RSV Prefusion F Vaccine for Prevention of Hospitalization in Older Adults.

Summary

In a nationwide, pragmatic randomized trial of 131,276 adults ≥60 years in Denmark, RSVpreF vaccination reduced RSV-related respiratory hospitalization by 83% and RSV-related lower respiratory tract hospitalization by 92% versus no vaccine, with similar serious adverse event rates. All-cause respiratory hospitalizations were modestly reduced.

Key Findings

• RSV-related respiratory hospitalization: 0.11 vs 0.66 events/1000 PY; vaccine effectiveness 83.3% (95% CI 42.9–96.9).
• RSV-related lower respiratory tract hospitalization: 1 vs 12 events; vaccine effectiveness 91.7% (95% CI 43.7–99.8).
• All-cause respiratory hospitalization reduced by 15.2% (95% CI 0.5–27.9).
• Serious adverse events occurred at similar rates between RSVpreF and control groups.

Clinical Implications

Supports offering RSVpreF vaccination to adults ≥60 years as part of seasonal prevention strategies to reduce RSV hospitalization burden, with safety comparable to control.

Limitations

• Open-label design could introduce behavior-related biases, although hospitalization endpoints mitigate this.
• Low absolute event numbers for RSV hospitalizations yield wide confidence intervals and a single-season setting limits generalizability.

Future Directions

Assess durability across multiple seasons, subgroup effects (e.g., frailty, comorbidities), coadministration strategies, and cost-effectiveness in diverse health systems.