TY - JOUR
T1 - Vaccine safety in Australia during the COVID-19 pandemic
T2 - Lessons learned on the frontline
AU - Laemmle-Ruff, Ingrid
AU - Lewis, Georgina
AU - Clothier, Hazel J.
AU - Dimaguila, Gerardo Luis
AU - Wolthuizen, Michelle
AU - Buttery, Jim
AU - Crawford, Nigel W.
N1 - Funding Information:
Immunisation clinics in Victoria have traditionally focused on children, however the (initial) adult focus of the COVID-19 program demonstrated the need to expand specialist services for adults. In partnership with the Department of Health, SAEFVIC helped establish an expanded network of Victorian Specialist Immunisation Services (VicSIS), funded by the Victorian Government. These services enable tailored clinical review for individuals experiencing or at risk for AEFI, as well as access to allergy services and vaccination under observation (, ). Clinics are staffed by subspecialists, most commonly immunologists and infectious diseases physicians, with dedicated services developed for patients with allergy and immunosuppressed individuals with underlying cancer. SAEFVIC established a central electronic referral hub, to better triage and coordinate appointments, and link with SAEFVIC's surveillance systems ().
Funding Information:
The authors would like to acknowledge SAEFVIC and MVEC staff, and the Victorian Department of Health, for their work in supporting vaccine safety surveillance in Victoria. Thanks also to our VicSIS, AusVaxSafety, International Network of Special Immunisation Services, and Global Vaccine Data Network colleagues.
Publisher Copyright:
Copyright © 2022 Laemmle-Ruff, Lewis, Clothier, Dimaguila, Wolthuizen, Buttery and Crawford.
PY - 2022/11/4
Y1 - 2022/11/4
N2 - 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.
AB - 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.
KW - COVID-19 vaccines
KW - immunisation
KW - pharmacovigilance
KW - surveillance
KW - vaccine safety
UR - http://www.scopus.com/inward/record.url?scp=85142181513&partnerID=8YFLogxK
U2 - 10.3389/fpubh.2022.1053637
DO - 10.3389/fpubh.2022.1053637
M3 - Article
C2 - 36408022
AN - SCOPUS:85142181513
SN - 2296-2565
VL - 10
JO - Frontiers in Public Health
JF - Frontiers in Public Health
M1 - 1053637
ER -
