Global Health Technologies Coalition - Advancing innovation to save lives.

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.

Interim study findings that will be presented at this week’s AIDS 2026 conference show that a new, once-weekly antiretroviral combination pill for HIV seems to be effective and well tolerated, with comparable results to currently available daily pills. The findings are from two ongoing large, multi-country Phase 3 trials comparing the new combination pill to current treatment options. The new combination treatment has the potential to greatly simplify HIV treatment for patients and health care providers by reducing treatment frequency—and potentially cost—which could help improve access and adherence. A new study in humans suggests that Merck’s Ervebo vaccine, which is licensed for the Zaire strain of ebolavirus, could offer some protection against the Bundibugyo strain of ebolavirus, fueling a growing number of calls to evaluate Ervebo in a clinical trial in the Democratic Republic of the Congo (DRC), the site of the rapidly expanding outbreak of Bundibugyo, for which there are no licensed vaccines. The World Health Organization has so far prioritized evaluation of Bundibugyo-specific vaccines, but the few in development are still months away from clinical trials in the DRC. A trial of Ervebo could provide some protection to people at risk in the outbreak sooner, since there is an international stockpile of Ervebo doses. The Africa Centres for Disease Control and Prevention is planning a trial that would test a two-dose vaccine regimen of Ervebo and an experimental vaccine targeting Sudan Ebola in health workers. Last week, IAVI and Biofabri announced that their Phase 2b clinical trial of tuberculosis (TB) vaccine candidate MTBVAC has reached full enrollment. The trial is evaluating the safety and efficacy of MTBVAC in preventing active TB disease in adolescents and adults with latent TB infection, as well as an additional cohort of participants who have never been exposed to TB infection, across 16 clinical research centers in South Africa, Kenya, and Tanzania. The current TB vaccine is more than 100 years old and provides incomplete protection in young children and does not prevent TB disease in adolescents and adults. MTBVAC, which is single-dose and well-suited for use in remote locations, could be a game-changer for TB control. 

Last week, the Serum Institute of India announced that it will manufacture a promising tuberculosis (TB) vaccine candidate in late-stage development under an agreement with the Gates Medical Research Institute (Gates MRI). The candidate, M72/AS01E, which is currently being evaluated in a late-stage clinical trial, was originally developed by GSK before being licensed to the Gates Foundation. It could become the first TB shot in more than 100 years if approved. The agreement aims to build up manufacturing capacity to ensure adequate supply of the vaccine for rapid, widespread scale-up in key communities, if it is eventually approved. The Gates MRI will transfer the technology and know-how to the Serum Institute, which will invest more than $100 million to scale up manufacturing capacity. A Phase 1 trial evaluating a potential fast-acting, single-dose malaria treatment found promising results, as the growing threat of resistance of the malaria parasite to first-line therapies has underscored the continuous need for new antimalarials. The trial, conducted by QIMR Berghofer in collaboration with UniSC Clinical Trials and sponsored by Medicines for Malaria Venture (MMV) and GSK, found that the novel drug MMV367/GSK3772701 rapidly killed malaria parasites and was generally well tolerated in infected volunteers, appearing to work by blocking two enzymes critical to the survival of the malaria parasite in red blood cells. The treatment candidate belongs to an entirely new class of antimalarials that work differently to existing treatments, making it less susceptible to resistance. It also has the potential to be administered as a single-dose therapy in the right combination with other anti-malaria compounds.A Phase 1 trial of a Bundibugyo ebolavirus vaccine candidate launched last week, making it the first vaccine candidate to enter clinical testing in the response to the ongoing outbreak in the Democratic Republic of Congo. The Coalition for Epidemic Preparedness Innovations (CEPI)-backed candidate was developed by University of Oxford scientists and uses the same viral vector platform as the Oxford/AstraZeneca COVID-19 vaccine. Since the early days of the outbreak, CEPI, the University of Oxford, and the Serum Institute have been working together to urgently advance the development of the investigational vaccine into clinical trials. The trial will be conducted in Oxford, United Kingdom among 50 healthy adults aged 18-55 years, evaluating the candidate’s safety and immune response. There are currently no approved vaccines or treatments for the virus. 

The Drugs for Neglected Diseases initiative (DNDi) and the Serum Institute of India have announced a new licensing agreement covering clinical testing and future access for a promising treatment for dengue, a fast-growing global disease threat. There is no specific treatment for dengue and control efforts currently rely on targeting the mosquito populations that carry the virus and deploying new vaccines, which have varying effectiveness in certain populations and haven’t achieved widespread coverage. The Serum Institute developed and optimized the monoclonal antibody treatment, finding promising safety and efficacy results in preclinical and Phase 1 and 2 trials, and is currently carrying out a Phase 3 clinical trial in India. Under the agreement, DNDi will lead a Phase 3 clinical trial set to begin early next year in dengue-endemic countries, including Malaysia, Thailand, and Brazil, and, if the treatment is successfully approved, DNDi will support affordable access in low- and middle-income countries.A new study published in The Lancet Infectious Diseases demonstrated promising results for an investigational vaccine candidate for Shigella sonnei, an important step toward developing a vaccine for the disease-causing bacteria. Shigella sonnei is one of the four species of Shigella, a highly contagious bacteria that infects tens of millions of people around the world, causing diarrheal disease. There are no licensed vaccines for any of the Shigella species, two of which, including S. sonnei, are becoming increasingly resistant to first-line antibiotics. The investigational vaccine provided high-level protection, an estimated vaccine efficacy of 89 percent, in a Phase 2 trial conducted among healthy adult participants at two US sites. The next step for researchers is to optimize the dose level and evaluate the vaccine in larger trials in high-burden settings that include children, who are among the most affected by shigellosis.Last week, the South Africa Medical Research Council and the Unit of Viral Evolution and Transmission at IRCCS Ospedale San Raffaele initiated a Phase 1 clinical trial to assess the safety and pharmacokinetic profile of a promising broadly neutralizing antibody (bnAbs) for eventual use to prevent HIV acquisition by infants and young children. bnAbs, a type of naturally occurring antibody that can neutralize multiple strains of HIV, are considered a promising approach in HIV research and could potentially be utilized in a long-acting option to protect infants from HIV transmission during breastfeeding, helping close critical gaps in HIV care options and access. IAVI and partners developed the bnAb from blood samples taken from adult participants living with HIV around the world; it was selected for further development following evidence of strong potency in preclinical trials. The trial will initially enroll 26 healthy adult volunteers to collect data on dose section, administration strategies, and safety to inform the planned infant trial.