RSV Bivalent Prefusion F Protein Vaccine in Pregnancy and Protection Against RSV-Associated Illness in InfantsA Systematic Review and Meta-Analysis
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Rabab Batool, PhD1; Ran Wang, MD2,3,4; Hala Obeid, BSc2,5 et al
Author Affiliations
- 1Department of Microbiology and Immunology, Dalhousie University, Halifax, Nova Scotia, Canada
- 2Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre and the Nova Scotia Health Authority, Halifax, Nova Scotia, Canada
- 3Departments of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada
- 4Laboratory of Infection and Virology, Beijing Pediatric Research Institute, Beijing Children’s Hospital, National Center for Children’s Health, Capital Medical University, Beijing, China
- 5Departments of Microbiology and Immunology, Dalhousie University, Halifax, Nova Scotia, Canada
- 6Department of Community Health and Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada
- 7British Columbia Children’s Hospital Research Institute, Vancouver, British Columbia, Canada
- 8Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada
Key Points
Question Does the respiratory syncytial virus (RSV) bivalent prefusion F protein (RSVpreF) vaccine, when administered during pregnancy, protect infants against RSV-associated lower respiratory tract infection hospitalization in real-world settings?
Findings In this systematic review and meta-analysis including 7 studies comprising 7112 infants, of whom 2684 were born to vaccinated mothers, RSVpreF was effective against RSV-associated lower respiratory tract infection hospitalization in infants from birth to 3 months and from birth to 6 months, when administered at least 14 days before delivery.
Meaning Results suggest that RSVpreF vaccine, when administered at least 14 days before delivery, provided high protection to infants against RSV-associated hospitalization; this supports the integration of RSVpreF into national immunization programs.
Abstract
Importance The respiratory syncytial virus (RSV) bivalent prefusion F protein vaccine (RSVpreF) administered during pregnancy has demonstrated efficacy in protecting infants against early-life RSV disease in the pivotal clinical trial.
Objective To conduct a systematic review and meta-analysis to synthesize real-world evidence on the effectiveness of RSVpreF in preventing RSV-associated lower respiratory tract infection (LRTI) in infants.
Data Sources PubMed, Scopus, and Europe PMC were searched from January 1, 2020, through January 30, 2026.
Study Selection A total of 1144 studies were initially identified. Eligible were nonrandomized studies reporting the effectiveness of RSVpreF vaccine in pregnancy in the prevention of RSV-associated LRTI in infants.
Data Extraction and Synthesis All studies were screened independently by 2 reviewers. Data were extracted on RSV-associated outcomes among infants born to women who received RSVpreF vaccination during pregnancy and infants born to unvaccinated women.
Main Outcomes and Measures The primary outcome was RSV-associated LRTI hospitalization. Odds ratios (ORs) were pooled using random-effects meta-analysis with the Hartung-Knapp adjustment and Sidik-Jonkman estimator. Vaccine effectiveness against RSV-associated LRTI hospitalization was calculated as (1 − OR) × 100% and assessed in infants from birth to age 3 months and from birth to 6 months, separately. The limited available data precluded meta-analysis of effectiveness against the secondary outcomes of RSV-associated emergency department visits, intensive care unit admissions, and death.
Results A total of 7 studies were included, comprising 7112 infants, of whom 2684 were born to vaccinated mothers. The studies collected data from January 2024 through April 2025 from Argentina, the UK, and the US. Pooled vaccine effectiveness against RSV-associated LRTI hospitalization was 82% (95% CI, 81%-82%; 3 studies, 4397 participants; I2 = 0%) in infants from birth to 3 months and 78% (95% CI, 70%-84%; 6 studies, 3008 participants; I2 = 18.7%) in infants from birth to 6 months, when mothers were vaccinated 14 days or more before delivery.
Conclusions and Relevance The results of this systematic review and meta-analysis suggest that postimplementation data support the effectiveness of RSVpreF in pregnancy for the prevention of RSV-associated LRTI hospitalization during the first 6 months of life. The results support the introduction of RSVpreF into routine antenatal immunization programs.
source: https://jamanetwork.com/journals/jamapediatrics/article-abstract/2853476?utm_source=chatgpt.com