Researchers Found Variable Aluminum Content in Infant Vaccines Inaccurately Measured and Reported

Bioinorganic chemist Christopher Exley, PhD, who has spent decades researching, writing and speaking about the neurological adverse effects of accumulation of aluminum in the brain, co-authored an article published this year that discussed aluminum content in vaccines routinely administered to infants.¹ Long recognized as an authority on the neurotoxicity of aluminum, during his distinguished career he has published hundreds of peer-reviewed studies in respected medical and scientific journals, including Frontiers in Neurology,² the Journal of Alzheimer’s Disease,³ the International Journal of Environmental Research and Public Health,⁴ among many other publications archived by the U.S. National Library of Medicine on Pub Med.

As a recognized expert on aluminum, he was asked to examine the brain of Carole Cross, a woman who had been exposed to excessive aluminum in drinking water following an industrial accident and, ultimately, died from a rare form of dementia.⁵ At the inquest after her death, Exley described the levels of aluminum found in her brain as “beyond belief.”⁶

Professor Exley’s reputation for possessing a thorough knowledge of, expertise in and ability to clearly communicate reasons for why aluminum is toxic if it accumulates in the human body has earned him the moniker “Mr. Aluminum,” and it has been said that, “Sooner or later, anyone who is interested in aluminum—and especially its effects on human health and biological systems—is bound to come across the work and writings of Christopher Exley, PhD, FRSB, professor of bioinorganic chemistry at Keele University in the United Kingdom.⁷ His latest book is entitled “Imagine You Are An Aluminum Atom: Discussions With Mr. Aluminum.”⁸

Unpopular Vaccine Research Leads to Retaliation

As Dr Exley has become more vocal about the potential for neurologic damage caused by aluminum and has re-examined the scientific evidence that aluminum vaccine adjuvants may play a role in the development of Alzheimer’s and autism,⁹ he has been attacked professionally and personally by those attempting to stop his research. A group of 100 scientists wrote a letter of support for his pioneering research into the link between aluminum and brain dysfunction “to express our concern over the possible interruption of research on aluminum and disease conducted by Christopher Exley and his group in your (Keele) University. They said:

We feel that Christopher Exley’s work conducted for so many years in line with the previous research of late Pr Birchall at Keele University has been an important service to the scientific community, patients and society in Europe and globally. We firmly declare that Pr Exley has always defended rigorous research independent of commercial conflicts of interest, and has freely carried out his research without any control by any of his sponsors.¹⁰

Nevertheless, even a quick online search finds a number of attacks on his reputation, alleging that he is “clueless,” “a pseudoscientist” and “the latest darling of the anti-vaccine movement.” The most often cited arguments challenging Professor Exley’s well documented evidence that accumulation of aluminum in the brain is toxic is that aluminum is a metal found in the earth and in the air, food and water, and that the exposure through vaccines is so low and poorly absorbed it can be assumed to be safe.¹¹

The FDA reported that their study on the safety of aluminum in childhood vaccines calculated an “insignificant” risk by totaling the amounts of aluminum for each vaccine included on a baby’s first-year vaccine schedule. Based on the exposure as it was calculated by federal health officials, that study concluded the “maximum amount of aluminum an infant could be exposed to over the first year of life would be 4.225 milligrams (mg), based on the recommended schedule of vaccines.”¹²

New Evidence Shakes the Foundation of Safety Argument

In the recently published study evaluating aluminum content in childhood vaccines, Dr. Exley and his colleagues provided evidence that the FDA’s method of determining total aluminum exposure from first-year vaccines may be based on a false set of data.¹³ They concluded that the amount of aluminum used in 13 childhood vaccines, as reported by the vaccine manufacturers, is not accurate for the majority of vaccine products. Further, they pointed out that there is no oversight to verify the accuracy of the amounts reported in product information inserts for vaccine administrators and users. The European Medicines Agency (EMA) and the FDA are responsible for validating the content of vaccines,¹⁴ including amounts of vaccine ingredients, but tend to rely on information provided by the manufacturers themselves.

Aluminum Salts Common in Inactivated Vaccines

Aluminum salts are the most commonly used vaccine adjuvants added to inactivated vaccines to provoke a strong immune system reaction and have been in diphtheria and tetanus vaccines since the 1930s and in pertussis containing vaccines since the late 1940s.^{15 16} Although it is recognized that aluminum adjuvants trigger a humoral immune system reaction, activating an antigen-specific response, the biological mechanism for immune activation is still not fully understood.^{17 18 19}

In the study, Dr. Exley and his colleagues explain that there are three different types of aluminum salts currently in use in vaccine manufacturing. Two—aluminum oxyhydroxide and aluminum hydroxyphosphate—are available for independent study but the third—aluminum hydroxyphosphate sulphate—is exclusive to Merck and is not available for impartial study. The way the aluminum content of vaccines is reported is, to quote Exley’s study, “vague, often inaccurate and confusing.”

For example, vaccine product information inserts list total aluminum content but some also break out the amount used as aluminum salts. The type of aluminum may be listed as one type (oxyhydroxide for example) but the vaccine may actually contain a different form (like hydroxyphosphate). There also is no explanation for vaccine administrators, parents and recipients as to why the amount of aluminum in vaccines ranges from 0.125 mg per 0.5 mL dose of vaccine (Prevnar 13) to 0.85 per dose (Pediarix).

Inaccurate Reporting of Aluminum Content in Vaccines

Exley and his team used “microwave-assisted acid and peroxide digestion followed by transversely heated graphite furnace atomic absorption spectrometry” to accurately measure the true levels of aluminum in 13 infant vaccines, then compared their findings to the numbers reported by the manufacturers, using “full statistical analyses including Bayesian methods.” Even allowing for a 10 percent manufacturing margin of error in either direction and a statistical significance level of P = 0.05, only three of the studied vaccines (Boostrix, Engerix Bin and Infanrix Hexa) actually contained the same amount of aluminum claimed by the manufacturers.

Six vaccines (Pentacel, Havrix, Adacel, Pedvax, Prevnar 13 and Vaqta) contained significantly more aluminum than was cited by manufacturers. Four vaccines (Infanrix, Pediarix, Kinrix and Synflorix) contained significantly less aluminum than was cited.

The researchers noted that the precise amount of aluminum in any given vaccine is presumably important or specific measurements would not need to be given in the vaccine product information inserts accompanying vials of vaccine administered by doctors and other medical personnel. They pointed out that too much aluminum may increase risks, too little may impact efficacy of the vaccines. The report reads:

The data are not reassuring. They suggest that vaccine manufacturers have limited control over the aluminium content of their vaccines. The aluminium content of individual vaccines within vaccine lots vary appear, akin to a lottery.²⁰

While noting that exposure to aluminum in the environment is unavoidable, the authors urge acknowledgement of aluminum’s known toxicity and potential for neurotoxicity. They voice the need for vaccine manufacturers and regulators to address the lack of good information pertaining to the content, biological activity and safety of vaccines that contain aluminum adjuvants.

A petition here that was filed with and accepted by the FDA reads, in part:

The FDA must ensure that vaccines in current use and those that will be on the market in the future are accurately labeled. Vaccine recipients and their caregivers must be able to rely on the FDA-approved labeling for these products, especially considering that they are given to babies and children.

Given that aluminum is a recognized neurotoxin, the authors concluded that, “its content in vaccines should be accurate and independently monitored to ensure both efficacy and safety… We cannot afford to be complacent about its injection into infants.”

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