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Nirsevimab decreased the subsequent risk of respiratory syncytial virus infection and wheezing in the 2023–2024 RSV season

Pediatric Research volume 98, pages 388–390 (2025)Cite this article

Preventing respiratory syncytial virus (RSV) infection in infants and young children is a global public health priority.1 Long-term respiratory outcomes associated with RSV infection are recurrent wheezing and childhood asthma, as respiratory viruses can cause airway epithelial damage, inflammatory changes in the airways, bronchial hyperresponsiveness, and cytokine overproduction.2 In July 2023, the U.S. Food and Drug Administration approved nirsevimab, a monoclonal antibody with an extended half-life for preventing RSV infection in both preterm and term infants.3 However, nirsevimab real-world impact post-approval and widespread use on its effectiveness in preventing respiratory infections and their consequences, especially wheezing, remains limited. Hence, we used a real-time database to compare the effectiveness of nirsevimab in immunized infants from the 2023–2024 RSV season who received nirsevimab prophylaxis to those who did not.

This population-based cohort study was conducted using the TriNetX Research Network, a de-identified electronic medical record database from 93 health-care organizations, which are mainly tertiary care centers in the U.S. but also include some global centers. Given the anonymized nature of the dataset as per the deidentification standard defined in Section §164.514(a) of the HIPAA Privacy Rule, the study was exempt from institutional review board review and informed consent. This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guidelines. We used International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes, Current Procedural Terminology (CPT), and RxNorm to identify the exposure, covariates, and outcomes (Supplementary eTable 1). We identified infants (i.e., age <12 months) who had an encounter for routine immunizations from October 1, 2023 to March 31, 2024: infants who received nirsevimab and at least one routine immunization were included in the nirsevimab group. Those who received only routine immunization but not nirsevimab were included in the non-recipient group. The index date was the date of the nirsevimab administration or the first encounter for routine childhood immunization. The outcomes of interest were RSV infection, including codes for bronchiolitis, bronchitis, pneumonia, otitis media, and upper respiratory infection all due to RSV, and wheezing. Infants were tracked from the index date until the earliest of the following censoring events: occurrence of the pre-specified outcomes, death, loss to follow-up, or the end of the follow-up period (up to 365 days after the index date).

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Author notes

  1. These authors contributed equally: Kevin Sheng-Kai Ma, Serena Y. Tsai.

  2. These authors jointly supervised this work: Camille N. Kotton, Jonathan M. Mansbach.

Authors and Affiliations

  1. Center for Global Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

    Kevin Sheng-Kai Ma

  2. Department of Dermatology, Massachusetts General Hospital, Boston, MA, USA

    Serena Y. Tsai

  3. Divisions of Hospital Medicine and Infectious Disease, Department of Pediatrics, Mass General for Children, Harvard Medical School, Boston, MA, USA

    Chadi M. El Saleeby

  4. Transplant and Immunocompromised Host Infectious Diseases Unit, Infectious, Diseases Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

    Camille N. Kotton

  5. Department of Pediatrics, Boston Children’s Hospital, Boston, MA, USA

    Jonathan M. Mansbach

Authors
  1. Kevin Sheng-Kai Ma
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  2. Serena Y. Tsai
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  3. Chadi M. El Saleeby
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  4. Camille N. Kotton
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  5. Jonathan M. Mansbach
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Contributions

Substantial contributions to conception and design: K.S.M., S.Y.T., J.M.M. Acquisition, analysis, and interpretation of data: K.S.M., S.Y.T. Drafting the article and revising it critically for important intellectual content: all authors. Final approval of the version to be published: all authors.

Corresponding authors

Correspondence to Kevin Sheng-Kai Ma or Jonathan M. Mansbach.

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Competing interests

C.M.E.: Pfizer, Inc. K.S.M., S.Y.T., C.N.K., J.M.M.: none reported.

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Ma, K.SK., Tsai, S.Y., El Saleeby, C.M. et al. Nirsevimab decreased the subsequent risk of respiratory syncytial virus infection and wheezing in the 2023–2024 RSV season. Pediatr Res 98, 388–390 (2025). https://doi.org/10.1038/s41390-024-03782-4

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