TGA Reveals Absence of Safety Threshold for Continued Approval of COVID-19 Vaccine.

In a candid response to a statutory information request, the Therapeutic Goods Administration (TGA) has officially disclosed a lack of defined safety thresholds in the event of severe deaths or adverse events occurring to Australians after receiving the COVID-19 vaccination.

On the 25th of January 2021, the TGA issued provisional approval for the Pfizer sponsored COVID-19 vaccine COMIRNATY BNT162b2. This provisional approval was issued based on further post marketing assessment and information being provided to the TGA from Pfizer. The TGA also stipulated that they will ‘not hesitate to take action if safety concerns are identified’.[1] Considering approval is apparently based on continued surveillance of this new vaccine technology, clear definition of a safety exit point would be expected.

We utilised the Commonwealth Freedom of Information Act 1982 to require the TGA to respond with all relevant information to our request. Our request focussed specifically on discovering what exact numerical ratio of deaths or adverse events was considered acceptable by the TGA for continued approval of the vaccine. The TGA was obliged to inform us of the point at which the number of deaths or severe adverse events in comparison to the number of doses administered would trigger a removal of the product from the market.

FOI 2223 - Notice of Decision R.pdf

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The response from the TGA notified us officially under the statutory Freedom of Information Act 1982 that the TGA does not hold any information detailing any numerical damage threshold above which approval will be removed. Furthermore, additional information was provided by the TGA of their refusal to abide by any clear definition of safety in relation to deaths or adverse events reported post approval.

Comfortingly, they stated that regulatory action could be taken based on identified safety issues.

‘we undertake considered investigations into safety signals as they arise and determine appropriate regulatory actions on the basis of the nature and impact of the safety issue.’[2]

Of great concern however, is the lack of definition determining the point at which any action would be taken.

‘The TGA does not use pre-determined numerical ratios or thresholds to determine regulatory actions’[3]

Information provided detailed protective measures reliant on consideration by the administrative body, but completely lacked any kind of definition of what the TGA considered to be ‘safe’ in regards to deaths and severe adverse events when maintaining approval of the product.

When searching for comparable situations where the TGA has removed approval for a product, one cannot look past the catastrophic damage caused by the continued approval for surgically inserted transvaginal mesh products.

In 2007, a Cochrane review reported a complete lack of evidence supporting the use of permanent surgically inserted vaginal mesh products for vaginal prolapse.[4] As early as 2008, women started reporting severe side effects post surgery.[5] In 2012, women began winning court cases against manufacturers of this product.[6]

However, it took nearly ten years for pressure to build to the point that in 2017, the TGA cancelled approval for specific types of the mesh device.[7]

If we compare the TGA’s safety policy with the COVID lockdown measures, we notice that the lockdown measures also lack any defined damage threshold. However unlike the power source of lockdowns coming from predicted damage, the TGA’s alarming lack of ‘stop loss’ threshold relates to actual damage occurring.

We appreciate the TGA’s forthright response on this matter, and believe that the Australian public needs to understand the lack of substance behind their continuous statements regarding future safety monitoring for the novel biological product.

In further exploration of this topic, another request under the Freedom of Information Act 1982 has been lodged for information specifically disclosing exactly what adverse events the TGA recognises to be a safety concern.

[1]'TGA provisionally approves Pfizer COVID-19 vaccine’ Australian Government Department of Health Therapeutic Goods Administration (media release, 25 January 2021) https:// www.tga.gov.au/media-release/tga-provisionally-approves-pfizer-covid-19-vaccine. [2]See ‘FREEDOM OF INFORMATION REQUEST FOI 2223’ page two. [3]See ‘FREEDOM OF INFORMATION REQUEST FOI 2223’ page two. [4] https://pubmed.ncbi.nlm.nih.gov/17636742/ [5] https://www.consumersafety.org/medical-device-lawsuits/vaginal-mesh/ [6] https://www.classaction.com/transvaginal-mesh/settlement/ [7]https://www.tga.gov.au/hubs/transvaginal-mesh