Senate Community Affairs Legislation Committee, , 1:03:47 to 1:17:01
Debate over spike protein testing, vaccine shedding, and the risk-benefit profile of COVID-19 boosters for elderly populations.
Topics: Health, Public safety
Speakers: Prof Anthony Lawler, Senator Malcolm Roberts, Prof Katherine Gibney, Hon Jenny McAllister, Speaker 18, Ellie Whiteaker
Uh thank you for extending the session, Mr. Comley, or can uh contributing to it. I'd like questions. Uh I think this would be for the TGA.
So we have our um Professor Gibney from Atagi online, just so you're aware, um, Senator Roberts.
Thank you. Blood testing for spike protein. Combining an anti-spike antibody test, which tests for protein spike protein in the body with an anti-nucleocapsid antibody test, which tests whether a person had the COVID virus itself. It is possible to see if a person has received spike proteins from the COVID vaccine or from COVID itself or both. Is this correct?
Uh thanks for the question, Senator Professor Anthony Law, Deputy Secretary of Health Products Regulation. I'm not sure that that's really a question for the TGA.
Who would you suggest we give it to?
Well I'm not sure. I mean I uh our our role is as you're aware is to regulate specific therapeutic goods. I'd suggest I mean I don't know whether the chief medical officer would.
Chief Medical Officer.
Uh I would need to take that on notice, uh Senator. I'd just um check to see if Professor Gibney would like to respond or not.
There are different tests available, but I think it's best that we take it on notice and get you the accurate details. Thank you.
Thank you. Someone like myself who did not have the COVID injections. Could test to see if I came in contact with the vaccine through secondary exposure or vaccine shedding. Is that correct?
When you say the COVID injection, do you mean the COVID vaccine?
Yes. No one?
Well, again, I'm I'm not sure that that's a I think that's a clinical question rather than the TGA question. I don't know.
Um again uh I'd need to take that on notice, Senator, but uh again uh Professor Gibney may wish to respond.
No, I I think it's really the same part of the same question. So I think that um yeah, we can take that on notice. Thank you.
Thank you. Is that test approved by the TGA to be administered in Australia? And if so, is a doctor choosing to administer the test where they think it will enhance patient diagnosis and care following good medical practice.
Senator, I'm I'm I'm not aware that that test has specifically been brought to the TGA for evaluation or approval, but I can check on that and hopefully come back to you with that. So can I just be really clear? We're talking about a specific test to test for spike protein, not uh not for COVID vaccine antibodies.
Correct.
I I I'll I'll see what I can do to come back to you in this session.
Thank you, because we've heard from patients that they've asked for it from their doctor, and the doctor said they're not going to do uh recommend it, not because of the test, but because of the pressure.
Uh I can't speak to the individual interactions between patients and their doctors with the advice that they might receive.
Uh, if you're background, that's all we've got.
I mean no, as I say, I I can't speak to that, but if if if I can't get that information for you now, happy to provide that on notice.
Now I agree that on an individual basis, a population of n equals one on that level. This test result may be read with care, must be read with care, and doctors could explain the nuisance to their patients. On a larger scale. The test does become instructional. Testing labs are legally required to hold this data for seven to twenty years, depending upon the test. Individual my health records also have the results and could be extracted and de-identified. Has your department, anyone, at Dagi, Chief Medical Officer Department ever gone back to these test results and compare the outcome based on vaccine I understand it's being used in Australia.
So I would I I guess I would make the observation, Senator, that uh we're we're I mean, we' w whether we whether we move from from N equals one to N equals 30 million, uh, we would be looking at undertaking epidemiological and population health uh level studies where there is uh a I think uh a reasonable um mechanistic or epidemiological uh rationale for intervention. Uh it it is not necessarily clear to me from your question what the purpose of such testing would be. And I would also highlight that the um the entry of such data into um information might mean that there would be the potential, and as you say, having to be read with gear, the potential for um uh unfortunately easy misinterpretation that result to to arrive at um erroneous conclusions which would potentially harm public health messaging.
Thank you. That's what I was getting at with the population of one. Individually, it may not be instructional, it may be just a guide, but uh over a number of people, a large population, then it would be uh quite useful.
I get I I think we're in agreement on that, Senator. I think my challenge would the challenge for me would be uh that simply putting it out to a population level might not necessarily get it to the point where it's useful for the determination of public health measures.
Well, we we we must have honest and truthful instructions around the test. So I get that, but the reason for it is that people can see whether or not the spike protein is still in the body because the experts in this country included said the spike protein just goes out of the body very quickly. Well, that's not what we're understanding from research overseas. So that's why. And you you're still recommending the COVID shots. I know of an elderly couple who got their seventh booster last week. This information will inform decisions today, let alone in the next outbreak. Anyone want to make a comment?
I'll make a comment. I guess the purpose of the COVID vaccine program has always been to prevent severe COVID disease. So prevent hospitalisations and deaths from COVID. We know that the elderly are by far and away the highest risk group. And that is reflected in Atari's vaccine advice, which is that people over 75 are recommended to receive two doses of COVID vaccine every year. And that is because it you know the thing that we are really interested in measuring and keeping tabs on is hospitalization rates and deaths from COVID rather than a blood test result. And that has continued in Australia and overseas to show the COVID vaccine has benefit in protecting older Australians from severe COVID, and that is reflected in our recommendations.
Thank you for that. What are you doing in regard to testing or assessing the data, scrutinising the data for the effects of the injections or the vaccines, whatever you want to call them, on the elderly themselves, the shots themselves?
So I guess there are two aspects to that. One is the safety aspects, and so that is already been described by the TGA, the whole process of assessing safety and the process of assessing effectiveness is through looking at hospitalisation rates and deaths and comparing those between people who've had a recent COVID vaccine and people who haven't. And those assessments have continued to show benefit from vaccine.
And I'll just if I may, Senator add to Professor Gibney's response. I think Professor Gibney's outlined that quite well. The other is the issue of safety, and we've had multiple conversations previously around our pharmacovigilance process, which goes to the identification reporting of adverse events. We have been very clear that we acknowledge that individuals can have adverse reactions to vaccines, including vaccines. They have resulted in appropriate adjustments to the product information. We've also acknowledged that there are rare but significant side effects, myocardising, myocarditis and pericarditis included. We have acknowledged that myocardi, we've had this conversation, Senator, around the we've had this conversation, Senator, previously around the fact that as science understanding and epidemiology involves regulators respond, and that's what we've done. But we also do very much hold to the view, which is held uh globally that uh the uh not only is the risk-benefit uh equation for COVID vaccination continues to be overwhelmingly positive, but uh myocard artists will take as an example that there is significant uh body of evidence and it grows regularly that the uh myocarditis, pericarditis, and other cardiac consequences of COVID infection far outweigh the um the consequences of cardiac uh of cardiac outcomes uh following vaccination, uh not only in terms of frequency but also in terms of severity.
Well thank you. And we could have a conversation which I need which I can't go into it right now, but the health minister at the time of the COVID shots being introduced was Greg Hunt. And he said the world, this is a quote, the world is engaged in the largest clinical vaccination trial because these shots were not tested other than by Pfizer, and they cancelled the test. And yet you still went ahead with it, or your department went ahead with it. So just be complete with the truth. Minister.
So if I if I if I might, so I think that the statement about being complete with the truth carries with it a certain um implication. Uh we've been very clear, I think, uh, through conversations, questions, answers, and questions on notice, the process that was followed. Uh we've had the conversation previously centre around the distinction between the emergency use authorisation uh that has been used by the countries versus the provisional pathway that we used here in Australia, which meant that we uh that we brought in um the evidence, we evaluated the evidence and we then uh validated the evidence with uh greater requirements of evidence production uh when the transition from provisional to full registration occurred, and as I've mentioned a number of times, we have um engaged in the most robust pharmacovigilance post-market monitoring of any medicines that we've seen in Australia, and the risk balance uh continues to be overwhelmingly positive on a population level. We do acknowledge that individuals have adverse events from vaccines, individuals have adverse events from medicines, which is why we balance the risks between pre-market authorization, post-market vigilance, and an appropriate updating when necessary of product information. It's also why it's important that we have that communication very clearly around people being able to make an informed risk between the risks of vaccination versus the significant risks of infection. I think to suggest that we have not been true or honest with what we're saying, I I think is is uh an unfortunate and um incorrect statement.
One final question, Senator Roberts.
One final question.
And then you're uh on on notice. Could you provide us with the list of and the descriptions of the tests that the vaccines went through in this country and internationally?
I I I believe we've we've uh provided previously, but we'll have a look and if we haven't, we will endeavour to provide that information.
Thank you. On notice. Uh Minister, will you undertake this research or is it in into the anti-spike antibody test? Or is there everything to lose and nothing to gain for the TGA and their results? People need to know whether or not they've still got spike protein in the body because we're seeing results overseas that they have, even though they were being told by the authorities and the experts that it goes out quickly. Will you undertake the research?
Senator, one of the things Australians can be very proud about is that our institutions are staffed with people and personnel who are incredibly skilled in providing guidance about the safe use of medicines in the Australian context. And this morning and last night, you've heard evidence from some of those people about the steps that are taken in our system to assure ourselves that the use of medicines in the Australian context is done safely and for the benefit of patients. I listened very carefully to the advice that Professor Lawler gave you just now. And he explained to you with some clarity about the approach that has been taken in the use of vaccines. I know that you are running a campaign. Um you've been running it in the entire time you've been in the Senate, but I think that officials have answered your questions very thoroughly this morning.
Thank you. Uh if you did the test that did it did the research on the test, you would be able to confirm that they're on the right track. But you're not doing it. Why are you not doing it? Because people.
Well Roberts, I'm going to share the call. We've come to time. I think they've I think we've thoroughly covered this topic. Senator Payman.