University educated mother of three and former disability consultant, advocate and Canberran, Mrs Kara Potter, wishes that she had been aware of the details of the Pfizer COVID-19 vaccine trial, before she had her booster shot on 8 January 2022.
Speaking on behalf of COVERSE, (an organisation founded by COVID-19 vaccine injured Australians), on 13 June at Australia’s Parliament House, Mrs Potter recounts her experience of severe COVID-19 vaccine injury, for the Senate Community Affairs Committee which was established to investigate Australia’s ongoing excess death rates.
Mrs Potter described her gratitude to her GP for diagnosing her injury quickly as a vaccine injury which fit the federal compensation guidelines and believes that she is only alive today because of her.
“I received my vaccine injury from my third Pfizer shot…I started with pericarditis, but the inflammation was much further spread than just in my heart. It went through to my lungs, and further to other parts of my body, including my brain. Over a period of about 5 months, I was quite acutely unwell…spent multiple trips into hospital, with about six weeks in hospital overall trying to recover from the initial acute injury. But since then, I am now chronically ill and disabled from the vaccine. I’m no longer able to work or drive or do many things at all really. It affects my whole body. My capacity to think and speak; my ability to walk; my regulatory system is completely disorganised. It has had a major catastrophic impact on myself and my family.”
Mrs Potter has previously shared more details of her story here at a public event in Canberra last year.
Throughout the day, the committee heard from witnesses including Mrs Potter, from the following invited organisations; The Australian Bureau of Statistics (ABS), The Australian Institute of Health and Welfare (AIHW), The Australian Medical Professionals Society (AMPS), COVERSE, National Rural Health Alliance, Asthma Australia, Stroke Foundation, Heart Foundation, Black Dog Institute and the Department of Health Care and Ageing.
Whilst Bindi Kindermann of the ABS, reported that, “The ABS statistics show that COVID- 19 was the main cause of excess deaths in 2021; 2022 and up until August 2023, which is the latest data available,” another witness, Australian anaesthetist, perioperative physician and treasurer of the Australian Medical Professionals Society (AMPS), Dr Jeyanthi Kunadhasan, believes that there is a significant potential contributing factor to excess deaths beyond COVID-19 itself, which is not well understood by either the authorities, or like Mrs Potter, by the general public.
Dr Kunadhasan stated: “…in order to fully understand the issue of excess deaths…there needs to be proper scrutiny of the intervention that was implemented on more than 90% of the Australian population. The COVID-19 vaccines”.
Labor Senator Louise Pratt, was quick to clarify with Dr Kunadhasan and AMPS whether they have concerns about other vaccines, “… or just covid vaccination specifically?”
President of AMPS, and speaking on behalf of AMPS and Dr Kunadhasan, cardiologist Dr Chris Neil replied: “I also would say we are supporters of vaccination within informed consent of course, …and with risk benefit appraisal. In regard to the Covid vaccine though, we are of the opinion…that signals from Australia’s pharmacovigilance database …are very sizeable.”
What Mrs Potter wishes she had known, is what Dr Kunadhasan later reported in her testimony. That she and 3500 other international medical and other professional volunteers discovered serious anomalies in the Pfizer trial data when they analysed in 2022, 500,000 pages of Pfizer documents related to their clinical trials.
These documents were released via court order in 2022 due to a successful lawsuit by attorney Aaron Siri. The US Food and Drug Administration had otherwise asked the court to keep the documents hidden for 75 years.
Dr Kunadhasan alleged ‘significant breaches in clinical practice,’ around the approval of the Pfizer vaccine, and during her testimony, she made a startling claim.
“At no time during the trial (Pfizer COVID-19 vaccine) was the intervention lifesaving.”
A claim that was challenged by Senator Pratt: “I think there would be other doctors that would refute whether or not your assertion that the vaccinations helped save lives…, ” she said.
Dr Kunadhasan replied: “I am only speaking to the original trial data. On the original trial data, on publicly available documentation, if you line up the deaths that occurred in the trial, along the 6-month period, at no point was the intervention live saving”.
In support of this claim, Dr Kunadhasan added: “More than 50% of the Australian population took Pfizer’s mRNA vaccine. At the pivotal point of Pfizer’s vaccine approval in Dec 2020, there was a gross misrepresentation in what was presented publicly,” she said.
Dr Kunadhasan explains further during the hearing: “To understand this, the Pfizer COVID-19 vaccine was approved in the US on 10 December 2020. The data cut-off date for that was 14 November 2020. Pfizer looked at it for six days and then submitted it on 20 November. So, publicly what was disclosed was at that point in the trial there were only six deaths, four in the placebo group and two in the vaccinated group, (suggesting a benefit of vaccination). But actually… it was 11 deaths. So, now we have deaths occurring in the clinical trial that are not reported in a proper time frame. Death is a very serious adverse event. Once the clinical site has been notified of a death, they’re supposed to tell the sponsor no later than 24 hours, immediately. We have documentation for one subject, subject 11141050. This subject died on 19 October, and this death was not publicly disclosed.”
Later in the hearing, Dr Kunadhasan added that other than not disclosing this subject’s death, this subject’s autopsy result, which was available prior to December ten 2020, was not publicly disclosed.
“So, they had an autopsy report, at least on 9 December, because there’s a specific diagnosis in the patient notes, and this was not disclosed publicly.”
Dr Kunadhasan reported that she is also a co-author of the first peer reviewed journal article in the medical literature, whose authors are unaffiliated with the trial sponsor (Pfizer) and who examined the original Pfizer COVID-19 trial data.
The authors conducted a forensic analysis of the 38 subject deaths in the six-month interim report of the Pfizer/BioNTech BNT162b2 mRNA Vaccine Clinical Trial.
Dr Kunadhasan explained that of the 38 total deaths, 21 were in the vaccinated arm and 17 were in the placebo. Of the 21, 10 adults were sudden adult deaths, and of those there were only two autopsies performed: with only one result available. “That’s the sudden cardiac death. The other autopsy report was a gentleman who was found in the laundry by his mother. That result is still not available. In the first place, how do you say something can’t be due to the vaccine if the autopsy result is pending? For the other eight sudden adult deaths, there were no autopsies,” says Dr Kunadhasan.
Mrs Potter stated that had she known there was no statistical benefit to taking an injection of a novel product, which has been confirmed to have caused her severe disability, she would have thought twice about taking it.
“If government authorities had known about the extra deaths in the Pfizer trials, the product should never have been approved. If the TGA went ahead with approval, ignoring the evidence in the same way they are now, then yes, I would have felt even more concerned about taking the Pfizer shot,” said Mrs Potter.
Dr Andrew Madry, also representing AMPS as a data analyst, added that the number of adverse events including deaths following COVID-19 vaccinations, which have been reported to the TGA’s Database of Adverse Event Notifications (DAEN), account for 23% of all adverse events reported in the whole 53 year history of the DAEN. And that’s for all medicines. It also takes up 38% of all cardiac disorders in the 53-year history. There are now 1024 reported deaths.
A copy of the AMPS submission to the committee also includes data from Dr Suzanne Niblett, PHD biological science and past research academic with the School of Medicine Newcastle University, that indicates all COVID-19 vaccines combined, from their introduction in 2021 until 31 March 2023, account for 138,046 adverse event reports where the covid vaccine was the suspected medicine, compared to 71,644 adverse event reports from January 1, 1971, where non Covid vaccines were the suspected medicine. This includes 17,474 for influenza vaccines.
Australia’s Therapeutic Goods Administration (TGA), were not present at the inquiry, however a spokesperson for the TGA responded later by comment to the claims made by Kunadhasan and AMPS:
“The TGA is deeply concerned by the poor quality of analysis and dangerous conclusions represented in the material provided by Australian Medical Professionals’ Society relating to COVID-19 vaccines. These claims are not supported by any credible evidence. Vaccination played a critical role in the response to COVID-19, and vaccination remains the best protection against severe disease. The TGA comprehensively rejects any assertion that the TGA has not acted with due diligence to ensure the quality, safety and efficacy of COVID-19 vaccines authorised for use in Australia.”
Dr Kunadhasan issued a further comment in response to this: “In the interests of patient safety, as soon as a spokesperson from the TGA comes forward, I will be happy to discuss with them upon what evidence they are basing the assertion of poor-quality analysis and dangerous conclusions,” she said.
Dr Kunadhasan added that she is still waiting on a reply to two unanswered letters to the TGA on this matter.
What is excess mortality?
According to the ABS submission to the inquiry, ‘Excess mortality is the difference between the observed number of deaths in a specified time-period and the expected number of deaths in that period.’
From their most recent December 2023 report, which provides the official excess deaths data, estimates showed that excess mortality was recorded for 2021 as 1.6%, 2022 at 11.7% and 2023 at 6.1% (until the end of August), with mortality lower than expected for 2020 (-3.1%).
This means that more Australians are dying than historically usual.
The senate inquiry, a motion repeatedly put forth by United Australia Party Senator Ralph Babet and finally successful on 26 March 2024, will aim to understand what could be driving this.
Whilst the TGA emphatically disagrees with Dr Kunadhasan’s and her 3500 volunteer colleagues’ potential explanation, it appears that the US state of Kansas may not.
For on 17 June, four days after the Australian witnesses were heard, Kansas’ Attorney General, Kris W. Kobach, also filed a detailed lawsuit against Pfizer, claiming that: “Pfizer must be held accountable for falsely representing the benefits of its COVID- 19 vaccine while concealing and suppressing the truth about its vaccine’s safety risks, waning effectiveness, and inability to prevent transmission.”
And although the ABS in their submission report only sixteen deaths officially due to COVID-19 vaccines, Ms Lauren Moran of the ABS, acknowledges that vaccination status is not recorded on death certificates: “We haven’t analysed deaths by vaccination status. We don’t have that information on the death certificate.”
Additionally, whilst the ABS stated that guidance has been provided to medical practitioners on how to record COVID-19 associations on death certificates, Moran answered a committee members query: “No, we haven’t yet produced guidance for medical practitioners around how to include vaccination as a cause of death on a medical certificate.”
Louise Gates from the Australian Institute of Health and Welfare stated however that their new initiative, The Covid Register will be collating death and COVID-19 vaccination data and will include: “The number of vaccines and the date the vaccine was taken. This work will be done in conjunction with the national centre for immunisation research,” she said.
This project will attempt to examine any potential association between vaccination and increased mortality.
An initiative that perhaps echoes the advice of Emeritus Professor of Immunology, University of Queensland, Robert Tindle, who in April this year, published a paper in the Royal Australian College of General Practitioners Journal on Long Covid, in which he stated:
“Because COVID-19 vaccines were approved without long-term safety data and might cause immune dysfunction, it is perhaps premature to assume that past SARS-CoV-2 infection is the sole common factor in long COVID.”
Mr Tindle added:
“There is concern that COVID-19 vaccination per se might contribute to long COVID, giving rise to the colloquial term ‘Long Vax(x)’. The spike protein of SARS-CoV-2 exhibits pathogenic characteristics and is a possible cause of post-acute sequelae after SARS-CoV-2 infection or COVID-19 vaccination. COVID-19 vaccines utilise a modified, stabilised prefusion spike protein that might share similar toxic effects with its viral counterpart.”
In apparent congruence with this concern, during the week following the senate hearing, a paper, removed from the medical journal The Lancet whilst in pre-print last year and authored by a number of international medical professionals, has now passed peer review.
In contrast to the small number of autopsies reported in the Pfizer trial data, the authors conducted what they report as the largest autopsy series in the world, in which they analysed the autopsies of 325 people who took covid vaccines and who died suddenly in the hours to weeks after vaccination. The analysis found that about 74% of the cases of sudden death were caused or contributed to by the vaccine.
Mrs Potter reflects on her experience testifying at the senate hearing:
“It was particularly poignant for me that the time I first shared my story before a Senate Inquiry was for the hearing looking into excess deaths. As I said in my evidence, I am grateful to my GP that I am alive today. For those of us in the vaccine injured, disabled and bereaved community, we are so very aware of the gauntlet that we have run and continue to run to access timely and appropriate medical care against a backdrop of continued government failure to investigate and inform medical groups on the risks, signals and potential treatments for our conditions. Devastatingly, we know that for many this has meant their lives have been lost. As I spoke yesterday, I was not only reminded of the weight of my own experience but also of those that I was representing. I hope our voices were heard.”
The Senate Committee will prepare a report based on their findings, by 31 August.
A full recording of all witness testimonies and cross examination by committee members can be accessed here.
