A post-marketing surveillance study of a human rabies vaccine in China (2020–2024)
Background and objective To evaluate the safety profile of Yisheng Jun’an® freeze-dried human rabies vaccine (Vero cell) through post-marketing surveillance in China (2020–2024), focusing on adverse reaction patterns and influencing factors. Methods A retrospective observational study analyzed 2,419 adverse events from the national Direct Adverse Event Reporting System (DAERS) and manufacturer-collected data. Adverse reactions were categorized by type, severity, and subgroup (age, gender, dose number, etc.) using the Medical Dictionary for Regulatory Activities (MedDRA) for standardized coding. Analysis of incidence rates with 95% confidence intervals, use of the chi-square test to assess associations, and cross-subgroup comparisons were conducted to elucidate the safety profile of the vaccine. Results In total, 2,419 AEs were reported, yielding an overall incidence of 7.406 per 100,000 doses (95% CI 7.11–7.71). Systemic reactions comprised 83.38% and local reactions 16.62%. Seventeen serious adverse events (0.70%) occurred; no deaths were reported and all recovered. The most common categories were general disorders/administration-site conditions (83.38%) and immune system disorders (5.70%). AEs were most frequent after the first dose (85.49%) and declined markedly with subsequent doses. Systemic reactions were more common in children (0–10 years: 37.99%). Conclusion Yisheng Jun’an® rabies vaccine exhibits a favorable safety profile with mild-to-moderate reactions, supporting its use in post-exposure prophylaxis.