Breakthroughs Blog: Child health

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. 

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 research team has discovered an all-new class of antibiotics that could, if it proves successful down the line, improve our ability to address some of the most drug-resistant bacteria in the world, as antimicrobial resistance continues to rise globally. The new molecule, lariocidin, attacks bacteria distinctly from other antibiotics by inhibiting bacteria’s ability to grow and survive. Lariocidin is also not toxic to human cells, not susceptible to existing mechanisms or antibiotic resistance, and it works well in an animal model of infection, underscoring its potential to be a gamechanger in the global fight against antimicrobial resistance, although years of further research are still needed.Scientists from the Institut Pasteur, in collaboration with Kumamoto University, have assessed a new rapid diagnostic test to identify pregnant women at elevated risk of transmitting Hepatitis B to their babies, which could help eliminate mother-to-child transmission of Hepatitis B during childbirth, especially in low- and middle-income countries. Hepatitis B is a leading cause of death globally and particularly affects resource-limited countries. While vaccination is available, available antiviral therapies do not provide a cure and existing tests can be costly and require specialized equipment that is often unavailable in these settings. The new test is highly effective, inexpensive to produce, easy to use, does not require electricity, can be used in higher temperatures, and provides results in 45 minutes, making it ideal for integration into routine antenatal care in decentralized, resource-limited settings.A recently published paper identified a novel method for delivering drugs in higher doses with less pain that could offer a better way to deliver long-lasting contraception or other drugs that need to be given over extended periods. The project, which began as part of a Gates Foundation-funded effort to expand contraceptive options, particularly in low-resource settings, created a new method of injecting drugs formulated into tiny crystals that can last for months or even years in the body. There are similar drug delivery methods that are already in use, but the new method can last longer and can also be injected through a smaller needle that is easier for patients to tolerate.

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. An experimental hormone-free birth control pill for men appears to be safe and well-tolerated in an early-stage, in-human study and successfully prevented sperm production in mammal studies. The drug, YCT-529, is being developed by YourChoice Therapeutics and Quotient Sciences and works by interfering with the vitamin A signaling necessary for sperm production. There are no male birth control pills available, but, in the future, an option like YCT-529 could help prevent unwanted pregnancies and reduce the burden traditionally placed on women for contraception.Last week, an international team of researchers reported that their Phase 3 clinical trial found that a vaccine that protects against five strains of meningitis is safe and effective, a finding that supports is use in routine childhood immunization programs in high-burden countries. The trial was conducted in babies and toddlers in Mali, one of the countries in the sub-Saharan African meningitis belt, so-called because of its high incidence rates and regular large-scale epidemics of meningitis. Previous trials demonstrated positive results for the vaccine in children over 12 months and adults. The vaccine could be a game-changer for meningitis control, and its affordability would also enable broad scale-up.Gilead recently published early data suggesting that a new formulation of its drug, lenacapavir, could be used to prevent HIV infection with just one shot per year. These exciting results follow data published last year that the drug could provide virtually complete protection with a twice-a-year shot. Reducing the dosage even further will only improve adherence by reducing the cost and burden on those taking the drug and their health care providers. The two-dose formulation of the drug is already under regulatory review, but Gilead is planning a Phase 3 trial of the once-yearly version to begin later this year.

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 research team at the Children's Hospital of Philadelphia has discovered a key process that could provide new insight into designing more effective antimalarial drugs, as rising antimicrobial resistance complicates the ongoing global fight against malaria by rendering current drugs less effective. One promising strategy to combat poor absorption or retention of drugs in the body is the use of prodrugs that can offer a more targeted attack. However, these prodrugs need to be activated, typically by an enzyme. By identifying the primary enzyme that activates multiple antimalarial drugs, these new findings could enable the development of prodrugs for malaria, which, by design, would also be less likely to lead to the emergence of drug resistance.New research shows that wastewater sampling, including in sewer systems and on airplanes, could predict new viral and bacterial outbreaks and the emergence of new variants of pathogens weeks or even months before they become widespread, in addition to being less invasive, more efficient, and faster than current methods. A new study from the US Centers for Disease Control and Prevention demonstrates how it was able to use wastewater sampling to detect the presence of avian flu in 2022 weeks before the virus was detected in poultry and then wild bird populations. Widespread and regular wastewater sampling would enable public health authorities to better surveil population and community health and, on a more micro level, help health care providers provide more accurate diagnoses and care for patients.  Last week, the Pediatric Praziquantel Consortium announced the first administration of its new pediatric schistosomiasis treatment to a preschool-aged child in Uganda, marking a critical step toward closing the long-standing treatment gap for young children for this parasitic disease, which affects millions of children in sub-Saharan Africa. The innovative therapy, designed specifically for children between three months and six years, is also child-friendly, palatable, and heat-stable, making it especially well-suited for this population and region. The rollout is part of a program aimed at integrating the treatment into health care systems and preparing for its broader rollout across the region, starting with Côte d’Ivoire, Kenya, Tanzania, and Senegal.