Abstract
Objective: To assess the efficacy and safety of maternal respiratory syncytial virus (RSV) vaccination on infant and perinatal outcomes. Study design: Systematic review and random-effects meta-analysis of randomized controlled trials (PubMed, Embase, CENTRAL). Six trials (18,011 pregnant women; 17,769 infants) comparing maternal RSV vaccines with placebo were included. Effects were pooled as risk ratios (RR). Result(s): Maternal RSV vaccination reduced severe RSV-associated lower respiratory tract infection (LRTI) (RR 0.35, 95% CI 0.15-0.87) and hospitalization (RR 0.53, 95% CI 0.37-0.76) within 180 days of birth. Medically attended RSV-LRTI was lower but imprecise (RR 0.47, 95% CI 0.18-1.21). No safety signal was observed for preterm birth (RR 1.15, 95% CI 0.95-1.38), low birth weight, or congenital malformations. Conclusion(s): Maternal RSV vaccination reduces severe infant RSV disease and RSV-related hospitalization with a reassuring perinatal safety profile. Trial registration: PROSPERO CRD42025636472.Copyright © The Author(s), under exclusive licence to Springer Nature America, Inc. 2026.
