SAEFVIC, Infection and Immunity, Murdoch Children's Research Institute, Melbourne, VIC, Australia.
Melbourne School of Population & Global Health, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, VIC, Australia.
Front Public Health. 2022 Nov 4;10:1053637. doi: 10.3389/fpubh.2022.1053637. eCollection 2022.
Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC), Victoria's vaccine safety service for reporting adverse events following immunisation (AEFI), has provided integrated spontaneous surveillance and clinical services for individuals affected by AEFI since 2007. We describe SAEFVIC's response to the COVID-19 vaccine program, and reflect on lessons learned for vaccine safety. The massive scale of the Australian COVID-19 vaccine program required rapid adaptations across all aspects of SAEFVIC's vaccine safety services. Collection of AEFI reports was streamlined and expanded, incorporating both spontaneous and active surveillance data. Dramatically increased report volumes were managed with additional staffing, and innovations to automate, filter, and triage reports for priority follow up. There were two major adverse events of special interest (AESI): thrombosis with thrombocytopaenia syndrome and myocarditis, with multiple other AESI also investigated. Rapid escalation mechanisms to respond to AESI were established, along with AESI-specific databases for enhanced monitoring. Vaccine education and training resources were developed and public-facing vaccine safety reports updated weekly. Frequent communication with local and national government and regulatory bodies, and consultation with specialist groups was essential. The COVID-19 vaccine program has highlighted the importance of vaccine safety in supporting public confidence in vaccines and informing evidence-based immunisation policy. Supporting the COVID-19 vaccine program has required flexibility in adapting to policy changes and evolving vaccine safety signals, careful triage and prioritisation, informatics innovation, and enhanced engagement with the public regarding vaccine safety. Long-term investment to continue strengthening vaccine safety systems, building on lessons learned, will be essential for the ongoing success of Australian vaccination programs.
社区疫苗不良事件监测（SAEFVIC）是维多利亚州针对接种后不良事件（AEFI）的疫苗安全服务，自 2007 年以来，一直为受 AEFI 影响的个体提供综合的自发监测和临床服务。我们描述了 SAEFVIC 对 COVID-19 疫苗计划的响应，并反思了疫苗安全方面的经验教训。澳大利亚 COVID-19 疫苗计划的大规模要求 SAEFVIC 的疫苗安全服务在各个方面迅速进行调整。AEFI 报告的收集得到了简化和扩展，包括自发和主动监测数据。通过增加人员配备、创新自动化、过滤和分类报告以进行优先跟进，管理了急剧增加的报告量。有两个主要的特别关注的不良事件（AESI）：血栓性血小板减少性紫癜综合征和心肌炎，还调查了多个其他 AESI。建立了针对 AESI 的快速升级机制，并为增强监测建立了 AESI 特定数据库。制定了疫苗教育和培训资源，并每周更新面向公众的疫苗安全报告。与地方和国家政府以及监管机构保持频繁沟通，并与专家组协商至关重要。COVID-19 疫苗计划强调了疫苗安全在支持公众对疫苗的信心和为循证免疫政策提供信息方面的重要性。支持 COVID-19 疫苗计划需要灵活适应政策变化和不断发展的疫苗安全信号，仔细甄别和优先排序，信息学创新，以及就疫苗安全问题与公众加强互动。为了澳大利亚接种计划的持续成功，长期投资继续加强疫苗安全系统，借鉴经验教训，将是必不可少的。
