The TGA won’t disclose the batch testing results – why not?
Answer: Because they didn’t understand what they were doing.
DNA cannot enter a cell if it isn’t encapsulated inside a lipid. For safety testing, the threshold for DNA contained in lipids should be much lower than DNA not encapsulated.
Hence why FOI 4558 was fully redacted.
Community Affairs Legislation Committee – 26/10/2023
HEALTH AND AGED CARE PORTFOLIO
Department of Health
Senator RENNICK: At the last Senate estimates, I put a question on notice that asked for evidence and results of safety testing with regard to commercially produced batches. I note recently there was an FOI, or freedom of information, request 4558 that also asked for the data on the batches. In your answer to my response was a link that had no actual data in it. I note that the FOI for 4558 was 70 pages of blanked out data. Can we get the batch information that was asked in this FOI that shows what was in the batches and the batch testing, please?
Prof. Lawler: Thank you, Senator. Can I clarify which question on notice you are talking about?
Senator RENNICK: Yes, sure. I can qualify that. It was SQ22-000539, question on notice 170 question 56. It is quite a mouthful.
Prof. Lawler: It is. Senator, I appreciate the irony, but I might have to take that on notice. That does predate my arrival.
Senator RENNICK: That’s fine. I want a commitment from you to be completely transparent about what was in those batches.
Prof. Lawler: I will give you a commitment to be as transparent as I can within the constraints of our freedom of information requirements.
Senator RENNICK: Yet again, this shouldn’t be commercial-in-confidence, because I know that’s what it is going to come back as. This is what is in those batches. People are forced to take this vaccine. We need to know, and they’ve got a right to know, that the TGA has evidence of doing the safety testing, which I’m sure you did to the best of your ability, and then what that testing did show. I will leave it as that. We will wait and see what we
Prof. Lawler: I appreciate that, Senator. We did have a conversation in a previous inquiry about whether people were or were not forced to take the vaccination. I understand the importance of the question. I hope you understand that I can only comply with the freedom of information requirements. I will get that.
Senator RENNICK: We did try through the production of documents. We can’t get it that way. With the safety testing of DNA in the vaccine, obviously with the trials they used one process. Obviously the commercially produced data used another process, which involved DNA plasma. In the safety testing, are the safety levels the same amount for naked DNA that is not encapsulated inside lipids as it is for DNA encapsulated inside a lipid that obviously then transfects the cell?
Prof. Lawler: Thank you very much for the question, Senator. I will ask Dr Scott Craig, who is our acting assistant secretary with our medical devices and product quality division, to provide some information.
Dr Craig: Thanks for the question, Senator. As I understand it—I missed part of the question as I was coming to the table—the DNA impurity test measures total RNA. It measures both the RNA package within lipids but also free DNA.
Senator RENNICK: So are there different levels specifications for encapsulated DNA versus what they call naked DNA?
Dr Craig: No. So the international recognised safety limit is built around total DNA.
Senator RENNICK: Total DNA regardless of whether or not it’s encapsulated inside a lipid?
Dr Craig: That’s correct.
Senator RENNICK: Thank you.