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Tracking Vaccine Dollars

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In this session with the Department of Health, I inquired about the total cost of our childhood vaccination program. While I didn’t receive an immediate response, the question was taken on notice.

The TGA also offered to provide a cost-benefit analysis of these vaccines. Frankly, I’m not expecting an honest reply. I will wait and see.

If they fail to deliver, I’ll pursue it at the next estimates. 

— Senate Estimates | February 2026

Transcript

Senator ROBERTS: How much do these vaccines cost the taxpayers every year: rotavirus, hep B and meningococcal ACWY?  

Dr Peatt: I don’t have the individual breakdowns of those vaccines, but I can tell you that, in 2024-25, the National Immunisation Program, which includes a raft of supporting activities that—  

Senator ROBERTS: Is that childhood vaccines?  

Dr Peatt: No, this is the full complement of National Immunisation Program vaccines and also other activities like communications and data collection, for example. We spent $762.8 million.  

Senator ROBERTS: Is there any chance of getting a breakout for the children’s vaccines?  

Dr Peatt: It’ll be dependent on whether that information is commercial-in-confidence, but I’ll take that on notice and get back to you.  

Prof. Lawler: I’ve mentioned previously that the regulator is involved in balancing the risk and benefit. I would highlight that it would be difficult to talk to the cost of vaccines unless we also recognise that these vaccine-preventable diseases cause an incredible burden of mortality, morbidity and cost. In fact, in the US, RSV is the leading infectious cause of paediatric hospitalisation. So the risk benefit is as important as the cost.  

Senator ROBERTS: That’s a good point, Professor Lawler—perhaps if you could include in that the benefits.  

Dr Peatt: Certainly.  

Senator ROBERTS: Denmark, Sweden, Norway, France and the Netherlands do not recommend rotavirus vaccines except for high-risk cases. The varicella vaccine in Denmark, Sweden, Norway, Finland, France and Portugal is not recommended except for high-risk cases, and hepatitis B vaccine is not recommended for routine use in Denmark, Norway, Finland, UK—Britain—France, Germany or the Netherlands. Surely the default is don’t vaccinate unless the need has been established. Can you show me any of these countries where the absence of the vaccination has led to a higher incidence of child harm—not infection but harm—than vaccinated countries?  

Dr Peatt: As my colleague Professor Lawler has outlined, it’s very difficult to compare different countries. That’s really because there are different disease impacts in each different country, which can be related to the public health measures that are in place and also the different diseases that are circulating. We also have different funding mechanisms. In Australia, we’re very fortunate to be in a country that has a program that provides vaccines for free that are recommended by our advisers. We are very fortunate in that sense. So I’d say that it’s very difficult to compare one country to another in terms of how they fund or recommend their vaccines. But I will throw to Associate Professor Katherine Gibney, who may be able to give you an idea about some of the assessment and information that they take into account when they recommend vaccines in the Australian context.  

Prof. Gibney: Certainly, ATAGI takes the epidemiology and burden of disease of each of these vaccine-preventable diseases into account as we consider who to recommend the vaccines for. Establishing a clinical need isn’t just about infection—in fact, counting numbers of infections is not particularly interesting. It’s hospitalisations, severe disease and death that we’re particularly interested in or long-term consequences that could be prevented through vaccination. So that’s really what we look at. The first question is: is there a need for a vaccine? Then we look at the vaccine. Considering that TGA has already assessed the effectiveness and the safety, we further review that in the context of the clinical need. Further to that, when we provide advice to PBAC, they look not only at the clinical effectiveness and need but also at the cost-effectiveness. So ATAGI don’t assess that, but that is assessed for every vaccine before a recommendation is made that it be added to the NIP.  

Senator ROBERTS: Well, could you show me anywhere where the absence of the vaccination has led to more hospitalisations and more deaths?  

Prof. Gibney: Certainly we can take that on notice and provide that.  

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Vaccine Trials: Fact vs. Fiction

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In this session, I asked about the system for testing childhood vaccines before authorisation and during use. I asked because the United States FDA has recently de-listed approximately half of their scheduled vaccines due to adverse events (side effects).

It was a simple question, yet the answer was “tag-teamed” across the panel of witnesses from the TGA to avoid answering it directly. It is damning that their own Database of Adverse Event Notifications (DAEN) shows numerous adverse events, which the TGA simply ignores.

Instead, they quote the benefits of vaccines, which have never actually been proven in field trials. I have spoken about this before: in comparisons between vaccinated and unvaccinated children, the unvaccinated were healthier. I will return to this line of questioning during the next estimates.

You will also note they relied on an answer provided to me in Question on Notice 3212, which has neither been published nor provided to me.

— Senate Estimates | February 2026

Transcript

Senator ROBERTS: Thank you. I come back to two separate points you raised. Ms Peatt, you mentioned that Australia assesses the vaccines. Do they do actual testing? What is the method of assessment? Trials?  

Dr Peatt: I’d have to throw to Professor Lawler about the assessment that the vaccines go through, but, from my knowledge, we don’t assess the vaccines. What we do do is rely on evidence and data to ensure their safety. I’ll hand to Professor Lawler.  

Senator ROBERTS: Okay. Where do that evidence and data come from?  

Mr Henderson: We have a process where we rigorously evaluate submissions provided by sponsors of these vaccines.  

Senator ROBERTS: The drug companies?  

Mr Henderson: The pharmaceutical manufacturers, who then sponsor—  

Senator ROBERTS: Submissions from the drug companies?  

Mr Henderson: Yes. We require a significant amount of evidence to support our assessments of the safety, efficacy and quality of those vaccines before they can be marketed and supplied in Australia.  

Senator ROBERTS: Let me understand this. I go back to March 2021. I think it was. I asked the previous head of the TGA, Professor Skerritt, or Dr Skerritt, what testing was done in this country on the COVID injections. He said none. They relied on the FDA. At the time he said that, it was after the FDA had admitted they did no testing themselves; they relied on Pfizer. You’re telling me you’re doing the same thing. Okay. The next—  

Mr Henderson: Sorry, Senator. I might just jump in there. No, all the COVID-19 vaccines are now what we call fully registered, so they have been assessed on a full suite of evidence to support safety, quality and efficacy of those vaccines. For COVID-19 vaccines, as well, we did have a program in place where we did batch testing of all vaccines in the TGA laboratories before they could be supplied in Australia.  

Prof. Lawler: I might add to that if I may, Senator. I note your use of the word ‘testing’. The role of the regulator—and this regulatory practice is standard worldwide—is that we undertake an unbiased and objective assessment of the evidence that is presented to us, particularly—  

Senator ROBERTS: From what entity? The supplier?  

Prof. Lawler: That was part of the rest of my answer, Senator. I’m going through the process that we follow. While, for the most part, that is supplied by the sponsor who is seeking registration of the product, it does undergo an appropriate assessment by our own experts to determine that the size of the sample, the controls that are placed, the primary endpoints, the outcomes and the adverse events—all of those elements of the study—indicate that the risk-benefit analysis is positive. The process that we undertake is similar to others.  

As Mr Henderson’s highlighted, during COVID we had a provisional registration pathway. This was during a time, as you would recall, when the risk-benefit of providing a provisional authorisation for that vaccine was high. Since then we have undertaken a transition of that vaccine through to a full market authorisation. There are other mechanisms for assessing the evidence, and obviously in this instance we can also rely on the real-world evidence that the overwhelming benefit—that the risk to benefit is positive given the number of lives saved by the administration of the COVID vaccine when compared to the incidence of adverse events.  

Senator ROBERTS: Mr Lawler, before I ask my—  

Prof. Lawler: Professor Lawler. Sorry, Senator.  

Senator ROBERTS: Professor Lawler, you said a minute ago in another answer ‘Australian disease patterns—forget overseas’. Now you’re saying they’re similar to others, so our testing is similar—or our assessment is similar to others; you don’t do testing.  

Prof. Lawler: I actually said neither of those things, Senator. I certainly didn’t say that we should forget other countries. What I said is that we make our own vaccine schedules based on the demography, the epidemiology, the disease patterns and so forth of Australia. We certainly have a mind to others. Just as an example, the disease patterns in the northern part of the world circulate to the southern part of the world some six months later. So we certainly have to be mindful of what’s going on in the rest of the world. We don’t forget what’s going on there. What I then said was that there are consistent, if not identical, approaches to regulatory decision-making around the world. There is significant positive collaboration and work sharing between regulators so that we can know what the appropriate practices are, particularly horizon scanning, so that we know what’s coming up. But I would highlight that the answer that I gave actually went to how we regulated during COVID, which was different to other countries. Other countries undertook what’s called an emergency-use authorisation. We undertook a process of provisional registration, which was an abbreviated and expedited process that did not lift from sponsors the requirement to provide appropriate evidence, particularly real-world evidence, and then the appropriate, more fulsome transition to full market authorisation thereafter.  

Senator ROBERTS: I can only go by what your predecessor said—that they relied on the FDA. Dr Peatt, you said the childhood injections are free.  

Dr Peatt: Yes.  

Senator ROBERTS: They’re actually paid for by $750,000 by the taxpayer.  

Dr Peatt: Yes. That’s correct. What I should have said is that they are provided free to people who are eligible for those vaccines. But, yes, they are fully funded by the government.  

Senator ROBERTS: The taxpayer.  

Dr Peatt: Yes.  

Senator ROBERTS: There’s no such thing as government money. It’s all taxpayer money.  

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A Simple Step Toward Safer Immunisation

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

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

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

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

— Senate Estimates | December 2025

Transcript

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

Mr Comley: That sounds to me like PBAC.

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

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

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

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

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

Senator ROBERTS: You can take it on notice.

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

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

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

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

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

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

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

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

Prof. Lawler: Absolutely.

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

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

Senator ROBERTS: Sure.

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

Senator ROBERTS: It does or doesn’t contain—

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

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Questions Raised on Safety of Infanrix Hexa Vaccine

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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

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