FDA hid GMO status of Covid drugs ..
.. buried facts to ensure the Cellular, Tissue and Gene Therapy Advisory Committee (CTGTAC) was not responsible for the US approvals which simply would not have happened had CTGTAC taken charge
good Substack folk,
(an Update is included at the end: CHD TV interview with Dr Jessica Rose)
many are by now are aware of all the issues and questions raised in this article by the War Room/Daily Clout:
Report 98: FDA Selected Its 'Vaccines Advisory Committee' - Not Its Gene Therapy Advisory Committee - to Recommend the COVID Injections for Emergency Use, Hid Nature of Products
.. you also know I have been spearheading with Katie Ashby-Koppens and Dr Julian Fidge the now extraordinary legal action against Pfizer and Moderna here in Australia for their Covid drugs fulfilling Australian legal definitions for being deemed GMOs, requiring GMO licenses (which they did not seek nor were granted), all of which the Australian government knew prior to provisionally approving them. Of course the Australian government did not inform Australians about these facts.
Towards the end of last year I finished off global legal research into GMO laws - the UK, South Africa, and the EU all have similar GMO legislation to Australia - all of those jurisdictions variously flouted their GMO laws (the UK and SA) or illegally ignored them (Australia and the EU).
For the UK situation I documented everything into a legal opinion for Andrew Bridgen MP:
.. and my findings on what occurred in the EU are set out in my peer reviewed paper: The Canaries in the Human DNA Mine.
I researched Canadian law and discovered they have no effective GMO laws when it comes to human drugs or therapeutics .. only plant based GMO legislation .. humans and GMOs don’t matter in Canada, it seems ..
The US research was difficult and took quite a while to unravel, but I believe I nailed it in the end .. but in saying that, some US legal eyes on my work is advisable, and feedback in the comments welcomed
The US FDA has certainly written a lot on Gene Therapy and put down all types of guidance .. question is, as the War Room/Daily Clout article above goes on to squarely and legitimately ask:
Why was all that completely ignored?
It all came down to what was needed to trigger the involvement of the Cellular, Tissue and Gene Therapy Advisory Committee (CTGTAC) before any proper attention would be given to the Gene Therapy / GMO nature of these Covid drugs .. as it turns out, it was the US National Environmental Policy Act, or NEPA, that was meant to trigger the CTGTAC to take the lead over the approvals of the Pfizer and Moderna Covid drugs, thereby pushing aside and taking away responsibility from the despicable Vaccines and Related Biological Products Advisory Committee (VRBPAC), and all of its rubber stamping efforts ..
VRBPAC: “Welcome Pfizer .. come in Moderna .. please, make yourselves comfortable .. I know its early, but anyone care for a drink?
.. returning to NEPA and the bad bad FDA ..
In short, every time a US government agency is required 'to action' something, particularly in the context of an application to government for anything, every government agency has to ask a threshold question: Is an Environment Assessment required in relation to this application?
If an Environmental Assessment (EA) is required, depending on the type of application, then a submitted EA can trigger all types of follow-on inquiries and demands for additional information from the applicants, and can often require escalation to a much more thorough and detailed Environmental Impact Statement, requiring further extensive information from the applicant, other designated 'stakeholders', and public consultation entitling the public to make submissions, after the relevant government department advertises to the nation the issues and types of submissions sought ..
.. can you see where this is going already?
Many of you have probably already worked it out but I need to say it anyway — Guess What? -- both Pfizer and Moderna were:
(a) Required to submit an Environmental Assessments (EA) with their Biologics License Applications (BLA) for their Covid drugs, which then required the FDA to;
(b) Initiate the extensive consultation process for an Environmental Impact Statement for both BLAs.
.. each BLA involving a separate process of course, for each application, requiring separate public consultations requesting submissions .. separate FDA advertisements to the US public advising them of the Gene Therapy nature of the drugs, also containing GMOs .. while asking all concerned citizens to make submissions
.. what a silly silly public relations exercise, right?
.. you all do of course remember the FDA did all of this, and news of the Gene Therapy nature of the drugs and their being GMOs becoming, subsequently, global public knowledge, right?
What, you don’t remember?
.. actually, neither do I .. so let us read on
Had the FDA gone through the motions of (b) it would have been revealed to all of the US population (and the World) that both the Pfizer and Moderna drugs are (a) Gene Therapies, and (b) contain GMOs by the FDA's own definitions .. and the FDA would have been required to go through the long consultation process of hearing and receiving stakeholder submissions and public submissions ..
.. which would have taken months and months and months .. well into 2021, likely leading to calls for further analysis of vials from both companies .. likely revealing the monstrous DNA contamination .. likely educating everybody - Globally - that not only does synthetic DNA integrate with natural Human genes - with disastrous consequences - but also the synthetic modRNA integrates too via reverse transcription .. the major ingredient in each vial
.. and by virtue of a properly detailed Environmental Assessment alerting to the fact of each sponsor's drug containing or deemed to be Gene Therapies and GMOs, the Cellular, Tissue and Gene Therapy Advisory Committee (CTGTAC) would have been called in to oversee the approval process
.. critically, the diabolical Vaccines and Related Biological Products Advisory Committee (VRBPAC) would have been pushed aside and had no role to play
.. meaning, there would have been “No Rubber Stamping for You” Pfizer and Moderna, to borrow from The Soup Nazis
I have rendered all of the above into a legal opinion here:
I did earlier share on 24 January 2024 the same legal opinion with a major US organisation typically known to immediately action such material, with whom I am intimately connected .. where despite the recipients sharing no misgivings as to the accuracy of my work, they have done nothing with the information .. so here we are, my sharing it all with you here
for you US legal eagles and groups with the resources, the legal opinion above very well possibly serves as a legal basis for having the BLAs granted to Pfizer and Moderna declared invalid after seeking Judicial Review of the FDA decision making process, due the FDA illegally giving Pfizer and Moderna a pass, in so far that the FDA did not require them to submit Environmental Assessments
.. the FDA gave an illegitimate reason at law for why Pfizer and Moderna did not have to submit EAs, and this was only revealed in late 2021, a long time after the BLAs were granted under Emergency Use Authorisations (EUAs) .. and by the way, the EUA legislation provided no legal measures for avoiding the required EAs .. but again, US lawyers please chime in here if you see something I missed - I will be watching the comments
The above legal opinion Failure by FDA to Require EAs from Pfizer and Moderna details some US legislation involving scientific knowledge for determining whether certain exemptions from having to submit EAs applied, or not ..
.. I consulted with a friend who is also an Associate Professor of Medicine to check my interpretation of those science parts and he agreed .. essentially revolving around whether the Pfizer and Moderna drugs were/are New Molecular Entities .. which indeed they are .. by virtue of which, EAs were absolutely required, but the FDA was quite frankly very dishonest in my view, and said the Pfizer and Moderna drugs are not New Molecular Entities, so both companies did not have to submit EAs
C’mon, right?
.. even the AusPARs here in Australia when the TGA provisionally approved both Pfizer and Moderna clearly acknowledge they each contain a New Biologic Entity: see Pfizer page 7 HERE, and Moderna page 7 HERE
in short .. the above legal opinion evidences the invalid decision by the FDA to exempt Pfizer and Moderna from EAs, which in turn directly assisted to take the decision making away from the CTGTAC
And if I am correct, the legal opinion should serve as a basis for seeking a US court intervention for declaring legally invalid the BLAs granted to Pfizer and Moderna
C’mon you Yanks, charge that judicial hill and take something back!
Were that to occur, there would be enormous liability consequences for the FDA as the decision to exempt both companies from EAs does not appear to have been made 'in good faith', which is a typical legal requirement for shielding government agencies from civil suits ..
.. Here the FDA decision exempting Pfizer and Moderna from submitting EAs appears to have been made knowing it was wrong .. very was clearly sooo wrong, it amounts to criminal behaviour
I will leave that last part to you US lawyers .. that criminality part .. it might prevent some of those on the Vaccines and Related Biological Products Advisory Committee from jumping into the revolving door that magically takes them to a multi-million dollar wonderland job with Big Pharma .. strange how that happens
good Substack folk, another labour of love
.. please share widely
UPDATE: 16 June 2024
I had the great pleasure of being interviewed by Dr Jessica Rose for CHD TV where in the first half we discuss the GMO legal definitions for the Pfizer and Moderna Covid drugs (which always applied in Australia, South Africa, the UK, and the EU), then detail (go to: 40:30 mins/secs) how the FDA kept this a secret from the US population and indeed, the World:
Another Legal issue I have raised is the fact that the FDA EUA should never have been granted because Pfizer used Ivermectin to rescue Process 1 jab clinical trial subjects when they became seriously ill.
https://geoffpain.substack.com/p/pfizer-knew-ivermectin-protects-against
Thank you, for your tireless work!