Australia's drug regulator admits it doesn't know extent of Covid vaccine harm

The Therapeutic Goods Administration is out of its depth

Australia's drug regulator, the Therapeutic Goods Administration (TGA), has no idea how many of the adverse events reported to its database are actually caused by the Covid vaccines.

Despite refusing to answer straightforward questions about how many reports it has assessed for causality, the TGA has confirmed that it does not have the information required to properly assess all adverse events (AEs) reported to its safety surveillance database, the DAEN (Database of Adverse Event Notifications).

Yet, there is a widespread perception that the TGA assesses all reports, particularly of serious AEs, for causality.

This is the stated belief of Country Medical Director of Pfizer Australia & New Zealand, Dr Krishan Thiru, who told a Senate Committee Hearing on 3 August 2023, "The TGA carefully analyses all of the reports that it receives and makes a determination if there is a link to the therapeutic product or not."

But by the TGA’s own admission, this is not the case.

Following Dr Thiru’s statement to the Senate, I asked the TGA to specify how many Covid vaccine adverse event reports they have assessed, and how many they have determined as causally linked to the vaccines.

The TGA expertly deflected, responding (emphasis mine):

“The TGA has received over 139,000 adverse event reports for COVID-19 vaccines. It is common for the reports to have limited information on which to conduct a causality assessment. For this reason, almost all reports received by the TGA are assigned a causality of ‘possible’, even where the reporter provides limited information, or information that suggests the adverse event was not related to vaccination. This enables the TGA to include a broad dataset in our statistical analyses which are used to identify signals. The TGA’s COVID-19 vaccine safety monitoring system has delivered clear results for the Australian public, including first in the world action on several emerging safety concerns.”

This wordy response confirms that, contrary to Dr Thiru’s claim, the TGA does not assess all reports to determine if there is (or is not) a link to the therapeutic product because it does not have the information required to do so.

Rather, the TGA assigns “almost all reports” a causality status of ‘possible,’ neither confirming nor denying causality. This allows enough uncertainty for the TGA to maintain that high AE reporting rates cannot be construed to indicate causality, while also avoiding the burden of proving that the reported AEs are not causally linked to the Covid vaccine products.

https://daen.tga.gov.au/medicines-search/ accessed 6 September 2023

As the TGA failed to answer my specific questions, I went back a second time, asking, how many AEs have you assessed and how many did you determine to be causally linked to the Covid vaccines?

This time, the response was even wordier, while managing to say nothing at all:

“The Therapeutic Goods Administration (TGA), which is part of the Department of Health and Aged Care, has robust processes for monitoring the safety of medicines and vaccines. Many of these processes have been enhanced dramatically for COVID-19 vaccines, making this the most intense safety monitoring of therapeutic goods ever conducted in Australia.

“Enormous amounts of real-world data, based on more than 13 billion doses of COVID-19 vaccines administered globally, continue to show that the benefits of vaccination strongly outweigh the potential risks, including rare serious adverse events. This is supported by the recent statement by the International Coalition of Medicines Regulatory Authorities (ICMRA), which is available at: www.tga.gov.au/news/media-releases/icmra-statement-safety-covid-19-vaccines.

“The Department has made extensive information available to the public about the COVID-19 vaccines, which is available at: www.health.gov.au/our-work/covid-19-vaccines. The TGA also publishes comprehensive regulatory information on its website at: www.tga.gov.au/products/covid-19. Since March 2021, the TGA has published a regular COVID-19 vaccine safety report, which is available at: www.tga.gov.au/news/covid-19-vaccine-safety-reports.

“In addition, the Department has provided detailed technical responses through appearances before the Senate Estimates Community Affairs Legislation Committee (transcripts and written answers to Questions on Notice are available at www.aph.gov.au/Parliamentary_Business/Senate_estimates/ca).”

I asked the TGA my questions a third time, this time with clear directions, in red. Additionally, I requested that if the TGA was refusing to answer my questions, that it provide an explanation as to why.

Email correspondence sent to the Department of Health by Rebekah Barnett, 16 August 2023

After following up a further three times, I received the following reply from a Department of Health spokesperson:

“We worked with our colleagues at the TGA to provide these two responses and we won’t be providing anything further for this query.”

The TGA outright refuses to tell the Australian public how many of the AEs reported to its safety surveillance database have been assessed for causality, and how many have been determined to be linked (or not) to the Covid vaccine products.

A ‘horribly conflicted’ business model

The unwillingness of the TGA to even explain why it won’t answer my straightforward questions and the lengths they went to in obfuscating to protect Dr Thiru, who appears to have misled the Senate (whether deliberately or not) raises a new question:

Who does the TGA work for? The Australian public? Or the drug sponsors?

A much-cited investigation into drug regulator funding conducted by Maryanne Demasi for the British Medical Journal found that the TGA receives more industry funding than any other regulator in the world, at 96 per cent. More than nine out of every ten applications for new drugs are approved by the regulator.

In the above-mentioned Senate Hearing after Pfizer’s Dr Thiru asserted (falsely) that the TGA assesses every reported AE to determine causality, Liberal Senator Alex Antic asked the panel representing the TGA, “does the TGA accept that it is horribly conflicted by virtue of that industry-funded model?”

The TGA panel disputed Senator Antic’s assertion, with Professor Tony Lawler, who replaced outgoing Professor John Skerritt as TGA head in June this year, countering that the portion of the TGA’s funding coming from industry is “somewhat lower” than 96 per cent.

However, Lawler appears to be quibbling over two per cent. In an email to a member of the public in September 2022, a TGA staffer stated that 94 per cent of their $210 million annual budget is funded by industry.

Little to no follow-up of injuries and deaths

As at 20 August, the TGA states that there were 139,404 reported AEs in relation to Covid vaccine products, at a rate of two reports per 1,000 doses administered. For the average Australian who has received three doses of vaccine, that’s a 6/1,000 reporting rate. For people onto their fifth dose, that’s a 1/100 reporting rate.

But Covid vaccine-injured scientist Rado Faletic says that proper follow-up of these reports by the TGA is rare. Faletic co-founded COVERSE, a charity dedicated to supporting Australians who have been injured by the Covid vaccines, after determining from personal experience that the TGA was not taking necessary and appropriate action on reported AEs.

Faletic’s Covid vaccine injury was one of the first to be covered in Australian mainstream news, in June 2022. He said that the TGA seemed “simply uninterested” in investigating his symptoms, telling news.com.au,

“I’ve done 50 rounds with the TGA on this.

“They’ve said, ‘We can find no safety signals,’ which I think is disingenuous if not outright lying. In my small personal circle I know over a dozen people with different long vax problems, [ranging from] ongoing headaches, memory problems or brain fog to some people who were basically bedridden for months.”

More than a year on, and after engaging with many other Covid vaccine-injured Australians through his work with COVERSE, Falectic’s view has not changed. Learning of the TGA’s response to my questions about AE report assessment, Faletic told me,

“Meaningful follow-up or investigation by the TGA seems far rarer than very serious and highly debilitating health conditions caused by these vaccines. It’s simply illogical that agencies such as the TGA can make claims about the safety of these products on the basis of not conducting timely investigations of very serious health issues that are strongly correlated with vaccination.”

While the TGA won’t say how many AEs it has assessed for causality, it is more forthcoming about the number of death reports that have been assessed and assigned causality. From the Covid vaccine safety report dated 24 August, “The TGA has identified 14 reports where the cause of death was linked to vaccination from 997 reports received and reviewed.”

However, it is unclear what the TGA means by “reviewed” when parents of deceased children say that the TGA has done no follow-up after their childrens’ post-vaccination deaths were reported to the DAEN.

One such parent is Raelene, mother of 23-year-old Caitlin Gotze, who died six weeks after suffering a bad reaction to her Pfizer vaccination. Eventually, the Coroner officiated the cause of death as asthma. However, Raelene says that Caitlin never had asthma, and that no one from the TGA has ever contacted her to gather more information on Caitlin’s reported death. Raelene needs to raise $20,000 to reopen the coronial inquest into Caitlin’s sudden death.

Sophie and Bruce, parents of 24-year-old Amy Sedgewick, tell a similar story. Amy’s untimely death followed nerve damage and other complications that onset with her Pfizer shots. As reported in The Australian in March 2023,

“Bruce reported Amy’s condition, and its suspected link to the vaccine, to the Therapeutic Goods Administration’s adverse events database in November 2021, five months before her death. He received nothing more than a pro forma automated response.

“As far as they are aware, their daughter’s decline and death has never been individually assessed by the TGA, the commonwealth authority tasked with monitoring vaccine side-effects and deaths.”

‘World class’ safety monitoring safeguards Big Pharma reputation and profits

The TGA says that it has “delivered clear results for the Australian public, including first in the world action on several emerging safety concerns.” By this we can assume they’re referring to their eventual public acknowledgment that the AstraZeneca vaccine had unquestionably killed 13 Australians, and that Covid vaccines can be associated with myocarditis and pericarditis in ‘rare’ cases.

However, despite withdrawing other medicines from the market after a single reported death, the TGA did not withdraw its provisional approval of AstraZeneca’s Covid vaccine, Vaxzevria. When the therapeutic became unavailable in March 2023, a spokesperson for the Department of Health advised me that in fact it was AstraZeneca who decided to discontinue the product in Australia, not the TGA, and that Vaxzevria remained provisionally approved.

The TGA maintains that there have been no Pfizer deaths and only one Moderna death since the Covid vaccine rollout began, but how would they know? A systematic review of 325 autopsies following deaths related to Covid vaccination up to 18 May 2023 found that, “a total of 240 deaths (73.9%) were independently adjudicated as directly due to or significantly contributed to by COVID-19 vaccination.”

But when asked if the TGA advises families of the deceased or medical professionals to have autopsies performed on individuals who died after Covid vaccination, a spokesperson for the TGA stated, “The TGA does not request autopsies, coronial investigations or make formal determinations of the cause of death,” adding that in most cases, a health professional or a coroner will determine the cause of death. In other words, the TGA has no process in place to ensure that a procedure key to determining cause of death in recently vaccinated persons is being undertaken.

The TGA hid child deaths reported in relation to Covid vaccines for fear that “disclosure of the documents could undermine public confidence.”

The TGA says that it constantly searches for safety signals, but refuses to say how often, by what methods, or to share what it has found when asked. Below is an excerpt from correspondence between myself and the TGA spanning several months, in which I asked a very specific set of questions about Proportional Reporting Ratio (PRR) analysis. The TGA sent a paragraph in reply not answering the questions, and then a chain ensued with me reiterating my questions and the TGA reiterating the reply that didn't answer the questions. Eventually, my request was denied both via media and Freedom of Information (FOI) processes.

Email from Rebekah Barnett to the TGA, 20 April 2023

Former head of the TGA, Professor John Skerrit, denied that cardiac arrest is a safety signal for Covid vaccines. Yet here is the TGA’s own PRR data on cardiac arrest, graphed (FOI 4032). It shows a PRR of >2, which is significant because it was decided at a meeting of the Advisory Committee for Vaccines in 2021 that any denominator over 1 would constitute a safety signal.

True extent of harm unknown

The true extent of Covid vaccine harm in Australia is as yet unknown. Vaccine safety surveillance data from the ‘control group’ of Western Australia (WA) during 2021, when the state had blanket vaccination but almost no Covid, suggests that it’s worse than the TGA safety reports indicate.

Concurrent with the Covid vaccine rollout, WA saw a 24x increase in reporting rate of AEs per 100,000 doses compared to all other vaccines combined. Background rates of myocarditis and pericarditis increased by 35 and 25 per cent, respectively. More than half of those who reported AEs presented at hospital.

There are now over 3,000 papers published in the scientific literature demonstrating mechanisms of Covid vaccine harm.

A peer-reviewed study of mRNA booster effects found that 1/35 participants sustained myocardial damage, confirming earlier reported indications that subclinical injury is occurring, but not being picked up in routine testing.

Repeat dosing of the mRNA vaccines in particular has been associated with immune tolerance, immune suppression, immune imprinting and increased infection rates, all of which will likely take a long time to play out and be properly detected and measured at population level.

It is quite possible that, just as promises that the vaccine stayed at the injection site turned out to be false, promises that it won’t integrate with human DNA are also false. New scientific findings on synthetic DNA contamination in the mRNAs, particularly in relation to the SV40 promoter, which is associated with cancer, are concerning.

The TGA, it would seem, is out of its depth, at least as far as public safety is concerned.

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Postnote

Understandably, Australians are now taking matters into their own hands - the lawsuits have begun. A class action lawsuit alleging that the TGA did not fulfill their duty to properly regulate the Covid vaccines is seeking compensation on behalf of Covid vaccine-injured Australians. The action has signed on over 1,000 members, and registration remains open for a limited time.

Contribute to Raelene’s GiveSendGo fund to raise $20,000 for an inquest into Caitlin Goetze’s death.