Community Affairs Legislation Committee
08/11/2022
Estimates
HEALTH AND AGED CARE PORTFOLIO
Office of the Gene Technology Regulator
[21:41]
Senator RENNICK: We’ve spoken before. I’ll ask this question again, and I’m happy to have the two professors answer as well. Is the Office of the Gene Technology Regulator actually going to perform any genotoxicity studies on the vaccine, given that no genotoxicity studies were done before the vaccine was rolled out?
Dr Bhula : Thank you for your question. Genotoxicity studies in terms of the impact of the vaccine would be part of the data package that’s submitted to the TGA. That’s not information that we require, because the OGTR does not look at patient safety as part of its remit under the Gene Technology Act. That’s a TGA question.
Senator RENNICK: Okay, then I’ll ask the professors. There was no genotoxicity study done for the rollout of the vaccine. The vaccine has been rolled out now for up to 18 or 20 months. Has any genotoxicity study been performed on the vaccine given that there are a number of modifications to the spike protein that weren’t in the initial virus?
Prof. Murphy : I’ll just see if Ms Duffy from the TGA is online, and whether TGA officials can provide any information about that. They are obviously across all of the material that’s submitted as part of the vaccine evaluation.
Ms Duffy : I’m sorry, I don’t have that information, but I’m happy to take it on notice and bring it back on Thursday if that suits you.
Senator RENNICK: That’s fine. Initially, when you looked at the assessment it said there were no genotoxicity studies done at all, or carcinogenic or longevity studies. I’m just curious if you’ve done any since?
Ms Duffy : We’ll go back and be able to provide that information on Thursday.
Senator RENNICK: I have a question for the Department of Health as a whole. Why did you, given that this was new technology, allow this vaccine to be rolled out without getting genotoxicity studies done, given that the actual vaccine virus contains methylpseudouridine that replaced uridine, you had three stop codons not one, you had a proline insertion at 986 and 987 and you added 70 adenine nucleotides to the poly(A) tail, which was going to increase its life span? Surely, all of those things—with a normal vaccine you attenuate the vaccine, you don’t put a superman cape on it and strengthen it by increasing its longevity.
Prof. Murphy : We have great confidence in our regulatory system, in our TGA, in our advisory committee on vaccines. The portfolio of information that they reviewed from the vaccine sponsors were sufficient to convince them that these vaccines were safe to roll out. The department, the delegate—who’s my delegate, in a sense. I have great confidence in the competence and training of those people advised by the various experts that they have. Their view was that there was an accumulation of data submitted before the vaccines were provisionally approved, and now we have multiple billions of doses administered without any evidence of the sorts of things that I think you are suggesting might be possible. We were very confident—
Senator RENNICK: I’m not suggesting anything. I’m happy to suggest that there have been almost 140,000 reported adverse events at a rate—I accept there are 20 million people who got the vaccine but that is at a rate of more than all reported injuries from vaccines since 1971 put together. We’ve all had multiple vaccine shots over the years. So to say that there’s no evidence, I completely dispute that. Plus, as for having confidence, we’ve had over 10 million cases of COVID in the first nine months since the borders were open in late December.
You yourself, Professor Kelly, said there was evidence of stopping the transmission. I’ve got the report here from the FDA that said Pfizer said there was no evidence of ever stopping transmission. They never tested for it. That came out in the European parliament three weeks ago. So I don’t see how you can say you’ve got confidence. You got it wrong on transmission, which is an easy benchmark to measure this stuff by.
Prof. Murphy : I don’t think we did get it wrong on transmission. I accept that evidence that Pfizer gave. But the clinical epidemiology—and Professor Kelly can attest to this—is before omicron there was clear evidence that vaccination was impacting on transmission. In fact, the vaccination was what controlled the delta wave in New South Wales. We absolutely accept that with omicron the vaccines are not as effective in controlling transmission, but all of the evidence we have suggests that they are highly effective in preventing severe disease and saving lives. So we might have had millions of cases but we would have had a very large number of deaths if we hadn’t had a highly vaccinated population.
Senator RENNI CK: It’s funny you say that, because I’ve got the six-month data here, from the New England journal, from the Pfizer trial. It shows that adverse events from the vaccine group were much, much higher than the placebo group. So, yet again, you say you’ve got evidence, and I’ve been tracking the New South Wales health data again, and there’s no evidence there. People who’ve had multiple boosters are the ones going to hospitals.
Senator Gallagher: I don’t think that’s true.
Prof. Murphy : That’s not true.
Senator RENNICK: No, it’s there. You can go and look at the New South Wales health data, if you like.
Prof. Kelly : It’s not true; you’re cherry-picking various bits of data there to discredit—
Senator RENNICK: That’s all I’ve got to work with, the New South Wales health data, because the other state departments don’t release anything.
Prof. Kelly : I dispute that that is the way—certainly how you are interpreting that data is not how I would interpret it, with my expert eye.
Senator RENNICK: I don’t have those particular New South Wales health numbers in front of me, but vaccinated 1, 2, 3, 4 groups all have higher numbers of hospital transmission and ICU admission.
Prof. Kelly : We know, absolutely, without hesitation, that, with fully vaccinated people, just two doses is enough to give at least a 30-times less chance of being hospitalised—in Australia; that’s Australian data.
Senator RENNICK: Based on what, because the non-clinical report said—
Senator Gallagher: Based on vaccination data.
Prof. Kelly : Based on the truth and facts.
Senator RENNICK: Be more specific than that. Actually quote the data source, please.
Prof. Kelly : That’s the data source from the national data that we have, in the Commonwealth, which is provided to us by the states and territories.
Senator RENNICK: Can you provide that to me? I haven’t seen the state data outside New South Wales.
Prof. Kelly : I’m very happy to provide that to you on notice.
Senator RENNICK: Okay. You accept you got it wrong with transmission, because you told my colleague last time—
Senator Gallagher: No.
Prof. Kelly : No, I do not accept that I got it wrong on transmission. The original papers, which I have read in full—not in extract as you seem to have done—demonstrate very clearly that there is an effect on infection, from the original trials of Pfizer and AstraZeneca and Moderna, and the others. Professor Murphy has said that the change to the virus and the higher transmissibility issues that we’ve dealt with for omicron over the last year have changed the ballpark significantly.
Senator RENNICK: So you’ve got studies that show—
Prof. Kelly : The original Pfizer studies—
Senator RENNICK: that you’ve got an immunoglobulin A response in the mucosal system? That’s not in the non-clinical report. It shows an immunoglobulin G response in the blood, not in the mucosal system.
Prof. Kelly : I’m talking about the clinical outcomes and the epidemiological outcomes of the phase 3 trials from the companies themselves.
Senator RENNICK: The phase 3 trials that I’ve got from the six-month data show adverse events are higher.
Prof. Kelly : I’m not talking about at six months. At six months, what we have found is that that particular immunity has waned, probably for the reasons—
Senator RENNICK: The non-clinical report shows that it wanes at up to 35 days.
Prof. Kelly : But that’s probably for the reasons that you’ve mentioned: they’re not very strong on mucosal immunity. So that is correct.
Senator RENNICK: No, that was immunoglobulin G. There have been no studies on the immunoglobulin A response in the mucosal system. The reason for that is that you’re not going to get an immunoglobulin A response in the mucosal system if you do an interim—
Senator Gallagher: This isn’t a lecture by Dr Rennick.
CHAIR: Could you phrase it is a question, Senator Rennick.
Senator RENNICK: Okay. Professor Kelly, have you got any studies that show an immunoglobulin A response in the mucosal system from the vaccine?
Prof. Kelly : The current vaccines that are on the market are not designed to deal with that system. They are dealing with other parts of immunity, and they do that very successfully in terms of protection against severe infection and death, as Professor Murphy has said. They are absolutely—
Senator RENNICK: I’m talking about transmission now. The question originally was with regard to what you said previously.
Senator Gallagher: We’re jumping around a fair bit.
Senator RENNICK: I’m asking: do you have any studies to back up your prior claims, and ATAGI’s prior claims, that it would reduce transmission? To do that, you’ve got to show an immunoglobulin A response in the mucosal system. Have you got any studies?
Senator Gallagher: No. Why would you?
Prof. Kelly : With respect, what you need to show is that there is no transmission or there is an influence on transmission. The actual mechanism for that is a completely different laboratory based study protocol.
Senator RENNICK: Are any of those studies done on immunoglobulin A and the mucosal system?
Prof. Kelly : Not that I’m aware of, but—
Senator RENNICK: Thank you. That’s all I need to know—not that you’re aware of.
