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GSK has shared the results of two highly anticipated Phase 3 studies investigating its potential “functional cure” for chronic hepatitis B, which affects more than 250 million people worldwide and is a leading cause of liver cancer. The drug bepirovirsen was found to be safe and more effective than the current standard of care in the studies, which included more than 1,800 patients across 29 countries. Bepirovirsen was also found to be capable of achieving a “functional cure,” defined in the studies as no hepatitis B surface antigens (a marker of active infection) detectable in the blood and no detectable genetic material from the virus for at least 24 weeks after treatment ends. The drug, if successfully approved, has the potential to transform treatment for people with chronic hepatitis B. Last week, IAVI announced that the first doses of experimental HIV vaccine antigens were administered in a Phase 1 trial designed to advance a new strategy for HIV vaccine development. Researchers from IAVI and Scripps Research are investigating the hypothesis that highly specialized vaccine immunogens, delivered in a specific sequence, can target critical cells in the immune system and train them to produce broadly neutralizing antibodies against HIV, which scientists widely agree could provide broad protection against the virus. The trial will take place at six clinical sites in South Africa, carried out by a group of African clinical research centers. A team of researchers led by the University of Virginia has shared findings that could transform the treatment of sepsis, the leading global cause of death, in Africa. With a research grant from the US National Institutes of Health, the scientists followed patients with HIV-related sepsis in eastern Africa for five years. They found that the most common cause of sepsis was tuberculosis and that immediate treatment, even before tuberculosis diagnosis, significantly improved survival rates. The findings show that this strategy of immediate tuberculosis treatment could save lives, as well as underline the need for more accurate rapid diagnostic tests for tuberculosis. 

A recent article explores how artificial intelligence (AI) could revolutionize the development of RNA drugs, which have emerged as a promising tool across health areas, from oncology to preventive vaccines. RNA-based therapies have demonstrated higher success rates than traditional pharmaceuticals and are associated with lower costs and much quicker drug discovery timelines. AI could help address current limitations of the technology by enabling faster and more accurate RNA target identification and expediting the testing of promising drug candidates, also leading to cost savings.  The World Health Organization (WHO) recently announced the prequalification of two rapid antigen tests for SARS-CoV-2, the virus that causes COVID-19, helping improve diagnostics access worldwide as the virus continues to circulate globally. The SD Biosensor Standard Q COVID-19 Ag Test and the Acon Biotech Flowflex SARS-CoV-2 Antigen Rapid Test were previously listed under the WHO’s emergency use listing. Their new designation makes them the first rapid antigen tests for SARS-CoV-2 to achieve WHO prequalification. This decision makes them eligible for procurement by United Nations agencies, global health partners, and other international stakeholders, helping ensure access to rapid, reliable diagnostic testing in low- and middle-income countries. A research team has used an innovative robotic system to develop a possible antibiotic candidate for priority bacterial threats, as the global danger of antimicrobial resistance continues to rise. Specifically, the researchers used the technology to rapidly screen more than 700 complex compounds in just one week, identifying a promising antibiotic candidate that demonstrated high effectiveness against bacteria, including strains similar to the deadly MRSA, while remaining non-toxic to human cells, suggesting it is a strong candidate for further drug development. The new process, which utilizes robotics and “click” chemistry, shows potential as a new method to expedite the typically slow drug discovery process. 

Last week, Moderna announced that it has received an award from the Coalition for Epidemic Preparedness Innovations (CEPI) for up to $54.3 million to support ongoing development of its bird flu mRNA vaccine candidate, after US government backing was cancelled earlier this year. There are currently no vaccines available specifically for bird flu, as the virus continues its worrying spread among animal populations in the United States and globally. A vaccine, especially one using the mRNA platform known for its speed and adaptability, could play a crucial role in curbing a future outbreak in humans with pandemic potential.  A research team led by the Australian Peter Doherty Institute for Infection and Immunity has identified a tool that can detect emerging hotspots for Buruli ulcer years before human infections occur, as the serious bacterial skin infection continues to spread across Australia and endures in other regions around the world. The infection has a long and variable incubation period, making it hard to identify when and where patients were exposed. The researchers tracked the excreta of possums, who have small ranges, making the presence of the bacterium that cause the infection in their excreta a likely sign that it is present locally. Then, they used DNA sequencing to compare the bacterial genomes of possum-derived and human-derived infections, finding where they overlapped to identify areas where human infections could occur. The method aims to allow public health authorities to implement targeted interventions early on, far before human cases occur. Two new studies looking at preventive RSV vaccines and drugs found that that their effectiveness waned over time, suggesting that boosters may be needed to ensure long-lasting protection, as RSV continues to pose a growing seasonal challenge, especially for older adults and infants. The first study found that one dose of the Abrysvo RSV vaccine was highly effective at preventing infections and reducing hospital, emergency department, and intensive care unit admissions in US veterans 60 and older, but this protection decreased over time, with the reductions most notable for immunocompromised individuals. A second study found that the long-acting monoclonal antibody nirsevimab was highly effective in hospitalized European children two years or younger for one season, but after that, protection waned. Both studies demonstrate the real-world impact of these crucial tools and suggest that boosters could be implemented to ensure long-lasting protection, especially for higher-risk individuals. 

2025 has been a whirlwind year for global health. In the United States, we've seen the integration of the US Agency for International Development (USAID) into the Department of State, transformation at the Department of Health and Human Services (HHS), and a complicated and prolonged budget process. Globally, we've seen setbacks and progress in HIV and malaria, an evolution at the World Health Organization (WHO), a multilateral win with the Pandemic Agreement adoption, and African partners stepping up to boost autonomy.As the year draws to a close, GHTC is reflecting on the innovations, policy shifts, and pivotal moments that defined 2025 and what they signal for the years to come.US global health leadership in transitionOn day one of his second term, President Donald Trump initiated an effort to realign US foreign assistance programs with the goal of making America safer, stronger, and more prosperous. This effort started with an overhaul of USAID, triggering a series of layoffs, stop-work orders that turned into award terminations, and withdrawals from multilateral partnerships, culminating in the agency’s official integration into the State Department on July 1.While this suspension and termination of USAID programs disrupted critical research projects and health services worldwide earlier this year, in September, the State Department unveiled the America First Global Health Strategy, which outlines a plan to reshape the US government’s global health programming, presenting opportunities for global health research and development (R&D).The new strategy centers multiyear bilateral agreements with countries while reducing ties with nongovernmental organizations and narrowing health focal areas. While critical questions remain on implementation—including on whether the agency still retains needed expertise and how it will coordinate with interagency technical partners like the US Centers for Disease Control and Prevention (CDC)—the strategy’s focus on integrating aid more directly into national health systems is a step forward in improving sustainability and self-reliance. The strategy also raises the exciting possibility that funds could be used to support “innovative, breakthrough technologies.”  Building on USAID’s successes and shortcomings in that space, the department has a clear opportunity to establish a centralized R&D fund—in complement to bilateral agreements—to invest in innovative tools that could leapfrog global health progress. Through collaboration with global health stakeholders and interagency partners, State could reshape US global health programs to continue to save lives; foster funding beyond US government resources, including through partner nations; and promote shared security and prosperity.Overhaul of US scientific and public health infrastructureThe United States has long been a leader in global health R&D and science more broadly, with American researchers, universities, companies, and patients benefiting. In 2025, sweeping changes at HHS reshaped America’s public health and research infrastructure. These far-reaching reforms aimed to advance administration priorities of promoting “gold standard science,” improving efficiency, transparency, and oversight and realigning investments to match administration objectives. At the National Institutes of Health (NIH) and CDC, these changes have included significant staff departures, among them seasoned leaders, and the appointment of many officials who were previously critics of these agencies. It has also included new policies to overhaul oversight of foreign awards and cap indirect costs, changes to longstanding vaccine guidance, and the terminations of numerous awards, including a wind-down of mRNA vaccine development activities. The speed and scale of these changes have raised concerns across the biomedical research and public health communities. While thoughtful reforms could yield benefits, experts warn that current actions risk driving US scientists abroad, disrupting promising clinical trials, weakening the pipeline of new tools, eroding trust in public health guidance, and weakening the structures that have sustained US scientific leadership. US budget swings and shutdowns2025 began with a race to fund the government, with President Trump signing the fiscal year 2025 budget into law in mid-March. While the budget maintained global health R&D-relevant funding lines at prior levels, it funded a government that now looked significantly different after sweeping layoffs and restructuring. Months later, the administration issued its budget request, proposing significant cuts and a restructuring of global health and research programs, reflecting far-reaching changes it had already begun to enact.In June, the administration proposed a request to rescind billions in funding for foreign aid. Though Senators stepped in to remove cuts to global programs for HIV/AIDS and several other health areas, the package ultimately became law, cancelling $500 million in previously appropriated global health funds and raising the possibility that this administration will continue to use rescissions as a tool to withdraw funding.  By late summer, Senate and House appropriators advanced interim funding bills that included higher-than-expected funding for global health and medical research, maintaining funding proposed for elimination by the administration. But then stalled negotiations triggered the longest-ever government shutdown, during which the administration implemented unprecedented furloughs and layoffs that affected critical staff at public health and health research agencies.While the shutdown ended on November 12, pushing the funding fight until January, and most associated layoffs were reversed, uncertainty about future funding for global health R&D persists, especially with a deeply divided Congress and the potential of further recissions.A year of setbacks and breakthroughs in HIV and malaria effortsGlobal HIV/AIDS and malaria efforts faced major setbacks in 2025 as declining US and international donor support has threatened decades of hard-fought progress. Funding cuts could lead to millions of additional HIV and malaria cases in the coming years and has already stalled promising research advancing new HIV and malaria tools.Amid these challenges, the June approval by the US Food and Drug Administration of lenacapavir, a twice-yearly injectable drug for HIV prevention, marked a major milestone and a reminder of the incredible progress possible through strong support for research. Developed by Gilead and supported by NIH-backed research, the drug offers an alternative to daily pills or bi-monthly injections, making prevention more accessible and easier to maintain. Global partners are stepping up to expand access, and Phase 3 trials of a once-yearly version are planned.In November, Medicines for Malaria Venture and Novartis shared Phase 3 trial results for GanLum, a new drug found to be highly effective at treating malaria, including drug-resistant cases, and capable of blocking disease transmission. Pending approval, it could help counter rising resistance to current treatments.Other notable R&D advances in 2025 also targeted the growing threat of antimicrobial resistance, including a Phase 3 trial for a novel antibiotic targeting a dangerous antibiotic-resistant pathogen, support for what could be the first-ever vaccine for Escherichia coli, and efforts to harness artificial intelligence to transform antibiotic discovery. These breakthroughs underscore the importance of sustained R&D investment and the efforts to ensure new tools reach those who need them.WHO restructures amid budget shortfallFacing a severe budget crisis and pressure from member states to reprioritize programs, WHO launched a sweeping overhaul in 2025, cutting staff, slashing its budget, and reorganizing core functions. At its February Executive Board meeting, member states approved a $1.1 billion budget reduction, leaving a remaining $1.7 billion shortfall for 2026 and 2027, despite a recent increase to membership dues and appeals for voluntary contributions.In late April, WHO announced a plan to halve its senior leadership team and consolidate departments. Infectious disease and climate and health programs remain relatively well-resourced, and merging several disease-specific initiatives into a new division could strengthen certain programs. However, neglected tropical diseases and health emergency preparedness and response programs face sharp cuts, while reductions in regional and in-house expert posts may weaken global lab and surveillance networks and delay critical guidance, raising concerns about WHO’s outbreak response capacity.One core R&D function spared from the worst cuts was WHO’s prequalification (PQ) program, which evaluates medical products to support regulatory approval and rollout in countries with less advanced regulatory authorities. The program has marked some important achievements this year, launching a new portal to improve transparency for developers, introducing a new streamlined review and guidance process for TB diagnostics, and prequalifying lenacapavir for HIV prevention through a compressed process completed in just 36 days. As WHO and the broader United Nations system grapple with financial strain and diminished donor support, questions remain about the capacity to deliver on their mandate. A major outbreak could test the limits of this leaner system.Pandemic Agreement provides hope in challenging year for multilateralismAt the World Health Assembly in May, delegates adopted the Pandemic Agreement, a milestone win for global health after three years of complex negotiations. However, consensus on a pathogen and access-benefit sharing system was not reached, requiring member states to return to the negotiating table to finalize an annex for adoption at next year’s assembly. Persistent disputes over the voluntary or legally binding nature of participation signal tough negotiations ahead.While the Pandemic Agreement is a huge win, pushback from key countries and declining pandemic preparedness investments raise concerns about global readiness. Annex negotiations and the 2026 United Nations High-Level Meeting on Pandemic Prevention, Preparedness, and Response will further test international unity on this crucial topic.Meanwhile, 2026 brought notable R&D advances to strengthen our defenses against pandemic threats. The Coalition for Epidemic Preparedness Innovations launched the first-ever adjuvant library of 25 immune-boosting substances to improve vaccine effectiveness and awarded $17.3 million for Phase 2 trials of a promising Nipah vaccine, among the first candidates targeting the priority virus to reach this critical stage. IAVI’s vaccine candidate for Lassa virus, another virus with pandemic potential, was also found to be safe and effective in a first-in-human Phase 1 trial, marking further R&D progress against concerning disease threats.Partners step up to fill gaps and boost autonomyAmid steep foreign aid funding losses, African nations are accelerating efforts to boost manufacturing and laboratory capacity on the continent and reduce reliance on external partners. At October’s Conference on Public Health in Africa in Durban, South Africa, thousands of participants endorsed The Durban Promise, a roadmap for Africa’s health sovereignty, urging action on manufacturing, financing, workforce and capacity development, and regulatory strengthening, a signal of growing continental unity.This momentum was echoed by the Accra Reset, led by Ghanaian President John Mahama, to forge further progress toward greater sovereignty and more equitable global cooperation. At the continental level, the Africa Centres for Disease Control and Prevention launched a new biomanufacturing fellowship to help meet the goal of producing 60 percent of Africa’s vaccine dose needs locally by 2040.South Africa held the G20 presidency this year, culminating in the first G20 summit held on African soil and a declaration focused on priorities for Africa and the Global South. The summit was punctuated by the absence of the United States, underscoring the imperative for greater African autonomy as international aid declines and health threats rise. With the United States assuming the G20 presidency next year, its priorities will be closely watched. Looking ahead to 2026If 2025 has taught us anything, it’s that global health is unpredictable and constantly evolving, so we won’t speculate on exactly what 2026 may bring. But a truth remains clear: global health R&D is a strong investment that pays off—saving lives, strengthening economies, and fueling scientific progress. As the United States redefines its approach and role in the broader global health ecosystem, it remains to be seen how it, and others, will step up to ensure that promising technologies in the pipeline are advanced to improve lives around the world.For other fascinating global health news delivered to your inbox weekly and to stay abreast of developments in 2026 and beyond, sign up now to receive GHTC’s R&D News Roundup newsletter.