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

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.

[1]  N. Crawford,et al.  Safety of COVID‐19 vaccine challenge in patients with immediate adverse reactions to prior doses: A multi‐centre cohort study , 2022, Allergy.

[2]  B. Carleton,et al.  Advancing the Science of Vaccine Safety During the Coronavirus Disease 2019 (COVID-19) Pandemic and Beyond: Launching an International Network of Special Immunization Services , 2022, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[3]  Daryl R. Cheng,et al.  Myocarditis and myopericarditis cases following COVID-19 mRNA vaccines administered to 12–17-year olds in Victoria, Australia , 2022, BMJ Paediatrics Open.

[4]  E. Duckworth,et al.  Victorian Specialist Immunisation Services (VicSIS) – bolstering adult clinics for COVID-19 vaccines , 2022, Human vaccines & immunotherapeutics.

[5]  E. Wood,et al.  Immune thrombocytopenia following immunisation with Vaxzevria ChadOx1-S (AstraZeneca) vaccine, Victoria, Australia , 2021, Vaccine.

[6]  L. Kiers,et al.  Guillain‐Barré Syndrome in an Australian State Using Both mRNA and Adenovirus‐Vector SARS‐CoV‐2 Vaccines , 2021, Annals of neurology.

[7]  J. Curnow,et al.  Australian and New Zealand approach to diagnosis and management of vaccine‐induced immune thrombosis and thrombocytopenia , 2021, The Medical journal of Australia.

[8]  C. Barr,et al.  The next frontier in vaccine safety and VAERS: Lessons from COVID-19 and ten recommendations for action , 2021, Vaccine.

[9]  S. Kochhar,et al.  Planning for COVID-19 vaccines safety surveillance , 2020, Vaccine.

[10]  K. Kim,et al.  What Is COVID-19? , 2020, Frontiers for Young Minds.

[11]  H. Kelly,et al.  Evaluation of ‘SAEFVIC’, A Pharmacovigilance Surveillance Scheme for the Spontaneous Reporting of Adverse Events Following Immunisation in Victoria, Australia , 2017, Drug Safety.

[12]  H. Clothier,et al.  Consumer reporting of adverse events following immunization , 2014, Human vaccines & immunotherapeutics.

[13]  H. Clothier,et al.  Active surveillance for adverse events following immunization , 2014, Expert review of vaccines.

[14]  George Bosilca,et al.  The next frontier , 1997 .

[15]  K. Shadan,et al.  Available online: , 2012 .