Senate Community Affairs Legislation Committee [Part 2], , 3:09:32 to 3:18:31
Inquiry into adverse event reporting discrepancies for childhood vaccines and scientific research regarding vaccine ingredients, such as aluminium adjuvants, and their potential neurological effects.
Topics: Health, Public safety
Speakers: Dr Tahli Fenner, Senator Alex Antic, Prof Anthony Lawler, Senator Ellie Whiteaker, Unknown Speaker, Dr Liz Develin, Gavin Matthews, Prof Michael Kidd
>> Yeah. Uh thank you. These are um probably questions for TGA and maybe a target
>> Yeah. The Itagi chair is online.
>> Online.
>> Excellent. I will just confirm uh that we have the chair of a target joining us online. Can you hear us?
>> Yes, I can.
>> Thank you.
>> Do you mind just stating your name for the Hansard record?
Katherine.
>> Yes, I'm Katherine. I'm co-chair of the target.
>> Okay. Um, so I think these probably are first for the TGA. Um and I just want to focus um on the issue of uh infantrics uh hexa which according to the daen system there have been 7,700 reports of adverse effects including over 20 reported deaths uh involving that childhood vaccines given to babies at 2 4 and 6 months. Um there's a Freedom of Information um release FOI 134 uh45 which showed an additional 26 deaths had been reported to the TGA's internal adverse events database between 07 and 2019 totaling almost 50 reported deaths. Can you tell me why there was a discrepancy in the uh in that reporting?
Yeah, thanks uh thank you uh Senator. So, Professor Anthony, deputy secretary health products regulation group. Uh Dr. Fenner who's the head of our farm vigilance branch has just come to the
>> uh Tarly Fer, assistant secretary pharmarmacco vigilance branch. Uh senator, sorry, could you repeat the question and the information that you're
seeking? Yeah. So, there was a long long sort of intro to the question, but essentially uh according to the the DAEN system, there have been 7,700 reports of adverse event um events, including over 20 reported deaths involving the Infandrix Hexa vaccine given the babies at 2, 4, and 6 months. Um there's also been a Freedom Information release 1345, uh which showed an additional 26 deaths have been reported to the TGA's internal adverse events database between 2007 and 2019. in totaling almost 50 reported deaths and I'm wondering why the discrepancy in those figures.
>> So I can't give you a specific answer about that but I can certainly take that on notice to come back and look at that. Uh what I can share with you is that the uh database is live um and it is updated and so uh there may be reports added or duplicates identified. Uh so there are sometimes there may be discrepancies at point points in time. Um but with regard to the discrepancies that you're asking about would have to have a look at that and take that on notice. So, so is it
the case though that an infant or has an infant ever actually died as a result of receiving a vaccine that one or any
>> So, I think um we've talked about this previously uh in the context of our adverse event reporting. adverse events um reported with a fatal outcome do not necessarily mean that the uh the uh medicine or vaccine in question caused that um that that death. And so we uh obvious um you unusual patterns of reporting or increased patterns of reporting. All of those reports are are investigent system and then when we undertake an investigation if there is a a signal that warrants it we would look at those
reports that pretty straightforward question the question is has a child ever died as a result of a direct result of receiving a vaccine.
>> Has a child ever died as a direct result of receiving a vaccine in general? >> Uh Senator, I'd have to take that on notice. As I said, we don't the adverse event reports that we receive don't establish causality in that sort of fashion and we are not uh we do not rediagnose or take the position of um a coroner. That is not our role. We're [clears throat] looking at population level data. Um so I think you know happy to provide more information on notice but
>> so if I if I may also add add um Senator I think it's very important that we are able to provide a a a more um complete answer because the answer to the question has a child ever died following vaccination is very different to the to to to the question um has a d a child died as a result of vaccination or indeed has a child died as a result of the vaccine and I think it's very important that we give you because um allergic reactions um idiosyncratic reactions a number of reactions can occur. Uh part of what um what um Dr. Penn has described in terms of our causality assessment is looking at those issues. But again, it's important to note that the database of adverse event notifications is a spontaneous um event reporting system that is intended to identify signals, not individual occasions.
>> Well, I mean, I would have thought it was quite straightforward, but let's perhaps flip to something a little bit different. I I want to know the answer to the issue of some the effect of some of the um exipients and adgivants that are involved that are the ingredients of uh of the vaccines. Um can vaccines all their components including those exipients and adjuant adgivants cross the bloodb brain barrier and if so which
Uh, Senator, I don't have information about you. There are lots of different perhaps you could be more specific about the particular ingredients you're interested in and [clears throat] we
>> Well, the question is do any of them, but for example, uh, does the aluminium adgivant does that cross the bloodb
U the you're talking about the adgiant that sits within within the Iran.
>> So I think what we can have talked about previously at Senate uh at Senate estimates um and I think we've provided information on notice is that there is um no concerns with regard to the use of aluminium in vaccines.
>> That's but with respect that's not the question
>> I can take I can take on notice to un to look into the specifics of your
>> Yeah. So Senator I would just highlight the these are these are quite specific questions around a broad range of vaccines.
>> Is that specific?
>> Yeah. It is quite a specific these are these go to the specific individual phcoinetic and physicochemical properties of vaccines and so it's important I think that we are able to provide you with specific and accurate responses to those technical questions.
I would have thought we've got experts from all across the field here. I I just I would have thought that's a very straightforward question. Um
>> what I can share with you, what I have at hand, [clears throat] Senator Antic, is that the amount of aluminium from vaccines entering the bloodstream is minimal and it doesn't result in measurable changes in blood aluminium levels. Um I so I can provide some references with regard to that on notice and um perhaps we can provide some more detail about the specifics of your question on notice as uh professor Lula has said it's a quite specific question [clears throat] that warrants a a quite specific answer.
>> Okay. Well, we haven't been able to get any answers so far. Um, have you got any research or the TGA have any research which reviewed the cumulative effects on repeated exposure of these components during infancy including their potential to accumulate or persist in brain tissue um and any associated neurological effects.
So Sandra, I don't know whether
>> I have I can probably provide some information with regard to that that would give some uh con perhaps some comparative context that dietary aluminium exposure increases substantially with age and over the first 18 years of life absorbed dietary aluminium is approximately 9 to 50fold higher than that from vaccines. So perhaps that gives a bit of context around