Safety of an SV-1 Cell Line-Based Varicella Vaccine Before and After Integration into the Expanded Program on...

Background/Objectives: Varicella is a highly contagious childhood disease that may cause severe complications in susceptible populations. The SV-1 cell line-based varicella vaccine (VarV [SV-1]) has been increasingly used in routine immunization; however, safety and reporting patterns during the transition from partial use to full Expanded Program on Immunization (EPI) implementation remain poorly characterized. This study aimed to evaluate the safety profile and reporting dynamics of VarV (SV-1) before and after its incorporation into the Expanded Program on Immunization in Jiangsu Province, China. Methods: A retrospective observational study was conducted using data from the Jiangsu Provincial Immunization Integrated Service Management Information System and the Chinese National Adverse Event Following Immunization (AEFI) Information System (CNAEFIS), including all reported AEFI following VarV (SV-1) vaccination among children under 6 years of age during 2021-2023. Temporal trends, distribution characteristics, and factors associated with AEFI reporting were assessed using descriptive analyses, negative binomial (NB) regression models, and interrupted time series (ITS) analysis. Results: A total of 1,208,500 doses of VarV (SV-1) were administered, and 634 AEFI cases were reported, corresponding to an overall reporting rate of 52.46 per 100,000 doses. Most reported events were mild, self-limiting common reactions, predominantly pyrexia and injection-site reactions. No serious adverse events were identified. Although no immediate level change was observed at EPI implementation, a significant increasing post-EPI trend was detected, consistent with enhanced surveillance sensitivity rather than a change in intrinsic vaccine safety. Abnormal reactions were rare and resolved without sequelae. Conclusions: AEFI reporting rates following VarV (SV-1) vaccination in Jiangsu Province were within expected ranges, predominantly mild and reversible. Findings support the favorable safety profile of the VarV (SV-1) in routine childhood immunization programs and provide real-world evidence to support continued implementation of the two-dose varicella vaccination strategy within the EPI.