Do Covid vaccines meet the definition of gene therapy?

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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 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 use of linearized 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 wasn’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 say. 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 says 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 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.

This article is a republication of an article originally published here by the Spectator Australia.

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  • Dr Julie Sladden

    Julie Sladden is a doctor (retired) and writer with over 25 years clinical experience across multiple disciplines in Australia and the UK. She is a passionate advocate for professionalism, ethics and transparency in healthcare.

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