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

<p>This independent audit evaluates the TGA COVID-19 Vaccine Safety Monitoring Plan (February 2021). The Plan operationalised National Cabinet's commitment to enhanced pharmacovigilance accompanying provisional approval, covering 68.4 million doses, 91.2% of Australia's rollout. Enhanced monitoring claims cannot be independently verified when the underlying processes are undocumented. This audit tests whether that verification is possible.The audit finds a systematic failure to demonstrate the enhanced monitoring underpinning Australia's largest provisional medicine rollout. Only 3 of 19 audited outputs (16%) are fully documented; 16 (84%) are partially or not documented. This is despite the TGA organising 2,218+ pages by Plan objectives for the Office of the Australian Information Commissioner (OAIC) in September 2024. The TGA reports 148 signals investigated and 57 regulatory actions taken (updated to 150 and 93 respectively in the subsequent Question on Notice 559). No audit trail links signals to actions, and 91 signals have no documented disposition in the record. The OAIC found that the implementation records could "not be located or do not exist". Senior TGA officials told the Senate (9 October 2025) that monitoring occurred through "day-to-day processes," without systematic tracking against Plan objectives. The TGA cannot demonstrate documented implementation of its own Safety Monitoring Plan. This is a potential failure of regulatory accountability for the largest provisional medicine rollout in Australia's history.The audit's open-source methodology applies ISO 19011:2018, ANAO guidance, and OSINT principles to public and FOI records, providing evidence for independent investigation and pharmacovigilance reform aligned with international standards and recognised good practice, including ICH E2E and CIOMS. It is published under CC BY 4.0: open access and independently replicable.The audit repository, containing the supporting evidence, primary sources, methodology, version history, and replication resources, is maintained at: https://github.com/paulrekaris/TGA-COVID19-Vaccine-Safety-Monitoring-AuditUpdated versions of this paper are available on SSRN: https://ssrn.com/abstract=6333058Version note: This revised version incorporates substantial additional documentary evidence and analysis that became available after the original version, including strengthened analysis of the pharmacovigilance statutory and regulatory framework and clarification of the relationship between provisional approval, enhanced safety monitoring and the regulator’s documented implementation of its monitoring commitments.</p>