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 17 enhanced-pharmacovigilance outputs across five objectives defining "enhanced monitoring" required for provisional approval, plus two additional governance outputs, totalling 19 assessed outputs. Data: Documentary evidence gathered 2022-2026 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 19 outputs as assessment criteria. Findings: 3 of 19 outputs (16%) fully documented. 16 (84%) 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 classification criteria are documented within the dataset, and the codebook defines the variables, classification codes, evidence tiers, and rating scales used in the evidence matrix underlying the TGA COVID-19 Vaccine Safety Monitoring Documentation Dataset. Reproducibility: The dataset is structured to support direct verification of headline findings. All summary statistics — status distribution, status-by-objective cross-tabulation, severity aggregation — are reproducible from the underlying matrix using standard analytical tools (spreadsheet software, R, Python). Companion data paper (SSRN): doi.org/10.2139/ssrn.6610438 Zenodo: doi.org/10.5281/zenodo.20175557 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