Senator: And we know process two wasn’t tested – there were only 252 people tested with process two unlike the 40,000 tested in process one.
I wouldn’t consider 252 a statistically significant number in terms of being sure about genotoxicity levels – would you agree with that?
TGA: Well you can’t just say a number is statistically significant – you need to understand the confidence intervals – you need to understand the extent the study is being powered.
You can’t just pull out a number, Senator, and say is that significant or not.
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The response by the TGA to this question is comical.
Testing a drug that is going to be rolled out to millions, no sorry, billions of people on 252 people is not statistically significant. Doesn’t matter which way you slice it, testing was inadequate.
Throwing around terms that this clown clearly doesn’t understand like confidence intervals isn’t going to let him off the hook. Furthermore, process one used “In vitro” transcription not “in vivo” transcription. Big difference.
Page 17 of TGA FOI 2389-6 says that the product is made by In-vitro transcription. This is the method of process 1 which uses pure DNA template outside of cells and doesn’t use poo or plasmids.
This means that process two had to use another step of filtration to filtrate the toxic plasmids out of the batches. The batches of which the TGA refuse to release any data on.
To claim the two different manufacturing processes are the same is just a lie. There were much greater risks with the manufacturing process used in the second process that was used on people.
Community Affairs Legislation Committee – 07/11/2024 – Estimates – HEALTH AND AGED CARE PORTFOLIO – Therapeutic Goods Administration
Senator RENNICK: Yes, that’s right. You just touched on two of those lipids, ALC-0159 and—I can’t remember. It started with a three. Was it 315?
Prof. Lawler : 0315 and 0159.
Senator RENNICK: There were no studies done on them, were there? You said that in the non-clinical report—
Prof. Lawler : No structural alerts had been identified.
Senator RENNICK: And you’re right—DNA outside the cell breaks down very quickly. I accept that. But those standards and benchmarks are for DNA that’s not encapsulated inside a lipid, and we know the process, too, wasn’t tested. There were only 252 people tested on the batch made out of process 2, unlike the 40,000 that were tested out of process 1. I wouldn’t consider the 252 a statistically significant number in terms of being sure about your genotoxicity safety levels. Would you think 252 is a statistically safe and significant number?
Prof. Lawler : You can’t just say a number and say, ‘Is it statistically significant?’ You need to understand the confidence intervals, and you need to understand the extent to which the study is powered. You can’t just pull out a number—with respect, Senator—and say, ‘Is that significant or not?’
Senator RENNICK: That was the number of people tested with process batch 2.
Prof. Lawler : I’m going to ask Dr Kerr to comment.
Dr Kerr : We’ve answered this question before. The mRNA that was produced between process 1 and process 2 is not different. The mRNA length, the code itself, is not different.
Senator RENNICK: No, I accept that. I’m not saying that. I’m saying DNA was used in process 2, which it was.
Dr Kerr : But the mRNA that was in the final product is not different, and the residual DNA limits are not different. The two products are the same.
Senator RENNICK: But process 1 didn’t use DNA. It was PCR amplified. It didn’t use DNA.
Dr Kerr : It did have DNA. The PCR amplified the DNA.
Senator RENNICK: But it wasn’t used in a batch where you used plasmids. You didn’t use plasmids for process 1.
Dr Kerr : Yes.
Senator RENNICK: That’s correct?
Dr Kerr : Plasmids were used for process 1.
Senator RENNICK: Are you sure about that?
Dr Kerr : Yes.
Senator RENNICK: I’ll come back to you on that, because that’s not what I’ve been told, but we’ll drop it.
