Is a re-examination of the safe levels of aluminium in vaccines required?

In February 2013 I raised a number of questions with the Medicines and Healthcare Regulatory Agency (MHRA) in relation to aluminium in vaccines. These questions were sent as a request under the Freedom of Information (FOI) Act 2000 and followed the receipt of promotional material from the Department of Health regarding immunisation of children.

My questions focused on the amount of aluminium that would enter into the body, bloodstream and brain of a child recipient and requested safety information in relation to this, including provision of scientific studies and/or evidence to support it.

The MHRA’s initial response was inadequate, as concluded by an internal review of the FOI response, and they were requested to provide a revised response, which was received in June 2013.

In summary, the MHRA conclude that an average boy following the Government recommended immunisation programme in the UK (excluding Gardasil and influenza vaccines) would receive 3.215 mg of aluminium intramuscularly. They emphasise that this is over a period of greater than 10 years and is far less than aluminium exposure from other environmental sources, including foods.

Following my reply to the MHRA’s initial FOI response they updated their revised response to state “exposure through the digestive system differs from exposure via vaccination as these are generally administered intramuscularly or subcutaneously. Mitkus et al. [2011] state that the body burden of aluminium from vaccines is not more than 2-fold higher than that received in the diet [my emphasis added]” and I will discuss the highlighted component later in this article.

The MHRA confirmed at the time that they do not hold data on how much of the aluminium enters into the bloodstream or brain. They do however accept evidence exists showing some aluminium “is retained in the body and some [is] found in the brain [but are] unaware of any evidence that demonstrates that aluminium from vaccines crosses the blood-brain barrier [or] that the aluminium in vaccines poses any serious health risks.” On these points, it is quite obvious that it would be difficult to determine whether aluminium deposits in the brain were from vaccines or other sources, unless of course studies existed looking at brain tissue from vaccinated versus unvaccinated human subjects. It is interesting to note the use of the term “serious health risks” regarding aluminium in vaccines, perhaps this needs to be addressed further to determine the non-serious health risks the MHRA are aware of.

Despite the apparent lack of studies comparing vaccinated versus unvaccinated people, there is clear evidence of the presence of aluminium in brain tissue, with extensive work being carried out by Professor Christopher Exley at Keele University. Some of his work was also brought to the attention of the MHRA in a separate FOI request in August 2018, regarding a potential link between aluminium from various sources, including vaccine adjuvants, and autism, however they would rather rely on epidemiological studies to determine vaccine safety. The MHRA are quite adamant when it comes to vaccines causing autism claiming that “the evidence is very clear that no such association exists.”

Returning to my earlier FOI request, it is apparent from the MHRA’s response that they and (according to the MHRA) the WHO rely extensively on work conducted by an FDA scientist Dr Robert Mitkus in a 2011 study titled ‘Updated aluminum pharmacokinetics following infant exposures through diet and vaccination’ published in the journal Vaccine. This study relies heavily on modelling and assumptions, as was pointed out to the MHRA by me, however they continue to rely upon it for the safety of vaccines in children in the UK. In their response, the MHRA state “using [their] assumptions Mitkus et al. modelled the slower release of aluminium adjuvant from the site of injection and at no time found that the estimated level of aluminium in infants exceeds the minimum risk levels (MRL) body burden [and] that the body burden of aluminium from vaccines is not more than 2-fold higher than that received in the diet.”

However, the co-founder of Children’s Health Defence, J.B Handley, when discussing the Mitkus et al. study understands that scientists studying the effects of aluminium adjuvants believe the study to be “somewhere between a professional disgrace and a fraudulent disaster.”

In addition to the above concerns these scientists share with the Mitkus et al. study, the Physicians for Informed Consent (PIC), an educational nonprofit organization focused on science and statistics have produced an erratum to the Mitkus et al. study exposing how the MRL used by Mitkus et al. is out by a factor of 7.8. As shown in the PIC graph below, taken from the erratum, “scaling down the MRL curves calculated by Mitkus et al. by a factor of 7.8 produces results that contradict the conclusions reached by Mitkus et al. concerning the safety of aluminium quantities in vaccines.”

In a separate PIC article, which also discusses how the FDA’s Mitkus et al. paper assumed that nearly 8 times (0.78%/0.1%) more aluminium can safely enter the bloodstream, it describes how, according to the PIC authors, Mitkus et al. incorrectly concluded that “aluminium exposure from vaccines was well below the safety limit.” The same article then goes on to quote Dr Christopher Shaw, professor at the University of British Columbia, who has performed numerous studies on the effects of injected aluminium on mice, as commenting:

“We knew that the 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”

It is apparent to me at least that, in light of the above, and when there is such a heavy reliance on the Mitkus et al. study, the MHRA should, at the very minimum, review their understanding of what the safe level of aluminium exposure from vaccination and the environment for children is. They need to then determine whether the current UK immunisation schedule fits within these findings and adjust accordingly if not.


Main image courtesy of CDC from Pexels



Nicholas Wells

Date Published

13th October 2020

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