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The Question TGA Won’t Answer

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The U.S. CDC has changed its guidance on vaccines. The new guidance states that it is not possible to declare vaccines safe because there is no proof that they are. I asked the TGA whether they had changed their own position as a result. The ensuing discussion was pure semantics, as the TGA tried to avoid agreeing with the CDC.

For the record, the theory of logic states: “An outcome that has not been proven impossible may be possible.” To avoid what comes next—a simple question—the TGA had to deny basic logic. That question was: If it MAY be possible, shouldn’t you take a fresh look?

In previous Estimates hearings, I have presented the TGA with peer-reviewed, published papers showing that adjuvants (preservatives) in vaccines can cause autism. These papers actually show causation—the damage to the brain caused by adjuvants used in vaccines.

The testimony from Professor Lawler was simply wrong, and I will revisit this question in the February Estimates.

— Senate Estimates | December 2025

Transcript

Senator ROBERTS: Now, I’d like to turn to vaccines and autism again. In America, the CDC have changed their guidance on vaccines and autism. The guidelines now read:

… there are still no studies that support the claim that any of the 20 doses of the seven infant vaccines recommended for … the first year of life do not cause autism.

The American FDA has accepted that vaccines may cause autism because there is no study to show they are safe. Yet I’ve sat here repeatedly, including earlier tonight, and been told by the TGA over and over again that they are safe. You can’t be right. Either there is proof they are safe, or there is not. Which is it?

Prof. Lawler: I discussed this at length with Senator Antic. The policy decisions and announcements of the FDA are matters for the FDA, and those questions should be directed to them. I would just highlight a couple of your question.

Senator ROBERTS: Correct.

Prof. Lawler: That’s not what they said.

Senator ROBERTS: That’s correct.

Prof. Lawler: They’ve not said that vaccines cause autism.

Senator ROBERTS: They’ve said:

… there are still no studies that support the claim that any of the 20 doses of the seven infant vaccines recommended … do not cause autism.

Prof. Lawler: I think you went on to say at the end of your question—and please correct me if I’m wrong—that the FDA is thereby saying that vaccines cause autism.

Senator ROBERTS: No. I said the FDA, though, has accepted that vaccines may cause autism because there are no studies to show they are safe.

Prof. Lawler: Again, the three-point statement that appeared in November on the CDC’s website, which replaced its previous guidance on vaccines and autism, was of a particular wording. It seemed to me to quite
clearly say that, in its view, it cannot be said that vaccines do not cause autism, because no studies have shown that they do not cause autism. As I mentioned previously in my response to the question by Senator Antic, there is a fundamental scientific challenge in stating that something exists because you haven’t been able to prove that it doesn’t. The scientific process is that an individual or a party that makes a scientific claim holds the onus to provide the evidence that supports that claim. For instance, if you’re claiming that vaccines cause autism, the obligation is on you or another person who’s claiming that to demonstrate the evidence that supports that claim. The challenge that we have in that space is that a significant amount of the initial conversation around vaccines causing autism arose from a 1997 article by then doctor Andrew Wakefield that was published in the Lancet and subsequently retracted and thoroughly debunked because there were personal, professional, ethical and methodological conflicts and flaws. Since then, there have been multiple studies over decades involving millions of children and adults who have received different types of vaccines over different years, and, in that time, there has been no demonstrated causal or associative link between vaccines and autism. So, as I say, if there is a claim there, it has never been substantiated by rigorous and dependable evidence, and all of the evidence that we have is supportive of the view that there is no link between vaccines and autism.

Senator ROBERTS: In my view—and I think this is probably correct—the approver has the onus to say that something’s safe. The approver is you, the TGA. According to FOI No. 1345-01, you had 43 sudden, unexpected deaths reported on your Adverse Event Management System following injection of the Infanrix hexa vaccine. Are none of those caused by the vaccine?

Prof. Lawler: I’ll throw to Dr Dascombe, who’s online, to respond to that. I will just say, initially, as I have said in response to your questions and the questions of others and indeed in the conversation that we had
previously this evening around mesh, the role of the regulator is to ensure that the risks are managed appropriately such that there is an effective balance for the community between access to a therapeutic product and the benefit derived from the product, and the risk that’s presented. As we’ve discussed on a number of occasions, overwhelmingly, for the COVID vaccine and for other vaccines, the risk-benefit profile is positive. Dr Dascombe, I’ll ask you to respond as well.

Dr Dascombe: To go to both of your questions, Senator, Professor Lawler has comprehensively answered on two occasions now tonight questions around the updated guidance from the US CDC. There are a couple of things that I’d reaffirm there, particularly from a post-market regulation of vaccines perspective. The TGA, like our international counterparts, takes an evidence based approach to the regulation of vaccines registered in Australia. This means that our regulatory decisions are based on the weight of available scientific evidence. There are a couple of key points worth confirming. There is no scientific evidence of a causal link between autism and any vaccine or vaccine ingredient. There is a substantial body of scientific evidence to refute the claim that vaccines are linked to autism. Neither the TGA nor any international regulator has detected or confirmed a safety signal for autism in any vaccine. Those are key points to reiterate, to your first question. To your second question, around reported adverse events with the Infanrix hexa vaccine on our Adverse Event
Management System, as you know, this is a system that relies on spontaneous reports from healthcare professionals, consumers, states, public health units and medicine sponsors. The existence of a report in that system and a report made to us doesn’t necessarily confirm that the vaccine has caused that death. We encourage reporting of all adverse events, even if there’s only a small chance that the vaccine is related to that death.

Senator ROBERTS: Thank you.

Prof. Lawler: Thank you for that, Dr Dascombe. I would also just reflect on your comment earlier about the onus on the approver to ensure that something is safe. That is correct. The challenge that every regulator in the world faces is that the only way to ensure that there is no risk in a product is to not approve any product for supply in the country. That’s the only way, and then the public would be quite rightly clamouring for access to goods that are enjoyed by populations around the world. So the role of the regulator here in Australia, as in other countries, is to appropriately assure itself that the evidence indicates that the risk-benefit profile is positive. As Dr Dascombe’s indicated, there’s no identified causal link between vaccines and autism.

Senator ROBERTS: You weren’t here, but I asked Professor Skerritt a question about the testing of the COVID Pfizer shots in Australia. He said, ‘Oh, no, we didn’t do any testing; we relied upon the FDA in America.’
At that time, it had been already been stated that the FDA did no testing itself and relied on Pfizer, and Pfizer cut short its trials because of the number of people who died. So we had a failed study that led to the approval of vaccines—of COVID injections—in this country, and no-one knew about it, yet it was open public knowledge in the United States. Let me continue. A Korean study published in Biomarker Research in September this year followed up 8.4 million Koreans and found as follows: within a 12-month period following their COVID jab, the vaccinated group had a 27 per cent greater chance of being diagnosed with cancer when compared to an unvaccinated group. This was a massive study. This does not prove causation, although many studies I have shared with you prove how these products cause cancer. It does prove correlation. Do you still maintain that COVID vaccines are safe?

Prof. Lawler: I do not recall, Senator, an article that you shared with me that does prove causation between these vaccines and cancer. Also, given the need to analyse the documents, I don’t have the article that you’re
describing in front of me, so I think it would be inappropriate for me to comment on it specifically.

Senator ROBERTS: Okay. I’ll check that. On 28 November 2025, Dr Vinay Prasad, director of the American FDA’s Center for Biologics Evaluation and Research, sent an email first reported by the New York Times. It
described findings from a recent internal FDA review of paediatric deaths reported to the Vaccine Adverse Event Reporting System, VAERS, between 2021 and 2024. According to the memo, an analysis of 96 reported
paediatric deaths among people aged from seven to 18 concluded that at least 10 were causally linked to COVID 19 vaccines, primarily due to vaccine induced myocarditis. Prasad describe this as a ‘profound revelation’. Professor Kidd, do you acknowledge that paediatric vaccines can cause death?

Prof. Kidd: I’m going to have to take that on notice.

Senator ROBERTS: You can’t acknowledge it or you can?

Prof. Kidd: I’m going to take it on notice.

Senator ROBERTS: The FDA analysis—

Prof. Lawler: I’m happy to provide some comment on that if you like, Senator.

Senator ROBERTS: Sure.

Prof. Lawler: We did respond to questions about Dr Prasad’s announcement earlier this evening when questioned by Senator Antic. As far as I’m aware—Dr Dascombe, please feel free to correct me—we have not at
this stage been provided with information regarding that. As we have indicated previously, we rely not only on our own information that comes through our own adverse event monitoring system but also on signals that come from other regulators. This is not a signal that has been replicated, to my knowledge, in other regulators. As I say, we have not had detailed information regarding Dr Prasad’s claim shared with us.
In terms of the question that you posed to Professor Kidd, one of the reasons we have robust postmarket vigilance in place for medicines, devices and, in fact, all therapeutic goods that we regulate is that we recognise
that individuals sometimes react to medicines. To give you an example, we have a number of other medicines—non-vaccine medicines—to which individuals can have allergic reactions. So it would be inappropriate, I think, for either Professor Kidd or me to say that people can’t react to these things. Our role as the regulator is to ensure that appropriate systems are in place to identify safety signals as they arise, to analyse them, to understand them and to respond to them in an appropriate way.

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A Simple Step Toward Safer Immunisation

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FOI requests, and the information they reveal, are an important element of Senate Estimates. In the past, a reference to the FOI number would prompt a staff member to appear with the relevant information to enable discussion. At the start of my question, a staff member approached the table with their laptop open—most likely with the FOI document displayed—so that system still exists. Nonetheless, Professor Lawler avoided discussing the FOI.

Some Senators provide their questions in advance so the FOI can be ready, however this also gives the witness time to prepare an evasive answer and removes the possibility of an unguarded admission. The point of my question was simple: the TGA’s own guidelines—which the FOI meeting notes confirmed—state that single-use medicines and vaccines should not contain preservatives. That unguarded admission is exactly what I was referring to. Professor Lawler stated that preservatives relate to multi-dose vaccines, not single-dose vaccines.

This is the argument I will make moving forward. At the last Estimates, I reviewed data that clearly linked preservatives in vaccines with autism. Single-use vaccines do not contain preservatives (or should not). Why don’t we immediately return to administering vaccines in single-use doses that are certified and tested as preservative and contaminant free? Then we can monitor autism cases in real time.

Many mothers have told me their child’s autism began the day after their shots. This approach would quickly show us whether there is a link in the real world. Let’s take a simple, immediate step to address this issue, and then conduct a full review of vaccine safety and efficacy.

— Senate Estimates | December 2025

Transcript

Senator ROBERTS: I reference freedom of information 26-2122, released 30 September 2025. It’s weirdly specific: the minutes of the pharmaceutical subcommittee of the advisory committee on prescriptions. I think
that’s part of the TGA. Is that correct?

Mr Comley: That sounds to me like PBAC.

Prof. Lawler: Can I clarify which committee you referenced?

Senator ROBERTS: Yes: the pharmaceutical subcommittee of the advisory committee on prescriptions. They’ll be coming to the TGA pretty soon.

Prof. Lawler: No. We have a number of advisory committees, but we don’t have an advisory committee on prescriptions. We have an advisory committee on medicines and an advisory committee on vaccines.

Senator ROBERTS: Perhaps if I give you the question you might be able to tell me. Held on 24 March 2015 and regarding the matter of preservatives in single-use injections, the meeting concluded:
… single-use injections should be preservative-free.
… if an ingredient is added for a reason other than use as a preservative, then the sponsor should provide scientific justification for inclusion at that concentration. Is this guideline still current?

Prof. Lawler: I must admit I don’t have that document in front of me, so I’m finding it hard to respond to that on the fly.

Senator ROBERTS: You can take it on notice.

Prof. Lawler: I’m happy to do that. The best I can take it is that we look to preservatives predominantly for multi-use vials because, obviously, there’s a period between them being used first—but I’m happy to take that on notice and come back to you.

Senator ROBERTS: It sounds like the answer to the question, ‘Is this guideline still current?’ is correct, but I’m not going to hold it to you. Thank you for that. The next questions, possibly also on notice, are: have you
allowed any single-use injection product to contain preservatives, and were all of those approvals compliant with your own guidelines?

Prof. Lawler: Again, given the first question, I’m happy to respond to that on notice, if that’s alright.

Senator ROBERTS: And could you provide the list of any that were approved. If you have allowed single-use injections to contain preservatives, why did you make the change to allow preservatives when your expert
committee opposed the idea?

Prof. Lawler: My understanding is that the committee you’re referencing—what was the date of the—

Senator ROBERTS: It was 24 March 2015—probably before your time.

Prof. Lawler: It was well before my time. That is an older committee. I think, in the interest of providing you with a comprehensive response, we’d be happy to roll those up into one response, if that’s alright.

Senator ROBERTS: I’d just like to know if it’s still current.

Prof. Lawler: Absolutely.

Senator ROBERTS: I’d like to know this too: Which multidose vaccines contain preservatives? Have you obtained safety data to show those preservatives are safe at the levels used?

Prof. Lawler: There are a number of branches across the TGA and also, potentially, ATAGI to which those questions apply.

Senator ROBERTS: Sure.

Dr Pengilley: To the best of my knowledge, the only use of preservatives in multi-use vials is for pandemic vaccines, and that, at the moment, is the influenza ones; COVID, just for clarity, doesn’t contain preservatives.
We haven’t—

Senator ROBERTS: It does or doesn’t contain—

Dr Pengilley: Does not. I probably can’t go into applications we have and haven’t had, but, as far as I know, we haven’t registered a preservative-containing pandemic vaccine—say, an H5N1 vaccine.

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Are Aluminium Adjuvants in Vaccines Linked to Autism?

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Aluminium adjuvants (preservatives) in vaccines are commonly blamed, at least in part, for the increase in autism. Recent work has been done that confirms this theory, so I asked the TGA about the subject. Research on aluminium was conducted on aluminium salts, but the jabs use a quite different type of aluminium which has not been safety tested. This is my exact question:

“A study published in September took biopsies from the brains of older children diagnosed with autism and found their brains contained significantly elevated levels of aluminium, especially aluminium hydroxide and aluminium phosphate, which are present in the hexa jabs. Has the health testing on aluminium build-up in our children’s bodies been done using water-soluble aluminium salts, which are not used in vaccine products, or has this research been done using the actual aluminium used in vaccine products, aluminium hydroxide and aluminium phosphate?”

This question was straightforward and simply put: have you tested the right type of aluminium for safety? The TGA feigned not understanding the question to avoid answering it. When pressed, they took the question on notice and then refused to provide further information, with Minister Gallagher covering for her bureaucrats. This is unbecoming for a senior bureaucrat and for the Minister.

Australians want an answer to this, and I will keep at the subject until I get one. The fact they are hiding from the question suggests the answer is as recent science is showing – aluminium preservatives in vaccines are causing autism in some children.

Transcript

Senator ROBERTS: My third and final set of questions is about aluminium adjuvants. Again, constituents are raising this. A study published in September took biopsies from the brains of older children diagnosed with
autism and found their brains contained significantly elevated levels of aluminium, especially aluminium hydroxide and aluminium phosphate, which are present in the hexa jabs. Has the health testing on aluminium
build-up in our children’s bodies been done using water-soluble aluminium salts, which are not used in vaccine products, or has this research been done using the actual aluminium used in vaccine products, aluminium
hydroxide and aluminium phosphate?

Prof. Lawler: Sorry; did you reference research? There was a question there about whether research has been done?

Senator ROBERTS: Has the research been done on babies’ brains using the aluminium found in vaccine products, aluminium hydroxide and aluminium phosphate, or has it been done using water-soluble aluminium
salts?

Prof. Lawler: Sorry; I’m just trying to be clear. Is the research that you’re asking me about the research that you cited?

Senator ROBERTS: No, I haven’t cited anything. To your knowledge, has the health testing on aluminium build-up in our children’s bodies been done using water-soluble aluminium salts, which are not used in vaccine
products, or has the research been done using the actual aluminium found in vaccine products, aluminium hydroxide and aluminium phosphate Prof. Lawler: I’m sorry; I don’t know the research that you’re specifically referring to.

Senator ROBERTS: Okay. I’ll send you some papers. Is the type of aluminium in vaccine products bioresistant? Does it ever leave the bodies of our children?

Prof. Lawler: Again, there are a number of very specific and very technical questions that you’re asking us. For the purposes of answering them, as I’ve previously indicated, we’re very happy to take these questions—

Senator ROBERTS: That’s fine. I’ve got nothing against taking them on notice.

Prof. Lawler: Okay. I would like to provide you with as fulsome a response as possible.

Senator ROBERTS: Thank you. Are repeated doses of low concentrations of aluminium adjuvant in a vaccine product more harmful than a single large dose? A related question: how many vaccine products
containing aluminium hydroxide and aluminium phosphate has the TGA authorised for administration to children? You’ll have to take that on notice.

Prof. Lawler: I certainly will have to take that on notice.

Senator ROBERTS: I only had a concern about the one I objected to. I have no concern about the rest at all. I appreciate that it’s a better answer. Individual vaccine products have been safety tested. Has any safety testing been done on multiple, concurrent administration of vaccine products to babies under six months, with special attention to multiple administration of low dose aluminium adjuvants?

Prof. Lawler: Professor Langham can add to this response. There has been not only significant research undertaken with respect to the administration of vaccines but there is significant real-world evidence over decades on the safety of the administration of the vaccines that we approve.

Prof. Langham: I have nothing further to add on that. As you’re aware, we have a number of avenues whereby safety signals from all registered products in Australia are overseen from a pharmacovigilance
perspective, as Dr Larter has already mentioned. We work closely with other global regulators and also with other research that’s published. As Professor Lawler has said, with the vast body of information that exists about these vaccines and their use in children, there have been no signals.

Senator ROBERTS: So you can’t answer the question as to whether or not—

Prof. Langham: I think I did answer the question.

Senator Gallagher: Yes. I think that’s definitely an answer.

Senator ROBERTS: I’ll ask it again. Has any safety testing been done on multiple concurrent administration of vaccine products to babies under six months, with special attention to multiple administration of low-dose
aluminium adjuvants? Can you tell me if multiple injections have a different effect from one or two injections?

Prof. Langham: The evidence that exists from a safety perspective is not only the clinical trial data that we receive upon registration but also the ongoing evidence from a real-world perspective of the use of these vaccines in those multiple dose formulations in many millions of children around the world.

Prof. Lawler: For many years.

Senator ROBERTS: I have a last question. Are aluminium adjuvants causing the spectrum of neurological conditions that are commonly called autism?

Prof. Lawler: I’m not aware of any accepted evidence that that is the case.

Senator ROBERTS: Minister, you may sigh—

Senator Gallagher: Do you know why I sigh, Senator Roberts? It’s because I have a child with autism, and I have vaccinated children, and I find it offensive.

Senator ROBERTS: Well, I find it offensive to not respond to a constituent, and I’m responding to constituents. That’s my job. They pay me.

Senator Gallagher: Well, I’ve had enough.

Senator ROBERTS: Professor Lawler, have you heard of these papers? I think this will be my last question, Chair.

CHAIR: Yes, it will be.

Senator ROBERTS: I’ve mentioned one by Dr Karla Lehmann from 2024 titled ‘Suspected Causes of the Specific Intolerance Profile of Spike-Based Covid-19 Vaccines’ in the European Society of Medicine. There’s one
from 2022 by El-Arif G et al called ‘Angiotensin II Type I Receptor (AT1R): The Gate towards COVID-19 – Associated Diseases’ published in Molecules. In 2023 Fajloun and Sabatier published ‘The Unsuspected Role of the Renin-Angiotensin System (RAS): Could its Dysregulation be at the Root of All Non-Genetic Human Diseases?’ in Bentham Science. In 2023 Parry, P et al wrote, ‘”Spikeopathy”: COVID-19 Spike Protein Is
Pathogenic, from Both Virus and Vaccine mRNA’ in Biomedicines (Journal). The last one is from Pelumbo, Avila and Naftolin in 2016 called ‘The Ovarian Renin-Angiotensin System (OVRAS): A Major Factor in Ovarian Function and Disease’ in PubMed by the National Institute of Health, the National Library of Medicine USA.

Prof. Lawler: I’d be very happy to receive those studies—I’ll speak on behalf of Professor Langham if she doesn’t mind. I would say that there is a very well established understanding of the importance of the renin-angiotensin-aldosterone system in a number of various elements of regulation of human function. I think it is well recognised that they are impacted by the COVID disease itself.

Senator ROBERTS: What part of the COVID disease?

Prof. Lawler: It will be very useful for us to review those articles so that we can be sure that they are reflective of the impact of COVID not, as suggested, an impact of the vaccine.

Senator ROBERTS: Good. Thank you very much. Would you like the references sent as paper copies, as attachments or by links?

Prof. Lawler: At your pleasure.

Senator Gallagher: Carrier pigeon.

Senator ROBERTS: Chair, I’ll be putting forward a number of questions on notice on the spike protein.

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