Nirsevimab effectiveness, number needed to immunize and impact on severe RSV outcomes, a test-negative study in Quebec, Canada.

Abstract

In 2024-25, Quebec implemented a universally publicly funded infant nirsevimab program. We estimated effectiveness, number-needed-to-immunize (NNI) and impact against severe respiratory syncytial virus (RSV) outcomes. A test-negative study estimated adjusted effectiveness among nirsevimab-eligible children RSV-tested during emergency room (ER) consultation or hospitalization between October 2024 and March 2025. Eligible children were born during the RSV season (at-birth group) or <6- to <19-month-olds healthy, preterm, with chronic conditions or living in remote regions (catch-up groups). We used 2023-24 respiratory hospitalization rates, RSV-positivity from a systematic hospital-based surveillance network, and Quebec 2024-25 coverage estimates to derive the theoretical NNI and averted hospitalizations. Effectiveness analyses included 3172 specimens linked to ER consultations (1775 [56·0%] from male and 1397 [44·0%] from female participants; 668 [21·1%] RSV-positive) and 1758 linked to hospitalizations (988 [56·2%] from male and 770 [43·8%] from female participants; 549 [31·2%] RSV-positive). Effectiveness was 86% (95% CI: 82-90) against ER consultation, 89% (95% CI: 84-92) against hospitalization (79% (95% CI: 60-89) for those with chronic diseases and 93% (95% CI: 83-97) for preterm infants), and 88% (95% CI: 58-97) against ICU admission. We estimated 41 at-birth and 58 catch-up immunizations needed to avert one RSV-associated hospitalization. We estimated that 72% (at-birth group) and 59% (catch-up group with 64% coverage by November) of RSV-associated hospitalizations were prevented, potentially increasing to 82% for a hypothetical coverage of 90% by October. Nirsevimab is highly effective and could more substantially impact the RSV burden through broad and timely administration to healthy-term and high-risk infants. Ministère de la santé et des services sociaux du Québec.