Your office obtained de-identified clinical data, patient data from the COVID-19 vaccine trials. And did that data form your decision on the vaccine, or did you just accept what the manufacturer said?
So Senator, of a long established process is that we receive an aggregate submission looking at the analysis of a patient data. And then during the review both our clinicians who review that data carefully and also our advisory committee for medicines which is composed of eminent clinicians across various disciplines, we do go back and ask a series of questions to the company, but of the global regulators only the US Food and Drug Administration, obtains individual patient data as a course of practise, so-
[Malcolm] So the answer is no?
So we do not obtain individual patient regulator. We’re simply not resolved to do so.
[Malcolm] Okay, that’s fine, I just needed the answer. So the TGA with all of it’s resources didn’t take the opportunity to review you the approximately 44,000 records on the vaccine testing. Yet you improved it to inject into millions of Australians?
I don’t agree, but we didn’t take the opportunity to review the results for trials. We spent many person months. In fact, probably several person years, you aggregate the size of a team of clinicians and others looking at that data. We looked at that data on 44,000 people and the trials was very carefully.
What clinical testing was done in Australia on the COVID-19 vaccines.
So for there were some vaccines that have had early stage trials done in Australia but it is not a requirement, but medicine or vaccines are clinically trialled in Australia, if it were a requirement we’d have far fewer medicines and vaccines on the market. We look for trials done in comparable populations. So we assume a trial done on an American is gonna be transferable to the Australian population. However, if there are trial groups missing such as we have a lot of Australians of Asian descent we’ll look at that in a trial data too.
So you also assume then that a trial by an American pharmaceutical company done on Americans is just acceptable?
We Don assume it’s just acceptable. We look at, as I’ve mentioned, the total amount of data for Pfizer is over 220,000 pages. And so that would fill many pallets of paper if it were deposited in the middle of this room. So we scrutinise, we review that data at extreme length. We spend thousands of of man and woman hours reviewing that data.
But no testing here.
We test the vaccine here in a laboratories. As I mentioned earlier, we have about 105 laboratory staff.
So are those tests to make sure that the control batches comply with the current batches in this country, or are they actually testing the vaccine for its efficacy, for its safety?
The tests are looking, well they relate to safety because they check the vaccines composition. They check that there’s no contaminants in it. And they check that it aligns with the requirements of-
So you’re not testing the vaccines efficacy or safety or risk?
We are looking at safety in a post market sense. The data from FDA and Safety comes from clinical trials that are being conducted globally. And I would add the same approach is accepted by all world’s major regulators, including Europe. So the European Medicines Agency, which regulates for European Union does not require trials to be done within Europe.
Are you aware there are major concerns about the FDA processes in America and many of the health agencies in America being completely tainted by pharmaceutical companies, all fix for interest.
TGA makes independent sovereign evaluations of vaccines, the government expressly rejected, this government expressly rejected a possibility of TGA automatically accepting US FDA decisions. So government position, and it was the accepted in this place when a bill went through the house was for TGA to continue to make its own sovereign decisions. And we don’t always make the same decisions as FDA around medicines and drugs.
And you rely upon various committees-
Yes, we do.
For approval of different types of drugs, including vaccines.
We rely on them from advice. So we have an active advisory committee for vaccines and an advisory committee for medicines, for example, that will go to treatments.
Have you assessed that committee’s composition for conflicts of interest?
Oh, very much so Senator and, first of all-
[Malcolm] Can we get a copy of that?
Senator, there would be individual personal information we could provide, I don’t think it’s appropriate to say, well, doctor so is X, but we could explain both the process and we could explain those candidates who were not considered-
[Malcolm] Yes, please.
So within those constraints, of course we would very welcome to-
[Malcolm] We’ll take from there.
It is absolutely important that the people on the committees do not have a conflict of interest.
I agree.
It would up the process.
Last question on this topic before I move on to a second one. Were the COVID-19 vaccines ever tested upon zero to four, four year olds? And could you please provide a copy of the data to prove that the vaccine is safe for young children and babies?
The vaccines are not approved for zero to four year olds. So they have not been approved in this country or in any major global regulator areas, there is an approval in China for a Chinese made vaccine, I think down to age three. But when I look at the US, when I look at Canada, Australia, Japan, Europe they are not approved in that age group.
When will they be approved?
It depends on the date of it’s submitted to us and whether it’s accessible.
Are you expecting at any time in the next three months before the new parliament comes in?
I can’t predict that we may receive an application midyear but it is really dependent on the completion of trials, and on the quality of the data.
Thank you, let’s move on then to the next topic. Can a COVID-19 vaccine enter and affect human DNA? Now a Swedish study and I’m gonna table this. A Swedish study has demonstrated that it could and while the paper, which is being distributed, at section four states, and I’ll quote, “At this stage we do not know if DNA reverse transcribe from BNT162b2 is integrated into the cell genome.” So they’re acknowledging that, “the fact is that the Australian government may have not independently confirmed whether it does or not.” So the question is, have you done so, have you kept us safe?
So we are familiar with this paper. It is actually quite widely discredited in the medical community for a number of reasons. Firstly, reverse transcriptase of the type required are not commonly found within cells, are not commonly found within the nucleus. And if this were plausible, you’d argue as I mentioned earlier, probably all of us sitting here have 20,000 genes and 20,000 mRNAs that are making various proteins on time. You’d have all those proteins clogging up the nucleus. The second issue is that the amount of messenger RNA used in this study was not the physiological levels. It was a very high level of messenger RNA. So this paper was published in a second or third tier journal and it’s been fairly widely discredited. And again, I’m happy to provide a bit more information on what experts in the field have said about this particular study.
Yeah, I’d welcome that. But my question was not whether the paper was good or not. The question is, has the Australian government independently confirmed whether the material does transcribe or not? So my question was, have you done that? And have you kept us safe from the possibility of that?
We do not believe it can plausibly-
[Malcolm] So that’s a belief?
For scientific evidence does not show-
[Malcolm] Can we see that scientific evidence, please?
[Malcolm] Okay, thank you.
[Malcolm And John] If could take that on notice.
Yes.
Thank you. Secondly, did the TGA issue authorization solely based upon the basis of the manufacturer’s data?
To which for vaccine, are you talking about?
[Malcolm] Pfizer?
So every medical product is submitted on the basis of, sorry is reviewed on the basis of a submission that a company or other sponsor makes. In every case, there are questions sometimes in the case of one of the COVID vaccines but I think questions numbered in the hundreds. There are many questions where we go back and request further data. We also look at data from studies if that vaccine is for example, already on the market as professor Murphy mentioned for AstraZeneca and Pfizer, where there was already use overseas, we look at that data, but the process is that the data does come from the organisation that submits it, but we don’t take it at face value. We drive pharmaceutical companies crazy by asking them dozens and quite often hundreds of questions and ask for more things.
Why did the TGA just refer to the manufacturer that and take their word for it? I know you just said-
Well, as I said, we don’t take their word for it. Otherwise we’d just be a rubber stamp. You might as well bother having a-
[Malcolm] That’s my concern.
We are not a rubber stamp. What do those people do all day? And I think it’s fair to say. When you’ve had, at the time we were reviewing the vaccines we had teams of people working seven days a week. So they were extremely busy reviewing hundreds of thousands of pages of data-
[Malcolm] My concern-
And these are very highly qualified people Senator.
My concern professor Skerrit is that there have been so many contradictions so many reversals of data, so many denials, so many orders, so many instructions, so many absurdities throughout this whole COVID and I call it a mismanagement.
[John] That’s your assertion?
That is my assertion. And there have been so many absurdities so many contradictions we’ve got one state predicting another state. We’ve got one state contradicting itself within over a period of weeks. We’ve got so many of these that people are rightly very very suspicious and concerned.
Well, I would also add the fact that Australia of course has a very high vaccination rate. And while there are some individuals who are suspicious or concerned about the data, a massive majority of Australians have chosen to become vaccinated. I’d also add that there is one national medicines regulator who has a role of looking at the safety, efficacy and quality of vaccines.
Okay, my next question goes to, is from constituents, many constituents. And I’d like to tell over these, please. I’m not tabling the questions. I’m tabling handout, listing reports and scientific publications on the toxicity of graphene oxides to living organisms.
[John] Oh, yes, it’s toxic.
My constituents have asked me to ask you about a recent UK study, which has formed the basis of criminal charges in that country. “Due to the presence of compounds including, graphene oxide in COVID-19 vaccines.” Graphene oxide is not on the ingredients list. Have you tested specifically for graphene oxide, or other unlisted chemicals in the COVID-19 vaccines?
We have and other regulators have assessed the vaccines. There is no graphene oxide in any of the vaccines.
Have you tested?
I would have to take that on notice but we have no evidence, we do-
You have no evidence, but have you tested for that?
I said, I’d have to take that on notice but I am absolutely confident. There is no graphene oxide vaccines, why on earth would you put it in there?
That’s what people want to know?
Yeah, why on earth would you do that?
[Malcolm] But we talk about that-
That probably sounds like some conspiracy theory again, Senator.
That’s usually used as a term to ridicule the person asking the question.
[John] It is and I’ll be using it that way.
Okay.
But to think that someone, and it’s not directed at you Senator, but to think that someone would put graphene oxide into a vaccine would amount to a conspiracy theory.
We may have some interesting material for your next sentiments.
[John] Thank you Senator.
Yes, you’ve already explained that graphene oxide is toxic to humans.
[John] Oh, yeah.
Professor Kelly, your response to Senator Rennick’s questions about the denial of people wanting to go overseas, from going overseas because of their global commitments. I’ve heard that so many times, minister whether it be from the leader in the senate, previous it was on the senate, Senator Corman, in answer to my request for data as to why we’re complying with UN requirements and UN policies, I get told because we have to comply with our global commitments. I understand that the Omicron variant entered Australia at a time when only vaccinated people were allowed into the country?
That’s correct, Senator.
Thank you, that’s all for me right now. And I’ll come back with the target.
