Vaccine safety in Australia during the COVID-19 pandemic: Lessons learned on the frontline

Abstract

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.

Real-world Nuvaxovid COVID-19 vaccine safety profile after first 100,000 doses in Australia, 2022-2023

“…This study is based on enhanced passive surveillance data, which will incur the known biases of spontaneous reporting systems, including under-reporting[16]. Although AEFI reporting is not mandated in Victoria this does not result in lower reporting, as is evidenced by Victoria being the lead jurisdiction by AEFI reporting volume nationally[16, 34]. However, in this study AEFI reporting was lower in the larger populated state of Victoria, despite similar number of doses being administered.…”

“…However, in this study AEFI reporting was lower in the larger populated state of Victoria, despite similar number of doses being administered. We hypothesize that pragmatic surveillance modifications made to ensure routine systems were not overwhelmed by the pandemic surge brought intentional focus and increased case ascertainment of medically attended events, such as chest pain[34, 35].…”

“…This study aimed to provide a description of AEFI reported following Nuvaxovid and is not structured to provide direct comparison to other brands administered in different phases of circulating COVID-19 disease incidence or surveillance processes initiated to accommodate the high volume of reporting through the pandemic [34,36]. SAFEVAC collates reports of adverse events and does not have identified data-linkage to disease notification datasets necessary to understand the impact of prior or coincident COVID-19 disease on AEFI occurrence and/or increase in incidence above background rates [37,38].…”

COVID-19 Vaccination Reporting and Adverse Event Analysis in Taiwan

“…Such recommendations could extend to improving surveillance systems to better capture adverse events, which is crucial for the timely detection and response to potential vaccine-related issues [ 28 ]. Enhanced surveillance not only aids in immediate risk management, but also contributes to the long-term goal of strengthening vaccine safety systems [ 31 ]. Transparency in reporting and the tailoring of public health communications are also fundamental to maintaining and building vaccine confidence [ 28 ].…”

Interdisciplinary Learning Health System Response to Public Vaccine Concerns

“…Vaccine safety surveillance of AEFI is a critical component of national immunisation programs [1,3]. In Victoria, Australia, jurisdictional vaccine safety services are provided by SAEFVIC through enhanced AEFI surveillance integrated with clinical services for all types of vaccines [4]. Vaccines have reduced the prevalence and incidence of vaccinepreventable diseases.…”