By Peter C. Gøtzsche at Brownstone dot org.

It has been surprisingly difficult to get an answer to a simple and highly relevant question: Is aluminium in vaccines harmful? After having studied the best evidence we have, the randomised trials, in great detail, I conclude that the answer is yes.

Like lead, aluminium is a highly neurotoxic metal. We will therefore expect vaccines containing aluminium adjuvants to cause neurological harms if the aluminium enters the nervous system in neurotoxic amounts.

The aluminium in the adjuvant is important for eliciting a strong immune response in non-live vaccines and their efficacy is related to their toxicity at the injection site. Immune-reactive cells engulf particles of aluminium adjuvant and distribute their load throughout the body, including to the brain, where they are killed, releasing their contents into the surrounding brain tissue where they can produce an inflammatory response.

The precise mechanism of action is not so important, but the data we have on the harms are, and they have been systematically distorted.

False Information from the European Medicines Agency (EMA)

In October 2016, my research group complained to the European Ombudsman about the EMA's mishandling of their investigation into the suspected serious neurological harms of the HPV vaccines. In his reply to the Ombudsman, EMA's Executive Director Guido Rasi stated that the aluminium adjuvants are safe; that their use has been established for several decades; and that the substances are defined in the European Pharmacopoeia.

Rasi gave the impression that the aluminium adjuvants in the HPV vaccines are similar to those used since 1926. However, the adjuvant in Gardasil, Merck's vaccine, is amorphous aluminium hydroxyphosphate sulfate, AlHO9PS (AAHS), which has other properties than aluminium hydroxide, the substance Rasi mentioned. Moreover, its properties are not defined in the pharmacopoeia. AAHS has a confidential formula; its properties are variable from batch to batch and even within batches. The harms caused by the adjuvant are therefore likely to vary. When we investigated whether the safety of AAHS has ever been tested in comparison with an inert substance in humans, we were unable to find any evidence of this.

Rasi mentioned that the assessment of the evidence for the safety of the adjuvants had been performed over many years by the EMA and other health authorities, such as the European Food Safety Authority, the FDA, and the WHO.

However, none of his five references supported his claim about safety. Three links, to EMA, FDA, and WHO, were all dead. One worked two years later but contained nothing of relevance. A link to the European Food Safety Authority was about the safety of aluminium from dietary intake, which has nothing to do with aluminium adjuvants in vaccines. Very little oral aluminium is absorbed from the gut, and much of what is absorbed is eliminated by the kidneys. The last link was to a WHO report that was also unhelpful. It mentioned that the FDA had noted that the body burden of aluminium following injections of aluminium-containing vaccines never exceeds US regulatory safety thresholds based on orally ingested aluminium, which is irrelevant information.

The Randomised Trials Document the Toxicity of Aluminium Adjuvants

As an expert witness for the Los Angeles law firm Wisner Baum, I have read 112,000 pages of confidential Merck study reports. If Merck's aluminium adjuvant causes serious neurological harms, one would expect to see more harm with Gardasil 9 than with quadrivalent Gardasil because it contains five more HPV antigens and more than double as much adjuvant, corresponding to 500 µg vs 225 µg aluminium.

And this is what we see. Three trials have compared Gardasil 9 with Gardasil, but two of them were so small, only 1,095 patients in total, with only 3 serious adverse events, that they cannot shed any light on this issue. The third trial, however, was large, with a total of 14...