Surveillance of adverse events following immunisation in Australia annual report, COVID-19 vaccines, 2022

This report summarises Australia's spontaneous surveillance data for adverse events following immunisation (AEFI) for COVID-19 vaccines given in 2022 reported to the Therapeutic Goods Administration (TGA). The TGA strongly promoted and facilitated adverse event reporting in preparation for and during the COVID-19 vaccine rollout as a core component of the most intensive vaccine safety monitoring ever conducted in Australia. There were 18,398 AEFI reports for COVID-19 vaccines administered in 2022, corresponding to an annual AEFI reporting rate of 89.6 per 100,000 doses of COVID-19 vaccines administered. The annual AEFI reporting rate for non-COVID-19 vaccines in 2022 was 18.8 per 100,000 doses administered to people of all ages. Overall, the most frequently reported symptoms were adverse events consistent with the expected side effects from vaccines, as reported in clinical trials. These were classified as 'gastrointestinal nonspecific symptoms and therapeutic procedures', headache, chest pain, myalgia and pyrexia. The most frequently reported adverse events of special interest were myocarditis and/or pericarditis, followed by thrombosis and thromboembolism, and anaphylaxis. Of all COVID-19 vaccine AEFI reports, 160 (0.9%) included a fatal outcome, of which over 60% were in people aged ≥ 60 years. Of these 160 reports, only one was assessed by a Vaccine Safety Investigation Group (VSIG) as a death likely to be causally linked to vaccination. This report confirms the value of spontaneous post-marketing vaccine pharmacovigilance, especially in the context of new vaccines using novel technologies and a near whole-of-population pandemic vaccination program. Ongoing safety monitoring continued to review and respond to reports of rare, unexpected conditions, such as myocarditis/pericarditis, with investigations resulting in changes to vaccine recommendations and product information. Overall, COVID-19 vaccine safety monitoring continued to demonstrate a reassuring safety profile for these vaccines, especially among children and adolescents aged 11 years and below, in whom COVID-19 vaccines were used for the first time in 2022 in Australia.