SynthesisInternational journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics2026
Maternal RSV vaccination for infant protection: A systematic review and meta-analysis of phase 3 trials with an integrated economic evaluation.
Synthesis in International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of maternal RSV vaccination against infant lower respiratory tract infections: a systematic review and meta-analysis.Frontiers in public health · 2026Pooled it
- Maternal safety outcomes of respiratory syncytial vaccination during pregnancy with a large-scale database.NPJ vaccines · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRespiratory syncytial virus (RSV) is a leading cause of hospitalization and mortality in early infancy. Maternal immunization offers a preventive strategy, but uncertainties regarding safety and economic value have limited its implementation.
objectivesTo synthesize phase 3 randomized trial evidence on the efficacy and safety of maternal RSV vaccination and to estimate its potential population and economic impact. By integrating a scenario-based modeling framework derived from pooled meta-analytic estimates, this review provides high-certainty, policy-relevant evidence to guide maternal immunization strategies in diverse settings. SEARCH STRATEGY: PubMed, MEDLINE, Scopus, and Google Scholar were searched up to April 2025 using predefined terms for RSV vaccination, pregnancy, and randomized controlled trials (RCTs). SELECTION CRITERIA: Phase 3 RCTs comparing maternal RSV vaccination with placebo and reporting neonatal or maternal outcomes were included. Non-randomized studies, monoclonal antibody trials, or reports lacking extractable data were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently screened studies, extracted data, and assessed risk of bias (RoB-2). Pooled risk ratios (RR) and absolute risk differences were calculated with random-effects models. Certainty of evidence was graded using Grading of Recommendations Assessment, Development and Evaluation (GRADE). A scenario-based cost-effectiveness model was applied to the Mexican birth cohort. MAIN
resultsFour phase 3 RCTs (17 391 women) were included. Maternal RSV vaccination halved the risk of infant RSV infection (risk ratio [RR] 0.47, 95% confidence interval [CI]: 0.29-0.76; number needed to vaccinate [NNV] 85) and reduced severe disease by 64% (RR 0.36, 95% CI: 0.21-0.60; NNV 127). No increased risks were observed for preterm birth, pre-eclampsia, or stillbirth. Certainty was moderate (any RSV) to high (severe RSV). In Mexico, universal vaccination at list price (US$295 per dose) would prevent approximately 20 769 infections and 228 neonatal deaths annually, though with high costs per case averted. At public-sector pricing (US$50 per dose), cost-effectiveness improved substantially.
conclusionsMaternal RSV vaccination is effective, safe, and potentially cost-justifiable in high-burden settings, supporting its integration into national immunization programs. PROSPERO registration: CRD420251014636 (March 2025).
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