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Objective <p>To assess the efficacy and safety of maternal respiratory syncytial virus (RSV) vaccination on infant and perinatal outcomes.</p> Study design <p>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).</p> Results <p>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.</p> Conclusion <p>Maternal RSV vaccination reduces severe infant RSV disease and RSV-related hospitalization with a reassuring perinatal safety profile.</p> Trial registration <p>PROSPERO CRD42025636472.</p>

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The impact of maternal respiratory syncytial virus vaccination on infant and perinatal outcomes: a systematic review and meta-analysis of randomized controlled trials

  • 期刊论文

  • 发表日期：

    2026年4月13日

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  • Jonathan Rodrigues Lopes,
  • Inês Martins Esteves,
  • Sofia Oliveira Dias,
  • Fátima Maria Thaiz da Fonte Gomes da Silva,
  • Gabrielle Catherine Dias Mafra da Silva,
  • Natália Botelho Libonati,
  • Regina Melittio Gasparetti,
  • Angelica Luciana Nau

摘要

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).

Results

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

Maternal RSV vaccination reduces severe infant RSV disease and RSV-related hospitalization with a reassuring perinatal safety profile.

Trial registration

PROSPERO CRD42025636472.