Maternal RSV Vaccine Prevents Infant Hospitalization

Maternal RSVpreF vaccination at least 14 days before delivery substantially reduced infant RSV-related hospitalizations.
*Systematic review/meta-analysis of observational studies; Level 2 (OCEBM).

Citation

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 Pediatrics. Published online September 8, 2026. doi:10.1001/jamapediatrics.2026.4074

Background

Respiratory syncytial virus is a major cause of serious breathing illness and hospitalization in young infants. A pregnancy vaccine may protect infants during their highest-risk first months of life.

Patients

Seven real-world studies included 7112 infants in Argentina, the United Kingdom, and the United States; 2684 were born to vaccinated mothers. Studies without a comparison group, relevant infant outcomes, or individual vaccination/outcome data were excluded.

Intervention

Maternal RSVpreF vaccine during pregnancy, mainly counted as effective exposure when given at least 14 days before delivery.

Control

Infants born to mothers who did not receive the vaccine.

Outcome

Respiratory syncytial virus–associated lower respiratory tract infection hospitalization.

Follow-up Period

Birth to 3 months and birth to 6 months.

Results

Outcome Pooled effect
Hospitalization, birth to 3 months (primary) 82% effectiveness (95% CI 81% to 82%); OR 0.18 (95% CI 0.18 to 0.19)
Hospitalization, birth to 6 months (primary) 78% effectiveness (95% CI 70% to 84%); OR 0.22 (95% CI 0.16 to 0.30)

RSVpreF: respiratory syncytial virus bivalent prefusion F protein vaccine; OR: odds ratio.

Absolute risk reduction and number needed to treat could not be calculated from the pooled case-control and test-negative study designs. Control was no maternal vaccine, not an active infant antibody strategy.

Limitations

All included studies were observational, with moderate to serious risk of bias from possible confounding. Most data came from the first season after program rollout, so the 6-month estimate may largely reflect younger infants. Evidence was limited for preterm infants, intensive care admissions, emergency visits, and deaths.

Funding

No specific funding reported; some authors disclosed industry-related institutional funding/honoraria.

Clinical Application

Offer RSVpreF during recommended pregnancy windows, ideally at least 14 days before delivery, to reduce early infant RSV hospitalizations.