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.
