Breakthroughs Blog: State Department

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.

Few diseases have shaped global health like the HIV/AIDS pandemic. Since it began, more than 40 million lives have been lost, leaving an enduring impact on families, communities, and health systems worldwide. But HIV has also become one of the clearest examples of what sustained research and development (R&D) can achieve. From antiretroviral therapies (ART) to long-acting prevention tools, decades of scientific innovation have fundamentally changed what is possible in the fight against HIV.This year, HIV innovation stands at a pivotal moment. Shifting funding landscapes and evolving global health priorities have raised important questions about how R&D for HIV will be sustained in the years ahead. As global leaders have reaffirmed the importance of continued R&D investment—such as through the recently adopted United Nations High Level Meeting political declaration on HIV/AIDS—we must also focus on the systems and programs that translate scientific breakthroughs into impact. Few advances better illustrate this balance than lenacapavir, or LEN, an injectable form of HIV prevention requiring only two injections per year, spaced 6 months apart. Unlike daily oral pre-exposure prophylaxis (PrEP), which depends on consistent adherence, LEN offers protection by eliminating daily pill burden for consumers and communities vulnerable to HIV.The journey of LEN reflects the long arc of HIV innovation. Decades of research supported by the US National Institutes of Health helped establish the HIV capsid as a promising drug target, creating the foundation for a new class of HIV medicines. Then, in 2006, researchers at Gilead Sciences began developing capsid inhibitors designed to suppress HIV replication while offering the potential for long-acting treatment. At the time, ART had transformed HIV from a fatal disease into a manageable chronic condition for millions of people, but treatment relied on daily medication, creating ongoing challenges for adherence and access.Following years of research and clinical development, the US Food and Drug Administration (FDA) approved LEN in 2022 as a treatment for adults living with multidrug-resistant HIV whose existing treatment regimens were no longer effective. While this approval marked an important milestone, researchers at Gilead continued exploring the drug's potential as a long-acting option for HIV prevention and found remarkable resultsThe first pivotal late-stage prevention trial of the drug, called PURPOSE 1, conducted among women in South Africa and Uganda—including pregnant and lactating women—found that LEN provided near-complete protection against HIV infection and outperformed daily oral PrEP. PURPOSE 2, a subsequent study, conducted across seven countries and including men and gender-diverse people, confirmed similarly high levels of protection in late 2024. Beyond their clinical success, these studies also represented an important step toward more inclusive HIV research by intentionally enrolling populations that have been historically underrepresented in clinical trials.  Just six months after Gilead submitted LEN for review as an HIV prevention tool, the FDA approved the drug in June 2025 under a priority review designation pathway. Because regulators were able to rely on the extensive safety data generated during the drug's earlier approval for HIV treatment, they could focus their review on its use as a novel preventive intervention. The result was an efficient regulatory process that maintained rigorous standards while accelerating future access to an important new prevention tool. Swift regulatory action extended beyond the United States. In October 2025, the World Health Organization (WHO) prequalified LEN in just 36 days using its abridged prequalification pathway. This expedited process enabled WHO to leverage assessments already completed by the European Medicines Agency’s (EMA) European Union-Medicines for all program, which provides scientific opinions on medicines for use in low- and middle-income countries, while conducting its own review focused on issues relevant to the global procurement and implementation of LEN.  This rapid review mattered because WHO prequalification serves as a critical gateway for procurement by many international organizations and countries, particularly in low- and middle-income countries. Accelerating this process helps ensure that countries are not waiting months or years for access after a product has already demonstrated its safety and effectiveness through other rigorous stringent regulatory approval processes.Accelerated regulatory approval and collaboration continued across multiple regions. Following FDA, EMA, and WHO approval, LEN rapidly advanced through regulatory processes in South Africa, Australia, Brazil, and Canada, and, as of today, it is approved by 17 regulatory bodies, including 12 countries in Africa. In several cases, regulators leveraged reliance mechanisms, such as WHO’s collaborative registration procedure, international collaboration, and priority review pathways to streamline review and accelerate access to this important breakthrough without compromising regulatory rigor. Swift regulatory action was soon matched by commitments from the United States; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Gilead to rapidly scale up access to LEN and accelerate generic production in high-burden countries.This coordinated approach, supported by political commitment and strategic public-private partnership, created an unusually efficient pathway from scientific discovery to implementation. Compared with earlier HIV prevention technologies, such as oral PrEP and the dapivirine vaginal ring, LEN has progressed through key milestones at a rapid pace. This allowed for accelerated product introduction of lifesaving technologies at the country level, while simultaneously shaping the market and demand for LEN and future prevention options. While every health technology faces unique scientific, regulatory, and access considerations, LEN demonstrates how thoughtful planning, regulatory preparedness, and collaboration between researchers, regulators, countries, multilateral organizations, and communities can significantly shorten the time between discovery and access.As conversations about the future of HIV innovation continue, LEN offers an important blueprint for global health innovation more broadly. It reminds us that sustained investment in R&D produces transformative breakthroughs, inclusive clinical trials generate stronger science, and innovative regulatory pathways can accelerate, rather than compromise, rigorous review. Moreover, the accelerated path from research to rollout illustrates the coordination and collaboration required to advance technologies through regulatory approval while simultaneously shaping markets to enable introduction at scale. The lessons from LEN are already informing the next generation of HIV prevention innovations, with developers pursuing earlier access and licensing strategies for products such as Merck's MK-8527. While the US government, the Global Fund, and Gilead have recently expanded commitments to scale up LEN, the ultimate measure of success will be whether LEN—and the innovations that follow it—reach the people who need them most.  The future of innovations for HIV, as well as tuberculosis, malaria, emerging threats with pandemic potential, and beyond, will require the same integrated approach. Scientific discovery, product development, efficient regulatory pathways, and equitable access cannot be treated as separate objectives; they are mutually reinforcing components. Innovation succeeds not when a product is approved, but when it reaches the communities whose lives it has the power to change. LEN has shown us what’s possible when the entire R&D ecosystem works together. The challenge now is ensuring that this success becomes the standard rather than the exception.

For decades, the United States has led the world in public investment in global health research and development (R&D). Federal support enabled the development of breakthrough technologies that are saving and improving lives in the United States and around the world. US government investment in global health R&D has also generated billions in domestic economic activity, created American jobs, and laid the foundation for future discoveries that will catalyze billions more in economic benefits in the years ahead. America’s leadership in global health R&D reflects the country’s values, entrepreneurial spirit, and commitment to improving lives globally. This year, to mark America’s birthday and celebrate the nation’s extraordinary contributions to advancing lifesaving innovation, GHTC is spotlighting four game-changing global health technologies developed by US innovators with federal support.A DR-TB drug transforming the global fight against TB Tuberculosis (TB) remains the world’s deadliest infectious disease, killing 1.23 million people in 2024 alone, with growing resistance making it even more deadly and difficult to treat.  Historically, treatment for drug-resistant TB (DR-TB) required up to 20 or more pills a day over the course of 18 months or more, and patients often experienced severe side effects, such as hearing loss. Even then, nearly half of patients who were able to access treatment went uncured.Pretomanid, developed by TB Alliance, a New York-based nonprofit product development partnership, represents a major advance in DR-TB therapy. As part of a six-month, all-oral combination regimen, it has drastically reduced treatment duration, complexity, and toxicity for patients.  This innovation was made possible through funding from the US Agency for International Development and the National Institute of Allergy and Infectious Diseases and was advanced in partnership with a broad coalition of American companies, nonprofits, and universities. Since its approval, TB Alliance has strived to make pretomanid-containing regimens more affordable and accessible, improving access to high-quality DR-TB treatment in the places that need it most.A groundbreaking HIV prevention drug poised to revolutionize the fight An estimated 40.8 million people globally are living with HIV/AIDS, and 1.3 million people became newly infected in 2024. Despite decades of progress, momentum toward ending HIV as a public health threat has slowed in recent years, and major gaps remain in our arsenal of prevention tools.  Gilead Sciences, a California-based biopharmaceutical company, developed lenacapavir, a groundbreaking new HIV prevention drug that requires just two injections per year. It offers discreet, long-acting protection, making HIV prevention more accessible and easier to sustain.  Developed using evidence from National Institutes of Health-funded research, lenacapavir is now being scaled up globally through a US Department of State-led partnership, helping ensure this innovation reaches communities in need. A next-generation polio vaccine bringing us closer to eradication The first polio vaccine, introduced in the 1950s, transformed polio from a disease that caused frequent, devastating epidemics into one on the brink of global eradication. However, outbreaks of vaccine-derived poliovirus in under-immunized communities globally have posed a major challenge to vanquishing the disease for good.To address this, PATH, a Washington-based nonprofit developer, partnered with the University of California, San Francisco; the Gates Foundation; and global collaborators to develop nOPV2, a next-generation oral polio vaccine. nOPV2 retains the advantages of the original oral vaccine but has been specifically engineered to reduce the risk of vaccine-derived outbreaks. This breakthrough benefitted from critical development support from the US Centers for Disease Control and Prevention.  More than 1 billion doses of nOPV2 have been administered in countries around the world, with an expanded network of manufacturers helping ensure global access and prevent outbreaks.  First FDA-approved Ebola treatment continuing to offer hope As the current outbreak of the Bundibugyo strain of Ebola in the Democratic Republic of the Congo (DRC) reminds us, Ebola outbreaks can rapidly escalate into international health emergencies. When the 2018-2020 outbreak of Zaire ebolavirus began in the DRC—the world’s second largest Ebola outbreak—there were no approved Ebola treatments. Inmazeb®, a novel antiviral medicine developed by Massachusetts-based Regeneron in collaboration with the Biomedical Advanced Research and Development Authority, was evaluated in a National Institutes of Health-supported trial during the outbreak. The strong results from that trial supported approval by the US Food and Drug Administration (FDA) in 2020, making Inmazeb the first FDA-approved treatment for Ebola, which has since been deployed in Ebola outbreaks in the DRC and Guinea. The most potent antibody in Inmazeb has now been recommended for priority evaluation during the current outbreak after demonstrating broad activity against multiple Ebola strains, including Bundibugyo, for which no approved therapeutics exist—highlighting how US-backed innovation continues to pay off and why sustained investment is needed to stay ahead of future threats.  Ensuring continued US leadership through sustained investment From transforming DR-TB treatment and HIV prevention to accelerating polio eradication and delivering the first Ebola therapy, the United States has long been at the forefront of global health innovation. These successes reflect the best of America: leadership, ingenuity, compassion, and a commitment to improving lives. Sustaining this impact will require continued investment and support in the programs, partnerships, and people that make such breakthroughs possible.

Last week, SC Johnson; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and the US Department of State announced a new agreement to accelerate access to an innovative malaria vector control tool in high-burden countries. This marks the second such partnership between the State Department, the Global Fund, and a US company to expand global access to new products under the department’s global health strategy, after one with Gilead for lenacapavir for HIV prevention. This initiative will scale up the SC Johnson Guardian™ spatial repellant tool, a small mesh fabric sealed inside a pouch that is hung indoors, releasing an active ingredient that repels mosquitoes for up to a year. The tool was recommended by the World Health Organization last year, the first new category of vector control products to be recommended in 25 years. The partners aim to reach 60 million people across ten-high burden countries with 30 million products over three years, with manufacturing based in Nairobi, Kenya. A new observational study found that even with only moderate levels of malaria vaccine coverage achieved, the initial introduction of the RTS,S/AS01 malaria vaccine in high-burden African countries has contributed to a significant reduction in deaths among children. Specifically, despite only moderate uptake of three doses and low uptake of the fourth, the vaccine was found to have saved the lives of one in eight eligible children in the first three African countries to offer the vaccine from 2019-2023, which represents a 13.2 percent reduction in death. These results add to the evidence supporting continued scale-up of RTS,S—one of two malaria vaccines now included in national immunization schedules in 25 sub-Saharan African countries—and underscore the promise of continued investment in developing new and improved malaria vaccines. Nonprofit Caring Cross has shared an early copy of data showing that, in a small study, a single infusion of engineered immune cells suppressed HIV long term in several patients, offering proof-of-concept for a single-shot functional cure. The approach, adapted from cancer research, involves extracting immune cells from participants living with HIV, engineering the cells to carry molecules that simultaneously kill infected cells and prevent the immune cells from becoming infected, and injecting them back into participants. HIV is notoriously hard to control because the virus persists in hard-to-eliminate latent reservoirs, requiring lifelong ongoing treatment to suppress the virus.  This research could pave the way for the development of a single, low-cost intervention that could sustain viral suppression without the need for regular therapy. The research, which is still in the very early stages, is scheduled to be presented at an upcoming scientific conference.