Peer-reviewed article

Post-licensure safety monitoring of nirsevimab in Western Australia 2024.

Kaija Strautins, Rachel Foong, Dale Carcione, Phoebe Spencer, Grace Pettigrew et al. · 16 Mar 2026

Abstract

BACKGROUND: Nirsevimab is a monoclonal antibody that prevents serious respiratory syncytial virus (RSV) illness among young children and first became available in Australia in 2024. Prior to the 2024 winter RSV season, the Western Australia (WA) Department of Health began offering nirsevimab to infants entering their first RSV season and children at high risk of severe RSV disease entering their second RSV season. As nirsevimab was a new product and post-marketing safety data were limited, routine reporting through established WA Vaccine Safety Surveillance (WAVSS) mechanisms was augmented to foster rigorous active monitoring of adverse events following immunisation (AEFI). METHODS: Two active surveillance methods were created: 1) weekly automated linkage between the Australian Immunisation Register and statewide healthcare datasets to search for possible AEFI; and 2) an online survey of parents whose newborns received nirsevimab. The data linkage process identified infants with specific ICD-10 codes presenting to an emergency department within 60 days of nirsevimab administration. The newborn survey was sent by SMS to parents consenting while in a maternity ward and queried symptoms in the week following nirsevimab administration. All potential AEFI identified through data linkage, parental survey, and routine WAVSS reports were assessed by experienced vaccine safety clinicians. RESULTS: Between April and September 2024, 23,143 infants received a dose of nirsevimab, including 9727 newborns and 12,195 infants aged under 1 year. Data linkage identified possible AEFI in 7 infants, of which 4 had underlying genetic conditions. The newborn survey SMS was sent to 4218 parents, of which 1106 (26%) responded; 46 (4%) reported that their newborn experienced a possible AEFI, none required medical attention. The most common reactions parents reported were expected and minor AEFI including gastrointestinal issues, injection site reactions, lethargy and irritability. WAVSS received 10 passively reported AEFI; 7 involved co-administration with a vaccine and 3 had concurrent viral infections. Across all three methods, no serious AEFI were attributed to nirsevimab following clinical review. CONCLUSION: WA's enhanced surveillance efforts support the safety of nirsevimab in newborns and infants.