Australia's drug regulator claims that LNPs carrying synthetic DNA into cells all over the body are safe, but refused to provide proof under a Freedom of Information request
If, big if, if they threw in the towel and admitted these injections were as bad as they were, I imagine more flack would be directed at Authorities and Authoritarians who implemented insane covid policies.
It is deeply troubling and profoundly disappointing to witness the TGA's lack of transparency and accountability regarding the safety claims of mod-RNA vaccines. The refusal to provide evidence under a Freedom of Information request casts a shadow of doubt over the agency's commitment to public health. When a regulator tasked with safeguarding the population cannot substantiate its claims about the safety of residual synthetic DNA encapsulated in lipid nanoparticles (LNPs), the question arises: whom does the TGA truly serve?
The implications of synthetic DNA carried by LNPs reaching every major organ system, as described in the work of Kämmerer et al., should be met with rigorous scientific investigation, not dismissive public relations statements. The absence of credible evidence to counter concerns about potential risks, such as genomic integration, cancer, and auto-immune responses, reflects a regulatory oversight that borders on negligence.
What amplifies the dismay is the TGA's bureaucratic obfuscation, highlighted in this account of FOI delays, misdirection, and refusal to engage meaningfully. This behavior not only undermines trust in the institution but also erodes the public's confidence in Australia's broader health regulatory framework.
The push for mod-RNA manufacturing partnerships with academia and industry raises serious questions about conflicts of interest. While the development of cutting-edge biomedical technology is commendable, it must not come at the expense of transparency, independent oversight, and, most importantly, public safety.
Australians deserve a regulator that prioritizes the health and well-being of its citizens above corporate or political interests. The lack of evidence for safety claims is shocking and unacceptable. It is imperative that the TGA provides clear and documented proof to back its assurances or admits that the evidence does not exist. Anything less is a disservice to the people it is meant to protect.
If I, as a practicing doctor, lied, obfuscated, obstructed, and clearly had no idea what I was talking about, I would be deregistered, sued, and possibly subjected to criminal charges.
The TGA has no accountability, because they are "The Science" and "The Experts".
I cannot be given a pen with a drug name on it as it may influence my objectivity.
The TGA may be 94% industry-funded, but this is fine.
" only about 7% of the TGA’s funding is provided through public funds. The remaining 93% of the TGA’s revenue is collected through industry fees and charges."
The root of all the evil in the TGA is their funding... "whomever pays the piper" n all that.
Quite plainly they do not work for us, the people of Australia, moreover, they facilitate gateways and open doors (with red carpets) for industry interests.
You’re so relentlessly tenacious in keeping the main point the main point:
TGA - where’s your evidence?!
Throughout the article, I visualised the TGA bureaucrats squirming in their publicly funded offices, whining how this persistent journo keeps demanding the evidence they don’t have.
Glad you’re on our side - the Aussie and global public, that is!
I am so impressed by your perseverance with the TGA! We all know that there is no such study or evidence in existence but fun to make them write all those letters anyway :) and will maybe make them pause before waiving through other kinds of mRNA "therapeutics".
There was a time where I thought I'd follow through on the development of the WHO document on "considerations" for the safety assessment of mRNA vaccines (produced long after the covid-19 vaccines were injected). There was one participant from Australia, from the TGA, and, if google images served up the correct person, a smiley, amiable, and probably relatively new arrival to Australia. One would hope for a more severe, acute, demanding and questioning physiognomy, with sound experience of pharmaceutical fraud. I have a feeling people are selected for these sorts of roles.
The Regulatory problem...
A company develops a new product it wants to profit from. It needs to be tested for safety and efficacy. It does this itself, according to Good Laboratory Practices (ha!). But the findings will obviously be biased. The TGA, after payment by the company, reads the data (maybe), if supplied, and approves the product, subject to additional payment? for quality testing? The company pays for everything, which is obviously problematic, but who else would pay? Australian tax payers? I'm not going to pay, because I'm not going to profit, and animal testing is extremely expensive (and I don't even like the animals being hurt). I don't claim to know the solution for this. Every drug should be labelled "let the buyer beware". Keep in the best health one possibly can, until one gets to an age where one is happy enough with the time passed, where one can accept or reject these drugs, knowing the full outcomes are unknown.
The crazy thing is, to the best of my knowledge, there isn't any clinical testing of the impact of LNPs carrying residual DNA at all. It's not even like the manufacturers tested it and said 'all good.' No one has tested it, and the regulator says 'all good.'
As a result of writing that I went to the WHO document (Annex 3), and it said (in the "Purity and Impurities" section)
"Consideration of the necessity of testing for dsRNA should take into account the design of the manufacturing process as not all processes produce dsRNA. The analyses should include sensitive and reliable assays for process- and product-related impurities, and strict upper (maximum allowable) limits should be specified for their content in the bulk purified mRNA."
I didn't see any specification of (maximum allowable) limits.
I suppose you've seen this (same Annex), denying any risk for mRNA vaxes, so I'm not sure what they thought the considerations above were about? ;)
"It should be noted that early theoretical concerns during plasmid DNA
vaccine development regarding the potential for integration of vaccine nucleic acids
into the host genome do not apply to mRNA vaccines for the following reasons:
■ The only known mechanism by which RNA can integrate into the
host genome requires the presence of a complex containing reverse
transcriptase and integrase.
■ Further, the design of candidate mRNA vaccines should be
considered so that they do not include specific RNA-binding sites for
primers required for the reverse transcriptase to initiate transcription.
In addition, the RNA would have to be relocated to the nucleus after
reverse transcription for the resulting product to be integrated.
■ Finally, the vaccine mRNA degrades within a relatively short time
once taken up by the body’s cells, as does the cell’s own mRNA.
During that entire time, the mRNA vaccine is expected to remain
in the cytoplasm, where it will be translated and then degraded by
normal cellular mechanisms.
Therefore, nonclinical studies do not need to be performed to specifically
address integration or genetic risks for mRNA vaccines."
We shouldn't have government jobs that require the holders to be obedient to these scientifically & ethically challenged corporate-Regulator approvals.
If the TGA approves a vaccine as safe and effective Victoria's Chief Health Officer must promote it as such.
Clarifying, I wasn't meaning to say the CHO should promote them - I was saying the job description demands the CHO promote them - something the highly biased TGA approvals don't deserve.
IF the TGA makes claims that ANY therapeutic good is "Safe and Effective" their PROOF should be tabled and proven, BEFORE a body of pharmaceutical scientists, BEFORE the Health Officers adopt it.
Otherwise, it's a case of the blind (and irresponsible) leading the blind (and stupid).
Many of us who have worked in medical circles for decades know our internal mantra is ALWAYS! "Check and verify".
How is it that those who did not carry out their duties in a satisfactory manner are not accountable? How do they get to sail off into the sunset, with their reputation intact and bonuses? It beggars belief!
If various Health practitioners, be they doctors or nurses, can be personally sued for malpractice, why can't this lot?
The writing is on the wall for the TGA.
If, big if, if they threw in the towel and admitted these injections were as bad as they were, I imagine more flack would be directed at Authorities and Authoritarians who implemented insane covid policies.
Won't happen in my lifetime. Too many people with too much to lose.
It is deeply troubling and profoundly disappointing to witness the TGA's lack of transparency and accountability regarding the safety claims of mod-RNA vaccines. The refusal to provide evidence under a Freedom of Information request casts a shadow of doubt over the agency's commitment to public health. When a regulator tasked with safeguarding the population cannot substantiate its claims about the safety of residual synthetic DNA encapsulated in lipid nanoparticles (LNPs), the question arises: whom does the TGA truly serve?
The implications of synthetic DNA carried by LNPs reaching every major organ system, as described in the work of Kämmerer et al., should be met with rigorous scientific investigation, not dismissive public relations statements. The absence of credible evidence to counter concerns about potential risks, such as genomic integration, cancer, and auto-immune responses, reflects a regulatory oversight that borders on negligence.
What amplifies the dismay is the TGA's bureaucratic obfuscation, highlighted in this account of FOI delays, misdirection, and refusal to engage meaningfully. This behavior not only undermines trust in the institution but also erodes the public's confidence in Australia's broader health regulatory framework.
The push for mod-RNA manufacturing partnerships with academia and industry raises serious questions about conflicts of interest. While the development of cutting-edge biomedical technology is commendable, it must not come at the expense of transparency, independent oversight, and, most importantly, public safety.
Australians deserve a regulator that prioritizes the health and well-being of its citizens above corporate or political interests. The lack of evidence for safety claims is shocking and unacceptable. It is imperative that the TGA provides clear and documented proof to back its assurances or admits that the evidence does not exist. Anything less is a disservice to the people it is meant to protect.
I agree Gary.
If I, as a practicing doctor, lied, obfuscated, obstructed, and clearly had no idea what I was talking about, I would be deregistered, sued, and possibly subjected to criminal charges.
The TGA has no accountability, because they are "The Science" and "The Experts".
I cannot be given a pen with a drug name on it as it may influence my objectivity.
The TGA may be 94% industry-funded, but this is fine.
Medically, it is now "caveat emptor".
Great work Rebekah.
Not to mention doctors can get suspended for years without trial for merely for posting their religious beliefs on social media... https://news.rebekahbarnett.com.au/p/doctor-under-emergency-five-year
🙏 your perseverance with these idiots is very much appreciated. Thank god we still have some decent journalists in Aust
Thanks, Rebekah, for your persistence in calling out those people who apparently 'do not owe a duty of care to Australian citizens'.
Letter dated January 2023
" only about 7% of the TGA’s funding is provided through public funds. The remaining 93% of the TGA’s revenue is collected through industry fees and charges."
Ref: last paragraph on Page 1: https://www.medicinesaustralia.com.au/wp-content/uploads/sites/65/2023/01/Budget_Life_sciences_industry_TGA_funding_27Jan23.pdf
The root of all the evil in the TGA is their funding... "whomever pays the piper" n all that.
Quite plainly they do not work for us, the people of Australia, moreover, they facilitate gateways and open doors (with red carpets) for industry interests.
And I have a copy of a 2022 email stating that 94% of TGA's funds came from industry the year prior. https://news.rebekahbarnett.com.au/p/australias-drug-regulator-admits
So it seems as though it hovers around 93-96% depending on the year.
TGA just got hammered... again! That agency and all its attending legislation needs to be made obsolete.
Thankyou Rebekah for fighting the good fight on our behalf. You are a credit to your craft.
I'm staggered (but probably shouldn't be) that so much obfuscation is being carried out to hide "nothing"! The old 'Sergeant Schultz' defence...
You’re so relentlessly tenacious in keeping the main point the main point:
TGA - where’s your evidence?!
Throughout the article, I visualised the TGA bureaucrats squirming in their publicly funded offices, whining how this persistent journo keeps demanding the evidence they don’t have.
Glad you’re on our side - the Aussie and global public, that is!
Keep at them RB!
I am so impressed by your perseverance with the TGA! We all know that there is no such study or evidence in existence but fun to make them write all those letters anyway :) and will maybe make them pause before waiving through other kinds of mRNA "therapeutics".
I don't think anything short of massive liability threats (class actions, being sued into oblivion) will make them pause...
The public do not need to know these things sayeth the mighty ones
:D And your point is? :D
Thanks for all your work.
There was a time where I thought I'd follow through on the development of the WHO document on "considerations" for the safety assessment of mRNA vaccines (produced long after the covid-19 vaccines were injected). There was one participant from Australia, from the TGA, and, if google images served up the correct person, a smiley, amiable, and probably relatively new arrival to Australia. One would hope for a more severe, acute, demanding and questioning physiognomy, with sound experience of pharmaceutical fraud. I have a feeling people are selected for these sorts of roles.
The Regulatory problem...
A company develops a new product it wants to profit from. It needs to be tested for safety and efficacy. It does this itself, according to Good Laboratory Practices (ha!). But the findings will obviously be biased. The TGA, after payment by the company, reads the data (maybe), if supplied, and approves the product, subject to additional payment? for quality testing? The company pays for everything, which is obviously problematic, but who else would pay? Australian tax payers? I'm not going to pay, because I'm not going to profit, and animal testing is extremely expensive (and I don't even like the animals being hurt). I don't claim to know the solution for this. Every drug should be labelled "let the buyer beware". Keep in the best health one possibly can, until one gets to an age where one is happy enough with the time passed, where one can accept or reject these drugs, knowing the full outcomes are unknown.
The crazy thing is, to the best of my knowledge, there isn't any clinical testing of the impact of LNPs carrying residual DNA at all. It's not even like the manufacturers tested it and said 'all good.' No one has tested it, and the regulator says 'all good.'
As a result of writing that I went to the WHO document (Annex 3), and it said (in the "Purity and Impurities" section)
"Consideration of the necessity of testing for dsRNA should take into account the design of the manufacturing process as not all processes produce dsRNA. The analyses should include sensitive and reliable assays for process- and product-related impurities, and strict upper (maximum allowable) limits should be specified for their content in the bulk purified mRNA."
I didn't see any specification of (maximum allowable) limits.
I suppose you've seen this (same Annex), denying any risk for mRNA vaxes, so I'm not sure what they thought the considerations above were about? ;)
"It should be noted that early theoretical concerns during plasmid DNA
vaccine development regarding the potential for integration of vaccine nucleic acids
into the host genome do not apply to mRNA vaccines for the following reasons:
■ The only known mechanism by which RNA can integrate into the
host genome requires the presence of a complex containing reverse
transcriptase and integrase.
■ Further, the design of candidate mRNA vaccines should be
considered so that they do not include specific RNA-binding sites for
primers required for the reverse transcriptase to initiate transcription.
In addition, the RNA would have to be relocated to the nucleus after
reverse transcription for the resulting product to be integrated.
■ Finally, the vaccine mRNA degrades within a relatively short time
once taken up by the body’s cells, as does the cell’s own mRNA.
During that entire time, the mRNA vaccine is expected to remain
in the cytoplasm, where it will be translated and then degraded by
normal cellular mechanisms.
Therefore, nonclinical studies do not need to be performed to specifically
address integration or genetic risks for mRNA vaccines."
We shouldn't have government jobs that require the holders to be obedient to these scientifically & ethically challenged corporate-Regulator approvals.
If the TGA approves a vaccine as safe and effective Victoria's Chief Health Officer must promote it as such.
promote perhaps, but not MANDATE
Clarifying, I wasn't meaning to say the CHO should promote them - I was saying the job description demands the CHO promote them - something the highly biased TGA approvals don't deserve.
IF the TGA makes claims that ANY therapeutic good is "Safe and Effective" their PROOF should be tabled and proven, BEFORE a body of pharmaceutical scientists, BEFORE the Health Officers adopt it.
Otherwise, it's a case of the blind (and irresponsible) leading the blind (and stupid).
Many of us who have worked in medical circles for decades know our internal mantra is ALWAYS! "Check and verify".
How is it that those who did not carry out their duties in a satisfactory manner are not accountable? How do they get to sail off into the sunset, with their reputation intact and bonuses? It beggars belief!
If various Health practitioners, be they doctors or nurses, can be personally sued for malpractice, why can't this lot?
Such a great body of work you've done over time Rebekah!
Would love to see you interviewed by aussie YouTuber Damien from "Other Side"
Other than him — Joe Rogan, Steve Kirsch, Chris Martensen would do 😎 or, Natalie and Clayton Morris of Redacted