Efficacy, Immunogenicity, and Safety of the Bivalent RSV Prefusion F (RSVpreF) Vaccine in Older Adults Over 2 RSV Seasons.

Summary

In adults ≥60 years, RSVpreF elicited strong neutralizing responses (GMFR ~12 at 1 month) that remained above baseline before season 2 (GMFR 4.7), with similar magnitude across age groups and chronic conditions. A durable safety and efficacy profile over two RSV seasons supports real-world use.

Key Findings

• Neutralizing titer GMFR was 12.1 at 1 month post-vaccination and 4.7 before season 2, remaining above baseline.
• Responses were robust across age strata (60–69, 70–79, ≥80; GMFR 12.0–13.0) and similar with vs without chronic conditions (GMFR 11.4–14.4).
• Favorable safety and durable vaccine efficacy were observed over two RSV seasons.

Clinical Implications

Supports routine RSVpreF vaccination in older adults, including those with chronic comorbidities, with expectations of durable protection over at least two seasons.

Limitations

• Immunogenicity evaluated in a subset (USA/Japan); full VE details not elaborated in this report.
• Follow-up limited to two seasons; longer durability and rare adverse events require ongoing surveillance.

Future Directions

Assess multi-season durability, effectiveness against severe outcomes, and performance in frail elderly and immunocompromised populations; monitor safety with real-world pharmacovigilance.