During my session with the Therapeutic Goods Administration (TGA) at Senate Estimates in November, I questioned them about a number of concerns.
Does the TGA agree that spike protein is pathogenic in COVID-19 vaccines? Professor Langham clarified that the spike protein is not pathogenic and is designed to trigger an antigen recognition and antibody response.
Has the TGA observed or seen reports of any adverse events related to the spike protein? Professor Langham responded that no such events have been observed, as the spike protein is quickly degraded by the body once it’s introduced s part of the mRNA vaccine.
What analysis did the TGA conduct regarding the spike protein’s suitability before vaccine approval? Professor Lawler agreed to provide detailed information on notice.
It has been demonstrated that spike proteins exert an inhibitory effect on the function of the angiotensin-converting enzyme 2 (ACE2), leading to dysregulation of the renin-angiotensin system. Is the TGA aware of this effect of spike proteins on ACE2 and on the renin-angiotensin system? Professor Langham explained that while the spike protein attaches to receptors, it does not cause harm on its own.
Is ‘long COVID’ the result of spike protein in the body coming from the Wuhan and alpha versions of COVID itself or is it from the vaccine products containing spike proteins, which are injected repeatedly in Australians? Professor Lawler responded that there is no accepted evidence to confirm such a link.
Has the TGA received any applications for treatments to remove spike proteins from the body and has the TGA engaged with research institutions on this matter? Professor Lawler clarified that the TGA has not received such applications, does not commission research, and focuses on regulating therapeutic goods.
The TGA emphasised that the overall risk-benefit profile of COVID-19 vaccines remains positive.
Transcript
Senator ROBERTS: Thank you. Does the TGA agree that spike protein is pathogenic?
Prof. Langham: Thank you for your question. The spike protein is not pathogenic. It does not contain any of the other parts of the COVID-19 vaccine that brings about a pathogenetic state. The spike protein is really there to encourage an antigen recognition and an antibody response by the body.
Senator ROBERTS: Okay. I’ll move on. Has the TGA observed or seen reports of any adverse effects of COVID vaccination that may be associated with the likely effects of spike protein?
Prof. Langham: As I said, the spike protein is not pathogenic. We’ve not seen any adverse events related to the spike protein, because—and we’ve discussed this previously—the spike protein is rapidly degraded by the
body once it’s introduced as part of the mRNA vaccine.
Senator ROBERTS: Really? Okay. What analysis did the TGA conduct regarding the suitability of spike protein in the COVID vaccines prior to approval? Could you please provide me with that material on notice.
Prof. Lawler: I’m taking that question to be: what did the TGA know about spike proteins prior to approving the COVID vaccines? Is that a fair—
Senator ROBERTS: I’d like to know what analysis you did regarding the suitability of spike protein in the COVID vaccines prior to approval, and I’d like that material on notice.
Prof. Lawler: I’m happy to respond to that question on notice. We have responded to similar questions previously.
Senator ROBERTS: Can you tell me about the analysis?
Prof. Lawler: As I said, I’m happy to take that question on notice.
Senator ROBERTS: Do you know about the analysis now? The question on notice is only if you don’t know something now.
CHAIR: Senator, the official is well entitled to take a question on notice. It’s not about not answering the question; it’s about taking an answer on notice.
Senator ROBERTS: Well, as I understand it, the guides to the witnesses include that if they want to take something on notice it’s only because they don’t know the answer now.
CHAIR: Yes, or they need to qualify or check the information or they don’t have the extent of the information.
Senator Gallagher: They don’t have the information with them to provide you a comprehensive answer, which is not unreasonable.
Senator ROBERTS: Okay. Have you received any reports, data or discussion from your pharmacovigilance system highlighting concerns about spike proteins following the introduction of the COVID vaccines? If so, could you please provide that information?
Prof. Langham: Again, I’m at a loss to understand the specifics of your question as to how our pharmacovigilance would relate to the specific aspect of the vaccine which is the spike protein. I think we can
answer very clearly what our pharmacovigilance results have been for the vaccine itself. But as to the specific aspects of the spike protein, the reason the mRNA vaccines include the spike protein as the antigenic stimulus results from many years of research that had been undertaken in the US by the National Centre for Vaccines to develop mRNA vaccines.
Prof. Lawler: And I’d just add to Professor Langham’s answer that the purpose of our pharmacovigilance and the way in which it monitors for and identifies to enable us to respond to emerging safety signals and trends is that it’s based on adverse events.
Senator ROBERTS: That’s all it’s based on?
Prof. Lawler: These are clinical events. So, there’s an expectation—indeed, an encouragement—that adverse events are reported, and these are reported on the basis of clinical nature. We also, as I mentioned previously, work with international partners on a network of pharmacovigilance activities that Dr Larter might like to speak to.
Dr Larter: We continue to engage with our international regulatory counterparts to look at not only spontaneous adverse event reporting but also linked data, and many of the rich datasets that are available globally,
to inform our safety monitoring. These processes enable us to identify emerging safety concerns well before we understand how they might be occurring, before the mechanisms of action are identified. That’s a strength. We don’t need to know exactly how they’re being caused to take regulatory action to ensure that the safety profile is up to date and available for treating health professionals.
Senator ROBERTS: There has been a multitude of papers about potential health impacts from spike protein on the renin-angiotensin system in the human body. It appears to be basic to human health—if not the key system then certainly one of the key systems to health. Is it your testimony today that the COVID vaccines containing spike proteins are still perfectly safe.
Prof. Lawler: We’re aware of the importance of the renin-angiotensin-aldosterone system. Professor Langham is a nephrologist. The reality is—I’m happy to come back if I’m wrong, but I don’t know whether we or any other regulator has ever said that a medication is perfectly safe. There are a number of processes that we follow in the assessment and market authorisation of a number of medicines. We have product information that clearly states the risks and potential adverse events—
Senator ROBERTS: Who is that from? Who is the product information from?
Prof. Lawler: The product information is produced—I guess, to the question, I’d like to say that we don’t maintain that the vaccine is perfectly safe. Every time we come here, we discuss with you the adverse events and the recognised and accepted potential adverse events. So, no, it’s not our position that the vaccine is perfectly safe. It is our clear position, and this is the clear scientific consensus, that the risk-benefit of COVID vaccines has been shown to be very safe and, in fact, the risk-benefit is significantly positive.
Senator ROBERTS: Okay; I won’t explore that any further. It has been demonstrated that spike proteins exert an inhibitory effect on the function of the angiotensin-converting enzyme 2, ACE2, leading to dysregulation of the renin-angiotensin system. Is the TGA aware of this effect of spike proteins on ACE2 and on the renin-angiotensin system?
Prof. Langham: It’s well known that the angiotensin receptor is important in how the virus exerts its effects on the body. As to what you are describing with the spike protein itself, on its own, it’s not able to cause any
problems. It connects to the receptor, but there is nothing else there behind the spike protein. It’s the virus itself that does cause problems, and the receptor that that virus attaches to is absolutely the angiotensin receptor.
Senator ROBERTS: Was the potential impact of spike proteins on the ACE2 receptor and the renin-angiotensin system considered as part of the analysis of the vaccines? I’d also like to come back again and ask: on
whose advice do you take the product safety?
Prof. Lawler: There are two questions there.
Senator ROBERTS: Yes, there are.
Prof. Lawler: I’d like to answer them in turn. Which one?
Senator ROBERTS: The first one is: was the potential impact of spike proteins on the ACE2 receptor and the renin-angiotensin system considered as part of the analysis of the vaccines?
Prof. Lawler: The process of the market authorisation and evaluation of medicines, including vaccines, is a comprehensive process that is based upon a significant dossier of information that goes to the safety, quality and efficacy of that particular medicine. In terms of whether that was a specific issue, I’m very happy to have a look at that and come back to you on that.
Senator ROBERTS: On notice—are you taking it on notice?
Prof. Lawler: Yes.
Senator ROBERTS: Thank you. Recently, German doctor Karla Lehmann, in her peer-reviewed scientific paper published in the journal of the European Society of Medicine commented that spike protein is ‘uniquely
dangerous’ for use in vaccine platforms—and this woman is generally pro-vaccine—because of the effects of spike protein causing ACE2 inhibition, leading to excessive angiotensin 2 and harmful overactivation of AT1R, the angiotensin 2, type 1 receptor. This analysis is supported by other research providing clear evidence of the pathogenic nature of spike protein and its unsuitability for use in vaccine platforms. Is the TGA aware of this review and analysis conducted by Karla Lehmann and her damning conclusions about the dangers of spike protein based vaccines?
Prof. Lawler: I don’t have that article. It would be useful, obviously, to review that. I think it’s also worth noting that a lot of the theoretical conversations around spike protein are mechanistic in nature rather than
supported by phenomenological or observational studies. So there are a lot of inferences drawn between a cellular mechanism and a clinical scenario that is very difficult to distinguish from the disease itself. Professor Langham, is there anything you would like to add?
Prof. Langham: I guess I would just support those comments that, when the vaccine with the spike protein as the antigenic stimulus is trialled in clinical trials, the sorts of physiological derangement of the renin-angiotensin-aldosterone system that might be described is not seen. So we do not see activation of the renin-angiotensin-aldosterone system with the clinical trials in terms of understanding the specific safety signals that have come from them. It has been quite widely demonstrated that the vaccines themselves are very well tolerated.
CHAIR: Senator, I’m due to rotate.
Senator ROBERTS: I just have two more questions on this thread.
CHAIR: Sure.
Senator ROBERTS: Is ‘long COVID’ the result of spike protein in the body coming from the Wuhan and alpha versions of COVID itself or is it from the vaccine products containing spike proteins, which are injected
repeatedly in Australians?
Prof. Lawler: I don’t believe there’s accepted evidence to confirm that that’s the case.
Senator ROBERTS: Has the TGA received any applications for treatments or protocols to remove spike proteins from the human body? Have you asked the National Health and Medical Research Council to advertise a
grant for this purpose? Are you working with any university around this topic—anything at all—either to cure spike protein damage for long COVID, if it exists, or for vaccine injury?
Prof. Lawler: The answer to the first question is not to my knowledge. The answer to the second question is that it’s not the role of the TGA to commission research from the National Health and Medical Research Council. And the answer to the third question is it is not the role of the TGA to generate knowledge; it is the role of the TGA to regulate therapeutic goods.
Senator ROBERTS: That’s the end of my questions on COVID spike protein. I have two more sets of questions.
CHAIR: Do you mean for the TGA?
Senator ROBERTS: Yes, for the TGA but on other topics
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