Respiratory syncytial virus prevention is finally here: An overview of safety.

Abstract

Background: A number of respiratory syncytial virus (RSV) prevention products have recently been approved in Australia. These products focus on highest risk groups, aiming to prevent RSV disease in young infants and older adults. While not currently included in the National Immunisation Program (NIP), an RSV vaccine (Arexvy, GlaxoSmithKline [GSK]) is available privately for adults ≥60 years, and some Australian jurisdictions have commenced RSV monoclonal antibody (nirsevimab) programs for infants in 2024.

Objective: This article summarises safety data regarding RSV prevention products approved in Australia, including vaccines for adults ≥60 years, maternal vaccines and monoclonal antibodies for infants.

Discussion: Clinical trial data found these products were largely well tolerated, with most local and systemic reactions being mild-moderate and short-lived. Proportions of serious adverse events were low. While very rare, potential safety signals being further assessed include risk of preterm birth following the maternal vaccine (Abrysvo, Pfizer) and Guillain-Barré syndrome (GBS) following RSV vaccines in older adults (Abrysvo and Arexvy). Close monitoring of these adverse events of special interest via post-licensure surveillance is underway.