Key result
Monoclonal antibodies and RSV vaccines reduce RSV-LRTI hospitalization, with nirsevimab cutting risk by ~84%.
Why the study?
Recent approvals of long-acting monoclonal antibodies and prefusion F protein-based vaccines shifted the RSV prevention landscape, creating a need to synthesize evidence on their efficacy and real-world effectiveness.
Do palivizumab, nirsevimab, and RSV vaccines reduce RSV-LRTI hospitalisation in infants, pregnant women, and older adults?
Meta-Analysis
Do palivizumab, nirsevimab, and RSV vaccines reduce RSV-LRTI hospitalisation in infants, pregnant women, and older adults?
Effect estimate: Pooled effectiveness 84% (nirsevimab OR-based) (95% CI 78-88)
Prophylactic strategies including palivizumab, nirsevimab, and RSV vaccines are highly effective in reducing RSV-associated lower respiratory tract infection hospitalisations across vulnerable populations.
Background Respiratory syncytial virus (RSV) remains a leading cause of lower respiratory tract infection (LRTI) and mortality among infants and older adults globally. The recent approval of long-acting monoclonal antibodies (mAbs) and prefusion F protein-based vaccines marks a significant shift in the prevention landscape. This systematic review aims to synthesise current evidence regarding the efficacy and real-world effectiveness of RSV interventions. Methods We searched PubMed, Scopus, and Web of Science for randomised controlled trials and observational studies published between January 1, 2018, and September 8, 2025, that evaluated palivizumab, nirsevimab, and RSV vaccines in infants, pregnant women, and older adults. The primary outcome was RSV-associated lower respiratory tract infection (RSV-LRTI) hospitalisation. Pooled efficacy and effectiveness were estimated using random-effects meta-analysis. This study is registered with PROSPERO, CRD420261285934. Findings In infants, palivizumab demonstrated effectiveness against RSV-LRTI hospitalisation up to 180 days post-discharge that varied substantially by analytical approach: OR-based studies yielded a pooled effectiveness of approximately 81% (95% CI: 57%–91%), while rate-ratio-based cohort studies produced a non-statistically significant estimate of 34% (95% CI: −17%–63%). Nirsevimab showed pooled efficacy/effectiveness of approximately 80–85% through 150–180 days post-dose, with consistent results across OR-based (84%, 95% CI: 78%–88%) and rate-ratio-based analyses (79%, 95% CI: 72%–85%). Maternal vaccine efficacy within 180 days after birth was 72% (95% CI: 61%–79%) against severe RSV-LRTI compared to 67% (95% CI: 53%–77%) against RSV-LRTI hospitalisations. In older adults, vaccination demonstrated robust protection during the first RSV season following vaccination, with a pooled vaccine effectiveness of 77% (95% CI: 69%–82%) against RSV-LRTI hospitalisations. Interpretation Prophylactic strategies demonstrate effectiveness in reducing the burden of RSV-associated diseases. Both palivizumab and nirsevimab provide robust protection against RSV-LRTI hospitalisation in their respective target populations. Additionally, both maternal and older adult vaccinations are effective in reducing RSV-associated diseases. Funding General Research Fund, AIR@InnoHK.
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Du et al. (2026) conducted a meta-analysis in Respiratory syncytial virus (RSV) lower respiratory tract infection. Long-acting monoclonal antibodies (palivizumab, nirsevimab) and RSV vaccines vs. Placebo or no intervention was evaluated on RSV-associated lower respiratory tract infection (RSV-LRTI) hospitalisation (Pooled effectiveness 84% (nirsevimab OR-based), 95% CI 78-88). Long-acting monoclonal antibodies and RSV vaccines demonstrated robust protection against RSV-LRTI hospitalisation, with nirsevimab showing 84% effectiveness (95% CI 78-88%).
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