Breakthroughs Blog: Malaria

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.

A Phase 1 randomized controlled trial found that a single dose of the ChAdox1 Rift Valley fever (RVF) vaccine was safe, tolerable, and elicited a strong immune response in 30 adults in Uganda, where RVF—a neglected, mosquito-borne disease that is considered a significant public health threat and a priority for vaccine development—is endemic. The trial was led by researchers at the Uganda Research Institute and the London School of Hygiene and Tropical Medicine Research Unit in Uganda and provides the first evidence supporting the vaccine from a trial in an endemic setting. While the vaccine could potentially be transformative for RVF prevention, further research is needed that follows participants for a longer period and includes a larger group of participants, including children, pregnant women, and immunocompromised people. Last week at the American Society of Tropical Medicine and Hygiene annual meeting, Medicines for Malaria Venture and Novartis shared the results of a Phase 3 study testing a new malaria treatment, known as GanLum, finding that the treatment was highly effective at treating malaria, including drug-resistant cases, and could also block disease transmission. GanLum was found to be 99.2 percent effective in curing patients, more effective than standard artemisinin-based combination therapies, the gold-standard malaria treatment introduced more than 20 years ago, whose use has been undermined since the emergence of partial resistance. The developers say that, pending regulatory approval, the new treatment could be rolled out within the next few years. South African pharmaceutical company Biovac is launching trials of a cholera vaccine, which, if it proves successful, could become the first vaccine developed from start to finish on the African continent. Africa faces the brunt of the global cholera burden but is almost entirely reliant on vaccines made internationally, which has become increasingly challenging in recent years as cases have risen sharply around the world and vaccine stocks have diminished. The African Union has committed to increasing the proportion of routine vaccines used in Africa that are manufactured on the continent from just 1 percent now to 60 percent over the next 15 years, an effort triggered by the access challenges African countries faced during the COVID-19 pandemic. 

An international research team, led by scientists at the University of Maryland School of Medicine, shared the results of the Phase 1 trial of a novel vaccine designed to protect against typhoid fever and non-typhoidal Salmonella infections, reporting that the vaccine produced a strong immune response and was safe and well-tolerated in a small group of healthy US adults. These encouraging findings pave the way for the next step of evaluating the vaccine in children. A single vaccine that targets Typhoid fever and non-typhoid Salmonella, both leading causes of illness and death in children in Africa, could be a game-changer for pediatric health. The vaccine could also help protect people in the United States and other high-income countries, where some types of Salmonella are common causes of foodborne illness. Following the example of the US military, who often wear uniforms treated with insecticide to repel mosquitoes in malaria-endemic regions, a research team has tested a similar approach to try to protect young children, who face a significant burden of malaria in sub-Saharan Africa. While existing vector control tools, such as insecticide-treated bednets, only protect children while they’re sleeping, a large randomized controlled trial in Uganda tested the efficacy of insecticide-treated baby wraps, used in conjunction with bednets. The trial found that the baby wraps were highly effective at preventing malaria infections. The dramatic scale of the reduction of new infections also suggests that malaria-carrying mosquitoes were biting during the daytime more often than previously thought, which could help guide the development of new vector control tools and approaches. Last week, The Safety of Antimalarials in the FIRst trimEster (SAFIRE) consortium announced that it had enrolled its first patient in Mali, marking the official start of the first-ever Phase 3 adaptive platform trial evaluating the efficacy and safety of antimalarial drugs in the first trimester of pregnancy. The trial is a landmark achievement that could not only help fill the crucial gap of safe and effective options for pregnant women at risk of malaria, but it is also a step toward equity and inclusion for clinical research and drug development in general, which have long excluded pregnant women, fueling the gap in the first place. SAFIRE partners have shared that early formative research in the communities where the trial will take place was a crucial step in ensuring that the design and process were appropriate and acceptable to the communities. The study will continue to progress in Mali, Burkina Faso, and Kenya. 

A Phase 1 clinical trial testing an experimental monoclonal antibody for malaria found that the highest dose of the treatment studied was highly effective in preventing malaria. Researchers from the University of Maryland, Sanaria, the Vital Narrative consultancy, and the Gates Medical Research Institute tested the monoclonal antibody, MAM01, in 37 adults who had never been exposed to malaria, who received either a single dose of varying sizes or a placebo, and then were infected by the bites of infected mosquitoes. None of the three recipients who received the highest dose had malaria parasites in their blood after infection. The monoclonal antibody could prove to be an important treatment option that provides immediate, high-level, and long-lasting protection with just one doseA Japanese research team has isolated natural compounds from marine sponges that demonstrate an ability to kill parasites that cause leishmaniasis, which affects approximately 12 million people around the world. Current treatments are highly toxic, cause serious side effects, and can be prohibitively expensive, leaving patients, particularly in low-income communities, which face a disproportionate burden of leishmaniasis, unable to access or complete treatment. Drug resistance is also complicating leishmaniasis treatment efforts. These findings could guide research into new treatment approaches and could potentially also be applied to other protozoan diseases like Chagas disease and African sleeping sickness. A new CRISPR-based RNA test could help track the parasites that spread Human African trypanosomiasis, or sleeping sickness, which affects around 500 people per year and many more livestock animals. The test can identify parasite species living in an animal’s blood, helping public health workers carry out targeted treatment of infected animals and prevent transmission to humans. This One Health approach to zoonotic or parasitic diseases could also be rolled out to address other diseases, such as Chagas disease or leishmaniasis.