INDIVIDUALIZED APPROACH TO VACCINATION CAN PREVENT AUTOIMMUNE DISEASE ONSET IN SUBSET OF POPULATION WITH GENETIC TESTING TO RULE OUT RISK FACTORS
Written by Kaire Downin January 04, 2016
Abstract
It is increasingly clear
that scientific literature has been able to identify risk factors associated
with adverse events following the administration of vaccinations in individuals
who develop autoimmune disorders as a result of the vaccination. A comprehensive
analysis of available literature shows that genetic markers have been
identified for people who are susceptible for developing autoimmune diseases
and that this population of people require an individualized approach to
vaccinations to prevent serious adverse events and even death. Even though
vaccines have been shown to be safe for a broad population, when evidence is
found that would prevent the small subset that have predispositions to
autoimmune diseases from developing serious complications, it is the duty of
our medical community to become knowledgeable and take precautions as to not
cause harm to the patients they serve.
Autoimmune disease that is not present before vaccination, can be
realized after vaccination due to the combination of genes, adjuvants, and
molecular mimicry that creates the environmental conditions for autoimmune
disease to occur resulting in debilitating, life-long disease and sometimes
death.
Intro
Comprehensive
systematic review findings are being exposed at alarming rates in the previous
few years regarding the incidence of autoimmune diseases and the link they have
to vaccinations. Neither scientists nor doctors seem to have a clear
understanding of the risk factors included in administering vaccinations to
people who have a proven autoimmune disorder or if autoimmune disorders are
negatively affected by vaccines, or even in some cases, caused by them. This
paper will seek to identify vaccines that have a higher incidence of reports to
Vaccine Adverse Event Reporting System (VAERS) for autoimmune disease onset after
administration and to identify what groups of people may be at a higher risk of
these events. The results will show where the scientific studies need to be
directed to assure safety of our most vulnerable population, the children and
infants receiving these vaccinations and ways to prevent the sudden onset of
autoimmune diseases or the exasperation of preexisting autoimmune conditions.
The Food and Drug Administration (FDA) recommends routine
vaccinations starting at birth. At this time there is no clear way to identify
if a newborn infant is genetically predetermined to have any kinds of autoimmune
disease without doing genetic testing or waiting to see how the baby’s body
develops before administering vaccinations. The FDA and World Health
Organization (WHO) believe that vaccinations are the most effective way to
prevent infectious diseases and have determined that vaccination must be
started in early infancy to protect the population from any outbreaks. However,
the long term effects and nature of autoimmune disease can take days to years
to manifest in the body (Guimarães, Baker, Perricone, & Shoenfeld, 2015) , complicating the
identification of the possible cause being a result of the vaccination. At this
time, the fact that autoimmune disorders can be caused by or exasperated by the
routine use of certain vaccines is considered rare, but possible (Geier & Geier, 2004; Girard, 2005; Schattner,
2005; Waisbren, 2008; Israeli, Agmon-Levine, Blank, & Shoenfeld, 2011; Israeli,
Agmon-Levin, Blank, Chapman, & Shoenfeld, 2012; Gatto, et al., 2013; Guimarães,
Baker, Perricone, & Shoenfeld, 2015) and is called Autoimmune
Syndrome Induced by Adjuvants (ASIA) (Agmon-Levin, Paz, Israeli, & Shoenfeld., 2009) .
Autoimmune conditions come in many forms. The American
Autoimmune Related Disease Association estimates over 50 million Americans
suffer from autoimmune diseases, however, the National Institute of Health
(NIH) only reports numbers associated with 24 diseases that have enough
epidemiological studies. Autoimmune diseases are listed in the top 10 causes of
death among female children and adults up to 64 years old. Research has shown autoimmune diseases to
have a genetic component (Niewold, Goulielmos, Tikly, &
Assassi, 2012)
and to have the ability to interact with environmental influences (Oksenberg & Brassat, 2006) . The most frequently
used and available immune-suppressant treatments can cause debilitating side
effects, including higher rates of infections for influenza and pneumonia (Gluck &
Muller - Ladner, 2008) . The initial signs and symptoms are
often unspecific and often don’t occur until the disease has affected the body
systems enough to become acute. The United States has the least amount of
research on the mechanisms, causes, and treatments of autoimmune disorders. To
compare the severity of this problem, the NIH recognizes 23.5 million Americans
living with autoimmune disease; as opposed to 9 million living with cancer, and
22 million living with heart disease. Despite these numbers, cancer funding is
at $6.1 billion compared to $591 million for Autoimmune diseases in 2003 (AARDA, 2004-2015) . To add one more comparison, the vaccine
industry funds $1.4 billion for US vaccine research and development annually,
46% comes directly from vaccine sales (pharmaceutical companies), 36% from
taxpayers (government agencies), and 18% from risk capital (private donors) (National
Vaccine Advisory Committee*, 1997) . Figure one has a list of the most relevant
associations between Vaccines and Autoimmune Diseases (Guimarães, Baker, Perricone, & Shoenfeld, 2015) .
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Methods
Research
databases were used to find full text articles about the risks involved of
autoimmune diseases being caused by vaccinations.
Using the JSTOR database and searching for (vaccinations
cause autoimmune) pulls up 234 search results. Some of these are about vaccine
research regarding trying to immunize against autoimmune diseases. The ones
chosen for this paper were (Seppa, 1997;T. Gluck, 2008; Lankes, 2009).
Another
search term in the same database (vaccinations autoimmune side effects) yields
4,204 results with no studies that were attempting to find links between
autoimmune disease and vaccination.
The
ACHS database returned 637,000 results with the terms “autoimmune diseases and
vaccinations.” Pubmed retrieves 3128 results.
(Shoenfeld, 2000)
Pubmed retrieves 26 responses to “autoimmune disease side
effect of vaccination,” however, not all of them fit the criteria for this
meta-analysis. The ones that did were (Bedard, 2010; Guimarães LE, 2015).
Using
the Oregon State University library database online search resulted in 285
results directly related to the search terms “Vaccines and Autoimmunity.” (Israeli, Agmon-Levin, Blank, Chapman, &
Shoenfeld, 2012) ,
(Agmon-Levin, et al., 2014) , (Gatto, et al., 2013) .
After
evaluating research, some citations were pulled from the original articles and further
expanded on including information about autoimmune statistics, adjuvants, and
previous research available about connects between autoimmunity and
vaccinations.
Results of findings
Positive
correlational findings
The most recent comprehensive literature reviews and
systematic analysis studies have identified Autoimmune (auto-inflammatory)
Syndrome Induced by Adjuvants (ASIA) to include fibromyalgia (FM) and chronic
fatigue syndrome (CFS) that occurs after the administration of vaccines. These
conditions are part of a spectrum that includes irritable bowel syndrome (IBS)
and temporomandibular joint disorders (TMJ).
All of these conditions are difficult to diagnose as they effect many
systems in the body, have common symptoms, and can have a major impact on the
quality of life for the patient (Agmon-Levin, Paz,
Israeli, & Shoenfeld., 2009; Agmon-Levin, et al., 2014; Guimarães, Baker,
Perricone, & Shoenfeld, 2015).
The Hepatitis B vaccine is mentioned
in several studies where adverse reactions that were reported included
autoimmune diseases, such as Multiple Sclerosis (Oliveira, Mota, Santos-Neto, & et al., 2014) , Macrophagic
myofaciitis (Israeli, Agmon-Levine, Blank, & Shoenfeld, 2011) , Guillain-Barre´
syndrome (Geier & Geier, 2004; Agmon-Levin, Paz,
Israeli, & Shoenfeld., 2009), multiple antigenic mediated
autoimmunity (MAMA) syndrome, rheumatoid arthritis (RA) and many more (Waisbren, 2008; Agmon-Levin, et al., 2014). It
is shown that the combination of molecular mimicry of the antigens, the adjuvant(s)
and genetic predispositions are the perfect storm for a result of autoimmune
disease acquired by vaccinations (Geier &
Geier, 2004; Waisbren, 2008; Israeli, Agmon-Levin, Blank, Chapman, &
Shoenfeld, 2012; Agmon-Levin, et al., 2014; Shaw, 2014; Guimarães, Baker,
Perricone, & Shoenfeld, 2015) The Hep B vaccine is commonly given
within the first few days of birth, before any kind of genetic testing is
performed to determine safety of administration of the vaccine. The majority of
adverse events reported to VAERS for the Hep B vaccine were experienced by
adult male and female patients within a few weeks of receiving the vaccine. The
most common reported problem being a positive re-challenge of RA or arthritis
in women in their 30’s, the most disabling event is neuropathy (Waisbren, 2008) .
The Human Papilloma Virus (HPV)
vaccines, Gardasil and Cervarix, have been associated with the onset of
debilitating autoimmune conditions such as systemic lupus erythematosus (SLE) and death (Guimarães, Baker, Perricone, & Shoenfeld, 2015) in otherwise healthy
individuals. The studies conducted for safety, paid
for by the pharmaceutical company GlaxoSmithKline, included control groups that
were given the adjuvant aluminum. These studies show no significant difference
and allowed the vaccine Cervarix to hit the market. In the studies for
Gardasil, reports were made about the serious adverse effects, including venous
thrombosis (which was occurring at higher rates than expected),
hypersensitivity reactions, anaphylaxis, motor neuron disease, and even deaths.
Autoimmunity was found to occur post-vaccination (Gatto, et al., 2013) . Furthermore, the incidence of autoimmune
disease in adolescent girls is 53 in 100,000 and 389 per 100,000 in women aged
19-30, the target for these vaccines (Verstraetena, et al., 2008) .
Negative
correlational findings
The WHO reports,
“In a third study, a pooled analysis of data
from 11 clinical trials involving nearly 30 000 participants aged >10 years,
of which 16 142 received at least 1 dose of Cervarix and 13 811 received either
a placebo containing aluminium hydroxide or 1 of 2 different hepatitis A
vaccines. No increased risk for the onset of autoimmune diseases after
administration of Cervarix was observed in comparison to the control group,” (The Global Advisory Committee on Vaccine Safety,
2014) .
This excerpt from the report, “Global Advisory Committee on Vaccine Safety, report of meeting held on 11-12 December 2013,” shares that the studies they are citing used placebos containing Aluminum Hydroxide which have been proven to cause Macrophagic myofasciitis, an autoimmune disease, that is triggered in genetically susceptible populations (Agmon-Levin, Paz, Israeli, & Shoenfeld., 2009; Israeli, Agmon-Levine, Blank, & Shoenfeld, 2011). This is one of the conditions that has specific genetic markers that can be identified and used as evidence of contraindications for the use of vaccines containing Aluminum Hydroxide. This is also evidence of the blatant disregard the WHO has for science that explicitly contradicts the universal safety the WHO is trying to claim about administering vaccinations to entire populations of people without consideration for genetic testing. When the control group is receiving one of the possible causes of the autoimmune disorders, there is no doubt that the experimental group and the control group would have similar finding (Verstraetena, et al., 2008; Guimarães, Baker, Perricone, & Shoenfeld, 2015).
People with existing Autoimmune conditions have been given many
vaccines due to the high risk of infections among this population. Small pox
vaccines have been studied among recipients with rheumatoid arthritis, systemic
lupus erythematosus, systemic sclerosis, and spondyloarthritis, with no cases
presenting with symptom flare up or adverse reactions (Oliveira,
Mota, Santos-Neto, & et al., 2014) . Influenza and pneumococcal vaccines have been recommended for
people with autoimmune diseases on (Schattner,
2005) . immunosuppressant therapies with results that show no adverse
reactions among this population. Among investigation, the average
antibody titers measured at one month and one year after vaccination show equal
or marginally less in the group of patients receiving immunosuppressant or
corticosteroid treatments when compared to the control group. Another
study showed that the levels were low enough not to provide protective
responses to the viruses that are being vaccinated against in 33% of patients
with RA and 21% of patients with systemic
lupus erythematosus (SLE) (Gluck
& Muller - Ladner, 2008) .
Discussion and Recommendation
Georgetown
University along with the Center for Biologics
Evaluation and Research (CBER) of the Food and Drug Administration (FDA),
is working on a project to identify the mechanisms of how autoimmunity is
related to vaccinations using the reports through VAERS database. A problem with
this kind of study is that because it is being overseen by the FDA, it holds a
conflict of interest due to the way that pharmaceutical companies contribute to
funding towards the FDA.
All
of the research found for this study claiming a lack of evidence that
autoimmune disorders can be caused or exasperated by vaccines has been funded
or performed by entities with a direct interest in the successful campaign of
vaccinations, including vaccine manufacturing companies. The British Medical
Journal reported that, “published influenza
vaccine studies sponsored by industry are treated more favorably by medical
journals even when the studies are of poor quality,” (Jefferson, Pietrantonj, Debalini, Rivetti, & Demicheli, 2009) .
Research
is available that shows successful trials with plant based vaccines that do not
use the same adjuvants that are associated with these adverse reactions and
long term injuries acquired through the administration of vaccines (Rybicki, 2014) .
There
are several states in the US that are now mandating vaccines along the FDA
schedule with no mandatory testing to determine if the children being given the
vaccines are at risk from receiving them. New protocols must be put into place
to assure the safety of the routine schedule with the current vaccine products
before blindly injecting children who may have genetic predispositions to
autoimmune diseases. The study of Vaccinomics is identifying the “one size fits
all” approach as dangerous to the populations at risk and calling for a more
individualized approach that includes ruling out the risk factors mentioned in
this paper (Goriely & Goldman, 2007;
Verstraetena, et al., 2008; (Poland & Kennedy, 2013). Any parent who
has a personal or familiar history of autoimmune disorders in their family
should be delaying all vaccines until genetic testing can be completed to
verify safety.
At
this time, in the state of OR and many others, there are ways to get personal
exemptions. However, even if the Physician attending to the patient knows of a
documentable contraindication to vaccines, they are not allowed to write
medical exemptions as per policy of health care provider teams and corporations.
If a parent were to no longer be able to care for their child with documented
contraindications, and that child was put in the care of another adult or
agency that was not aware of or privy to the medical history or research the
parent has completed, and there is nothing on that child’s medical file,
another attending physician or pharmacist (who are allowed to administer
vaccinations without looking at the patients’ medical history) could administer
vaccines and injure the child. This is a very dangerous practice for the
percentage of individuals with the genetic markers that could be affected due
to the administration of vaccines containing adjuvants like aluminum hydroxide.
The
medical community holds that if there is evidence of wide spread success in a
drug, it is worth the risk of the smaller incidence of adverse reactions.
However, there is more than enough literature to show that there are specific
risk factors that should surpass the bias of selective assessment, especially
when the diseases most aim to prevent are now so rare and treatment for those
diseases is more available (Girard, 2005) . Routinely immunizing infants against
sexually transmitted diseases and diseases of the blood in a low risk
population is counterproductive when the risks of long term debilitating
diseases can be ruled out with a simple blood test.
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