Is The TGA Meeting Its Charter?
Responsibilities Of The TGA
As part of the Australian Department of Health, the Therapeutic Goods Administration – TGA – has specific responsibilities around regulating therapeutic goods, including prescription medicines and vaccines. According to its own customer service charter, “Its overall purpose is to protect public health and safety.” Its conduct since the early part of 2020 has many people asking the question: Is The TGA Meeting Its Charter?
The following link leads to a Go Fund Me page, which has now been closed off – no more funds, thank you. However, update 27, dated 6th July was interesting. The frustration is palpable. (To read it, scroll down the page to the bottom of the latest update and click on “see older updates”)
Essentially, it outlines the obstacles placed in the way of having an application for assessment accepted.
Nikolai Petrovsky And Vaccinology – Background
A bit of background. Nikolai Petrovsky is an SA-based vaccine developer. He has contracted to the US government and provided them with number of vaccines. His company has developed a number of effective vaccines against SARS, MERS and Swine Flu, amongst others.
He has developed a Covid-19 vaccine, which has been trialled and is in use in Iran. He has been trying, virtually since day 1 of the Covid-19 pandemic, to get approval from the TGA (Australian Therapeutic Goods Association, Aussie equivalent of the UK’s MHRA).
Despite having a track record of successful vaccine development, government grants went to Uni of Queensland, with no history of anything to do with vaccines. Predictably, their phase I trials failed and their effort ended.
The TGA has since granted a provisional determination (the application for which cost $50k, I am told) that Vaxine Pty Ltd can now apply for provisional registration. Goodness knows how much that will cost. On their website, the TGA says:
“In making its decision to grant Vaxine Pty Ltd a provisional determination, the TGA considered all eligibility criteria, including factors such as the evidence of a plan to submit comprehensive clinical data and the seriousness of the current COVID-19 pandemic.”
This clearly applies to those it chooses. Not to Pfizer, Astra-Zeneca or Moderna. More from the TGA website:
“We carefully assess the results of clinical trials and the way in which the trials were conducted. We require well-designed trials of a sufficient length with a sufficient number of people who represent the people for whom the vaccine is intended. The results must demonstrate that the benefits of the vaccine greatly outweigh the risks.”
I was going to highlight some of that excerpt, but it is 100% nonsense when applied to the provisional approvals TGA gave to Pfizer, et al. There are few benefits to the provisionally approved covid-19 vaccines. The risks – including immune system degradation, as well as serious adverse events, short- and long-term – continue to grow.
THEY DON’T STOP INFECTION, SYMPTOMS OR TRANSMISSION
Covid-19 Case Numbers In Australia
Check out this graph, from health.gov.au, on Covid-19 case numbers >
- No vaccines in 2020.
- Vaccinations rolled out throughout 2021.
- Mass vaccination achieved by end 2021
What has happened in 2022?
Is the current state of the pandemic classified as serious, or not, when viewed in a historical perspective? What would the graph suggest?
The existing vaccines clearly DO NOT WORK. They don’t stop infection, symptoms or transmission.
- Why do health authorities continue to insist they do?
- Why are adverse events not being investigated as matter of the highest priority in analysing risk vs benefit?
- Why are obstacles continuing to be placed before Vaxine Pty Ltd?
- When all benign explanations are ruled out, what conclusion must be drawn?
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Ref 1 – TGA Provisional determination – https://www.tga.gov.au/tga-grants-provisional-determination-vaxine-pty-ltd-its-covid-19-recombinant-protein-vaccine
Ref 2 – TGA vaccine assessment overview – https://www.tga.gov.au/vaccines-overview