ReviewJournal of pharmaceutical policy and practice2026
Maternal RSV vaccination: clinical efficacy, safety, and global policy considerations: a systematic review.
Review in Journal of pharmaceutical policy and practice, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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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.
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Respiratory syncytial virus (RSV) is among the leading causes of lower respiratory tract illness in newborns worldwide. This study reviews evidence on the efficacy and safety of maternal RSV vaccination. Methods: PROSPERO registered this PRISMA-compliant systematic review (CRD42024566335). Keywords associated with RSV, respiratory infections, newborns, and immunisation were used in a search of PubMed/MEDLINE, Embase, Scopus, Web of Science, and Cochrane CENTRAL (inception to mid-2026). Because of the heterogeneity of the studies, a descriptive synthesis of the safety and efficacy data was performed instead of a formal meta-analysis. Results: Sixteen publications - four real-world studies and twelve generated from nine separate parent trials/datasets (including three subgroup or subset analyses and post-hoc studies from two RCTs) - met the inclusion criteria. Depending on the dose, formulation, and length of follow-up, maternal immunisation was linked to a lower incidence of severe RSV-related lower respiratory tract infections in newborns, with efficacy/effectiveness varying from roughly 39% to 100%. Trial-based efficacy results were generally in line with real-world effectiveness data from national and multicenter initiatives in the US, UK, and Argentina. Preterm birth outcomes differed depending on the formulation: a bivalent RSVpreF vaccine (Pfizer MATISSE trial; [Li, Y., Wang, X., Blau, D. M., Caballero, M. T., Feikin, D. R., Gill, C. J., Madhi, S. A., Omer, S. B., Simões, E. A. F., & Campbell, H. (2022). Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: A systematic analysis. Conclusion: There was no discernible rise in major adverse outcomes for mothers or newborns. Real-world data from a variety of situations now supports the conclusion that maternal RSV vaccination consistently decreased newborn RSV hospitalisation and severe disease. However, ongoing post-marketing surveillance and formulation-specific safety reporting are necessary due to variations in preterm birth risk that rely on timing and formulation.
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