The TGA has no idea how many people have been killed by the covid gene-vaccines

How corporate lobbying broke Australia's drug safety system

Australia has no idea how many people have been killed and injured by the covid gene-vaccines as the reporting system is broken, multiple doctors have said.

Drug regulator the Therapeutic Goods Administration (TGA) continues to claim that only 14 deaths out of 1004 reports are “linked to” the products in its latest safety report for November.

This is the official figure quoted trustingly by media because it is the drug regulator that says it.

Corporate media never looks into how the TGA arrives at this figure or whether it should be reported as gospel instead of what it actually is: a disputed claim based on a broken system.

Multiple experts have now sounded the alarm, saying not only is the number of gene-vaccine deaths wildly understated, but the entire system used by the TGA to assess drug safety is a danger to public health.

Australia has no idea how many people were harmed by the gene-vaccines, with most estimates in the thousands and some as high as 30,000 dead.

The Australian Medical Professional’s Society (AMPS) said excess deaths have surged at rates up to 17 percent above baseline average since the products were first distributed, prompting them to hold an inquiry in Canberra on October 18.

Expert presentations from the inquiry can be viewed on Rumble here.

AMPS has also compiled a book called Too Many Dead which can be downloaded free at the AMPS website here.

How injury data is collected by a system designed for under-reporting

It may come as a shock to some, but the TGA does not systematically collect and investigate reports of covid gene-vaccine injury.

It’s a voluntary system. If you don’t tell them, it’s not in the figures.

It’s up to doctors, hospitals and patients to report any suspected adverse events to the TGA.

To flag a potential injury, you or your doctor must fill out an online form at the TGA’s website here, or via your state or territory health department website, or call a pharmacist hotline.

These reports go into the Database of Adverse Events Notifications (DAEN) for investigation by the TGA.

These reporting methods are obscure. You have to go looking for them on the TGA website. The average person has no idea how. Many people tried to tell their doctors that they were injured by the injection only to be dismissed with: “it couldn’t be that”, without investigation.

Another government body, AusVaxSafe, conducts active monitoring of covid gene-vaccine safety. This consists of sending people a self-reporting survey on Day 3 after injection. As with all surveys, the results you get depend on the questions you ask. Their report does not say if there was an open field for people to write things like “heart attack”, or if they could only select from the six mild symptoms listed in the report (such as “fever”).

“So what if you’ve got a coma, a stroke, a heart attack, psychosis - you’re dead -whatever. How do they pick up these things from a questionnaire?” asked AMPS President Christopher Neil, a leading cardiologist.

There were no radio or TV ads for how to report a gene-vaccine injury during the rollout.

Nobody in the general public has heard of the “black triangle scheme”. Nobody was encouraged to report anything.

The government messaging was: “safe and effective” and “get vaccinated, it’s the best way to protect yourself and your community from covid”.

Instead of encouragement to report side effects there was overwhelming propaganda to promote the products, coupled with censorship and coercive mandates.

The media demonised voices of caution and labelled them “anti-vaxxers”, a hate-speech term of exaggeration that made ordinary people afraid to speak out.

Doctors were professionally bullied not to say anything negative about the products.

Autopsies checking for vaccinal spikes, which would have been definitive, were not encouraged for people dying unexpectedly within 30 days of injection. In Germany an autopsy study revealed several deaths blamed on heart attacks were in fact caused by the gene-vaccine, immediately revealing the problem of unreliable reporting.

Doctors, who typically see patients for about 10 minutes on bulk billing, do not get paid for the extra time it takes to fill out a covid vaccine injury report.

Patients don’t know how to report. Even if they recognise their injury as likely caused by the gene-vaccine they often think they’d have to prove it, or aren’t sure, and so they don’t report.

Hospitals actively discouraged people from reporting deaths, including that of Adelaide doctor Barry Schultz who died 18 days after his first Pfizer shot.

Healthcare professionals were not asking patients if their problem could have anything to do with the gene-vaccines. They would just treat the symptoms.

Regulatory expert Phillip Altman wrote in Too Many Dead:

“If safety signals such as cardiac arrest, pulmonary embolism, stroke, sudden death, cancer, diabetes and neurological disease such as dementia occur significantly above baseline values and are not duly recognised, there is no point in having an adverse drug-event reporting system.”

Estimates of Australians killed in the thousands

The TGA has no idea how many people were killed and injured by the gene-vaccines because the voluntary reporting system broke under censorship, propaganda and medical board bullying of healthcare professionals.

Here follows a selection of expert opinions of the possible number of deaths and the under-reporting factor in Australia’s DAEN.

• AMPS President Christopher Neil said the official TGA claim of only 14 deaths from 1004 notifications was extremely misleading.
  

  “By a conventional understanding, the real number deaths attributable to covid-19 vaccinations in Australia must be several times the total number actually reported.”

  Dr Neil said the adjudication process used by the TGA was non-transparent and unique in the history of pharmacovigilance.
  

  “Traditionally, one would have expected a regulator to accept the overall tally of death notifications as an important signal, and following this, to try to understand the situation and react accordingly.
  

  “If we accept from those numbers that all but 14 notifications were unrelated and coincidental - with well over 900 of these death notifications being essentially spurious, despite often having been made by treating doctors - then this actually implies that the rate of true signal detection is just 1 in 70… an absurd claim that has never been made in the history of pharmacovigilance.
  
  “If an over-reporting factor of 70 were correct, then passive surveillance pharmacovigilance would be a waste of time. In fact, the opposite is true: everyone knows that under-reporting prevails in passive surveillance systems.”
  

• Barrister Julian Gillespie told the ASF conference in November he has identified roughly 30,000 dead and more than 255,000 severely injured by the covid gene-vaccines. Mr Gillespie is spearheading a class-action lawsuit against 35 central defendants including Pfizer, Moderna and AstraZeneca.

Julian Gillespie at the ASF conference, November 19. Pic: Alison Bevege

• GP and adjunct professor of medicine David Richards said:
  “According to the European Medicines Agency, mortality associated with the Pfizer vaccine was reported to be one in 20,000 to one in 50,000.
  
  “According to AusVaxSafety, one in 110 individuals reported a reaction severe enough to seek medical attention.
  
  “If this were true, with around 70,000,000 vaccine doses delivered in Australia one would anticipate around 600,000 reactions to have been recorded and up to 3500 deaths. That would suggest DAEN is probably picking up about one to two per 100 deaths and around one in 1000 reactions in its reporting system.
  
  “The way to improve this is to provide a financial incentive to doctors to encourage reporting.”

  

  (left): Flier for December 4 book launch, Sydney. (right) Forest of the Fallen shows people’s gene-vax stories. Pic: Bevege

• Regulatory expert Phillip Altman’s 2022 covid report said it is widely acknowledged that all adverse event reporting systems both here and overseas are under-reported, including by more than 40 times.

“We know our DAEN system is completely broken as it only admits to 14 deaths being caused by the covid-19 “vaccines”. We know this is not true. Our DAEN system is not picking up important safety signals. More than 1000 reports of deaths have been recorded in the DAEN system but the TGA continues to admit to only 14 deaths due to the “vaccines” and even more incredulously the TGA admits to no child deaths despite 9 such reports.” he wrote on Substack.

“Why should we believe them when they refused to investigate more than 30,000 non-covid-19, post-vaccination, unexplained Australian deaths above what would normally be expected following the rollouts of the “vaccines”?”

Letters From Australia asked the TGA in June what its estimated under-reporting factor was for the DAEN.

They couldn’t say. They tossed a word salad about how the system was “robust” instead.

“The TGA has a well-established and robust system to detect and investigate potential safety issues … Anyone at any time can make an adverse event report to the TGA through multiple reporting channels …

“It is acknowledged that some adverse events may go unreported, however the extensive data received by the TGA, together with cooperative arrangements with international regulators, provides a high level of confidence …”

You get the picture.

The TGA says only some adverse events “may” go unreported. Experts, however, say large numbers of injuries definitely go unreported, and that this is widely known.

On August 1, after I tried again, the TGA took a harder line.

“While some people may choose not to report adverse events, extensive data received by the TGA together with cooperative arrangements with international regulators provides a high level of confidence …”

So, it’s your fault if you didn’t report your injury, because you chose not to.

Dr Phillip Altman, who has decades of experience interacting with the TGA, told Letters From Australia in July that contrary to their claims, the TGA was not even following up reports of adverse reactions.

“People are reporting adverse drug effects and they’re not being followed up by the TGA,” he said.

In November, Dr Melissa McCann also said the TGA were not following up reports.

“There’s about 140,000 adverse events reported virtually none of which – I know this from personal interactions with people who have made reports - virtually none of which have been followed up by the TGA,” she said at the Australians for Science and Freedom conference in Sydney.

Letters From Australia asked the TGA in November how many adverse event reports they had followed up on, but they did not respond.

The TGA says in its November safety bulletin that it “closely reviews” all deaths reported.

Dr McCann has launched a class action to get justice and compensation for the gene-vaccine injured - donations welcomed here.

The Australian excess deaths rate soared in 2021 with the roll-out of the gene-vaccines and is tracking at 10.9 percent higher than baseline average for the year to August 31, according to the Australian Bureau of Statistics. That is 11,974 more dead Australians than expected, of which 3282 (about a quarter) were due to covid.

According to the Bradford Hill criteria of causation, a well-regarded technique to ascribe causality, the covid gene-vaccines are likely responsible for at least some of the excess deaths that have soared since the jab rollout in 2021, and yet they are not being investigated.

There is, however, one reliable way to catch unreported gene-vaccine deaths.

The Health Department can compile the all-cause mortality figures stratified by age and gene-vaccine status (as of date of injection), expressed as a proportion to eliminate the bias of higher numbers of injected people.

All-cause mortality catches everyone who died from every reason. Differences between the injected and uninjected categories would reveal unexpected and unreported deaths.

Letters From Australia repeatedly asked the Health Department for this figure for over a year. They refused, repeatedly, to release it, saying it was too hard.

“The specific information requested has not been produced by the Department and complex technical work is required to analyse all-cause mortality data from Registries of Births, Deaths and Marriages alongside immunisation information recorded in the Australian Immunisation Register,” the TGA responded via email in June.

“Following peer review and broad expert support of confirmed methodologies for analysis, the Department is committed to transparency with its findings and its approach to analysing mortality outcomes.”

The government could simply release the raw data for qualified people such as Professor Norman Fenton to analyse it publicly. But they have not.

To understand how this outrageous situation could have happened in a modern democracy, it’s necessary to step back in time to 2018.

How corporate lobbying broke the safety system in 2018

The controversial gene-vaccines, an entirely new class of drug, were distributed in 2021 under a new process called “provisional registration” which lacks the rigour required to meet the safety standards of full registration.

Provisional registration was introduced in 2018 after pharmaceutical industry group Medicines Australia successfully lobbied then-health minister Peter Dutton for a review of regulation to make it faster, cheaper and easier for corporations such as Pfizer to bring products to market by “removing unnecessary red tape for industry”.

Stage one of the review, led by Lloyd Sansom, recommended streamlining medicines to market. The report was co-written by Will Delaat, a former managing director of Merck Sharp & Dohme and chair of Medicines Australia until December 2011.

Medicines Australia, which represents Pfizer, AstraZeneca, GSK, Sanofi and Bayer among others, made a submission to the senate committee reviewing the proposed Bill in 2017.

Director of Policy and Research Elizabeth de Somer wrote:

“We understand a number of our member companies are ready to lodge applications with the TGA for designation as a provisionally approved medicine. The new provisional approval pathway therefore stands to benefit patients particularly in situations of very high unmet clinical need, and we ask the Committee to recommend its passage. If necessary, we would support separation of the relevant provisional approval provisions in a stand-alone Bill, to ensure the earliest possible access to innovative treatments for Australian patients.”

Medicines Australia was most interested in provisional approval for reducing time to market. New drugs only have up to 25 years of patent protection after which they become generic and lose their profit margins.

So the TGA Act was altered in 2017 to create the category of provisional registration, becoming law in 2018.

Elizabeth de Somer was then promoted to chief executive at Medicines Australia, while retaining her advisory post at University of NSW where she reviews the Masters program for students of pharmaceutical medicine. She is also active on advisory boards for Macquarie and Sydney universities as well as the Chief Medical Officer’s advisory group on National Health and Climate Strategy, as Linkedin shows.

The new provisional registration category created in 2018 allows drug companies to sell their products before safety testing for full registration has been completed.

Companies can sell their drug for up to six years after providing “evidence of a plan to submit comprehensive clinical data”, as the TGA says on its website.

That is why the Pfizer gene-vaccine was distributed in Australia all through 2021 and 2022 when the clinical trials had not yet ended. The clinical trials only finished in February 2023 and may never be regarded as complete since the control group was destroyed after just two months.

How do you know if gene-vaccines cause increased heart attack rates or rare cancers in recipients after a year, if you destroy your placebo group in two months and give everyone the product? There’s nobody to compare it to.

Safety monitoring broken by censorship

To compensate for the extra risk created by provisional registration, the new TGA rules created the black triangle scheme with claims of “additional monitoring”.

A black triangle is placed on product labelling and inserts to remind practitioners to report any suspected adverse events.

Letters From Australia asked the federal Health Department in August how much it spent advertising the Black Triangle Scheme (alerting doctors and consumers to report) versus how much it spent promoting the gene-vaccines. A Health Department spokesman replied that advertising contracts are published on AusTender, without revealing the figures.

While the system primarily relies on voluntary reports to establish the drug’s safety profile, manufacturers are also required to do pharmacovigilance monitoring on their own products.

The TGA advises drug companies to monitor “internet and social media reports” to help in this endeavour.

“The internet, including social and digital media, is an important source of reports of suspected adverse reactions. You should regularly screen the internet (such as websites, webpages, blogs, vlogs, social networks, internet forums, chat rooms and health portals) or digital media you own, fund, manage or are responsible for, for potential reports of suspected adverse reactions,” The TGA says.

These exact same companies are funding third parties to suppress and censor those online reports.

Journalist Lee Fang reported on Tuesday that Moderna used AI and a former FBI agent to spy on online gene-vaccine discussions that might threaten its products, and funded non-government organisation Public Good Projects to shut them down as “misinformation”.

Working hand-in-glove with big corporations, Australia’s government secretly censored social media during the covid pandemic and removed people who talked about their gene-vaccine injuries, smearing them as “anti-vaxxers”, as revealed by Freedom of Information (FOI) requests.

FaceBook tells the Health Department they censored gene-vaccine injured people as per request. Source: FOI 3953

The federal Department of Health and Aged Care told FaceBook to take down groups where gene-vaccine injured Australians were seeking support and sharing their stories in 2021, as exposed by FOI request 3953, and they did.

The Home Affairs Department made 4213 censorship requests to Twitter related to covid, as exposed by Senator Alex Antic through FOI.

Twitter jumped to censor gene-vax injured people in 2021 for Australia’s Home Affairs and Health Departments

Injured people were swept under the carpet and banned from online spaces where, according to the TGA, drug companies are supposed to be scanning for those stories to build the safety profile of the medication.

In March 2021, as the gene-vaccine products were distributed, all medical professionals were threatened with disciplinary action by the combined medical boards at AHPRA if they raised concerns about the products, and AHPRA set up a website to snitch on any doctors who did.

“Any promotion of anti-vaccination statements or health advice which contradicts the best available scientific evidence or seeks to actively undermine the national immunisation campaign (including via social media) is not supported by National Boards and may be in breach of the codes of conduct and subject to investigation and possible regulatory action,” AHPRA said in its March statement.

Of course, the “best available scientific evidence” was by government decree on a new product, for an emerging infectious disease, for which there would obviously be dissenting science as the product was all new. This crushed real science which is open to debate and new information. It’s no surprise they got it wrong.

People have died, and they don’t know how many.

Phil Schultz (left) whose brother was killed by Pfizer sets up a Forest of the Fallen in Sydney with journalist Rebekah Barnett (right). Pic: Alison Bevege

Censorship, propaganda led to catastrophic fail

It doesn’t take Einstein to see that if you release a whole new class of injectable medication with several components never before used at scale in human populations, and don’t test them properly first, that you are asking for trouble.

The TGA was aware of the red flags as early as March 2021 via a metric called the proportional reporting ratio (PRR), which highlights safety signals for reassessment, as released under FOI 4032. A PRR of 10 shows the drug causes 10 times more injuries than the background rate.

The Advisory Committee on Vaccines set the PRR for the covid gene-vaccines at one, as Senator Gerard Rennick reported.

But by March 2021, just two months into the rollout, the PRR for chest discomfort was 12.25 while presyncope (pre-fainting dizziness indicating something is wrong) was 21.42.

By the end of September 2021, pericarditis had a PRR of 12.33, cardiac discomfort 20.55, four separate menstrual disorders ranged from 10.4 to 12.79 (making the aggregate in the 40s even while they told women it didn’t affect fertility).

Retinal artery occlusion (blocking the blood to the retina so you go suddenly blind) was 17.05, and pulmonary infarction (blocking blood supply to the lungs) was a whopping 36.53.

It is not known if anything was done about it. The products are still on the market, promoted as safe.

Instead of alerting GPs, doctors and hospitals of a potential safety signal, the government conducted a blitz of “safe and effective” messaging, organised in 2020 before the preliminary trials had even finished.

They censored dissidents and boosted “trusted sources” like Dr Norman Swan who promoted the products on the ABC, telling the credulous Sarah Ferguson in February: “now everyone (over 18) can have a fourth booster”, with a huge grin as if it were a late Christmas gift.

At the Australians for Science and Freedom conference in November, a GP asked the expert panel:

“Why was there not more of a directive from the health officers, that we have cut short this trial and therefore doctors need to report every single adverse outcome they are seeing regardless of whether they think that outcome came from the vaccine or not?”

Dr Melissa McCann at UNSW on November 19. Donate here. Pic: Alison Bevege

Dr Melissa McCann answered:

“I was a pharmacist before I was a GP and there was something called a blue-card system. There was constant encouragement in every publication… “you don’t have to be certain just suspicious” - and that was the TGA’s catchline for reporting adverse events.

“That’s the opposite of what happened during covid, it was “yes you’re obliged to report everything but bear in mind that for almost all adverse events they’re unrelated to the vaccine.”

“And that was what was told to everyone … they’ve been given out to millions of people round the world, and that’s true they had been - but what was known to the TGA but not communicated to doctors was that even at that point (we’re talking February 2021), there was 1300 deaths and thousands of adverse reports to Pfizer - and none of that was communicated to doctors

“What it created was almost if someone came in and said ‘this happened to me after the vaccine’, that they were - to the shame of medicine - met with ‘that doesn’t happen from the vaccine, don’t even say that’ and sometimes it was absolute ridicule and there was enormous discouragement to even draw the conclusion it was vaccine related.”

As of November 2, a total of 1004 deaths were reported to the TGA for all covid vaccines combined, the TGA said.

If the under-reporting factor is 30, and the reports that the TGA refuses to admit are, in fact true, that would mean that barrister Julian Gillespie is right and 30,000 Australians have died from these products, wrongly recorded as strokes or heart-attacks or other causes.

Corporate lobbyists want even faster approvals

Multiple medical professionals worldwide have called for the products to be taken off the market until proper safety testing has been conducted, but regulators remain deaf.

By contrast, the corporate lobbyists have decided that the time to market for new drugs is not fast enough, they want it even faster.

Medicines Australia chief executive Elizabeth de Somer tweeted a picture of Prime Minister Anthony Albanese at the National Press Club in February:

“(Albanese) says we must "balance urgent action with a focus on long-term reform and investment, delivering the lasting progress that Australia needs". This must include bold reform for Australia's health systems so patients have fast access to innovative medicines.”

Former Health Department secretary Jane Halton, the long-term chair of CEPI which acts as a vaccine marketing arm for the Bill and Melinda Gates Foundation, was appointed by the government to review Australia’s procurement of the covid gene-vaccines and treatment. CEPI wants new vaccines in just 100 days instead of the normal careful decade or more of testing, and says mRNA is the platform to do it with.

The main problem with the government’s procurement was that it hadn’t pre-purchased even more gene-vaccines for 2024, as she told the ABC in September 2022.

The Halton review found no problems with the provisional gene-vaccine approvals.

“A provisional registration process, underpinned by a ‘rolling review’, enabled a timely and effective response. There is no provision under law for TGA emergency use provisions to require a sponsor to submit data. Consequently, adjustments to the registration processes for COVID-19 products were made including:

Enabling multiple products for the same condition (COVID-19) to be eligible for provisional designation and approval;

• accepting rolling data;

• introducing various conditions of registration and post-approval commitments;

• introducing the ability to make multiple regulatory decisions within one application;

• accepting use of international labels; and

• organising ad-hoc meetings of the Advisory Committee on Vaccines (ACV) or Advisory Committee on Medicines (ACM).

To accommodate these adjustments, changes were agreed and implemented to various legislative instruments, including but not limited to the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990 and the Poisons Standard.” - Review of Covid-19 Vaccine and Treatment Purchasing and Procurement, September 2022.

These changes made to speed drugs to market during the covid panic should be made permanent policy, Halton said.

“Consideration should be given to permanent implementation of changes made during the pandemic which ease regulatory burden and do not impact public safety,” she wrote in the review, released under FOI.

Why bother testing at all? Just dish it out and see what happens.

Increasing numbers of health professionals are now saying: Australia’s dysfunctional drug regulation system is a serious threat to public safety.

Contributing authors from AMPS book Too Many Dead will be speaking at the launch in Sydney, NSW, on December 4 and in Warner, Queensland, on December 7.

UPDATE: 10 December - replaced broken link to AHPRA and Medical Boards March 2021 statement telling healthcare workers not to criticise the covid gene-vaccines. Now archived link is there.

20 December - AHPRA and Medical Boards March 9 statement threatening doctors with regulatory action if they spoke against the gene-vaccine has been taken down, causing broken links. The Wayback Machine archived copies are, curiously, only showing the first page without the relevant, controversial part. AHPRA has put the March 9 statement back on the internet with “superceded” stamped all over it here.

The link to the AHPRA media release threatening health staff is still up here.

2 October 2024 - fixed a broken link to 2021 report on AusVaxSafety data.