COVID-19 vaccines gene therapy

Do Covid Vaccines Meet the Definition of Gene Therapy?

6 November 2023

6.4 MINS

Serious questions are being asked of Australia’s Office of the Gene Technology Regulator.

It seems like a lifetime ago that an enjoyable night in consisted of the couch, popcorn, and a feel-good movie. Not anymore. With the hotbed of post-pandemic questions filtering through Australia’s Parliament, I’ve discovered riveting viewing can be found in an evening of ‘Senate-estimates-live’ if you get the right participants. Nothing quite matches the drama and real-time manoeuvering between our elected representatives and the bureaucrats. The only comparable analogy is that of a high-level game of chess… with higher stakes.

We had such a night recently. The scheduled appearance of AHPRA, the TGA, and the Office of the Gene Technology Regulator (OGTR), joined by Senators Rennick and Roberts, promised to be popcorn-worthy viewing. And it was.

Five minutes before the closing of the session at 11 pm, the final question was handed to Senator Rennick. I was wakened from my somnolence as the Senator asked, ‘Have we got the Gene Technology Regulator here?’

The following conversation may well be the biggest bombshell drop in the COVID-19 vaccine drama so far.

In the absence of the pending HANSARD transcript (ref. 27445), the conversation goes like this:

Senator Rennick: ‘I have a Pfizer document here from their own website. It says, “Gene therapies are delicate, intentional processes encapsulating the desired gene. Manufacturing gene therapies is challenging and it requires certain steps including transfection.” That is on Pfizer’s own website.

‘Then I had also from the website of the American Society of Gene and Cell Therapy “because the vaccine (it’s referring to the Covid mRNA vaccine) introduces new genetic material into cells for a short period of time to induce antibodies, it is a gene therapy” as defined by the American Society of Gene and Cell Therapy.

‘And then the TGA [in] its own Pfizer nonclinical report page 19 says the proposed commercial scale manufacturing process includes the use of linearised plasmid DNA template for mRNA production. So, we’ve now got Pfizer themselves who admit that the mRNA vaccines are gene therapy, the American Society of Gene and Cell Therapy admits the mRNA vaccines are gene therapy, and we’ve got the TGA themselves admit the DNA was used in the manufacturing process. Why wasn’t the actual mRNA vaccine tested for genotoxicity, and why didn’t the (OGTR) look at it in terms of Gene Technology?’

Dr Raj Bula (Office of the Gene Technology Regulator):

‘Thank you for your question, Senator. I think the first part about the genotoxicity that question has been asked before. Because the Therapeutic Goods Administration was the approving authority for the vaccine products, that is a question for TGA on GMO toxicity.

‘In relation to your question around manufacturing, I think it’s useful to put a bit of context around that in that the committee is aware the mRNA Covid-19 vaccines were fully formulated and imported into Australia, which meant that there was actually no manufacture of the mRNA or the vaccine product itself here in Australia. If indeed the mRNA was being manufactured here, and it’s correct, that gene technology was used in the modification of the mRNA then under the Gene Technology Act, an approval would have been required for that manufacturing step.’

Senator Rennick: ‘That contradicts what you’ve said previously. You’ve said previously gene therapy and gene technology weren’t used. Now you’re saying because it was produced in another country, that you’re not responsible for checking the gene therapy.’

Dr Bhula: ‘So, the Gene Technology Act, it doesn’t reach into manufacturing in other countries.’

Senator Rennick: ‘But it still involves transfection here. It transfects cells of Australian citizens.’

Dr Bhula: ‘I disagree with that.’

Senator Rennick: ‘Well, that’s what Pfizer says. Even they admit transfection is a part of gene therapy.’

Dr Bhula: ‘No senator.’

Senator Rennick: ‘So you’re disagreeing with Pfizer, the people who actually made the vaccine that transfection isn’t a part of gene therapy.’

Chair: ‘I think she’s disagreeing with you at the moment.’

Senator Rennick: ‘Well, it’s not my words. I’ll just read out what Pfizer said.’

Gallagher: ‘Welcome to my world.’

Dr Bhula: ‘I think it comes down to a definition of what is a gene therapy.’

Senator Rennick: ‘Yep, that’s right. And I’m relying on the manufacturer.’

This little exchange at the eleventh hour of Senate estimates had me wide-eyed and jaw dropped.

In my view, the OGTR has undermined their answers to Senator Rennick in Feb 2023 (as follows):

Senator Rennick: ‘Under section 30C of the Therapeutic Goods Act, the secretary of the Commonwealth Department of Health must seek advice from the Office of the Gene Technology Regulator on the safety and efficiency of any product that uses GMO as defined by the Gene Technology Act. Do you have evidence of where the secretary has written to you asking for advice on the safety and efficacy of the COVID-19 vaccines?’

Dr Bhula: ‘Thank you for your question, Senator. Where the particular vaccine involves a GMO, there’s a reciprocal arrangement, if you like, for OGTR to seek advice from the TGA in terms of a risk assessment around that GM vaccine and vice versa. The TGA may also request advice from the OGTR.’

Senator Rennick: ‘Do you have documentation of that?’

Dr Bhula: ‘For GM vaccines, yes.’

Senator Rennick: ‘Where they’ve written to you for the Pfizer one?’

Dr Bhula: ‘No, because the mRNA vaccines are not required to be regulated through the OGTR.’

Senator Rennick: ‘Did they write to you and actually ask you that question?’

Dr Bhula: ‘No, because they’re not required to be regulated through the OGTR.’

Senator Rennick: ‘But how would they know, because you’re the expert? And, by the way, gene technology involves both replication and transcription.’

Dr Bhula: ‘Yes.’

Senator Rennick: ‘Which is what the mRNA vaccine does.’

Dr Bhula: ‘But the mRNA COVID-19 vaccines did not involve any step of genetic modification…’

Senator Rennick: ‘They produce proteins.’

Dr Bhula: ‘Or a GMO…’

Chair: ‘Senator Rennick, would you allow Dr Bhula to finish her answers?’

Dr Bhula: ‘Which meant that that didn’t require regulatory oversight by the OGTR.’

Senator Rennick: ‘Well, I dispute that. Look up gene technology. But, anyway, thank you.’

In February 2023, the OGTR asserted that there was no documentation between the TGA and the OGTR regarding the mRNA vaccines. They say the mRNA vaccines were not required to be regulated through the OGTR because they did not involve a GMO or any step of genetic modification.

However, in October 2023, the OGTR said they don’t have oversight because the Gene Technology Act doesn’t reach into manufacturing in other countries, and the mRNA Covid-19 vaccines were fully formulated outside of Australia.

Please bear with me while I explain the significance of this moment.

Senator Rennick has tabled several documents from Pfizer, the TGA, and the American Society of Cell and Gene Therapy confirming that COVID-19 mRNA injections are indeed gene therapy products involving genetic modification during manufacture.

Importantly, the OGTR concedes that if what Senator Rennick is saying is true, then the mRNA injections are GM products and should be regulated by the OGTR if they were manufactured in Australia, but they do not have oversight because the Covid-19 mRNA injections were manufactured overseas.

Here’s where it gets interesting.

The Gene Technology Act 2000 requires that such gene technology products fall under the regulation of the OGTR as soon as they hit Australian shores, with GMO ‘dealings’ including manufacture, import, transport, and disposal. The OGTR’s response to Senator Rennick last week that the mRNA products were not regulated by them because they were manufactured outside of Australia appears to contradict what is written in the Gene Technology Act.

There’s something else. Let’s look at the concept of ‘manufacture’. Both the mRNA (Pfizer and Moderna) and viral vector (AZ) Covid-19 injections are pro-drugs, meaning they tell the body to ‘manufacture’ the final product. In this case, this final product is the spike protein. This means the final manufacturing step does indeed happen on Australian soil, in the bodies of injected Australians.

An (anonymous) Australian professor of science and medicine explains it this way:

‘… the concept of “manufacture” here is an interesting one as with the mRNA and also the adenoviral vector vaccines the final act of “manufacture” occurs in the body into which these products are injected.

‘This is because they are designed to induce the manufacture of spike protein production in vivo [in the human body] (the manufacture) as their final step. Without this final manufacturing step, they don’t work.

‘So, in effect when the products are injected into a human body in Australia, then the final act of genetic manufacture does indeed occur in Australia.

‘What the OGTR are proposing is thereby a nonsense. If they are redefining the Act in this way then it means we can create all manner of new genetic organisms and providing we do this in vivo (in living organisms) then it is now outside the purview of the OGTR – how wonderful – the virology community will be ecstatic that they can now do these things in vivo without going to the OGTR.’

‘So what?’ you may say.

Well, this, dear reader, brings us to the seriousness of the issue. A legal case filed in Australia’s Federal Court claims the Pfizer and Moderna products always met Australian legal definitions for being deemed genetically modified organisms and should, therefore, have obtained GMO licenses from the OGTR. They did not.

What, you may ask, is the penalty for dealing in GMOs without a license? You can read more about that here.

Even more serious is what this potentially means for the millions of Australians who were assured the mRNA vaccines were not gene therapy, making fully informed consent null and void. Not to mention their health in this ‘world’s largest experiment’.

One thing is certain: this isn’t the last we have heard about the OGTR.


Originally published in The Spectator Australia. Photo by Nataliya Vaitkevich.

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  1. Jim Twelves 6 November 2023 at 8:18 am - Reply

    Julie, brilliant, thank you. So if the so called GMO vaccines inflicted on Australians caused adverse effects and even death, and our government gave them indemnity. Presumably that indemnity is now null and void as the product was not correctly regulated. Therefore our government is off the hook and all the law suits need to go to the manufacturer after all?

  2. Leonie Robson 6 November 2023 at 8:51 am - Reply

    Talk about smoke and mirrors!
    How these people sleep at night amazes me….oh, that’s right, on a big pillow of money.
    Thank God for Senator Rennick.
    Thank God for you Julie, and your band of faithful warriors. Your opponents are formidable and protected by the corrupt and powerful, may they all be exposed for the greed and evil behind it all.
    Continued prayers for you all.

  3. Countess Antonia Maria Violetta Scrivanich 6 November 2023 at 9:47 am - Reply

    In my opinion, another case of lies and criminal negligence by the TGA which should have warned the Australian Government of the truth about the vaccines . My first baby and I nearly died . Numerous specialists had warned me “another pregnancy will kill you”. I hate the TGA because its approval of Filshie Clips (which I did not want—I wanted my tubes tied instead ) robbed me of 17 years of what should have been the best years of my young life, gave me daily excruciating pain and nausea , and, in 2002 nearly killed me . The Clips killed TV Presenter Adriana Xenides whose abdomen burst as mine nearly did ! There is no Class Action in Australia against Filshie Clips despite many womens’lives being ruined .When will Australian governments stop believing in the TGA and demand an Inquiry into its negligence ?

  4. Stephen Lewin 6 November 2023 at 10:11 am - Reply

    Thank you Dr Julie for keeping on the investigation and with the challenges still being faced with covid 19

  5. Kim Beazley 6 November 2023 at 6:13 pm - Reply

    The simple answer to this question is “NO, they’re not”. And it IS that simple. And if Senator Rennicjk had not been so eager to interrupt Dr Bhula, he would have heard the answer which should have silenced him (perhaps that was why he interrupted):

    “Dr Bhula: ‘But the mRNA COVID-19 vaccines did not involve any step of genetic modification or a GMO. Which meant that that didn’t require regulatory oversight by the OGTR.”

    To this, Senator Rennick replied, “Well, I dispute that. Look up gene technology.”, and that was that.

    So here’s what other experts say about gene technology, just so Dr Sladden and Senator Rennick can get it straight.

    Why Dr Sladden keeps making these claims is cause for concern, because put in simple layman’s terms, we’re talking about apples and oranges, something you would expect a doctor to understand better than anyone.

  6. Warwick Marsh 7 November 2023 at 9:23 am - Reply

    Great article!!!! HUge Thanks Dr Julie Sladden!!!!

  7. Gail Petherick 17 January 2024 at 10:57 pm - Reply

    Thank you Senator Rennick for pushing through to ask vital questions about gene therapy relating to vaccines, and any changes that may come genetically through the Pfitzer vaccine. Thank you for also referring to what the TGA’s role has been and showing where things fell short of extra testing. Thank you Dr S Julia for the remarkable research and for following through on these vital issues, especially as we in Australia were advised it was an ‘experimental vaccine’ being used and introduced. We deserve the chance to ask questions about the vaccine in hindsight- otherwise we will never be able to assess the vaccines or its content, or its side effects or success or damage incurred. (Formerly new vaccines had control groups with very strict guidelines and duty to the public, so if anything was amiss with side effects withdrawal of a product was possible)

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