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

This independent citizen-led audit systematically evaluates the TGA COVID-19 Vaccine Safety Monitoring Plan (February 2021), which operationalised National Cabinet's commitment to enhanced pharmacovigilance accompanying provisional approvals. The audit assesses documented evidence for 19 audited outputs across four years, covering 68.4 million doses (91.2% of Australia's rollout). The audit confronts a core challenge of regulatory governance: asymmetric information, where citizens cannot independently verify "enhanced" monitoring claims when the underlying processes remain undocumented. The audit finds systematic documentation failures in the context of Australia's largest provisional medicine rollout, creating a "black box" governance problem in which claimed "enhanced" monitoring cannot be independently verified. Only 3 of 19 outputs (16%) are fully documented, while 16 (84%) are partially or not documented, despite the TGA organising 2,218+ pages by Plan objectives for the OAIC (September 2024) and identifying, but refusing to process, 399 Plan-aligned documents for citizen access (FOI 25-0166). The TGA reports 148 signals investigated and 57 regulatory actions taken (subsequently updated to 150 signals in Senate Question on Notice 559), yet no documented audit trail links signals to actions or accounts for the disposition of the remaining 91 signals (61.5%). The Office of the Australian Information Commissioner (Decision [2025] AICmr 54) concluded that the requested documents "cannot be found or do not exist" following OAIC-directed searches of the Department's electronic document and records management systems. Senior TGA officials told the Australian Senate (9 October 2025) that monitoring occurred via "day-to-day processes" without systematic tracking against the Plan, leaving enhanced-monitoring implementation unverifiable in the documentary record. Independent academic research by Phillips et al. (Vaccine 2021), based on interviews with 17 Australian vaccine-safety experts before the COVID-19 immunisation program, identified opportunities for better integration of Australia's pharmacovigilance resources, clearer governance structures and regular evaluation, providing important pre-rollout context for the governance issues examined here. The resulting assurance gap is a governance concern: the available record does not provide sufficient documentary assurance to independently verify that a major national commitment to enhanced monitoring, tied to provisional approval, was systematically implemented, tracked and assured. The audit provides evidence for independent investigation by Australian oversight bodies and reform of pharmacovigilance and provisional-approval frameworks to align with international standards and recognised good practice, including ICH E2E and CIOMS. Its open-source, falsifiable methodology applies ISO 19011:2018, ANAO guidance, and OSINT principles to public and FOI records, evaluating the TGA against the enhanced-monitoring commitments in its own February 2021 Plan and relevant international pharmacovigilance standards and guidance. The underlying audit repository for this report, containing supporting evidence, primary source documents, methodology, version history, and replication resources, is maintained at: https://github.com/paulrekaris/TGA-COVID19-Vaccine-Safety-Monitoring-Audit