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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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