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I questioned the Department of Defence regarding their ongoing COVID-19 vaccine mandates.

Other major institutions, like the Federal Police, have dropped these requirements, acknowledging that the evidence on safety and efficacy has shifted significantly.

While the Surgeon General tried to frame these injections as “recommended” not “mandatory” for general staff, the reality is that vaccine mandates are still hanging over the heads of our defence members.I don’t care where a soldier is stationed in the world; if a treatment isn’t proven safe or effective, our defence personnel shouldn’t be forced to take it just to keep their jobs.

— Senate Estimates | October 2025

Transcript

Senator ROBERTS: Okay. I’d like to move to vaccine mandates. The Australian Federal Police and other major Commonwealth institutions have removed their mandates for COVID-19 injections on the basis that resulting major health problems from the injections contrasted with very few benefits from the injections, which evidence now shows are neither safe nor effective. Does the Department of Defence still mandate COVID-19 vaccination for employees?  

Adm. Johnston: Senator Roberts, the Surgeon General will come to the table to talk through our vaccine approach. While the Surgeon General is getting to her notes, Senator Roberts, as you would appreciate, the employment basis for the Australian Federal Police is largely domestic and delivered in a very different health environment to that which the ADF often finds itself, particularly when we are overseas or operating in very remote or austere occasions. So the circumstances of what law enforcement agencies might do or those agencies based domestically in Australia might do are not equivalent to the employment circumstances our people are often in.  

Senator ROBERTS: I accept that, Admiral Johnston. As I said in the last phrase of my concluding sentence, these are injections ‘which evidence now shows are neither safe nor effective’. I don’t care where they are on the planet. They’re neither safe or effective, and that’s now accepted.  

Rear Adm. Bennett: There are two aspects with respect to vaccinations, and I think your question is specifically around the COVID vaccine?  

Senator ROBERTS: Yes. Do you still mandate COVID-19 vaccination for employees?  

Rear Adm. Bennett: Defence routinely vaccinates our personnel both on entry and annually for certain vaccines, and then there are also operational requirements for vaccination that might be specified on an operational health support order. With respect to the COVID vaccine, on entry we follow the national advice, from the Australian Technical Advisory Group on Immunisation, around recommendations for vaccines. Defence’s approach has changed over time as those recommendations have changed. The COVID vaccine is safe and effective, but the need for vaccination has changed as the virus has changed, as the prevalence of the virus in our community has changed and as the population’s immunity has changed as they’ve either had COVID or received vaccines. We follow the current recommendations, which I could describe: primary course is still recommended, but an annual booster is recommended for certain populations at risk or for people who, on discussion with their own treating clinician, would like to protect themselves from the virus that year.  

Senator ROBERTS: Does that mean it’s voluntary?  

Rear Adm. Bennett: It is recommended, but it’s not mandatory. That’s correct.  

Senator ROBERTS: So you’ve ended the mandates  

Rear Adm. Bennett: There are two aspects, as I said: on entry and routinely. On operations, there has been an order for vaccination because, as you can appreciate, when personnel go on deployment they are often living together in close quarters and there are different viruses circulating depending on where an operation occurs. The risks of people becoming unwell are much greater, both for themselves and for their mates. But, having said that, with the shift in the virus, Joint Health Command, my team, is consulting with the service chiefs to consider how they feel about the removal of that mandate and about looking at operations on a case-by-case basis—so, should there be a risk, considering what vaccinations may be warranted then. That work’s currently underway.  

Senator ROBERTS: How do you assess the risks? Whose medical advice do you take?  

Rear Adm. Bennett: ATAGI’s—the Australian Technical Advisory Group on Immunisation. We follow their advice on all vaccinations and then consider our own needs for vaccination.  

Senator ROBERTS: Do you ever go against ATAGI?  

Rear Adm. Bennett: No—well, it depends on what you mean ‘against’. We may go beyond. ATAGI don’t just look at safety and efficacy; they look at the cost to the system. For those vaccines that are recommended, for instance, on the National Immunisation Program, we may provide more routinely in Defence for our personnel because, again, of those operational and other aspects.  

Senator ROBERTS: Are you aware that there are significant risks to healthy young people and that many other Commonwealth entities, including the Australian Federal Police, have now revoked their vaccine mandates?  

Rear Adm. Bennett: Nearly all states and territories and organisations have revoked mandates. That’s not all on safety; it’s on need as well. All vaccines do have an adverse-effect profile, and part of vaccination is the clinician understanding that profile and informing each individual, case by case, of what that is. The balance of benefits versus risk is considered always in vaccination. As far as COVID goes, the recommendations provided are that, on balance, the benefits of vaccinating people at risk and others are considered to outweigh what is a small incidence of adverse side effects. 

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.

CHAIR: Thank you.

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.

President Trump recently called on vaccine manufacturers to support their claims regarding the safety and efficacy of their products. It was these assurances that led him to launch Operation Warp Speed to develop the COVID vaccine and has defended the product in the years since.

It now appears President Trump is open to reconsidering his position on vaccine safety. I hope he does. A critical review of the claims made by vaccine manufacturers is likely to show a very high level of data tampering, misrepresentation, and outright lies.

This will mostly be around vaccine quality, not design. Many of our vaccines are produced as cheaply as possible and contain high levels of heavy metals, such as aluminium, which act as a preservative. These are causing harm to our children.

I hope the President reaches the same conclusion I have – that the mRNA platform is dangerous and should never have been used as the basis for the COVID vaccines developed under Operation Warp Speed.

Transcript

The significance of this is stunning. President Trump has been misled on the safety and efficacy of the COVID vaccines for a very long time. From this post it sounds like he has been kept in the dark and fed lies. I look forward to the president realising that and taking action to defend the health of all Americans by banning the mRNA vaccine platform. 

In further developments last week Robert F Kennedy Jr, the United States Secretary of Health and Human Services, announced significant changes to the authorisation of mRNA COVID-19 so-called vaccines. It’s important to understand this was not a banning of mRNA—not yet anyway. It’s important to clarify the new measures. The Food and Drug Administration, the FDA, approved updated COVID-19 shots for the autumn season in America and imposed new restrictions, effectively ending their emergency-use authorisations. This is only a partial victory for mRNA critics such as me. The measures did terminate emergency-use authorisations that had allowed this dangerous, killer product to be given to anyone over six months of age. 

What some claiming victory may have missed is that mRNA shots for COVID were given normal approval for a limited range of people. This includes anyone over 65 and anyone from five to 65 with an underlying medical condition. Moderna was approved for children over six months with an underlying medical condition. Is it a massive reduction in approval? Yes. Is it a ban? No. President Trump’s statement overnight suggests there are more developments to come. 

Last week I spoke of many new peer reviewed studies which show how this harm is occurring right through the human body. Tonight I will talk about the data, which shows this harm is occurring. We have proof of the harm, and we have the science showing causality. The Defense Medical Epidemiology Database is part of the United States Defense Medical Surveillance System. It enables queries of de-identified medical data coded in the International Classification of Diseases classifications for active duty personnel, filtered on demographics and occupational categories. In 2021 whistleblowers reported significant increases in medical conditions compared to 2016 to 2020 baselines, prompting congressional scrutiny and resulting in a finding of data-handling errors. In 2023 outdated 2021 DMED data confirmed elevated diagnoses, including hypertensive disease up 23 per cent, ovarian disfunction up 35 per cent, pulmonary embolism up 44 per cent, Guillain Barre syndrome up 15 per cent, oesophagus cancer up 13 per cent and breast cancer up seven per cent. Myocarditis was up 151 per cent. Remember the sample set here is millions of people of the United States military. These are—or were—healthy, fit individuals and their families. 

The harm is getting worse. Data for 2023 to 2025, using the same pre-COVID baseline, shows persistent elevations, terrifying elevations, over pre-COVID levels. Myocarditis is up 154 per cent; digestive organ cancer up 16 per cent in 2021 and up 43 per cent in 2024; brain cancer up 16 per cent in 2021 and 43 per cent in 2024; and blood coagulation defects up 25 per cent in 2021, 58 per cent in 2022 and then 32 per cent in 2023 as injection rates fell. That’s pretty damning. It shows that those who call this poison the clot shots are not entirely wrong. It gets worse, much worse. Conditions which may be potentially vaccine related and are certainly COVID-response related are up. Suicidal and homicidal ideation was up 46 per cent in 2021 and 86 per cent in 2024. Obesity was up 27 per cent in 2021, 69 per cent in 2022, 162 per cent in 2023 and 262 per cent in 2024. It’s okay though. Novo Nordisk has Ozempic on the market to fix that obesity problem. Who owns Novo Nordisk? Morgan Stanley, BlackRock, Vanguard and Norges. I call them ‘BlackRock Inc.’. This gaggle of rapacious wealth funds invest the wealth of the world’s predatory billionaires. 

Who owns Pfizer, the cause of this obesity epidemic? You guessed it, BlackRock. They own the problem and the solution. Did someone say COVID was just a— (Time expired) 

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.

✅ 100% agree!

Sourced from Secretary Kennedy on X @SecKennedy:

Medical decisions should be made based on one thing: the wellbeing of the person—never on a financial bonus or a government mandate.

Doctors deserve the freedom to use their training, follow the science, and speak the truth without fear of punishment.

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?  

Prof. Langham: Yes, that’s correct.  

Senator ROBERTS: Thank you. 

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

The Civil Aviation Safety Authority (CASA) claims there are no side effects from COVID Vaccines.  I’ve asked them multiple times to search their medical records database and report how many times the word “myocarditis” and other conditions have appeared over the years in the medical assessments of pilots.

They tried telling me that conducting such a search wasn’t possible, however they seem to have forgotten that they advised they had done such a search, in a previous Question on Notice, proving it can be done.

The real issue is that they are unwilling to conduct a search for the subsequent years because they know the number of matches have increased over the years, which would force them to admit there is a problem.

Transcript

CHAIR: Welcome back. Senator Roberts.

Senator ROBERTS: Thank you for appearing again. CASA has again refused to provide, in SQ24-001131, the number of times myocarditis and other conditions are mentioned in your medical records system. What are
you hiding?

Ms Spence: Nothing. As we’ve explained before, the medical records don’t allow themselves to be interrogated in the way that you’ve asked. But, as we have indicated previously, we have no evidence or examples of any pilot who has been impacted by a COVID vaccination in a way that has meant they weren’t airworthy.

Senator ROBERTS: You don’t take the word of British courts and our own health authorities here?

Ms Spence: I’m simply explaining to you what’s in our system. We have no-one who’s reported having become unairworthy as a result of a COVID vaccination. Nothing has changed from when we provided evidence
to you on this basis in numerous estimates hearings.

Senator ROBERTS: Okay. We’ll come back to that. This is a simple matter. You simply search your database for the word myocarditis, and you give this committee the number of matches that are returned. Why do you
refuse to do that?

Ms Spence: Because, Senator, as I think—again—we’ve explained previously, if we were to do that, it wouldn’t necessarily align with any examples of myocarditis. I can’t explain it anymore than I have previously, and that Andreas Marcelja has and Kate Manderson has. We’ve got nothing more to add, I’m sorry, Senator.

Senator ROBERTS: Then you say it is an unreasonable diversion of resources. That’s freedom-ofinformation talk, and I don’t know if you realise this, but that excuse doesn’t fly in the Senate. You’re in parliament. How many hours did it take you to answer SQ23-003267, dated 13 February 2023?

Ms Spence: I’d have to take that on notice, Senator.

Senator ROBERTS: Okay. How many resources did it take you to answer that question?

Ms Spence: I’ll take that on notice, Senator.

Senator ROBERTS: Thank you. CASA seems to change between two different excuses on this issue—the same issue. Most recently you’ve said it’s too hard and voluminous. Before, you just said it wouldn’t be useful
without context. It seems like you can do the search; you just don’t want to. My question is: can you do this search for those words in your medical records system?

Ms Spence: Senator, the—

Senator ROBERTS: Yes or no?

Ms Spence: Yes.

Senator ROBERTS: Thank you. I can’t imagine that answer is no, because you’ve already done it. Thank you for confirming it. What specifically has changed since you answered SQ23-003267 in February 2023 that means it’s impossible for you to answer the same question in the same way in SQ24-001131?

Ms Spence: My recollection, Senator, was—the issue that we’ve got is that we could do a search and the word could come up. We’ve got no way, without significant resources, to actually determine how often that word is actually linked to someone who has experienced that condition. We’d have to review every time that the word came up to determine whether it’s actually linked to a specific example, sorry.

Senator ROBERTS: I’m concerned. You mean that you’re telling me that CASA won’t get off its backside and examine something unless the answer’s easy?

Ms Spence: No, Senator, that’s not what I said.

Senator ROBERTS: There’s a bit of work involved here. You’re responsible. You’re the sole person responsible for the safety of our commercial aviation system.

Ms Spence: And we put our resources where it makes the most difference.

Senator ROBERTS: I want the question answered. What specifically has changed—then we can come back to this hearing and talk about the context. Right now, I’m asking why the Senate shouldn’t refer you for contempt, for blatantly refusing to do something you can do—seemingly out of convenience or to try to hide the answer.

Ms Spence: Senator, I’ve got nothing further to add. I’m not trying to hide anything. I’m simply saying that to get the answer that you’re after would require us to go through what could be a voluminous number of examples of the word, with no way of being able to determine which one is actually related to a specific example of that, and that’s what we’ve said consistently throughout our appearances.

Senator ROBERTS: Can you just provide the answer to the question? The number of times—

Ms Spence: I’ll take that on notice, Senator.

Senator ROBERTS: Thank you. AstraZeneca has been withdrawn. AstraZeneca was found to be dangerous and not effective in the British court system. You refuse to give me, after many attempts, the name of any agency or person—expert—as to who you’ve based your assessment that vaccines were safe.

Ms Spence: Senator—

Senator ROBERTS: AstraZeneca has been withdrawn. What is CASA doing to test—

CHAIR: Senator Roberts, I’m going to let Ms Spence answer that, in all fairness. I’m going to—

Senator ROBERTS: I didn’t get to my question yet.

CHAIR: I think you said ‘you refused’ or something like that. You were going along ‘who was the expert that said’. And I remember sitting in this building when our Prime Minister was carried out on a sultan’s chair with every Premier because of AstraZeneca and all that sort of stuff. But I think you should at least allow Ms Spence just to answer that claim—

Senator ROBERTS: Fine, but I haven’t asked my question yet.

CHAIR: No, but you made a claim—an assertion. I do want to give her the chance, Senator Roberts. Thank you.

Ms Spence: Unfortunately, Senator, you could go through Hansard and find it as well. We have relied on the health experts—

Senator ROBERTS: Go through what?

Ms Spence: Sorry, Senator; if you want to follow up on issues around AstraZeneca, they should be referred to the health department, not the Civil Aviation Safety Authority.

Senator ROBERTS: I want to know what you’re doing to make sure that pilots who took AstraZeneca are not at risk.

Ms Spence: We have not seen any example of a pilot being incapacitated as a result of a COVID vaccination.

Senator ROBERTS: Again it seems to me that CASA is waiting for the evidence to jump into its face.

Ms Spence: I have nothing else to add, I’m sorry, Senator.

Senator ROBERTS: Have you checked?

Ms Spence: Before we came to Senate estimates, yes, I asked whether there had been any examples of a pilot coming up in our system as having been incapacitated as a result of a COVID vaccination, and the answer has not changed from the last time we appeared before this committee.

Senator ROBERTS: Specifically, AstraZeneca?

Ms Spence: No, Senator, all COVID vaccinations.

Senator ROBERTS: Would it be worth checking, because we now know that AstraZeneca is dangerous?

Ms Spence: Senator, it wouldn’t matter what vaccination they had. The question is: has any pilot been incapacitated as a result of a COVID vaccination? That would include AstraZeneca, as well as the other types of
vaccinations.

Senator ROBERTS: I get that, but do we need to remind you that some pilots are afraid to report their injuries?

Ms Spence: Senator, if you’ve got pilots who you know are incapacitated, or if pilots are approaching you who said they are incapacitated, as a result of a COVID vaccination, I can only encourage you to get them to report that. They can do it anonymously through the ATSB response, but I cannot act on what I have no knowledge of.

I sent a letter to Prime Minister Anthony Albanese supporting Russell Broadbent’s request for him to address the concerning findings in a recent scientific report prepared by Canadian virologist Dr. David Speicher.

My Letter to Prime Minister

Report Prepared by Dr. David Speicher

Russell Broadbent MP’s Letter to the Prime Minister

Special Council Meeting | 11 October 2024

Council Meeting Details » Town of Port Hedland