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. 2024 Apr 4;12(4):383.
doi: 10.3390/vaccines12040383.

Effectiveness of Nirsevimab Immunoprophylaxis Administered at Birth to Prevent Infant Hospitalisation for Respiratory Syncytial Virus Infection: A Population-Based Cohort Study

Guillermo Ezpeleta  1 , Ana Navascués  2   3 , Natividad Viguria  3   4 , Mercedes Herranz-Aguirre  3   4 , Sergio Enrique Juan Belloc  5 , Juan Gimeno Ballester  6 , Juan Carlos Muruzábal  7 , Manuel García-Cenoz  1   3   8 , Camino Trobajo-Sanmartín  1   3   8 , Aitziber Echeverria  1   3   8 , Iván Martínez-Baz  1   3   8 , Noelia Vera-Punzano  1   3 , Itziar Casado  1   3   8 , Héctor López-Mendoza  1 , Carmen Ezpeleta  2   3 , Jesús Castilla  1   3   8
Affiliations

Effectiveness of Nirsevimab Immunoprophylaxis Administered at Birth to Prevent Infant Hospitalisation for Respiratory Syncytial Virus Infection: A Population-Based Cohort Study

Guillermo Ezpeleta et al. Vaccines (Basel). .

Abstract

Respiratory syncytial virus (RSV) infection is a frequent cause of hospitalisation in the first few months of life; however, this risk rapidly decreases with age. Nirsevimab immunoprophylaxis was approved in the European Union for the prevention of RSV-associated lower respiratory tract disease in infants during their first RSV season. We evaluated the effectiveness of nirsevimab in preventing hospitalisations for confirmed RSV infection and the impact of a strategy of immunisation at birth. A population-based cohort study was performed in Navarre, Spain, where nirsevimab was offered at birth to all children born from October to December 2023. Cox regression was used to estimate the hazard ratio of hospitalisation for PCR-confirmed RSV infection between infants who received and did not receive nirsevimab. Of 1177 infants studied, 1083 (92.0%) received nirsevimab. The risk of hospitalisation for RSV was 8.5% (8/94) among non-immunised infants versus 0.7% (8/1083) in those that were immunised. The estimated effectiveness of nirsevimab was 88.7% (95% confidence interval, 69.6-95.8). Immunisation at birth of infants born between October and December 2023 prevented one hospitalisation for every 15.3 immunised infants. Immunisation of children born from September to January might prevent 77.5% of preventable hospitalisations for RSV in infants born in 2023-2024. These results support the recommendation of nirsevimab immunisation at birth to children born during the RSV epidemic or in the months immediately before to prevent severe RSV infections and alleviate the overload of paediatric hospital resources.

Keywords: hospitalisation; infants; monoclonal antibodies; nirsevimab; respiratory syncytial virus; vaccination effectiveness; vaccination impact.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Weekly number of hospitalisations for confirmed respiratory syncytial virus infection during the 2023–2024 season among infants born in Navarre in 2023 and 2024 by birth month.
Figure 2
Figure 2
Flow chart of the population cohort of infants born from October to December 2023.
Figure 3
Figure 3
Effectiveness of nirsevimab in preventing laboratory-confirmed respiratory syncytial virus cases.
Figure 4
Figure 4
Observed incidence of hospitalisation for confirmed respiratory syncytial virus infection and estimated incidence of hospitalisations prevented by birth month among children born in Navarre in 2023 and follow-up from October 2023 to 14 January 2024.
See this image and copyright information in PMC

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