Expert Consensus on Long-acting Monoclonal Antibodies for RSV Prevention in Children

Overview

The ARMADA Taskforce provides evidence-based recommendations endorsing long-acting monoclonal antibodies (LAmAbs) for preventing respiratory syncytial virus (RSV) in infants and high-risk children. They recommend LAmAbs for infants under 8 months without maternal RSV vaccination, preterm infants under 12 months, and children under 24 months with high-risk conditions, emphasizing seasonal administration and equitable global access.

Background

Respiratory syncytial virus (RSV) is a leading cause of bronchiolitis and pneumonia in young children, causing millions of infections and hospitalizations annually worldwide. Historically, prevention relied on palivizumab, limited to high-risk infants such as those born prematurely or with chronic conditions. New long-acting monoclonal antibodies, including nirsevimab, offer improved efficacy and potential for broader use. Clear, evidence-based guidelines are essential to optimize their implementation and reduce the global RSV burden.

Data Highlights

The ARMADA Taskforce systematically reviewed 2145 citations, identifying 81 relevant studies demonstrating that LAmAbs are highly efficacious, well-tolerated, and cost-effective in preventing RSV disease across diverse populations. Cost-effectiveness is particularly noted at immunization prices below USD $5 in low- and middle-income countries. The Taskforce recommends LAmAbs for infants <8 months without maternal vaccination, preterm infants <12 months, and children <24 months with high-risk conditions, with seasonal administration tailored to local RSV epidemiology.

Key Findings

• LAmAbs significantly reduce RSV disease burden in infants and young children, including those without traditional risk factors.
• Recommended for all infants <8 months if maternal RSV vaccination is absent, preterm infants <37 weeks’ gestation <12 months, and children <24 months with high-risk conditions (e.g., chronic lung or heart disease).
• Seasonal administration is preferred; in RSV-endemic regions, local decisions on year-round versus seasonal dosing are advised.
• LAmAbs demonstrate strong efficacy, safety, and cost-effectiveness, especially when priced affordably in low- and middle-income countries.
• Global implementation requires collaboration among stakeholders to ensure equitable access and affordability.
• Further research is needed on LAmAbs’ long-term impact, effectiveness in special populations, and integration with maternal RSV vaccination.

Clinical Implications

Clinicians should consider LAmAbs as a primary preventive strategy for RSV in infants and high-risk children, especially where maternal vaccination is unavailable. Seasonal timing aligned with local RSV activity optimizes protection. Efforts to improve access and affordability in low-resource settings are critical to reduce global RSV morbidity and mortality.

Conclusion

The ARMADA Taskforce’s consensus provides a comprehensive, evidence-based framework to guide the global use of long-acting monoclonal antibodies for RSV prevention, aiming to substantially reduce childhood RSV disease burden worldwide.

References

1. ARMADA Taskforce 2024 -- Comprehensive Review and Expert Recommendations on Long-acting Monoclonal Antibodies for Preventing Respiratory Syncytial Virus Infection