Breakthroughs Blog: Maternal health

The Gates Foundation has awarded ProFound Therapeutics up to $35 million to find new drug targets for preeclampsia, a high blood pressure condition during pregnancy that can be severe for mother and child and is a significant contributor to maternal and fetal deaths globally, particularly in low- and middle-income countries. ProFound will utilize their vast repository of proteins and data to improve scientific understanding of how preeclampsia is developed in the body, with the goal of identifying promising approaches for future drug development. Once targets are identified, the company will explore their features using an AI tool and then evaluate them in laboratory experiments.Last week, the Coalition for Epidemic Preparedness Innovations (CEPI) announced that it will invest up to $16.5 million to advance the development of an African-developed vaccine candidate for the Bundibugyo strain of Ebola, which is behind the fast-growing outbreak in the Democratic Republic of the Congo. CEPI’s support will help advance the candidate through preclinical development and into an early-stage clinical trial in Africa. The vaccine candidate uses a technology that is utilized by a licensed vaccine against smallpox and mpox and has elicited long-term immunity in a vaccine targeting the Zaire strain of Ebola. It is the fifth Bundibugyo-specific vaccine candidate supported by CEPI in response to the current outbreak and the only of the five designed to induce two major parts of the immune system, both B- and T-cells, for comprehensive and long-lasting immunity.A novel tuberculosis (TB) vaccine candidate failed to match the current, more-than-100-years-old vaccine in preventing TB infections in newborns, according to the recently shared results of a Phase 3 trial conducted among 6,897 healthy newborns in sub-Saharan Africa. TB remains the world’s leading infectious disease killer and there is an urgent need for a new vaccine—the current TB vaccine, BCG, is effective at preventing some types of TB in infants, but it offers inconsistent protection in adults against pulmonary TB. One of 17TB vaccine candidates in the pipeline, the vaccine in the trial, VPM1002, is a genetically modified recombinant BCG vaccine developed by the Serum Institute of India. While disappointing, the results of the trial do provide significant insights about how best to design robust, feasible efficacy trials for future vaccine candidates.

Last Thursday, the World Health Organization (WHO) announced that, with support from Gavi, the Vaccine Alliance, it will allocate 70,000 doses of an approved Ebola vaccine to the Democratic Republic of the Congo, which is facing the largest Ebola outbreak in the country’s history. The vaccine, Ervebo, targets Ebola Zaire, the most common Ebola strain, not the Bundibugyo strain behind the current outbreak—for which there are no approved vaccines —but early laboratory and animal data suggest it may provide some cross-protection. Twenty thousand doses will be used in a Phase 3 trial to evaluate whether the vaccine offers cross-protection for Bundibugyo, while the remaining doses will be allocated to frontline health care workers, serving the dual goals of providing some protection for at-risk populations against severe illness and death during the current outbreak while gathering critical data to inform use of the vaccine in future Bundibugyo outbreaks.Researchers at the Walter and Eliza Hall Institute of Medical Research have developed a rapid blood test that could improve detection of iron deficiency, a widespread health challenge disproportionately affecting mothers and children in low-resource settings where access to conventional laboratory-based screening methods are limited. Using a finger-prick blood sample, the test provides results within 15 minutes without the need for specialized laboratory infrastructure and highly trained health care providers. It has demonstrated strong correlation with gold-standard laboratory methods used in high-income countries and includes a built-in reference line to make the results easier to interpret. The test is currently undergoing evaluation in sub-Saharan Africa.The Coalition for Epidemic Preparedness Innovations (CEPI) shared last week that it will dedicate $4.17 million to four research projects designed to assess whether additional vaccines currently or previously licensed against Ebola Zaire could offer some cross-protection against severe illness and death during the current rapidly growing outbreak of Bundibugyo Ebola. Specifically, the funding will go to teams at the University of California, Los Angeles in the United States; the Institute of Tropical Medicine in Belgium; the University of Oxford in the United Kingdom; and the MRC-University of Glasgow Centre for Virus Research in the United Kingdom. The research teams will use blood samples from vaccinated individuals to assess immune responses and potential cross-reactivity of antibody responses, helping establish and standardize antibody tests for Bundibugyo, inform interpretation of clinical trial results, and guide future strategies. These research initiatives will support trials during the current outbreak and complement ongoing efforts to develop Bundibugyo-specific vaccines. 

Preeclampsia affects millions of pregnancies around the world, claiming the lives of 42,000 women each year and contributing significantly to fetal and newborn mortality and complications. Early detection and management are crucial to prevent progression to eclampsia, which is characterized by seizures and can be life-threatening.  The burden of preeclampsia is greatest in low- and middle-income countries (LMICs), where workforce shortages, limited laboratory capacity, and procurement challenges undermine the implementation of recommended tools and protocols.  Despite its global impact, preeclampsia remains under-researched and under-represented in the health innovation pipeline compared to conditions with similar prevalence that are not specific to women. These challenges have created critical gaps in screening, diagnosis, and treatment, but new tools in the pipeline could help transform care, particularly in low-resource settings worldwide. Rethinking preeclampsia screening and diagnosis Preeclampsia screening aims to identify high-risk pregnant women before symptoms appear and before they can be formally diagnosed, enabling closer monitoring and preventive care. Screening has traditionally relied on a checklist to evaluate patient history and risk factors. While simple, this approach has shown limited effectiveness and depends heavily on the accuracy of assessment.Newer recommended approaches that combine risk-factor screening with biomarker testing offer improved predictive performance. However, they require medical and laboratory imaging infrastructure that is not widely available in LMICs, limiting their uptake.  Preventive therapies, including low-dose aspirin, calcium supplements, and antihypertensive medications, are recommended for women identified as high risk, but they are not consistently offered to women in LMICs. As a result, many women are diagnosed later in pregnancy, when risks are greater.  The Accelerating Innovation for Mothers project identified 89 preeclampsia risk screening tools in the R&D pipeline but concluded current approaches are unlikely to adequately address the needs of women in LMICs, underscoring the need for greater investment in tools explicitly designed to address their realities.  Artificial intelligence (AI) is emerging as a promising tool to bridge screening and diagnosis gaps. With support from the Gates Foundation, Siemens Healthineers is developing an AI-driven tool that leverages data from blood tests already routinely performed as part of prenatal care to screen for both preeclampsia and anemia. By using existing samples and integrating screening for multiple conditions, this tool could enable more efficient and scalable screening in resource-limited settings. Confirmatory preeclampsia diagnosis relies on detecting elevated blood pressure and the presence of protein in urine, alongside the potential presence of severe symptoms. This requires trained health care workers and access to laboratory equipment, which can hinder accurate, timely diagnosis in resource-challenged environments. Monod Bio, with Gates Foundation support, is developing a rapid, point-of-care diagnostic test that can deliver results in less than 15 minutes. Using an AI-derived algorithm to analyze results, this tool could significantly reduce workforce and equipment needs. Together, these innovations reflect a promising shift toward designing tools specifically to address the needs of low-resource environments, rather than adapting tools used in high-income contexts, a shift essential to closing global gaps in care. Expanding the treatment pipeline There is currently no specific cure for preeclampsia other than early delivery, which can be dangerous for both mother and baby, especially in low-resource settings. Existing treatments focus on managing symptoms, including preventing seizures with magnesium sulfate and controlling blood pressure with antihypertensive medications. A new generation of therapies aims to go further by addressing underlying disease causal pathways, rather than managing symptoms alone.  A research team at the University of Nebraska Medical Center, supported by a Gates Foundation grant, is advancing an innovative treatment based on a naturally occurring compound that reduces the levels of a protein that plays a key role in the development of preeclampsia. In preclinical studies, the compound has improved vascular function, reduced inflammation, and lowered blood pressure. Importantly, it is also stable at room temperature and inexpensive to produce, making it well-suited for settings with limited resources. Another Gates-supported team at the Medical College of Wisconsin has launched a clinical trial evaluating a promising supplement for preeclampsia. The compound, which occurs naturally in foods, has been shown to improve vascular functions in animal models and early human studies. It is also shelf-stable and inexpensive. These novel therapeutics could help transform preeclampsia care by slowing or halting the progression of the condition, rather than simply responding to the presence of symptoms. Their affordability and suitability for austere settings could also help expand access for women who currently lack effective treatment options. Looking ahead Preeclampsia mortality rates remain far too high, reflecting long-standing gaps in research advancing women’s health and a lack of tools suited to low-resource settings. Innovations that leverage emerging technologies like AI and respond to the needs of pregnant women everywhere could help save more mothers and babies worldwide. Solutions designed for LMIC health systems could also strengthen care in underserved or overstretched settings in high-income countries like the United States, where rising health care costs, workforce shortages, and even conflict-related supply chain disruptions are straining health care service delivery.  Turning this potential into impact will require sustained investment to ensure innovations are not only developed but designed for and delivered to the women who need them most. 

IAVI recently announced the start of a first-in-human clinical trial evaluating a combination injection of four broadly neutralizing antibodies, with the aim of eventually developing a tool to prevent HIV transmission in infants during the postnatal period. The combination shot includes four antibodies that target different HIV receptors, including IAVI’s broadly neutralizing antibody ePGT121v1-LS. The current trial is evaluating safety, dosing, pharmacokinetics, durability, and efficacy in 118 adult participants across the United States and Peru, and, if successful, could pave the way for future studies in infants. A research team has identified a bacterium strongly associated with noma, a potentially fatal infection for which the underlying cause is poorly understood. The researchers used metagenomic sequencing and machine learning algorithms to analyze saliva samples from children with acute noma. They identified a bacterial species that may be responsible for the disease, which was detected in the early stages of infection and does not carry known antibiotic resistance genes, suggesting that infection could be effectively treated with existing antibiotics if detected early enough. These findings also pave the way for the development of diagnostic tools that can detect noma early on, when treatment is most effective and before irreversible damage has been done. Last week, Butterfly Network shared that it received regulatory clearance from the US Food and Drug Administration for its artificial intelligence (AI)-powered ultrasound, offering a critical new tool to improve maternal care in low-resource settings with limited access to prenatal imaging. Compared to traditional ultrasounds that rely on expensive technology, the new device is more affordable and provides results in less than two minutes with fewer inputs. The tool has already been deployed in Malawi and Uganda, and this latest approval will enable its widespread rollout in the United States.