Research Roundup: Sleeping sickness drug approval, Lassa and rabies vaccine trial, Global health R&D partnership

Every May for the last 79 years, member states of the World Health Organization (WHO) have gathered in Geneva, Switzerland for the annual World Health Assembly (WHA). The Assembly remains one of the most important moments on the global health calendar, offering insight into how countries are responding to emerging health challenges and where political momentum is building around the future of global health governance, financing, and innovation. This year, however, Geneva felt markedly different. Conversations throughout the week reflected an ecosystem in transition. The global health community is grappling with constrained resources and evolving geopolitical priorities. Meanwhile, WHO reform efforts, persistent budget challenges, and upcoming leadership transitions across multilateral institutions contributed to a broader sense that global health is entering a new phase. Adding to this uncertainty, the United States did not formally participate in assembly proceedings for the first time in WHO's history following its withdrawal from the organization earlier this year.  The assembly also convened amid an evolving Ebola emergency and recent hantavirus outbreak, grounding at times abstract debates about preparedness, coordination, and health security in the realities of active disease outbreaks affecting communities around the world. Against this backdrop, WHA served not only as a decision-making forum but also as a barometer of where global health is headed. For GHTC, three high-level themes emerged that will help shape our advocacy in the months ahead:  1. Innovation must be matched by scale, delivery, and sustainable financing.  Throughout the week, one message surfaced consistently across discussions with WHO leaders, product developers, donors, and civil society organizations: scientific breakthroughs are essential to improving health outcomes, but their impact depends on whether new tools can be produced, financed, delivered, and accessed by the communities that need them most. Today, the challenge is twofold. Continued investment in R&D remains critical to delivering the next generation of vaccines, diagnostics, and therapeutics, particularly for diseases and conditions where significant gaps persist. At the same time, many effective technologies already exist but are not reaching those who need them. Addressing both realities will require increased financing across the R&D to delivery continuum, accelerated regulatory pathways, increased local manufacturing capacity, and more responsive procurement and delivery systems to ensure that innovations are both advanced and translated into impact.  This dual imperative carries particular urgency amid ongoing uncertainty in global health financing. As donors reassess priorities and international institutions face budget constraints, important questions remain about who will finance the next generation of health innovations and ensure their deployment at scale.  Discussions throughout WHA highlighted growing concerns that funding across the entire innovation continuum, from R&D to product introduction, market shaping, and implementation, may not keep pace with scientific advances and need, widening the gap between what is possible and what is accessible. 2. Country ownership is operational, not aspirational.  Perhaps the most significant shift visible throughout Geneva was the growing expectation that countries and regions will increasingly drive and implement their own health priorities.This was particularly evident in discussions marking the first anniversary of the Global Coalition for Local and Regional Production, Innovation, and Equitable Access. Representatives from France, the United Kingdom, the European Union, Indonesia, South Africa, and the African Union repeatedly emphasized the coalition's goal of enabling countries—particularly in the Global South—to become producers, developers, and innovators of health technologies. This conversation reflected a fundamental evolution in how many stakeholders view health security and access: local and regional production is no longer seen primarily as a pandemic preparedness objective but rather as a cornerstone of resilient health systems, economic development, and long-term sustainability. At the same time, discussions throughout the week underscored that manufacturing alone is insufficient; strong regulatory systems are equally critical to ensuring that health products reach communities efficiently and safely. This was reinforced by WHO's newly announced partnership with the African Medicines Agency (AMA) aimed at strengthening regulatory harmonization and reliance, improving safety surveillance, building regulatory capacity, and supporting innovation and local manufacturing across the continent. Similar themes also emerged from GHTC's dialogue with WHO's Prequalification (PQ) team. WHO officials described PQ as an indispensable but ultimately transitional program. The organization's long-term vision is for mature national and regional regulatory authorities to reduce reliance on PQ over time. For that vision to become reality, institutions like AMA and other regional regulatory bodies must develop the technical capacity, regulatory maturity, and trust needed to independently oversee health products.3. AI and emerging technologies are already being deployed.  During WHA week, it became clear that artificial intelligence (AI) and other emerging technologies are no longer hypothetical future solutions, they are already being integrated into health systems and product development. The focus has shifted from how they could be used to how they can be deployed and governed more effectively.  For instance, within WHO's PQ program, the PQ team highlighted the growing use of digital tools and AI-enabled systems to improve efficiency and transparency. Earlier this year, WHO launched its electronic prequalification submission portal, now the mandatory application submission pathway for manufacturers. Looking ahead, the PQ team is exploring how AI tools can streamline product reviews and reduce administrative burdens. Beyond regulatory systems, member states and stakeholders debated WHO's broader role in shaping governance frameworks for AI and digital health as part of the official WHA agenda. While many emphasized AI's potential to boost productivity, discussions consistently returned to concerns of how the organization will navigate challenges in transparency, accountability, data privacy, and public trust.Another major recurring concern was the risk that technological advances could deepen existing disparities if lower-resource countries lack the infrastructure, expertise, or regulatory frameworks necessary to benefit from them. As AI becomes increasingly integrated into global health R&D and delivery, ensuring that these technologies narrow, rather than widen, health gaps will be an increasingly important challenge.Carrying these lessons forward WHA79 underscored that global health is entering a new chapter, one defined by financial constraints, shifting political dynamics, evolving models of partnership, and rapid technological change. Yet amid this uncertainty, one message remained clear: the pursuit of equitable access to health innovation is both a global priority and a shared responsibility. As a coalition, GHTC will carry three priorities forward from Geneva: 1. We will continue advocating for innovation across the full product lifecycle. Investments in research, development, and access pathways must occur in tandem, so new technologies can reach the communities they are intended to serve at scale. For GHTC, this reinforces the importance of maintaining a diverse ecosystem of product developers, manufacturers, implementers, procurement agencies, regulators, civil society organizations, and community leaders to transform scientific advances into public health gains.  2. We recognize the growing emphasis on country ownership and the value of local leadership. As governments increasingly prioritize local production and health sovereignty, GHTC will work to ensure that R&D is a core pillar of these efforts through our Global Partners Network, dialogues with WHO, and engagement in global forums.  3. We will advocate for a future in which all countries have the capacity to contribute to and see their people benefit from the development of lifesaving technologies. Emerging technologies hold tremendous promise for advancing R&D against global health threats. Realizing that promise, however, will require intentional efforts to accelerate R&D, strengthen local capabilities, expand access, build trust, and promote equitable governance. GHTC will support policies that bolster innovation ecosystems worldwide, not only in countries with the greatest resources.The conversations in Geneva made clear that the future of global health will be shaped by parallel progress in innovation and access—driving new breakthroughs while strengthening the systems and local leadership needed to deliver them equitably at scale to the people who need them most. 

A Phase 1 clinical trial testing a candidate that could become the first vaccine for leishmaniasis, a disfiguring skin disease, is set to begin soon in Kenya and Brazil, where the disease in endemic, as well as in Cincinnati, Ohio, as the disease risk grows in the United States. The Global Health Innovative Technology (GHIT) Fund is supporting the trial, which will test the safety and immune response of the candidate in healthy people. The vaccine, which was developed using CRISPR gene-editing technology to mutate the parasite that causes the disease, previously demonstrated strong results in mice and has received US Food and Drug Administration approval as an investigational new drug, which allows the product to be tested in humans. The Coalition for Epidemic Preparedness Innovations (CEPI) has announced that it is providing funding to fast-track the development of three Ebola Bundibugyo virus vaccine candidates, as the concerning outbreak of the Bundibugyo strain, for which there are no approved vaccines, continues to grow in the Democratic Republic of the Congo and Uganda. Specifically, the funding will support preclinical development and Phase 1 clinical testing of Moderna’s mRNA vaccine candidate; help accomplish a key early step in vaccine manufacturing for IAVI’s vaccine, which is based on the organization’s rVSV vaccine platform; and help the University of Oxford prepare for a Phase 1 trial of its vaccine, which is based on the same platform as its Oxford/AstraZeneca COVID-19 vaccine.  Last week, Zendal announced the launch of the international MTBVAC AVANTE consortium to accelerate clinical development and prepare regulatory and policy pathways to ensure broad and equitable access of the MTBVAC tuberculosis (TB) vaccine candidate over the next four years. The current TB vaccine is more than 100 years old and offers inconsistent protection in adults against pulmonary TB, so a new and improved vaccine that is safe and effective across diverse populations who face TB risk will be essential to ending the pandemic. With funding from the Global Health EDCTP3, the consortium of 12 European and African partners will initially support two major ongoing trials in high-TB regions in sub-Saharan Africa, one evaluating the vaccine in adolescents and adults and one comparing the candidate’s protection in newborns to the existing vaccine.