AUTHOR=Ma Juan , Chen Long , Tang ShiFang , Shi Yuan TITLE=Efficacy and safety of respiratory syncytial virus vaccination during pregnancy to prevent lower respiratory tract illness in newborns and infants: a systematic review and meta-analysis of randomized controlled trials JOURNAL=Frontiers in Pediatrics VOLUME=Volume 11 - 2023 YEAR=2024 URL=https://www.frontiersin.org/journals/pediatrics/articles/10.3389/fped.2023.1260740 DOI=10.3389/fped.2023.1260740 ISSN=2296-2360 ABSTRACT=To evaluate the effectiveness and safety of respiratory syncytial virus (RSV) vaccination during pregnancy in preventing lower respiratory tract infection (LRTI) in infants and neonates, we conducted a systematic search of randomized controlled trials (RCTs) in five databases (PubMed, Embase and Cochrane Library, Web of Science, Cochrane Center Register of Controlled trial) until May 1, 2023. Using RevMan5.4.1 software, we performed a meta-analysis of the eligible trials. Our analysis included six articles and five RCTs. The meta-analysis revealed significant differences in the incidences of LRTI (RR: 0.64; 95% CI 0.43, 0.96; p = 0.03) and severe LRTI (RR: 0.37; 95% CI 0.18, 0.79; p = 0.01) between the vaccine group and the placebo group for newborns and infants. These differences were observed at 90 days, 120 days, and 150 days after birth (P=0.003, P=0.05, P=0.02, P=0.03, P=0.009, P=0.05). At 180 days after birth, there was a significant difference in the incidence of LRTI between the two groups (RR: 0.43; 95% CI 0.21, 0.90; p = 0.02). The safety results showed a significant difference in the incidence of common adverse events between the two groups (RR: 1.08; 95% CI 1.04, 1.12; p <0.0001). However, there was no significant difference in the incidence of serious adverse events (RR: 1.05; 95% CI 0.97, 1.15; p = 0.23), common and serious adverse events (RR: 1.02; 95% CI 0.96, 1.10; p = 0.23), or common and serious adverse events among pregnant women and newborns and infants (RR: 0.98; 95% CI 0.93, 1.04; p = 0.52). In conclusion, maternal RSV vaccination is an effective and safe immunization strategy for preventing LRTI in postpartum infants, with greater efficacy observed within 150 days of birth.