Maternal RSV vaccine: a systematic review and meta-analysis of immunogenicity and perinatal safety

This systematic review and meta-analysis assess the immunogenicity and maternal-fetal safety profile of RSV prefusion F (RSVpreF) vaccination during pregnancy. PubMed, Scopus, Embase, Cochrane, and Web of Science databases were searched for relevant studies. Only randomized controlled trials (RCTs) evaluating the safety, efficacy, and immunogenicity of RSVpreF vaccination in pregnant women were included. Six RCTs, involving 17,212 participants, were analyzed. The vaccine significantly boosted maternal anti-RSV neutralizing antibody levels, with a standardized mean difference (SMD) of 1.40 for RSV-A and 1.11 for RSV-B, both with high statistical significance. Infants born to vaccinated mothers had a 49% reduced risk of RSV-associated lower respiratory tract illness within 180 days post-vaccination (OR = 0.51, 95% CI: 0.40-0.64). Preterm birth rates did not differ significantly between the vaccine and placebo groups (OR = 1.09, 95% CI: 0.87-1.37). The vaccine was not associated with increased risks of serious adverse events or perinatal complications. Maternal RSVpreF vaccination significantly elevates neutralizing antibody levels against RSV subtypes A and B without increasing the risk of serious adverse events or preterm delivery. These findings support the safety and immunogenicity of RSV vaccination in pregnant women, reinforcing its potential utility in protecting neonates against RSV-related morbidity.