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Arrogant TGA head Dr John Skerritt ducks for cover as Roberts accuses him of vaccine impropriety
Federal Police should be investigating Professor John Skerrit’s onshore and offshore bank accounts. Former PM Scott Morrison accrued $52 Million while PM. How much has Bro John salted away? (https://cairnsnews.org/2022/02/23/scott-morrison-under-the-microscope/)
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.
Covid Medical Network letter is indictment of medical authorities
Letter to the Editor
Dear Australian Community
In the midst of your grief and sorrow and utter exhaustion from the devastating effects of the unnatural catastrophic weather events we have just been subjected to, we ask that you pause for 15 minutes to read and digest this message and linked letter and take action.
This letter exposes the COVID-19 and “vaccine” mandate Fraud and serves as an indictment of Australia’s purported health leaders, those men and women who were and are meant to guide all Australians in living the healthiest life possible … a mission they have failed to perform for over two years now.
It is a stunning document we ardently request you share everywhere, so our Australian Community can learn and confirm the facts many have come to know or suspect, while gaining strength in the knowledge that hundreds of Australia’s leading doctors, scientists, and academics have also had enough and are fed-up!
North Coast NSW, Australia, barrister Julian Gillespie is a co-author and signatory to this 52-page Letter, with hundreds of pages of supporting evidence, in collaboration with the Australian Covid Medical Network.
Here is the letter:
https://www.covidmedicalnetwork.com/open-letters/open-letter-to-atagi.aspx
It comes from the combined effort of Australia’s leading clinical doctors, scientists,
research academics, health care professionals, overseas specialists, and lawyers working together over many months.
The material presented has been ‘fact checked’ by the vigorous peer-review process to present the Truth.
This Letter has also been received by every Federal, State, and Territory MP and Senator, in order to inform them of a variety of scientific Truths being flagrantly ignored by both these health ‘leaders’, and the Ministers responsible for overseeing their conduct.
We urge you to please take a small amount of time out of your demanding day to call and email your Federal and State/Territory representatives and get them to ask the same Questions, and Demand the same Answers you will see in the Letter.
Armed now with the facts, the history, and the evidence of a litany of wilful instances of malfeasance, it is now time for the wider Community to say ‘enough is enough’ and call an end to all “vaccine” mandates and false COVID narratives.
We need our doctors, nurses, teachers, lawyers, transport industry, farmers, military, police, religious leaders, government employees, corporations, business people, ordinary workers, and everyday community members – vaxxed and unvaxxed – to stand together and demand an end to all COVID “vaccine” mandates, ban any further rollout of this experimental gene-based treatment, and demand a full and transparent public enquiry.
Australia’s future is in our own hands. What you and I do right now, today, will determine what kind of world we end up living in, and the world our children and grandchildren inherit.
They are trying to divide and conquer us, and silence all opposition. Already, planned protests in all capital cities are being impacted as millions of people struggle with the utter devastation caused by these incredibly harmful and destructive weather events being rolled out across the East Coast of Australia.
Please understand the gravity of the situation we are currently facing and take action NOW. Thank you and may the Divine Creator’s Light and Love be with us all at this dark and challenging time for humanity.
Once again, here is the link to the Letter together with supporting Annexures:
https://www.covidmedicalnetwork.com/open-letters/open-letter-to-atagi.aspx
from Diane Drayton Buckland
Queensland
Therapeutic Goods Authority, AHPRA answerable only to WHO
by Alison Ryan
Are these Government bureaucracies contemptuous of investigation and accountability because they are WHO affiliated?
ATAGI members include Director of the National Centre for Immunisation Research and Surveillance, itself a member of the WHO-led project Vaccine Safety Net (VSN).
https://en.wikipedia.org/wiki/Australian_Technical_Advisory_Group_on_Immunisation
https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/vaccine-safety-net/vsn-members/national-centre-for-immunisation-research-and-surveillance-of-vaccine-preventable-diseases
TGA is a WHO Collaborating Centre for Drug Quality Assurance
https://apps.who.int/whocc/List.aspx?K5BSqfJdqi0s4VqVDkw8cA==
and AHPRA (Ahpra) is a designated World Health Organization (WHO) Collaborating Centre for Health Workforce Regulation.
https://www.ahpra.gov.au/about-ahpra/our-engagement-activities/who-collaboration.aspx
Read on from Senator Malcolm Roberts, Queensland
“The Therapeutic Goods Administration (“TGA“) and their buddies, the Australian Technical Advisory Group on Immunisation (“ATAGI“) and the unaccountable Australian Health Practitioner Regulation Agency (“AHPRA“), have enabled the distortion of science in Australia that has seen COVID vaccines mandated, the minimising of vaccine reactions, banning of alternative treatments and general COVID mismanagement.
“In this final Senate Estimates session before the election is inevitably called I tried to desperately get straight answers out of Australia’s Chief Health bureaucrats about how they could do so much of this without evidence.
“Watch here as the TGA ducks and weaves in interrogation.
“Doctors and other health professionals feel great pressure to not report adverse events or sentiment which could undermine the vaccine rollout. Health Bureaucrats continue to deny such pressure exists despite official guidelines saying that Doctors could be de-registered for opposing supposed public health measures from the government. AHPRA threatens to deregister Doctors but is a private corporation with no accountability to the Senate or the Australia Public.
“The TGA has been morally deficient in their blind acceptance of overseas data provided by the pharmaceutical companies to approve COVID vaccines. Despite this, they bat away any criticism or safety concerns as simply a conspiracy theory. As I said, conspiracy theory is “used as a term to ridicule the person asking the question” and what did one of our Chief Health Officers respond to that? “It is and I’ll be using it that way”. The contempt these bureaucrats have for openness and transparency is palpable.
“AHPRA is an unaccountable private organisation that holds the threat of de-registration over the head of any Doctor who dares give advice against vaccination counter to the Government line. They must be held accountable and the primacy of the confidential doctor-patient relationship must be restored.
Copied from: http://www.malcolmrobertsqld.com.au/questioning-the-tga-at-senate-estimates
See the latest from Senator Malcolm Roberts here: http://www.malcolmrobertsqld.com.au/latest-news
Cairns News 