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. Last Wednesday, the World Health Organization (WHO) announced that it had prequalified an at-home, over-the-counter assay for hepatitis C virus (HCV), the first self-test to be prequalified for HCV, which causes an estimated 1 million new infections globally each year. The prequalification of the assay, manufactured by OraSure Technologies, extends the 2017 prequalification of the company’s HCV test for professional use. Self-testing is recommended to complement existing testing services based on evidence demonstrating that it increases access to and uptake of services. The prequalification status will hopefully enable procurement in low- and middle-income countries, expanding access to HCV testing and treatment services and helping to contribute to the global goal of HCV elimination.The Safety of Antimalarials in First Trimester consortium, made up of scientific and social research experts on malaria in pregnancy has kicked off preparation for the first-ever Phase 3b clinical trial testing the efficacy and safety of antimalarials in women in their first trimester of pregnancy, which will be cosponsored by Medicines for Malaria Venture and the Liverpool School of Tropical Medicine. Pregnant women are typically excluded from clinical trials out of fear of causing harm, leaving few medicines for malaria treatment and no medicines for prevention available for women in their first trimester despite the significant health risks associated with malaria in pregnancy. The data from this trial could enable pregnant women and all women of childbearing age to safely take these antimalarial medicines without risk of causing harm, as well as support the design of future trials targeting other infectious diseases affecting pregnant women in low- and middle-income countries.  New research has led to the discovery of a potent adjuvant, PVP-037, that could induce a greater, more durable, and broader immune response to vaccines. Adjuvants are compounds that enhance the immune response, which are key to vaccine development, particularly for inactivated virus vaccines. Researchers identified the compound by screening a library of more than 200,000 small molecules found in human immune cells. In mice, an optimized form of the adjuvant boosted antibodies against flu and SARS-CoV-2 when given alongside disease-causing antigens. The compound is stable, easy to work with, and can be formulated in most drug delivery systems, which would make it easier to integrate it into vaccine development. Further research will be needed to study how the adjuvant performs in the presence of actual pathogens, assess its impact on the durability of immune responses, and test whether it works across age groups.

Last week, rain clouds gathered over Geneva as delegates from all over the world completed their annual pilgrimage to the World Health Assembly (WHA), the World Health Organization’s (WHO’s) annual forum for the 194 member states. The somber background reflected the mood heading into the meeting, as many were expecting this year’s gathering to be a washout. A visibly weary WHO Director-General Dr. Tedros Adhanom Ghebreyesus expressed his disappointment on the opening day that negotiations on a pandemic accord had not been completed in time for a WHA vote. Representatives also expected contentious fights over sexual and reproductive health and geopolitical conflicts, such as the ones in Ukraine and Gaza, to spill over into the proceedings, freezing debate and derailing possible progress on agenda items ranging from climate and health to universal health coverage. Yet, despite some serious bumps in the road, WHA also showcased that any multilateral system obituary is premature and that multilateralism can still deliver the necessary change we need to advance the global health agenda.   WHA approves new IHR amendments, resets timeline for pandemic agreement negotiationsAll eyes were on whether member states could come together to finalize the negotiations around the pandemic accord, a proposed convention to address some of the shortcomings exposed during the COVID-19 pandemic, as well as amendments to the International Health Regulations (IHR), an existing framework that codifies member state and WHO responsibilities in preparing for and responding to a public health emergency.  Heading into WHA, many stakeholders waited with bated breath to see if member states could bring both these processes across the finish line. Unfortunately, despite two long years of grueling negotiations, countries were unable to forge sufficient consensus to approve the pandemic accord. Instead, countries agreed to extend the mandate of the intergovernmental negotiating body, which coordinates the deliberation process for another year, providing additional time to reach compromises around the most contentious issues (financing, technology transfer—the process by which knowledge is transferred from the originator of a technology to other manufacturers to support the diffusion of health technologies into additional markets—, and a proposed access- and benefit-sharing system, which would pair commitments by countries around the sharing of pathogen samples and sequencing data with commitments from manufacturers to set aside a dedicated portion of their products for equitable distribution during health emergencies).  Nonetheless, member states notched a desperately needed win in reaching consensus on amendments to the IHR, achieving an agreement in the final hours of WHA. The consensus takes on added significance given that country representatives were not only in a race against time but also against fast-eroding trust in multilateralism, which was deeply fractured by the pandemic and subsequent geopolitical conflicts. The amendments to these technical rules, last revised in 2005 following the SARS outbreak, represent the first significant change in international law in the aftermath of the COVID-19 pandemic. While there were many changes to the IHR, one that stands out the most is that the added provisions include a commitment to solidarity and equity on strengthening access to medical products and to financing, including specific text that directs countries to promote research and development (R&D) and strengthen local production of quality, safe, and effective relevant health products. The previous IHR did not include any mention of R&D or the need to ensure equitable access to new tools.   WHA reinvigorates maternal and child health agenda  Progress was also made on a couple of other fronts in Geneva. Alarmed by the stagnation of progress in reducing maternal and child mortality, member states passed a critical resolution committing to specific actions to prevent the deaths of women, babies, and children.The resolution, led by Somalia and other cosponsors, commits countries to tackle the leading causes of maternal and child deaths, particularly in the hardest-hit nations. In it, countries agreed to improve access to maternal health services, including sexual and reproductive services, and comprehensive child health services through stronger primary health care and expanded access to emergency services. It also urges countries to develop and invest in tools that enable access to essential quality medicines for pregnant women, lactating women, mothers, and newborns and calls on WHO to strengthen and expand collaborative efforts, such as those promoted by WHO technical departments and the Global Accelerator for Pediatric formulations, or GAP-f, network, for facilitating better access to medicines for children. The WHA resolution marks WHO’s first significant action on maternal mortality in nearly a decade, following the adoption of the Global Strategy for Women’s, Children’s and Adolescents’ Health in 2015. Antimicrobial resistance in the spotlight  Antimicrobial resistance (AMR) also was in the spotlight in Geneva. With the United Nations High-Level Meeting (UN HLM) on AMR taking place in New York in September and a high-level ministerial meeting in Saudi Arabia in November, this year has been supercharged with attention on the issue, with WHA featuring numerous AMR events, roundtables, and initiatives.  Delegates approved a resolution to accelerate national and global responses on AMR, with many of them highlighting it as a crucial building block for the meetings in the fall. The resolution welcomes WHO’s strategic and operational priorities to address drug-resistant bacterial infections in the human health sector, which include prevention of infections; universal access to affordable, quality diagnosis and appropriate treatment of infections; strategic information, science and innovation; and effective governance and financing of the human health sector response to AMR.  The resolution also calls on member states to support investments in R&D for new tools to combat AMR and replenish the shockingly waning pipeline, to strengthen the capacities and standards of laboratories, and to participate in the WHO’s Global Antimicrobial Resistance and Use Surveillance System, or GLASS.While WHA did ultimately feature some contentious moments, especially around the geopolitics of Ukraine and Gaza, and major pushback on sexual and reproductive health, the latter almost derailing the adoption of several key decisions, the wins on IHR, maternal and child health, and AMR will have reverberations beyond WHA. Delegates hope that these wins will provide the necessary momentum to continue to make progress on the pandemic accord and at the UN HLM on AMR in the fall.  

A new report launched at Davos, from the World Economic Forum and the McKinsey Health Institute, refocused the spotlight on women’s health back in January. The report found a stark gap in health between women and men, adding up to 75 million years of life lost annually due to poor health or early death. This health gap is incredibly costly—closing it would benefit 3.9 billion women and would boost the global economy by $1 trillion by 2040 due to reductions in early deaths and health conditions, as well as the greater capacity for women to make socioeconomic contributions.In recognition of International Women’s Day, GHTC is spotlighting technologies, both available and still in development, that could help close the gender health gap and move us toward gender equity by both addressing the leading causes of morbidity and mortality for women and girls and empowering them to take control of their health and future. 1. CAB-LA and the dapivirine ring for HIV preventionHIV remains a major global challenge, especially for women and girls, who account for more than half of the 37.7 million people living with HIV and 46 percent of new infections in 2022. While the introduction of oral pre-exposure prophylaxis (PrEP) has helped drive significant declines in HIV infections globally, challenges adhering to the regimen of daily pills, as well as issues of stigma, have limited its impact in certain populations, including adolescent girls and young women. Long-acting cabotegravir (CAB-LA), developed by ViiV Healthcare, is a HIV prevention option administered by injection once every two months. CAB-LA offers an option that for many is easier to consistently use and also more discreet to receive than daily oral PrEP, which can reduce a barrier to use for those who fear stigmatization if their HIV status is exposed.The dapivirine ring, developed by the nonprofit International Partnership for Microbicides, is a flexible silicone ring inserted in the vagina that slowly releases the antiretroviral medication dapivirine over one month to reduce the risk of HIV infection. The ring offers an alternative discreet, user-controlled prevention option for women at high risk of HIV who are unable or prefer not to use other prevention methods.2. HPV vaccine and self-sampling for cervical cancer prevention and treatmentCervical cancer is the fourth most common cancer in women globally, but 90 percent of deaths from cervical cancer and more than 80 percent of cases occur in low- and middle-income countries (LMICs). This is mostly due to lack of access to human papillomavirus (HPV) vaccination (nine out of every ten cases of cervical cancer are caused by persistent HPV infection) and cervical screening and treatment services. Ensuring girls and women have access to HPV vaccines and testing can help to address the persistently high burden of preventable HPV cases and cervical cancer deaths.As of 2023, there are six vaccines for HPV available globally, which all protect against the highest-risk types of HPV that cause the most cervical cancers. While there have been many studies demonstrating the safety and efficacy of HPV vaccines, a new study published in January of 2024, which was the first to monitor a national cohort of women over a significantly long period of time (the study looks at women born between 1988 and 1996), found zero cases of cervical cancer—reinforcing HPV vaccines as a lifesaving tool that has and will continue to be a game changer for women’s health. Regular screenings for cervical cancer are globally recommended and are crucial because cervical cancer can be cured if diagnosed and treated early on. Yet 67 percent of women between 20 and 70 have never been screened for cervical cancer (by HPV or other tests). HPV self-sampling, an approach recommended by the World Health Organization (WHO) for women 30 to 60, has been shown to be about as reliable as sampling by health care providers. Additionally, it has also been shown to nearly double use of cervical cancer screening services because it offers privacy and convenience, requires little time and effort, and reduces any embarrassment, pain, or anxiety that may be associated with sampling done by health workers. 3. Next-generation contraceptivesAn estimated 257 million people globally who want to avoid pregnancy are not using safe, modern methods of contraception, leading to unintended pregnancies and then unsafe abortions, which cause up to 13 percent of all maternal deaths. Unacceptable or unsuitable contraception options are one of the leading causes of unintended pregnancy. An estimated 40 percent of women in LMICs who use a contraceptive stop within a year because of challenges, including side effects, the burden of sticking to a daily regimen, and the time and monetary cost of having to travel, sometimes far distances, to get new prescriptions. Introduction of the daily oral birth control pill helped contribute to a major increase in contraceptive use globally over the past 50 years, but contraception technology has not seen major innovations in generations, and the field is deeply underfunded, highlighting the need for new, less burdensome contraceptive options.Lyndra Therapeutics is developing a once-monthly contraceptive pill, currently in preclinical development, that could serve as one such alternative. Researchers are also developing longer-acting injectable contraceptive products, including a six-month injectable contraceptive being advanced by FHI 360. Microarray patches are another novel contraceptive option in early-stage development—they work by releasing hormones over several months and are discreet and easy to use at home. Contraception, and specifically access to a variety of contraceptive options that fit varying needs, allows women and girls to have autonomy over their bodies and lives. There remains a gap in further research into nonhormonal contraceptive options that cause fewer uncomfortable side effects or contraceptives for men that take the burden off of women.4. AI-enabled ultrasoundsAlmost 800 women died from preventable causes related to pregnancy and childbirth every day in 2020. While there are many contributing factors, one significant challenge is lack of access to diagnostic tools like ultrasounds. Fifty percent of women in LMICs received no ultrasound scans during the course of their pregnancy. Even where ultrasounds are available, they are usually bulky, expensive, and require specializing training or knowledge to operate, forcing patients to travel to specific health care facilities to access them. New technologies like Philip’s Lumify Handheld Ultrasound, which can be connected to a mobile device, offer a more compact, portable option in emergency situations or in low-resource settings when traditional ultrasounds are not available or are not feasible. The Bill & Melinda Gates Foundation is funding Philips to accelerate the adoption of artificial intelligence (AI) algorithms that can be used with the scanner to simplify the identification of key pregnancy abnormalities, with results already showing that the AI-enabled technology helped to improve informed decision-making in the care of pregnant women in rural, underserved communities. Nimble, compact technologies like this ensure that more women have access to basic, lifesaving technologies and that women, along with their health care providers, can make informed decisions about their health and pregnancy, reducing the likelihood of death from preventable causes.5. Postpartum bleeding solutionsPostpartum hemorrhage (PPH), or excessive bleeding after childbirth, is the world’s leading cause of maternal death and can lead to lasting disability and psychological trauma, despite being preventable and treatable. Adolescent pregnancies carry a higher risk of postpartum hemorrhage because adolescent uteruses are not fully developed enough to sustain a healthy pregnancy—pregnancy complications, as well as unsafe abortions, are the leading cause of death among 15- to 19-year-old girls globally.PATH and Sinapi developed a technology, called the Ellavi uterine balloon tamponade, which builds on a low-cost solution some health care providers had been using to combat PPH called a “condom catheter,” which uses items commonly found and self-assembled in a clinic to insert a condom into the uterus and then fill it with water to exert pressure on the uterine walls and stop the flow of blood. The Ellavi device was optimized to be a high-quality, simple-to-manufacture and -use, and affordable version of the “condom catheter” that could be deployed globally to save even more lives. Another simple, inexpensive solution to PPH comes in the form of a plastic sheet with a pouch to collect and measure the volume of blood loss. This tool helps health care providers better recognize when women are in danger and take action. In one large-scale study in Africa, this sheet, when used in combination with other WHO-recommended treatment options for PPH, reduced the number of women experiencing severe bleeding by 60 percent and also reduced the number of deaths from PPH.These innovative but simple and low-cost technologies are not moneymakers, but they can greatly reduce preventable maternal deaths, particularly among adolescents, illustrating a paradox in women’s health—the gap persists because many technologies that could have a tremendous impact, particularly in LMICs, do not necessarily yield the greatest profit.While these five solutions highlighted have the potential to save lives and empower women, it is clear that closing the cavernous gender gap in health will require many more new tools and improved access to existing ones. Greater investment in R&D for conditions that specifically affect women and girls and expanded roles for women and girls to engage and lead across the R&D sector can help ensure more breakthroughs are realized in our lifetimes and that resulting tools are designed with the diverse needs of women and girls in mind.

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. Scientists have discovered that a naturally occurring strain of bacteria could help reduce the transmission of malaria by stopping the development of parasites in a mosquito’s gut. The bacteria, TC1, was found by chance when GSK scientists noticed that one of their mosquito colonies had stopped becoming infected with malaria parasites and later identified TC1 as the cause. Researchers have since observed that the bacteria works by secreting a small molecule, called harmane, which inhibits the parasite’s growth and that can be ingested by mosquitoes if mixed with sugar or absorbed by contact, opening the possibility for it to be used as an abatement tool. A recent study found that the bacteria can reduce a mosquito’s parasitic load by up to 73 percent, and trials in Burkina Faso are ongoing to assess the intervention’s effectiveness and safety in real-world settings.An international team of researchers has identified a genetic variant among some people of African ancestry that is associated with them having naturally lower viral loads of HIV—thereby slowing their illness progression and lowering the risk of them transmitting the virus. According to the researchers, this is the first new genetic variant related to HIV infection discovered within the last nearly 30 years. Between 4 to 13 percent of people of African origin are thought to carry this variant, which was discovered through an analysis of the DNA of almost 4,000 people of African ancestry infected with HIV-1. The scientists now intend to continue studies to more fully understand how exactly this variant impacts HIV replication.Health experts are warning that dengue poses a danger to pregnant women, as new research has found that the disease can cause serious health complications for both mothers and their unborn babies. A recent study from the University of Surrey found that mild infection can make a pregnant individual 77 percent more likely to give birth before 32 weeks and can more than double the risk of the child being born with extremely low birth weight, which can affect brain development. This work builds on prior research that found pregnant women are three to four times more likely to die after becoming infected and 450 times more likely if their infection progresses into dengue hemorrhagic fever. There are currently no specific treatments for dengue, and existing vaccines are not recommended for pregnant women.