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First- and Second-Year Outcomes After Nirsevimab Immunization
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First- and Second-Year Outcomes After Nirsevimab Immunization

JAMA Pediatrics·August 10Open Access
PediatricsConfirms priorSafety signalAsthmaEar, Nose, And Throat Bacterial InfectionLower Respiratory Tract InfectionRespiratory Syncytial Virus InfectionMatched Cohort StudyMonoclonal AntibodyInfantBeyfortusNirsevimab

Summary

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What was studied

This nationwide matched cohort study evaluated nirsevimab effectiveness against RSV-LRTI-related hospitalizations across two consecutive RSV seasons (2023–2024 and 2024–2025) in French infants, and assessed whether protection persisted into a second year and whether nirsevimab was associated with hospitalizations for non-RSV infections and asthma.

Key findings

Nirsevimab reduced RSV-LRTI-related hospitalizations by 66% (95% CI, 61%–70%) in year 1 of the 2023 cohort and 72% (95% CI, 69%–75%) in year 1 of the 2024 cohort (0.8% vs 2.4% and 0.5% vs 1.9% immunized vs unimmunized, respectively). No protection carried into the second year (wHR, 1.03; 95% CI, 0.73–1.43). Notably, nirsevimab was associated with higher rates of ENT bacterial infection hospitalizations in year 1 (wHR 1.36–1.43) and in year 2 (wHR, 1.56), and with higher asthma hospitalization rates in year 2 (wHR, 1.24; 95% CI, 1.05–1.46).

Study limitations

- Observational design cannot exclude residual confounding despite 1:1 matching and weighted Cox models. - The ENT and asthma signals in year 2 may reflect surveillance or healthcare-seeking bias rather than a true causal effect. - Full text was not available; analysis is based on the abstract and reported results only.

Clinical implications

Nirsevimab provides strong, consistent protection against RSV hospitalization in the first season across consecutive years of use, but clinicians should be aware that protection does not extend into a second RSV season. The unexpected associations with ENT bacterial infections and asthma hospitalizations in year 2 warrant further investigation before drawing causal conclusions.

Caveats

  • The associations with ENT bacterial infections and asthma hospitalizations in year 2 are observational and may be confounded by differential healthcare-seeking behavior or unmeasured factors; causality cannot be established.
  • The full text of the article was not accessible; all extracted data are from the abstract and results section only — key subgroup analyses or sensitivity analyses may be missing.
  • The sample size tag (n=250,198) reflects the combined total across both cohorts (74,672 + 175,526); these are distinct cohorts, not a single pooled trial.
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  • Two impact flags were applied (safety_signal for ENT/asthma associations; confirms_prior for RSV effectiveness) — this is unusual but warranted given the dual nature of the findings.

Related Questions

Explore related topics

Does nirsevimab protection against RSV last beyond the first season in infants?What are the safety signals associated with nirsevimab in real-world infant cohorts?How does nirsevimab effectiveness compare across the 2023-2024 and 2024-2025 RSV seasons?

Publication Details

Year
2026
Journal
JAMA Pediatrics
Sample Size
n=250,198
Source
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