Major Error Found in Vaccine Aluminum Safety Calculation

When evaluating the safety of vaccines, adjuvants must be taken into account. The most commonly used vaccine adjuvant is aluminum,¹ a demonstrated neurotoxin that is added to certain vaccines to increase your immune response and, with that, theoretically a higher response of protective antibodies.

Despite aluminum's known health risks, it's widely suggested that aluminum in vaccines is safe, including for newborn babies, but a math error in a key U.S. Food and Drug Administration study² — revealed by scientists at Physicians for Informed Consent (PIC) — raises new safety concerns.

When the aluminum adjuvant was first approved for use in vaccines more than 90 years ago, it was approved based on demonstration of efficacy — safety studies weren't performed. A 2002 document from the FDA even states:³

"Historically, the non-clinical safety assessment for preventive vaccines has often not included toxicity studies in animal models. This is because vaccines have not been viewed as inherently toxic, and vaccines are generally administered in limited dosages over months or even years."

That being said, in 2002, researchers with the U.S. Centers for Disease Control and Prevention's Agency for Toxic Substances and Disease Registry (ATSDR) released a study on the effect of medical aluminum exposure on public health in order to estimate the infant body burden of aluminum in infants following a standard vaccination schedule during the first year of life.⁴

They found that, while the body burden of aluminum from vaccinations exceeded that from dietary sources, it was still below the minimal risk level established by ATSDR. In 2011, FDA scientists updated the 2002 study with a current pediatric vaccination schedule and other updated parameters,⁵ and that is where PIC found what is described as a "crucial math error."

Error Suggests Aluminum in Childhood Vaccines May Not Be Safe

The 2011 paper compared aluminum exposure from vaccines in infants to the ATSDR safety limit of oral aluminum. They concluded at the time:⁶

"Using these updated parameters we found that the body burden of aluminum from vaccines and diet throughout an infant's first year of life is significantly less than the corresponding safe body burden of aluminum modeled using the regulatory MRL.

We conclude that episodic exposures to vaccines that contain aluminum adjuvant continue to be extremely low risk to infants and that the benefits of using vaccines containing aluminum adjuvant outweigh any theoretical concerns."

In an erratum published by PIC, however, it's noted that the study based its calculations on 0.78% of oral aluminum being absorbed into the bloodstream instead of the value of 0.1% used by the ATSDR.

"As a result," PIC noted, "the FDA paper assumed that nearly 8 (0.78%/0.1%) times more aluminum can safely enter the bloodstream, and this led the authors to incorrectly conclude that aluminum exposure from vaccines was well below the safety limit."⁷ Christopher Shaw, a professor at the University of British Columbia who has studied the effects of injected aluminum, explained in a news release:⁸

"We knew that the [2011] Mitkus et al. paper modeling aluminum clearance had to be inaccurate since it was assuming that injected aluminum kinetics were the same as the kinetics of aluminum acquired through diet.

Now, in addition, we see that they did their modeling based on using the incorrect level of aluminum absorption. What is particularly striking is that despite all these errors, since 2011, Mitkus et al. is used by CDC and other entities as the basis for claiming that aluminum adjuvants are safe."

Serious Concerns Over Aluminum Adjuvants

In 2011, Shaw and Canadian scientist Lucija Tomljenovic published a paper in Current Medicinal Chemistry questioning whether aluminum vaccine adjuvants are safe. They cited experimental research that showed aluminum adjuvants may cause serious immunological disorders in humans and pose a risk for autoimmunity, long-term brain inflammation and associated neurological complications.

"In our opinion, the possibility that vaccine benefits may have been overrated and the risk of potential adverse effects underestimated, has not been rigorously evaluated in the medical and scientific community," they wrote.⁹

In one of their studies, mice were injected with aluminum at a dose meant to correlate with that given to U.S. children through vaccines, and they spaced out the injections based on the mice's developmental stages. What they found was that once the mice reached adulthood (which occurs at the age of 6 months), the treated mice had permanent behavioral impairments.

In addition to noting that aluminum adjuvants can persist in the body long-term and penetrate the blood-brain barrier, the adjuvants were found to trigger adverse neurobehavioral outcomes in the mice at vaccine-relevant exposures. "Efforts should be made to reduce Al [aluminum] exposure from vaccines," they concluded.¹⁰

In another study, Shaw, Tomljenovic and colleagues suggested that aluminum may induce adverse neurological and immunological effects, and overstimulation of the immune system in early infancy via vaccinations could play a role in neurobehavioral disorders.¹¹ In 2014, Tomljenovic and colleagues wrote:¹²

"There is now sufficient evidence from both human and animal studies showing that cumulative exposure to aluminium adjuvants is not as benign as previously assumed.

Given that vaccines are the only medical intervention that we attempt to deliver to every living human on earth and that by far the largest target population for vaccination are healthy children, a better appreciation and understanding of vaccine adjuvant risks appears warranted."

Further, in an interview I conducted with Tomljenovic in 2015, she explained:

"There is a huge body of research that shows that if you overstimulate the immune system at the periphery, especially in the critical stage of early development, you are going to influence the brain in a negative way, and by doing so, you can create irreversible damage.

Again, this is research that is rarely discussed, because it really shows that there is reason to question the safety of the burden of vaccines given to infants."

Problems Inherent to Adjuvants

Dr. Suzanne Humphries, author of "Dissolving Illusions: Disease, Vaccines, and The Forgotten History," is among those who has raised concerns over the problems with not only aluminum but also adjuvants in general, since they're intended to provoke an inflammatory immune response.

As noted by Humphries, who spoke on the subject of aluminum in vaccines in Tampere, Finland, in November 2015, "babies are programmed to be anti-inflammatory," meaning the placenta and breast milk help "program" the child to maintain a noninflamed state.

In order to make these killed, subunit or toxoid vaccines work, an adjuvant must be used to sufficiently stir or aggravate the immune system into action. By so doing, vaccines "violate the natural programming of the baby's immune system."

Further, even if aluminum is removed from vaccines, the risk of immune system brain disorder remains — even if the new adjuvant is nontoxic. As explained by Tomljenovic in our interview, by overstimulating your immune system, you run the risk of breaking self-tolerance and leading to autoimmunity. Japanese researchers revealed this in a 2009 study on mice, concluding:¹³

"Systemic autoimmunity appears to be the inevitable consequence of over-stimulating the host's immune 'system' by repeated immunization with antigen, to the levels that surpass system's self-organized criticality."

What's more, without aluminum, a large number of vaccines would have to be eliminated since there are no viable alternatives. Perhaps this is why researchers looking into adverse events after immunization with an aluminum-containing vaccine wrote in 2004, "Despite a lack of good-quality evidence we do not recommend that any further research on this topic is undertaken."¹⁴

Aluminum Linked to Alzheimer's

In the 2002 ATSDR study, the researchers were clear about aluminum's distribution pattern in the body, including the fact that it "distributes widely to the various body tissues," reaching the kidneys, spleen, liver, heart, lymph and eventually the brain.¹⁵ Aluminum has a known ability to cross the blood-brain-barrier, so any aluminum in the blood can be transported into the brain.

Research has found a strong link between aluminum exposure and Alzheimer's disease. Patients with a genetic mutation that predisposes them to early onset of Alzheimer's and more aggressive disease have universally high aluminum content in their brains.¹⁶ Aluminum may damage your brain function in a number of ways, including:¹⁷

• Adversely influencing neuronal function and survival
• Potentiating damaging redox activity
• Disrupting intracellular calcium signaling that systematically wears down cellular defenses
• Worsening the adverse effects of other heavy metals
• Influencing gene expression

A 2010 paper also pointed out that aluminum salts "can increase levels of glial activation, inflammatory cytokines and amyloid precursor protein within the brain," and, "Both normal brain aging and to a greater extent, Alzheimer's disease are associated with elevated basal levels of markers for inflammation."¹⁸

CDC Vaccine Schedule Leads to Greatest Aluminum Burden

Research published in the Journal of Trace Elements in Medicine and Biology found the CDC's childhood vaccine schedule — when adjusted for bodyweight — exposes children to a level of aluminum that is 15.9 times higher than the recommended "safe" level.^19,20

The researchers pointed out that previous efforts to assess the aluminum burden created by vaccines were based on "whole-body clearance rates estimated from a study involving a single human subject."

They also used an aluminum citrate solution that is not used in vaccines, which may affect the excretion rate. Further, infants have immature renal function, which will inhibit their ability to filter and excrete toxins in the first place. The researchers used three models in to estimate the expected acute and long-term whole-body accumulation of aluminum in children as follows:

1. The CDC's 2019 childhood vaccine schedule
2. The CDC's vaccine schedule modified to use low dose aluminum DTaP and aluminum-free Hib vaccines
3. Dr. Paul Thomas' "vaccine-friendly plan,"²¹ which recommends giving only one aluminum-containing vaccine per visit (max two) and delaying certain vaccinations

The CDC's standard schedule resulted in the greatest expected aluminum burden in all model assumptions, while Thomas' schedule resulted in the lowest.

Further research into these options should be a priority for vaccine research, considering the serious questions about the safety of aluminum in vaccines and the fact that considering aluminum-free vaccines or at least limiting the number of aluminum-containing vaccines received at one time may be prudent.

Increasing research is the goal PIC hopes to reach by publishing the math error in the featured 2011 study as well. In a news release, Dr. Shira Miller, president of PIC, said:

"We posted the Mitkus 2011 erratum … in hopes of bringing it to the attention of scientists and researchers who are interested in the safety of the quantities of injected aluminum found in childhood vaccines and would be in a position to further research the safety concern."²²