RENOIR Trial — RSVpreF Vaccine Efficacy over Two Seasons

his letter reports extended efficacy data from the phase 3 RENOIR trial evaluating the bivalent RSVpreF vaccine in adults aged 60 and older across two RSV seasons. Conducted in seven countries, the trial showed sustained protection against RSV-associated lower respiratory tract illness (LRTI) with ≥3 symptoms: 88.9% efficacy in season one, 77.8% in season two, and 81.5% pooled across both seasons. Efficacy against RSV A and B remained high (80.6% and 86.4%, respectively). Protection was lower for less severe endpoints (LRTI with ≥2 symptoms and acute respiratory illness). Subgroup analyses suggested consistent efficacy across age groups and high-risk conditions, though wide confidence intervals limited interpretation in older cohorts. The findings support durable protection from a single RSVpreF dose and inform revaccination strategies.

his letter reports extended efficacy data from the phase 3 RENOIR trial evaluating the bivalent RSVpreF vaccine in adults aged 60 and older across two RSV seasons. Conducted in seven countries, the trial showed sustained protection against RSV-associated lower respiratory tract illness (LRTI) with ≥3 symptoms: 88.9% efficacy in season one, 77.8% in season two, and 81.5% pooled across both seasons. Efficacy against RSV A and B remained high (80.6% and 86.4%, respectively). Protection was lower for less severe endpoints (LRTI with ≥2 symptoms and acute respiratory illness). Subgroup analyses suggested consistent efficacy across age groups and high-risk conditions, though wide confidence intervals limited interpretation in older cohorts. The findings support durable protection from a single RSVpreF dose and inform revaccination strategies.