Aluminium (Aluminum) Hydroxyphosphate Sulphate and the HPV Vaccine

Evil by any other name

Recently I was asked to comment on the aluminium adjuvant, aluminium hydroxyphosphate sulphate (AAHS) used in the HPV vaccine, Gardasil. I am sharing my opinion on this aluminium adjuvant with you in this musing. Please read this in the context of my previous posts ‘Under The Skin’ and ‘HPV Vaccine’.

I began by asking myself the question.

Why does Merck continue to use their self-proclaimed proprietary adjuvant, aluminium hydroxyphosphate sulphate (AAHS) in the Gardasil vaccine?

Actually, to my knowledge, Merck’s homemade adjuvant is not proprietary, as neither it, the aluminium salt, nor its use is protected in law. So why does Merck use this adjuvant and not one of the more conventional aluminium adjuvants such as aluminium oxyhydroxide or aluminium hydroxyphosphate. One might also turn this question around and ask why other vaccine manufacturers do not use Merck’s adjuvant.

This is a conundrum. The manufacture of aluminium adjuvants is not, as they say, rocket science. Rather it is bucket science and requires the cheapest of ingredients and the most basic of technology. Even better, it is completely unregulated and there are no checks upon the consistency and composition of the final product barring the most elementary internal checks by the manufacturer. Neither the FDA nor the EMA measure the aluminium content of vaccines. They wholly rely upon information provided to them by the manufacturer (see, for example).

So why does Merck choose to complicate the formulation of an aluminium adjuvant by adding an additional step to the manufacturing process. The additional step essentially involves partial substitution of phosphate on an amorphous aluminium hydroxyphosphate matrix with sulphate. Thus, where there were only phosphate groups, as for aluminium hydroxyphosphate, there are phosphate and sulphate groups in Merck’s aluminium hydroxyphosphate sulphate adjuvant. Sometimes abbreviated as AAHS.

The fascinating history of AAHS suggests very strongly that it was not developed specifically for use in Gardasil (see the recent paper.)

It was used in vaccines prior to Gardasil though it was described in Merck’s vaccine literature as something else, often just plain aluminium hydroxide. I assume that the latter was to protect their application of AAHS against a requirement for clinical studies demonstrating its safety, as would otherwise be required for any vaccine that included a novel adjuvant. However, why use a novel adjuvant, AAHS, when other so-called tried and tested aluminium adjuvants are readily available. Why go through what is essentially a cover up to use their novel adjuvant when other adjuvants should suffice.  

I think that the answer is relatively straightforward and relates to an historical ignorance of how aluminium adjuvants really work (see, my seminal paper.)

The role of the aluminium adjuvant is to trick the body into ‘thinking’ that it is under attack from a foreign substance, such as a bacterium or virus. Vaccines that use ‘live’ antigens, such as the disease-causing entity be it a virus or a bacterium have a chequered history of safety and efficacy. They are designed to give the vaccine recipient a mild form of a disease. Mild being a condition that an individual copes with without undue suffering while also imprinting the memory of that disease for the body’s future reference. This is the theory. However, there are no mild forms of some diseases (e.g. anthrax) and there is the additional problem of creating in recipients a live vaccine form of a disease that through mutation may eventually circumvent the body’s defences (e.g. polio). For these reasons alone alternatives to live vaccines are required if vaccination against a disease is required.

Adjuvants are used to fill this void. Rather than inject a live antigen such as a virus or bacterium, adjuvanted vaccines are composed of something, usually a protein or derived from a protein, from the virus or bacterium in question that is believed to be antigenic. This ‘dead’ antigen does not cause a mild form of the disease and in essence is not usually in itself sufficiently antigenic to instigate any form of immune response. The latter problem could probably be overcome if a greater concentration of the dead antigen was injected. However, dead antigens are actually quite expensive, as they have to be manufactured, for example in a chicken egg, and processed to be suitable thereafter for injection in a vaccine. Creating vaccines that included sufficiently large amounts of dead antigen would invariably make a vaccine uneconomic. It would also make the vaccine much more difficult to manufacture and bring to the market.

Aluminium adjuvants are the vaccine manufacturers ‘dirty little secret’, their answer to the expense and inconvenience of ‘dead’ vaccines while also avoiding the many potential complications of using live vaccines.

Vaccine manufacturers have never admitted to any detailed understanding of how aluminium adjuvants really work. They have colluded with ‘the great and the good’ of immunology in perpetuating a number of myths relating to their mechanism of action such as the depot theory among others. They have also colluded with the aluminium industry in suggesting that aluminium salts used as adjuvants in vaccines are benign with absolutely no health or safety implications whatsoever. Do they really expect others to accept such nonsense? If aluminium adjuvants are so benign, why do they work? If they are so benign, why does the repeated use of aluminium adjuvants as placebos in vaccine clinical trials result in myriad serious adverse events in vaccine recipients (see for example.)

Aluminium adjuvants are only effective because they induce acute cytotoxicity at the vaccine injection site (see my paper.)

It is this toxicity, characteristically a reddening of the skin at the injection site due to a local inflammatory reaction, which attracts immune-reactive cells to the vaccine injection site. These cells set about cleaning up the cellular debris, the particles of aluminium adjuvant AND any co-injected dead antigen at the vaccine injection site (see for example.) The latter manifesting as the basis for any possible immune reaction and the eventual production of antibodies against the dead antigen in question.

Vaccine manufacturers test the efficacy of their vaccine by measuring blood-based antibody titres against the dead antigen. They are looking at quantitative indices as well as persistence of the antibody response. The amount of aluminium salt included as an adjuvant depends upon these indices. If antibody titres are too low and/or too short-lived then more aluminium salt will be included in the preparation. Similarly, they do not want antibody titres to be too high or too persistent; they do not want to give the recipient the disease they are supposedly vaccinating against.

This is how the aluminium content of a vaccine is regulated, if regulated at all. Regulation is based solely upon the efficacy of a vaccine to induce an optimum antibody response. Absolutely no quarter is given to the toxicity of the aluminium adjuvant beyond its role in initiating antibody production.

In this respect, aluminium salts are ideal adjuvants as there are absolutely no regulations governing their use. This means that there is no regulation on the amount of aluminium that can be injected and there is no regulation on the nature of the aluminium salt used as an adjuvant. In essence, it goes even further than this in that there is clear collusion between industry and regulators in not recognising that different aluminium salts will have different biological effects upon injection. This latter point, that different aluminium salts have different biological effects upon injection, has actually been acknowledged, even highlighted, by Merck scientists studying AAHS.. However, this publication apart, manufacturers and regulators alike consider all aluminium salts equally benign.

Merck’s choice of AAHS over other commercially available aluminium adjuvants is wholly economical. At some point in Merck’s history of using aluminium adjuvants in the manufacture of vaccines, they probably inadvertently created an aluminium adjuvant that was consistently more potent than either aluminium oxyhydroxide or aluminium hydroxyphosphate. The bucket chemistry of aluminium adjuvant manufacture lends itself easily to such an explanation of how they began to use AAHS. By using AAHS, they found that they were able to use dead antigens with lower potency and, importantly, significantly lesser amounts of such antigens per vaccine injection. It is a critical consideration that the antigen is the only expensive part of a vaccine; costs cannot be cut elsewhere so any reduction in cost of the antigen per vaccine is a considerable increase in profit per vaccine.

In using AAHS Merck takes full advantage of overt collusion between governments and the aluminium industry in classifying aluminium as wholly benign in the human body. All parties know this to be untrue but only money is at stake here not human suffering.

I know that Merck is well aware of the toxicity of their adjuvant. I am not saying that they understand why it is so toxic but their actions in ensuring that it is not independently tested for safety prove this point. They are, of course, not alone in this respect, as there have not been any clinical trials to asses adequately the safety of aluminium adjuvants used in human vaccination.

The sulphate group in AAHS is critical to its increased potency and hence toxicity. I asked Merck on more than one occasion to provide me with samples of AAHS so that my group could study its efficacy as an adjuvant. They refused each time both formally by letter, citing no reason, and informally by simply ignoring my requests.

I built my scientific reputation on a detailed understanding of the bioinorganic chemistry of aluminium (over 200 peer-reviewed published papers, see my website).

My research on the inorganic chemistry of aluminium is published in esteemed chemical journals and is included in latest editions of textbooks on aluminium chemistry. I am entirely confident that if we had had the opportunity to study AAHS we would have identified the critical issue at the heart of its potency as an adjuvant. We would have shown that the presence of sulphate in its structure, a much more acidic anion than phosphate, increases the dissolution of adjuvant at the injection site and so resulting in a higher concentration of the biologically-reactive Al³⁺_(aq). In the simplest terms, AAHS delivers more bang for your buck than either aluminium oxyhydroxide or aluminium hydroxyphosphate. This particular acuity is not only efficient in enabling a high antibody titre of the dead antigen but it is also more potent in raising an antibody response to Al³⁺_(aq). The latter is almost certainly why the HPV vaccine is responsible for myriad serious adverse events and including such debilitating conditions as ME/CFS and POTS.

More specifically it is why AAHS in Gardasil is responsible for myriad adverse effects in a high proportion of recipients, at least 2% of recipients based upon Merck’s own clinical trial data. It has long since been time that Merck follows the example of Glaxo Smith Kline and Cervarix (see my paper) and withdraws Gardasil from the market until it is proven safe for human use.

To conclude, it has been my opinion for several years now that there should be a moratorium on the use of aluminium adjuvants in human vaccination and subcutaneous immunotherapy. The accepted facts that as many as 2% of recipients of aluminium adjuvanted vaccinations suffer a wide continuum of serious adverse effects including death is unequivocal testimony to the danger of these products. The accepted fact that in clinical trials a similar proportion of individuals receiving so-called placebos including aluminium adjuvants suffer similar if not identical serious adverse effects is unequivocal testimony to the role of aluminium in causing these serious adverse effects. It is my opinion that the myriad documented illnesses suffered by individuals following vaccination against HPV with Gardasil are caused by the AAHS adjuvant used in this vaccine. There are no safety trials for Gardasil that refute this opinion.

End the tyranny of Gardasil now.