Adverse Events Reported Following RSV Prefusion F Protein Vaccines Administration Among Approved Populations: A Cross-Sectional Study

Abstract

Introduction. Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infections among children and older adults. Two RSV prefusion F protein (RSVpreF) vaccines currently are approved for adults aged 60 years and older. However, little is known about the adverse events reported among individuals in this age group who have received an RSVpreF vaccine. The purpose of this study was to compare adverse events reported by nonpregnant adults (≥60 years old) who received an RSVpreF vaccine.
Methods. This study included individuals who reported a vaccine-related adverse event to the Vaccine Adverse Event Reporting System (VAERS). Data abstracted from VAERS were recoded into standardized adverse event categories for analysis.
Results. A total of 2,321 individuals were included. The three most frequently reported adverse event categories were neurologic, musculoskeletal, and constitutional symptoms. Recipients of Arexvy™ (Respiratory Syncytial Virus Vaccine, Adjuvanted) reported more injection site reactions compared with those who received Abrysvo™ (Respiratory Syncytial Virus vaccine). There were no adverse event categories that were more commonly reported among Abrysvo™  recipients compared with Arexvy™ recipients.
Conclusions. The adverse events observed in this study were consistent with findings from previous Phase II/III trials. The higher frequency of injection site symptoms among Arexvy™  recipients may be attributable to the adjuvant included in Arexvy™ but absent in Abrysvo™. Overall, these findings indicate that both vaccines provide safe protection against RSV for older adults, with minimal side effects, in a population that previously had no vaccination option.