Breakthroughs Blog

Last week, the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend approval of Moderna’s mRNA influenza vaccine for older adults. In a Phase 3 trial in more than 40,000 adults in 11 countries during the 2024-2025 flu season, the vaccine demonstrated significantly better protection than standard-dose shots. Moderna's vaccine also uses mRNA technology, meaning it can be updated more quickly to match circulating flu strains compared to traditional vaccines that use egg-based methods. After initially agreeing to review the vaccine, the FDA had previously raised concerns about the Phase 3 trial for the vaccine, prompting backlash from vaccine and public health experts, before deciding to go ahead with its review. Following the recommendation, the FDA will make a final decision on approval, which is expected by early August.The Global Health Innovative Technology (GHIT) Fund has started an emergency framework to surge support and funding for the development of rapid and point-of-care diagnostic technologies in response to the Ebola outbreak caused by the Bundibugyo virus in the Democratic Republic of the Congo and Uganda. There are currently no approved vaccines, therapeutics, or point-of-care diagnostics for Bundibugyo virus. GHIT Fund is prepared to support fast-track funding for infections caused by filoviruses, which include Ebola, with the aim of advancing a diagnostic test, particularly one that is suited to low- and middle-income countries with limited infrastructure, that can improve control capacity for this and future outbreaks.  Inflammatix is collaborating with the University of Nebraska Medical Center to explore the use of the company’s diagnostic test platform for hantaviruses after the recent hantavirus outbreak exposed gaps in testing capacity due to limited technology and testing standards. Inflamattrix’s TriVerity test is a blood-based test that used machine learning to detect infection. It previously received clearance from the US Food and Drug Administration as a sepsis test in 2025. The partners are aiming to develop a tool that can assess the early signatures of infection in people with high-risk exposure to the virus, which could help improve early response capacity in future outbreaks.  

Fatherhood is often framed as a life milestone, but far less attention is paid to men’s role in deciding if or when that milestone occurs. Nearly half of all pregnancies, around 121 million globally each year, are unintended, highlighting major gaps in contraceptive access and limitations in today’s methods. Boosting investment in the research and development (R&D) of new and improved contraceptive options, including for men, offers a critical opportunity to strengthen reproductive autonomy, advance gender equality, and help prevent unintended pregnancy. The gendered burden of pregnancy prevention Without male contraceptive options beyond condoms and vasectomy, the physical, financial, logistical, and emotional burden of pregnancy prevention has long fallen on women.  While a wide range of options exist for women, from pills to injections, patches, and implants, an estimated 257 million women worldwide who want to avoid pregnancy are not using safe, modern methods of contraception due to a combination of social barriers (such as cultural or religious opposition), structural challenges (including limited access to high-quality services or education), and technological limitations (such as unpleasant side effects or short duration of protection). These barriers are especially pronounced in low- and middle-income countries—in sub-Saharan Africa, nearly one in four women has an unmet need for contraception.  Addressing this gap requires expanding options for women, such as methods that are longer acting, more discreet, have fewer side effects, and require fewer health care provider visits, as well as expanding contraceptive choice for men. New male contraceptive options to replace or complement female contraceptives could help rebalance the shared responsibility for family planning, empower men to have greater autonomy over their own reproductive health decision-making, and contribute to reducing unintended pregnancy. The gap in male contraception Limited innovation in male contraception reflects decades of underinvestment—not a lack of demand. Research shows strong interest in male contraceptives among men in diverse settings worldwide, alongside high trust in male partner birth control use among female partners, with preferred product types and attributes varying across contexts. Despite this clear demand, progress in male contraceptive innovation has been slow, in part due to the limited funding landscape. Contraceptive R&D has relied heavily on public and philanthropic funding, with the Gates Foundation playing a lead role. Private-sector engagement has remained limited due to perceived uncertainty about the potential market, unclear regulatory pathways, high development costs, and the broader historical underinvestment in contraception R&D. The continued success of products currently in clinical development has the potential to spark greater engagement in the field from diverse investors. Male contraceptive innovations on the horizon  While the pipeline lags behind demand, several exciting and innovative tools and approaches are advancing through clinical development.  The most advanced product in development is a reversible hormonal gel, NES/T, which can be applied once daily to the upper arms and shoulders. The gel is absorbed through the skin and suppresses sperm production. Originally developed by the Population Council and the US National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development, it is now being advanced by Contraline, which recently announced the launch of Phase 3 trial planning. Nonhormonal male contraceptive options are another promising area of research because they target sperm function directly, avoiding hormone-related side effects. Contraline’s ADAM™ is a nonhormonal injectable device that blocks sperm flow for an extended period before dissolving. It has demonstrated encouraging safety and efficacy data in a first-in-human trial, with Phase 2 planning underway. YourChoice Therapeutics and Columbia University’s YCT529 is a first-in-class nonhormonal daily pill that suppresses sperm production and has shown positive results in a small, early human trial.  The path ahead When the US Food and Drug Administration approved the first oral contraceptive pill for women in 1960, its rapid, widespread adoption transformed reproductive autonomy and expanded economic, education, and career opportunities for women, carrying benefits that reverberated across entire economies and contributed to broader gender equality. Continued innovation in female contraceptives remains essential to ensure options better fit the needs and lifestyles of women worldwide.  But this progress should also be matched by investment in novel male contraceptives. Ensuring that everyone who wants to use contraception can access safe, effective, and acceptable options will expand choice, strengthen reproductive autonomy, and contribute to a more equitable and resilient future for family planning at a time when reproductive health protections are increasingly constrained worldwide. 

The Democratic Republic of the Congo has approved the use of a new single-dose oral treatment for sleeping sickness, a potentially fatal disease which is endemic in several countries in Central and West Africa. The approval of Acoziborole Winthrop, codeveloped by the Drugs for Neglected Diseases initiative (DNDi) and Sanofi, follows successful Phase 2 and 3 clinical trials conducted in the DRC and Guinea by DNDi in partnership with national authorities, which demonstrated that the drug is safe and effective. Existing treatments require a ten-day oral treatment regimen or a combination of injection and oral therapy that requires several days of hospitalization for patients in the most advanced stages. The DRC approval, which will make the drug available free of cost to patients in the country, is expected to be followed by endorsements in other endemic countries soon.A research team from the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health has shared promising early results from a first-in-human clinical trial comparing a new investigational vaccine against Lassa fever and rabies to a licensed rabies vaccine, finding that the vaccine candidate was safe and induced rapid and robust immune responses against both viruses. There are currently no available vaccines for Lassa fever, a dangerous disease considered a priority threat with epidemic and pandemic potential that is common in parts of Western and sub-Saharan Africa, which also have a high burden of another severe disease: rabies. A dual vaccine could help streamline health care delivery in settings with limited health care infrastructure; the vaccine candidate can also be freeze-dried for storage, making it well suited to low-resource settings where it can be difficult to maintain the cold chain. Last week, DNDi, the Medicines for Malaria Venture (MMV), and the Global Antibiotic Research and Development Partnership (GARDP) announced a new cooperative agreement to explore how the three organizations can work together to advance global health research and development (R&D) amid global aid cuts and calls to reshape the global health architecture. The organizations plan to pool their expertise and resources to advance the R&D of effective and affordable medicines, while centering patient needs and equity. In addition, the partners will collaborate on policy advocacy and communications activities to raise awareness of the impact and promise of the nonprofit product development partnership model in advancing innovative, lifesaving medicines for critical, but often overlooked, diseases.  

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.