With each new day we find more evidence of conflicts of interest, lies from the supposed “experts” and none of these bureaucrats want to acknowledge it. We need a Royal Commission to bring their lies out into the daylight.
Senator ROBERTS: Can you tell me how many medicines were approved under the provisional approval pathway during the COVID period 1 July 2020 to date? My numbers are 13 vaccines and six drugs; is that correct?
Dr Skerritt: Are you talking specifically about COVID treatments and COVID vaccines?
Senator ROBERTS: No, any vaccines or drugs that have been approved using the provisional pathway.
Dr Skerritt: I will start with COVID vaccine treatments. There have been seven COVID vaccines and eight COVID treatments. I’ll just check whether I’ve got the numbers for other medicines during that period. You’re talking about the provisional approval pathway?
Senator ROBERTS: Yes.
Dr Skerritt: From 1 July this year there have been five provisional approvals. From the period 1 July 2021 to 30 June 2022 there have been 23. That would include those COVID treatments. What it does show is a lot of other medicines, such as cancer medicines, such as medicines for rare conditions, have also been approved. In the financial year 2021, from 1 July 2021 to 30 June 2022, there were five. Over the period you’re talking about, that would add up to 33.
Senator ROBERTS: How many drugs have been approved under the normal process during that same period?
Dr Skerritt: During the same period? I will add the three financial years and I’ll check my mental arithmetic. So 36 this current financial year, and 117. These are either new approvals or new indications approved. And 95 the year before. So, it is a significant percentage, but not most of them.
Senator ROBERTS: Is the maximum provisional approval period six years because it can take that long to get drugs approved under the old approval system?
Dr Skerritt: A provisional approval is only valid for two years and then the company either has to come back and show why they cannot obtain all the data within the period and apply for an extension.
Senator ROBERTS: No, the maximum provisional approval?
Dr Skerritt: They can apply for further lots of two years.
Senator ROBERTS: Is the maximum provisional approval—
Dr Skerritt: Overall the maximum period is six years, but it’s not six years off the bat.
Senator ROBERTS: It’s two years with extensions.
Dr Skerritt: They are possible extensions; they’re not guaranteed.
Senator ROBERTS: How much money do you save pharmaceutical companies by switching from full approval to express approval? I understand it’s hundreds of millions per approval?
Dr Skerritt: It actually costs the pharmaceutical companies more in regulatory fees for provisional approval.
Senator ROBERTS: No, I didn’t say regulatory fees. How much are you saving the pharmaceutical companies by giving them express or provisional approval rather than going through the six-year period for getting proper approval?
Dr Skerritt: No, you’ve misinterpreted the system. It’s not a six-year period to get full regulatory approval.
Senator ROBERTS: It varies. I accept that.
Dr Skerritt: Most of our approvals are submitted as a standard approval, especially, for example, if it wasn’t a public health emergency or it’s a drug that already has others in the same category. They’re submitted as a standard approval.
Senator ROBERTS: Dedicated trials for their drugs, I understand, can be hundreds of millions of dollars. How much time and money would they save by going express?
Dr Skerritt: We would not give a provisional approval to a medicine unless there were clinical trials.
Senator ROBERTS: How much money does it save if they do a provisional without doing a formal or normal approval process? How much money does it save the drug company?
Dr Skerritt: I don’t believe there are necessarily savings. The situation would be different for every drug. It’s really important to emphasise there were very extensive clinical trials for the vaccines and treatments that have been through provisional approval.
Senator ROBERTS: My understanding is that it can cost hundreds of millions of dollars to get the full approval process. Without the dedicated trial, they could save hundreds of millions of dollars per drug?
Dr Skerritt: I don’t necessarily agree with you.
Senator ROBERTS: When does the provisional approval for Pfizer expire?
Dr Skerritt: The two-year period will be two years from the anniversary of the first approval. I would emphasise that in certain countries—
Senator ROBERTS: What is that date?
Dr Skerritt: The products are now fully approved.
Senator ROBERTS: What is the date of provisional approval expiry?
Dr Skerritt: For the very first approval, for 16 years and over, the two-year period finishes on 25 January 2023.
Senator ROBERTS: I have in front of me a document called the Australian Public Assessment Report for Tozinameran, from Comirnaty (Pfizer), dated December 2021. Is this the approval application for the paediatric version of the Pfizer vaccine?
Dr Skerritt: No, it is not. An Australian Public Assessment Report is a summary of the assessment that we did of the application. You mentioned Pfizer. The actual application is over 220,000 thousand pages of paper from Pfizer for that particular group of vaccines.
Senator ROBERTS: I reference page 61, which states:
Limitations of the current application data. Safety follow-up is currently limited to median 2.4 months post dose 2 in cohort 1, and 2.4 weeks for the safety expansion cohort.
What is the safety expansion cohort?
Dr Skerritt: Remember, also, this was going back to the time of approval. We now have hundreds of millions, actually more than a billion, people who have been vaccinated with that vaccine and experience going on since December 2020, when the first vaccination was done. The safety expansion cohort is in a clinical trial where individuals are monitored closely and the data reported back to regulators for periods of months, leading to years, after their vaccination.
Senator ROBERTS: Did you recommend this substance based on 2.4 weeks of safety testing or did you get more in? If so, over what period? How many months?
Dr Skerritt: Remember the initial approval from TGA was based on that two months of follow-up, but we also had the experience of other countries that had more than a month before starting mass vaccination campaigns. When we approved Pfizer on 25 January2021, we were in almost daily contact with the British, who by that stage had vaccinated millions of British people by 25 January 2021. Real-world evidence played a very important role in both the approvals and in the ongoing safety monitoring of these vaccines.
Senator ROBERTS: So you relied on data from other countries and you relied for periods of months, merely months. It can’t be more than six months, because there’s a gap between application and approval and to give time for collection of data and analysis. There should be years of data before we start putting this stuff into our children, yet it’s months.
Dr Skerritt: I disagree in the context of a pandemic and a public health crisis. Regulators globally felt that it was appropriate to do initial approvals—
Senator ROBERTS: You’re the Australian regulator.
Dr Skerritt: As the head of the Australian regulator, I would do precisely the same if I had my time again. The alternative would have been to leave Australians unvaccinated through the course of 2020, 2021 and 2022, and there would have been tens of thousands more Australian deaths.
Senator ROBERTS: Can I reference a letter from the Commonwealth Department of Health and Aged Care, signed by Radha Khiani, Director, Governance and Coordination section, in which the department makes this claim. The letter from 4 November 2022, just last week, states:
A large team of technical and clinical experts at the TGA carefully evaluated the data submitted by the sponsor. A treatment or vaccine is only provisionally approved if this rigorous process is completed.
This document concerned the use of Pfizer stages 2 to 3 cynical trial data in support of their application for provisional approval. Did the TGA check the stage 2 and stage 3 clinical trial data from Pfizer? Did you check it?
Dr Skerritt: We did check the phase 2 and phase 3 clinical trial data from Pfizer and we also took it to independent external medical experts as well as consumer representatives.
Senator ROBERTS: Referencing Freedom of Information No. 2289, in which the applicant requested a copy of the stage 2 and stage 3 clinical trial data, the TGA responded that the ‘TGA does not hold any relevant documents relating to the request’. That was a request for stages 2 to 3 clinical trial data.
Dr Skerritt: Without seeing what’s in your hand, I believe that you asked for individual patient data rather than the phase 2 and phase 3 clinical trial data. I can give you my word that we assessed the phase 2 and phase 3 clinical trial data; otherwise, what else did we do? Look at the colour of the label on the bottle? That is the main thing our team of several thousand clinicians look at in reviewing a new vaccine, the phase 2 and phase 3 clinical trial data. It is the centrepiece.
Senator ROBERTS: The freedom-of-information request then asked for ‘any documents confirming the process of analysing this data to a decision, including meetings, notes, dates and times’. Again the TGA replied, ‘We have no relevant documents.’ Did you review the stage 2 and stage 3 data or not, and, if you did, why did you tell this freedom-of-information applicant you did not have these documents? Which document is the lie? One of them is.
Dr Skerritt: I don’t have that document in front of me. We can review it on notice. But we reviewed the phase 2 and phase 3 clinical trial data at length.
CHAIR: This really needs to be the last one so I can share the call.
Senator ROBERTS: I just want you to think about this and confirm it or otherwise: and ‘the trail data contained sufficient proof the vaccines were safe and effective, sufficient to meet the criteria for provisional approval’; is that correct?
Dr Skerritt: Correct. Yes.
Senator ROBERTS: I asked a question earlier, Professor Skerritt, about the number of drugs approved under the full approval process, the normal process. If you exclude the number of drugs that you said were new uses for existing drugs and medical devices, what is the figure for new drugs approved under the full approval process in the last three years?
Dr Skerritt : It will be about 90, but I’ll give you the exact answer on notice. We approve between 30 and 40 new drugs a year.
Senator ROBERTS: You also confirmed your view that ‘the trial data contained sufficient proof that the vaccines were safe and effective, sufficient to meet the criteria for provisional approval’. Yet after 18 months and analysing the data, some of the world’s leading virologists and pharmacologists from UCLA, Stamford and here in Australia found that the ‘Stage 2 and Stage 3 trial data showed the vaccine was associated with a 36 per cent increase in serious adverse events’ and ‘out of every 10,000 people injected, 18 will experience a life-threatening or altering complication, and the vaccine should not have been approved, as it caused more harm than it prevented’. That’s what they said. One of the papers—there are several papers—is titled ‘Serious adverse events of special interest following mRNA COVID-19 vaccination in randomised trials in adults’. How could ATAGI review the data and conclude that everything was fine, with the world’s leading experts on the subject, in a peer reviewed and published paper, then finding the exact opposite? Did you approve the vaccine in a deal with colleagues in the pharmaceutical industry?
Dr Skerritt : I think that’s an offensive allegation, and we certainly did not.
Senator ROBERTS: You had colleagues in the pharmaceutical industry.
Dr Skerritt : We did not approve the vaccine in a deal with colleagues in the pharmaceutical industry.
Senator ROBERTS: You had colleagues in the pharmaceutical industry.
Dr Skerritt : I wouldn’t say that they were colleagues; we work with people. We also work with—
Senator ROBERTS: That’s what I mean: you worked with them.
Dr Skerritt : people in terms of the courts, including the criminal court. So, we work with people in the pharmaceutical industry and we work with other government people, but they’re not colleagues in the sense of working for the same organisation.
Senator ROBERTS: Did you do a deal or come to an arrangement with the—
Dr Skerritt : No.
Senator ROBERTS: It could have been just provisional approval to get it through. Did you do that with the pharmaceutical industry?
Dr Skerritt : No. No, that’s an offensive and unfounded allegation, and I’d like you to withdraw it.
Senator ROBERTS: There are thousands of people who are dead, and we’ll get on to that in the next session.
Dr Skerritt : I disagree with you. There are 14 deaths associated with vaccines in Australia, all—
Senator ROBERTS: We’ll get on to that in the next Senate estimates.
Dr Skerritt : I look forward to it.
Senator ROBERTS: Yes, so do I.