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 recently published study found that a malaria vaccine candidate given to women who planned on becoming pregnant was safe and effective for both the women and their babies. This exciting research could lead to a vaccine to protect pregnant individuals— who are often excluded from clinical trials—and their babies from malaria in the face of an estimated 50,000 maternal deaths and 200,000 stillbirths every year caused by malaria infections in pregnancy. The investigational attenuated vaccine, PfSPZ, will next be tested for use during pregnancy and in a larger study on preconception use. Just as the World Health Organization and the Africa Centres for Disease Control and Prevention declared the current mpox outbreak a public health emergency last week, SIGA Technologies and the National Institute of Allergy and Infectious Diseases at the US National Institutes of Health reported mixed results from a preliminary analysis of a study testing the smallpox antiviral treatment Tpoxx against mpox. While the study, which took place in the Democratic Republic of Congo and began during the 2022 global outbreak, did not meet the trial’s primary endpoint of reducing the time to lesion resolution within a 28-day treatment period, the company says these results are not entirely unexpected and is highly encouraged that Tpoxx did elicit a “meaningful improvement” in some participants with severe cases, supporting a potential use case as post-exposure treatment for patients with severe mpox. The company also pointed to four other ongoing studies that significantly differ from the Congo trial and will provide additional data on the treatment.The NxTAG Respiratory Pathogen Panel, which detects and differentiates between common respiratory viruses, recently received 510(k) clearance from the US Food and Drug Administration. The combination test, which was developed with support from the Biomedical Advanced Research and Development Authority (BARDA) can, from a single swab, detect and differentiate 19 common respiratory viruses, including the virus that causes COVID-19, influenza A and B, and RSV, allowing health care workers to test patients and provide appropriate treatment rapidly. BARDA’s support is part of a broader effort to advance diagnostic testing platforms that can be rapidly adapted to emerging threats.

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. The results of a new study presented at the 2024 International AIDS Conference showed that long-acting injectable cabotegravir was safe and well tolerated as an HIV pre-exposure prophylaxis method in cisgender women before and during pregnancy. These exciting results come from an extension study of the efficacy trials among cisgender women that analyzed the outcomes of more than 300 pregnancies and infants. There has been limited data on the safety of long-acting injectable cabotegravir during pregnancy, so hopefully, these findings can fill that knowledge gap and lead to greater access to this highly effective HIV prevention option for this population, who may experience biological changes and social dynamics that can increase their likelihood of acquiring HIV during and after pregnancy.Last week, the Administration for Strategic Preparedness and Response at the US Department of Health and Human Services announced $25 million in funding to Walgreens to support a decentralized clinical trial testing COVID-19 vaccines. The study specifically aims to identify vaccine correlates of protection, or measurable immunity markers that correlate with protection against disease, using licensed or authorized COVID-19 vaccines to help assess immunity duration and streamline future clinical trials. This decentralized approach, which will include about 20 Walgreens pharmacies in urban, suburban, and rural communities, allows for a more diverse pool of study participants by bringing the study closer to where participants live. The funding comes through Project NextGen, a US government-led program to accelerate the development of next-generation COVID-19 technologies, including vaccines.  New data shows that Merck & Co.’s monoclonal antibody is safe and effective at reducing the incidence of respiratory syncytial virus (RSV)-related infections in infants. The Phase 2b/3 trial tested clesrovimab, also known as MK-1654, in healthy pre-term and full-term infants, finding that the antibody reduced the incidence of RSV-related infections over 150 days when compared to a placebo and hit key safety measures. The company announced that detailed findings will soon be presented to the scientific community and filed with global regulators. Hopefully, the antibody will eventually serve as an additional tool in the growing toolkit of new vaccines and monoclonal antibodies to address the burden of RSV in infants and older adults.

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.