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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
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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

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One of the Worlds best reporters, Bill Still, with his breaking report including an update from one of the worlds best Epidemiologists. Sounds like the walls are closing in on various medical entities around the world, that "may" have been part of something shocking!

Would there be medical entities in Australia that would need to be held accountable? Video of his report starts at the approx 52 Second Mark.

The Truth About COVID At Last!

https://www.youtube.com/watch?v=ZpMfMWV3DlQ

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Thank you for doing this vital work.

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I wrote to James Merlino MP today with a raft of science backed research why masks are not necessary or effective and some information regarding updates on effects of the inoculations called vaccines but aren't. Although I will be retiring mid year after a nearly 50 year career, the thrust of my communication was the detrimental effects that masks were having on midwifery and medical personnel creating a decrease in efficiency due to hypoxic effects and hypercapnia and effects on our cognition. We are chronically understaffed ,since December staff are jumping ship. We are frantically busy and wearing the masks is having a detrimental effects on our immune system. So I hope while they sit in their comfortable offices they…

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Replying to

It is hoping that they will gain some education. Janes was always a reasonable person. I have met face to face with my Fed and State member showing them information that corrects the propaganda.

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Yet Qantas is going ahead with it’s ‘no vaccine passport no flying’ policy.

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Rhonda Kerslake
Rhonda Kerslake
Mar 22, 2021
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I know this will not go down well with many, but if people boycotted this nonsense then we start to will, its all about power and voice. To many are in the comfort zone and don’t wish to realise that they are making it worse by complying to these ridiculous rules. All it will take is to boycott. We the people have to power to not go into a shop to scan or sign in. It’s about them controlling us. We must turn it around and control them. To many are just to lazy to step out of what they have been programmed to for to long. Thinking that what they had will be ok if they take the jab…

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Robin Hood
Robin Hood
Mar 21, 2021

No people in power are ever going into any jails. Jails are for pedos.

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Rhonda Kerslake
Rhonda Kerslake
Mar 21, 2021
Replying to

Have faith stay in the light don’t let the dark take over or it will consume you, Justice will take place.

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