Breakthroughs Blog: Maternal health

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A new study from a team at the Liverpool School of Tropical Medicine found that the drug nitisinone works as a potent contact insecticide for killing the mosquito species that spread malaria, dengue, Zika, and other emerging mosquito-borne viral threats, offering hope of a new approach to combating insecticide resistance. Nitisinone, which is currently used to treat a rare genetic condition in humans, kills mosquitoes by blocking an enzyme that is necessary for them to process human blood, which is not a pathway targeted by any currently used insecticides. The research suggests that the drug could be formulated for use in indoor residual spraying or insecticide-treated bed nets, helping eliminate mosquitoes even in settings where rising insecticide resistance has undermined the effectiveness of current vector control methods.Early last week, the Gates Foundation announced a $2.5 billion commitment through 2030 to accelerate research and development on women’s health. Specifically, the funding will help advance more than 40 innovations in five critical areas: obstetric care and maternal immunization, maternal health and nutrition, gynecological and menstrual health, contraceptive innovation, and sexually transmitted infections. These areas were selected based on extensive data about where innovation can save and improve the most lives and where there are persistently high rates of misdiagnosis, as well as direct insights from women in low- and middle-income countries about their needs, preferences, and challenges.Last week, IAVI; the Mutala Trust; ReiThera; and the Ragon Institute of Mass General Brigham, the Massachusetts Institute of Technology, and Harvard University announced that the first doses of an investigational HIV vaccine candidate were administered in their Phase 1, first-in-human clinical trial. The clinical trial is taking place at three sites in Zimbabwe and South Africa among 120 healthy adults, including people living with HIV. Carrying out the trial in sub-Saharan Africa, which faces the highest disease burden, will help ensure the vaccine is effective and relevant in the communities where it is most needed. The vaccine candidate is designed to stimulate the immune system, particularly CD8+ T cells, to recognize and target critical structural regions of the virus. Scientists believe CD8+ T cells could potentially target HIV-infected cells, so the trial will also assess whether the vaccine candidate could be part of future therapeutic or cure technologies.

We have seen tremendous strides toward gender equity and improved women’s health around the world, enabled through innovative technologies that empower and lift up women—but there’s still tremendous work to be done.   African women face a disproportionately high risk of dying from communicable diseases like HIV, tuberculosis, and malaria that are endemic in Africa, as well as a higher risk of pregnancy and birth complications than women outside the continent. At the same time, women are also the backbone of the health workforce in Africa, playing a vital role in supporting the health and wellbeing of their families and communities.  Yet, despite their unique understanding of the health challenges and needs of African women and communities, women in Africa are massively underrepresented in the field of research. Only 31 percent of professional researchers in sub-Saharan Africa are women, mirroring the 33.3 percent of researchers that are women globally. Moreover, women researchers have a harder time getting funding and support for their work.This gender gap has profound consequences—it contributes to gaps in our understanding of women’s health issues and in our arsenal of tools to treat women. For example, pregnant women and other women of childbearing age have long been excluded from clinical trials, leading to insufficient or unsafe options for these populations for a variety of diseases and health areas.To celebrate the achievements of African women, we’re spotlighting six African women researchers who have made significant contributions to global health research and supported the next generation of African researchers, including women.Dr. Damaris Matoke-Muhia Dr. Damaris Matoke-Muhia is a Kenyan molecular biologist who is leading the fight against malaria and other vector-borne diseases in Africa. She currently serves as Entomology Division Head at the Kenya Medical Research Institute, as well as a Kofi Annan Global Health Leader Fellow at the Africa Centres for Disease Control and Prevention.Dr. Matoke-Muhia has studied the behavior of mosquitoes for more than a decade, investigating why we’ve seen changes like shifts in biting habits, the emergence of a malaria vector previously endemic to Asia in Africa, and increasing resistance to insecticides, which have made these vectors harder to control, as well as researching new techniques to improve vector control. Through her work with the Pan-African Mosquito Control Association, Dr. Matoke-Muhia has also helped train other African women to become experts and leaders in vector control. She uniquely understands the need for women, who are often the ones implementing tools like bed nets to protect their families and communities, to be at the forefront of research and control efforts: “It is important that we ensure equal representation, as far as leadership, because women speak from experience and from what has worked and not worked at community levels. Women should always be at the forefront at leadership levels, which is key to elimination of malaria on the continent.”Dr. Monique Wasunna Dr. Monique Wasunna, a Ugandan-born doctor and researcher, has for decades been at the frontlines of African research into neglected tropical diseases. She worked for many years at the Kenya Medical Research Institute and currently serves as Africa Ambassador of the Drugs for Neglected Diseases initiative (DNDi), an organization she joined at its conception in 2003. In her current role, Dr. Wasunna engages African policy leaders and stakeholders to support research and development (R&D) collaborations that deliver new treatments for neglected disease. Throughout her career, Dr. Wasunna has led numerous clinical trials to find better treatment options for neglected diseases. At DNDi, her work helped the organization advance several groundbreaking new treatments for neglected tropical diseases, including an improved, affordable therapy for leishmaniasis and an all-oral cure for sleeping sickness, which replaced a toxic treatment that was the only previously available option.Dr. Wasunna is also a founding member of the Leishmaniasis East Africa Platform, which promotes clinical research and research capacity-building for leishmaniasis in the East Africa region. The platform has supported clinical trials that resulted in improved treatments for visceral leishmaniasis; trained hundreds of people in clinical care, research, and data management; and upgraded laboratories and hospitals across the region, enabling African researchers and research institutions to lead efforts to address neglected tropical diseases, like leishmaniasis, which are high concentrated on the continent.As she says in a piece cowritten by Dr. Wasunna and Dr. Matoke-Muhia, “African women scientists have already proven that they can lead inclusive, groundbreaking research and shape global health solutions. But we cannot wait another five generations for gender parity.”Dr. Delese Mimi DarkoDr. Delese Mimi Darko is a Ghanaian pharmacist who transformed her country’s regulatory and clinical trial ecosystem as head of Ghana’s regulatory agency and will now apply her expertise to the entire continent as she becomes the first-ever Director General of the African Medicines Agency, a recently established initiative to boost Africa’s regulatory capacity and ensure the safety and quality of medical products.As Chief Executive Officer of Ghana’s Food and Drug Administration and in previous roles during her multiple decades working at the agency, Dr. Darko helped establish a strong, stable, and integrated national regulatory system, which has achieved the World Health Organization’s highest maturity level designation. She also pioneered clinical trial regulation in the country, helping make the country a clinical trial leader in the West African region. Dr. Darko has taken on various advisory roles throughout her career, furthering partnerships and initiatives that support R&D and regulatory harmonization across the continent.In addition to helping transform the research and regulatory ecosystem of her country and now the broader African continent, paving the way for the next generation of African innovators, Dr. Darko has also highlighted the need for more female leaders: “Women [are] generally more altruistic and are therefore able to better consider other opinions and views. This makes us better team players and better leaders who, as a consequence, are able to take bold decisions based on wider consideration.”Dr. Quarraisha Abdool KarimDr. Quarraisha Abdool Karim is a South African infectious disease epidemiologist who for decades has been a global pioneer in HIV/AIDS research, leading research that has shaped the global HIV prevention landscape, particularly focusing on technologies for women. In 2001, Dr. Abdool Karim and her husband, also a world-class HIV/AIDS researcher, brought together a group of top HIV researchers to form the Center for the AIDS Program of Research in South Africa, which is today one of most influential HIV/AIDS research programs in the world.Dr. Abdool Karim’s work demonstrating that antiretrovirals previously only used to treat HIV/AIDS could also be used to prevent sexually transmitted HIV laid the foundation for the HIV prevention approach, pre-exposure prophylaxis, that is widely used today.Dr. Abdool Karim and her center’s work also led to the development of broadly neutralizing antibodies, antibodies that can neutralize a wide range of HIV variants, after discovering that one of the center’s study participants produced unique antibodies that not only attacked the strain of HIV she had but also targeted a broad swath of the HIV strains circulating globally. The isolation and recreation of these antibodies in a lab was a game changer—many of the most promising HIV cure strategies in development use them.Dr. Abdool Karim has spoken about the unique potential of researchers from backgrounds underrepresented in science to tackle those often-ignored areas of health and scientific query, saying, “these were very much our problems in Africa that few others were working on…and if we waited for solutions from elsewhere, it wasn’t going to come. We had to take the lead.”Professor Faith Osier  Professor Faith Osier is a Kenyan malaria researcher and professor who currently serves as Chair in Malaria Immunology and Vaccinology at Imperial College London and President of the International Union of Immunological Societies, the first African and only second women to hold the role. Professor Osier has dedicated her career to studying the immune response to the malaria parasite, particularly looking at what parts of the response can help protect against infection, information that is key to designing more effective malaria vaccines.  Professor Osier helped develop a custom tool, the first of its kind in Africa, which includes more than 100 parasite proteins that are potential targets of antibody responses. The tool helps researchers quickly test which proteins are triggered in strong immune responses using blood samples from malaria patients, giving researchers a clue into what proteins they should target in future vaccines.Professor Osier also built an international network of partners to share samples and epidemiological data on malaria parasites across Africa, which now spans 12 sites across seven sub-Saharan African countries. The network has assembled a dataset of 10,000 samples, each of which has been systematically analyzed, helping develop a map of parasite diversity across the region. The network has also helped develop malaria research capacity in Africa, providing training opportunities for students and early-career researchers. Professor Osier has spoken about her strong belief in the need to build African research capacity, “I think there has been a massive change in awareness or great momentum to support scientists in developing countries so that they can work on the problems that are facing their own countries, and I think it’s very important.”Dr. Francine NtoumiDr. Francine Ntoumi is an award-winning Congolese molecular biologist who founded and currently serves as President and Executive Director of the Congolese Foundation for Medical Research in the Republic of Congo, as well as Professor of Molecular Epidemiology of Infectious Diseases at the Institute of Tropical Medicine at the University of Tübingen, Germany.While Dr. Ntoumi’s own research has focused on malaria, tuberculosis, and COVID-19, she has also been a leading advocate of boosting African health research capacity and specifically supporting African women researchers throughout her career, as the first African leader of the Multilateral Initiative on Malaria and through her leadership at the  Central African Network on Tuberculosis, HIV/AIDS and Malaria, which works regionally to boost research capacity. “It might be difficult to convince Congolese girls they could be the next Marie Curie, but easier to convince them they can be me!” she said. “We have to banish this idea that only men can have ambition. If you are female and have scientific ability, you need to stand up.”These incredible female scientists and many others have contributed to considerable strides in research into the biggest health challenges facing the African continent and helped elevate African researchers, particularly women researchers, paving the way for a healthier, more scientifically engaged future for Africa and African women. Photo credits from top to bottom: Kenya Medical Research Institute, Drugs for Neglected Diseases initiative, Ghana Food and Drugs Authority, CAPRISA, Imperial College London, Congolese Foundation for Medical Research

It is the wish of mothers everywhere to give their babies the healthiest possible start to life. It’s a feeling I remember well as I prepared to give birth to my son Homer amid an active flu and respiratory syncytial virus (RSV) season and a global pandemic—full of hope and full of fear. The first few weeks of a baby’s life are particularly worrisome and nerve-racking for any new parent. That’s because while our little ones are quickly learning to see, grasp, and respond to our voices, it will take up to three months for parts of their still-developing immune systems to mature fully. During this time, they are particularly vulnerable to viruses and bacteria that are an everyday part of life. While my husband and I were lucky to have our son enter this world in a clean and modern hospital and to be able to mostly “bubble” ourselves off from the outside world during those early days, not every parent is so fortunate. It is a well-established reality in global health that a person’s chance of survival is heavily influenced by the circumstances of their birth—including where they are born—but this disparity is especially pronounced in neonatal health.  Each year, more than 2 million babies die in their first month of life and around 2 million more are stillborn—with 98 percent of those deaths occurring in low- and middle-income countries (LMICs). These losses reflect some of the most profound and preventable health inequities globally. The potential of maternal immunization To save more babies during their vulnerable first weeks of life, scientists are increasingly looking to harness the potential of the long-standing approach of maternal immunization in an entirely new way. Pregnant women naturally pass on protective antibodies to their developing babies during pregnancy in a process known as passive immunity. As a result, vaccinating women during pregnancy can not only protect them from dangerous diseases but can also protect their newborns during their first few weeks to months of life. Maternal immunization is not a new concept. Flu vaccines, as well as tetanus, diphtheria, and pertussis (whooping cough), or Tdap, vaccines are given to mothers worldwide as a routine part of prenatal care—I received both in my third trimester—and have proved stunningly successful. Neonatal tetanus deaths worldwide have been reduced by more than 95 percent since the late 1980s thanks, in significant part, to maternal immunization, and maternal pertussis vaccination has been shown to be 95 percent effective in preventing infant deaths from whooping cough.More nascent on the scientific front are efforts to develop vaccines designed specifically for pregnant women for the purpose of maternal immunization.  Historically, research into maternal vaccines has been limited, largely due to concerns about the ethical and safety considerations of studying and administering vaccines during pregnancy.  But thanks to interest and investments from major global health research funders like the Gates Foundation and its efforts to better characterize statistical baselines for “normal” pregnancy outcomes to meaningfully enable comparative research, a small but promising pipeline of new maternal vaccines has emerged. Harnessing maternal vaccines to combat leading causes of infant death The first-to-market new maternal vaccine was an RSV vaccine from Pfizer, which was first approved by the US Food and Drug Administration in August 2023, making it the first and, still, the only available maternal vaccine to protect infants against RSV, a common respiratory disease that claims the lives of 100,000 children under five each year, with half of those deaths occurring before six months of age. The vaccine, which is given to pregnant women between weeks 32 to 36 of pregnancy, helps protect infants during their first six months of life.More recently, the vaccine was recommended and then later prequalified last month by the World Health Organization, which should help support the procurement and uptake of the vaccine worldwide, particularly in LMICs, where the mortality burden of RSV is the greatest.Beyond RSV, maternal vaccines are being advanced against two other infections that are significant drivers of infant deaths worldwide, Group B Streptococcus (GBS) and Escherichia coli. GBS bacteria, if transmitted to an infant during pregnancy or childbirth, can lead to serious and deadly conditions, including meningitis, pneumonia, or sepsis. It’s a common infection: about one in four pregnant women carry it, but the resulting health outcomes for infants are drastically different depending on where in the world one gives birth. In high-income countries, pregnant women are screened for GBS as part of routine prenatal care, and, if infected, they are given antibiotic treatments prior to delivery. In low-income countries, with less capacitated health systems, this care is less likely to occur, leading to a stark difference in health outcomes. An estimated 97 percent of infant GBS deaths are in LMICs.But the future could look brighter. A promising maternal vaccine for GBS from Pfizer completed Phase 2 clinical trials in 2023 and received a breakthrough designation from the US Food and Drug Administration to expedite its development and review. A second vaccine candidate from MinervaX is also in Phase 2 development. Researchers estimate that maternal GBS vaccination could prevent more than 50,000 GBS-related deaths and 170,000 preterm births annually. Similar to GBS, E. coli is a common bacterium, often transmitted from mothers to their babies during childbirth, which can cause serious illnesses, including meningitis and sepsis. Proper screening and antibiotic treatment during pregnancy can greatly reduce these risks, but for those newborns that do develop sepsis, the speed with which treatment is delivered is a key determinant of survival. The risk of death from neonatal sepsis increases by 7.6 percent every hour that treatment is delayed, underscoring the risk for infants in LMICs, who are more often born outside health facilities and far from medical care.GHTC member the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator is supporting the development of GlyProVac’s maternal E. coli vaccine, which is still in the early stages of development but, if proven effective, could one day save the lives of at-risk newborns.Healthy beginnings, hopeful futuresAs a parent, I’ve experienced the fear and feeling of helplessness that often comes with having a sick infant. You snuggle and comfort their fragile bodies, doing what you can—including vaccination when available and accessible—but often, especially in low-resource settings, there is little to do beyond monitoring, waiting, and hoping they get better. I know that if the option existed to get a few additional shots to help protect my baby during those early vulnerable weeks of life, I, and so many mothers worldwide, would joyfully jump at the opportunity. In the years ahead, maternal immunization could play an even greater role in preventing hundreds of thousands of newborn and fetal deaths. By embracing its promise, we can help give babies everywhere a healthy beginning and a hopeful future. 

There is a well-known Chinese proverb that says, “Women hold up half the sky,” but when it comes to global health, sadly, humanity has a lot of ground to make up to close the stark gap between the health outcomes of women and men.While women tend to live longer than men, this longevity often comes with a greater burden of disease and disability, underscoring the urgency of addressing sex-based disparities in health care. Women, on average, spend 25 percent more of their lives in poor health compared to men, they are 52 percent more likely than men to have an adverse drug reaction and 29 percent more likely to die from one, and they’ve been found in one multi-decade study to be diagnosed later than men for more than 700 diseases. Research and development (R&D) for female-specific conditions also remains vastly underfunded: only 1 percent of R&D funding focuses on non-cancer-related women’s health.Yet despite these sobering statistics and new threats to the future of women’s health care and research funding, GHTC remains optimistic. With sustained support and investment, the scientific landscape holds immense potential to drive breakthroughs that can close these gaps and improve health outcomes for women worldwide.Thus, in recognition of International Women’s Day, GHTC is spotlighting five promising technologies in the research pipeline that could improve women’s health globally.1. A new treatment for gonorrheaGonorrhea is a sexually transmitted infection, more prevalent among women than men, that can cause serious health issues—from pelvic inflammatory disease to infertility and ectopic pregnancies—if left untreated. Combating gonorrhea has become more complicated in recent years, as growing drug resistance has reduced the arsenal of available treatment options.But, excitingly, a new, much-needed breakthrough is on the brink. A first-in-class antibiotic, zoliflodacin, developed by GHTC member the Global Antibiotic Research and Development Partnership, was found to be effective in a large-scale global Phase 3 clinical trial in 2023. If approved, it would become the first new antibiotic for treating gonorrhea in decades. The drug is also taken orally, which would simplify treatment administration for clinicians around the world, and its nonprofit developer, which is committed to delivering affordable access to the product, has the right to commercialize it in more than three-quarters of the world’s countries, including all low-income countries and most middle-income countries. Another second promising antibiotic for gonorrhea from GSK, gepotidacin, is also in late-stage development.2. A therapeutic vaccine for cervical cancerCervical cancer is the fourth most common cancer in women globally, claiming the lives of 350,000 women each year. Nine out of every ten cases of cervical cancer are caused by human papillomavirus (HPV) infection.Since the introduction of the first preventative HPV vaccine nearly two decades ago, global efforts have focused on expanding immunization coverage worldwide, as well as advancing research that has reduced vaccine schedules from multiple doses to just a single dose, easing administrative costs. Yet, despite these efforts, there remain significant gaps in immunization coverage—only 27 percent of girls worldwide received an HPV vaccine dose as of 2023—underscoring the need for additional complementary treatment and prevention tools.That’s where therapeutic cervical cancer vaccines could offer promise. What if we could administer a shot to patients who have already developed precancerous lesions due to HPV that could eliminate HPV-infected calls before those cells become cancerous? This theoretical possibility could become a reality in the future. A Phase II trial of the investigational therapeutic HPV vaccine Vvax001 reported results in January, finding that the vaccine successfully induced regression of precancerous lesions in half of all trial participants. Among patients with advanced precancerous lesions, the traditional intervention is surgery to remove the affected areas, which carries the risk of side effects and complications. An effective therapeutic vaccine could reduce the number of patients who ultimately require surgery and offer advantages as an intervention that is far easier and less costly to administer in resource-limited settings worldwide.3. Inhalable oxytocin to reduce PPHPostpartum hemorrhage (PPH), or excessive bleeding after childbirth, is the leading cause of maternal deaths worldwide. While the hormone oxytocin is often administered to women following childbirth to prevent PPH by causing the uterus to contract, oxytocin products are traditionally heat-sensitive and administered via injection or intravenously, which can make this intervention challenging to administer in certain settings around the world.To solve this issue, researchers at Monash University have developed an inhalable form of oxytocin that is formulated as a dry powder requiring no refrigeration. Prior clinical research has shown that the product is comparable in effect to injected oxytocin, and now, scientists are advancing research on the best means to administer it. In late 2023, a Phase I trial assessed administration of the product using a low-cost inhaler system called the ICOone. If this product ultimately reaches the market, it could offer a much-needed alternative that would make this lifesaving drug easier to store and administer to women in need, no matter where they live.4. Biodegradable contraceptive implantsMany women worldwide choose to use contraceptive implants as their contraceptive method. These products offer unique advantages for certain women: they are long-acting and easy to use; once inserted, there is no need for users to take or do anything on a daily, weekly, or monthly basis. But eventually, they must be removed when they are no longer effective or when users change their reproductive plans. This removal procedure requires trained health care providers, and it can create an access barrier for women worldwide who live far away from health care facilities.That’s why researchers are working to advance biodegradable implants, which would dissolve into the body over time, eliminating the need for removal. In February 2024, GHTC member FHI 360 launched a Phase 1 trial of a biodegradable implant, Casea S, which aims to prevent pregnancy for 18 to 24 months. At the time, it marked the first biodegradable contraceptive implant to undergo human trials in over 20 years. While the trial will still take a few years to complete and further research will be required, if the implant is successful, it could not only help solve health care access challenges but could also address a middle-ground need between existing implants that last years and long-acting injectables, which usually last three months. FHI 360 also has a second biodegradable contraceptive implant in its portfolio, which is in early-stage development and uses a different contraceptive hormone.5. A new drug to prevent preeclampsiaPreeclampsia is a dangerous pregnancy-related condition that affects between 2 and 10 percent of pregnancies worldwide and claims the lives of more than 70,000 mothers and 50,000 babies each year. While low-dose aspirin and calcium supplements are recommended to women who are at high risk of the condition, there is currently no medicine approved specifically to prevent preeclampsia. That could change in the coming years thanks to emerging research.A British biotech company has developed an investigational, once-daily oral drug, MZe786, to prevent preeclampsia, which is in early-stage development. In animal studies, the drug, which is a form of aspirin that also releases hydrogen sulfide, elicited an improvement in maternal and fetal outcomes compared to aspirin alone. While further confirmation of these effects in human clinical trials is needed and it could be many years before such a product potentially reaches market, in 2022, the drug was awarded a fast-track development status by the United Kingdom’s regulatory agency, becoming the first pregnancy-related drug to receive this status, signifying its potential to address an urgent and unmet need.All five of these promising products are inspiring examples of the stepwise progress achieved through past investments in women’s health research, but we also hope that they will serve as a rallying cry to what more could be possible if we were to devote adequate resources to addressing these challenges.This International Women’s Day, we hope that the global community will further commit to investing in innovations for women’s health and to expanding the representation of women in clinical research. After all, closing the women’s health gap is not only essential to the well-being and future of millions of women and girls worldwide, but it will also enrich the well-being and economic stability of their families, communities, and nations. It’s a responsibility and opportunity we can’t ignore.