Prof. Federico Martinón-Torres (Instituto de Investigación Sanitaria, Spain) presented results from the NIRSE-GAL (NCT06180993), a prospective, longitudinal, population-based study [1]. Between October 2023 and March 2024, infants born in Galicia, Spain, were offered a single dose of nirsevimab and were followed up using electronic health records for 18 months (two RSV seasons). Recurrent hospitalisations were defined as ≥2 hospitalisations, and outcomes were assessed for RSV-related lower respiratory tract infection (LRTI), all-cause LRTI, bronchitis/bronchiolitis, and all-cause hospitalisations. The effect of nirsevimab was estimated by comparison with historical data (2016-2023).
The final dataset included 12,492 children (N=11,196 immunised and 696 non-immunised). The overall risk reduction (RR) in recurrent RSV-related LRTI hospitalisation with nirsevimab was 85.5%, although significant RRs were seen only in the second season (78.2%, 2024-2025). Recurrent all-cause LRTI hospitalisations were significantly reduced in both seasons, with an RR of 75.5% overall, 74.7% for the first season, and 62.4% for the second season. Furthermore, recurrent hospitalisations due to acute bronchitis/bronchiolitis were also significantly reduced following nirsevimab immunisation, with RRs of 81.6%, 75.9%, and 76.9% overall, and for the first and second seasons, respectively. Similarly, risk reduction was seen for all-cause recurrent hospitalisations, corresponding to RRs of 16%, 29%, and 7.4% (not significant for the second season).
“Universal administration of nirsevimab as part of a regional or national programme significantly reduced the burden of recurrent hospitalisations due to RSV specifically, but also due to lower respiratory tract infections and bronchiolitis,” said Prof. Martinón-Torres. “We think these findings are important for healthcare planning and for evaluating the implementation of prophylaxis against RSV.”
- Razzini JL, et al. Impact of universal nirsevimab immunisation on recurrent RSV-related hospitalisations across 2 consecutive RSV seasons: NIRSE-GAL study. 6th ESCMID Vaccines, 10–13 September 2025, Lisbon, Portugal.
Medical writing support was provided by Mihai Surducan, PhD.
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