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.
Transcript (click)
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.
Transcript (click)
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.
Hello Sir
Not only narrative is falling apart , Commonwealth Bank of Australia , has brochures out , tell citizens to stop , financial abuse , the only financial abuse is being caused by the institutions , by rising interest rates , nine times in two month , they are causing , all the abuse that happens in homes and sending good families bankrupt , just to send money to Ukraine , a war nobody wants , by the reports that I hear , there’s corruption and money laundering .
How about using that money to help all its Australian citizens .
Yes stop the abuse , absolutely
Perhaps Senator Roberts should ask Skerritt who the major financiers are to the TGA.
That would be interesting
Big Pharma are, which makes it a conflict of interest.
Amazing. Good work Senator, for flustering him.
It’s all based on overseas nothing on Australia, this being s the plan for our country. The UN, Bill Gates and the Dictating Klaus Schwab’s and co are make by billions of dollars, the banks stakeholders and shareholders involved own the drug companies, like everything else in this world. Gold and Precious metals Gold hidden underground in volts, the fraudulent activity going on laundering money that’s the gold and precious metals is being used for. Printing money is the evils of there corruption throughout the world. In Australia, looking around Queensland Australia, every entrance to towns and cities has red painted at speed signs, signs that can be dismantled and used for blockades. This means shows the Digital ID on Vaccine’s to be mandatory mandated in our country, noone can run or hide from the policing of the New World Order presents itself. Shedding has been proven around the world, people who are not Vaccinated are getting Vaccinations through the shedding if mRNA and oxides causing all sorts of issues in women as well as, nowhere to Run and hide from these Poisoning untested human trials Vaccine’s. The Bill Gates and Fauci’s science murdering people every day but that’s hard ok to do so. People in the public forum go to Gail for murder, but not the drug companies or the likes of Bill Gates and the Dictating Klaus Schwab’s with World Politicians in so called Governments involved, they are murderers and getting away with it.
Well done Senator! Keep up the good work. It must be so frustrating to keep presenting and asking for clear answers and evidence, yet they keep spewing back their unbelievable lies and cover up.
Keep up the pressure on these inept bureaucrats. Thank you Senator Roberts
The narrative is falling apart thanks to amazing people like Senator Malcolm Roberts. There is no longer anywhere for them to hide. Maintain The Great Resist.
Mandates are NOT legal. If you are pressured to be excluded from a venue if you are not vaxxed, take their info and send it to the human rights commission, they will take it from there. The more that do this the better. What happens in the USA will eventually happen here, it stands to reason as Australia is becoming more and more Americanised. Example “two times” what the hell happened to the word “Twice”?
Do the research, there are things out there to combat shedding. I am taking them and for almost 3 years I have walked among the walking dead and have had no symptoms and no other effects. Read well what you can use, some will annihilate the graphene oxide, others will only control it. Same with the Spike Protein. ALWAYS USE a product that will take it away altogether, don’t be satisfied with a bandaid treatment.
A side effect of this vaxx is odema – I have seen our son who was the spitting image of his father, go into an overbloated human. I have no way of changing his mind about the vaxx, so I know in 5 years from now, we will lose him to this poison and also with our other 3 children. Sad when kids die before parents.
Royal Commission might be a problem.
With only a hand full of true, honest people within our federal government and the court system also failing, how can we find someone be it a man or a woman that has not sold their sole to the so called delete of this world ????????????
Despite the woke main stream media continuing with the bought and paid for assertions of the safety of these mRNA technojabs, increasingly people are investigating these suspicious claims and the supportive data behind them, such that we are rapidly losing confidence in our healthcare regulatory authorities.
Gday Malcolm, brilliant work. That guy is a lying scumbag. The TGA approved the mRNA “vaccines” declaring them safe but had no data to prove it. They claim they reviewed reports from other countries and other monitoring data. What data did they review and what conclusions were reached and why? Their own website shows vaccine injuries far in excess of the threat. Also https://www1.health.gov.au/internet/main/publishing.nsf/Content/C50CAE02452A48A7CA2587320081F7BF/$File/covid_19_australia_epidemiology_report_67_reporting_period_ending_23_october_2022.pdf This report shows No comorbidities 618 but how many were injured or killed by the vaccines who had zero comorbidities?
I could go on and on. He said Pfizer now has full approval. A royal commission is essential. How many pregnant women lost babies? What about excess mortality? It is not explained by blaming Covid deaths as you can see from the above.
I also have a Pfizer post-marketing report from April 2021 show death reports from test group.
You raelly wantg to stop the jabs… ALL JABS…. ask Government/TGA/Health Minister/ CHOs to show proof of the covid virus in the first place. There is NO PROOF that there has EVER been any virus. I know you believe there is a virus, Senator Roberts, but the doctors you are listening to are wrong. They are mistaken. Or perhaps deep in the virus delusion.
I thank you for all you are doing. Dealing with these criminals can not be easy. You are appreciated.
I admire your tenacity Malcolm and just hope common sense and researched reason overcome these bloated,ignorant and arrogant bureaucrats and supposed “medical experts”. I was appalled last week to hear that fatuous WEF adherent,Hanson Young being so dismissive and rude to your excellent and again well researched speech and yet she was not admonished by the chair.We put so much on your shoulders and I do feel that eventually we will win. However I sincerely hope you and the few other thinking and investigative senators and politicians are not damaged by the bile and unresearched nonsense being thrown at you by our weak supposed representatives. Have they forgotten they are our tax paid servants not the other way around. How come our pathetic PM has Covid yet again after being injected ? Keep strong and my sincere thanks for your efforts.
Well said, Cynthia! I totally agree with you. Full marks to Senator Roberts – keep up the good work!
Well done Senator,excellent work. There has been a lack of transparency that is desperately required by the people, as the trust in our government is at an all time low. Crimes against humanity must not be tolerated and must be exposed when found. Keep up the excellent work.
The Australian TAXPAYERS THERAPEUTIC GOODS ASSOCIATION is FUNDED by BIG PHARMA, from memory it is 98% or is it 93%, definitely in that number.
Good job Malcolm.
Another one for the trapdoor treatment.
Good job Malcolm. I wonder whether TGA independently checked on the initial BigPh published claim i.e., Relative Risk Ratio of 95% when the Absolute Risk Ratio was only 0.84%. This sleight of hand at the outset – what with wildly inaccurate / fraudulent simulations and fraudulent PCR tests set at crazy cycle thresholds (to wildly inflate case numbers) at the outset – arguably served to fuel a gross exaggeration of the state of affairs / “casedemic” – did the TGA actually check all these assertions by BigPh – or just accept them. Was the jab EUA just an “authorisation” or did the TGA decide to just “approve” it and, if so, why? Has the latest flu combo jab been tested as such and where are the trial results? I think the last version was tested on 6 mice – did they survive? If the approval / authorisation applied to the early variants of the virus, not sure how it applies now since other variants have appeared. I wonder if it will be possible to have a Royal Commission run by those who have no conflicts of interest, are not receiving any perverse incentives, are interested in truth, accountability & justice and are not operating under some nefarious external agenda..? Roll on ‘23…
Good to see this lying SOB’s true colours exposed for all to see. The crony public servant system might protect them, but they still have to show their faces in public, they may be free, but they’ll fear to venture.
Since these public servants clearly no longer serve the interests of the people, they are no longer of any useful purpose and must be sacked.
Well done Malcolm.
14 deaths!!!!!! There are none so blind than those who WILL NOT SEE.😥😥 I hope all these officials who had a hand in the pushing of these injections and mandates etc have to stand and literally face the families of those who have died, and have those injured.
Sadly nearly all of skerrits arguments have been proven to be false
This cover up and evasion must end it’s time the people pushing these things admit the truth there is now undeniable proof we have been lied to