The review was led by a collaboration between the University of Edinburgh and the University of Granada in Spain, with contributions from Public Health Scotland, the Pan-American Health Organization, and colleagues at six other UK-based universities. The research team pooled data from 16 studies covering more than four million pregnancies between 2023 and 2025, making it one of the most comprehensive assessments to date of how maternal RSV vaccination programmes are performing outside the controlled conditions of clinical trials. By synthesising evidence from these early national rollouts, the authors sought to estimate not only how many pregnant women are receiving the vaccine, but also how well it is working and how safe it is in routine practice.

The technical case for maternal RSV vaccination rests on a straightforward biological principle. When a pregnant woman is vaccinated, her immune system generates antibodies against the virus, and these antibodies cross the placenta to reach the developing fetus. This process, known as passive immunisation, means that babies are born already carrying protective antibodies against RSV, shielding them from the moment of birth through the most vulnerable months of infancy, when their own immune systems are still immature and their airways are small enough to be dangerously compromised by infection. The new review confirms that this approach translates effectively from trials into the real world, with the vaccine reducing the risk of RSV-related hospitalisation in babies under six months by approximately 74 per cent.

Dr Ting Shi, of the University of Edinburgh’s Usher Institute, said the real-world performance matched expectations from the original clinical trials. “We found the vaccine reduced the risk of RSV-related hospitalisation in babies under six months by around 74 per cent, which lines up well with what the clinical trials predicted, and we found no evidence of an increased risk of preterm birth,” he said. “But uptake during the first vaccination seasons was low. Timing matters too. The vaccine works best when it’s given at least two weeks before birth, so making sure women can access it early in their eligibility window is key.”

The safety findings carry particular weight for a vaccine administered during pregnancy, a context in which even rumours of harm can rapidly undermine confidence. Drawing on data from more than 16,000 pregnancies, the review found no evidence of an increased risk of preterm birth among women vaccinated between 32 and 35 weeks of gestation, the window in which the vaccine is typically offered. This population-level evidence, gathered across multiple health systems and countries, provides reassurance that complements the trial data and offers policymakers a firmer foundation on which to build and defend national immunisation programmes.

The uptake figures, however, tell a more troubling story. Since the maternal RSV vaccine was introduced in the United Kingdom in September 2024, Scotland recorded its highest coverage in October 2025, when 62 per cent of pregnant women had been vaccinated, while England reached a peak of 58 per cent in August 2025. The United States, by contrast, recorded some of the lowest overall uptake, with an estimated 27 per cent of pregnant women vaccinated during the first year the maternal RSV vaccine was available there, where it is delivered alongside other preventive interventions. The researchers note that these figures fall below those achieved by other maternal vaccines, such as the whooping cough vaccine, over the same period, suggesting that RSV immunisation has yet to become embedded in routine antenatal care in the way that longer-established maternal vaccines have.

Beneath the headline national averages, the review uncovered persistent and concerning disparities. Evidence indicates lower uptake of the RSV vaccine among some socioeconomic and ethnic groups, among women with reduced access to healthcare, and among younger mothers. These patterns echo long-standing inequities in maternal immunisation more broadly, in which the families who face the highest burdens of infectious disease are often the least likely to receive preventive care. Dr Kimberly Marsh, Viral Respiratory Pathogens lead at Public Health Scotland, said the review demonstrates that protection is not being distributed equally. “This review shows that maternal RSV vaccination is protecting babies from severe illness but uptake is not equal across all communities,” she said. “Monitoring vaccine coverage and addressing barriers faced by some ethnic groups and more deprived communities will be important to ensure that all families can benefit from protection the RSV vaccine offers to babies.”

The implications of these disparities extend beyond individual health outcomes. RSV places a substantial seasonal burden on paediatric intensive care units every winter, and the effectiveness of a vaccination programme in reducing that burden depends on achieving sufficiently high and evenly distributed coverage. If uptake remains concentrated among more affluent, better-served populations, the public health dividend of the vaccine will be blunted, and the communities already experiencing the worst outcomes from RSV infection will continue to bear a disproportionate share of the disease. The review’s authors argue that targeted outreach, improved supply chain systems, and robust immunisation policies are needed as RSV vaccination programmes are rolled out globally, so that the benefits of the intervention reach the full population of newborns rather than a privileged subset.

Dr Evelyn Balsells of the University of Granada emphasised that the scientific evidence is now firmly established and that the remaining challenge is one of implementation and equity. “Research shows that RSV vaccination during pregnancy protects babies,” she said. “Efforts to increase uptake and reduce disparities will be essential to maximise the benefits of maternal RSV vaccination.” Her point underscores a familiar trajectory in vaccinology: the development of a safe and effective product is only the first step, and the harder work of building delivery systems, public trust, and equitable access often determines whether a vaccine fulfils its potential at the population level.

As additional countries introduce RSV prevention programmes in the coming seasons, the authors argue that continued analysis of emerging real-world evidence will be essential. Systematic monitoring of vaccine coverage, effectiveness, and safety allows health authorities to track the impact of immunisation, support policymakers and healthcare workers in their decision-making, and inform pregnant individuals about the choices available to them. The first two years of maternal RSV vaccination have demonstrated that the science works: the vaccine is effective, the safety signal is reassuring, and the protection it confers on newborns is substantial. The task now facing health systems around the world is to close the gap between what the vaccine can achieve and what it is actually delivering, ensuring that every baby who could benefit from protection against one of childhood’s most common and dangerous viruses has the chance to receive it.

Subject of Research: Real-world uptake, effectiveness and safety of maternal RSV vaccination worldwide

Article Title: Global study finds stark differences in RSV vaccine uptake

Article References: Global study finds stark differences in RSV vaccine uptake. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: RSV, maternal vaccination, vaccine uptake, systematic review, infant health, public health, vaccine safety, health equity, University of Edinburgh, The Lancet Regional Health – Europe, respiratory syncytial virus, pregnancy

The most striking technical finding concerns respiratory syncytial virus, or RSV, a ubiquitous pathogen that is the leading cause of bronchiolitis, a chest infection that can progress to severe breathing difficulties and hospital admission in infants. A systematic review and meta-analysis included in the Series pooled data from 16,394 pregnancies and found that maternal RSV vaccination was associated with an approximately 74 percent lower risk of hospitalisation for RSV-related lower respiratory tract infection in babies younger than six months. This figure is remarkable because it reflects real-world effectiveness rather than the idealised conditions of a clinical trial, confirming that antibodies generated in a vaccinated mother do indeed cross the placenta in sufficient quantity and with sufficient potency to protect her newborn during the period when the infant immune system is too immature to mount its own robust defence against the virus.

Safety data from the same pooled analysis provided additional reassurance. The researchers did not identify a statistically significant association between maternal RSV vaccination and preterm birth, one of the principal concerns that has historically complicated the evaluation of any intervention administered during pregnancy. The authors are careful, however, to note that continued safety monitoring remains essential as vaccination programmes expand across larger and more diverse populations. They also emphasise a crucial operational detail: vaccination must be delivered within the recommended gestational window, allowing enough time before birth for the maternal immune response to mature and for protective immunoglobulin G antibodies to be transferred actively across the placenta to the fetus. Timing, in other words, is not a bureaucratic nicety but a biological requirement for the intervention to work as designed.

Yet the Series makes clear that biological efficacy means little if the vaccine never reaches the arm that needs it. Evidence reviewed by the authors reveals substantial and persistent inequalities in access across Europe. One UK study included in the review found that women living in the most deprived areas had 72 percent lower odds of receiving maternal RSV vaccination than women living in the least deprived areas. This is not a marginal disparity but a near-total gradient running along socioeconomic lines, and it mirrors patterns previously documented for influenza and pertussis vaccination in pregnancy. The result is a paradox in which the babies at highest risk of severe outcomes from RSV, often those born into communities with poorer housing, higher exposure to smoke and reduced access to paediatric care, are precisely the ones least likely to benefit from a vaccine that could keep them out of hospital.

Professor Asma Khalil, Professor of Obstetrics and Maternal Fetal Medicine at City St George’s and Chair of the Series, framed the problem in terms of systems rather than science. Maternal vaccination, she noted, is one of the most powerful public health interventions available, protecting both pregnant women and their babies from serious infectious diseases, but introducing a vaccine is only the first step. Women need timely access, trusted information and convenient services if these programmes are to achieve their full benefit. Her assessment that countries should begin preparing now for the next generation of maternal vaccines, rather than waiting until new programmes are introduced, forms the central argument of the Series and reflects a recurring lesson from public health history: retrofitting equity into a rollout is far harder than building it in from the start.

The urgency of that preparation is underscored by the vaccine pipeline now advancing through clinical development. A paper in press for the Series, led by Professor Paul Heath, Professor of Paediatric Infectious Diseases at City St George’s, examines the next generation of maternal vaccines, among the most advanced of which target group B streptococcus, a bacterium that is a leading cause of neonatal sepsis and meningitis worldwide. A maternal GBS vaccine, administered during pregnancy, could prevent infections that currently strike within hours or days of birth, when diagnosis is difficult and deterioration can be rapid. Heath described the moment as a new era for maternal immunisation, noting that while the value of protecting mothers and babies through vaccination during pregnancy has been understood for decades, a pipeline of new vaccines could now prevent serious infections in the earliest months of life. The challenge, he argued, is ensuring health systems are ready to deliver these vaccines effectively, monitor their impact and make sure all families can benefit regardless of where they live or their circumstances.

What does readiness look like in practice? A separate paper in press for the Series mapped maternal vaccination policies across all 53 countries of the WHO European Region and reviewed 163 studies and policy sources. The analysis identified common factors associated with higher uptake: vaccines that are free at the point of care, offered as part of routine antenatal services, delivered by healthcare professionals with clear responsibility for recommending and administering them, and supported by robust monitoring systems. Conversely, the barriers that suppress uptake are equally consistent, including the burden of additional appointments, language difficulties, fragmented services and inconsistent recommendations between providers. The policy mapping thus converts a vague aspiration of better access into a concrete checklist that ministries of health can act upon, and it suggests that the difference between a successful programme and a failing one often lies in administrative design rather than in vaccine science.

Surveillance emerges as another weak link. A review accepted for publication within the Series examined maternal pertussis vaccination programmes across seven European countries and found substantial differences in how disease burden, vaccine uptake and programme impact are monitored. Without standardised surveillance, policymakers cannot reliably estimate vaccine effectiveness, detect safety signals or identify emerging inequalities. The Series therefore calls for coverage to be routinely monitored by deprivation, ethnicity and migration status so that underserved communities are not left behind as new programmes are introduced, and for stronger, more consistent surveillance systems to underpin the expansion of maternal immunisation. On the safety side, the Series explores the World Health Organization’s new causality assessment approach, a structured framework for determining whether a health event occurring after vaccination in pregnancy is plausibly related to the vaccine or has another explanation. This matters because miscarriage, preterm birth and hypertensive disorders occur during pregnancy regardless of vaccination status, and an event that follows vaccination does not by itself establish causation. Structured assessment, the authors argue, should complement wider surveillance systems, clinical studies and pregnancy registries.

Perhaps the most sobering statistic in the Series concerns the evidence base itself. A review of vaccine research found that almost 95 percent of late-stage vaccine trials conducted between 2018 and 2023 explicitly excluded pregnant participants, leaving clinicians to make decisions about vaccinating pregnant women with limited direct evidence. This exclusion reflects a long-standing culture of caution, but the Series argues it is self-defeating: excluding pregnant women from trials does not protect them, it simply forces them to use vaccines in pregnancy based on weaker data. The authors support greater inclusion of pregnant women in research, alongside robust systems for evaluating safety and monitoring outcomes for mothers and babies.

The Series closes with a set of coordinated recommendations: making maternal vaccination a routine component of antenatal care across Europe, strengthening monitoring of uptake, safety and inequalities, integrating maternity and immunisation records, improving support for underserved communities, coordinating preparation for future vaccine programmes, establishing a European coordination group for maternal vaccine rollout, and developing a European Maternal Immunisation Preparedness Plan. As Professor Khalil concluded, the evidence is clear that maternal vaccination can save lives and reduce serious illness in mothers and babies; the challenge now is ensuring those benefits reach all families, which will require coordinated action across health services, public health agencies and policymakers. The science, it seems, has done its part. The systems must now catch up.

Subject of Research: Effectiveness, safety and equitable delivery of maternal vaccination in Europe

Article Title: Maternal vaccines protect babies from serious infections, but unequal access limits benefits across Europe

Article References: Maternal vaccines protect babies from serious infections, but unequal access limits benefits across Europe. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: maternal vaccination, RSV, infant health, health inequality, pregnancy, group B streptococcus, vaccine safety, Europe, public health policy, surveillance, antenatal care, The Lancet Regional Health – Europe

The study, led by Shaolong Ren and colleagues working with the World Health Organization, is the first to quantify how the uneven introduction of nirsevimab, a long-acting monoclonal antibody licensed in 2022, and RSVpreF, a maternal vaccine licensed in 2023, could reshape global inequalities in infant RSV disease. The researchers built a static deterministic model that combined comprehensive epidemiological data on RSV burden, seasonality, and hospitalisation risk by birth month and age in months with country-level information on licensing and uptake as of June 2025. They then compared two futures: a world in which no country had introduced the products, and the world as it actually stood in mid-2025, with implementation frozen at that moment.

The baseline picture for 2019 revealed stark regional contrasts. The WHO African Region carried the highest incidence of RSV-associated acute lower respiratory infection, at 117.4 episodes per 1000 person-years, and the highest attributable mortality, yet paradoxically recorded the lowest hospital admission rate, just 12.6 per 1000 person-years. The Eastern Mediterranean Region, by contrast, had the highest admission rate at 29.9 per 1000. The African Region also showed the highest in-hospital case fatality ratio at 1.54 percent, closely followed by the South-East Asia Region at 1.49 percent. Crucially, in-hospital deaths accounted for only about 21 percent of RSV-attributable deaths in the African Region, meaning roughly four in five infants who died of RSV did so without ever reaching a hospital bed. Together, the African, South-East Asia and Eastern Mediterranean regions accounted for 88 percent of all infant RSV deaths.

The authors argue that the low hospitalisation rates in the highest-burden regions do not reflect milder disease. Instead, they point to barriers of affordability, distance and time to reach care. Severe RSV illness is treatable with supportive measures such as supplemental oxygen and intravenous hydration, but children in resource-limited settings often cannot access these in time. A recent study in Bangladesh underscored the point: 18.4 percent of children requiring hospitalisation were denied admission because of insufficient bed capacity, and those turned away faced a hazard ratio for death of 1.56 compared with children who were admitted. This pattern also implies, the researchers note, that preventive interventions could deliver even greater absolute benefit in poorly resourced settings, by averting the out-of-hospital deaths that currently dominate the mortality toll.

Against this backdrop, the implementation landscape as of June 2025 was strikingly skewed. Nirsevimab had been licensed in 54 countries and RSVpreF in 64, but only 16 and 12 countries respectively had incorporated them into their national immunisation programmes, and the overwhelming majority of those were high-income countries. The European Region accounted for 34 nirsevimab and 35 RSVpreF licences, and the Region of the Americas for 8 and 12, while the African Region had zero nirsevimab licences and just two for RSVpreF, and the South-East Asia Region only two of each. Of the countries that had licensed nirsevimab, 53 of 54 were high- or upper-middle-income; for RSVpreF the figure was 59 of 64. No low-income country had licensed either product.

The projections that followed were sobering. Under the June-2025 scenario, an estimated 4.64 million doses of nirsevimab and 1.96 million doses of RSVpreF would be administered annually, averting roughly 91,000 infant RSV hospital admissions and about 300 deaths worldwide. That translates to reductions of just 3.7 percent of global infant RSV admissions and 0.4 percent of deaths. The benefits were overwhelmingly concentrated in wealthy nations: high-income countries, which received about 90 percent of averted admissions and over 70 percent of averted deaths, saw reductions of 33.2 percent in hospitalisations and 29.1 percent in mortality. Middle-income countries saw relative reductions below 5 percent, and low-income countries, with no uptake at all, saw none.

The model’s assumptions were grounded in real-world evidence. Nirsevimab was assigned 83 percent effectiveness against RSV-associated hospital admission and 81 percent against attributable death, drawn from meta-analyses of real-world data; RSVpreF was assigned 71 and 77 percent respectively, informed by a test-negative study in Argentina. The model accounted for seasonal immunisation strategies with birth doses and catch-up doses for nirsevimab, year-round maternal vaccination in most countries, and mutual exclusivity between the two products to avoid double-counting protection. Uncertainty was propagated through 1000 simulation draws for each input parameter, and sensitivity analyses varying uptake, effectiveness, and alternative mortality data from the Global Burden of Disease Study 2023 all produced trends consistent with the main findings.

Most striking was what happened to measured inequality. The researchers ranked countries by RSV-attributable infant mortality and divided the global population into quintiles, then calculated the ratio of deaths between the highest- and lowest-risk fifths. Under no implementation, that ratio stood at 18.3, already a staggering expression of inequity. Under the June-2025 scenario it rose to 20.8, meaning the rollout of these lifesaving products is projected to make global RSV mortality inequality worse, not better. Within WHO regions, the increases were most pronounced where several countries had introduced the products: the ratio in the Region of the Americas climbed from 5.8 to 10.4, and in the European Region from 12.7 to 22.1. The authors warn that, drawing on the history of pneumococcal and rotavirus vaccines, coverage disparities between rich and poor countries can persist for years after initial introduction, so the true widening could exceed even these projections over the next five years.

There are signs that access may eventually improve. The WHO’s Strategic Advisory Group of Experts recommended infant RSV passive immunisation in late 2024, the WHO prequalified the maternal vaccine in March 2025, and Gavi’s board approved a funding window for RSV maternal immunisation programmes in July 2025. Yet the Gavi programme is not expected to introduce vaccines until 2028 and will initially reach only a handful of eligible countries. The study’s authors point to pooled procurement through UNICEF- and PAHO-led initiatives, the Gates Foundation-supported development of multi-dose vial formulations of the maternal vaccine, tiered pricing, technology transfer and stronger national immunisation advisory capacity as routes to accelerate adoption. At this juncture, they conclude, coordinated action by international agencies, governments, manufacturers and researchers is essential to ensure that the tools now transforming infant RSV outcomes in wealthy countries reach the infants who bear the greatest burden of the disease.

Subject of Research: Global regional inequality in infant RSV morbidity and mortality under expanded passive immunisation

Article Title: Regional inequality in infant RSV morbidity and mortality burden in the era of expanded RSV passive immunisation: a global projection modelling study

Article References: Ren, S., Cong, B., Zou, J., Guo, L., Nair, H., Sparrow, E., Feikin, D. R., & Li, Y. (2026). Regional inequality in infant RSV morbidity and mortality burden in the era of expanded RSV passive immunisation: a global projection modelling study. eClinicalMedicine, 100, Article 104219. https://doi.org/10.1016/j.eclinm.2026.104219

Image Credits: AI Generated

DOI: 10.1016/j.eclinm.2026.104219

Keywords: RSV, nirsevimab, RSVpreF, infant health, global health equity, modelling study, low- and middle-income countries, hospitalisation, maternal vaccination, monoclonal antibodies, WHO, vaccine access

The vaccine in question is built on the prefusion F protein, the conformation of the viral surface glycoprotein that RSV displays when it is about to fuse with a host cell. This prefusion form exposes the key antigenic sites that elicit the most potent neutralizing antibodies, which is why it has become the preferred scaffold for both RSV vaccines and antibody therapeutics. When administered during pregnancy, typically between 24 and 36 weeks of gestation, the vaccine stimulates the mother to produce antibodies that cross the placenta, arming the newborn with passive protection during the most vulnerable first months of life. The strategy has proven effective, but it has also been shadowed by safety concerns that have shaped the entire regulatory debate around maternal RSV immunization.

Those concerns are not trivial. In earlier clinical testing, some trials of maternal RSV vaccines were halted after interim data suggested an excess of preterm deliveries among vaccinated mothers. A previous rapid review pooling all tested maternal RSV vaccines, including candidates that never reached the market, reported an association with preterm birth. Because prematurity remains the leading cause of death in children under five worldwide, and because survivors face elevated odds of lifelong complications ranging from respiratory disease to neurodevelopmental impairment, even a modest safety signal demands rigorous scrutiny. At the same time, RSV itself kills, and the alternative preventive option, the monoclonal antibody nirsevimab, is expensive enough that maternal vaccination remains the primary strategy in much of the world. Policymakers therefore need a clear answer about where the true risk lies.

To provide that answer, a Finnish research team conducted a systematic review and meta-analysis following the PRISMA reporting guidelines. The authors searched PubMed, Scopus, and Web of Science on August 1, 2025, with no language or date restrictions, and screened the resulting records in Covidence. Their inclusion criteria were deliberately narrow: they considered only studies of the market-approved prefusion F vaccines, RSVPreF and RSVPreF3, given to pregnant individuals, and only studies reporting preterm birth, defined as any delivery before 37 weeks and zero days of gestation. They excluded trials of the non-approved vaccine formulations precisely because those candidates had already been withdrawn over preterm birth signals and could confound the safety picture of the products actually in clinical use.

The screening process winnowed 404 identified studies down to just seven that met all criteria. Three were randomized controlled trials, together encompassing 12,833 births, and all were multinational, conducted across as many as 24 countries. Four were observational studies, retrospective or prospective, covering 4,245 births, and all four came from the United States. Vaccination typically occurred between gestational weeks 24 and 36. Where birthweight was reported, in four of the seven studies, the means were comparable between vaccine and control groups, ranging from 3.2 to 3.34 kilograms in vaccinated pregnancies against 3.15 to 3.42 kilograms in controls. Risk of bias was low in two of the randomized trials and raised some concerns in one, while the observational studies were rated moderate in three cases and serious in one, assessed with the Cochrane RoB 2.0 and ROBINS-I tools respectively.

The pooled results tell a story of two evidence streams in tension. In the randomized trials alone, the meta-analysis found a statistically significant increase in preterm birth risk among vaccinated mothers, with a relative risk of 1.26 and a 95 percent confidence interval of 1.08 to 1.46, and notably zero heterogeneity across trials. Yet when the researchers turned to the observational data, the signal vanished and even reversed direction: the relative risk was 0.78, with a confidence interval spanning 0.46 to 1.32 and substantial heterogeneity of 63 percent. Combining all seven studies yielded no overall association between maternal RSV vaccination and preterm birth, with a relative risk of 0.96 and a wide confidence interval of 0.68 to 1.38, accompanied by 80 percent heterogeneity. The certainty of this evidence was rated as low using the GRADE framework, downgraded for risk of bias and imprecision, since the interval includes both meaningful benefit and meaningful harm.

The authors attribute the discordance between trial and observational findings primarily to differences in the lower gestational age threshold for vaccination. The randomized trials enrolled women from 24 or 28 weeks of pregnancy, whereas every observational study administered the vaccine only from 32 weeks onward. Because the risk of spontaneous preterm delivery naturally concentrates in the window shortly after vaccination in earlier-gestation cohorts, a lower enrollment threshold is more likely to capture deliveries that occur soon after immunization, a pattern that can be misread as vaccine-caused when the two events are merely close in time. The geographic restriction of the observational data to the United States, compared with the multinational scope of the trials, adds a second layer of difference in populations, healthcare systems, and coding practices that may further explain the divergence.

On the secondary outcome, the analysis rested on only two studies reporting neonatal intensive care unit admissions, covering 3,620 births. The pooled estimate actually favored vaccination, with a relative risk of 0.74, meaning roughly 24 fewer NICU admissions per 1,000 infants, but the confidence interval of 0.34 to 1.61 was so wide that no firm conclusion is possible. The certainty of evidence here was rated very low, reflecting the observational origin of the data, small sample, high heterogeneity of 92 percent, and risk of bias. Birthweight and other neonatal morbidities were prespecified as additional outcomes, but inconsistent reporting across the included studies prevented formal meta-analysis, underscoring how early the evidence base for neonatal safety outcomes beyond preterm birth remains.

These findings arrive at a consequential regulatory moment. The Global Advisory Committee on Vaccine Safety has concluded that, despite the preterm birth concerns, the benefits of maternal RSV vaccination outweighed the risks in 98 percent of simulations when the vaccine is given between 27 and 36 weeks of gestation. On that basis, the WHO Strategic Advisory Group of Experts issued recommendations in September 2024 that were subsequently endorsed by the WHO itself. Real-world effectiveness data from the 2024-25 season in England and Scotland have already shown highly favorable outcomes, confirming that the vaccine works when deployed at population scale. The authors note, however, that hybrid immunization strategies deserve continued consideration, because nirsevimab offers superior protection, and the preterm birth signal observed within the randomized trials has not been conclusively resolved.

The review’s authors are candid about its limits. With only seven studies, publication bias could not be properly assessed; ongoing trial registries were not searched; and rare vaccine-related adverse events cannot be detected without large-scale nationwide surveillance. The subgroup signal in randomized trials, a 26 percent relative increase in preterm birth with tight confidence intervals, stands as the single most important caveat in an otherwise reassuring picture, and the low-to-very-low certainty ratings mean the true effect could plausibly fall on either side of harm or benefit. What the analysis establishes is that the totality of current evidence on the approved prefusion F vaccines does not confirm an overall association with preterm birth, and that NICU admissions were numerically lower among vaccinated infants. As maternal RSV vaccination scales up globally, the authors argue, continued pharmacovigilance focused on gestational outcomes, alongside studies of broader neonatal morbidity, is not optional but essential. The vaccine’s promise for protecting newborns from one of childhood’s deadliest pathogens is real; so is the responsibility to keep watching.

Subject of Research: Safety of maternal RSV prefusion F vaccination regarding preterm birth and neonatal intensive care admission

Article Title: RSV‐Pre‐F Vaccination During Pregnancy and Neonatal Outcomes—A Systematic Review and Meta‐Analysis

Article References: Leskinen, N., Haapanen, M., & Kuitunen, I. (2026). RSV‐Pre‐F Vaccination During Pregnancy and Neonatal Outcomes—A Systematic Review and Meta‐Analysis. Immunity, Inflammation and Disease, 14(9), Article e70510. https://doi.org/10.1002/iid3.70510

Image Credits: AI Generated

DOI: 10.1002/iid3.70510

Keywords: RSV, maternal vaccination, preterm birth, prefusion F vaccine, meta-analysis, systematic review, neonatal outcomes, NICU admission, nirsevimab, vaccine safety, randomized controlled trials, public health