FOI to the TGA December 2020

About 9 documents coughed up after about 6 months (will check/edit later), most were completed useless, only the Pfizer doc (created by Pfizer) had anything of any interest. “Document 9”
Document 9 – BioNTech Pfizer Investigator Brochure (pdf)

Email to the Office of the Australian Information Commissioner after TGA did not provide the documents requested, Mon, 28 Jun 2021.

MR21/00268 Jxxx Bxxxx and Department of Health – Next Steps [SEC=OFFICIAL]

 

Dear Lachlan,

I appreciate the opportunity to amend my IC Review, given that the TGA has not fulfilled provision of the requested documents. The documents provided do not provide the comprehensive clinical trial reports – the RESULTS of the trials. Documents outlining the planning and structure of the trials, not the RESULTS of HUMAN trials. A couple of references to mice trial results, but GLARINGLY OBVIOUS LACK OF HUMAN trial RESULTS. Redacting s4,5,6 data from Doc9 provides NO RESULTS of any value at all.

The TGA has NOT provided the requested information.

I bring to your attention the complete lack of mention of effects on fertility in all but one document I believe.

UNTESTED for the effects on fertility.

Document 9:

“5.3.1.15
Reproductive and developmental toxicity
Macroscopic and microscopic evaluation of male and female reproductive tissues were included in the GLP repeat-dose toxicity study testing BNT162a1, BNT162b1, BNT162b2, and BNT162c1 in rat (Section 5.3.1). No changes in these tissues were reported. Specific fertility and embryofetal development studies are ongoing.
Where are the RESULTS of that testing?? UNTESTED for effects on fertility.

“5.3.1.13
Genotoxicity
The components of all BNT162 vaccines (lipids and RNA), are not suspected to have genotoxic potential. No impurity or component of the delivery system warrants genotoxicity testing. Therefore, in accordance with the WHO guideline (WHO Technical Report Series, No. 927, “Annex 1: WHO guidelines on nonclinical evaluation of vaccines”, 2005), no genotoxicity studies were performed. UNTESTED.

5.3.1.14
Carcinogenicity
RNA itself, and the lipids used in the BNT162 vaccines have no carcinogenic or tumorigenic potential. Furthermore, according to ICH S1A (ICH S1A Guideline: “Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals”, November 1995), no carcinogenicity studies are required for therapeutics that are not continuously administered. Therefore, no carcinogenicity studies were performedUNTESTED.

Going to Section 6, “Effects in Humans”, and the critical results have been redacted. What are they hiding? How can an informed decision be made when they are clearly HIDING the RESULTS. No informed consent can be made without the information. S4,S5,S6, HEAVILY REDACTED. It’s not hiding personal information, it’s hiding the EFFECTS ON HUMANS. An “affected third party”? Who, the public?? Of course they are affected, which is why the public should be provided this information. The manufacturers? Of course, profits will be affected should the trial RESULTS be provided to the public. Conflicts of interest? If the public were able to make an informed decision they wouldn’t have a bar of this UNTESTED, EXPERIMENTAL, INJECTION.

Where are the trial results for cytokine responses 3 months post injection??
Where are the trial results for cytokine responses when the recipient comes in contact with a run of the mill coronavirus 2 weeks post injection??
Where are the disclosures for mRNA triggered diseases through “gain of function” in the injections or their components??

 
The TGA has NOT provided the requested information.
Furthermore, in order to establish possible reasons for deliberately withholding actual test results from the public, the IC Review of this process should investigate:

What contractual, and/or funding arrangements have been made between Bill and Melinda Gates Foundation (BMGF), Gavi, the Vaccine Alliance (GAVI), World Health Organisation (WHO), International Monetary Fund (IMF), World Economic Forum (WEF), The Doherty Institute, Pfizer, Moderna, Oxford (“vaccine” manufacturers), with either – the Theraputic Goods Administration (TGA), the Australian Government Department of Health, or Australian Government agencies, or key staff.

Full disclosure of funders, grants and monies received from industry.

  1. The Therapeutic Goods Special Account (under Section 80 of the Public Governance, Performance and Accountability Act 2013 and Section 45 of the Therapeutic Goods Act 1989)
  2. TGA’s activities are fully cost recovered from fees and charges imposed on industry, with the exception of Government funding provided for the alignment of Australia and New Zealand therapeutic arrangements, and departmental funding for the operation of the Drug Control Section and Medicines Scheduling Secretariat.
  1. Having regard to the above, please provide a list of all, Contractors, Agents, agencies (Governmental and Non-Governmental), individuals – (Corporate and non corporate), Domestic and international who have paid “fees and charges” to fund the TGA, for the period 2017 onward if they are from major players eg. BMGF, WHO, GAVI, IMF etc.
  2. A table listing the amounts received by TGA from each of the above named parties.
  3. Whether the amounts relate to specific grants or projects.

Additionally, what contracts or agreements have been made with reference to language used by Australian Government agents or agencies regarding “safe”, “approved” and “tested” when referring to the COVID-19 “vaccines”? Clearly these injections (they are not vaccines by medical definition) are UNTESTED, and are NOT SAFE. They have been “approved” for emergency use, according to guidelines created by UNELECTED, self appointed, foreign entities (WHO, UN).
The public are being DELIBERATELY DECEIVED when being told they are “tested”, “approved” and “safe”. I notice the latest television advertising now states the injection is “free and simple”. Yes, it is “free”, and simple for the simple, but still UNTESTED and UNSAFE. Why wouldn’t the Australian Government and it’s agencies be truthful and disclose publicly that these experimental injections are UNTESTED for the effects on fertility and autoimmune responses, along with a plethora of serious side effects? The AstraZeneca “vaccine” to be terminated in October because it has been demonstrated by INJURIES (not test results) to be UNSAFE. The “trial” for these injections is the “vaccine rollout”. The public ARE THE TRIAL, why doesn’t the Australian Government and it’s agencies disclose that THE PUBLIC ARE THE TRIAL?

“Next Steps”I wish to continue this IC review application, with the addition of the above to be included in the investigation.

Obviously I wish to seek review of both the TGA’s classification of “irrelevant” (relevant) information in documents 1-9 (the s 22(1) material) and the TGA’s classification of exempt information in document 9 (the sections 4-7 redacted material).

Regards, Jxxx Bxxxx

The rest of the practically useless documents released, all funded by pharma.

Document 7 – COV005 study (pdf)
Document 5 – COV003 study (pdf)
Document 3 – COV002 study (pdf)
Document 2 – COV001 statistical analysis plan (pdf)
Document 1 – COV001 study (pdf)

The TGA was asked in writing, after the above documents were produced, are medical professionals provided that information as a matter of procedure, redacted or unredacted, and their response was “No”. If I can find that Email I will quote it exactly (lost a C drive since then).

Other investigations

Buried somewhere in Document 9 (lost my notes from back then), mid paragraph, well into the document, there is a passage that states (and I will try and find it again), that “some” severe adverse reactions, (ie Myocarditis, Pericarditis and how many others) have not been included in this document.

All of the “vaccines” have “proprietary ingredients” ie. secret ingredients they don’t want to divulge to give away the “secret”. SM-102 was the “proprietary ingredient” of the Moderna product. The Safety Data Sheet for SM-102 available to the public AFTER “vaccine” global launch was not the same as the Safety Data Sheet first published.
Safety Data sheet for SM-102, recovered via the Wayback Machine. MS-102FromMay2021 (pdf)

SM-102

Some snippets of interest:
Acute Tox. 2
H310 Fatal in contact with skin.
Carc. 2 H351 Suspected of causing cancer.
Repr. 2 H361 Suspected of damaging fertility or the unborn child.
STOT RE 1 H372 Causes damage to the central nervous system, the kidneys, the liver and the respiratory system through prolonged or repeated exposure.