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Australians are routinely assured that deaths arising from Covid vaccination are vanishingly rare, based on the drug safety regulator’s claim that it has identified only 14 deaths linked to vaccination out of more than 70 million doses given.

The other thousand-plus deaths reported to the Therapeutic Goods Administration’s (TGA) safety surveillance database, the DAEN, are widely assumed to be merely coincidental, and the TGA has encouraged this perception, frequently asserting that “most deaths that occur after vaccination are not caused by the vaccine.”

Moreover, the TGA gives the impression that all reported deaths are thoroughly investigated, stating that “the TGA closely reviews all deaths reported in the days and weeks after COVID-19 vaccination.”

TGA Has Misled the Public

However, new documents released under Freedom of Information (FOI) laws and obtained by Canberra Daily suggest that the public has been misled.

Contrary to widespread belief, the documents show that the TGA does not thoroughly investigate every death reported to the DAEN. This is even the case where people died on the same day that they received their Covid shot.

Canberra Daily can reveal that out of 35 reports of Australians whose deaths occurred on the same day as their Covid vaccination, the TGA completed a causality assessment for only 24. The remaining 11 deaths had no causality assessment report available.¹

Further, not a single one of these 35 ‘day zero’ deaths was referred to the Vaccine Safety Investigation Group (VSIG), an expert panel which is supposed to be convened for the most serious adverse events following immunisation (AEFI), especially ones that have the potential to change the benefit-risk balance of a vaccine, or to threaten public confidence in vaccine safety.

In correspondence with the TGA, Canberra Daily was additionally able to confirm that the drug safety watchdog has never ruled out a causal link between the vast majority of deaths reported and Covid vaccination.

In fact, all reported deaths are considered by the regulator to be possibly linked to vaccination, despite regular public statements implying the opposite.

“Inexcusable”: Dr Suzanne Niblett

Dr Suzanne Niblett, a science researcher who uncovered the 35-day zero deaths through a series of FOI requests, called the revelations “unbelievable” and “inexcusable.”

“Continuous reports stating that only 14 deaths have been linked to these vaccines seems like a very misleading comment when you haven’t actually properly analysed all of the other thousand plus deaths,” Dr Niblett told Canberra Daily.

Describing the TGA’s safety surveillance systems as a “black box,” Dr Niblett said it took serial FOI requests over many months to obtain ‘time to death’ information on reported deaths associated with Covid vaccination.

As well as the 35 deaths that occurred on the same day as Covid vaccination, Dr Niblett found that, for reports where time-to-death information was available, one in four occurred within three days of a Covid shot being administered.²

Thirty-nine per cent of deaths occurred within a week of vaccination, and 86 per cent within six weeks. This is what’s known as a temporal relationship, which Dr Niblett stressed cannot be brushed aside.

“Temporality is an integral component of assessing whether a causal link exists between a medicine and an adverse event,” said Dr Niblett, who is working to publish her findings, produced in collaboration with a working group of scientists and healthcare professionals affiliated with the Australian Medical Professionals Society.³

Science researcher Dr Suzanne Niblett. Image: Dystopian Down Under.

The World Health Organisation (WHO) stipulates in its guidelines that the temporal relationship between an AEFI and administration of a drug is one of the criteria that should be considered by regulators when assessing causality.

However, it is also acknowledged that temporal association does not automatically imply causality, as in large populations, coincidences can occur.

Concerning Dr Niblett and her colleagues was the fact that for 25 per cent of reported deaths following Covid vaccination, the TGA didn’t hold time-to-death information at all.

“You’d think you’d be following up to find out that kind of detail,” said Dr Niblett, questioning how the TGA could possibly conduct proper reviews of post-vaccination deaths in the absence of such essential information.

“All Deaths Carefully Reviewed”: TGA

A spokesperson for the TGA told Canberra Daily,

“All deaths reported to the TGA are carefully reviewed to assess whether vaccines could have caused or played a role in the fatal outcome. This review considers the strength of the evidence available.

“It is not designed to determine if an event was not linked, but rather whether the clinical conditions which led to a fatal outcome represent an emerging safety signal for the vaccine.”

“Importantly, cause of death is determined by coroners and treating doctors, not the TGA.”

The spokesperson highlighted that certain criteria must be met for a VSIG to be convened, such as there being no other obvious explanation for the death, and there being sufficient information provided in the report to allow for a meaningful assessment.

As the majority (73 per cent) of Covid vaccine death reports have been made by health professionals or state or territory health departments, it is unlikely that an obvious alternative explanation for the deaths, such as a car accident, would prevent convening of a VSIG, especially in cases of death on the same day, or within days of Covid vaccination.⁴

This suggests the likelihood that the TGA did not convene a VSIG for these deaths because of insufficient information. Asked what efforts the TGA went to to obtain the necessary information to properly investigate these deaths, a spokesperson responded,

“If further information is required to complete the assessment, it is requested from the reporter and/or the relevant state or territory health authority and/or coroner.

“Not all requests for information result in additional information being provided to the TGA.”

In a follow-up email, the spokesperson confirmed that even in cases of deaths where vital information is missing from the report, where no causality assessment report exists, or where a VSIG has not been convened, the TGA considers that every death has been “carefully reviewed.”

“TGA Had No Record of It”: Leon Anderson

However, it is unclear what the TGA means by “carefully reviewed” when families of the deceased consistently say that the TGA has made no contact after their loved ones’ post-vaccination deaths were reported to the DAEN.

Sydney-based exercise physiologist Leon Anderson alleges that not only did the TGA not follow up on his 30-year-old brother’s sudden death in October 2021 six weeks after his AstraZeneca vaccine, but the TGA lost the report made by his brother’s GP.

“Despite the doctor having a copy of the submission, the TGA claimed they had no record of it,” Anderson wrote in an unpublished submission to the Senate’s Excess Mortality Inquiry last year.

“When I raised this issue with the TGA, their response was shockingly nonchalant, suggesting that I simply resubmit the report, disregarding the potential implications of their reporting system losing crucial reports submitted by healthcare professionals.”

Despite the fact that the TGA does not require that autopsies be conducted in cases of unexplained death after vaccination, Anderson’s family ensured that Matt underwent an autopsy after dying suddenly in his sleep. However, the family gained no further insight, with the cause of death being attributed to ‘unascertained natural causes.’

“The pathologist advised Matt’s death was determined to be not caused by the vaccine based solely as they had not found any evidence of Vaccine Induced Thrombotic Thrombocytopenia (VITT) which was the main primary concern with the Astra-Zeneca vaccine at that point in time,” said Anderson, highlighting the frustratingly high bar for proving a vaccine link so early in the vaccine rollout, when comparatively little research had been published on potential vaccine side effects.

30-year-old Matt Anderson died suddenly in his sleep within weeks of his AstraZeneca Covid vaccination. His death was attributed to natural causes despite no identifiable cause. Image: Leon Anderson.

Underscoring Anderson’s point, one of the causality assessments for an Australian who died on the same day as their Covid booster shot states that causality is “unlikely” because “vaccination has not been linked to the medical conditions causing this person’s illnesses and subsequent death.”⁵

“According to information released by the TGA, there are four other reports of individuals who died after receiving the same vaccine batches as Matt,” Anderson said. These included two other young men, 30 and 29 years old.

“The batches associated with Matt’s vaccine garnered over 160 adverse event reports and over 50 reports of serious injuries,” most of which were “either cardiac or thrombotic in nature.”

Yet, Anderson said that the TGA eventually advised that it would not conduct further investigations or complete the WHO causality assessment for Matt’s reported death “due to the limited information available on the cause of his death.”

Matt’s resubmitted death report is now one of the 1,034 that the TGA claims to have “carefully reviewed” but not linked to vaccination.

Anderson, who is a collaborator with Dr Niblett on the time-to-death investigation, said that his experience with trying to get his brother’s death properly investigated made him question how many of the 1,048 deaths reported to the TGA (as at 25 April) had actually undergone proper causality assessment according to WHO guidelines.

“No Surprise”: Dr Rado Faletič

Dr Rado Faletič, Director of COVERSE, a nonprofit providing support to Covid vaccine-injured Australians, said that it was “no surprise” that the TGA had not investigated these reported deaths further.

“In the Covid vaccine-injured and bereaved community, not a single person reports being followed-up or investigated by the TGA, despite many of those injured continuing to suffer long-term harms that their medical teams attribute to the Covid vaccines,” Dr Faletič told Canberra Daily.

Dr Faletič said that fast onset of symptoms was a common factor in vaccine injuries, mirroring the time to death data collected by Dr Niblett.

COVERSE Director, Dr Rado Faletič. Image: Dystopian Down Under.

“In our patient data, and similar data amongst overseas patient groups, around half of those harmed suffered the onset of serious symptoms within 24 hours of their vaccination, including conditions such as myocarditis (inflammation of the heart muscle),” he told Canberra Daily.

“So it does not make sense that the TGA would not take such quick onset of symptoms leading to death more seriously and be more transparent with the public that these deaths may very well be caused by Covid vaccination.”

Dr Faletič called on the government to commit resources to undertaking scientific investigations of serious AEFI cases and to provide meaningful compensation to those affected.

The federal Covid vaccine injury compensation scheme closed in September last year having approved only 418 (8.4 per cent) of 4,941 claims received. 1,057 claims remained in progress at the closure of the scheme – the remainder had been rejected or withdrawn.

A Covid vaccine injury class action representing over 2,000 Australians against the Federal Government may be the last port of call for the injured and for bereaved families who can make no further progress with the TGA on pursuing clarity and accountability over unexplained deaths after vaccination.

It is reasonable to surmise that the lack of candour in communications from the TGA and health authorities about the limitations of their safety surveillance activities may be a contributor to declining vaccination rates and trust in health institutions across the board.

A pivot towards transparency and straight-talking would undoubtedly cause some initial disruption, but the long-term implications for rebuilding trust would surely be worth it.

Can they really afford not to?

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Originally published at Dystopian Down Under. Image via Adobe.

1. FOI 25-0115 requested causality assessments and minutes and/or other related documentation from VSIG meetings for all 35 ‘day zero’ deaths reported to the DAEN in relation to Covid vaccination. Only 24 causality assessment reports were provided. [↩]
2. FOI 25-0047 requested time-to-death data for ‘accepted’ cases of death listed on the DAEN where Covid vaccines have been listed as ‘suspected’ medicines from 1 December 2020 to 5 September 2024. The resulting spreadsheet can be downloaded via the TGA FOI disclosure log, searchable by its release date, 8 November 2024. [↩]
3. Time-to-Death Analysis, by Dr Suzanne Niblett and colleagues. [↩]
4. Information on the sources of notifications submitted to the TGA for Covid vaccine AEFIs between 1 January 2020 and 31 December 2023 comes from FOI 4910. [↩]
5. FOI 25-0015, Document 1. Note, this is the only document on which the decision rationale has not been redacted. All other information, including age, sex, reactions and conditions, and vaccine brand, are redacted on all causality assessments released by the TGA, precluding the possibility of ‘peer review’ of the TGA’s interpretations. [↩]