Documentation Gap Analysis: Independent Audit of TGA COVID-19 Vaccine Safety Monitoring Plan

This independent audit systematically evaluates the TGA COVID-19 Vaccine Safety Monitoring Plan (February 2021) — a National Cabinet-endorsed framework implementing enhanced pharmacovigilance under provisional approvals covering 68.4 million doses (91.2% of Australia's rollout).Findings reveal systematic documentation failures. Only 3 of 19 outputs (16%) are fully documented; 16 (84%) are partially or not documented — despite TGA classifying 2,218+ pages for OAIC review. TGA reports 148 signals investigated and 57 actions taken, yet no audit trails link signals to actions or account for 91 unresolved signals. Senior TGA officials testified (Senate, 9 October 2025) that monitoring occurred through "day-to-day processes" without systematic Plan tracking, confirmed by OAIC Decision [2025] AICmr 54.Methodology applies ISO 19011:2018, ANAO guidance, and OSINT principles to public and FOI records. Open-source, falsifiable, CC BY 4.0.Full evidence base and methodology: https://github.com/paulrekaris/TGA-COVID19-Vaccine-Safety-Monitoring-AuditAlso available on SSRN: https://ssrn.com/abstract=6333058Zenodo DOI: https://doi.org/10.5281/zenodo.17731054