Efficacy and Safety of RSV Vaccine in Older Adults

What is the efficacy and safety of the investigational bivalent RSV prefusion F protein-based vaccine in adults aged 60 years and older?

Study design: Ongoing phase 3, randomized, placebo-controlled trial

Population

Number of patients studied: 34,284 (17,215 in the vaccine group and 17,069 in the placebo group)
Inclusion criteria: Adults aged 60 years or older
Exclusion criteria: Not specified

Interventions

Experimental group: Single intramuscular injection of RSVpreF vaccine at a dose of 120 μg (RSV subgroups A and B, 60 μg each)
Control group: Single intramuscular injection of placebo

Primary outcome: Vaccine efficacy against seasonal RSV-associated lower respiratory tract illness with at least two or at least three signs or symptoms

Secondary outcomes

Vaccine efficacy against RSV-associated acute respiratory illness: 62.1% (95% CI, 37.1 to 77.9)

Safety outcomes or Adverse Events

Local reactions: 12% in the vaccine group, 7% in the placebo group
Systemic events: 27% in the vaccine group, 26% in the placebo group
Adverse events through 1 month after injection: 9.0% in the vaccine group, 8.5% in the placebo group
Injection-related adverse events: 1.4% in the vaccine group, 1.0% in the placebo group
Severe or life-threatening adverse events: 0.5% in the vaccine group, 0.4% in the placebo group
Serious adverse events: 2.3% in both the vaccine and placebo groups

Conclusion

RSVpreF vaccine prevented RSV-associated lower respiratory tract illness and RSV-associated acute respiratory illness in adults (≥60 years of age), without evident safety concerns.