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

ABSTRACT This independent citizen-led audit systematically evaluates the TGA COVID-19 Vaccine Safety Monitoring Plan (February 2021)—a National Cabinet-endorsed framework implementing legally mandated enhanced pharmacovigilance under provisional approvals. The audit assesses documented evidence for 20 Plan-specified outputs across four years, covering 68.4 million doses (91.2% of Australia’s rollout). The audit confronts regulatory governance’s core challenge: asymmetric information, where citizens cannot independently verify “enhanced” monitoring claims when processes remain undocumented. Findings reveal systematic documentation failures unprecedented in the context of Australia’s largest provisional medicine rollout—a “black box” problem where claimed “enhanced” monitoring cannot be independently verified. Only 3 of 20 outputs (15%) are fully documented, while 17 (85%) are partially or not documented—despite TGA classifying 2,218+ pages and 399 “Plan-aligned” documents (FOI 25-0166). TGA reports 148 signals investigated and 57 actions taken, yet no documented audit trails link signals to actions or account for the disposition of the remaining 91 signals. Senior TGA officials testified to the Australian Senate (9 October 2025) that monitoring occurred via “day-to-day processes” without systematic Plan tracking, rendering enhanced-monitoring compliance unverifiable. Independent academic research [Phillips et al. (Vaccine 2021)] documented the same structural weaknesses identified by 17 vaccine-safety experts in pre-rollout assessments—weaknesses persisting four years later. The audit provides evidence for independent investigation by Australian oversight bodies and reform of pharmacovigilance and provisional-approval frameworks to align with international standards (ICH E2E, CIOMS). Its open-source, falsifiable methodology applies ISO 19011:2018, ANAO guidance, and OSINT principles to public/FOI records, evaluating TGA against its own provisional approval and risk management plan requirements.