Projecting maximum potential demand for nirsevimab to protect eligible US infants and young children against respiratory syncytial virus in the 2024/2025 season

Vaccine. 2025 Apr 19:53:127109. doi: 10.1016/j.vaccine.2025.127109. Epub 2025 Apr 11.

Abstract

Nirsevimab is a long-acting monoclonal antibody that protects infants and young children against severe respiratory syncytial virus (RSV) disease. Children are eligible for one 50 mg dose, one 100 mg dose, or two 100 mg doses of nirsevimab based on age, weight, time of year, maternal vaccination, and risk of severe disease. In winter 2023/2024, we developed a model to project the number of nirsevimab doses needed to immunize all eligible U.S. children during the 2024/2025 season. We grouped all births from March 2023 through March 2025 into weekly cohorts, partitioned those cohorts based on eligibility criteria, and computed eligibility for each partition. In the absence of maternal RSV vaccination, we estimated U.S. children would be eligible to receive 4.3 million nirsevimab doses in 2024/2025, of which 48% would be 100 mg doses. Projections of total eligibility can be used to inform production goals and avoid shortages of nirsevimab.

Keywords: Infants and young children; Nirsevimab demand; Respiratory syncytial virus.

MeSH terms

  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Antiviral Agents
  • Child, Preschool
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Respiratory Syncytial Virus Infections* / prevention & control
  • Respiratory Syncytial Virus, Human / immunology
  • Seasons
  • United States / epidemiology
  • Vaccination

Substances

  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents