Maternal RSVpreF vaccine tied to fewer infant RSV hospitalizations

Real-world data support giving the respiratory syncytial virus (RSV) bivalent prefusion F protein vaccine (RSVpreF) during pregnancy to protect infants from RSV-associated lower respiratory tract infection (LRTI) hospitalization through the first 6 months of life, according to a systematic review and meta-analysis published in JAMA Pediatrics.

In its pivotal clinical trial, RSVpreF given during pregnancy showed efficacy in protecting infants against early-life RSV disease. The investigators set out to determine whether that protection has held up in routine use since the vaccine’s introduction.

How was real-world effectiveness assessed?

The research team searched PubMed, Scopus, and Europe PMC from January 1, 2020, through January 30, 2026, initially identifying 1144 studies. Nonrandomized studies reporting the effectiveness of RSVpreF in pregnancy against RSV-associated LRTI in infants were eligible, and 2 reviewers independently screened each study. Outcomes were extracted for infants born to women vaccinated during pregnancy and for infants born to unvaccinated women.

Odds ratios (ORs) were pooled through random-effects meta-analysis with the Hartung-Knapp adjustment and the Sidik-Jonkman estimator. Vaccine effectiveness against RSV-associated LRTI hospitalization, the primary outcome, was calculated as (1 − OR) × 100% and evaluated separately for infants from birth to age 3 months and from birth to 6 months.

Vaccine effectiveness through 3 and 6 months

The 7 included studies covered 7112 infants, 2684 of whom were born to vaccinated mothers, with data collected from January 2024 through April 2025 in Argentina, the United Kingdom, and the United States. When mothers were vaccinated 14 days or more before delivery, pooled effectiveness against RSV-associated LRTI hospitalization was 82% (95% CI, 81%-82%; 3 studies, 4397 participants; I² = 0%) among infants from birth to 3 months and 78% (95% CI, 70%-84%; 6 studies, 3008 participants; I² = 18.7%) among infants from birth to 6 months.

Data on the secondary outcomes, RSV-associated emergency department visits, intensive care unit admissions, and death, were too limited to support meta-analysis.

Based on the postimplementation evidence, the investigators wrote that the findings support incorporating RSVpreF into routine antenatal immunization programs.

Reference:

Batool R, Wang R, Obeid H, et al. RSV bivalent prefusion F protein vaccine in pregnancy and protection against RSV-associated illness in infants: a systematic review and meta-analysis. JAMA Pediatr. 2026;180(11):1213-1221. doi:10.1001/jamapediatrics.2026.4074