# The literature on aluminum adjuvants is very suspicious. Small IQ tax is plausible - can any experts help me estimate it?

I am a PhD biostatistician who has worked on a project in this area. I am hoping to crowdsource opinions on this issue, especially from readers with knowledge of neurology, nephrology and/or toxicology.  
  
The recent news cycle motivated me to spend some time reading up on the safety literature for aluminum vaccines. Aluminum is not in the Covid vaccine, but it is in many [childhood vaccines](https://www.cdc.gov/vaccinesafety/concerns/adjuvants.html).  
  
I am deeply unsettled by what I found. Here is a summary. I would appreciate being corrected in the comments:  
  
\- The science on this topic is surprisingly neglected. Aluminum is a known neurotoxin in small concentrations in the brain. So, the obvious follow-up question: "Is the amount accumulated from childhood vaccines so small as to be irrelevant?" Unfortunately, aluminum has not undergone rigorous safety testing for cumulative cognitive effects. **The fact that I** **could not find a convincing answer reflects a multi-decade policy failure.**  
  
-The evidence for safety cited by regulators and mainstream review papers appears to have **gaping issues** (see end of post for notes on the studies Mitkus et al (2011) and Karwowski et al (2018). They do not justify anywhere near the amount of faith being placed in them.)  
  
-Mainstream educational sources are gaslighting readers by suggesting that the net exposure in vaccines is less than dietary exposure, e.g. here is what [CHOP's Vaccine Education Research Center](https://www.chop.edu/centers-programs/vaccine-education-center/vaccine-ingredients/aluminum) says  
![](https://39669.cdn.cke-cs.com/rQvD3VnunXZu34m86e5f/images/82f15cccdf5fafbdcc6497894caf4224404dd709fd4f7745.png)  
 but this fails sanity checks with basic multiplication, given the oral bioavailability of aluminum is about [0.1 - 0.3% in diet and <0.01% in antacids according to the ATSDR](https://www.atsdr.cdc.gov/ToxProfiles/tp22-c2.pdf). No wonder people are going nuts about the public health experts.  
  
-There is a whole literature of claims on blood brain barrier mechanics, chemical state of the aluminum after injection, and transport via macrophages, which regulators are ignoring, but should probably affect the analysis of Mitkus 2011. I am entirely unqualified to judge and don't particularly trust this literature, so I'm ignoring this but looking forward to comments on the topic.  
  
-Alternatives to aluminum exist, including mRNA and other new adjuvants. In the 2000's, regulators pushed industry to remove mercury from childhood vaccines; they should consider doing this again.  
  
-A cognitive tax due to aluminum on the scale of ~0.1 IQ point for the first Hepatitis B shot is plausible (that's just from the first 250 micrograms of Al. There are > 4 mg in the whole schedule). That's my rough fermi estimate, based on an experiment showing developmental delay in premature infants exposed to hundreds of micrograms aluminum in IV fluids ([Bishop et al 1997](https://pubmed.ncbi.nlm.nih.gov/9164811/)). This estimate is extremely sensitive to assumptions about renal clearance and sensitivity of brain development in premature infants compared to full term. Can anyone suggest a more accurate method? With this approach: does anyone know enough nephrology to pin down the length of time that intravenous aluminum in Bishop's premies would have spent circulating in blood, given their reduced renal function? Anyone know enough neuro to comment on whether impacts on cognitive development should be linear in the amount of neurotoxin? How much larger should it be in premies vs term infants?  
  
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Notes on failures in the literature:  
  
Claims of safety of aluminum seem to bottom out in mainly two papers: Karwowski et al (2018) and Mitkus et al (2011). The FDA cites Mitkus 2011 to determine a tolerable risk level of aluminum exposure and argues that vaccine exposure is below it; the UK health authority and various review papers (such as [this one](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7090020/#B29))) cite Karwowski as evidence of low accumulation of aluminum in infants.

**Study 1**

-[Mitkus et al (2011)](https://pubmed.ncbi.nlm.nih.gov/22001122/) which the FDA commissioned on this topic, argues that exposure to aluminum due to vaccines is low compared to oral exposure limits. The trouble is that the study uses an old and unusually large dietary absorption figure (0.78%) \[apparently Keith et al 2002, to which Mitkus is an update, uses the same number\], and that 0.78% number is now well out of range from more recent estimates: average 0.1% bioavailability from diet according to the [ATSDR](https://www.atsdr.cdc.gov/ToxProfiles/tp22-a.pdf).

This criticism is also made [here](https://www.prweb.com/releases/physicians_for_informed_consent_reports_on_researchgate_landmark_fda_paper_on_aluminum_safety_in_vaccines_has_crucial_math_error/prweb16960398.htm). If this criticism is correct, vaccine exposure appears to be well above the scale of dietary aluminum exposure. Eyeballing the figures in Mitkus, reducing the MRL by a factor of 8 seems to consume more or less the entire safety margin, and should reverse the conclusion of safety. I have been unable to find an adequate regulatory response to this criticism.

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**Study 2:**

-[Karwowski et al (2018)](https://pubmed.ncbi.nlm.nih.gov/28919482/) is cited in a number of review articles to argue that the body aluminum burden in infants attributable to vaccine Al content has been minimal. But based on the limited results presented, the study does not seem capable of supporting such a takeaway, due to lack of variability in the regressor variable (total vaccine aluminum dose). The analysis runs a regression and finds that aluminum contents in the blood and hair of 9-13-month-olds are not correlated with prior vaccination aluminum exposure. But the spread of the aluminum exposure range in their data is incredibly small, so this regression analysis could not have had any power to detect a signal. I can't be certain because they don't plot their data or report a coefficient table, but the paper says of their sample: "Median estimated cumulative vaccine aluminum load was 2.9 mg (range: 1.43-3.55mg, ***IQR = 0.11mg***)." Most of their patients were following the schedule - great for the patients! But terrible for the experiment quality. The small variability they did have was probably age-correlated - so, the increased aluminum due to having had more shots would have been spread out in a larger infant's body. Not to mention, hair gets cut by the time a child reaches 13 months, blood clears rapidly, and the early exposure is probably what matters most for the brain. **This study appears to be basically useless**, and it is damning that a mainstream review such as [Destafano, Bodenstab, and Offit (2019)]( https://pubmed.ncbi.nlm.nih.gov/30753348/) would say: "The strongest evidence of the safety of aluminum in childhood vaccines is provided by \[Karwowski et al 2018\]."