Research Roundup: Investigational once-yearly HIV prevention planning, Newborn antimalarial rollout, Bundibugyo Ebola research

Last week, the World Health Organization (WHO) prequalified multi-dose vials of the maternal vaccine against respiratory syncytial virus (RSV), enabling rollout in lower-income countries. RSV poses a severe global threat, especially for children under five and newborns, in particular. The Gates Foundation supported the development of a multi-dose version of Pfizer’s Abrysvo maternal RSV vaccine, which is administered to pregnant people in their third trimester, protecting newborns against infection and greatly reducing babies’ risk of being hospitalized with RSV. Multi-dose vials simplify the logistics of vaccination, allowing health care professionals to vaccinate more people with fewer vials, which need to be stored and transported in ultra-cold conditions. The prequalification now enables international organizations, like Gavi, the Vaccine Alliance, which has already put implementation plans in place, to procure them for rollout in low-income countries. A research team has developed a nanobody-based antivenom that could provide a more flexible and effective approach for treating snakebites, which kill tens of thousands of people globally and disable hundreds of thousands more. Traditional venom is made by processing antibody-filled blood from horses injected with small doses of venom, but the quality of these antivenoms can vary, they can cause severe allergic reactions, they are expensive to produce, and they offer inconsistent protection across snakebites from different species. Nanobodies, tiny versions of antibodies, can move through tissue more quickly and reach venom before it can cause permanent damage. In a new study, all mice treated with the nanobody-based treatment survived. The treatment also prevented the most severe effects of the venom, is not expected to cause unwanted side effects, and remained intact at high temperatures, which is key in the resource-constrained rural settings that face heightened risk. Further studies will be needed to optimize the dose and ensure safety and efficacy in humans, but the study suggests that nanobody-based antivenoms could be a promising approach for further study. Immunoscript Life Science will receive up to $8.9 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to further development of its thermostable next-generation self-amplifying RNA (saRNA) vaccine platform, which could help improve access to RNA vaccines globally. mRNA vaccines have demonstrated significant promise as a tool against emerging disease threats because of the speed, flexibility, and adaptability with which they can be produced, but their requirement for ultra-cold temperatures for storage and transportation has proven a barrier to access in low-resource and remote settings. The saRNA vaccine platform, now owned by Immunoscript, is an alternative technology that could help overcome challenges associated with the cold chain. With CEPI’s funding, the company will conduct an early-stage trial in people in India to assess the safety and immune response of the technology. 

Fungi have existed for hundreds of millions of years, long before dinosaurs walked the Earth, but fungal infections have become a rapidly growing challenge for human health in recent decades.Fungal diseases affect more than 300 million people each year, disproportionately impacting people in low-resource settings and those with weakened immune systems, including people living with HIV, cancer patients, and transplant recipients. Most fungal infections affect superficial tissue like the skin, nails, or hair and can cause chronic illness and productivity loss. Though less common, invasive fungal infections can spread throughout the body and are associated with high mortality.Why fungal diseases are becoming harder to ignoreThe rising incidence of fungal infections is driven by a variety of factors, including conflict, poverty, urbanization, pollution, travel, and climate change, which increase exposure, heighten vulnerability, and expand the reach of dangerous fungal pathogens. At the same time, advances in medicine mean more people are living longer with conditions that weaken the immune system, increasing the number of people at greater risk. Growing antifungal resistance is also making infections harder to treat and further limiting already scarce treatment options.Despite the mounting burden, fungal disease remains underprioritized, underdiagnosed, under-surveilled, and underfunded, making it one of the world’s most neglected global health threats.Why innovation is falling behindFungal infections receive less than 1.5 percent of all infectious disease research and development (R&D) funding, contributing to sparse pipelines for both therapeutics and diagnostics. Closing these gaps will require greater investment in R&D, particularly for tools designed for resource-constrained settings and targeting the pathogens that pose the greatest threat to human health. Stronger regulatory and procurement systems and international collaboration will also be essential to ensure emerging tools are affordable and accessible worldwide.Despite persistent gaps, several promising innovations demonstrate the potential for R&D to transform the global response to fungal disease.Promising advances in antifungal treatmentThere are currently only four classes of antifungal medicine available, many of which are associated with serious side effects or require lengthy, hospital-administered treatment courses. The pipeline of new antifungal therapies also remains thin.The World Health Organization (WHO) reported last year that only nine antifungal therapies were in clinical development to address WHO’s designated top four priority pathogens, including three in Phase 3 development. Although the Phase 3 trial for one of those candidates has since been terminated, another candidate, olorofim, developed by Shionogi and F2G, recently reported positive Phase 3 trial results. If approved, it could become the first antifungal treatment with a novel mechanism of action for that infection in more than 20 years.Earlier-stage research is also yielding promising advances. Researchers recently discovered that an antibiotic could target a priority fungal pathogen by switching it back from its invasive form to a less harmful form. This antibiotic could help existing antifungal drugs target dangerous fungal pathogens, allowing lower, less toxic doses of those drugs to be used.Together, these advances offer hope of a new generation of antifungal therapies.The future of fungal diagnosticsDiagnostic tools for critical fungal pathogens exist but with significant limitations, including invasive sampling requirements, long turnaround times, limited pathogen coverage, and inadequate sensitivity. Many also depend on sophisticated laboratories and highly trained staff, making them difficult to deploy in resource-constrained settings globally that bear a disproportionate burden of fungal disease.The MycoMEIA® assay developed at Johns Hopkins University and commercialized by Pearl Diagnostics represents a recent advance in antifungal diagnostics. The test received US Food and Drug Administration clearance in 2025. It uses a urine sample, which is much simpler and less invasive for patients than current options, and provides results in just a few hours.Another promising research development illustrates where fungal diagnostics may be headed next. Researchers at the Mayo Clinic and Zepto Life Technology recently reported early results from a new diagnostic platform that was able to identify 18 different fungal pathogens with a single test. While still in development, such approaches could not only streamline diagnosis for health care providers and patients, but also reduce costs and resource requirements, making them well-suited for resource-constrained settings.Closing the innovation gap Fungal diseases and antifungal resistance are attracting greater international attention, but the response still lags behind the scale and pace of this growing threat. Increased investment in the R&D of fit-for-purpose innovations, paired with stronger regulatory and health systems and global coordination, will be crucial to ensure new diagnostics and treatments emerge from the pipeline and reach the patients who need them most.