A plasmid is a small, circular, double-stranded DNA molecule.
If the batches using plasmids to produce the mRNA were not filtrated properly then DNA would have entered human cells via transfection.
The plasmids used in the vaccine contained the SV40 promoter that targets the cell nucleus.
Given this risk it beggars belief the TGA did not perform genotoxicity testing.
Especially since large particles were identified in the batches. As I point out, FOI 3390-11 shows 67 particles greater than 10 microns in one batch. This is too large for mRNA. Such large particles are more likely to be DNA, probably nucleus targeting plasmids.
You will note that as I am exposing these dangers, Blair Comley interrupts my questioning by deflecting about my questioning.
He would have received a message from TGA goons telling him to shut me up as I was exposing their negligence.
Tony Lawler also has a crack about my prior question on endogenous reverse transcriptease enzymes, which do exist but which the TGA want to ignore knowing the massive risk they overlooked.
As usual the chair accedes to their requests. The officials then again distract from the question by getting upset about my comment that their answers are inadequate.
Make no mistake we are dealing with evil people when it comes to the Australian Health Department.
They engaged in a massive psychological operation that caused the deaths of thousands of Australians and are now scrambling to cover their tracks.
They must be held to account for their crimes.
Community Affairs Legislation Committee
05/06/2024
Estimates and Health and Aged Care Portfolio
Senator RENNICK: Hi, guys. This morning I asked about deaths in 2021. I have asked this question numerous times. I’ve been given a study that has somehow tried to refute that. I looked at the study. The study related to deaths in 2022, but 2022 was completely different in character to 2021, because in 2022 COVID was in the community, so I don’t know why you gave me a study relating to an entirely separate year, a different year to 2021. I’ll leave that as a comment. But I do want to refer to a media release that was put out by the Department of Health and Aged Care and the Office of the Gene Technology Regulator addressing misinformation on the regulation of mRNA vaccines. Effectively, you were saying that ‘the TGA is responsible for assessing all COVID-19 vaccines before they can be used in Australia’ and that ‘the TGA rigorously assesses any COVID-19 vaccine for safety, quality, and effectiveness’. How can you say that, especially in regard to genotoxicity, when, in your own product assessment report, on page 31, for the Pfizer vaccine, you note that you’ve got missing information—use in pregnancy and while breastfeeding, immunocompromised patients, use in frail patients with comorbidities, use in patients with autoimmune or inflammatory disorders, interaction with other vaccines, long-term safety data. I’ll note that the testing was done on PCR-amplified DNA, and commercial batches were actually made from linearised plasmids that involved E. coli and that E. coli that was not filtrated could have got into batches. So how can you possibly say—and I don’t care if it is the OGTR or yourself, the TGA—that the testing of the vaccine was thorough when you didn’t do all the testing I just noted?
Prof. Lawler : Dr Kerr is just coming to the table. You’re asking about a number of different groups, so it might be worth getting Dr Bhula from the Office of the Gene Technology Regulator up as well. It may be, however, that there are some particularly technical elements to questions that you’ve asked, so it may be that after this we may be in a position—
Senator RENNICK: I don’t want to overcomplicate the answer. I mean, there was a raft of testing that wasn’t done, so you can’t say it was thoroughly tested if you didn’t do all that testing.
Prof. Lawler : I take your point entirely. I don’t want to overcomplicate the answer either. We had a back and forth last time, and it ended up being about an enzyme that wasn’t actually a real enzyme. So I want to be in the situation of being able to understand your question very clearly and give you a very clear answer, because I know that we’ve had these conversations previously. Before we do, just on the testing issue, I might ask Dr Kerr to comment and then maybe Dr Bhula can on the issues you raised around the OGTR.
Dr Kerr : I think your question is about the linearised plasmid. The end product, the mRNA product, is not different between the two processes.
Senator RENNICK: It’s noted in your own product assessment report—sorry, it’s in the non-clinical report, page 19, that you have actually noted that you used two separate methods. So the process is the product, right? So I’ll go to page 19—
Dr Kerr : No, that’s not correct actually, Senator Rennick—
Senator RENNICK: It says:
The proposed commercial scale manufacturing process includes use of linearised plasmid DNA template for mRNA production, whereas in early development phases PCR-amplifiied
DNA template was used.
So there were two different processes, two different risks.
Dr Kerr : That is correct, but the end product, the mRNA product, is the same.
Senator RENNICK: But a different process was used that introduced the risk of E. coli ending up in the batches if it was not filtrated properly?
Dr Kerr : The product is actually filtrated quite effectively, and we do actually look to make sure that the company is doing that properly. We evaluate the filtration and purification steps during the evaluation process and then we check them in the batch-release process after they have been released in Australia. That has been done for every single batch released in Australia.
Senator RENNICK: If that’s the case, and it was done properly, why did you use different testing mechanisms for the DNA that used fluorescent testing and the mRNA that actually used QPCR testing—so one understated DNA and one overstated mRNA?
Dr Kerr : Are you referring to the Pfizer production process?
Senator RENNICK: I’m referring to the testing—FOI 33090-11. That actually gave the results of a particular batch, and I note that that batch had 67 particles that were greater than 10 microns. So that’s much bigger than the size of the virus. It’s more likely to be DNA or a bacteria.
Dr Kerr : But within the allowed specifications for a pharmaceutical product.
Senator RENNICK: Sorry?
Dr Kerr : It passed the test applied to it. That is a passing result.
Senator RENNICK: It passed the test for naked DNA. It didn’t pass the test for encapsulated DNA. Is that correct?
Dr Kerr : The test is for total DNA, and it passed the test.
Mr Comley : Chair, I feel like we’re moving into a little bit of a rolling debate, and I think Dr Kerr should get more of an opportunity to answer the questions rather than a staccato. I think it’s a bit difficult for my officer—
Senator RENNICK: Are you trying to deflect here?
Mr Comley : No, no—
CHAIR: Senator Rennick, Mr Comley is making a point of order—
Senator RENNICK: My questions were all entirely relevant here.
CHAIR: No, I don’t believe that’s the point of order he’s making. Senator Rennick, as you know, it’s hard for me to follow as chair if I can’t hear all the answers and also your fulsome questions, so could we provide a bit of space for that, please. Dr Kerr.
Dr Kerr : I also note that we’ve answered these questions multiple times in previous questions on notice. I stand by what we’ve said before multiple times, that—
Senator RENNICK: That’s fine, but I’m asking you now as a question.
CHAIR: Senator Rennick.
Senator RENNICK: Okay—inadequate, but let’s take it as it is.
Prof. Lawler : Sorry—
CHAIR: Sorry, Senator Rennick, the professor has the call.
Prof. Lawler : I note that you said ‘inadequate’, and I take that. But this question was itself discussed at the last Senate appearance, and we’ve answered that with SQ23-02047 and SQ23-002051.
Senator RENNICK: And the reason why I’m asking again—which is my prerogative to do as a senator—is that I wasn’t happy with the answer, because more and more results are coming out that are showing that they’re finding DNA in the actual batches.
CHAIR: Senator Rennick, at this point the officials have answered the question—
Senator RENNICK: Chair, I’m explaining why—because there’s more evidence coming out; that’s all.
CHAIR: I appreciate your dissatisfaction with the answer, but they’ve answered the question to the best of their ability, and that is their obligation, and I believe as chair it’s met. I think it’s useful to move on so that we can enable both you and Senator Roberts to get to your next questions.
