The safety data for aluminium in vaccines was funded by...
The FDA has a strict safety limit for injected aluminium. The vaccine schedule breaks it by 50 times.
In part one we looked at the official ‘line’ on why aluminium is safe to use in vaccines; it has been used for decades, and you absorb more aluminium from your food. Neither one of these statements stand up to even the mildest nudge of scrutiny. If you were seeking informed consent on vaccines containing aluminium, those two arguments would be presented to you. With them both utterly demolished, where can we go next? Let’s wander further behind the curtain and see how deep the rot goes.
There’s one study that is actually cited as a defense of aluminium in vaccines, it’s called the Miktus paper. Published in 2011, it was a strategic, institutional response to a growing crisis of confidence in the American vaccination program. By the late 2000s, questioning the vaccine schedule had gone mainstream with Jenny McCarthy and Jim Carrey forcing the issue onto Larry King. Rumbling alongside this, the FDA was embroiled in a bruising legal battle over the safety of a vaccine preservative called Thimerosal. By exploring the history of this moment, and what led to the creation of the Miktus paper, we’ll come to understand how utterly broken the regulatory system really is.
The FDA ultimately ‘won’ the legal case, but they were forced to remove Thimerosal from their vaccines products. In the years surrounding the case, the mood at the FDA was defensive, because questioning their $20 billion vaccine industry was becoming a trend. As attention shifted onto the other ingredients used in vaccines, it was clear many of them had been “Grandfathered” in. They’d been in use for so long that safety was assumed rather than demonstrated clinically. Like any great salesman, the FDA pivoted this blind spot into a feature.
Effectively their line was “hey the reason we don’t need safety data is because we’ve been injecting aluminium for decades”. A defense they made official and still use today. Whilst thimerosal could be removed from vaccines, it was just a preservative after all, aluminium is core to the functionality of their vaccines. If the aluminium domino falls, the $20 billion industry would be in big trouble.
The question the FDA needed to answer was really very simple. “Your vaccine schedule means infants receive aluminium, a known neurotoxin. Sometimes an infant receives multiple aluminium vaccines on the same day. Do you have data on what is a ‘safe’ amount of aluminium that can be injected into an infant in a single sitting?”
To this question, the FDA simply had no answer. We still don’t have a proper answer to this question even today. Shouldn’t we know the safety limit for injected aluminium?
With no response from the regulators, there was a doctor with a fairly decent answer to this question, but it wasn’t the answer the FDA wanted. Doctor Bob Sears had made a very astute observation: safety data did already exist on aluminium. Sears found that the FDA already had a safety limit for aluminium in infants, and it was 5 mcg per kilo per day.
So…there was an answer after all!?
Exceed this limit, and the FDA themselves said aluminium can cause neurodevelopmental problems, impaired bone growth and bone mineralisation; it’s toxic basically. So how does this limit compare to vaccines an infant receives during the first 12 weeks of a baby’s life?
On the NHS, when an infant goes for their 8 week health check, they’ll get the 6-in-1 and the MenB vaccine on the same day. Depending on the brands used, that could be as much as 1320 mcg of aluminium in a single day. For an average 5kg baby, that’s 264 mcg per kilo, which is 52 times the safe limit the FDA had already set.
What!?
How is that possible?
It’s possible because the FDA, the industry they protect, and the scientists who do their work will use sophistry, bullying, groupthink, and a war of attrition to obscure what I just told you. By the end of your honest venture into the data, you’ll be confused and exhausted. You’ll probably just given in trying to work out the answer.
What they’ll tell you is the safe limit (which really is an FDA regulation) is different to the limit for vaccination, because an IV is different to vaccination.
The safe limit I’m showing you here, they’ll say, is utterly irrelevant to the dose babies receive during vaccination. When someone puts this argument to you, ask them this: “Ok, then what is the exact safe limit of injected aluminium for an 8 week old infant, and how do we know what it is?”
The sophistry you’ll be faced with is a strategy of deflection to obscure the lack of data on this very important question. The truth is, the FDA’s 5 mcg limit is very relevant to the dose babies receive during vaccination. To demonstrate why will require us to follow the FDA’s path.
How did the FDA come to set this limit?
It began in the 1970s with a crisis in kidney patients. Doctors noticed a mysterious, fatal condition in patients undergoing long-term dialysis who, previously mentally sharp, began suffering from stuttering, seizures, and rapid-onset dementia. It became known as ‘Dialysis Dementia.’
In 1976, Dr. Allen Alfrey identified the cause: aluminum. The water used for dialysis contained aluminum which, because the patients’ kidneys weren’t working, crossed the blood-brain barrier and destroyed grey matter. The results of the data was crystal clear: aluminium is unambiguously neurotoxic, it definitely causes dementia and alzheimers “like” symptoms, so the debate would have to shift towards just how much is toxic, and where in the body it must go before it produces toxicity.
The discovery triggered years of growing anxiety among pediatricians. Throughout the 1980s and early 90s, they tried to sound the alarm that premature infants were physiologically almost identical to these dialysis patients. Like them, premature babies have very low kidney function, and like them, they are often fed intravenously (IV).
The concern was that the IV feeds used for babies—complex mixtures of amino acids and electrolytes—were heavily contaminated with aluminum as a manufacturing byproduct. For two decades, researchers argued that by feeding premature babies this way, they were bypassing the gut’s natural barrier which blocks 99% of ingested aluminum. It was delivering a known neurotoxin directly into the bloodstream of infants who couldn’t excrete it.
Finally, in 1997 the hypothesis was tested. The Bishop study was a randomised control trial in which one group of preterm babies were fed aluminium rich feed, and the other were fed aluminium depleted feed. Those babies were then followed up at 18 months, and the results were stark. It was the validation of twenty years of warnings.
The babies fed with aluminium contaminated feeds had statistically significant impaired mental development. The study proved that when aluminum accumulates in a baby, it significantly increased their risk of having a Mental Development Index (MDI) below 85 —roughly 15% lower than average. Bishop and his colleagues confirmed what had long been feared: they were watching a known neurotoxin damage the development of the most vulnerable population.
The study was the primary catalyst for the FDA creating a specific federal regulation (21 CFR 201.323) to protect infants from aluminum toxicity in intravenous feeding. In 2004, the FDA fully implemented this rule, which mandates that fluids used for IV feeding must not contain more than 25 micrograms of aluminum per liter. The actual wording of the regulation created this remarkable statement:
“Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.”
When administered by IV, aluminium becomes toxic at 4 mcg per kilogram per day.
So the FDA knows that aluminium becomes neurotoxic at 4 to 5 mcg per kilo per day and crucially, it “may occur at even lower rates of administration”. The wording of their own regulation should have jolted the FDA and the medical establishment into action. Why? Because their vaccine schedule contains multiple vaccines that contain high doses of aluminium, and at 8 weeks old, infants can receive 264 mcg per kilo on a single day.
So let’s return to those who will contest these arguments, they’ll say, “see! That safety limit he is quoting is for Intravenous administration, which is not the same as vaccination!” It’s true, but the reply is simple. “If we are content to give babies fifty times the dose of aluminium that’s toxic when given via IV, then we must have very strong clinical data to support this large dose right? What exactly is the toxic dose of aluminium when given via intramuscular injection?”
These were the very questions the FDA were struggling to answer throughout the 2000s. Aluminium had long been proven as neurotoxic, it was unambiguously poisoning people who were exposed to it. Now people had realised the FDA already knew it was neurotoxic in babies when given intravenously. Furthermore, the childhood vaccine schedule was awash with high doses of aluminium. Dismissing the Hollywood stars raising these questions as cranks was their primary strategy (hello informed consent), but what if the taboo lifted? What if the mockery stopped working? They would need an answer.
So what was the FDA’s answer? What clinical data were they in possession of which determines the safety limit for injecting infants with a proven neurotoxin? They just didn’t have that data. Spoiler: they still don’t. Despite this, many advanced health economies are content to inject infants with a known neurotoxin, at 264 mcg of per kilo on multiple occasions. They have no clinical data to determine if that dose is poisonous or not. I can feel the screams from people still wed to this regulatory system saying “but the vaccines are tested in placebo controlled trials, that’s the data we use”. Are they tested against placebos? We’ll return to that… but for now let’s remain in the late 2000s.
At the end of the first decade of the millennium, with all that had happened, the FDA were in desperate need of something. They needed a defense of their use of neurotoxic aluminium in vaccines… and this is how the Mitkus paper was born.
Imagine you’re the FDA. Imagine you’re trying to get ahead of this lingering safety issue. Aluminium is dotted across your burgeoning vaccine schedule and you realise your critics have a strong case; you’re blind to its toxic effects. You have no real idea of its safety profile. You need to work out its safety profile, so you get to work designing a study. You don’t have to imagine the scenario, because subscribers to The Digger will know, I created a game that simulates this exact scenario.
It should come as no surprise that there’s a lot wrong with this study. The first and most obvious of these problems is the study isn’t a clinical trial. It didn’t gather any new data in in humans, it didn’t run toxicity tests on animals, it didn’t synthesize the hundreds of studies available on aluminium toxicity, it wasn’t a meta-analysis or a cochrane review. So what was it? It was a simple mathematical model which simulated the rate at which vaccine aluminium might clear from an infant’s body, then compared the theoretical ‘burden’ of aluminium left against a known toxic dose… for eating aluminium rather than injecting it.
What’s worse, the data they used on how fast aluminium clears from the body had two major flaws. First, it was for a totally different kind of aluminium than the one used in vaccines. The ‘clearance rate’ used was for Aluminium citrate, which is a soluble like salt and clears very rapidly, whilst the composition used in vaccines is aluminium phosphate, which is crystalline and purposefully designed not to dissolve. Imagine the difference between how a salt would feel on your tongue vs the feeling of tiny insoluble crystals.
The second major problem was the clearance data came a single male volunteer. A chap called Nicholas Priest injected himself with 0.7 mcg of aluminium, which to my calculations is tiny. An 8 week old infant receives 1900x more aluminium than this from the two first injections on the schedule. It was also a different formula to the one used in vaccines, and it was injected into a vein rather than a muscle. The dose is so small it’s likely the body can clear it immediately without ever being overloaded, hence the very rapid clearance rate which could then be fed into the Mitkus model.
Injecting it into a vein, at such a low dose, allows the kidneys to start clearing it immediately, another thing that just doesn’t happen in a real injection. Completely different formula, an order of magnitude lower dose, and a beneficial administration method. Call me a cynic, but I can’t help coming to the conclusion that this Priest study looks designed to clear Aluminium from the body as rapidly as possible. Such a finding would be very useful to the pharmaceutical and aluminium industry.
Having looked around for the very paper that props up the safety of the entire vaccine industry, I finally found it. As I always do, I looked for the acknowledgements or conflict of interest section. I often say that nothing surprises me anymore, but for some reason, this put my jaw on the floor.
The study propping up the safety of aluminium in the entire vaccine schedule, was funded by the Aluminium Association in Washington and the Aluminium Institute in London. The Priest data, worthless as it already is to the question at hand, was funded by Aluminium lobbyists.
How did Mitkus and his co-authors not come to the conclusion this Priest data was utterly useless? Because it has huge value to you if you’re trying to get a very particular answer from your modelling study. It’s really very simple, a model study is designed to get a particular answer. Change the inputs, change the assumptions, and you literally change the answer. To really cover your tracks, you need multiple bogus, irrelevant, exaggerated, or selectively chosen numbers, and hey presto, you get your answer. Garbage in, Garbage out. Even here that phrase underplays what’s happening, because what the modellers ‘get out’ is exactly what they need. Garbage in, regulatory gold out.
We can state the Mitkus model in english, because in doing so all of its assumptions and absurdities percolate to the surface. When we write out what the model does in english, it would say "If we assume that 1320 mcg of solid vaccine nanoparticles injected into muscle dissolve and clear just as rapidly as the 0.7 mcg soluble aluminum salts Dr. Priest injected into his own blood, and if we determine the 'safe limit' by calculating the body burden derived from eating aluminum, and do so using the a high 0.78% absorption rate rather than using the strict limits for intravenous fluids, then the mathematics confirm the aluminium in the vaccine schedule is safe."
There are so many other reasonable numbers that Mitkus could have put into their model, and near enough every combination you might try would get you a ‘TOXIC’ result, but the set of numbers Mitkus chose to use, as bizarre as each choice is, gets them a result of “NOT TOXIC”. The reason I wanted to turn this into a game was because explaining it all is so tedious that I’d simply lose you all at how absurd the their choices are. Needless to say that the Mitkus paper, like the Priest paper, was absolutely designed to produce a ‘non toxic’ result, and it has now been propping up the use of high doses of neurotoxin in the childhood vaccination schedule for at least 15 years.
You’ll find this ‘data’ (a mathematical equation with interchangeable inputs) dotted across UK, European and American healthcare literature designed to convince you they’ve done their homework. They haven’t. The doses of aluminium they’re injecting into infants is large, it’s true effect on those infants is not understood, but there’s good reason to believe it is causing serious harm. The Mitkus paper should in the very least have been an animal study in which the animals were given the vaccination schedule, then sacrificed and studied to examine if and where aluminium was absorbed into their body. Why didn’t the regulators do this? Why haven’t UK regulators done it? Why haven’t european regulators done it? We’ll investigate further in part three.
I am sure you are aware of our published paper on Mitkus et al., see https://www.sciencedirect.com/science/article/abs/pii/S0162013417303380?via%3Dihub
Brilliant article, very readable and understandable for those of us without a strong scientific background. And brilliant work by Dr Exley, too.