Data Sheet 1_Efficacy and safety of maternal RSV vaccination against infant lower respiratory tract infections: a systematic review and meta-analysis.docx

Pooled vaccine effectiveness against infant RSV-associated hospitalisation was 79.7% (95% CI 73.9–84.2) within 3 months and 68.1% (57.1–76.3) through 6 months. Randomised efficacy against severe RSV-LRTI was 70% for the licensed Pfizer vaccine, closely concordant with the real-world effectiveness; efficacy against medically attended RSV-LRTI was 51.5% (36.3–63.1). Preterm birth was modestly increased in the randomised trials (Mantel–Haenszel RR 1.17, 95% CI 1.03–1.32), but the signal was not robust: it became non-significant after excluding the GSK trial (GRACE; 1.10, 0.95–1.27), and for the licensed Pfizer vaccine, the increase was small and not robustly significant (pivotal MATISSE trial 1.20, 0.98–1.46; three-trial Pfizer pool 1.21, 1.00–1.46), while observational data showed a biologically implausible protective association (0.90, 0.82–0.99), consistent with healthy vaccinee confounding.

No other maternal or neonatal safety signal was identified. Certainty of evidence was moderate for effectiveness and efficacy.</p>Conclusion<p>Maternal RSVpreF vaccination confers substantial, generalisable protection against infant RSV disease, with randomised and real-world evidence in close agreement. For the licensed Pfizer vaccine administered within its approved 32–36-week window, no robustly significant increase in preterm birth is established, supporting its continued programmatic use alongside ongoing post-marketing surveillance.</p>Systematic review registration<p>Unique Identifier: CRD420261400053 crd.york.ac.uk/PROSPERO/view/CRD420261400053</p>