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

Research hypothesis: The TGA cannot produce verifiable documentation demonstrating systematic implementation of its COVID-19 Vaccine Safety Monitoring Plan (February 2021), which specified 20 outputs defining "enhanced monitoring" required for provisional approval.

Data: Documentary evidence gathered 2021-2025 via FOI requests, OAIC decisions, Senate testimony, public TGA reports, and peer-reviewed literature. Assessed against ISO 19011:2018 and ANAO standards using the Plan's 20 outputs as benchmarks.

Findings: 3 of 20 outputs (15%) fully documented. 17 (85%) partially or not documented. Signal detection achieved 0% full implementation across 8 outputs; governance achieved 0% documentation. OAIC Decision [2025] AICmr 54 confirmed requested records "cannot be found or do not exist." Senate testimony (9 October 2025) confirmed Plan "never systematically tracked" and monitoring occurred through "day-to-day processes." No documentation verifies enhanced monitoring conditions were met before 68.4 million provisional doses transitioned to full registration.

Interpretation: Absence of proof that enhanced monitoring was systematically implemented, not proof that no monitoring occurred. Findings establish evidence base for formal audit by oversight bodies, parliamentary scrutiny, FOI appeals, and further research.

The complete audit repository with all primary source documents, version history, and detailed methodology is available on GitHub: https://github.com/paulrekaris/TGA-COVID19-Vaccine-Safety-Monitoring-Audit