Breakthroughs Blog: WHO

This fall has brought a flurry of global forums, political negotiations, and shifting priorities that will shape the global health agenda through the end of the year and into the next. Across these discussions, one message has become increasingly clear: the global health architecture is changing, but the need for new and better health technologies has not diminished. If anything, the pressures facing health systems, the emergence of new infectious disease threats, and persistent gaps in access make sustained investment in research and innovation more important than ever. GHTC had the privilege to participate in a season of global forums, from the United Nations (UN) high-level meeting (HLM) on pandemic prevention, preparedness and response (PPPR) in New York City, New York to the World Health Summit (WHS) in Berlin, Germany. As we reflect on our takeaways and next steps from these forums, we see both opportunities and risks. There is considerable momentum to rethink how global health institutions operate, how resources are mobilized, and how countries shape their own health priorities while preserving the scientific expertise, partnerships, and predictable financing needed to develop and deliver lifesaving innovations.  UNGA and the unfinished business of PPPR Three years ago, UN member states gathered in New York for the PPPR HLM, amid a profound sense of global urgency emerging from the COVID-19 pandemic. This September, member states returned to the issue against a more complicated geopolitical backdrop, with renewed attention to pandemic preparedness alongside persistent disagreements over equity, intellectual property, and international cooperation, echoed in other ongoing processes forging pandemic priorities.  After months of negotiations, member states were unable to reach consensus on the PPPR political declaration ahead of September’s HLM, and the text was referred to the broader UN assembly this month, where it was subsequently adopted. Though there were some initial snags in its adoption, the declaration reaffirms the importance of international cooperation and advances several priorities for health innovation, including sustained investment in research and development, stronger public-private partnerships, and expanded regional manufacturing capacity. Together, these commitments reflect a comprehensive vision of preparedness that seeks to pair innovation with the manufacturing and partnerships needed to bring new tools to scale.These negotiations also highlight a challenge that extends beyond the political declaration: how to translate commitments on pandemic preparedness into the practical capabilities countries need to detect and respond to emerging threats. During HLM week, GHTC and Adjuvant Capital hosted a roundtable discussion with US Department of State Bureau of Global Health Security and Diplomacy and multilateral stakeholders examining lessons from Ebola, including the critical role of diagnostics, surveillance, and innovation in strengthening outbreak response. The multifaceted dialogue reinforced that preparedness is not simply a question of having the right technologies available; countries also need the systems, partnerships, and sustained resources to deploy those technologies effectively. Investments in R&D, surveillance, regulatory capacity, and access must therefore be understood as interconnected components of preparedness, rather than competing priorities.Topline takeaway: This fall’s PPPR discussions showed that broad support for pandemic preparedness can coexist with deep disagreements over international cooperation, making both sustained investment in vaccines, diagnostics and therapeutics and workable mechanisms for research coordination and equitable access all the more critical. The measure of progress will not be the strength of the next declaration, but whether countries are better equipped to detect, prevent, and respond to the next outbreak.  WHS and the innovation agenda The global health community gathered again in Berlin in October for WHS. Against a backdrop of evolving global health priorities, momentum for change, and pressure on traditional financing models, the summit offered a chance to consider how innovation can strengthen health systems, address persistent gaps in access, and support resilience in the face of emerging challenges.For GHTC, a particularly valuable discussion centered on the role of product development partnerships (PDPs) in advancing health innovations for diseases and populations too often overlooked by traditional commercial markets. GHTC co-moderated a session convened by Medicines for Malaria Venture, bringing together perspectives from PDPs and their partners on the evolving challenges of developing and delivering new health technologies. The discussion highlighted both the value of the PDP model and the pressures facing these partnerships as the global health financing landscape changes. PDPs have demonstrated what is possible when scientific expertise, public and philanthropic investment, and cross-sector partnerships are brought together around shared health priorities. Yet developing a new medicine, vaccine, or diagnostic is a long-term undertaking. Unpredictable financing can disrupt research pipelines, weaken scientific partnerships, and jeopardize years of progress.This concern extended well beyond the PDP discussion. Across conversations with funders, financing partners, and GHTC members, a recurring theme at the summit was the need for greater consistency and predictability in global health financing. While there is understandable interest in pursuing new financing models and greater efficiency, innovation cannot be sustained through short-term funding cycles alone. Predictable investment is essential to maintaining the research infrastructure, scientific talent, and partnerships that make progress possible.  Innovation remains central to the global health agenda, but the changing financing landscape also raises difficult questions about who will support research for diseases and health needs that remain underserved by commercial markets. As traditional donors reconsider their commitments to global health assistance and countries face competing demands on limited resources, there is a risk that important research priorities will be deprioritized precisely when sustained investment is needed most. New financing approaches are welcome, but they must complement rather than simply replace the long-term public and philanthropic commitments that have historically made much of this research possible.Topline takeaway: Innovation remains central to the global health agenda, but translating scientific advances into meaningful health outcomes requires more than promising technologies. Sustainable financing, effective partnerships, supportive policy environments, and equitable access must remain part of the conversation. For GHTC and its members, WHS reinforced the importance of connecting R&D priorities with the broader systems and policies needed to bring innovations to the people who need them. Looking ahead: Keeping innovation central The implications of this fall’s global forums will extend well beyond the declarations adopted and discussions held. Several interconnected processes, including ongoing negotiations on the Pathogen Access and Benefit-Sharing annex to the Pandemic Agreement, the Accra Reset, and Lusaka Agenda, will help shape how global health institutions operate, how research is funded, and how countries participate in developing and accessing new technologies. As these reform efforts advance, it will be important to ensure that research and innovation are not overlooked in discussions that often focus primarily on health financing and service delivery. These evolving mechanisms are also starting to take shape as the World Health Organization prepares to elect a new Director-General, one who will face consequential questions about which technical capacities to preserve, where to focus investment, and how to maintain the expertise and global coordination that underpin innovation and access. As these conversations continue, several priorities stand out. Global health institutions must become more effective and responsive without sacrificing the scientific and technical capacities that underpin progress. Financing reforms must recognize that research and innovation require long-term, predictable investment. And efforts to strengthen country ownership must create meaningful opportunities for countries to shape research agendas, build scientific capacity, and benefit from the innovations they help advance. Perhaps most importantly, global health R&D cannot be treated as a secondary consideration in debates about governance and financing. New vaccines, diagnostics, medicines, and other health technologies are essential to achieving the very goals these reforms are intended to advance. For our coalition, the task ahead is to work with our members and partners to ensure that innovation remains central to these discussions, that commitments are translated into practical action, and that the global health ecosystem emerging from this period of change is better equipped to deliver for the people and communities it serves.

Recently published results from a Phase 2b trial testing a new regimen for people with chronic Trypanosoma cruzi infection could offer a safer, more practical treatment option for the infection, which affects more than seven million people globally, mainly in Latin America, and can develop into Chagas disease. Compared to the current standard regimen that involves twice-a-day treatment for 60 days and is frequently accompanied by uncomfortable side effects, leading to treatment failure, the new regimen involves a 30-day course taken once daily. Trial participants treated with the shorter regimen had significantly reduced side effects, found it easier to follow, and saw lower treatment interruption. If it continues to demonstrate success in large Phase 3 trials, the regimen could transform treatment for patients globally, as T. cruzi infection becomes a growing challenge in the United States, Europe, and Japan.The first participants have been vaccinated in a trial in the Democratic Republic of the Congo (DRC), where the country’s ongoing outbreak of the Bundibugyo strain of Ebola has now become the largest Ebola outbreak in the country’s history and the second largest in history. Health workers in Bunia, a DRC city at the center of the outbreak, were the first to be vaccinated in the real-world efficacy trial evaluating whether the Ervebo vaccine, which is designed to target the more common Zaire strain, offers some cross-protection against Bundibugyo. There are no approved vaccines for Bundibugyo Ebola, and there were no candidates in late-stage development before the start of the outbreak of the rarer strain of the virus, which has only caused three outbreaks since it was first discovered around 20 years ago. Since the outbreak began, global partners have fast-tracked the development of earlier-stage candidates, but researchers hope the Ervebo vaccine could provide some protection before those candidates are ready for evaluation in DRC. As artificial intelligence (AI) continues to rapidly transform many aspects of technology and science, including health research, a new report from the World Health Organization (WHO) speaks to how stakeholders can help ensure AI-enabled health research is conducted responsibly and benefits everyone. According to the report, while AI has the potential to accelerate health innovation and improve health outcomes, it also presents risks related to equity, privacy, safety, transparency, and more. WHO suggests that researchers, ethics committees, regulators, funders, and policymakers can act to strengthen ethical oversight of AI throughout the health research continuum. WHO also notes that most AI development remains concentrated in high-income settings and contends that strengthening leadership, capacity, and participation in AI in low- and middle-income countries will be important to ensuring the technology does not exacerbate existing inequities in health and health research. 

Last week, Gilead Sciences announced that it has expanded the scope of its voluntary licensing agreements with six manufacturing partners, who are already manufacturing the recently approved twice-yearly lenacapavir for HIV prevention, to include investigational once-yearly lenacapavir. Following the unprecedented Phase 3 trials for twice-yearly lenacapavir, an ongoing Phase 3 trial is evaluating a once-yearly option that could provide a full year of prevention with just one annual dose, further expanding prevention options and addressing persistent barriers to uptake and adherence. Establishing these agreements at this early stage helps manufacturers, regulators, health systems, and communities prepare for the broad, rapid, and equitable scale-up of the once-yearly option, if it is eventually approved. The World Health Organization (WHO) has updated its malaria guidelines to include Coartem® Baby, the first antimalarial developed specifically for newborns and young infants weighing between two and five kilograms. This patient group previously had no medicine specifically designed for their unique needs, leaving them to be treated with modified doses of formulations intended for older children, raising the risk of treatment failure or toxicity. The drug was developed by Novartis and partner Medicines for Malaria Venture (MMV), with financial support from the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. WHO’s inclusion of Coartem® Baby in the guidelines informs and enables malaria-endemic countries to introduce the treatment in national malaria programs, supporting broader access. After receiving prequalification by WHO and approval from Swiss and Ghanian regulatory authorities, Coartem® Baby has so far been rolled out in 11 countries. The Coalition for Epidemic Preparedness Innovations (CEPI) recently announced that it is awarding $3.9 million to support research projects aimed at improving understanding of the Bundibugyo ebolavirus behind the ongoing outbreak in the Democratic Republic of the Congo. Specifically, the funding will support modelling and analytic teams led by the Institut National de Recherche Biomédicale, Imperial College London, and Makerere University School of Public Health. These teams will collect, integrate, and analyze outbreak data to guide the outbreak response; inform the design of fast, efficient vaccine clinical trials; and support longer-term preparedness against similar outbreaks in the region. To ensure long-term applicability, the partners have placed a strong emphasis on capacity strengthening and open sharing of data and methods, so that the tools and knowledge these projects generate can be utilized in future outbreaks in the region. 

Fungi have existed for hundreds of millions of years, long before dinosaurs walked the Earth, but fungal infections have become a rapidly growing challenge for human health in recent decades.Fungal diseases affect more than 300 million people each year, disproportionately impacting people in low-resource settings and those with weakened immune systems, including people living with HIV, cancer patients, and transplant recipients. Most fungal infections affect superficial tissue like the skin, nails, or hair and can cause chronic illness and productivity loss. Though less common, invasive fungal infections can spread throughout the body and are associated with high mortality.Why fungal diseases are becoming harder to ignoreThe rising incidence of fungal infections is driven by a variety of factors, including conflict, poverty, urbanization, pollution, travel, and climate change, which increase exposure, heighten vulnerability, and expand the reach of dangerous fungal pathogens. At the same time, advances in medicine mean more people are living longer with conditions that weaken the immune system, increasing the number of people at greater risk. Growing antifungal resistance is also making infections harder to treat and further limiting already scarce treatment options.Despite the mounting burden, fungal disease remains underprioritized, underdiagnosed, under-surveilled, and underfunded, making it one of the world’s most neglected global health threats.Why innovation is falling behindFungal infections receive less than 1.5 percent of all infectious disease research and development (R&D) funding, contributing to sparse pipelines for both therapeutics and diagnostics. Closing these gaps will require greater investment in R&D, particularly for tools designed for resource-constrained settings and targeting the pathogens that pose the greatest threat to human health. Stronger regulatory and procurement systems and international collaboration will also be essential to ensure emerging tools are affordable and accessible worldwide.Despite persistent gaps, several promising innovations demonstrate the potential for R&D to transform the global response to fungal disease.Promising advances in antifungal treatmentThere are currently only four classes of antifungal medicine available, many of which are associated with serious side effects or require lengthy, hospital-administered treatment courses. The pipeline of new antifungal therapies also remains thin.The World Health Organization (WHO) reported last year that only nine antifungal therapies were in clinical development to address WHO’s designated top four priority pathogens, including three in Phase 3 development. Although the Phase 3 trial for one of those candidates has since been terminated, another candidate, olorofim, developed by Shionogi and F2G, recently reported positive Phase 3 trial results. If approved, it could become the first antifungal treatment with a novel mechanism of action for that infection in more than 20 years.Earlier-stage research is also yielding promising advances. Researchers recently discovered that an antibiotic could target a priority fungal pathogen by switching it back from its invasive form to a less harmful form. This antibiotic could help existing antifungal drugs target dangerous fungal pathogens, allowing lower, less toxic doses of those drugs to be used.Together, these advances offer hope of a new generation of antifungal therapies.The future of fungal diagnosticsDiagnostic tools for critical fungal pathogens exist but with significant limitations, including invasive sampling requirements, long turnaround times, limited pathogen coverage, and inadequate sensitivity. Many also depend on sophisticated laboratories and highly trained staff, making them difficult to deploy in resource-constrained settings globally that bear a disproportionate burden of fungal disease.The MycoMEIA® assay developed at Johns Hopkins University and commercialized by Pearl Diagnostics represents a recent advance in antifungal diagnostics. The test received US Food and Drug Administration clearance in 2025. It uses a urine sample, which is much simpler and less invasive for patients than current options, and provides results in just a few hours.Another promising research development illustrates where fungal diagnostics may be headed next. Researchers at the Mayo Clinic and Zepto Life Technology recently reported early results from a new diagnostic platform that was able to identify 18 different fungal pathogens with a single test. While still in development, such approaches could not only streamline diagnosis for health care providers and patients, but also reduce costs and resource requirements, making them well-suited for resource-constrained settings.Closing the innovation gap Fungal diseases and antifungal resistance are attracting greater international attention, but the response still lags behind the scale and pace of this growing threat. Increased investment in the R&D of fit-for-purpose innovations, paired with stronger regulatory and health systems and global coordination, will be crucial to ensure new diagnostics and treatments emerge from the pipeline and reach the patients who need them most.