Case study: Developing enhanced surveillance of adverse events following COVID-19 immunisation in NSW

Prior to COVID-19, the process for reporting and managing adverse events following immunisation (AEFIs) was routine ‘business as usual’ for NSW public health units (PHUs), with approximately 650-800 AEFI reports through to the Therapeutic Goods Administration (TGA) each year, and high-level adverse events of significance (including deaths) requiring expert panel review occurring every 1-2 years.

On 22 February 2021, the first COVID-19 vaccine became available, and the NSW vaccine rollout began. The increase in vaccines administered – and resulting increase in adverse events and workload of the NSW health system – necessitated the development of an enhanced surveillance and reporting program for AEFIs (the COVID-AEFI program). This involved:

• enhanced surveillance and signal detection from the Public Health Rapid, Emergency, Disease and Syndromic Surveillance (PHREDSS) system, laboratories, clinicians, PHUs and the TGA
• daily team huddles with direct reporting to the Chief Health Officer, and escalation when necessary for cases of concern
• daily immunologist reviews of reported cases
• enhanced reporting to the TGA with early flagging of high-risk cases and detailed case reports
• weekly statewide email communication regarding reporting requirements for AEFIs, clinical management of AEFIs, and updates from the TGA website and ATAGI (Australian Technical Advisory Group on Immunisation)
• expert panels to address complex cases, diagnostic uncertainty and family concerns.

This enhanced process placed considerable strain on the workloads of PHU and Ministry staff. Further, the Ministry and TGA grappled with the heightened public scrutiny of AEFIs resulting from the COVID-19 vaccine. Rapid recruitment occurred to support AEFI reporting, investigation and advice; the Ministry’s COVID AEFI Team grew from two staff members to more than 20 over 4–6 weeks. However, this adaptation was seen as necessary and impactful. The investigation and proactive management of AEFIs through this enhanced system also increased vaccine confidence and acceptability in the NSW community.