Breakthroughs Blog

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.

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 team of Brazilian researchers has developed a simple test that can detect exposure to any of the four strains of dengue virus, as well as the Zika virus, as dengue cases continue to rise to a concerning degree in the region. The test was first validated with blood samples from mice experimentally infected with the viruses and then with hundreds of blood samples donated by people during the 2015-2017 Brazilian Zika epidemic. It uses technology that can be easily adapted for use in automated systems and rapid point-of-care tests and could serve as a key tool in the case of a Zika outbreak, allowing health care providers to test the immunity of at-risk groups while accounting for the possibility of cross-reactivity with antibodies produced after infection by dengue.Last week, IAVI and Biofabri announced that the first doses of tuberculosis (TB) vaccine candidate MTBVAC have been administered in a critical large-scale Phase 2b trial testing the safety and efficacy of MTBVAC to prevent active TB lung disease in adolescents and adults. While there is a vaccine for TB, it is more than 100 years old and has limited efficacy in preventing pulmonary TB, the most common form in adults. A new vaccine could be a game changer in the global fight against this leading infectious disease. MTBVAC is also a single-shot vaccine, making it easier to administer in low-resource and remote settings, and the partners developing it are committed to ensuring that, if proven successful in further trials, there will be a sufficient, affordable supply in the places where it is most needed.The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) last week announced a $2 million award to Immunethep to develop a vaccine against invasive strains of Escherichia coli. The funding will support work on a conjugate peptide-based vaccine candidate designed to induce immunity to E coli, which can cause serious, life-threatening infections that are becoming harder to treat with the rising prevalence of antimicrobial resistance. There are currently no vaccines for E coli. The candidate has demonstrated efficacy against E coli, as well as four other priority bacterial pathogens in animal models, and, if it continues to prove successful, could be a key tool for preventing serious bacterial infections in vulnerable populations.

The World Health Organization (WHO) has faced tumultuous times over the past few years, and this year’s Executive Board (EB) meeting seemed to bring a chaotic new chapter. Major tectonic political shifts worldwide have plunged the global health organization into serious talks about its long-term funding, sustainability, scope, and ability to deliver on its core mandate.   The EB was anything but business as usual, though member states did their level best to address the political tensions du jour while trying to move through a regular agenda that spanned issues from noncommunicable diseases and maternal and child health to global health security and climate and health. Here are some reflections from a hectic week in Geneva: “We do expect things to change...”  - Assistant Director-General for Business Operations Raul Thomas1. Member states agree to reduce the WHO budget and mostly commit to a 20 percent increase in assessed contributions.In his opening remarks before the WHO EB, Director-General Dr. Tedros Adhanom Ghebreyesus noted that even before the United States and Argentina’s withdrawal announcements, WHO was planning to shrink spending because of a shortfall caused by economic difficulties in many donor countries.  WHO’s budgetary shortfalls overshadowed the first several sessions of the EB, with many member states expressing concern over the sustainability of WHO’s financing in the next biennial budget. Ultimately, a decision was made to lower the program budget to $4.9 billion (from $5.3 billion). Assistant Director-General for Business Operations Raul Thomas captured the general sentiment of EB funding conversations, conveying that WHO’s cash flow is secure for now, but WHO leadership “expects things to change” regarding the viability of the organization’s budget.   However, member states harped over what should change. Many supported a 20 percent increase in assessed contributions—something that members had agreed to at the World Health Assembly (WHA) two years ago—that would reduce the organization’s reliance on voluntary contributions from member states, while others, specifically Russia and China, showed opposition to this plan.   Several member states emphasized the importance of continuing down a path toward sustainable financing through the WHO investment round and developing alternative short- and long-term resource mobilization plans. Member states also urged WHO to distribute information about what the 20 percent increase in assessed contributions would mean for each country. Given the reduced budget, countries insisted on costing all 2025 draft resolutions and decisions prior to any vote during this year’s session.   “It’s back to basics...” - WHO Regional Director for Europe Dr. Hans Kluge2. WHO leadership and member states stress progress and continued need for reform.In the wake of the larger discussions held during the EB about prioritization due to the cash crunch the WHO is facing, there was also a strong focus on the continued need to streamline and reform the organization. WHO Regional Director for Europe Dr. Hans Kluge called for the organization to go “back to basics.” Dr. Kluge emphasized the importance of remaining steadfast to WHO’s organizational mission while being adaptive to emerging threats like antimicrobial resistance (AMR).  Director-General Dr. Tedros also referenced WHO reforms in his opening remarks, acknowledging the significant improvements the organization has made over the last five years, including the newly introduced prequalification framework for novel products. At the same time, Dr. Tedros emphasized the need for continued reform and underscored the importance of engaging in constructive dialogue with member states moving forward.  During the final two days of the EB, member states agreed to several internal improvements and left the door open for further reform discussions at WHA. Citing concerns over its unclear mandate and overlap with other divisions, member states decided to extend by one year the operations of the Standing Committee on Health Emergency Prevention, Preparedness, and Response—which was first established in 2022 to provide guidance and recommendations to the EB and the Director-General on WHO’s emergency response—through May of next year to further evaluate the role of the committee and other similar bodies in health emergencies.  3. Global health security, maternal and child health, and the nexus of climate and health remain key topics.Member states did manage to untangle themselves from WHO’s structural dialogues to fully engage with the more than 47 agenda items on the docket this year.  WHO’s work in health emergencies featured prominently on the agenda once more, though much of the discussion centered around the need to adjust the scope of WHO’s activities. A few member states, including the European Union, Australia, Ethiopia, Finland, and the Republic of Korea, reaffirmed their commitment to the Pandemic Accord, including the then-upcoming negotiations that took place last week, as critical to advancing the prevention, preparedness, and response agenda, including access to medical countermeasures.Dozens of member states shared their appreciation of WHO’s report and draft action plan on women’s, children’s, and adolescents’ health and emphasized their commitment to advancing this agenda item, though Dr. Tedros highlighted that despite progress, “we still have a long way to go.” Equity and access were primary topics of concern for many countries. Several countries also advocated for greater urgency in accelerating efforts for maternal and child health and stressed the importance of intersectoral policies for vulnerable populations. Mentions of research and development were notably absent from the discussion, despite its critical role in addressing gaps in maternal, newborn, and child health, particularly in low-resource settings.  Countries also deliberated the draft global action plan on climate change and health. The plan, which includes some strong R&D provisions, outlines strategic frameworks for building climate-resilient health systems. However, it was surprising to note the absence of the threat of AMR, which is mentioned only once in the document. AMR is poised to cause 10 million annual deaths by 2050 and likely more with the growing influence of rising temperatures and evolving zoonotic diseases. Concerns over cost also dominated the discussion on this agenda item, and several member states, including Malaysia, Bangladesh, and representatives from the Africa Group, highlighted the need to include common but differentiated responsibilities—a longstanding equity principle in climate negotiations that holds historical emitters to a higher bar of responsibility for climate action.4. Civil society engagement continues to be a challenge at the EB.At the tail end of the EB, member states zeroed in on the role of civil society in these debates. While there seemed to be general agreement on the overall usefulness of non-state actor (NSA) statements in WHO proceedings, we did see the continued trend of politicizing otherwise straightforward processes governing NSA access and status with WHO. Member states held a fervent debate over WHO’s Framework on Engagement with non-State Actors (FENSA), which outlines clear criteria and principles for attaining status with the WHO. During the debate, some member states questioned the framework, with representatives from the Eastern Mediterranean and African Regions, as well as China and Russia, all expressing concern over the Centre for Reproductive Rights and Women Deliver receiving status from WHO. The delegate from Egypt captured this sentiment best: “Our reading of FENSA is that it is the foundation and main criteria that we use to accept or reject NSAs — it’s the foundation, but it is not obligatory for member states to accept only on this criteria.”  While on the surface, this debate may appear like an outlier, it marks a broader shift in how some member states are approaching the global health agency, as it has become more commonplace in the last few years to overturn or question established frameworks, rules, and processes at WHO based on national politics. This is especially concerning for civil society, which has seen its ability to meaningfully engage in these forums curtailed over the years.Dr. Tedros concluded the EB by acknowledging the endurance of countries in getting through such a substantial agenda this year and the significance of WHA later this May. While we often talk about the importance of these forums for combatting specific health threats, this year feels like a bigger moment and pivot point for the global health architecture as a whole. Will WHO be able to shoulder the financial blow, make the necessary reforms, and find a way to become more sustainable in its operations? Or will the global health community look back at this moment as the start of the unraveling of the global health ecosystem? Only time will tell.

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 prospective cohort study of patients with drug-resistant tuberculosis (TB) found that the six-month, all-oral BPaL (bedaquiline, pretomanid, and linezolid)-based regimens recommended by the World Health Organization were safe and highly effective, providing critical data from real-world settings with a high burden of drug-resistant TB to support global guidelines recommending their use. The results were comparable to previous Phase 3 clinical trials testing the regimens. Further research is needed to test the regimens among other key populations, including children and people with severe forms of extrapulmonary TB.A recently published analysis found that the 2023 global supply of seasonal influenza vaccines has been stable since 2019, suggesting that production capacity was sustained through the COVID-19 pandemic. Monitoring seasonal vaccine production capacity is important for estimating the capacity to manufacture vaccines in the case of an outbreak of pandemic influenza because pandemic influenza vaccines are produced primarily by the same or similar manufacturers, technology, and facilities as seasonal flu vaccines. The analysis found drastic disparities in production capacity between high-income and low- and middle-income countries and found that the majority of pandemic vaccines, in the case of a novel flu pandemic in the near future, would be egg-based. The author noted that advancing novel influenza vaccines, including mRNA vaccines, could greatly improve global production capacity and pandemic preparedness in the face of pandemic influenza, given they would be faster to produce than egg-based vaccines.A team of researchers has engineered an improved paper-based device for collecting and transporting blood samples of HIV patients. In low-resource settings with limited clinical and laboratory facilities, paper-based devices have become one way that HIV patients can collect their blood to be shipped and analyzed in distant laboratories. The new device has wax-printed patterns that create precise channels and collection spots, ensuring that it consistently collects the same volume of blood and thereby reducing the chances of inaccurate readings. A clinical pilot found that the device more accurately measured the extent of HIV infection compared to the industry gold standard and was also better at detecting drug-resistant viral mutations, enabling physicians to make better care decisions.