Over a 3 year battle, Paul Rekaris & Dr Julie Sladden have battled to expose hard truths behind Australia’s vaccine safety oversight. The TGA had denied accountability documents existed, until they didn’t. The battle continues
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A three-year battle under the Freedom of Information (FOI) Act has pulled back the curtain on a troubling contradiction at the heart of Australia’s pharmaceutical regulation. The Therapeutic Goods Administration (TGA) the body charged with safeguarding public health, claims both to possess and not possess documentation showing how it monitored Covid 19 vaccine safety.
This paradox is not just bureaucratic bungling. It raises serious concerns about transparency, legal compliance, and the integrity of our public health system during one of the most consequential vaccine rollouts in history.
The Safety Plan That May Not Have Been Followed
When Covid-19 vaccines received provisional approval in early 2021, they did so under strict conditions. Unlike full approvals, provisional status hinges on limited clinical data, making robust post-market surveillance not optional, but legally mandatory.
The TGA’s own Covid 19 Vaccine Safety Monitoring Plan, released in February 2021, promised enhanced safety oversight, including:
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Active monitoring of adverse events
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Real-time safety signal detection
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Immediate investigation of unexpected outcomes
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Regular public updates
These measures were intended to ensure that Australians could trust the vaccines during a high-stakes, fast-moving global health emergency. Yet, when asked to show how it had implemented this plan, the TGA replied that the relevant documentation “does not exist.”
Then, in a stunning reversal, it claimed it did in fact hold "ample documentation" of compliance.
A Contradiction That Defies Accountability
The TGA’s inconsistent FOI responses violate not only public expectations but also statutory obligations. Under Section 24A of the FOI Act, an agency can only deny access to documents if they genuinely do not exist or cannot be found after reasonable searches. In this case, neither applied.
Worse still, the TGA is required by multiple laws and international guidelines to maintain clear records of how safety monitoring is carried out, especially for provisionally approved medicines.
The agency’s refusal to provide documents, then admission of their existence, followed by repeated delays, paints a picture of regulatory confusion or worse, willful obfuscation.
Documents Surface Under Pressure
It wasn’t until the Office of the Australian Information Commissioner (OAIC) intervened that the TGA disclosed more than 2,200 pages of documents, including:
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679+ pages on signal detection
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406+ on regulatory responses
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303+ detailing adverse event assessments
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250+ pages of public communication records
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274+ on stakeholder collaboration
These were the very implementation documents that, for over a year, the TGA claimed either didn’t exist or couldn’t be produced.
This long delay rendered the information nearly useless during the critical mass vaccination period undermining the very purpose of safety transparency in the first place.
A Broken Information Management System?
The disclosures raise an alarming question: If the TGA couldn’t access its own safety documentation, how could it possibly detect real-time safety signals?
In its submissions to the OAIC, the TGA admitted:
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It only searched records from February 2022 onward, skipping the first year of rollout
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It assessed plan objectives in isolation instead of holistically
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It failed to locate daily collaboration logs with WHO/ICMRA, even though they were referenced in the Safety Plan
This points to a deeper systemic failure, one that cuts across information management, legal compliance, and risk governance.
In another FOI case (#5275), the TGA again claimed Pfizer’s post-market safety data "did not exist", even though its Safety Plan explicitly required the collection of that very data.
A Crisis of Trust
Our original FOI request FOI 3643 took 1,133 days to resolve. It spanned the entirety of Australia’s vaccine rollout. And even now, with follow-up requests underway, the TGA is once again initiating a “practical refusal” process, citing resource constraints.
But this isn’t about red tape. It’s about accountability in the most consequential public health initiative in modern history.
The TGA’s inability or unwillingness to promptly disclose safety monitoring records raises a chilling possibility: That key conditions for vaccine approval may have been formalities, not functional obligations.
If the regulator cannot confirm whether it implemented its own safety protocols, then what is it regulating?
Final Questions
The TGA's handling of vaccine safety documentation raises several urgent questions:
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Was the Covid-19 Vaccine Safety Monitoring Plan ever operational, or simply a checkbox to enable provisional approval?
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How can the TGA reconcile its contradictory claims of having “no records” and “ample documentation”?
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Can a regulator that fails to track its own compliance realistically monitor national safety outcomes?
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How can the public trust any provisionally approved medicine if oversight obligations are unverifiable?