacille Calmette-Guerin vaccine—the only licensed vaccine for TB, which is more sensitive and cannot be frozen— and break down barriers to vaccine distribution in low-income and low-resource settings around the world.A new paper found that more than 10 percent of people in rural Myanmar have been exposed to a diverse range of sarbecoviruses, a group of coronaviruses that includes Sars and Sars-Cov-2. Researchers also emphasized that the paper confirmed the risk of direct spillover from bats, especially in remote, rural areas. While there were no signs of human-to-human transmission of these viruses, the findings highlight the ongoing occurrence of spillovers and the need for surveillance of both disease outbreaks and rural areas with high wildlife-human interface, as well as ensuring strong biosecurity laboratory measures are in place.

The US Agency for International Development (USAID) released a new report on its global health research and development (R&D) programs for fiscal year 2022 that includes unprecedented insight into the product development programs the agency supported—and highlights the need for additional, dedicated resources for global health research.Why it matters: The report gives insight into an agency that is a key sponsor of global health product development.Due to a lack of commercial incentive for industry investment, most global health research is supported by public funders, most notably the US government.Several US agencies support global health research, but USAID is the only agency with a mandate to improve global health and development. The agency excels at pushing products through the end of the research pipeline and advancing tools to suit the needs of people in low-resource settings.What’s new: This report includes an unprecedented 13-page appendix detailing USAID’s individual product-level investments. By our count, USAID supported at least 59 products in 2021 covering multiple health areas and product types.By the numbers: In 2021, USAID spent US$165 million in baseline funding and $50 million in COVID-19 supplemental funding on health product development and research to assess the best way to implement new products and practices.Research spending from baseline funds increased slightly over the prior year (+$4 million) — but continued to decline as a proportion of total global health spending. In 2021, proportionate spending on research dropped slightly to 5.1 percent, continuing a years-long pattern. If the trend continues, GHTC estimates that proportionate spending on R&D will drop to 4.2 percent by 2026 unless Congress passes a policy like the Supporting Innovative Global Health Technologies (SIGHT) Fund to direct more dedicated funding to R&D.Our take: GHTC applauds the release of the report and the additional detail provided by USAID. We call policymakers’ attention to the continued need for additional, dedicated resources for global health research at USAID that this report exposes.

As is tradition, the World Health Organization (WHO) Executive Board (EB) kicked off what promises to be another packed multilateral calendar. While much has remained the same, this year’s forum also ushered in noteworthy shifts in deliberations, dynamics, and dialogue that advocates should be aware of. Here are GHTC’s top takeaways from the week: 1. EB shrinks space for civil society engagement. As civil society delegates entered the halls of WHO for the EB for the first time since 2020, they were confronted with a harsh reality: The ability for non-state actors to meaningfully participate in these meetings is at an all-time low. New protocols had been introduced limiting delegation size and physical and structural changes put in place that left civil society literally on the outside looking in. Gone are the days when civil society could be physically present in the assembly room to follow the proceedings. Instead, advocates were relegated to a small, hot, and stuffy overflow room, more akin to a small press room, located far away from the official proceedings, hampering their ability to connect with officials and country delegates, which is often the most valuable part of the week. As EB participation and the number of agenda items have ballooned, WHO has also imposed new constraints on civil society statements, which have hit non-state actors particularly hard. WHO has tried to force civil society organizations to come together and develop single constituency statements for certain agenda items, a challenge that often further dilutes specific technical feedback from a diverse set of voices as various WHO-accredited institutions try to reconcile diverging views into a single, cohesive communication. Individual interventions are now reduced to just one minute, and they must be uploaded to a WHO database prior to the start of that agenda item. Apart from the challenge of distilling feedback and technical input down to around 100 words, the requirement to upload in advance prohibits advocates from rebutting issues that arise during debate or meaningfully influencing the decision making in real time. Other United Nations (UN) agencies, such as the World Trade Organization and the World Intellectual Property Organization have far more robust and meaningful civil society engagement processes that could serve as better models for WHO to emulate. 2. Debate on WHO’s work in health emergencies goes into the next round. Global politics tend to spill over into the parliamentary debates at EB, and this year was no different with the war in Ukraine creating serious tension between western allies and Russia. Much of the debate surrounding WHO’s role in health emergencies was derailed by several testy back-and-forths between delegations, leading to disruptions and little progress on key agenda items. A new ten-point proposal from WHO Director-General Dr. Tedros Adhanom Ghebreyesus to improve preparedness and response to health emergencies also received mixed reviews from WHO member states, with many warning the WHO secretariat not to move ahead of member states and the already ongoing processes to amend the International Health Regulations and negotiate a pandemic accord.  The latter did make waves at this EB, as the WHO Intergovernmental Negotiating Body (INB) published a “zero-draft,” that included a few surprises. The draft features some strong, equity-focused language, as well as calls for building and strengthening country regulatory, manufacturing, and innovative research and development (R&D) capacities for pandemic-related products. Surprisingly, it also features numerous callouts and provisions focused on intellectual property, including incentivizing relevant transfers of technology and know-how, forcing manufacturers that receive public funding to disclose prices for pandemic-related products, and time-bound waivers on medical countermeasures that can accelerate or scale up manufacturing, signaling the key battlegrounds for upcoming negotiations.  The biggest stunner, though, is a brand-new section focused on creating a new WHO Pathogen Access and Benefit-Sharing System (the “PABS System”) that would collect and equitably distribute a portion of all globally produced vaccines and other medical products during pandemics. According to the draft, 10 percent of total global production of pandemic products would be allocated to WHO, with half donated and half bought at an “accessible” price. Now, deliberations on the specific provisions will begin in earnest ahead of the World Health Assembly (WHA) in May, with the INB hosting two meetings in the next few months to debate individual chapters of the draft.  3. Implementation of the clinical trials resolution enters its next phase as member states argue about scope. Member states also debated the implementation of last year’s clinical trials resolution during the session on global health emergencies. Delegates noted the progress WHO had made over the past year in leading consultations and mapping the current clinical trial networks landscape. A few countries underscored the importance of inclusiveness and equity and called for greater technical support from WHO. On the contrary, in response to a WHO proposal to develop a complementary self-assessment tool to measure the maturity of the clinical trial ecosystem at national and international levels, the United States and United Kingdom instead urged the WHO secretariat to keep its focus limited to the scope of the actual resolution until more progress is achieved. The WHO is now set to move forward with a process to develop draft guidelines for clinical trials, with the help of experts and member states, that is expected to be in place by WHA. 4. Universal health coverage (UHC) reemerges as a priority from COVID-19 slumber. In 2019, UHC was the “it” topic of global health. It featured prominently on the agenda of WHO meetings and the UN held a high-level meeting on the subject to advance a new framework to achieve the Sustainable Development Goals. Then came the pandemic, and focus and attention on the topic slipped. This year, UHC is back on the map, having featured heavily at this year's EB.  During the broader discussion on UHC, WHO member states highlighted the importance of primary health care and health system strengthening, as well as considered and ultimately passed a resolution on strengthening diagnostics capacity. The resolution urges member states to address a range of diagnostic issues, including increasing local production, streamlining regulatory approaches, and addressing access barriers. It also calls for greater investment in diagnostic R&D and more systemic funding of capacity-building infrastructure for diagnostics, as well as urges WHO to enact specific technical changes to facilitate and catalyze diagnostic development.  The next couple of months will continue to deliver multilateral developments at a breakneck pace, and given the interlinkages between the many multilateral processes underway, it will be vital for advocates to understand the full landscape of possible changes to the global health architecture. While the dynamics may be shifting, it is encouraging to see that the research agenda is present throughout these different dialogues, both in Geneva and beyond. 

2022 G-FINDER report highlights the inadequacy of global health R&D funding: GHTC offers key takeaways for the global health communityThe release of the 2022 G-FINDER report sheds light on current funding trends in global health research and development (R&D). Despite hard-won advocacy victories by GHTC and the global health advocacy community, neglected diseases are living up to their moniker from a funding standpoint, as global investment in HIV/AIDS, tuberculosis (TB), malaria, and neglected tropical diseases (NTDs) remains far below levels required to overcome these persistent and devastating health threats. The new report highlights several new and ongoing funding trends. GHTC has identified three findings of particular importance to the global health research community.Funding for NTDs dropped precipitously; funding shortfalls for HIV/AIDS, malaria, and TB persist.Funding for NTDs included within the G-FINDER scope decreased by 10 percent in 2021, falling to their lowest total since 2009. NTDs impact more than a billion people each year, disproportionately afflicting women and children. The reduction in funding is particularly alarming given that many of the targets set in the WHO roadmap on NTDs (2012-2020) have not been met. Outside of NTDs, funding for malaria saw a substantial 5.7 percent dip, HIV/AIDS investment experienced a modest uptick of 2.7 percent, and TB funding remained virtually flat, dipping less than a tenth of a percent. While these three diseases receive more resources than NTDs, their funding levels are significantly below that which is needed to overcome these health crises and reach global health and development targets, like the Sustainable Development Goals.Funding for Product Development Partnerships (PDPs) declined for the fourth consecutive year.PDPs are the leading engines of medical innovation for diseases that lack sufficient commercial market incentives. Thus, it is distressing to see that neglected disease R&D funding for PDPs fell by 18 percent in 2021, continuing a multiyear backslide. Current PDP funding sits 40 percent below its peak, which was 13 G-FINDER cycles ago. The most recent dip was driven by reduced investment from large donors like the Bill & Melinda Gates Foundation, the UK Foreign, Commonwealth & Development Office, and the US Agency for International Development (USAID). These findings also highlight the need to further diversify funding sources for PDPs, as well as global health R&D more broadly. Specifically on the US government funding front, PDP funding was not the only area in which USAID funding declined. Neglected disease R&D funding from the agency reached a record low, further highlighting the need for additional mechanisms within USAID to facilitate supporting medical innovations for unmet needs. During the virtual launch event for the report, keynote speaker Dr. Peter Hotez noted the vital role that US agencies like USAID and the US National Institutes for Health play in the global health R&D ecosystem.Funding for platform technologies and non-disease-specific investment is on the rise. For the seventh consecutive year, funding for non-disease specific (NDS) R&D increased, rising by 5.6 percent. Specifically, investment in platform technologies grew for the fourth consecutive year and now accounts for 22 percent of NDS funding. Much of the past year’s growth was buoyed by an increase in drug-related platform technologies, which historically received the smallest share of funding. This trend dovetails with a larger shift of investments toward drugs, as overall drug R&D funding eclipsed vaccine R&D funding for the first time in 2021.Overall, the global health advocacy community has made incredible strides in protecting and growing funding for global health innovation. This past year in the United States, GHTC helped support the passage of a global health research-friendly fiscal year 2023 omnibus package, which included significant funding increases across nearly every line relevant to global health R&D, as well as complimentary directives that will support global health R&D across several agencies. However, the challenges of competing global interests and tough funding environments are formidable, as shown by the G-FINDER report. This coming year presents a number of strong opportunities to elevate attention and support for resources for global health innovation, including United Nations High-Level Meetings on TB and universal health coverage. We urge leaders around the world to step up and invest in lifesaving global health R&D, and our advocacy community partners to continue to hold the world accountable for ensuring health and health equity for all.