Marissa Chmiola

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 coughMore 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.

Malaria is one of the world’s oldest and deadliest diseases. Thanks to international efforts to develop and scale up prevention tools and treatments, significant gains have been made over the past few decades in fighting this dangerous disease. But challenges, such as growing drug and insecticide resistance, climate change, and disruptions from COVID-19, have hampered control efforts. While both malaria cases and deaths steadily declined from 2000 to 2019, since then, cases have been on the rise and reported deaths have not returned to pre-pandemic levels—indicating progress against the disease has stalled and underscoring the need for continued research and development of new tools.In recognition of World Malaria Day, test your knowledge of this deadly disease and the innovations being advanced to end malaria:

To celebrate Valentine’s Day, GHTC staff embraced our health policy wonkiness by participating in the time-honored beltway tradition: #HealthPolicyValentines. For those who are unfamiliar, this tradition started in 2012 when a former staffer and Twitter aficionado at the US Department of Health and Human Services, Emma Sandoe, became inspired to “tweet one ‘health policy valentine’ every day until Valentine’s Day.” Other health policy experts soon joined in with their own poems and puns related to health care, and an annual tradition was born. Now every February, health policy wonks tweet out their most creative #HealthPolicyValentines. This year, GHTC staff joined in on the fun to share our passion for global health research and development (R&D). Here are our favorites:  Roses are red 🌹 Congress is divided ➗ But if it could deliver strong health R&D funding 💪💰 I’d be delighted 👍#HealthPolicyValentines— Marissa Chmiola (@MarissaChmiola) February 12, 2024 Roses are red Noma’s a place in DC But it was also recognized by @WHO As the latest NTD#HealthPolicyValentines #BeatNTDs— Marissa Chmiola (@MarissaChmiola) February 12, 2024 Roses are red 🌹 CRs are now “laddered” 🪜 Giving more headaches to health wonks 😣Whose brains already feel scattered 🤯#HealthPolicyValentines— Marissa Chmiola (@MarissaChmiola) February 12, 2024 Mosquitoes are spreading Into regions anew #Malaria is not only a threat in Africa It’s hit Maryland too.#HealthPolicyValentines — Philip Kenol (@Phil_kenol88) February 13, 2024 Penicillin was Sir Fleming’s great findThe field of medicine redefinedSo Fleming won a Nobel and changed historyBut the threat of #AMR is now no mysteryWe need new drugs, tests, & vaccines designedA historic poem from our colleague Anum Adrees! #HealthPolicyValentines 🧫💌— GHTC (@GHTCoalition) February 13, 2024 @USAID’s health R&D has saved millionsThat is a fact!But to supercharge it’s workCongress must pass the SIGHT Act#HealthPolicyValentines— Alex Long (@W_AlexLong) February 14, 2024 Roses are redValentine’s Day is blahI don’t get why CongressCan’t just authorize #PAHPA#HealthPolicyValentines— Alex Long (@W_AlexLong) February 14, 2024 From GHTC staff Anum: Valentine’s is in FebruaryMarch is the month afterRemember March 2020?Yeah, that was a disasterOf pandemic threats we should be warySay the disease forecastersSo let’s get pandemic-readyAnd develop those vaccines faster!#HealthPolicyValentines 💝— GHTC (@GHTCoalition) February 14, 2024 The times we live in are rather scaryBut today, we feel quite contraryWe love these #HealthPolicyValentinesThey give us hope that through our work, we can save lives!One last poem from our colleague Hannah! 💌💝— GHTC (@GHTCoalition) February 14, 2024

The health ministers of G20 nations concluded their annual meeting last weekend with the adoption of an “outcome document” that includes welcome commitments to advance the research and development (R&D) of health products. While normally such a ministerial-level meeting would end with the release of a formal consensus communique, broader geopolitics derailed this process, with Russia and China opposing the inclusion of language condemning the Russian war of aggression against Ukraine. Below we break down what R&D commitments are included in the outcome document, why it matters, and where conversations are expected to go from here. What’s in the declaration? At the highest level, G20 nations made commitments to strengthen the global health architecture and “build more resilient, equitable, sustainable and inclusive health systems equipped to address ongoing global health challenges and future public health emergencies with equitable access to safe, effective, quality-assured and affordable vaccines, therapeutics, diagnostics, and other medical countermeasures.” They also reaffirmed their commitment to ending the epidemics of AIDS, tuberculosis, and malaria; achieving polio eradication; advancing universal health coverage (UHC) and the Sustainable Development Goals (SDGs); and tackling antimicrobial resistance (AMR). On the latter issue of AMR, the ministers vowed to strengthen R&D for AMR and further the development of novel antimicrobials. They welcomed the work of various international initiatives and GHTC members including the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Global Antibiotic Research and Development Partnership (GARDP) and voiced continued support for the Global AMR R&D Hub, which was established under the German G20 presidency to promote AMR R&D coordination. On the broader issue of R&D for pandemic prevention, preparedness, and response (PPPR), G20 leaders agreed to support a World Health Organization (WHO)-led consultative process to develop an interim (and potentially later permanent) medical countermeasures (MCMs) mechanism to coordinate the end-to-end R&D, manufacturing, procurement, and equitable delivery of MCMs during health emergencies. They advised that such a mechanism should consider a “network of networks” approach, building off existing international and regional partnerships, and should be coherent with the outcomes of ongoing efforts to amend the International Health Regulations (IHR) and advance a binding pandemic instrument. Additionally, the ministers underscored the need to strengthen local and regional R&D networks and manufacturing capabilities, especially in low- and middle-income countries, as well as voiced support for what many call the “100 Days Mission” to develop and make available safe and effective vaccines, therapeutics, and diagnostics within 100 days of the identification of a pandemic or epidemic threat. They also noted the importance of public-private R&D partnerships—calling out the contributions of GHTC members the Coalition for Epidemic Preparedness Innovations (CEPI), Medicines Patent Pool (MPP), and FIND—and technology transfer and knowledge sharing “on voluntary and mutually agreed terms.”Why it matters?  G20 nations currently conduct and fund the majority of the world’s health R&D. Thus, it is great to see G20 leaders reaffirm the importance of R&D to achieving UHC, SDGs, and PPPR and demonstrate political will to accelerate R&D efforts. However, the outcome document is short on specifics as to how G20 countries intend to operationalize their many promises, and it disappointingly includes no new funding targets or commitments.  Additionally, going into this year’s G20 cycle, many observers and health advocates also expected that the G20 under the Indian presidency would play a more active role in envisioning and detailing a specific proposal for the creation of an end-to-end MCMs mechanism or platform to succeed and build upon the Access to COVID-19 Tools Accelerator. Instead, the G20 simply promised to support a WHO-led consultative process to design an interim mechanism and punted it to the International Negotiating Body (INB) process for a pandemic instrument to determine the prospects for a permanent MCMs platform. What’s next? With G20 nations offering few specifics on a vision to reimagine the global health architecture and advance an MCMs platform, the focal point for change is now squarely within the separate but interrelated processes now underway to amend the IHR, advance a pandemic accord that will create a more comprehensive framework for how countries will prevent and respond to outbreaks, and design an interim MCMs platform. While these processes have been ongoing, the deliberations have been stymied as countries struggle to reach consensus around thorny R&D topics like access and benefit sharing, with some pushing for more aggressive legally binding commitments for transparency, conditions on public R&D funding, patent waivers, and new supply chain mechanisms for ensuring low- and middle-income countries access to medical countermeasures. Questions remain on the full scope of some of the processes, and how they will delineate which issues will be tackled where and with the target date of May 2024 for the adoption of an instrument rapidly approaching and the INB and IHR processes largely behind schedule, it remains to be seen what tangible changes for R&D can be realized. While it is impossible to know what exactly what the future of these negotiations hold, GHTC promises to continue to watch, weigh in, and report back in the months ahead as these interrelated processes unfold. Stay tuned! 

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.