SAEFVIC: Surveillance of adverse events following immunisation (AEFI) in Victoria, Australia, 2019-2020

Adverse event following immunisation (AEFI) surveillance in Victoria is conducted through Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC), an enhanced surveillance system integrated with clinical services for vaccinees experiencing an AEFI. This report summarises SAEFVIC's surveillance and vaccine pharmacovigilance activities in 2019 and 2020.

A retrospective cohort study approach was used to analyse AEFI reports submitted in 2019 and 2020, compared to those since 2015. Data were categorised by vaccinee demographics (age; sex; pregnancy; and Indigenous status), vaccines administered and reported AEFI. Age cohorts were defined as best fit to the National Immunisation Program age groups. Proportional reporting ratio was determined for perceived signals being investigated. Clinical services and educational activities were described.

There were 3,828 AEFI reports received in 2019 and 2020 (28.8 per 100,000 population), with 7.6% defined as serious; 52% of all reports were female vaccinees; 56 of 464 reports among adult females (12.1%) were pregnant vaccinees; and 29 reports (0.9%) were Indigenous Australians. Reporting trends by age group were similar across all cohorts. No vaccine safety signals were confirmed. Telehealth consultations at Specialist Immunisation Clinics increased in 2020 in-line with Medicare eligibility criteria changes. Educational resources on various vaccine safety topics were published, particularly the anticipated coronavirus disease 2019 (COVID-19) vaccination program.

AEFI surveillance in Victoria continues to be robust through the SAEFVIC model and provides confidence in informing the safety profile of vaccines administered in Australia. These data provide a baseline for AEFI surveillance for comparison to the COVID-19 vaccination program commenced in 2021.