Debunking The ‘Safe & Effective Vaccine’ Lie
No drug (or vaccine) is “safe”…..not a single one. This is a fact that all credible clinicians and pharmacologists understand. It is indisputable
In Australia, the law had to be amended to permit the government claim that the COVID-19 “vaccines” were “safe”.
No other drug/therapeutic can be described as “safe” by law.
In drug development/regulatory terms, there are basically two phases of safety monitoring.
The first phase is during drug clinical trials where safety and efficacy data is collected in a number of various clinical trials covering a various number of subjects. This number can be hundreds or a few thousand patients.
These trials are performed over limited time and involve limited follow up observation time. It therefore follows that it is critically important to monitor the real world use of any new drug when used on a large scale to detect any safety signals that may have been missed in the clinical trials involving relatively small number of patients/subjects.
This is called pharmacoviligence. Pharmacoviligence involves setting up reporting systems so that any health professional or user can report any adverse event regarding a newly released drug and this data is collected for analysis to determine if the reported safety signal (adverse event) was actually caused by the drug.
Only by collecting and analysing large amounts of data can safety signals be critically identified to help determine if the drug actually caused the adverse event or if the adverse event just occurred by chance.
It is the belief of many (including myself) that the pharmacoviligence system of reporting and assessing safety signals regarding the COVID-19 “vaccines” has been purposefully corrupted in order to minimise these safety signals and support the claim the COVID-19 “vaccines” are “safe”.
All the Covid “vaccines” were labelled with a Black Triangle symbol on the packaging to indicate that incomplete safety data has been collected on these experimental gene-based and Provisionally Approved injections.
The Black Triangle symbol was to alert doctors and health professionals that they should alert the TGA to ANY adverse event reported to them by patients without attempting to assess if the injection caused the adverse event or if the adverse event occurred by chance.
The only problem is that most doctors were not told or did not understand what the Black Triangle meant and most doctors simply hand waved away any health problems reported to them by patients following injections.
If we were allowed to have a Royal Commission in Australia I believe it would be shown that the Australian Therapeutic Goods Administration (TGA) has failed in its duty to adequately instruct doctors to report adverse events and to itself investigate in a professional, credible and diligent way the deaths and serious potential Covid vaccine injuries reported to it in the Drug Adverse Event Notification scheme (DAEN).
I have often referred to the DAEN scheme in my Substacks.
The potential corruption of pharmacoviligence systems has now been amply demonstrated by the cover up of Covid “vaccine” related deaths in the US under the Vaccine Adverse Event Reporting System (VAERS) overseen by the US Centre for Disease Control (CDC).
Australia has its own CDC now (OMG!).
I reproduce in full below the incredibly important report by Dr. Ryan Cole and Dr. David Wiseman (12 July) on how the CDC VAERS cover up has been achieved. Video presentation HERE
With more than 39,000 deaths being reported to VAERS (noting that this may only represent a tiny fraction of the actual deaths that occurred in association with the Covid jabs, maybe only two percent) the official CDC position is that NO DEATHS ARE ATTRIBUTABLE TO THE COVID-19 VACCINE.
This is outrageous.
Our TGA claims only 14 deaths but, in my opinion, this is because few of the 1054 deaths reported to DAEN have been properly followed up.
I urge you to view the 1hr presentation by Cole and Wiseman. It amply demonstrates that the pharmacoviligence systems upon which we depend to accurately determine the safety of drugs are completely BROKEN and captured.
We have no reliable way of knowing if any new drugs are safe or not given the Covid experience.
This is a sobering analysis – what did OUR drug regulators (TGA) know and when did they know it?
The CDC calls VAERS “the nation’s early warning system for vaccine safety.” The system works by collecting reports of health problems that happen after vaccination, then watching for patterns.
When a particular problem shows up more often after a particular shot than you’d expect by chance, that pattern is called a safety signal. A signal isn’t proof the vaccine caused the problem. It’s a flag that says: this deserves a closer look.
For more than 18 months during the COVID vaccine rollout, that system was missing hundreds of these signals. Not because the reports weren’t there, but because of how the FDA analyzed them.
When a public records request finally forced the agency’s weekly signal reports into the open in January 2025, the data showed something strange: one vaccine was generating almost all the signals, while two others generated almost none.
Sen. Ron Johnson’s Permanent Subcommittee on Investigations went looking for why. Its April 29, 2026 hearing drew on 11 million pages of FDA and CDC records obtained by subpoena.
The internal emails told a clear story. FDA staff were warned as early as December 2020 that their analysis method was hiding signals for certain vaccines. The scientists who built that method had already created a fix for the problem.
The fix was never used, and the FDA analyst who kept sounding the alarm was told to stop.
Dr. David Wiseman, a research bioscientist who testified at the hearing, joins Dr. Cole to walk through what the data shows. His published analysis puts the number of lost signals at 763 at minimum.
The emails explain how they went missing, and what the agency knew while it happened.
1. The Numbers That Don’t Add Up
The records covered the FDA’s weekly signal reports from January 2021 through July 2022. To find signals, the FDA relies on a statistical method called Empirical Bayesian Data Mining. It scans every report and flags any vaccine-and-reaction pairing that shows up far more often than chance would predict.
What is a “Bayesian” signal?
“Bayesian” is just a style of statistics that stays cautious when the numbers are small. If only a handful of reports link a vaccine to a reaction, the method holds back rather than sounding a false alarm.
Once the reports pile up beyond what chance can explain, it flags the pairing as a signal worth investigating. The point is to avoid crying wolf, not to bury real warnings.
One week’s report makes the pattern obvious. On April 29, 2022, the FDA logged 124 signals, split like this:
- Janssen: 110 signals
- Moderna: 6 signals
- Pfizer: 8 signals
That lopsided result, roughly nine to twenty-two times more Janssen signals than the other two vaccines, held steady week after week for the entire period.
The details made it stranger. Most of the few Pfizer and Moderna signals weren’t even medical problems. They were paperwork issues: a product prepared incorrectly, a dose given to someone the wrong age.
The serious clinical signals, the ones involving real injuries, landed almost entirely on Janssen. A system working properly does not produce a result that lopsided.
So Dr. Wiseman checked the FDA’s numbers against other databases and the published research, and found the signals that should have been there. At least 763 of them, he calculated, had dropped out of the FDA’s analysis, and larger datasets push the count into the thousands.
Every one was a potential risk the FDA was legally required to investigate. Under the rules for emergency-authorized products, the agency didn’t even have to prove the vaccine caused the harm to be obligated to look.
“These signals that were lost represent still mostly uninvestigated potential risk. FDA was legally required to consider without needing to determine causality.” — David Wiseman
The FDA’s own released data showed just 124 signals (far left). Adding back the signals lost to three separate flaws, explained in the next section, rebuilds the true count step by step to 887, with hundreds more borderline cases the FDA never examined at all. (Source: Wiseman, 2025)
2. How Signals Disappear
The biggest reason signals went missing has a name: masking. When two vaccines cause the same reaction at similar rates, the FDA’s method can let them hide each other, so a real problem looks normal.
What is masking?
To judge whether a reaction is unusual after one vaccine, the FDA compares it against a baseline: the rate of that same reaction across all the other vaccines. But that baseline included the other COVID vaccines.
So Pfizer’s heart-inflammation reports were measured against a baseline that already contained Moderna’s heart-inflammation reports, and vice versa. Each vaccine made the other look ordinary. The signal was real; the comparison erased it.
Dr. Wiseman used an analogy from the hearing. Line up hemlock and arsenic next to a cup of tea, and both poisons obviously look dangerous. But secretly stir the arsenic into the tea first, then compare the hemlock against that spiked tea, and the hemlock suddenly looks harmless.
You’re measuring one poison against a baseline that’s already poisoned. Dr. Cole put it more simply: one zebra among a hundred kangaroos stands out. Add a second zebra to the group, then compare the first zebra against the whole herd, and it no longer looks out of place.
On the left, hemlock and arsenic each look dangerous when measured against a clean baseline (tea). On the right, arsenic has been mixed into the baseline itself, so hemlock now looks safe by comparison.
This is masking: hiding one hazard by folding a similar one into the measuring stick. (Source: Wiseman, 2025)
Masking wasn’t the only problem. Dr. Wiseman found two more:
- Truancy: Hundreds of signals that appeared in other databases and in the published research were simply missing from the FDA’s records, with no explanation for where they went.
- Filtering: The FDA set the bar for what counts as a signal higher than the method’s own inventor recommended. A higher bar means fewer signals clear it, so real warnings got filtered out before anyone reviewed them.
3. What the FDA Knew and Chose Not to Fix
Here is what turns a statistical problem into a scandal: the people who built the FDA’s detection system were the ones who spotted the flaw. In a 2022 paper, three researchers laid out the masking problem plainly, and two of them were insiders.
William DuMouchel invented the exact math method the FDA uses. Dr. Ana Szarfman brought that method into the agency and made it the standard for catching drug and vaccine problems.
Their conclusion was damning: the method was hiding real signals, and the software already had a built-in setting that would fix it. When the inventors of a system tell you it’s broken, that carries weight.
And they weren’t the only warning. The internal record shows a steady drumbeat:
- December 2020: Dr. Szarfman flags the masking risk to FDA colleagues, before the vaccines are even widely rolled out.
- March 2021: She shares an analysis finding 49 examples of “extreme masking,” including hidden signals for sudden cardiac death and stroke.
- Same period: Another FDA official, Dr. David Menschik, runs his own check and confirms the problem independently.
- September 2021: Instead of fixing it, senior official Peter Marks reports that Dr. Szarfman “has been asked to cease and desist,” meaning she was ordered to stop.
Dr. Szarfman was blunt about what the broken method meant.
“I am not astonished that [FDA’s data mining system] was unable to detect these signals.” — Dr. Ana Szarfman, per internal communications shared by David Wiseman
The reason for shutting her down wasn’t scientific. It was about optics, as one internal email spelled out.
“Results from adjusting parameters that raise or lower sensitivity of the alerts as the vaccination campaign is underway could lead to confusion and have unintended consequences, e.g. regarding vaccine confidence.” — Dr. Zinderman, FDA, per internal communications shared by David Wiseman
The people paying the price were sitting across the table from Dr. Marks. Through 2021 and into 2022, vaccine-injured patients from the group React19 met with him and his staff, asking only to be believed.
Marks told them, more than once, that VAERS showed no safety signals, even while the FDA’s own analysts were documenting that the system was hiding them. These were people who lined up for their shots, did what they were asked, and were told the system saw nothing wrong.
4. A Broken Early Warning System
The problem doesn’t stop with COVID. The same researchers warned that the flood of COVID vaccine reports now sitting in VAERS has damaged the database’s ability to catch problems with any future vaccine, like a smoke detector so clogged it may not go off for the next fire.
At least three European studies of their own vaccine databases reached the same conclusion.
Put the pieces together, and the system is weak at every stage:
- The math method hides signals for vaccines that cause similar reactions.
- Only an estimated one percent of real adverse events ever get reported in the first place.
- When a fix was available, the FDA chose not to use it.
Dr. Marks himself understood what was at stake. In a line Dr. Wiseman read back to the Senate, Marks had written that failing to catch and communicate a serious vaccine problem “could impact confidence, not only in COVID vaccines, but in all vaccines.”
Sen. Johnson’s investigation is still open, and it’s not yet clear whether anyone will be held accountable. But the fix is not a mystery. It comes down to three things:
- Use the correct analysis settings the FDA already had access to.
- Protect the staff who report problems instead of silencing them.
- Release the safety data in full.
“What’s the point of even having a system if you’re not going to act on it… and now to know that your system’s broken, and you haven’t replaced your system.” — Ryan Cole
Looking Forward
The data, the emails, and the sworn testimony are public now. What Dr. Wiseman’s work makes clear is that this isn’t just history. The missing signals still haven’t been investigated, and the detection system still runs the same way it did.
Getting the records released took years of effort. Whether it leads to a system that actually works is the next question, and the one worth watching.
See more here substack.com
Some bold emphasis added