Australia Needs Independent Drug Scrutiny — the TGA is Compromised

In Senate Estimates, Professor Brendan Murphy, former Chief Medical Officer for the Australian Government and now Health Secretary, rejected the suggestion that the TGA ever took a position on vaccine mandates.

You can listen to him saying here that the government only supported mandates in limited circumstances earlier in the COVID injection roll-out. He says they were only needed in health, disability and aged care settings due to their high vulnerability.

National Cabinet had no strong position on community-wide mandates. Professor Murphy claims that everyone, including other departments and jurisdictions, took their own position. The TGA did not promote the COVID injections or mandates. Incredible!

The TGA authorised Moderna’s injection for young children with co-existing health conditions despite the fact the study is only being conducted in healthy children. That study is also not yet completed. ATAGI’s guidance is that the ‘vaccine’ is recommended ONLY for high-risk children with a comorbidity. Under questioning, the TGA admits it does not require patient level data and relies on a dossier from the sponsor (the pharma company). The ATAGI advice was that this shot be reserved for use in ‘at-risk’ children, i.e those with immuno-compromising pre-existing conditions.

I asked the TGA about reporting performances in the DAEN database of adverse events including fatalities. I wanted to know whether adverse event notifications were higher in those parts of the country where reporting is required compared to those without mandatory reporting. I’m advised that reporting rates are not higher in the jurisdictions where it is obligatory to report. The TGA has advised that consumer reporting of adverse events directly to the TGA increased by 28-fold in 2021 compared to 2020. Similarly, health professionals submitted nearly three times as many adverse event reports to the TGA in 2021 compared to 2020.

Strict independence of scrutiny for these products is clearly needed and is now being called for by a highly regarded epidemiologist.

Mortality figures for cancer are higher since the injections were introduced. The COVID products were not tested for carcinogenic properties simply because those responsible have taken the position that the substances involved don’t warrant such studies. The TGA did review Pfizer product on paper only for genotoxic and carcinogenic potential. In its dossier, Pfizer justified the absence of studies into cancer risk based on the exposure threshold concept. However, there is an absence of repeat dose toxicity data and the assessment of the stimulation of cytokine release.

Pfizer’s dossier, as sponsor of the product, adequately justified the authorisation of its use in Australia by the TGA, and so we joined what former Minister for Health, Greg Hunt, called the largest human trial and the largest vaccination trial that the world has ever engaged in.

Transcript

Senator ROBERTS: Let’s talk about approval of paediatric COVID vaccines. The TGA approved the Moderna COVID paediatric vaccine on 19 July last year for children aged six months to five years. According to
your website, this was based on the results of the KidCOVE clinical trial run by Moderna in the USA and Canada. The approval was for all children, but ATAGI’s guidance is that the vaccine is recommended only for high-risk kids having one of a list of serious comorbidities. Is that correct?

Dr Langham: I believe so. I would have to check the current ATAGI guidance, though. I can take that one on notice.

Senator ROBERTS: Thank you. The KidCOVE clinical trial is listed on clinicaltrials.gov as ‘a study to evaluate the effectiveness of Moderna’s vaccine in healthy children’—healthy children—’aged six months to 12
years’. On what basis did TGA authorise the use of a vaccine, tested on healthy kids, for use in Australia on high-risk kids with serious comorbidities?

Dr Langham: What we’ve learned throughout the pandemic is that the disease of COVID is most damaging to those with other comorbidities, and particularly people who have immune systems that don’t work well. Our recommendation, or the recommendation of ATAGI and the recommendation of the TGA, would have been to be able to support young children with precisely those conditions by demonstrating that the virus was safe and efficacious in a healthy population.

Senator ROBERTS: The study was to evaluate effectiveness of Moderna’s vaccine in healthy children, yet you’ve approved it for children with comorbidities—no basis.

Dr Langham: Again, it is the sort of thing that can be extrapolated. It was very important to be able to provide a protective therapy for young Australians who were at risk of serious illness from COVID-19.

Senator ROBERTS: You just extended the study into a completely different field without testing?

Prof. Murphy: You can’t do the clinical trials—those trials have to be done in healthy children. You wouldn’t be able to do that first in-population trial in people with severe underlying diseases. You’d have to get healthy volunteers. The ATAGI advice considers all of the other risks of COVID as well. The safety can be shown in healthy people but the ATAGI advice is relevant to the risk of severe COVID. There’s no disconnect there.

Senator ROBERTS: Your approval was in July 2021. That clinical trial finishes in November 2023, so it is not even finished yet. The TGA must have worked from interim documents. Did the TGA evaluate the patient-level data, or did you just take Moderna’s word for it, like you took Pfizer’s word for it?

Mr Henderson: The Moderna vaccine was approved through the provisional pathway, which is a wellestablished pathway. It was an established pathway before the pandemic. That allows for approval based on
interim clinical data, and data will be supplied on a rolling basis over a period of time.

Senator ROBERTS: Did you evaluate the patient-level data before you approved it?

Mr Henderson: We have answered questions in relation to patient-level data. At the TGA, we do not require patient-level data. We do require clinical data that is sufficient evidence from the sponsor of the vaccines.

Senator ROBERTS: So you relied on sponsors of the vaccines?

Mr Henderson: We relied on the dossier provided by the sponsor, with clinical data provided.

Senator ROBERTS: Would this be misfeasance on the part of the TGA?

Mr Henderson: Sorry, Senator, I’m not sure—

Senator ROBERTS: Let’s move on. Quality of reports in the DAEN: the DAEN reports can come from medical practitioners and also the general public. How many of the reports of deaths from COVID vaccines
recorded by DAEN came from members of the public and how many from medical practitioners?

Mr Henderson: I don’t have those exact numbers with me. I will take it on notice.

Senator ROBERTS: Why is the first question you ask, when a person makes a report: ‘Are you a medical practitioner or a member of the public?’

Mr Henderson: It is to allow us to have as rich a dataset as we can.

Senator ROBERTS: Why is the first question that one?

Ms Duffy: It allows the triaging of the subsequent questions as you go through the form.

Senator ROBERTS: Checking these reports—my staff have checked the reports—suggests there is a waiting room at the DAEN database holding reports that have been made but not yet checked and registered, which seems logical. How many reports of COVID vaccine harm are waiting to be checked? How many of those are reports of death or serious injury?

Mr Henderson: Again, I don’t have those numbers with me. I will take that on notice.

Senator ROBERTS: Thank you. Were more reports to DAEN made by states with mandatory adverse vaccine effect notifications—which I think is New South Wales, Queensland and Western Australia, which is
only 62 per cent—as against states without mandatory reporting of vaccine harm?

Mr Henderson: Senator, could you repeat the question?

Senator ROBERTS: Was there a higher proportion of reports of adverse events from states with mandatory adverse vaccine effect reporting notifications?

Mr Henderson: I would have to take that detailed question on notice.

Senator ROBERTS: There is now a call for a vaccine safety office from an epidemiologist. He is pretty highly regarded, from my understanding. He is calling for independence in the scrutiny. When we have a
provisionally approved medication, surely, it’s even more important to have a very strict reporting of adverse events?

Mr Henderson: We have a very comprehensive and rigorous safety monitoring system at the TGA. We use a number of mechanisms to look for safety signals, as well as talking to our international regulator colleagues and sharing information in relation to safety issues with the vaccines.

Senator ROBERTS: Have you done any testing on what percentage of doctors and the public are reporting adverse events?

Mr Henderson: No, we haven’t done that study. I will take that on notice.

Senator ROBERTS: Let’s go to carcinogenicity of the vaccine. The European Medicines Agency, EMA, had a 140-page assessment report for the Pfizer vaccine. On page 55, it says: No genotoxicity nor carcinogenicity studies have been provided. It then says: The components of the vaccine are lipids, an mRNA, which are not expected to have genotoxic potential. The carcinogenicity part of that statement was skated straight over. I want to ask you about that. Did you receive any genotoxicity or carcinogenicity studies in support of the Pfizer application?

Mr Henderson: I do not believe that we did, Senator.

Senator ROBERTS: The words ‘carcinogenicity’ and ‘cancer’ do not appear in your 42-page assessment report. Did you review the Pfizer product from the perspective of cancer?

Mr Henderson: I believe there was no need for that. I will take it on notice.

Senator ROBERTS: According to the data from the Australian Bureau of Statistics, in their latest release of the provisional mortality statistics, we know that it under-represent deaths—this was from the head of the ABS the other night—by 15 per cent because it does not include autopsy reported deaths, only doctor reported. The figures for provisional mortality from cancer were as follows: based on average for January-February over the last four years, 3,637; January- February cancer deaths in 2023, 3,803—plus 15 per cent; and for 2021 it was 3,816. Both years are above trend. It should be remembered that trend includes autopsy deaths and the provisional mortality figures do not. Yet the provisional mortality figures for cancer are above the past figures. The problem is worse than these figures suggest. Let’s review: we have injections that were approved without carcinogenicity testing. We now have a spike in cancer. Can you please show me where you have investigated this spike and ruled out it being from the COVID injections? Have you even considered that?

Prof. Murphy: There is no evidence that increase in cancer risk is vaccine-associated. As Professor Langham said, there have been many billions of doses of these vaccines administered. If there was a significant association with cancer, I think the international data would have shown it. There is no evidence that there is an association.

Senator ROBERTS: The reference to lipid nanoparticles in earlier conversations around COVID vaccines suggested that the nanoparticles stayed near the injection site, then passed out of the body. Am I remembering that correctly?

Dr Langham: Senator, that’s correct. We’ve dealt with this on a number of occasions, in answer to other questions on notice as well.

Senator ROBERTS: Documents released in the Pfizer-gate court-ordered document dump showed that Pfizer knew at the time of seeking approval for their product that the lipid nanoparticles not only collected at the
injection site but significant concentrations were also recorded in the adrenal glands. A table in the Pfizer test data showed they accumulated in the ovaries, the liver, the kidneys, the brain and the adrenal glands; they go all over the body. Did you know at the time of the Pfizer application that lipid nanoparticles collected across the body?

Dr Langham: Senator Roberts, what you are describing is a particular aspect of the pre-clinical studies by which an element of the lipid nanoparticles was labelled with a fluorescent label. What is seen in those studies is the fluorescent label and not necessarily the lipid nanoparticles.

Senator ROBERTS: Is it still your position that this build-up does not have an adverse health effect?

Dr Langham: Correct.

Senator ROBERTS: Why did former minister Greg Hunt say, ‘The world is engaged in the largest clinical vaccination trial’? Why did he say that as health minister?

Dr Langham: I can’t speak for Minister Hunt’s comment; I am sorry.

Senator ROBERTS: We have dealt with other agencies and employers who relied on you, as the TGA. They cite your advice as the basis of their policies and decisions: CASA, the Civil Aviation Safety Authority, Fair
Work Commission, Fair Work Ombudsman, Department of Employment and Workplace Relations, judiciary, the Department of Home Affairs, the Department of Agriculture, Fisheries and Forestry, the NSW Council for Civil Liberties, state and federal health ministers, the chief medical officer and the chief health officer all drove vaccine mandates. The national cabinet cited you guys. Millions of people have been gutted, based on these horrendous facts and injuries, all pointing their finger at you. Do the members of the board of the TGA understand the concept of misfeasance in public office?

Prof. Murphy: There is no board of the TGA. The TGA is part of the department of health.

Senator ROBERTS: Do the heads of the TGA understand the concept of misfeasance?

Prof. Murphy: We very much understand the concept of misfeasance, and we totally reject any suggestion that has taken place. I should point out that the TGA has never taken a position on vaccine mandates. The TGA’s remit is to assess the safety and efficacy.

Senator ROBERTS: Do you support them or not?

Prof. Murphy: The Commonwealth department has supported them in limited circumstances, particularly early on, when transmission reduction was much more beneficial. We certainly supported them for aged-care
workers and disability workers. The Commonwealth department has not taken a strong position on community-wide mandates. Some of the state and territory governments have taken a much stronger position.

Senator ROBERTS: Who from your senior leadership advised former Prime Minister Scott Morrison to buy the injections, at billions of dollars, to then give them to the states, to indemnify the states, to also then provide the health monitoring data so that vaccine mandates could be introduced? The state premiers then said that they mandated vaccines on the basis of the national cabinet, which the Chief Medical Officer is associated with. Then we saw the former Prime Minister mandate vaccines in Defence, the Australian Electoral Commission and aged care. Then the former Prime Minister said repeatedly, daily, for two weeks, ‘We have no vaccine mandates in this country.’ It was a blatant lie. Did you do anything to stop him lying?

Prof. Murphy: I can’t comment on what the former Prime Minister said. I know he supported vaccine mandates in aged care and disability. That was very much a national cabinet position because of the high
vulnerability of the residents and workforce in those settings. I don’t believe national cabinet took a community-wide mandate approach. Various agencies—state, territory, Commonwealth and private sector agencies—made their own decisions about that. I don’t think it is fair to say that the TGA has been promoting vaccine mandates. It’s not their remit and they have never done it.

Senator ROBERTS: Did you do anything to stop it?

CHAIR: Thank you, Professor Murphy. Senator Roberts, I do need to share the call. Are you able to place the remainder of your questions on notice at this point?

Senator ROBERTS: Yes.