In early December 2025, the U.S. FDA announced immediate and sweeping reforms to its vaccine approval and monitoring processes. These changes include stricter clinical trials, restrictions on high-risk groups such as pregnant women, and a comprehensive overhaul of vaccine safety monitoring.
I asked the Australian TGA whether they were following these developments and if there was a need for Australia to adopt similar measures. Their response was a “no,” wrapped in many pointless words.
Health Secretary Kennedy is making great progress in dragging the medical establishment back to the center. At present, I believe pharmaceutical companies and their profits exert too much influence on our health administration, to the detriment of common sense, honesty, and duty of care.
I will continue to hold the TGA to account.
– Senate Estimates | December 2025
Transcript
Senator ROBERTS: For now. The FDA announced immediate and sweeping reforms to their vaccine approval and monitoring processes, including stricter clinical trials; restrictions on high-risk groups, such as pregnant women; and an overhaul of the vaccine safety monitoring system. This is going on under a new administration. The reforms closely mirror measures which operated in Australia until COVID, when our safety assessments and monitoring were watered down with fast-track approval and emergency-use authorisation for a multitude of drugs. Will you accept that weak approval processes, high-adverse events and blanket denials that anything is wrong have undermined confidence in the entire health system in this country?
Prof. Lawler: There are a couple of things there, if I might comment. We didn’t use emergency-use authorisation. We adopted what is called a provisional pathway—
Senator ROBERTS: It’s equivalent.
Prof. Lawler: It’s not equivalent; it’s quite different. The reason that we undertook it was that, like the rest of the world, we recognised that there were risks that the community was facing, and we worked very closely with other regulators to understand what was emerging. Tonight, you previously mentioned relying on the FDA. It’s really important that, when we talk about reliance, it’s a specific term. It’s not like, if the FDA has approved it, then we automatically register it—
Senator ROBERTS: I’m just using Professor Skerritt’s words.
Prof. Lawler: I wasn’t here when Professor Skerritt gave you those words; I’m just trying to explain where we’re at.
Senator ROBERTS: He said he didn’t do any testing here—
CHAIR: Senator Roberts, can we let Professor Lawler finish his answer, please.
Prof. Lawler: It’s not like, if the FDA hasn’t approved it, we say, ‘You shall not pass.’ What happens is that we look to the information that other regulators have when making our own decisions. I think the important thing as well to note is that we do very much rely on our approvals. We do have, as other regulators have, both pre-market and post-market evaluation and monitoring. But the point that you made about trust is a very important one. We had a presentation at our International Coalition of Medicines Regulatory Authorities earlier this year about trust. There was a very strong driver of trust in institutions, in regulations and in health professionals. The very strong downward driver of it is misinformation and disinformation. Part of the challenge that we have is that, as we hear very frequently, there are a lot of studies, for instance, of very low quality that are being taken up and used as evidence or proof of causal links that just do not exist. Part of the challenge we have is that we do strive to rebuild trust. On two occasions in the last two months, the chief medical officer and I have endeavoured to do that through public statements, and it is a constant battle.
Senator ROBERTS: It’s something we’ve found agreement on. I understand there was a paper in the Lancet a few years ago that said that 50 per cent of medical papers are not valid. Now, we’ve got increasing knowledge coming out and evidence showing that big pharma has heavily influenced the scientific papers and has corruptly done so. This is my last question. Will you monitor the changes in the United States in case the new team under Kennedy is actually right about what has gone before them and right about the changes being necessary?
Prof. Lawler: We monitor all of the developments by our international collaborative partners in regulation.
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.
I spoke with Dr. Marcelle Noja, who expressed sympathy for those whose health has been compromised by mesh complications.
When asked about the Australian Pelvic Floor Procedure Registry’s failures in following up with patients, she stated that this question would be taken on notice.
I also inquired about the steps the government is taking to assist with the cost of remedial surgeries; this question was likewise taken on notice.
Regarding the differences in approach taken by the UK and New Zealand—where mesh has been banned or severely restricted—I was informed that, because the mesh is used for other treatments, Australia has decided against a total ban on the product.
Due to time constraints, I will submit the remaining unasked questions on notice.
— Senate Estimates | December 2025
Transcript
Senator ROBERTS: Let’s move on to pelvic mesh. Following a Senate inquiry, a formal government apology, overwhelming evidence of harm and international bans in multiple countries, transvaginal mesh continues to be implanted in Australian women daily. Can you explain why these devices have not yet been banned and what specific evidence would be required for the health department to recommend an immediate hold to their use?
Dr Noja: Thank you for this question and thank you advocating for many of the patients who have had urogynaecological mesh and had negative outcomes as a result of it. The TGA was similarly concerned with the impacts of urogynaecological mesh. That is why we have taken a number of actions in relation to this. When we look at postmarket activities in relation to mesh, and in fact all products, we undertake a risk analysis, we look at the evidence, and we go to the companies and ask them for information in relation to those products. When it came to these products, we did look at the products and we found that, for many, the evidence was not there to support their ongoing inclusion. Many of those products were actually removed from the Australian Register for Therapeutic Goods. However, for some of the products, we did find that, for some health conditions, there was still benefit for patients. So, for those products, we have continued to include them in the register. However, in support of patients, we have done other activities. We have undertaken a number of reforms. Some of those include increasing information for patients. That means more information about the product, more information about what may occur and working closely with the health professionals to make sure that information does get to consumers. We’ve also recently implemented mandatory reporting regulations for mesh. What we found was that the TGA did not have significant signals to be able to act on doing something. Under this new regulation, it will be mandatory for healthcare facilities to report all adverse events to us. We will then be able to pick up signals sooner and act faster. We continue to monitor this, and this includes undergoing ongoing signal-detection activities. These are critical devices for some Australians, so we really have to be balanced in what we remove from the register versus what we allow to continue, as well as how patients can access it.
Prof. Lawler: I’ll add briefly, as Dr Noja has said, that the role of the regulator is to understand the balance between the risk to patients and the benefits to patients. As we’ve heard, there are certain instances with certain products and certain conditions where there continues to be strong benefit. One of the roles that we take as a regulator is to regularly update product information so that the information that’s necessary for patients to make informed decisions is available to them for conversation with their registered health practitioner.
Senator ROBERTS: Dr Noja, perhaps you can correct me on this, but this is my understanding—I take note of what you said—on the back of the 2018 inquiry, a pelvic mesh registry, the Australian Pelvic Floor Registry, was established. Unfortunately, this registry fails to track long-term health outcomes of mesh affected women, because it only tracks certain women from certain hospitals and only for a period of 24 months. That may have changed. You can correct me if I’m wrong. Will the government amend the failings of the Australian Pelvic Floor Procedure Registry and instead establish a comprehensive, long-term health monitoring program?
Dr Noja: Responsibility for the pelvic floor mesh registry doesn’t sit with the TGA; it sits with my colleagues in another part of the department. I’m not sure if our colleagues from HERD are here. I don’t believe they are. We can take that on notice and talk to our colleagues to provide you with an answer.
Senator ROBERTS: Thank you. The mesh clinics established after the 2018 inquiry are fundamentally failing women by providing only partial medical intervention. Apparently these clinics will remove mesh devices but categorically refuse to repair the resulting extensive damage, leaving women in a state of severe medical compromise. Can you explain why these clinics are permitted to create additional harm?
Prof. Lawler: We’re not familiar with the practices of those clinics. The regulation of clinics and health practitioners is not a responsibility of the TGA, and, as I mentioned previously, these are largely conversations between patients and their treating health practitioners. We are not responsible for the management of the operation of those clinics.
Senator ROBERTS: Can you give any advice to women who are still in a lot of pain—not medical advice, but where to go?
Dr Noja: The TGA has established a range of information on our website. We have what’s called the mesh hub, and I’m happy to provide that link to anyone in the committee, if that’s helpful. The mesh hub includes a range of information for people who have suffered from mesh injury. It includes information about accessing various aspects of our Medicare system as well as treatment options and information about other services that are available to them.
Senator ROBERTS: The mesh hub?
Dr Noja: That’s correct.
CHAIR: Senator Roberts, I’m just flagging that I will need to shift the call shortly.
Senator ROBERTS: I’ll keep sprinting.
CHAIR: You’re in the sprint, yes.
Senator ROBERTS: Every day Australian women are facing an impossible choice due to pelvic mesh complications—and I’m sure you’re aware of that—draining their retirement savings and suffering ongoing medical trauma. Many women are forced to access their superannuation on compassionate grounds to fund critical mesh removal or repair surgeries, while others completely forgo necessary care due to prohibitive costs. What steps will the government take to establish a comprehensive support system for women that covers the full cost of surgeries and ongoing care that they need from being harmed by a government-approved medical device? Perhaps the minister might want to comment, as well as you, Dr Noja.
Dr Noja: I will allow the minister to comment, but I will just note that our website does include information for patients with respect to what services they can seek support with. There are a number of MBS and PBS items available to them, which they can seek access to, and there are a number of available resources there for them.
Senator Green: For completeness, I’ll take your question on notice so I can provide you with some information about what supports are available. I don’t disagree with you that these women have gone through an awful ordeal. I’m confident that we’ll be able to give you some fulsome information about what’s available, but you should continue to raise these issues.
Senator ROBERTS: Last question in this sprint—the UK, Scotland and New Zealand have banned or severely restricted transvaginal mesh use, due to unacceptable harm rates, but Australian women continue to receive these implants daily. That doesn’t seem to make sense to me. What makes Australian women different from British or New Zealand women and justifies continuing a practice that other countries apparently have deemed too dangerous?
Dr Noja: I will note that the TGA doesn’t tend to ban devices. Our approach is around inclusion versus exclusion of products so that there remain a number of pathways available to clinicians should they deem it appropriate for a member of the public to have access to a product. The reason we don’t ban products is that it is important that patients get the best appropriate care for their individual circumstance. I really respect your comments around what we are doing to protect women, and, as I mentioned, we have actually undertaken a number of actions specifically related to these products. As part of our post-market review and our action, we did upclassify some products and remove others, but it is important that these products remain available. They are used for other surgical procedures, apart from urogynaecological conditions, so it is important we make sure that access is available. We just have to have rigour around where access occurs to ensure that the products are fit for purpose in how they’re being used. Part of that, really, is the patient information and making sure that patients are appropriately provided with all the information they need to support them in making sure that it is the right decision for them.
Senator ROBERTS: I hear what you say, and I acknowledge it, but why is the mesh banned in other countries and not banned here?
Dr Noja: I don’t believe it is banned in other countries. Australia has taken the step to upclassify these products. Other countries have not gone as far as Australia has, in terms of its regulatory approach. Some countries are continuing to look at these products and make decisions about what they do, but they will be making those decisions based on the evidence they have in front of them and the signals and risks that they’ve seen in the patients that are presenting in their jurisdiction.
Prof. Lawler: In your question you did say that in other countries these products have been banned or significantly restricted. As Dr Noja has indicated in her answer, we have also undertaken some actions that have restricted those devices, through the upscheduling and through the removal of some from the register, and also through the imposition of conditions of inclusion. So we have taken regulatory actions as well.
Senator ROBERTS: So you’re going to send me more information and the minister is going to give me an answer on notice, and I’m going to stay on the treadmill.
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.
This exchange during Senate Estimates with the Therapeutic Goods Administration (TGA) sums up just how bad Estimates has become under the Albanese Labor Government.
The TGA is well aware that Senators only have a few minutes to ask questions, and they understand that the more they can stall, the less likely it is they’ll have to say anything that could cause problems for their Minister—regardless of the truth. Because of this, the Minister will not require the “witness” to answer the question, nor will the Committee Chair—both of whom are Labor Senators.
My first question was a genuine attempt to clarify misinformation circulating online about aluminium intake. The answer was a simple “yes.” Keep that in mind when you watch the video. Instead of confirming the obvious and allowing us to move on to another question about aluminium in vaccines, the opportunity was taken to stall for time by debating whether the question should even be asked at all. Dr. Lawler, Deputy Secretary of the Health Products Regulation Group within the Department of Health, oversees the agencies and committees the Government uses to spread responsibility, avoiding accountability. He was exactly the right person to direct these questions to.
The data I presented was straightforward: the level of aluminium in vaccines is unsafe for infants by an order of magnitude. Yet the TGA spent a great deal of time on their pre-prepared responses insisting that vaccines are safe. They refuse to accept any data showing that this level of exposure is causing health issues in infants. I then asked whether our vaccines had been subject to gold standard testing—a term used on many occasions by “witnesses” attending Estimates to defend COVID vaccines – yet suddenly, the gold standard is no longer relevant to … vaccines! Suddenly, testing a product against a double-blind placebo (saline) is now considered “unsafe,” despite this being the standard for a century?
In reality, what Big Pharma has been doing for years—and what the TGA has allowed them to do in Australia—is to compare new vaccines (or medications for that matter) against existing ones, rather than saline. If the harm detected is the same as that already being caused by the “placebo” medication, it’s deemed safe. This is not how things should be.
I will continue this line of questioning until we get a proper inquiry into the level of heavy metal contamination in infant vaccines.
— Senate Estimates | October 2025
Transcript
Senator ROBERTS: Thank you for being here again, especially Professor Lawler. Before I start, can we deal with a statement I hear on the internet all the time—that you get more aluminium in your food than you do in vaccines. Aluminium in food is ingested at 0.3 per cent. In vaccines, it’s ingested at 100 per cent. Individual results may vary. Is this a fair statement?
Prof. Lawler: I’m not sure where you’re seeing that. I don’t have the information you’re referencing in front of me.
Senator ROBERTS: I’m asking you whether it’s accurate.
Prof. Lawler: I’m not sure that is necessarily a question for the TGA to respond to. We can provide you with information on the process that we undertake in terms of the evaluation and authorisation of therapeutic goods, including vaccines. Is this a claim that the TGA has made?
Senator ROBERTS: No. That’s my understanding. What is the TGA’s recommended maximum daily intake of aluminium for a child aged six months, please?
Prof. Lawler: By mouth as a recommended daily intake?
Senator ROBERTS: Yes.
Prof. Lawler: I don’t believe that the TGA sets a recommended daily ingestion of aluminium, Senator.
Senator ROBERTS: What is the daily maximum for a child of six months that can ingest aluminium in food?
Prof. Lawler: I would suggest that those are probably questions best posed to Food Standards Australia New Zealand, Senator.
Senator ROBERTS: The US Food and Drug Administration recommends exposure of five micrograms per kilogram in infants. At six months, the average weight of an infant is seven kilograms, making the maximum daily exposure 35 micrograms. The Infanrix hexa vaccine contains 825 micrograms of aluminium per dose, which is 24 times its safe daily limit. Do you accept injecting children at 23 times the safe level? Do you accept that this unsafe aluminium exposure is a contributing factor to aluminium derived autism?
Prof. Lawler: I will throw to Dr Dascombe in a moment. I will answer a couple of the things there in reverse order, if I may. The first is that, in answer to your second question, no. I don’t believe that there is a recognised regulator—I’m happy to be corrected—that does.
Senator ROBERTS: Rather than relying on someone else, do you have any data or research?
Prof. Lawler: I’m just trying to answer your question. I don’t believe that there is another regulator. I’m just using that as back-up. We have seen no credible safety signal that aluminium load either in single or scheduled immunisation delivery is a contributor to autism. The second thing I would say is that I am not sure this is the forum, nor do we have the time, to clarify the distinction between injected and ingested aluminium. They are quite different biomechanical processes. I don’t think the two are comparable. I will ask Dr Dascombe to add to that answer.
Dr Dascombe: I echo the comments of Professor Lawler. Neither the TGA nor any international regulator has detected or confirmed any safety signals relating to any vaccine and autism. This is also supported by the weight of scientific evidence.
Senator ROBERTS: What is the TGA guidance for the injection of multiple vaccines into a six-month-old at the same time causing amplified aluminium? Each of those doses has aluminium adjuvant, a preservative, so each of them is 24 times the daily safe limit.
Prof. Lawler: My apologies for breaking in, Senator. There are a couple of points on that. It is not the practice or the role of the TGA to make recommendations on immunisation schedules. That sits within the province of ATAGI, the Australian Technical Advisory Group on Immunisation. I would also highlight that we have frequently responded to questions around the aluminium load in the vaccination schedule and their consequences. Most recently, but perhaps more recently, is a Senate question on notice 24-003075. We have discussed it in this place a number of times.
Senator ROBERTS: You see the problem. Just one vaccine can be 24 times over the safe daily limit. You are recommending injecting multiple of them at the same time. These infants could be getting over 100 times the safe limit and you just keep on injecting them right in there and then claim aluminium poisoning isn’t the reason they come down with autism in some cases the very next day. How can you justify this?
Prof. Lawler: I will answer those questions in reverse order, if I may. I will answer the second. There is no indication that the vaccination schedule is linked to autism. Indeed, it has been highlighted not just today but previously. There’s no credible evidence that there is a linkage between vaccination and autism. As I just indicated in my previous answer, it is not the role of the TGA to recommend vaccinations. We assess them for safety, quality and efficacy. It’s the role of ATAGI to recommend the vaccination schedules.
Senator ROBERTS: Why don’t you tell the pharma companies to reduce the aluminium preservatives down to safe levels so you can get parents to trust your vaccine again and the parents can trust your advice again?
Prof. Lawler: There are a couple of elements in your question. We evaluate the submissions from sponsors and evaluate the process of manufacture and quality control to ensure that the balance of risk versus benefit is appropriate. That is a determination that we make not only in the authorisation but also in the post-market monitoring through our pharmacovigilance of any therapeutic good with the inclusion of vaccines. In terms of trust, we recognise that there is an active campaign to undermine the trust of regulators, the TGA particularly. We undertake to restore or bolster the trust of the public, which I have to say was during the pandemic and is still, despite some narratives, at a high level. We seek to do that through education and guidance. We do that through being very clear and transparent about what we do and by addressing dis- and misinformation when and if it occurs.
Senator ROBERTS: How many vaccines in the Australian schedule have been subject to a gold standard trial, meaning specifically a randomised double blind placebo control study where the placebo is saline and not another vaccine?
Prof. Lawler: I recognise that you weren’t here before lunch. We had a conversation with Senator Antic regarding the use of the term ‘gold standard’. We recognise that the use of a placebo control randomised double control trial—there are a number of different terminologies used—is of a very high standard and presents robust and dependable evidence. The challenge, of course, is whether something constitutes a gold standard in the way that you have used it. It actually very much depends on context. We use controlled or blinded trials or placebo trials when we are interested in determining the difference between a control arm and an intervention arm. This is really effective when we’re looking at incremental improvements in therapies or when we’re looking at the introduction of new therapies. The challenge we have, of course, is that when there is an established therapy that has been shown over decades using both documented and real-world evidence to be both safe and effective, it is ethically questionable—and, in some instances, ethically indefensible—to use a placebo in that non-intervention arm. I will give you two examples, if I may. We have vaccine preventable diseases, and we have a very clear demonstration of reduction in not only mortality but morbidity in those diseases. Let’s choose polio and small pox, diseases that have had a specific impact for many decades and have led to untold suffering. One of them has been eradicated by the use of vaccines and one of them has been virtually eradicated. If we were to introduce placebo controlled trials for those drugs, that would be horrendously unethical. We would be essentially and knowingly infecting children with a disease that could kill, paralyse or maim when we know that there is a way of preventing that. That’s not ethically defensible.
Senator ROBERTS: What you are saying is that there has been no double blind placebo control study where the placebo was saline and not another vaccine?
Prof. Lawler: No. What I am saying is that would not be an appropriate approach to be taking today with the vaccines we use.
Senator ROBERTS: Has it been taken in the past?
Prof. Lawler: I also would highlight that the introduction of vaccines occurred some time ago. And also—
Senator ROBERTS: So it has not been done?
Prof. Lawler: I will let you finish.
Senator ROBERTS: So it has not been done, then, the tests?
Prof. Lawler: Whether these—
Senator ROBERTS: A double blind trial?
Prof. Lawler: Well, we’ve actually already taken on notice to provide concrete evidence on which of those vaccines has been subjected previously to blinded control trials.
Senator ROBERTS: How many COVID vaccines have been destroyed because they aged out? What was the purchase cost for those products?
Prof. Lawler: Dr Anna Peatt from the national immunisation division will respond to that.
CHAIR: This is your last question, Senator Roberts.
Dr Peatt: Senator, could you please repeat the question? I didn’t quite hear it.
Senator ROBERTS: Certainly. How many COVID vaccines have been destroyed because they aged out? What was the purchase cost for those products?
Dr Peatt: Senator, I would have to take that question on notice. I don’t have that available with me today.
Senator ROBERTS: Was close to 35 per cent of the multibillion-dollar COVID vaccine supply binned or trashed?
Dr Peatt: I would have to take that question on notice.
Senator ROBERTS: I am asking for you specifically to tell us whether or not it was 35 per cent.
Dr Peatt: I don’t have that figure in front of me.
Senator ROBERTS: I am asking for you to just say what the figures are. Can you confirm that is 35 per cent of what we bought?
https://img.youtube.com/vi/uj4SbhAiGMU/maxresdefault.jpg7201280Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2025-10-22 18:08:302025-10-22 18:08:37A Case Study in Avoidance
In the July sitting, the Albanese Government introduced the Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Bill 2025. Most of the bill was a tidy-up of poorly drafted health legislation from the previous parliament.
However, one section was slipped in — a new power allowing the Therapeutic Goods Administration (TGA) to declare a drug shortage based merely on the suspicion of a future shortage. This would then enable the approval of drugs that haven’t been properly tested or assessed.
The TGA already has a similar power with a higher threshold for approval. This new legislation appears to be nothing but a pretense to give the TGA sweeping authority to bypass safety testing and scrutiny for new drugs. Even under the current “higher bar,” Section 19(1) has been used to approve 135 current drugs and 600 expired or lapsed ones — a total of 735 approvals of new drugs – or versions of drugs in two years.
I asked the Minister to provide an example of how Australians might be disadvantaged without these new powers. The Minister couldn’t answer. So I must ask — who actually wrote this? It clearly wasn’t the Government.
One Nation will repeal Section 19(1) and ensure that every new drug is subject to proper safety testing and full regulatory oversight.
Watch the video and see for yourself how clueless this Government is.
Transcript
Senator ROBERTS:Minister, the existing wording of section 19(1) already allows the TGA to approve the use of a drug that is not registered or approved in Australia, in the event of a shortage. That power has been used for 135 current approvals, and for 600 expired and lapsed approvals, for a total of 735 approvals of new drugs or versions of drugs in two years. Why do you need new powers when the existing wording is clearly no barrier to approval?
Senator McALLISTER(New South Wales—Minister for the National Disability Insurance Scheme): Thanks for the question, Senator Roberts. The advice that I’ve been provided is that the amendment goes to the ability to act in advance of a shortage arising—knowing that a shortage is coming towards us down the pipeline rather than being required to wait until the shortage actually arises. It will allow the government and the authorities to get ahead of shortages in relation to pharmaceuticals.
Senator ROBERTS: Thank you, Minister. Minister, can you provide an example of a situation where this new power would be needed because the old wording did not provide for that situation?
Senator McALLISTER: Senator Roberts, I think I’ve explained the principle, which is that from time to time we know that shortages of pharmaceuticals do arise. They arise because of interruptions to global supply chains or, sometimes, an interruption in a particular facility’s manufacturing capability. That disruption doesn’t immediately translate into a shortage, but we know, logically, that it will at some moment. These provisions allow us to get ahead of that situation.
Senator ROBERTS: My previous question was theoretical, to understand the process that informed the legislation. This question, Minister, is not theoretical: in what situation has the existing wording of section 19(1) failed to provide a good outcome for everyday Australians? Could you give me a real example, please?
Senator McALLISTER: There are multiple shortages that are managed by the TGA, and we want to be in the best possible position in the future to be able to manage them as they arise.
Senator ROBERTS: Just one example, please, Minister—not a theoretical one, not a hypothetical; just one concrete example of where this has been needed in the past and was not available.
Senator McALLISTER: Senator, it’s not my intention to trawl over previous decisions and circumstances, but it is the case that, from time to time, we can see in advance the potential for a shortfall, and we want to give the TGA the best possible opportunity to be able to intervene and make sure that the medicines that Australians need are available.
Senator ROBERTS: That seems to be confirmation, Minister, that it has not happened in the past. There’s no need for it.
Senator McALLISTER: That doesn’t follow from the advice I’ve provided to you, Senator Roberts. There are shortfalls from time to time in medications that are important for Australians. The TGA presently acts to manage those and works very actively. We want to make sure that, in future, they have all of the tools available to them to be able to do that, and we consider this to be an important amendment that will assist the TGA in that task.
Senator ROBERTS: Minister, thank you. You say that there are examples, but you won’t give me any, so let’s move on. Under this new low bar for approval, a pharmaceutical company would be tempted to avoid applying for a regular approval, which is expensive and time consuming, when they could just have their drug waved through under a spurious scarcity rumour—not fact but pending scarcity. Minister, what safeguards are in this legislation to ensure that big pharma does not create a false scarcity story to avoid making a normal authorisation application?
Senator McALLISTER: The TGA relies on intelligence; the TGA does not rely on rumours. The premise of your question is incorrect. It remains my position, as I’ve explained a number of times now, that it’s really important that we are able to act when we are aware of a forthcoming shortage or the possibility of a shortage of critical medicines. Australians rely on the availability of these, and it’s an important function that the TGA serves in protecting the supply chain.
Senator ROBERTS: Minister, this is getting to be disappointing. You keep telling me there are many examples and it’s concrete, but I don’t get anything. Let’s move on. Minister, under this bill, is there a time limit for the approval, and, if so, can the approval be renewed at the end of that period, creating what is, in effect, a permanent approval where they just keep extending it?
Senator McALLISTER: Senator Roberts, when you’re speaking about an approval, which particular approval are you referring to? Obviously, the legislation canvasses quite a range of different approvals.
Senator ROBERTS: Any temporary approval.
Senator McALLISTER: The advice I am provided is that the approval, by its nature, is temporary and expires as the shortage is resolved.
Senator ROBERTS: So, if the shortage is not resolved, is there a time limit for that approval to be enforced? If there is, can it automatically be renewed—in other words, granting a bypassing of the normal full regulatory approval process?
Senator McALLISTER: I appreciate the senator waiting while I obtain advice. I want to give accurate information to the Senate. The advice I’ve been provided is that these are statutory criteria that need to be met for any approval, and the TGA would need to be satisfied that those statutory conditions were met. However, it is the case that, ordinarily, these circumstances resolve themselves, so we do see shortfalls from time to time, and they are generally resolved over time. Our interest is making sure that any short-term shortages or impacts on Australians can be managed and that the TGA has the tools to do so.
Senator ROBERTS: So, Minister, is there a time limit and is it automatically renewed if the shortage continues beyond that time limit?
Senator McALLISTER: The advice that I have is that the approval would be provided with a time limit. That doesn’t prevent a reconsideration of the same questions, but it would be against the same criteria that I referred to in my earlier answer to your question.
Senator ROBERTS: So it’s highly likely we would just continue. The TGA has already approved certain drugs, including the product Pfizer sells as a COVID vaccine—their word. It’s already been approved for full TGA approval based, according to the TGA, on the safety profile data experienced during emergency use authorisation. Minister, will this legislation provide yet another way big pharma can make an end run around Australia’s longstanding authorisation process?
Senator McALLISTER: No. That’s a very leading question. The purpose of the legislation is set out in the explanatory memorandum and in other documentation around the bill, and there has been a Senate inquiry into the bill. Our objective is to make sure that Australians have the medicine that they need, even when shortfalls arise globally, and that we are in the best position to manage any consequences when we do see interruptions to global supply chains.
Senator ROBERTS: Of the 735 drugs granted authorisation under the existing legislation, how many are now subject to an application for full approval or have been approved based, according to the TGA, on the adverse events profile of the drug during approval under section 19(1) in the same way Pfizer’s Comirnaty was?
Senator McALLISTER: I am not in a position to confirm the numbers that you’ve cited in your question, nor do I have information about the numbers of applications on foot in various processes administered by the TGA. Perhaps you might like to think about another way of getting to the information that you’re interested in.
Senator ROBERTS: I will ask again and will try and break up the question: of the 735 drugs granted authorisation under the existing legislation, how many are now subject to an application for full approval?
Senator McALLISTER: As I indicated to you, Senator, I don’t have that information with me, nor would you expect me to. It’s a very detailed question.
Senator ROBERTS: Okay, I won’t continue with the other breakdowns of the question. Let’s move on to the next question. Does a drug approved under section 19(1) also go on the Pharmaceutical Benefits Scheme and, if so, does the normal negotiation on price still occur, or do we just pay whatever the drug company wants us to pay?
Senator McALLISTER: Thank you for waiting, Senator Roberts. I was seeking advice, again so that I can provide you with accurate information. The advice I have is that the standard process is for a medicine or product to be listed with the ARTG first before being considered by the PBS.
Senator ROBERTS: Thank you, Minister. The TGA have been enjoying unrivalled, unquestioned and unaccountable power since the start of COVID. Minister, why is the government extending the powers of the TGA again, with a bill that provides zero parliamentary oversight of the new powers?
Senator McALLISTER: I don’t agree with many of the propositions that are embedded in your question, Senator Roberts. I think I’ve been really clear about the purpose of the bill, or at least the elements which you’re asking me about now. Your very first question was: why do we need these additional provisions and abilities for the TGA? The answer is: from time to time we see shortages arise, where interventions are required to protect the interests, particularly the health interests, of Australian consumers. We want to make sure that the TGA has the capacity to manage these kinds of shortfalls.
Senator ROBERTS: Thank you, Minister. I appreciate what you just said; I don’t agree with it at all, because the TGA has run roughshod over the people of Australia when it comes to health. They are not held accountable. We need to return, in my opinion, to the days when the department of health approved or did not approve a drug and then the department could be held accountable to the parliament. That’s not the case for the TGA. It completely bypasses the parliament. So I foreshadow my amendment to introduce a provision to the existing legislation that any approval issued under this legislation must be by way of legislative instrument to allow parliamentary scrutiny. We, not the TGA, represent the people. The TGA has so many close contacts and close conflicts of interest with big pharma. It gets 96 per cent of its revenue from big pharma. Minister, why is there so little parliamentary oversight of our health bureaucracy?
Senator McALLISTER: Senator Roberts, I think you and I have different views about the level of oversight. The TGA is part of the department of health. The department of health appears regularly at Senate estimates. There are also a range of forums in which the parliament may ask questions about these issues, including, of course, in this place, in our own question time. Our government is committed to scrutiny, and I simply disagree with the proposition that you have made in your question just now.
Senator ROBERTS: You’re welcome to disagree, Minister. I’m sure that you welcome my disagreement. We saw the previous head of the TGA, Professor John Skerritt, retire from the TGA and, eight months later, get a job on the board of Medicines Australia, the big pharma medical lobby in this country. We also see that the TGA gets 96 per cent of its revenue from big pharma. That is a reason why we need to take the approval of drugs away from the TGA. Big pharma is not trusted, and, by association and due to their COVID mismanagement, we don’t trust the TGA anymore. I move One Nation amendment (1) on sheet 3379 as circulated:
(1) Schedule 2, Part 6, page 22 (line 1) to page 23 (line 22), omit the Part, substitute:
Part 6—Therapeutic goods approvals
Therapeutic Goods Act 1989
52 Subsection 19(1)
Repeal the subsection, substitute:
(1) The Secretary may, by legislative instrument, grant an approval to a person for the importation into, or the exportation from, Australia or the supply in Australia of specified therapeutic goods that are not registered goods or listed goods:
(a) for use in the treatment of another person; or
(b) for use solely for experimental purposes in humans;
and such an approval may be given subject to such conditions as are specified in the instrument.
Note: For variation of an approval for use of the kind referred to in paragraph (1)(b), see subsection (4B).
(1AAA) A legislative instrument made under subsection (1) must set out the reasons for the approval.
53 Subsection 19(4B)
Omit “by notice in writing”, substitute “by legislative instrument”.
Senator RUSTON (South Australia—Deputy Leader of the Opposition in the Senate): I would like to make a couple of comments on the contribution that Senator Roberts has just made in relation to his amendment to this particular bill. I probably would have a great deal of sympathy with Senator Roberts’s position, particularly after the comment made by the government that they’re committed to scrutiny. I don’t think anything could be further from the truth, when we’ve seen the amount of times that transparency has been denied in this place. In fact, this morning we had a half-hour contribution about the refusal of this government to be transparent when it comes to the NDIS. So I certainly have a great deal of sympathy with Senator Roberts in relation to the lack of scrutiny of their actions that the government are largely prepared to allow this parliament and the Australian public over their time in government.
But, in saying that, I understand that one of the most critical issues facing Australia in recent times has been drug shortages, for a number of reasons, of medicines and treatments coming into Australia. As a legislature, whilst safety and efficacy are at the forefront of every decision we make in relation to providing treatments and access to treatments for Australians through the necessary processes that exist within the department of health—and that includes through the TGA—one of the things we must always do is make sure that there is quick access because we know that so many Australians rely on treatments.
When there are shortages, the government must be able to act with some haste to put supplementary or substitute treatments and medications in place to ensure that Australians are not denied the life-saving and life-changing treatments they often rely on. At no time should safety ever be compromised for Australians, but we do understand that many Australians rely on the agility of our health department and its agencies to do that. But we acknowledge the lack of scrutiny and the lack of transparency that have become a hallmark of this government.
Senator McALLISTER: I’d like to indicate the government’s voting position. As I understand it, Senator Roberts’s amendment seeks to essentially require certain decisions to be made by way of a legislative instrument rather than by notice of writing. The government consider that this would be unnecessarily burdensome and would deprive the TGA of the flexibility that is necessary to manage the health interests of Australians, and we won’t be voting in favour of Senator Roberts’s amendment.
The CHAIR: The question before the chair is that amendment (1) on sheet 3379, moved by Senator Roberts, be agreed to.
https://img.youtube.com/vi/HfuEERh_KRQ/maxresdefault.jpg7201280Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2025-08-19 08:55:112025-09-04 22:49:41Is This a Backdoor for Big Pharma?
One Nation will restore direct oversight, supervision, accountability, and control to Parliament, removing influence from pharmaceutical companies over drug and product approvals.
Recently the head of the Therapeutic Goods Administration (TGA) Professor Skerrit left his role at the TGA and commenced work with Medicines Australia, which is the lobby group for the pharmaceutical industry. In effect, the professor is now working for the companies he recently regulated.
This is entirely unacceptable. The health of everyday Australians and trust in the medical establishment is too important to leave in the hands of a broken system rife with cronyism and self-interest.
We will return the power to authorise drugs and medical devices back to the Minister for Health, who will be responsible for delegating these decisions to his own departmental staff.
This system will ensure that the Minister’s decisions will be subject to rigorous parliamentary scrutiny, prevent conflicts of interest and most importantly remove the direct relationship between the TGA and pharmaceutical companies they are supposed to regulate.
Security of employment in the public service should prevent the revolving door we currently have between the TGA and pharmaceutical companies and ensure the best possible outcome for everyday Australians.
https://i0.wp.com/www.malcolmrobertsqld.com.au/wp-content/uploads/2025/04/ethan-hooson-6U-dmJ7WoDk-unsplash.jpg?fit=1026%2C684&ssl=16841026Senator Malcolm Robertshttps://www.malcolmrobertsqld.com.au/wp-content/uploads/2020/04/One-Nation-Logo1-300x150.pngSenator Malcolm Roberts2025-04-22 18:27:222025-04-22 18:27:54Restoring Parliamentary Oversight and Accountability in Drug and Product Approval
This is a great session to demonstrate how far Estimates has fallen. I asked a perfectly simple question: if a person followed the TGA’s COVID-19 “vaccine” schedule, how many shots would they have had by now? Watch as they bob and weave to avoid answering this simple question.
Part of the reason for this is to use up time. The TGA session attracts a lot of interest, and my time is limited, so the longer they can draw out the answer, the fewer questions they have to answer.
I then asked about a new study showing that the COVID-19 jabs produced spike proteins for almost two years after injection, despite being told that the vaccines stayed in the injection site and passed out of the body in a matter of hours.
Professor Lawler tried to discredit the research, which was conducted by Yale, and refused to acknowledge that the spike proteins from the “vaccine” were being produced for years after vaccination, despite the paper stating exactly that. A substantial amount of my time was spent on them saying very little that they could be held accountable for later.
I also asked about other studies linking vaccines with autism and received a similar response: the link between vaccines and autism has been discredited—nothing to see here, move on. The link between autism and vaccination has been well established, even with the small number of papers that have survived the bullying from big Pharma to protect their sacred cash cow.
I will not stop pursuing the truth about vaccine harm.
Note: This video combines two separate sessions into one video file.
Transcript 1
CHAIR: Senator Roberts.
Senator ROBERTS: My questions are all to do with the TGA. Technology is marvellous, isn’t it? Potentially hundreds of doctors and constituents are watching. The TGA approach to COVID has been based—correct me if I’m wrong—on two original shots, then boosters to maintain currency, because MRNA technology offered waning protection over time. If a person had taken the recommended COVID shots at the time they were recommended, from March 2021 until now, how many COVID injections would the person have had?
Prof. Lawler: I’m not sure, necessarily, whether that’s a TGA question. The role of the TGA is very much to—
Mr Comley: I think we have an appropriate officer joining the table, Dr Anna Peatt, who I think can help you on this because I think she’ll need to go to the nature of ATAGI’s advice for vaccines for individuals. I think it would also go to the question about different categories of individuals receiving different recommendations over that period of time, reflecting the risk profile for those individuals. Dr Peatt, would you like to, perhaps, have a crack at this?
Dr Peatt: Yes, I will. It’s actually quite a difficult question to answer because the eligibility for COVID-19 vaccines has changed over the course of the pandemic. So, really, you can’t actually answer the question unless you know the specifics of the individual that you’re referring to. Someone who was aged 75 years or over at the start of the pandemic may have had upwards of eight vaccines over that course, but it really depends on the individual circumstances. In Australia we don’t have vaccination mandates at the moment, so it also comes down to people’s individual choices. But, ultimately, it comes down to vaccinators’ advice.
Senator ROBERTS: So eight in total, most likely. Can you confirm the TGA is still recommending boosters every six months for immunocompromised people and every 12 months for adults under 64.
Prof. Lawler: I can’t confirm that, because the TGA’s role is not to recommend immunisation. The TGA’s role is to assess the safety, quality and efficacy of therapeutic goods.
Senator ROBERTS: But you do monitor the injections, the results and the DAENs, don’t you? Do you have a role—
Prof. Lawler: That’s correct.
Senator ROBERTS: Thank you. Good.
Prof. Lawler: No. That’s correct, but that’s not the same as what you asked previously. The difference is that the role of the Therapeutic Goods Administration is to assess pre-market therapeutic goods for safety, quality and efficacy, and, where appropriate, to undertake post-market monitoring. That’s why we undertake pharmacovigilance activity and assess adverse events. That is not the same as monitoring and recommending specific immunisation schedules. That’s the role of ATAGI.
Senator ROBERTS: I understand that. But surely you would monitor the number of doses that people have because, as I understand it, don’t you monitor DAENs? Isn’t the monitoring super critical, especially when you have provisional authorisation for these injections?
Prof. Lawler: As I think we provided previously, the vaccines that we’re discussing are not provisionally registered. They have transitioned to full registration. But, as I said, the role of the TGA is to monitor adverse events as and when they occur, and as they are reported.
Senator ROBERTS: Last week, I understand that Yale School of Medicine released a preprint of a study titled ‘Immunological and Antigenic Signatures Associated with Chronic Diseases after COVID-19 Vaccination’. That study found that spiked protein remained in patients who had received at least one COVID vaccine for, in one case, 709 days and counting. When did the TGA realise that spiked protein from the mRNA technology could stay in the body for years?
Prof. Lawler: Can I clarify, because I have previously indicated there are quite a lot of studies out there, is that the Bhattacharjee article from Yale last week? I think it is.
Senator ROBERTS: Last week, Yale School of Medicine released a preprint of a study titled—
Prof. Lawler: Thanks. So that is, as you say, an article in preprint. I would like to reflect on that article. The first line of the abstract reads: COVID-19 vaccines have prevented millions of COVID-19 deaths. And the intro says: The rapid development and deployment of COVID-19 vaccines have been pivotal in mitigating the impact of the pandemic. These vaccines have significantly reduced severe illness and mortality associated with SARS-CoV-2 infection. Additionally, vaccinated individuals experience a lower incidence of post-acute sequelae of COVID-19 … or long COVID, thus highlighting an additional potential benefit of receiving the COVID-19 vaccines. It might seem like I’m not answering your question in reading those first few lines out, but I think it’s really important that a feature of the public debate on this matter has been the convenient picking out of individual findings from papers. I think it’s really important to note that. In terms of the paper itself, it was a small study, with 42 cases that reported post-vaccination syndrome after COVID vaccination and it had 22 controls with no symptoms. There are some challenges with the article. There was a very small sample size, which included insufficient subgroup numbers to adequately assess the effect of previous infection. There was a lack of analysis of potential confounders, such as other medical conditions and medication use, and a lack of standardised case definition for PBS—noting that the symptoms of PBS are general and are associated with a range of other conditions. I think that there is some really interesting information in that article. I particularly like the introduction where it clearly indicates the benefits of vaccination. But I would also say that it is challenging, potentially, to draw too much of an inference from its findings.
Senator ROBERTS: Professor Lawler, I don’t know which question you answered but let me ask my question again. When did the TGA realise spiked protein from the mRNA technology could stay in the body for years?
Prof. Lawler: We will inform you when we have evidence that that is the case.
Senator ROBERTS: So you are not aware of it at the moment?
Prof. Lawler: We will inform you when there is evidence that it is the case that spiked protein persists in the body for years. I think one of the things that is most notable—
Senator ROBERTS: Let’s move on then. You’ve answered the question. For clarity, if a person has spiked protein in their system years after injection, something must be making that spiked protein and renewing it in their system. Is that correct?
Prof. Lawler: I might ask Professor Langham to respond to that.
Prof. Langham: I think what Professor Lawler is trying to say is that we are not aware of any robust evidence that supports the presence of spiked protein being in the system of recipients of the COVID-19 vaccine for years. When we do undertake reviews of relevant studies—and I might add, this as an ongoing process that the TGA undertakes for every single product that is registered on the ARTG—our robust and thorough review of evidence is such that should there be a finding that we would consider scientific, then that absolutely would be accepted. That is the case for the question that you are asking. We are not aware of any scientific and robust findings that demonstrate prolonged circulation of spiked protein in the human body.
Senator ROBERTS: Let’s continue. If a person already has spike protein in their system, and they need more mRNA technology—more spike proteins—and if, for that person, those are long lived as well, could there be people walking around with dangerous levels of spike protein as a result of following ATAGI’s guidelines? Surely you’ve considered this.
Prof. Lawler: Thank you for the question. As we discussed previously, one of the roles of the TGA is to undertake ongoing post-market pharmacovigilance. As a result, we continually receive and accept reports of adverse events. We use those to work toward the identification of safety signals. We take more of a phenomenological approach to identifying risky safety profiles, as has been highlighted previously. We’re firmly of the view that the risk-benefit ratio of these vaccines is overwhelmingly positive.
Senator ROBERTS: Let’s continue. The Yale study examined 64 vaccinated subjects. One in 64, in this case, retained spike for almost two years and counting. Extending that sample to Australian consumers, doesn’t that indicate, certainly, that tens of thousands of Australians are dealing with spike protein build-up in their body? Does even the possibility of that concern you?
Prof. Langham: I think what we’ve been trying to say is that not all of the research that is published is of a high level of scientific quality.
Senator ROBERTS: Excuse me, Ms Langham—
Prof. Langham: I’m sorry, Senator. We’ve been here before. It’s Professor Langham, thank you.
Senator ROBERTS: Sorry, Professor Langham—I mean that sincerely. I wasn’t trying to cast any aspersions. Professor Lawler just read glowingly, in response to one of my questions, about aspects of this study.
Prof. Lawler: I’m not sure that ‘glowingly’ would describe by situation. I think there was a balanced argument. However, one of the things we do undertake when we scientifically review a paper is to look at the rigour of it. It is acknowledged within the paper that there are certain limitations to the study. Some of the findings include the fact that there were potential differences in the immune profiles of individuals with PBS and that PBS participants had lower levels of spike protein antibodies. There was serological evidence suggestive of recent Epstein-Barr virus reactivation. But I think it’s quite important—and it’s actually quite challenging to convey this in this forum—to note that the presence of a study saying something should not be taken as meaning that without a robust analysis of the rigour of that study. It’s important to note that this was a small case study. There were 42 cases and 22 controls. That means the ability to extrapolate from that in the way you suggested is actually really limited and potentially misleading. I don’t mean it’s deliberately misleading; it can lead to misleading outcomes.
Senator ROBERTS: Let me understand from the previous Senate estimates and from this one. Are you saying that spike proteins are harmless?
Prof. Lawler: No, I don’t believe we said that last time or this time.
Senator ROBERTS: That’s why I asked the question—for clarification. The Yale study found immune cell— in this case T cell—exhaustion. Do you accept the science that mRNA technology has caused T cell exhaustion in some consumers, leading to a condition that causes chronic tiredness, brain fog, dormant conditions like Epstein-Bar and cancer becoming active again, and in general an increased susceptibility to new infection?
Prof. Lawler: Part of the challenge in responding to that is that we’re responding to a definition outlined within the study as a post-COVID-19-vaccination syndrome that is characterised by a wide range of symptoms which have been, as far as I can determine, selected by the authors. They include such things as you’ve mentions, like exercise intolerance, excessive fatigue, numbness, brain fog, neuropathy and others. But the authors themselves note that PBS is not officially recognised by health authorities, and there’s no consensus definition of the syndrome. One of the things I was trying to say—and, again, I wouldn’t characterise it as a glowing endorsement of the article—is that it is encouraging that even small studies are looking at these things. One of the things that has been levelled at the TGA previously is that we are blind to science or not interested in hearing new ideas. It’s actually very encouraging to see this kind of research, but it needs to be taken within the context of rigorous research methodology.
Senator ROBERTS: ‘Long COVID’, a phrase that Dr Skerritt used at estimates in May 2022, was the theory tested by Yale in a literature review entitled ‘The long COVID puzzle: autoimmunity, inflammation, and other possible causes’. That was published in May 2024. This studied viral persistence, inflammation, autoimmune damage and latent viral reaction following exposure to COVID, naturally or by injection. Minister, is your government ignoring a ticking time bomb with these mRNA vaccines, one that you are making worse by still recommending that people take these products? You’re still recommending it.
Senator McCarthy: We certainly, through the health minister, look out for all Australians in relation to their care, health and wellbeing, but I will refer to officials in terms of the technical aspects of your question.
Prof. Lawler: I’m not sure if I’m answering your question here, so I’m happy to hear it again if I’m not. One of the things that we do find that has been supported by multiple studies—in fact, studies that are cited within the Yale article—is that COVID vaccination actually leads to a decreased incidence of both the post-acute sequelae of COVID and also the prevalence of long COVID. So we know that those are not only protective for hospitalisation and death, as are their indications within the Register of Therapeutic Goods, but also protective for some of the long-term sequelae of COVID infection.
Senator ROBERTS: Okay, let’s move on to vaccine harm generally. An article in Science, Public Health Policy & the Law—there’s an interesting combination; science, public health and law—titled ‘Vaccination and neurodevelopmental disorders: a study of nine-year-old children enrolled in Medicaid’ found: … the current vaccination schedule may be contributing to multiple forms of NDD; that vaccination coupled with preterm birth was strongly associated with increased odds of NDDs compared to preterm birth in the absence of vaccination; and increasing numbers of visits that included vaccinations were associated with increased risks of ASD. For those at home, an NDD is a neurodevelopmental disorder such as autism or OCD, and ASD is autism spectrum disorder. This study of 41,000 nine-year-olds in Florida came out this month and finds, with statistical certainty, that childhood vaccines are associated with neurodevelopmental disorders and autism. Have you seen this paper? And, if not, why not?
Prof. Lawler: I’m familiar with the journal that you outline; I’m familiar with the nature of the articles that are provided for publication and the level of peer review that occurs. I’m not familiar with that journal article specifically, and it would probably be inappropriate of me to comment on it without it in front of me.
Senator ROBERTS: The autism vaccine link is the most contentious issue in medicine right now, based on the number of people affected. Is this wilful ignorance on your part? Prof. Lawler: That is an interesting question. It’s not a contentious link. There was an article some years ago that drew links between the measles, mumps and rubella vaccine and the incidence of autism. That has been serially and profoundly debunked; it’s been retracted from the media. There’s no evidence currently that there is a link between vaccination and autism. Unfortunately, the continued promulgation of such a link is suspected to be one of the drivers of vaccine hesitancy and falling vaccine rates.
Senator ROBERTS: I would argue, based upon the timing, that the COVID shots, the mandating of COVID shots and the adverse effects of the COVID shots would have done a lot of damage to the credibility of vaccines in general. If I give you the link, Professor Lawler, will you undertake to review the study and come ready to discuss the connection between vaccines and neurodevelopmental disorders, including autism, at the next estimates?
Prof. Lawler: I’m very happy to receive any link and read any article, and to come back and have a comment. I do have with me Dr Sophie Russell, who’s the acting director of the Pharmacovigilance Branch.
Dr Russell: Thanks for the question. I’ll just make one small comment about the Yale study. The Yale study that you refer to was not able to properly account for previous COVID-19 infection due to insufficient case numbers. We would, of course, be happy to provide on notice a broader critical analysis, but I’ll reinforce what Professor Lawler has said—that, to date, the TGA has not found a causal association between any vaccination and neurodevelopmental disorder—and I would like to reassure you that we are continually monitoring for those particular adverse events in COVID-19 vaccinations.
Senator ROBERTS: In that paper, entitled ‘Vaccination and neurodevelopmental disorders: a study of nine-year-old children enrolled in Medicaid’, I’ve seen a graph. The multiplier for ASD is 3.14—the vaccinated have 3.14 times more ASD than the unvaccinated; for hyperkinetic syndrome it’s three times; for epilepsy or seizures it’s 4.2 times; for learning disorders it’s 9.8 times—almost 10 times; for encephalopathy it’s 7.7 times; and, for at least one of the listed neurodevelopmental disorders, it’s four times. Let’s move on—
CHAIR: Senator Roberts, just before you do, in a couple of minutes I’ll be seeking to rotate the call, as I understand Senator Rennick has some more questions. You still have the call, but I’m just giving you some early warning that I’ll be seeking to rotate in a few minutes.
Senator ROBERTS: I understand from previous testimony that the TGA has a lab with more than 100 staff, which is a lot. Can you tell me what steps you have taken to monitor spike protein activity amongst Australian consumers of the mRNA technology used in COVID?
Prof. Lawler: I’ll ask Dr Kerr to join us at the table. I would probably contest the comment that that’s a lot of staff. We have staff that are appropriate to the role of ensuring qualities and standards within our therapeutic goods.
Senator ROBERTS: I wasn’t casting aspersions that way, Professor Lawler; I was saying that that’s a lot of staff to do some of the work that I’ve just raised.
Prof. Lawler: We have a lot of work to do. I think the numbers are quite appropriate.
Dr Kerr: May I have the question again, please?
Senator ROBERTS: I understand from previous testimony that the TGA has a lab with more than 100 staff. Can you tell me what steps you have taken to monitor spike protein activity amongst Australian consumers of the mRNA technology used in COVID?
Dr Kerr: The subject of our testing is actually the vaccine itself. We have spent a lot of time ensuring that the vaccine complies with the quality requirements. We do look at the expression of the protein from the vaccine in vitro, but we do not take samples from Australians to test for the COVID spike protein. That is not our role.
Senator ROBERTS: So you don’t monitor it in that way?
Dr Kerr: We’re not a pathology laboratory. We don’t take samples from Australians—from humans.
Senator ROBERTS: So the answer to my next question: have you been actively testing people to check spike protein levels and to test for antigens indicating myocarditis, Guillain-Barre, Epstein-Barr—which is also called herpes 4—and the other 1,240 other known side effects of mRNA technology, as provided by Pfizer? Have you been testing for anything to do with that? These are known adverse events from Pfizer. Have you been testing?
Dr Kerr: I might defer to my colleague Dr Russell.
Dr Russell: As Professor Lawler highlighted earlier, we take a broader approach to postmarket safety issues. Published literature and clinical testing are all part of our assessment. When we are looking into safety signals in the postmarket space, we’re looking at that in the Australian context. We are looking at the number of cases that are reported to the TGA and the number of cases that are reported to the World Health Organisation database; we’re liaising with our comparable international regulators and looking at published literature. There’s a variety of areas that we look to, to consider the strength of the evidence between a clinical condition and vaccination, and that informs our regulatory actions.
Senator ROBERTS: Thank you, but how do you know about the incidents if you’re not actually testing?
Prof. Lawler: Sorry—the incidence of clinical episodes?
Senator ROBERTS: Adverse events, yes—actively checking people for spike protein levels.
Dr Russell: Just to clarify, I’m not aware of any evidence that correlates spike protein levels with a clinical syndrome or diagnosis. What we are looking for in the postmarket space is clinical symptoms or conditions that are caused by the vaccine.
Senator ROBERTS: Wow. Thank you.
Prof. Lawler: If I could just add to that, we’ve endeavoured to be clear previously—and I won’t on this occasion read out the SQoNs that we’ve answered—that our pharmacovigilance program, in keeping with the standard and accepted practice of regulators around the world, is based on clinical adverse events. As Dr Russell has highlighted, there is not a correlation that is currently identified between spike protein levels and clinical events. Our adverse event monitoring process, our pharmacovigilance process, in keeping with the actions and practice of regulators globally, is to capture, analyse, understand and, where necessary, respond in a regulatory fashion to safety signals identified through clinical events. So those clinical events are identified. As I’ve mentioned, we have many events—I don’t have the number in front of me, but certainly over 100,000—of variable severity that we have analysed and responded to, and we have made significant regulatory changes in response to that. The clinical approach that we take to adverse event monitoring is entirely in keeping with the pharmacovigilance practices of global regulators.
Senator ROBERTS: Thank you, Professor Lawler. So you don’t do testing, so you presumably rely upon adverse event notifications. Ahpra have ensured those reports were not made. You can’t possibly be relying only on the few doctors with the courage to stand up against Ahpra—or was ‘rare’ the outcome you worked back from? Did you just assume it was rare and work backwards to justify it?
Prof. Lawler: It’s unfortunate that Ahpra isn’t here to respond to that. I think it’s pretty clear that—
Senator ROBERTS: It’s well known.
Prof. Lawler: Sorry, Senator. What’s well known?
Senator ROBERTS: It’s well known that Ahpra has been suppressing doctors’ voices.
Prof. Lawler: I would make the distinction if I may—and, again, Ahpra is not here to respond and defend itself against that comment—that what you are characterising as misinformation around vaccine and the disease is very different to the reporting of adverse events. I would also contend that the volume of adverse events that were reported would indicate the threshold for reporting adverse events is quite low, and that’s exactly where we want it to be. We want to be detecting adverse events.
CHAIR: Senator Roberts, I am due to rotate the call, but if there’s time we we’ll come back to you. We have about 25 minutes, so can I just get an indication of who has further questions?
Senator Rennick, Senator Kovacic and Senator Roberts, you have further questions?
Senator ROBERTS: Yes, please.
Transcript 2
Senator ROBERTS: I want to go back to continue the discussion we had about testing, or the lack of testing. In estimates in May 2022, I asked whether the mRNA from the vaccines, the injections, transcribed into the patients’ own DNA, permanently modifying their DNA. In light of the work that has been done since, including the latest Yale study that I quoted, could a plausible theory be that the mRNA technology does indeed transcribe and the mRNA technology does permanently alter the human genome in some people?
Prof. Lawler: We did have an exchange with Senator Rennick earlier around the incorporation of DNA and RNA into the human genome. There was a comment made around it being down to a series of highly improbable steps. The challenge that I think we face—and I’ll ask Dr Kerr to add to that—is that there is a point at which a plausible theory requires supporting evidence. In the absence of that supporting evidence, it needs to be rejected. We’ve had 50 years of biotechnology in this field, there have been many billions of doses of these vaccines and other vaccines of similar technology administered, and there’s been no evidence of such incorporation. As to the plausible theory, there are some mechanisms that you could arguably say lead to that in very unusual circumstances, but there is no evidence and no real-world data to support that. Dr Kerr.
Dr Kerr: Thank you. I’ll add to Professor Lawler’s statement that there’s a very rigorous regulatory framework that operates globally to ensure that any residual DNA in biotechnology products or the mRNA vaccines is adequately controlled and the risks are adequately managed.
Senator ROBERTS: Minister, will you review the legal position of the TGA, specifically the issue of them committing malfeasance in office due to their wilful ignorance of harms from the pharmaceutical industry products they promote?
Senator McCarthy: I reject, outright, your question in this regard, and I’m sure the government does have great faith in the TGA.
Senator ROBERTS: Thank you. I want to move on to a major anti-hydroxychloroquine study published in Biomedicine & Pharmacotherapy under Dr Danyelle Townsend. It has been retracted after its dataset was exposed as unreliable, bordering on outright fraudulent. The paper, titled Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis, found that treating hospital patients with HCQ, hydroxychloroquine, resulted in an increased mortality rate and led to health authorities banning hydroxychloroquine as a treatment for COVID. This was the reverse outcome to what many practitioners were experiencing prescribing hydroxychloroquine for COVID. Minister, did your government issue restrictions against using hydroxychloroquine for COVID on 24 March 2020—I know the Liberal Party was in office at the time. Did the government issue restrictions against using hydroxychloroquine for COVID on 24 March 2020 to make room in the market for the vaccines, despite a body of evidence saying hydroxychloroquine was effective?
Senator McCarthy: I’ll defer to the officials.
Prof. Lawler: I was not in this role at that time; I had a different role in a different place. My understanding, though, is that the decision on hydroxychloroquine was based on a position supported by global regulators that there was a lack of efficacy in this and, similarly, concerns that individuals seeking to use the treatment might potentially perturb them and deter them from validated effective treatments. I’m certainly not aware that there is any underlying motivation to benefit any other treatment on a commercial basis.
Senator ROBERTS: So it was an internationally agreed position?
Prof. Lawler: In terms of our established relationship with regulators, it is my understanding that it was a fairly agreed position that hydroxychloroquine was not an effective treatment for COVID.
Senator ROBERTS: So now it’s a ‘fairly agreed’ position. It didn’t rely on the science; it was just fairly agreed?
Prof. Lawler: Senator—
Senator ROBERTS: Were there any studies done—any basis for this in fact, in data?
Prof. Langham: It absolutely was an evaluation of the science and the concerns for public safety that led to changes in the restriction in the prescribing of hydroxychloroquine. There was no supportive evidence for its efficacy and, as there was a concern that people were—and absolutely were—moving towards taking hydroxychloroquine in the false belief that it was going to help them with COVID, there were fewer people that were being vaccinated and there was also a greater risk of a poor outcome. That restriction was removed on 1 February this year.
Prof. Lawler: I also highlight that we’ve answered this question about hydroxychloroquine before, in SQ22- 000147 and also SQ21-000687.
Senator ROBERTS: Okay. Let’s move on. In Senate estimates in May 2021, Professor Skerritt, your predecessor, the former head of the TGA, said of the COVID vaccine injection technology: … the idea is to introduce sufficient spike protein to activate the immune system so that it mimics a COVID infection so that your B cells and T cells can start to mount an immune response to protect the person from catching COVID. He also said: … it’s the messenger RNA that’s translated into protein which is a spike protein. Messenger RNAs are inherently unstable. In fact, that’s why the Pfizer and Moderna vaccines require this little lipid coat, this little lipid nanoparticle. … … … And the lipids are hydrolyzed, destroyed by the body fairly rapidly … Is this still an accurate statement of the technology behind COVID MRNA vaccines?
Prof. Langham: The specifics of your concern around that statement?
Senator ROBERTS: Is it accurate? Is Professor Skerritt’s statement accurate still?
Prof. Lawler: The process of immunogenicity as described by Professor Skerritt absolutely is. There’s the central dogma that MRNA is translated to protein. It’s the mechanism by which proteins are created. The MRNA is coded for spike protein. It’s created within the cell and expressed on the cell’s surface. That then engenders an immune response through antigenic presentation. That is the standard process for vaccine utilisation. As Professor Skerritt highlighted, the MRNA is inherently unstable and readily broken down. That’s why it’s encapsulated with a lipid nanoparticle which contains four different types of lipid. That enables its introduction to the cell, where it can exert its cellular effect.
Senator ROBERTS: Is it true, as he said, that the lipids are hydrolysed and destroyed by the body fairly rapidly?
During my session with the Therapeutic Goods Administration (TGA) at Senate Estimates in November, I questioned them about a number of concerns.
Does the TGA agree that spike protein is pathogenic in COVID-19 vaccines? Professor Langham clarified that the spike protein is not pathogenic and is designed to trigger an antigen recognition and antibody response.
Has the TGA observed or seen reports of any adverse events related to the spike protein? Professor Langham responded that no such events have been observed, as the spike protein is quickly degraded by the body once it’s introduced s part of the mRNA vaccine.
What analysis did the TGA conduct regarding the spike protein’s suitability before vaccine approval? Professor Lawler agreed to provide detailed information on notice.
It has been demonstrated that spike proteins exert an inhibitory effect on the function of the angiotensin-converting enzyme 2 (ACE2), leading to dysregulation of the renin-angiotensin system. Is the TGA aware of this effect of spike proteins on ACE2 and on the renin-angiotensin system? Professor Langham explained that while the spike protein attaches to receptors, it does not cause harm on its own.
Is ‘long COVID’ the result of spike protein in the body coming from the Wuhan and alpha versions of COVID itself or is it from the vaccine products containing spike proteins, which are injected repeatedly in Australians? Professor Lawler responded that there is no accepted evidence to confirm such a link.
Has the TGA received any applications for treatments to remove spike proteins from the body and has the TGA engaged with research institutions on this matter? Professor Lawler clarified that the TGA has not received such applications, does not commission research, and focuses on regulating therapeutic goods.
The TGA emphasised that the overall risk-benefit profile of COVID-19 vaccines remains positive.
Transcript
Senator ROBERTS: Thank you. Does the TGA agree that spike protein is pathogenic?
Prof. Langham: Thank you for your question. The spike protein is not pathogenic. It does not contain any of the other parts of the COVID-19 vaccine that brings about a pathogenetic state. The spike protein is really there to encourage an antigen recognition and an antibody response by the body.
Senator ROBERTS: Okay. I’ll move on. Has the TGA observed or seen reports of any adverse effects of COVID vaccination that may be associated with the likely effects of spike protein?
Prof. Langham: As I said, the spike protein is not pathogenic. We’ve not seen any adverse events related to the spike protein, because—and we’ve discussed this previously—the spike protein is rapidly degraded by the body once it’s introduced as part of the mRNA vaccine.
Senator ROBERTS: Really? Okay. What analysis did the TGA conduct regarding the suitability of spike protein in the COVID vaccines prior to approval? Could you please provide me with that material on notice.
Prof. Lawler: I’m taking that question to be: what did the TGA know about spike proteins prior to approving the COVID vaccines? Is that a fair—
Senator ROBERTS: I’d like to know what analysis you did regarding the suitability of spike protein in the COVID vaccines prior to approval, and I’d like that material on notice.
Prof. Lawler: I’m happy to respond to that question on notice. We have responded to similar questions previously.
Senator ROBERTS: Can you tell me about the analysis?
Prof. Lawler: As I said, I’m happy to take that question on notice.
Senator ROBERTS: Do you know about the analysis now? The question on notice is only if you don’t know something now.
CHAIR: Senator, the official is well entitled to take a question on notice. It’s not about not answering the question; it’s about taking an answer on notice.
Senator ROBERTS: Well, as I understand it, the guides to the witnesses include that if they want to take something on notice it’s only because they don’t know the answer now.
CHAIR: Yes, or they need to qualify or check the information or they don’t have the extent of the information.
Senator Gallagher: They don’t have the information with them to provide you a comprehensive answer, which is not unreasonable.
Senator ROBERTS: Okay. Have you received any reports, data or discussion from your pharmacovigilance system highlighting concerns about spike proteins following the introduction of the COVID vaccines? If so, could you please provide that information?
Prof. Langham: Again, I’m at a loss to understand the specifics of your question as to how our pharmacovigilance would relate to the specific aspect of the vaccine which is the spike protein. I think we can answer very clearly what our pharmacovigilance results have been for the vaccine itself. But as to the specific aspects of the spike protein, the reason the mRNA vaccines include the spike protein as the antigenic stimulus results from many years of research that had been undertaken in the US by the National Centre for Vaccines to develop mRNA vaccines.
Prof. Lawler: And I’d just add to Professor Langham’s answer that the purpose of our pharmacovigilance and the way in which it monitors for and identifies to enable us to respond to emerging safety signals and trends is that it’s based on adverse events.
Senator ROBERTS: That’s all it’s based on?
Prof. Lawler: These are clinical events. So, there’s an expectation—indeed, an encouragement—that adverse events are reported, and these are reported on the basis of clinical nature. We also, as I mentioned previously, work with international partners on a network of pharmacovigilance activities that Dr Larter might like to speak to.
Dr Larter: We continue to engage with our international regulatory counterparts to look at not only spontaneous adverse event reporting but also linked data, and many of the rich datasets that are available globally, to inform our safety monitoring. These processes enable us to identify emerging safety concerns well before we understand how they might be occurring, before the mechanisms of action are identified. That’s a strength. We don’t need to know exactly how they’re being caused to take regulatory action to ensure that the safety profile is up to date and available for treating health professionals.
Senator ROBERTS: There has been a multitude of papers about potential health impacts from spike protein on the renin-angiotensin system in the human body. It appears to be basic to human health—if not the key system then certainly one of the key systems to health. Is it your testimony today that the COVID vaccines containing spike proteins are still perfectly safe.
Prof. Lawler: We’re aware of the importance of the renin-angiotensin-aldosterone system. Professor Langham is a nephrologist. The reality is—I’m happy to come back if I’m wrong, but I don’t know whether we or any other regulator has ever said that a medication is perfectly safe. There are a number of processes that we follow in the assessment and market authorisation of a number of medicines. We have product information that clearly states the risks and potential adverse events—
Senator ROBERTS: Who is that from? Who is the product information from?
Prof. Lawler: The product information is produced—I guess, to the question, I’d like to say that we don’t maintain that the vaccine is perfectly safe. Every time we come here, we discuss with you the adverse events and the recognised and accepted potential adverse events. So, no, it’s not our position that the vaccine is perfectly safe. It is our clear position, and this is the clear scientific consensus, that the risk-benefit of COVID vaccines has been shown to be very safe and, in fact, the risk-benefit is significantly positive.
Senator ROBERTS: Okay; I won’t explore that any further. It has been demonstrated that spike proteins exert an inhibitory effect on the function of the angiotensin-converting enzyme 2, ACE2, leading to dysregulation of the renin-angiotensin system. Is the TGA aware of this effect of spike proteins on ACE2 and on the renin-angiotensin system?
Prof. Langham: It’s well known that the angiotensin receptor is important in how the virus exerts its effects on the body. As to what you are describing with the spike protein itself, on its own, it’s not able to cause any problems. It connects to the receptor, but there is nothing else there behind the spike protein. It’s the virus itself that does cause problems, and the receptor that that virus attaches to is absolutely the angiotensin receptor.
Senator ROBERTS: Was the potential impact of spike proteins on the ACE2 receptor and the renin-angiotensin system considered as part of the analysis of the vaccines? I’d also like to come back again and ask: on whose advice do you take the product safety?
Prof. Lawler: There are two questions there.
Senator ROBERTS: Yes, there are.
Prof. Lawler: I’d like to answer them in turn. Which one?
Senator ROBERTS: The first one is: was the potential impact of spike proteins on the ACE2 receptor and the renin-angiotensin system considered as part of the analysis of the vaccines?
Prof. Lawler: The process of the market authorisation and evaluation of medicines, including vaccines, is a comprehensive process that is based upon a significant dossier of information that goes to the safety, quality and efficacy of that particular medicine. In terms of whether that was a specific issue, I’m very happy to have a look at that and come back to you on that.
Senator ROBERTS: On notice—are you taking it on notice?
Prof. Lawler: Yes.
Senator ROBERTS: Thank you. Recently, German doctor Karla Lehmann, in her peer-reviewed scientific paper published in the journal of the European Society of Medicine commented that spike protein is ‘uniquely dangerous’ for use in vaccine platforms—and this woman is generally pro-vaccine—because of the effects of spike protein causing ACE2 inhibition, leading to excessive angiotensin 2 and harmful overactivation of AT1R, the angiotensin 2, type 1 receptor. This analysis is supported by other research providing clear evidence of the pathogenic nature of spike protein and its unsuitability for use in vaccine platforms. Is the TGA aware of this review and analysis conducted by Karla Lehmann and her damning conclusions about the dangers of spike protein based vaccines?
Prof. Lawler: I don’t have that article. It would be useful, obviously, to review that. I think it’s also worth noting that a lot of the theoretical conversations around spike protein are mechanistic in nature rather than supported by phenomenological or observational studies. So there are a lot of inferences drawn between a cellular mechanism and a clinical scenario that is very difficult to distinguish from the disease itself. Professor Langham, is there anything you would like to add?
Prof. Langham: I guess I would just support those comments that, when the vaccine with the spike protein as the antigenic stimulus is trialled in clinical trials, the sorts of physiological derangement of the renin-angiotensin-aldosterone system that might be described is not seen. So we do not see activation of the renin-angiotensin-aldosterone system with the clinical trials in terms of understanding the specific safety signals that have come from them. It has been quite widely demonstrated that the vaccines themselves are very well tolerated.
CHAIR: Senator, I’m due to rotate.
Senator ROBERTS: I just have two more questions on this thread.
CHAIR: Sure.
Senator ROBERTS: Is ‘long COVID’ the result of spike protein in the body coming from the Wuhan and alpha versions of COVID itself or is it from the vaccine products containing spike proteins, which are injected repeatedly in Australians?
Prof. Lawler: I don’t believe there’s accepted evidence to confirm that that’s the case.
Senator ROBERTS: Has the TGA received any applications for treatments or protocols to remove spike proteins from the human body? Have you asked the National Health and Medical Research Council to advertise a grant for this purpose? Are you working with any university around this topic—anything at all—either to cure spike protein damage for long COVID, if it exists, or for vaccine injury?
Prof. Lawler: The answer to the first question is not to my knowledge. The answer to the second question is that it’s not the role of the TGA to commission research from the National Health and Medical Research Council. And the answer to the third question is it is not the role of the TGA to generate knowledge; it is the role of the TGA to regulate therapeutic goods.
Senator ROBERTS: That’s the end of my questions on COVID spike protein. I have two more sets of questions.
CHAIR: Do you mean for the TGA?
Senator ROBERTS: Yes, for the TGA but on other topics
These questions are about Infanrix Hexa and SIDS and are based on information contained in Freedom of Information documents 3828 (document 9) and 1345 (document 1). This vaccine is approved to protect against nine different strains of six diseases: Diphtheria, Tetanus, three strains of Pertussis, Hepatitis B, Influenza type B, and three types of inactivated Polio viruses. Each vial containslactose, sodium chloride, aluminium chloride, hydroxide, aluminium phosphate, phenoxyethanol medium, potassium chloride, polysorbate 20 and 80, formaldehyde, glycine, sodium phosphate, dibasic dihydrate, potassium phosphate monobasic, neomycin sulfate, polymyxin B sulfate and 2-phenoxyethanol. There is a lot happening in that single jab.
All of these chemicals are given to six-week-old babies, again a month later and then again as a booster, in many cases. There are 17 reported deaths on the DAEN (Database of Adverse Event Notifications) from this product and another 26 reported deaths on your internal Adverse Event Management System (AEMS) going back to 2010. The report from 2010 is that the child died on the same day as the injection, with no other suspected medications or health issues. The child was injected and then died. Why is that death still on the AEMS and not on the public DAEN after 14 years?
Once again, the public servant feigned not understanding the question before deflecting and failing to answer, offering instead to take the question on notice. The reason our vaccines are considered safe and effective is because cases where they were not safe are covered up, as is happening here. There is no reason for the specific case I am asking about to still be withheld from the public. The facts of the matter were clear in 2010 and they are clear now: the vaccine is full of harmful substances and killed that child.
Transcript
Senator ROBERTS: My next set of questions are about Infanrix hexa and SIDS. My questions are on the vaccine Infanrix hexa using information contained in freedom of information 3828 document 9 and freedom of information 1345 document 1. Constituents are raising this issue with me. This vaccine is approved to protect against nine different strains of six different diseases, and, for brevity, these are diphtheria, tetanus, three strains of pertussis, hepatitis B, influenza type B and three types of inactivated polio viruses. Each vile contains lactose, sodium chloride, aluminium chloride, hydroxide, aluminium phosphate, phenoxyethanol medium, potassium chloride, polysorbate 20 and 80, formaldehyde, glycine, sodium phosphate, dibasic dihydrate, potassium phosphate monobasic, neomycin sulfate, polymyxin B sulfate and 2-phenoxyethanol. There is a lot happening in that single jab.
You give all of those chemicals to six-week-old babies, then again a month later and then again as a booster, in many cases. To my question: there are 17 reported deaths on the DAEN—that’s the Database of Adverse Event Notifications—from this product and another 26 reported deaths on your internal Adverse Event Management System, AEMS, going back to 2010. The report from 2010 is that the child died on the same day as the injection and there were no other suspected medications or health issues. The child was injected, and he died. Why is that still on the Adverse Event Management System and not on the public Database of Adverse Event Notifications? Isn’t 14 years long enough to have processed the report?
Prof. Lawler: So there are two questions there. On the first, I think it’s going to be very difficult for us to give you a satisfactory answer now on the basis of a 14-year-old report, so we will have to take that on notice as well. And the second question, sorry?
Senator ROBERTS: Why is the report still on the Adverse Event Management System and not on the public Database of Adverse Event Notifications?
Prof. Lawler: Was that the first or the second question?
Senator ROBERTS: The second one.
Prof. Lawler: Then the answer is probably the same.
Senator ROBERTS: Okay; 10 of the 28 deaths on the Adverse Event Management System record cause of death as Sudden Infant Death Syndrome, and three on the Database of Adverse Event Notifications. Can you confirm that, in a limited number of cases, routine childhood vaccinations have caused Sudden Infant Death Syndrome—SIDS?
Dr Larter: It’s very important to remember that the reporting of an adverse event or death to the TGA does not necessarily mean that the vaccine caused the death, or even that the reporting doctor necessarily considered that the death was caused by the vaccine. We strongly encourage all consumers and health professionals to have a very low threshold for reporting suspected adverse events, even if there is only a very small chance that the vaccine was the cause. To date the TGA has not identified SIDS as an adverse event associated with Infanrix.
Senator ROBERTS: There are 14 other cases of babies dying within three days of injection with this product, including three others that died on the same day. Why hasn’t the TGA investigated these deaths, and why are they still hidden on the Adverse Event Management System, which I understand—correct me if I’m wrong—is internal?
Dr Larter: That is correct. The TGA’s Adverse Event Management System is the database that contains all the detailed information regarding adverse events reported to the TGA. The Database of Adverse Event Notifications for medicines is our public database, which includes de-identified adverse event information. The vast majority of reports made to the TGA are included in the public database. However, where the case has been rejected or where it’s a duplicate, these cases are not published. In terms of why an individual case is not included in the public database, we would need to take those questions on notice.
Senator ROBERTS: Could you also tell me then, as part of the other part of the question, why the TGA hasn’t investigated these deaths?
Dr Larter: Again, we can confirm on notice. The TGA does have robust processes in place for investigating reported deaths after vaccination, as we’ve previously advised. We work very closely with state and territory jurisdictional immunisation committees and public health units to investigate any death that’s reported to us after vaccination. So, while I cannot confirm the details of the individual cases, they will have been investigated by the TGA.
Senator ROBERTS: We don’t want personal details. Here’s your ideal opportunity to show off the TGA now, on notice. There are 14 other cases of babies—
Prof. Lawler: Sorry, can I just respond? It is actually very difficult to give a fulsome response on cases that are, in some instances, 14 years old.
Senator ROBERTS: Well, perhaps you could tell us why you haven’t done the response.
Prof. Lawler: I would hope, Senator, that you would not want us to be providing information to you without the information that we require. So I understand—
Senator ROBERTS: What do you mean by that?
Prof. Lawler: What I’m saying is that I’m assuming that you would not want us to prevaricate or invent information simply for the purposes of providing an answer. As you said earlier yourself, an appropriate reason for taking a question on notice is because we don’t have the information in front of us.
Senator ROBERTS: That’s fine.
Prof. Lawler: So Dr Larter has endeavoured to make clear the processes that we do follow for the purposes of giving you specific information about some specific cases that you have raised. We will need to take that on notice.
Senator ROBERTS: Absolutely. That’s fine. That’s in accordance with the witness guide. There are 14 other cases of babies dying within three days of injection with this product, including three others that died on the same day. Why hasn’t the TGA investigated these deaths? Sorry, I’ve asked that question. But 29 of the deaths were male babies and 14 were female. Have you investigated why the hexa product is twice as likely to kill male babies as female babies?
Prof. Lawler: I’ll go to Dr Larter in a moment. The assertion or implication that you make, that it is twice as likely to kill babies, I think is an inappropriate statement to make, and it’s not reflective of an understanding of vaccine safety or statistics.
Dr Larter: Again, reporting of an adverse event does not mean that that adverse event is causally related to the vaccine. We do investigate all deaths and adverse events following immunisation.
Senator ROBERTS: Thank you for that. That finishes my second set. I’d like to have a third set after Senator Rennick.
CHAIR: You’ve still got a couple of minutes.
Senator ROBERTS: I don’t want to start the third set and then leave it halfway through
